Application of Sigma Metrics Analysis for the Assessment and Modification of Quality Control Program in the Clinical Chemistry Laboratory of a Tertiary Care Hospital.

PubMed

Iqbal, Sahar; Mustansar, Tazeen

2017-03-01

Sigma is a metric that quantifies the performance of a process as a rate of Defects-Per-Million opportunities. In clinical laboratories, sigma metric analysis is used to assess the performance of laboratory process system. Sigma metric is also used as a quality management strategy for a laboratory process to improve the quality by addressing the errors after identification. The aim of this study is to evaluate the errors in quality control of analytical phase of laboratory system by sigma metric. For this purpose sigma metric analysis was done for analytes using the internal and external quality control as quality indicators. Results of sigma metric analysis were used to identify the gaps and need for modification in the strategy of laboratory quality control procedure. Sigma metric was calculated for quality control program of ten clinical chemistry analytes including glucose, chloride, cholesterol, triglyceride, HDL, albumin, direct bilirubin, total bilirubin, protein and creatinine, at two control levels. To calculate the sigma metric imprecision and bias was calculated with internal and external quality control data, respectively. The minimum acceptable performance was considered as 3 sigma. Westgard sigma rules were applied to customize the quality control procedure. Sigma level was found acceptable (≥3) for glucose (L2), cholesterol, triglyceride, HDL, direct bilirubin and creatinine at both levels of control. For rest of the analytes sigma metric was found <3. The lowest value for sigma was found for chloride (1.1) at L2. The highest value of sigma was found for creatinine (10.1) at L3. HDL was found with the highest sigma values at both control levels (8.8 and 8.0 at L2 and L3, respectively). We conclude that analytes with the sigma value <3 are required strict monitoring and modification in quality control procedure. In this study application of sigma rules provided us the practical solution for improved and focused design of QC procedure.

Destructive analysis capabilities for plutonium and uranium characterization at Los Alamos National Laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tandon, Lav; Kuhn, Kevin J; Drake, Lawrence R

Los Alamos National Laboratory's (LANL) Actinide Analytical Chemistry (AAC) group has been in existence since the Manhattan Project. It maintains a complete set of analytical capabilities for performing complete characterization (elemental assay, isotopic, metallic and non metallic trace impurities) of uranium and plutonium samples in different forms. For a majority of the customers there are strong quality assurance (QA) and quality control (QC) objectives including highest accuracy and precision with well defined uncertainties associated with the analytical results. Los Alamos participates in various international and national programs such as the Plutonium Metal Exchange Program, New Brunswick Laboratory's (NBL' s) Safeguardsmore » Measurement Evaluation Program (SME) and several other inter-laboratory round robin exercises to monitor and evaluate the data quality generated by AAC. These programs also provide independent verification of analytical measurement capabilities, and allow any technical problems with analytical measurements to be identified and corrected. This presentation will focus on key analytical capabilities for destructive analysis in AAC and also comparative data between LANL and peer groups for Pu assay and isotopic analysis.« less

Sigma Metrics Across the Total Testing Process.

PubMed

Charuruks, Navapun

2017-03-01

Laboratory quality control has been developed for several decades to ensure patients' safety, from a statistical quality control focus on the analytical phase to total laboratory processes. The sigma concept provides a convenient way to quantify the number of errors in extra-analytical and analytical phases through the defect per million and sigma metric equation. Participation in a sigma verification program can be a convenient way to monitor analytical performance continuous quality improvement. Improvement of sigma-scale performance has been shown from our data. New tools and techniques for integration are needed. Copyright © 2016 Elsevier Inc. All rights reserved.

Updated operational protocols for the U.S. Geological Survey Precipitation Chemistry Quality Assurance Project in support of the National Atmospheric Deposition Program

USGS Publications Warehouse

Wetherbee, Gregory A.; Martin, RoseAnn

2017-02-06

The U.S. Geological Survey Branch of Quality Systems operates the Precipitation Chemistry Quality Assurance Project (PCQA) for the National Atmospheric Deposition Program/National Trends Network (NADP/NTN) and National Atmospheric Deposition Program/Mercury Deposition Network (NADP/MDN). Since 1978, various programs have been implemented by the PCQA to estimate data variability and bias contributed by changing protocols, equipment, and sample submission schemes within NADP networks. These programs independently measure the field and laboratory components which contribute to the overall variability of NADP wet-deposition chemistry and precipitation depth measurements. The PCQA evaluates the quality of analyte-specific chemical analyses from the two, currently (2016) contracted NADP laboratories, Central Analytical Laboratory and Mercury Analytical Laboratory, by comparing laboratory performance among participating national and international laboratories. Sample contamination and stability are evaluated for NTN and MDN by using externally field-processed blank samples provided by the Branch of Quality Systems. A colocated sampler program evaluates the overall variability of NTN measurements and bias between dissimilar precipitation gages and sample collectors.This report documents historical PCQA operations and general procedures for each of the external quality-assurance programs from 2007 to 2016.

[Analytical quality in biological monitoring of workers exposed to chemicals: experience of the Prevention and Safety at the Workplace Service in Modena].

PubMed

Alpaca, R I Paredes; Migliore, A; Di Rico, R; Canali, Claudia; Rota, Cristina; Trenti, T; Cariani, Elisabetta

2010-01-01

The quality of laboratory data is one of the main factors in guaranteeing efficacy of biological monitoring. To analyze the quality of laboratory data used for biological monitoring of exposed workers. A survey involving 18 companies employing 945 workers in the area of Modena, Italy, was carried out in 2008. Most of the 9 private laboratories receiving biological samples did not perform directly part or all of the laboratory assessments requested, but this was not indicated in the final report. Major problems were observed in the application of internal quality control, and only one laboratory participated in external quality assessment for blood lead measurements. Our results raise major concerns on the traceability and reliability of laboratory assessments performed for biomonitoring of exposed workers. Systematic evaluation of the quality of analytical data would be highly recommendable.

42 CFR 493.1445 - Standard; Laboratory director responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic... result is found to be unacceptable or unsatisfactory; (5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and...

Recommendations for accreditation of laboratories in molecular biology of hematologic malignancies.

PubMed

Flandrin-Gresta, Pascale; Cornillet, Pascale; Hayette, Sandrine; Gachard, Nathalie; Tondeur, Sylvie; Mauté, Carole; Cayuela, Jean-Michel

2015-01-01

Over recent years, the development of molecular biology techniques has improved the hematological diseases diagnostic and follow-up. Consequently, these techniques are largely used in the biological screening of these diseases; therefore the Hemato-oncology molecular diagnostics laboratories must be actively involved in the accreditation process according the ISO 15189 standard. The French group of molecular biologists (GBMHM) provides requirements for the implementation of quality assurance for the medical molecular laboratories. This guideline states the recommendations for the pre-analytical, analytical (methods validation procedures, quality controls, reagents), and post-analytical conditions. In addition, herein we state a strategy for the internal quality control management. These recommendations will be regularly updated.

Environmental Response Laboratory Network (ERLN) Data Submission Requirements

EPA Pesticide Factsheets

These Environmental Response Laboratory Network specifications are essential to the mission of providing consistent analytical data of know and documented quality for each Analytical Service Request (ASR).

Quality assurance for health and environmental chemistry: 1990

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gautier, M.A.; Gladney, E.S.; Koski, N.L.

1991-10-01

This report documents the continuing quality assurance efforts of the Health and Environmental Chemistry Group (HSE-9) at the Los Alamos National Laboratory. The philosophy, methodology, computing resources, and laboratory information management system used by the quality assurance program to encompass the diversity of analytical chemistry practiced in the group are described. Included in the report are all quality assurance reference materials used, along with their certified or consensus concentrations, and all analytical chemistry quality assurance measurements made by HSE-9 during 1990.

Environmental Response Laboratory Network (ERLN) Laboratory Requirements

EPA Pesticide Factsheets

The Environmental Response Laboratory Network requires its member labs follow specified quality systems, sample management, data reporting, and general, in order to ensure consistent analytical data of known and documented quality.

Interlaboratory comparability, bias, and precision for four laboratories measuring analytes in wet deposition, October 1983-December 1984

USGS Publications Warehouse

Brooks, Myron H.; Schroder, LeRoy J.; Willoughby, Timothy C.

1987-01-01

Four laboratories involved in the routine analysis of wet-deposition samples participated in an interlaboratory comparison program managed by the U.S. Geological Survey. The four participants were: Illinois State Water Survey central analytical laboratory in Champaign, Illinois; U.S. Geological Survey national water-quality laboratories in Atlanta, Georgia, and Denver, Colorado; and Inland Waters Directorate national water-quality laboratory in Burlington, Ontario, Canada. Analyses of interlaboratory samples performed by the four laboratories from October 1983 through December 1984 were compared.Participating laboratories analyzed three types of interlaboratory samples--natural wet deposition, simulated wet deposition, and deionized water--for pH and specific conductance, and for dissolved calcium, magnesium, sodium, sodium, potassium, chloride, sulfate, nitrate, ammonium, and orthophosphate. Natural wet-deposition samples were aliquots of actual wet-deposition samples. Analyses of these samples by the four laboratories were compared using analysis of variance. Test results indicated that pH, calcium, nitrate, and ammonium results were not directly comparable among the four laboratories. Statistically significant differences between laboratory results probably only were meaningful for analyses of dissolved calcium. Simulated wet-deposition samples with known analyte concentrations were used to test each laboratory for analyte bias. Laboratory analyses of calcium, magnesium, sodium, potassium, chloride, sulfate, and nitrate were not significantly different from the known concentrations of these analytes when tested using analysis of variance. Deionized-water samples were used to test each laboratory for reporting of false positive values. The Illinois State Water Survey Laboratory reported the smallest percentage of false positive values for most analytes. Analyte precision was estimated for each laboratory from results of replicate measurements. In general, the Illinois State Water Survey laboratory achieved the greatest precision, whereas the U.S. Geological Survey laboratories achieved the least precision.

Quality and safety aspects in histopathology laboratory

PubMed Central

Adyanthaya, Soniya; Jose, Maji

2013-01-01

Histopathology is an art of analyzing and interpreting the shapes, sizes and architectural patterns of cells and tissues within a given specific clinical background and a science by which the image is placed in the context of knowledge of pathobiology, to arrive at an accurate diagnosis. To function effectively and safely, all the procedures and activities of histopathology laboratory should be evaluated and monitored accurately. In histopathology laboratory, the concept of quality control is applicable to pre-analytical, analytical and post-analytical activities. Ensuring safety of working personnel as well as environment is also highly important. Safety issues that may come up in a histopathology lab are primarily those related to potentially hazardous chemicals, biohazardous materials, accidents linked to the equipment and instrumentation employed and general risks from electrical and fire hazards. This article discusses quality management system which can ensure quality performance in histopathology laboratory. The hazards in pathology laboratories and practical safety measures aimed at controlling the dangers are also discussed with the objective of promoting safety consciousness and the practice of laboratory safety. PMID:24574660

Missed detection of significant positive and negative shifts in gentamicin assay: implications for routine laboratory quality practices.

PubMed

Koerbin, Gus; Liu, Jiakai; Eigenstetter, Alex; Tan, Chin Hon; Badrick, Tony; Loh, Tze Ping

2018-02-15

A product recall was issued for the Roche/Hitachi Cobas Gentamicin II assays on 25 th May 2016 in Australia, after a 15 - 20% positive analytical shift was discovered. Laboratories were advised to employ the Thermo Fisher Gentamicin assay as an alternative. Following the reintroduction of the revised assay on 12 th September 2016, a second reagent recall was made on 20 th March 2017 after the discovery of a 20% negative analytical shift due to erroneous instrument adjustment factor. The practices of an index laboratory were examined to determine how the analytical shifts evaded detection by routine internal quality control (IQC) and external quality assurance (EQA) systems. The ability of the patient result-based approaches, including moving average (MovAvg) and moving sum of outliers (MovSO) approaches in detecting these shifts were examined. Internal quality control data of the index laboratory were acceptable prior to the product recall. The practice of adjusting IQC target following a change in assay method resulted in the missed negative shift when the revised Roche assay was reintroduced. While the EQA data of the Roche subgroup showed clear negative bias relative to other laboratory methods, the results were considered as possible 'matrix effect'. The MovAvg method detected the positive shift before the product recall. The MovSO did not detect the negative shift in the index laboratory but did so in another laboratory 5 days before the second product recall. There are gaps in current laboratory quality practices that leave room for analytical errors to evade detection.

Managing the Pre- and Post-analytical Phases of the Total Testing Process

PubMed Central

2012-01-01

For many years, the clinical laboratory's focus on analytical quality has resulted in an error rate of 4-5 sigma, which surpasses most other areas in healthcare. However, greater appreciation of the prevalence of errors in the pre- and post-analytical phases and their potential for patient harm has led to increasing requirements for laboratories to take greater responsibility for activities outside their immediate control. Accreditation bodies such as the Joint Commission International (JCI) and the College of American Pathologists (CAP) now require clear and effective procedures for patient/sample identification and communication of critical results. There are a variety of free on-line resources available to aid in managing the extra-analytical phase and the recent publication of quality indicators and proposed performance levels by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) working group on laboratory errors and patient safety provides particularly useful benchmarking data. Managing the extra-laboratory phase of the total testing cycle is the next challenge for laboratory medicine. By building on its existing quality management expertise, quantitative scientific background and familiarity with information technology, the clinical laboratory is well suited to play a greater role in reducing errors and improving patient safety outside the confines of the laboratory. PMID:22259773

ASVCP quality assurance guidelines: control of preanalytical, analytical, and postanalytical factors for urinalysis, cytology, and clinical chemistry in veterinary laboratories.

PubMed

Gunn-Christie, Rebekah G; Flatland, Bente; Friedrichs, Kristen R; Szladovits, Balazs; Harr, Kendal E; Ruotsalo, Kristiina; Knoll, Joyce S; Wamsley, Heather L; Freeman, Kathy P

2012-03-01

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and documents recommendations for control of preanalytical, analytical, and postanalytical factors related to urinalysis, cytology, and clinical chemistry in veterinary laboratories and is adapted from sections 1.1 and 2.2 (clinical chemistry), 1.3 and 2.5 (urinalysis), 1.4 and 2.6 (cytology), and 3 (postanalytical factors important in veterinary clinical pathology) of these guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. © 2012 American Society for Veterinary Clinical Pathology.

Sigma metrics as a tool for evaluating the performance of internal quality control in a clinical chemistry laboratory.

PubMed

Kumar, B Vinodh; Mohan, Thuthi

2018-01-01

Six Sigma is one of the most popular quality management system tools employed for process improvement. The Six Sigma methods are usually applied when the outcome of the process can be measured. This study was done to assess the performance of individual biochemical parameters on a Sigma Scale by calculating the sigma metrics for individual parameters and to follow the Westgard guidelines for appropriate Westgard rules and levels of internal quality control (IQC) that needs to be processed to improve target analyte performance based on the sigma metrics. This is a retrospective study, and data required for the study were extracted between July 2015 and June 2016 from a Secondary Care Government Hospital, Chennai. The data obtained for the study are IQC - coefficient of variation percentage and External Quality Assurance Scheme (EQAS) - Bias% for 16 biochemical parameters. For the level 1 IQC, four analytes (alkaline phosphatase, magnesium, triglyceride, and high-density lipoprotein-cholesterol) showed an ideal performance of ≥6 sigma level, five analytes (urea, total bilirubin, albumin, cholesterol, and potassium) showed an average performance of <3 sigma level and for level 2 IQCs, same four analytes of level 1 showed a performance of ≥6 sigma level, and four analytes (urea, albumin, cholesterol, and potassium) showed an average performance of <3 sigma level. For all analytes <6 sigma level, the quality goal index (QGI) was <0.8 indicating the area requiring improvement to be imprecision except cholesterol whose QGI >1.2 indicated inaccuracy. This study shows that sigma metrics is a good quality tool to assess the analytical performance of a clinical chemistry laboratory. Thus, sigma metric analysis provides a benchmark for the laboratory to design a protocol for IQC, address poor assay performance, and assess the efficiency of existing laboratory processes.

The CCLM contribution to improvements in quality and patient safety.

PubMed

Plebani, Mario

2013-01-01

Clinical laboratories play an important role in improving patient care. The past decades have seen unbelievable, often unpredictable improvements in analytical performance. Although the seminal concept of the brain-to-brain laboratory loop has been described more than four decades ago, there is now a growing awareness about the importance of extra-analytical aspects in laboratory quality. According to this concept, all phases and activities of the testing cycle should be assessed, monitored and improved in order to decrease the total error rates thereby improving patients' safety. Clinical Chemistry and Laboratory Medicine (CCLM) not only has followed the shift in perception of quality in the discipline, but has been the catalyst for promoting a large debate on this topic, underlining the value of papers dealing with errors in clinical laboratories and possible remedies, as well as new approaches to the definition of quality in pre-, intra-, and post-analytical steps. The celebration of the 50th anniversary of the CCLM journal offers the opportunity to recall and mention some milestones in the approach to quality and patient safety and to inform our readers, as well as laboratory professionals, clinicians and all the stakeholders of the willingness of the journal to maintain quality issues as central to its interest even in the future.

National Water Quality Laboratory, 1995 services catalog

USGS Publications Warehouse

Timme, P.J.

1995-01-01

This Services Catalog contains information about field supplies and analytical services available from the National Water Quality Laboratory in Denver, Colo., and field supplies available from the Quality Water Service Unit in Ocala, Fla., to members of the U.S. Geological Survey. To assist personnel in the selection of analytical services, this catalog lists sample volume, required containers, applicable concentration range, detection level, precision of analysis, and preservation requirements for samples.

How to conduct External Quality Assessment Schemes for the pre-analytical phase?

PubMed

Kristensen, Gunn B B; Aakre, Kristin Moberg; Kristoffersen, Ann Helen; Sandberg, Sverre

2014-01-01

In laboratory medicine, several studies have described the most frequent errors in the different phases of the total testing process, and a large proportion of these errors occur in the pre-analytical phase. Schemes for registration of errors and subsequent feedback to the participants have been conducted for decades concerning the analytical phase by External Quality Assessment (EQA) organizations operating in most countries. The aim of the paper is to present an overview of different types of EQA schemes for the pre-analytical phase, and give examples of some existing schemes. So far, very few EQA organizations have focused on the pre-analytical phase, and most EQA organizations do not offer pre-analytical EQA schemes (EQAS). It is more difficult to perform and standardize pre-analytical EQAS and also, accreditation bodies do not ask the laboratories for results from such schemes. However, some ongoing EQA programs for the pre-analytical phase do exist, and some examples are given in this paper. The methods used can be divided into three different types; collecting information about pre-analytical laboratory procedures, circulating real samples to collect information about interferences that might affect the measurement procedure, or register actual laboratory errors and relate these to quality indicators. These three types have different focus and different challenges regarding implementation, and a combination of the three is probably necessary to be able to detect and monitor the wide range of errors occurring in the pre-analytical phase.

ASVCP quality assurance guidelines: control of preanalytical and analytical factors for hematology for mammalian and nonmammalian species, hemostasis, and crossmatching in veterinary laboratories.

PubMed

Vap, Linda M; Harr, Kendal E; Arnold, Jill E; Freeman, Kathleen P; Getzy, Karen; Lester, Sally; Friedrichs, Kristen R

2012-03-01

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and provides recommendations for control of preanalytical and analytical factors related to hematology for mammalian and nonmammalian species, hemostasis testing, and crossmatching and is adapted from sections 1.1 and 2.3 (mammalian hematology), 1.2 and 2.4 (nonmammalian hematology), 1.5 and 2.7 (hemostasis testing), and 1.6 and 2.8 (crossmatching) of the complete guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. © 2012 American Society for Veterinary Clinical Pathology.

Practical solution for control of the pre-analytical phase in decentralized clinical laboratories for meeting the requirements of the medical laboratory accreditation standard DIN EN ISO 15189.

PubMed

Vacata, Vladimir; Jahns-Streubel, Gerlinde; Baldus, Mirjana; Wood, William Graham

2007-01-01

This report was written in response to the article by Wood published recently in this journal. It describes a practical solution to the problems of controlling the pre-analytical phase in the clinical diagnostic laboratory. As an indicator of quality in the pre-analytical phase of sample processing, a target analyte was chosen which is sensitive to delay in centrifugation and/or analysis. The results of analyses of the samples sent by satellite medical practitioners were compared with those from an on-site hospital laboratory with a controllable optimized pre-analytical phase. The aim of the comparison was: (a) to identify those medical practices whose mean/median sample values significantly deviate from those of the control situation in the hospital laboratory due to the possible problems in the pre-analytical phase; (b) to aid these laboratories in the process of rectifying these problems. A Microsoft Excel-based Pre-Analytical Survey tool (PAS tool) has been developed which addresses the above mentioned problems. It has been tested on serum potassium which is known to be sensitive to delay and/or irregularities in sample treatment. The PAS tool has been shown to be one possibility for improving the quality of the analyses by identifying the sources of problems within the pre-analytical phase, thus allowing them to be rectified. Additionally, the PAS tool has an educational value and can also be adopted for use in other decentralized laboratories.

The Empower project - a new way of assessing and monitoring test comparability and stability.

PubMed

De Grande, Linde A C; Goossens, Kenneth; Van Uytfanghe, Katleen; Stöckl, Dietmar; Thienpont, Linda M

2015-07-01

Manufacturers and laboratories might benefit from using a modern integrated tool for quality management/assurance. The tool should not be confounded by commutability issues and focus on the intrinsic analytical quality and comparability of assays as performed in routine laboratories. In addition, it should enable monitoring of long-term stability of performance, with the possibility to quasi "real-time" remedial action. Therefore, we developed the "Empower" project. The project comprises four pillars: (i) master comparisons with panels of frozen single-donation samples, (ii) monitoring of patient percentiles and (iii) internal quality control data, and (iv) conceptual and statistical education about analytical quality. In the pillars described here (i and ii), state-of-the-art as well as biologically derived specifications are used. In the 2014 master comparisons survey, 125 laboratories forming 8 peer groups participated. It showed not only good intrinsic analytical quality of assays but also assay biases/non-comparability. Although laboratory performance was mostly satisfactory, sometimes huge between-laboratory differences were observed. In patient percentile monitoring, currently, 100 laboratories participate with 182 devices. Particularly, laboratories with a high daily throughput and low patient population variation show a stable moving median in time with good between-instrument concordance. Shifts/drifts due to lot changes are sometimes revealed. There is evidence that outpatient medians mirror the calibration set-points shown in the master comparisons. The Empower project gives manufacturers and laboratories a realistic view on assay quality/comparability as well as stability of performance and/or the reasons for increased variation. Therefore, it is a modern tool for quality management/assurance toward improved patient care.

42 CFR 493.643 - Fee for determination of program compliance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... laboratory's scope and volume of testing (excluding tests performed for quality control, quality assurance... procedure or examination for a single analyte. (Tests performed for quality control, quality assurance, and... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Administration...

Median of patient results as a tool for assessment of analytical stability.

PubMed

Jørgensen, Lars Mønster; Hansen, Steen Ingemann; Petersen, Per Hyltoft; Sölétormos, György

2015-06-15

In spite of the well-established external quality assessment and proficiency testing surveys of analytical quality performance in laboratory medicine, a simple tool to monitor the long-term analytical stability as a supplement to the internal control procedures is often needed. Patient data from daily internal control schemes was used for monthly appraisal of the analytical stability. This was accomplished by using the monthly medians of patient results to disclose deviations from analytical stability, and by comparing divergences with the quality specifications for allowable analytical bias based on biological variation. Seventy five percent of the twenty analytes achieved on two COBASs INTEGRA 800 instruments performed in accordance with the optimum and with the desirable specifications for bias. Patient results applied in analytical quality performance control procedures are the most reliable sources of material as they represent the genuine substance of the measurements and therefore circumvent the problems associated with non-commutable materials in external assessment. Patient medians in the monthly monitoring of analytical stability in laboratory medicine are an inexpensive, simple and reliable tool to monitor the steadiness of the analytical practice. Copyright © 2015 Elsevier B.V. All rights reserved.

Quality management and accreditation in a mixed research and clinical hair testing analytical laboratory setting-a review.

PubMed

Fulga, Netta

2013-06-01

Quality management and accreditation in the analytical laboratory setting are developing rapidly and becoming the standard worldwide. Quality management refers to all the activities used by organizations to ensure product or service consistency. Accreditation is a formal recognition by an authoritative regulatory body that a laboratory is competent to perform examinations and report results. The Motherisk Drug Testing Laboratory is licensed to operate at the Hospital for Sick Children in Toronto, Ontario. The laboratory performs toxicology tests of hair and meconium samples for research and clinical purposes. Most of the samples are involved in a chain of custody cases. Establishing a quality management system and achieving accreditation became mandatory by legislation for all Ontario clinical laboratories since 2003. The Ontario Laboratory Accreditation program is based on International Organization for Standardization 15189-Medical laboratories-Particular requirements for quality and competence, an international standard that has been adopted as a national standard in Canada. The implementation of a quality management system involves management commitment, planning and staff education, documentation of the system, validation of processes, and assessment against the requirements. The maintenance of a quality management system requires control and monitoring of the entire laboratory path of workflow. The process of transformation of a research/clinical laboratory into an accredited laboratory, and the benefits of maintaining an effective quality management system, are presented in this article.

DOE Office of Scientific and Technical Information (OSTI.GOV)

King, A.G.

The Pacific Northwest Laboratory (PNL)/Analytical Chemistry Laboratory (ACL) and the Westinghouse Hanford Company (WHC)/Process Analytical Laboratory (PAL) provide analytical support services to various environmental restoration and waste management projects/programs at Hanford. In response to a US Department of Energy -- Richland Field Office (DOE-RL) audit, which questioned the comparability of analytical methods employed at each laboratory, the Sample Exchange/Exchange (SEE) program was initiated. The SEE Program is a selfassessment program designed to compare analytical methods of the PAL and ACL laboratories using sitespecific waste material. The SEE program is managed by a collaborative, the Quality Assurance Triad (Triad). Triad membershipmore » is made up of representatives from the WHC/PAL, PNL/ACL, and WHC Hanford Analytical Services Management (HASM) organizations. The Triad works together to design/evaluate/implement each phase of the SEE Program.« less

Lack of grading agreement among international hemostasis external quality assessment programs

PubMed Central

Olson, John D.; Jennings, Ian; Meijer, Piet; Bon, Chantal; Bonar, Roslyn; Favaloro, Emmanuel J.; Higgins, Russell A.; Keeney, Michael; Mammen, Joy; Marlar, Richard A.; Meley, Roland; Nair, Sukesh C.; Nichols, William L.; Raby, Anne; Reverter, Joan C.; Srivastava, Alok; Walker, Isobel

2018-01-01

Laboratory quality programs rely on internal quality control and external quality assessment (EQA). EQA programs provide unknown specimens for the laboratory to test. The laboratory's result is compared with other (peer) laboratories performing the same test. EQA programs assign target values using a variety of methods statistical tools and performance assessment of ‘pass’ or ‘fail’ is made. EQA provider members of the international organization, external quality assurance in thrombosis and hemostasis, took part in a study to compare outcome of performance analysis using the same data set of laboratory results. Eleven EQA organizations using eight different analytical approaches participated. Data for a normal and prolonged activated partial thromboplastin time (aPTT) and a normal and reduced factor VIII (FVIII) from 218 laboratories were sent to the EQA providers who analyzed the data set using their method of evaluation for aPTT and FVIII, determining the performance for each laboratory record in the data set. Providers also summarized their statistical approach to assignment of target values and laboratory performance. Each laboratory record in the data set was graded pass/fail by all EQA providers for each of the four analytes. There was a lack of agreement of pass/fail grading among EQA programs. Discordance in the grading was 17.9 and 11% of normal and prolonged aPTT results, respectively, and 20.2 and 17.4% of normal and reduced FVIII results, respectively. All EQA programs in this study employed statistical methods compliant with the International Standardization Organization (ISO), ISO 13528, yet the evaluation of laboratory results for all four analytes showed remarkable grading discordance. PMID:29232255

Developing and Implementing Inquiry-Based, Water Quality Laboratory Experiments for High School Students to Explore Real Environmental Issues Using Analytical Chemistry

ERIC Educational Resources Information Center

Mandler, Daphna; Blonder, Ron; Yayon, Malka; Mamlok-Naaman, Rachel; Hofstein, Avi

2014-01-01

This paper describes the rationale and the implementation of five laboratory experiments; four of them, intended for high-school students, are inquiry-based activities that explore the quality of water. The context of water provides students with an opportunity to study the importance of analytical methods and how they influence our everyday…

Sigma metrics as a tool for evaluating the performance of internal quality control in a clinical chemistry laboratory

PubMed Central

Kumar, B. Vinodh; Mohan, Thuthi

2018-01-01

OBJECTIVE: Six Sigma is one of the most popular quality management system tools employed for process improvement. The Six Sigma methods are usually applied when the outcome of the process can be measured. This study was done to assess the performance of individual biochemical parameters on a Sigma Scale by calculating the sigma metrics for individual parameters and to follow the Westgard guidelines for appropriate Westgard rules and levels of internal quality control (IQC) that needs to be processed to improve target analyte performance based on the sigma metrics. MATERIALS AND METHODS: This is a retrospective study, and data required for the study were extracted between July 2015 and June 2016 from a Secondary Care Government Hospital, Chennai. The data obtained for the study are IQC - coefficient of variation percentage and External Quality Assurance Scheme (EQAS) - Bias% for 16 biochemical parameters. RESULTS: For the level 1 IQC, four analytes (alkaline phosphatase, magnesium, triglyceride, and high-density lipoprotein-cholesterol) showed an ideal performance of ≥6 sigma level, five analytes (urea, total bilirubin, albumin, cholesterol, and potassium) showed an average performance of <3 sigma level and for level 2 IQCs, same four analytes of level 1 showed a performance of ≥6 sigma level, and four analytes (urea, albumin, cholesterol, and potassium) showed an average performance of <3 sigma level. For all analytes <6 sigma level, the quality goal index (QGI) was <0.8 indicating the area requiring improvement to be imprecision except cholesterol whose QGI >1.2 indicated inaccuracy. CONCLUSION: This study shows that sigma metrics is a good quality tool to assess the analytical performance of a clinical chemistry laboratory. Thus, sigma metric analysis provides a benchmark for the laboratory to design a protocol for IQC, address poor assay performance, and assess the efficiency of existing laboratory processes. PMID:29692587

Evaluation of nutrient quality-assurance data for Alexanders and Mount Rock Spring basins, Cumberland County, Pennsylvania

USGS Publications Warehouse

Witt, E. C.; Hippe, D.J.; Giovannitti, R.M.

1992-01-01

A total of 304 nutrient samples were collected from May 1990 through September 1991 to determine concentrations and loads of nutrients in water discharged from two spring basins in Cumberland County, Pa. Fifty-four percent of these nutrient samples were for the evaluation of (1) laboratory consistency, (2) container and preservative cleanliness, (3) maintenance of analyte representativeness as affected by three different preservation methods, and (4) comparison of analyte results with the "Most Probable Value" for Standard Reference Water Samples. Results of 37 duplicate analyses indicate that the Pennsylvania Department of Environmental Resources, Bureau of Laboratories (principal laboratory) remained within its ±10 percent goal for all but one analyte. Results of the blank analysis show that the sampling containers did not compromise the water quality. However, mercuric-chloride-preservation blanks apparently contained measurable ammonium in four of five samples and ammonium plus organic nitrogen in two of five samples. Interlaboratory results indicate substantial differences in the determination of nitrate and ammonium plus organic nitrogen between the principal laboratory and the U.S. Geological Survey National Water-Quality Laboratory. In comparison with the U.S. Environmental Protection Agency Quality-Control Samples, the principal laboratory was sufficiently accurate in its determination of nutrient anafytes. Analysis of replicate samples indicated that sulfuric-acid preservative best maintained the representativeness of the anafytes nitrate and ammonium plus organic nitrogen, whereas, mercuric chloride best maintained the representativeness of orthophosphate. Comparison of nutrient analyte determinations with the Most Probable Value for each preservation method shows that two of five analytes with no chemical preservative compare well, three of five with mercuric-chloride preservative compare well, and three of five with sulfuricacid preservative compare well.

222-S Laboratory Quality Assurance Plan. Revision 1

DOE Office of Scientific and Technical Information (OSTI.GOV)

Meznarich, H.K.

1995-07-31

This Quality Assurance Plan provides,quality assurance (QA) guidance, regulatory QA requirements (e.g., 10 CFR 830.120), and quality control (QC) specifications for analytical service. This document follows the U.S Department of Energy (DOE) issued Hanford Analytical Services Quality Assurance Plan (HASQAP). In addition, this document meets the objectives of the Quality Assurance Program provided in the WHC-CM-4-2, Section 2.1. Quality assurance elements required in the Guidelines and Specifications for Preparing Quality Assurance Program Plans (QAMS-004) and Interim Guidelines and Specifications for Preparing Quality Assurance Project Plans (QAMS-005) from the US Environmental Protection Agency (EPA) are covered throughout this document. A qualitymore » assurance index is provided in the Appendix A. This document also provides and/or identifies the procedural information that governs laboratory operations. The personnel of the 222-S Laboratory and the Standards Laboratory including managers, analysts, QA/QC staff, auditors, and support staff shall use this document as guidance and instructions for their operational and quality assurance activities. Other organizations that conduct activities described in this document for the 222-S Laboratory shall follow this QA/QC document.« less

Review of Pre-Analytical Errors in Oral Glucose Tolerance Testing in a Tertiary Care Hospital.

PubMed

Nanda, Rachita; Patel, Suprava; Sahoo, Sibashish; Mohapatra, Eli

2018-03-13

The pre-pre-analytical and pre-analytical phases form a major chunk of the errors in a laboratory. The process has taken into consideration a very common procedure which is the oral glucose tolerance test to identify the pre-pre-analytical errors. Quality indicators provide evidence of quality, support accountability and help in the decision making of laboratory personnel. The aim of this research is to evaluate pre-analytical performance of the oral glucose tolerance test procedure. An observational study that was conducted overa period of three months, in the phlebotomy and accessioning unit of our laboratory using questionnaire that examined the pre-pre-analytical errors through a scoring system. The pre-analytical phase was analyzed for each sample collected as per seven quality indicators. About 25% of the population gave wrong answer with regard to the question that tested the knowledge of patient preparation. The appropriateness of test result QI-1 had the most error. Although QI-5 for sample collection had a low error rate, it is a very important indicator as any wrongly collected sample can alter the test result. Evaluating the pre-analytical and pre-pre-analytical phase is essential and must be conducted routinely on a yearly basis to identify errors and take corrective action and to facilitate their gradual introduction into routine practice.

Quality-assurance plan for the analysis of suspended sediment by the U.S. Geological Survey in Montana

USGS Publications Warehouse

Dodge, Kent A.; Lambing, John H.

2006-01-01

A quality-assurance plan has been developed for use by the sediment laboratory of the U.S. Geological Survey Montana Water Science Center in conducting activities related to the analysis of suspended sediment. The plan documents quality-assurance policies for sediment-laboratory certification, personnel responsibilities and training, documentation requirements, and laboratory safety. The plan also documents quality-assurance procedures related to laboratory equipment and supplies, sample management, sample analysis, analytical quality control, and data management.

Long story short: an introduction to the short-term and long-term Six Sigma quality and its importance in the laboratory medicine for the management of extra-analytical processes.

PubMed

Ialongo, Cristiano; Bernardini, Sergio

2018-06-18

There is a compelling need for quality tools that enable effective control of the extra-analytical phase. In this regard, Six Sigma seems to offer a valid methodological and conceptual opportunity, and in recent times, the International Federation of Clinical Chemistry and Laboratory Medicine has adopted it for indicating the performance requirements for non-analytical laboratory processes. However, the Six Sigma implies a distinction between short-term and long-term quality that is based on the dynamics of the processes. These concepts are still not widespread and applied in the field of laboratory medicine although they are of fundamental importance to exploit the full potential of this methodology. This paper reviews the Six Sigma quality concepts and shows how they originated from Shewhart's control charts, in respect of which they are not an alternative but a completion. It also discusses the dynamic nature of process and how it arises, concerning particularly the long-term dynamic mean variation, and explains why this leads to the fundamental distinction of quality we previously mentioned.

[Automation and organization of technological process of urinalysis].

PubMed

Kolenkin, S M; Kishkun, A A; Kol'chenko, O L

2000-12-01

Results of introduction into practice of a working model of industrial technology of laboratory studies and KONE Specific Supra and Miditron M devices are shown as exemplified by clinical analysis of the urine. This technology helps standardize all stages and operations, improves the efficiency of quality control of laboratory studies, rationally organizes the work at all stages of the process, creates a system for permanent improvement of the efficiency of investigations at the preanalytical, analytical, and postanalytical stages of technological process of laboratory studies. As a result of introduction of this technology into laboratory practice, violations of quality criteria of clinical urinalysis decreased from 15 to 8% at the preanalytical stage and from 6 to 3% at the analytical stage. Automation of the analysis decreased the need in reagents 3-fold and improved the productivity at the analytical stage 4-fold.

[The subject matters concerned with use of simplified analytical systems from the perspective of the Japanese Association of Medical Technologists].

PubMed

Morishita, Y

2001-05-01

The subject matters concerned with use of so-called simplified analytical systems for the purpose of useful utilizing are mentioned from the perspective of a laboratory technician. 1. The data from simplified analytical systems should to be agreed with those of particular reference methods not to occur the discrepancy of the data from different laboratories. 2. Accuracy of the measured results using simplified analytical systems is hard to be scrutinized thoroughly and correctly with the quality control surveillance procedure on the stored pooled serum or partly-processed blood. 3. It is necessary to present the guide line to follow about the contents of evaluation to guarantee on quality of simplified analytical systems. 4. Maintenance and manual performance of simplified analytical systems have to be standardized by a laboratory technician and a selling agent technician. 5. It calls attention, further that the cost of simplified analytical systems is much expensive compared to that of routine method with liquid reagents. 6. Various substances in human serum, like cytokine, hormone, tumor marker, and vitamin, etc. are also hoped to be measured by simplified analytical systems.

Performance specifications for the extra-analytical phases of laboratory testing: Why and how.

PubMed

Plebani, Mario

2017-07-01

An important priority in the current healthcare scenario should be to address errors in laboratory testing, which account for a significant proportion of diagnostic errors. Efforts made in laboratory medicine to enhance the diagnostic process have been directed toward improving technology, greater volumes and more accurate laboratory tests being achieved, but data collected in the last few years highlight the need to re-evaluate the total testing process (TTP) as the unique framework for improving quality and patient safety. Valuable quality indicators (QIs) and extra-analytical performance specifications are required for guidance in improving all TTP steps. Yet in literature no data are available on extra-analytical performance specifications based on outcomes, and nor is it possible to set any specification using calculations involving biological variability. The collection of data representing the state-of-the-art based on quality indicators is, therefore, underway. The adoption of a harmonized set of QIs, a common data collection and standardised reporting method is mandatory as it will not only allow the accreditation of clinical laboratories according to the International Standard, but also assure guidance for promoting improvement processes and guaranteeing quality care to patients. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Closing the brain-to-brain loop in laboratory testing.

PubMed

Plebani, Mario; Lippi, Giuseppe

2011-07-01

Abstract The delivery of laboratory services has been described 40 years ago and defined with the foremost concept of "brain-to-brain turnaround time loop". This concept consists of several processes, including the final step which is the action undertaken on the patient based on laboratory information. Unfortunately, the need for systematic feedback to improve the value of laboratory services has been poorly understood and, even more risky, poorly applied in daily laboratory practice. Currently, major problems arise from the unavailability of consensually accepted quality specifications for the extra-analytical phase of laboratory testing. This, in turn, does not allow clinical laboratories to calculate a budget for the "patient-related total error". The definition and use of the term "total error" refers only to the analytical phase, and should be better defined as "total analytical error" to avoid any confusion and misinterpretation. According to the hierarchical approach to classify strategies to set analytical quality specifications, the "assessment of the effect of analytical performance on specific clinical decision-making" is comprehensively at the top and therefore should be applied as much as possible to address analytical efforts towards effective goals. In addition, an increasing number of laboratories worldwide are adopting risk management strategies such as FMEA, FRACAS, LEAN and Six Sigma since these techniques allow the identification of the most critical steps in the total testing process, and to reduce the patient-related risk of error. As a matter of fact, an increasing number of laboratory professionals recognize the importance of understanding and monitoring any step in the total testing process, including the appropriateness of the test request as well as the appropriate interpretation and utilization of test results.

Category 1 external quality assessment program for serum creatinine.

PubMed

González-Lao, Elisabet; Díaz-Garzón, Jorge; Corte, Zoraida; Ricós, Carmen; Perich, Carmen; Álvarez, Virtudes; Simón, Margarita; Minchinela, Joana; García-Lario, José Vicente; Boned, Beatriz; Biosca, Carmen; Cava, Fernando; Fernández-Fernández, Pilar; Fernández-Calle, Pilar

2017-03-01

The Commission of Analytical Quality and the Committee of External Quality Programs of Spanish Society of Laboratory Medicine (SEQC) in collaboration with the Dutch Foundation for the Quality organized the first national category 1 External Quality Assessment Programs (EQAP) pilot study. The aim is to evaluate the standardization of serum creatinine measurements in the Spanish laboratories through a category 1 external quality assurance program with commutable material and reference method assigned values. A total of 87 Spanish laboratories were involved in this program in 2015. Each day a sample control was measured by duplicate during 6 consecutive days. Percentage deviations and coefficients of variation obtained were compared with quality specifications derived from biological variation. A total of 1044 creatinine results were obtained. Laboratories were coded in 11 different method-traceability combinations. Only enzymatic methods get all results within the acceptability limits. To participate in a category 1 EQAP is a valuable tool to assess the standardization degree in our country; a big effort should be made to promote laboratories to change their procedures and to use enzymatic creatinine methods, in order to achieve a satisfactory standardization degree for this important analyte.

International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants.

PubMed

Gosselin, Robert C; Adcock, Dorothy M; Bates, Shannon M; Douxfils, Jonathan; Favaloro, Emmanuel J; Gouin-Thibault, Isabelle; Guillermo, Cecilia; Kawai, Yohko; Lindhoff-Last, Edelgard; Kitchen, Steve

2018-03-01

This guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH) for providing haemostasis-related guidance documents for clinical laboratories. This inaugural coagulation ICSH document was developed by an ad hoc committee, comprised of international clinical and laboratory direct acting oral anticoagulant (DOAC) experts. The committee developed consensus recommendations for laboratory measurement of DOACs (dabigatran, rivaroxaban, apixaban and edoxaban), which would be germane for laboratories assessing DOAC anticoagulation. This guidance document addresses all phases of laboratory DOAC measurements, including pre-analytical (e.g. preferred time sample collection, preferred sample type, sample stability), analytical (gold standard method, screening and quantifying methods) and post analytical (e.g. reporting units, quality assurance). The committee addressed the use and limitations of screening tests such as prothrombin time, activated partial thromboplastin time as well as viscoelastic measurements of clotting blood and point of care methods. Additionally, the committee provided recommendations for the proper validation or verification of performance of laboratory assays prior to implementation for clinical use, and external quality assurance to provide continuous assessment of testing and reporting method. Schattauer GmbH Stuttgart.

Analytical performance evaluation of a high-volume hematology laboratory utilizing sigma metrics as standard of excellence.

PubMed

Shaikh, M S; Moiz, B

2016-04-01

Around two-thirds of important clinical decisions about the management of patients are based on laboratory test results. Clinical laboratories are required to adopt quality control (QC) measures to ensure provision of accurate and precise results. Six sigma is a statistical tool, which provides opportunity to assess performance at the highest level of excellence. The purpose of this study was to assess performance of our hematological parameters on sigma scale in order to identify gaps and hence areas of improvement in patient care. Twelve analytes included in the study were hemoglobin (Hb), hematocrit (Hct), red blood cell count (RBC), mean corpuscular volume (MCV), red cell distribution width (RDW), total leukocyte count (TLC) with percentages of neutrophils (Neutr%) and lymphocytes (Lymph %), platelet count (Plt), mean platelet volume (MPV), prothrombin time (PT), and fibrinogen (Fbg). Internal quality control data and external quality assurance survey results were utilized for the calculation of sigma metrics for each analyte. Acceptable sigma value of ≥3 was obtained for the majority of the analytes included in the analysis. MCV, Plt, and Fbg achieved value of <3 for level 1 (low abnormal) control. PT performed poorly on both level 1 and 2 controls with sigma value of <3. Despite acceptable conventional QC tools, application of sigma metrics can identify analytical deficits and hence prospects for the improvement in clinical laboratories. © 2016 John Wiley & Sons Ltd.

Errors in the Extra-Analytical Phases of Clinical Chemistry Laboratory Testing.

PubMed

Zemlin, Annalise E

2018-04-01

The total testing process consists of various phases from the pre-preanalytical to the post-postanalytical phase, the so-called brain-to-brain loop. With improvements in analytical techniques and efficient quality control programmes, most laboratory errors now occur in the extra-analytical phases. There has been recent interest in these errors with numerous publications highlighting their effect on service delivery, patient care and cost. This interest has led to the formation of various working groups whose mission is to develop standardized quality indicators which can be used to measure the performance of service of these phases. This will eventually lead to the development of external quality assessment schemes to monitor these phases in agreement with ISO15189:2012 recommendations. This review focuses on potential errors in the extra-analytical phases of clinical chemistry laboratory testing, some of the studies performed to assess the severity and impact of these errors and processes that are in place to address these errors. The aim of this review is to highlight the importance of these errors for the requesting clinician.

Summary Report for the Evaluation of Current QA Processes Within the FRMAC FAL and EPA MERL.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Shanks, Sonoya T.; Redding, Ted; Jaussi, Lynn

The Federal Radiological Monitoring and Assessment Center (FRMAC) relies on accurate and defensible analytical laboratory data to support its mission. Therefore, FRMAC must ensure that the environmental analytical laboratories providing analytical services maintain an ongoing capability to provide accurate analytical results to DOE. It is undeniable that the more Quality Assurance (QA) and Quality Control (QC) measures required of the laboratory, the less resources that are available for analysis of response samples. Being that QA and QC measures in general are understood to comprise a major effort related to a laboratory’s operations, requirements should only be considered if they aremore » deemed “value-added” for the FRMAC mission. This report provides observations of areas for improvement and potential interoperability opportunities in the areas of Batch Quality Control Requirements, Written Communications, Data Review Processes, Data Reporting Processes, along with the lessons learned as they apply to items in the early phase of a response that will be critical for developing a more efficient, integrated response for future interactions between the FRMAC and EPA assets.« less

Performance criteria and quality indicators for the post-analytical phase.

PubMed

Sciacovelli, Laura; Aita, Ada; Padoan, Andrea; Pelloso, Michela; Antonelli, Giorgia; Piva, Elisa; Chiozza, Maria Laura; Plebani, Mario

2016-07-01

Quality indicators (QIs) used as performance measurements are an effective tool in accurately estimating quality, identifying problems that may need to be addressed, and monitoring the processes over time. In Laboratory Medicine, QIs should cover all steps of the testing process, as error studies have confirmed that most errors occur in the pre- and post-analytical phase of testing. Aim of the present study is to provide preliminary results on QIs and related performance criteria in the post-analytical phase. This work was conducted according to a previously described study design based on the voluntary participation of clinical laboratories in the project on QIs of the Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Overall, data collected highlighted an improvement or stability in performances over time for all reported indicators thus demonstrating that the use of QIs is effective in the quality improvement strategy. Moreover, QIs data are an important source for defining the state-of-the-art concerning the error rate in the total testing process. The definition of performance specifications based on the state-of-the-art, as suggested by consensus documents, is a valuable benchmark point in evaluating the performance of each laboratory. Laboratory tests play a relevant role in the monitoring and evaluation of the efficacy of patient outcome thus assisting clinicians in decision-making. Laboratory performance evaluation is therefore crucial to providing patients with safe, effective and efficient care.

CAP/ACMG proficiency testing for biochemical genetics laboratories: a summary of performance.

PubMed

Oglesbee, Devin; Cowan, Tina M; Pasquali, Marzia; Wood, Timothy C; Weck, Karen E; Long, Thomas; Palomaki, Glenn E

2018-01-01

PurposeTesting for inborn errors of metabolism is performed by clinical laboratories worldwide, each utilizing laboratory-developed procedures. We sought to summarize performance in the College of American Pathologists' (CAP) proficiency testing (PT) program and identify opportunities for improving laboratory quality. When evaluating PT data, we focused on a subset of laboratories that have participated in at least one survey since 2010.MethodsAn analysis of laboratory performance (2004 to 2014) on the Biochemical Genetics PT Surveys, a program administered by CAP and the American College of Medical Genetics and Genomics. Analytical and interpretive performance was evaluated for four tests: amino acids, organic acids, acylcarnitines, and mucopolysaccharides.ResultsSince 2010, 150 laboratories have participated in at least one of four PT surveys. Analytic sensitivities ranged from 88.2 to 93.4%, while clinical sensitivities ranged from 82.4 to 91.0%. Performance was higher for US participants and for more recent challenges. Performance was lower for challenges with subtle findings or complex analytical patterns.ConclusionUS clinical biochemical genetics laboratory proficiency is satisfactory, with a minority of laboratories accounting for the majority of errors. Our findings underscore the complex nature of clinical biochemical genetics testing and highlight the necessity of continuous quality management.

External quality-assurance results for the National Atmospheric Deposition Program and the National Trends Network during 1986

USGS Publications Warehouse

See, Randolph B.; Schroder, LeRoy J.; Willoughby, Timothy C.

1988-01-01

During 1986, the U.S. Geological Survey operated three programs to provide external quality-assurance monitoring of the National Atmospheric Deposition Program and National Trends Network. An intersite-comparison program was used to assess the accuracy of onsite pH and specific-conductance determinations at quarterly intervals. The blind-audit program was used to assess the effect of routine sample handling on the precision and bias of program and network wet-deposition data. Analytical results from four laboratories, which routinely analyze wet-deposition samples, were examined to determine if differences existed between laboratory analytical results and to provide estimates of the analytical precision of each laboratory. An average of 78 and 89 percent of the site operators participating in the intersite-comparison met the network goals for pH and specific conductance. A comparison of analytical values versus actual values for samples submitted as part of the blind-audit program indicated that analytical values were slightly but significantly (a = 0.01) larger than actual values for pH, magnesium, sodium, and sulfate; analytical values for specific conductance were slightly less than actual values. The decreased precision in the analyses of blind-audit samples when compared to interlaboratory studies indicates that a large amount of uncertainty in network deposition data may be a result of routine field operations. The results of the interlaboratory comparison study indicated that the magnitude of the difference between laboratory analyses was small for all analytes. Analyses of deionized, distilled water blanks by participating laboratories indicated that the laboratories had difficulty measuring analyte concentrations near their reported detection limits. (USGS)

National Water Quality Laboratory - A Profile

USGS Publications Warehouse

Raese, Jon W.

2001-01-01

The U.S. Geological Survey (USGS) National Water Quality Laboratory (NWQL) is a full-service laboratory that specializes in environmental analytical chemistry. The NWQL's primary mission is to support USGS programs requiring environmental analyses that provide consistent methodology for national assessment and trends analysis. The NWQL provides the following: high-quality chemical data; consistent, published, state-of-the-art methodology; extremely low-detection levels; high-volume capability; biological unit for identifying benthic invertebrates; quality assurance for determining long-term water-quality trends; and a professional staff.

Quality indicators in laboratory medicine: a fundamental tool for quality and patient safety.

PubMed

Plebani, Mario; Sciacovelli, Laura; Marinova, Mariela; Marcuccitti, Jessica; Chiozza, Maria Laura

2013-09-01

The identification of reliable quality indicators (QIs) is a crucial step in enabling users to quantify the quality of laboratory services. The current lack of attention to extra-laboratory factors is in stark contrast with the body of evidence pointing to the multitude of errors that continue to occur in the pre- and post-analytical phases. Different QIs and terminologies are currently used and, therefore, there is the need to harmonize proposed QIs. A model of quality indicators (MQI) has been consensually developed by a group of clinical laboratories according to a project launched by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The model includes 57 QIs related to key processes (35 pre-, 7 intra- and 15 post-analytical phases) and 3 to support processes. The developed MQI and the data collected provide evidence of the feasibility of the project to harmonize currently available QIs, but further efforts should be done to involve more clinical laboratories and to collect a more consistent amount of data. Copyright © 2012 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

The quality of laboratory aspects of troponin testing in clinical practice guidelines and consensus documents needs to be improved.

PubMed

Aakre, Kristin M; Langlois, Michel R; Barth, Julian H; Misra, Shivani; Watine, Joseph; Oosterhuis, Wytze P

2014-11-01

The European Federation of Laboratory Medicine (EFLM) and the Union of European Medical Specialists (UEMS) joint Working Group on guidelines recently proposed a checklist to help standardize the description of laboratory investigations in clinical practice guidelines (CPG). Nine CPGs or consensus documents published from 2011 to 2013 describing the investigation of chest pain, diagnosis of acute coronary syndrome, or myocardial infarction were evaluated against the published checklist. Clinical use of troponin analysis are commonly dealt with but the publications present variable, vague and sometimes conflicting information regarding this laboratory test being very much relied on upon making a diagnosis of acute coronary syndrome. Most of the laboratory related checklist items are not considered or need to be updated e.g. suggested analytical quality goals are not applicable for the high sensitive assays and important interferences that may lead to false positive or negative diagnoses are commonly not mentioned. The current paper sums up important analytical and biological issues related to troponin assays and gives suggestions for analytical quality goals that could be included in CPG's. Copyright © 2014 Elsevier B.V. All rights reserved.

Analytical performance of 17 general chemistry analytes across countries and across manufacturers in the INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain.

PubMed

Weykamp, Cas; Secchiero, Sandra; Plebani, Mario; Thelen, Marc; Cobbaert, Christa; Thomas, Annette; Jassam, Nuthar; Barth, Julian H; Perich, Carmen; Ricós, Carmen; Faria, Ana Paula

2017-02-01

Optimum patient care in relation to laboratory medicine is achieved when results of laboratory tests are equivalent, irrespective of the analytical platform used or the country where the laboratory is located. Standardization and harmonization minimize differences and the success of efforts to achieve this can be monitored with international category 1 external quality assessment (EQA) programs. An EQA project with commutable samples, targeted with reference measurement procedures (RMPs) was organized by EQA institutes in Italy, the Netherlands, Portugal, UK, and Spain. Results of 17 general chemistry analytes were evaluated across countries and across manufacturers according to performance specifications derived from biological variation (BV). For K, uric acid, glucose, cholesterol and high-density density (HDL) cholesterol, the minimum performance specification was met in all countries and by all manufacturers. For Na, Cl, and Ca, the minimum performance specifications were met by none of the countries and manufacturers. For enzymes, the situation was complicated, as standardization of results of enzymes toward RMPs was still not achieved in 20% of the laboratories and questionable in the remaining 80%. The overall performance of the measurement of 17 general chemistry analytes in European medical laboratories met the minimum performance specifications. In this general picture, there were no significant differences per country and no significant differences per manufacturer. There were major differences between the analytes. There were six analytes for which the minimum quality specifications were not met and manufacturers should improve their performance for these analytes. Standardization of results of enzymes requires ongoing efforts.

Systematic Assessment of the Hemolysis Index: Pros and Cons.

PubMed

Lippi, Giuseppe

2015-01-01

Preanalytical quality is as important as the analytical and postanalytical quality in laboratory diagnostics. After decades of visual inspection to establish whether or not a diagnostic sample may be suitable for testing, automated assessment of hemolysis index (HI) has now become available in a large number of laboratory analyzers. Although most national and international guidelines support systematic assessment of sample quality via HI, there is widespread perception that this indication has not been thoughtfully acknowledged. Potential explanations include concern of increased specimen rejection rate, poor harmonization of analytical techniques, lack of standardized units of measure, differences in instrument-specific cutoff, negative impact on throughput, organization and laboratory economics, and lack of a reliable quality control system. Many of these concerns have been addressed. Evidence now supports automated HI in improving quality and patient safety. These will be discussed. © 2015 Elsevier Inc. All rights reserved.

The Hazardous-Drums Project: A Multiweek Laboratory Exercise for General Chemistry Involving Environmental, Quality Control, and Cost Evaluation

ERIC Educational Resources Information Center

Hayes, David; Widanski, Bozena

2013-01-01

A laboratory experiment is described that introduces students to "real-world" hazardous waste management issues chemists face. The students are required to define an analytical problem, choose a laboratory analysis method, investigate cost factors, consider quality-control issues, interpret the meaning of results, and provide management…

Pre-analytical issues in the haemostasis laboratory: guidance for the clinical laboratories.

PubMed

Magnette, A; Chatelain, M; Chatelain, B; Ten Cate, H; Mullier, F

2016-01-01

Ensuring quality has become a daily requirement in laboratories. In haemostasis, even more than in other disciplines of biology, quality is determined by a pre-analytical step that encompasses all procedures, starting with the formulation of the medical question, and includes patient preparation, sample collection, handling, transportation, processing, and storage until time of analysis. This step, based on a variety of manual activities, is the most vulnerable part of the total testing process and is a major component of the reliability and validity of results in haemostasis and constitutes the most important source of erroneous or un-interpretable results. Pre-analytical errors may occur throughout the testing process and arise from unsuitable, inappropriate or wrongly handled procedures. Problems may arise during the collection of blood specimens such as misidentification of the sample, use of inadequate devices or needles, incorrect order of draw, prolonged tourniquet placing, unsuccessful attempts to locate the vein, incorrect use of additive tubes, collection of unsuitable samples for quality or quantity, inappropriate mixing of a sample, etc. Some factors can alter the result of a sample constituent after collection during transportation, preparation and storage. Laboratory errors can often have serious adverse consequences. Lack of standardized procedures for sample collection accounts for most of the errors encountered within the total testing process. They can also have clinical consequences as well as a significant impact on patient care, especially those related to specialized tests as these are often considered as "diagnostic". Controlling pre-analytical variables is critical since this has a direct influence on the quality of results and on their clinical reliability. The accurate standardization of the pre-analytical phase is of pivotal importance for achieving reliable results of coagulation tests and should reduce the side effects of the influence factors. This review is a summary of the most important recommendations regarding the importance of pre-analytical factors for coagulation testing and should be a tool to increase awareness about the importance of pre-analytical factors for coagulation testing.

Analytical performance specifications for external quality assessment - definitions and descriptions.

PubMed

Jones, Graham R D; Albarede, Stephanie; Kesseler, Dagmar; MacKenzie, Finlay; Mammen, Joy; Pedersen, Morten; Stavelin, Anne; Thelen, Marc; Thomas, Annette; Twomey, Patrick J; Ventura, Emma; Panteghini, Mauro

2017-06-27

External Quality Assurance (EQA) is vital to ensure acceptable analytical quality in medical laboratories. A key component of an EQA scheme is an analytical performance specification (APS) for each measurand that a laboratory can use to assess the extent of deviation of the obtained results from the target value. A consensus conference held in Milan in 2014 has proposed three models to set APS and these can be applied to setting APS for EQA. A goal arising from this conference is the harmonisation of EQA APS between different schemes to deliver consistent quality messages to laboratories irrespective of location and the choice of EQA provider. At this time there are wide differences in the APS used in different EQA schemes for the same measurands. Contributing factors to this variation are that the APS in different schemes are established using different criteria, applied to different types of data (e.g. single data points, multiple data points), used for different goals (e.g. improvement of analytical quality; licensing), and with the aim of eliciting different responses from participants. This paper provides recommendations from the European Federation of Laboratory Medicine (EFLM) Task and Finish Group on Performance Specifications for External Quality Assurance Schemes (TFG-APSEQA) and on clear terminology for EQA APS. The recommended terminology covers six elements required to understand APS: 1) a statement on the EQA material matrix and its commutability; 2) the method used to assign the target value; 3) the data set to which APS are applied; 4) the applicable analytical property being assessed (i.e. total error, bias, imprecision, uncertainty); 5) the rationale for the selection of the APS; and 6) the type of the Milan model(s) used to set the APS. The terminology is required for EQA participants and other interested parties to understand the meaning of meeting or not meeting APS.

Keeping It Simple: Can We Estimate Malting Quality Potential Using an Isothermal Mashing Protocol and Common Laboratory Instrumentation?

USDA-ARS?s Scientific Manuscript database

Current methods for generating malting quality metrics have been developed largely to support commercial malting and brewing operations, providing accurate, reproducible analytical data to guide malting and brewing production. Infrastructure to support these analytical operations often involves sub...

Empirical insights and considerations for the OBT inter-laboratory comparison of environmental samples.

PubMed

Kim, Sang-Bog; Roche, Jennifer

2013-08-01

Organically bound tritium (OBT) is an important tritium species that can be measured in most environmental samples, but has only recently been recognized as a species of tritium in these samples. Currently, OBT is not routinely measured by environmental monitoring laboratories around the world. There are no certified reference materials (CRMs) for environmental samples. Thus, quality assurance (QA), or verification of the accuracy of the OBT measurement, is not possible. Alternatively, quality control (QC), or verification of the precision of the OBT measurement, can be achieved. In the past, there have been differences in OBT analysis results between environmental laboratories. A possible reason for the discrepancies may be differences in analytical methods. Therefore, inter-laboratory OBT comparisons among the environmental laboratories are important and would provide a good opportunity for adopting a reference OBT analytical procedure. Due to the analytical issues, only limited information is available on OBT measurement. Previously conducted OBT inter-laboratory practices are reviewed and the findings are described. Based on our experiences, a few considerations were suggested for the international OBT inter-laboratory comparison exercise to be completed in the near future. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

Defining a roadmap for harmonizing quality indicators in Laboratory Medicine: a consensus statement on behalf of the IFCC Working Group "Laboratory Error and Patient Safety" and EFLM Task and Finish Group "Performance specifications for the extra-analytical phases".

PubMed

Sciacovelli, Laura; Panteghini, Mauro; Lippi, Giuseppe; Sumarac, Zorica; Cadamuro, Janne; Galoro, César Alex De Olivera; Pino Castro, Isabel Garcia Del; Shcolnik, Wilson; Plebani, Mario

2017-08-28

The improving quality of laboratory testing requires a deep understanding of the many vulnerable steps involved in the total examination process (TEP), along with the identification of a hierarchy of risks and challenges that need to be addressed. From this perspective, the Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is focusing its activity on implementation of an efficient tool for obtaining meaningful information on the risk of errors developing throughout the TEP, and for establishing reliable information about error frequencies and their distribution. More recently, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has created the Task and Finish Group "Performance specifications for the extra-analytical phases" (TFG-PSEP) for defining performance specifications for extra-analytical phases. Both the IFCC and EFLM groups are working to provide laboratories with a system to evaluate their performances and recognize the critical aspects where improvement actions are needed. A Consensus Conference was organized in Padova, Italy, in 2016 in order to bring together all the experts and interested parties to achieve a consensus for effective harmonization of quality indicators (QIs). A general agreement was achieved and the main outcomes have been the release of a new version of model of quality indicators (MQI), the approval of a criterion for establishing performance specifications and the definition of the type of information that should be provided within the report to the clinical laboratories participating to the QIs project.

Laboratory and quality assurance protocols for the analysis of herbicides in ground water from the Management Systems Evaluation Area, Princeton, Minnesota

USGS Publications Warehouse

Larson, S.J.; Capel, P.D.; VanderLoop, A.G.

1996-01-01

Laboratory and quality assurance procedures for the analysis of ground-water samples for herbicides at the Management Systems Evaluation Area near Princeton, Minnesota are described. The target herbicides include atrazine, de-ethylatrazine, de-isopropylatrazine, metribuzin, alachlor, 2,6-diethylaniline, and metolachlor. The analytical techniques used are solid-phase extraction, and analysis by gas chromatography with mass-selective detection. Descriptions of cleaning procedures, preparation of standard solutions, isolation of analytes from water, sample transfer methods, instrumental analysis, and data analysis are included.

Quality-Assurance Data for Routine Water Analyses by the U.S. Geological Survey Laboratory in Troy, New York-July 1997 through June 1999

USGS Publications Warehouse

Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

2006-01-01

The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance/quality-control data for the time period addressed in this report were stored in the laboratory's SAS data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality- control samples analyzed from July 1997 through June 1999. Results for the quality-control samples for 18 analytical procedures were evaluated for bias and precision. Control charts indicate that data for eight of the analytical procedures were occasionally biased for either high-concentration and (or) low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, total aluminum, ammonium, calcium, chloride, specific conductance, and sulfate. The data from the potassium and sodium analytical procedures are insufficient for evaluation. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 11 of 13 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. Blank analysis results for chloride showed that 22 percent of blanks did not meet data-quality objectives and results for dissolved organic carbon showed that 31 percent of the blanks did not meet data-quality objectives. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 14 of the 18 analytes. At least 90 percent of the samples met data-quality objectives for all analytes except total aluminum (70 percent of samples met objectives) and potassium (83 percent of samples met objectives). Results of the USGS interlaboratory Standard Reference Sample (SRS) Project indicated good data quality for most constituents over the time period. The P-sample (low-ionic-strength constituents) analysis had good ratings in two of these studies and a satisfactory rating in the third. The results of the T-sample (trace constituents) analysis indicated high data quality with good ratings in all three studies. The N-sample (nutrient constituents) studies had one each of excellent, good, and satisfactory ratings. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 80 percent of the samples met data-quality objectives for 9 of the 13 analytes; the exceptions were dissolved organic carbon, ammonium, chloride, and specific conductance. Data-quality objectives were not met for dissolved organic carbon in two NWRI studies, but all of the samples were within control limits for the last study. Data-quality objectives were not met in 41 percent of samples analyzed for ammonium, 25 percent of samples analyzed for chloride, and 30 percent of samples analyzed for specific conductance. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 84 percent of the samples analyzed for calcium, chloride, magnesium, pH, and potassium. Data-quality objectives were met by 73 percent of those analyzed for sulfate. The data-quality objective was not met for sodium. The data are insufficient for evaluation of the specific conductance results.

Quality Indicators in Laboratory Medicine: from theory to practice. Preliminary data from the IFCC Working Group Project "Laboratory Errors and Patient Safety".

PubMed

Sciacovelli, Laura; O'Kane, Maurice; Skaik, Younis Abdelwahab; Caciagli, Patrizio; Pellegrini, Cristina; Da Rin, Giorgio; Ivanov, Agnes; Ghys, Timothy; Plebani, Mario

2011-05-01

The adoption of Quality Indicators (QIs) has prompted the development of tools to measure and evaluate the quality and effectiveness of laboratory testing, first in the hospital setting and subsequently in ambulatory and other care settings. While Laboratory Medicine has an important role in the delivery of high-quality care, no consensus exists as yet on the use of QIs focussing on all steps of the laboratory total testing process (TTP), and further research in this area is required. In order to reduce errors in laboratory testing, the IFCC Working Group on "Laboratory Errors and Patient Safety" (WG-LEPS) developed a series of Quality Indicators, specifically designed for clinical laboratories. In the first phase of the project, specific QIs for key processes of the TTP were identified, including all the pre-, intra- and post-analytic steps. The overall aim of the project is to create a common reporting system for clinical laboratories based on standardized data collection, and to define state-of-the-art and Quality Specifications (QSs) for each QI independent of: a) the size of organization and type of activities; b) the complexity of processes undertaken; and c) different degree of knowledge and ability of the staff. The aim of the present paper is to report the results collected from participating laboratories from February 2008 to December 2009 and to identify preliminary QSs. The results demonstrate that a Model of Quality Indicators managed as an External Quality Assurance Program can serve as a tool to monitor and control the pre-, intra- and post-analytical activities. It might also allow clinical laboratories to identify risks that lead to errors resulting in patient harm: identification and design of practices that eliminate medical errors; the sharing of information and education of clinical and laboratory teams on practices that reduce or prevent errors; the monitoring and evaluation of improvement activities.

42 CFR 493.1200 - Introduction.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (that is, preanalytic, analytic, and postanalytic) as well as general laboratory systems. (b) The...) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing § 493.1200 Introduction. (a) Each laboratory that performs nonwaived testing must establish and maintain written policies...

Analytical techniques: A compilation

NASA Technical Reports Server (NTRS)

1975-01-01

A compilation, containing articles on a number of analytical techniques for quality control engineers and laboratory workers, is presented. Data cover techniques for testing electronic, mechanical, and optical systems, nondestructive testing techniques, and gas analysis techniques.

Environmental Response Laboratory Network Membership and Benefits

EPA Pesticide Factsheets

Member laboratories must meet core requirements including quality systems, policies and procedures, sample and data management, and analytical capabilities. Benefits include training and exercise opportunities, information sharing and technical support.

Analytical Chemistry Laboratory. Progress report for FY 1996

DOE Office of Scientific and Technical Information (OSTI.GOV)

Green, D.W.; Boparai, A.S.; Bowers, D.L.

The purpose of this report is to summarize the activities of the Analytical Chemistry Laboratory (ACL) at Argonne National Laboratory (ANL) for Fiscal Year (FY) 1996. This annual report is the thirteenth for the ACL. It describes effort on continuing and new projects and contributions of the ACL staff to various programs at ANL. The ACL operates in the ANL system as a full-cost-recovery service center, but has a mission that includes a complementary research and development component: The Analytical Chemistry Laboratory will provide high-quality, cost-effective chemical analysis and related technical support to solve research problems of our clients --more » Argonne National Laboratory, the Department of Energy, and others -- and will conduct world-class research and development in analytical chemistry and its applications. Because of the diversity of research and development work at ANL, the ACL handles a wide range of analytical chemistry problems. Some routine or standard analyses are done, but the ACL usually works with commercial laboratories if our clients require high-volume, production-type analyses. It is common for ANL programs to generate unique problems that require significant development of methods and adaption of techniques to obtain useful analytical data. Thus, much of the support work done by the ACL is very similar to our applied analytical chemistry research.« less

Participation and performance in INSTAND multi-analyte molecular genetics external quality assessment schemes from 2006 to 2012.

PubMed

Maly, Friedrich E; Fried, Roman; Spannagl, Michael

2014-01-01

INSTAND e.V. has provided Molecular Genetics Multi-Analyte EQA schemes since 2006. EQA participation and performance were assessed from 2006 - 2012. From 2006 to 2012, the number of analytes in the Multi-Analyte EQA schemes rose from 17 to 53. Total number of results returned rose from 168 in January 2006 to 824 in August 2012. The overall error rate was 1.40 +/- 0.84% (mean +/- SD, N = 24 EQA dates). From 2006 to 2012, no analyte was reported 100% correctly. Individual participant performance was analysed for one common analyte, Lactase (LCT) T-13910C. From 2006 to 2012, 114 laboratories participated in this EQA. Of these, 10 laboratories (8.8%) reported at least one wrong result during the whole observation period. All laboratories reported correct results after their failure incident. In spite of the low overall error rate, EQA will continue to be important for Molecular Genetics.

Extra-analytical quality indicators and laboratory performances.

PubMed

Sciacovelli, Laura; Aita, Ada; Plebani, Mario

2017-07-01

In the last few years much progress has been made in raising the awareness of laboratory medicine professionals about the effectiveness of quality indicators (QIs) in monitoring, and improving upon, performances in the extra-analytical phases of the Total Testing Process (TTP). An effective system for management of QIs includes the implementation of an internal assessment system and participation in inter-laboratory comparison. A well-designed internal assessment system allows the identification of critical activities and their systematic monitoring. Active participation in inter-laboratory comparison provides information on the performance level of one laboratory with respect to that of other participating laboratories. In order to guarantee the use of appropriate QIs and facilitate their implementation, many laboratories have adopted the Model of Quality Indicators (MQI) proposed by Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of IFCC, since 2008, which is the result of international consensus and continuous experimentation, and updating to meet new, constantly emerging needs. Data from participating laboratories are collected monthly and reports describing the statistical results and evaluating laboratory data, utilizing the Six Sigma metric, issued regularly. Although the results demonstrate that the processes need to be improved upon, overall the comparison with data collected in 2014 shows a general stability of quality levels and that an improvement has been achieved over time for some activities. The continuous monitoring of QI data allows identification all possible improvements, thus highlighting the value of participation in the inter-laboratory program proposed by WG-LEPS. The active participation of numerous laboratories will guarantee an ever more significant State-of-the-Art, promote the reduction of errors and improve quality of the TTP, thus guaranteeing patient safety. Copyright © 2017. Published by Elsevier Inc.

Introducing Quality Control in the Chemistry Teaching Laboratory Using Control Charts

ERIC Educational Resources Information Center

Schazmann, Benjamin; Regan, Fiona; Ross, Mary; Diamond, Dermot; Paull, Brett

2009-01-01

Quality control (QC) measures are less prevalent in teaching laboratories than commercial settings possibly owing to a lack of commercial incentives or teaching resources. This article focuses on the use of QC assessment in the analytical techniques of high performance liquid chromatography (HPLC) and ultraviolet-visible spectroscopy (UV-vis) at…

Quality-Assurance Data for Routine Water Analyses by the U.S. Geological Survey Laboratory in Troy, New York - July 2005 through June 2007

USGS Publications Warehouse

Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

2009-01-01

The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's Lab Master data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality control samples analyzed from July 2005 through June 2007. Results for the quality-control samples for 19 analytical procedures were evaluated for bias and precision. Control charts indicate that data for eight of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: total aluminum, calcium, magnesium, nitrate (colorimetric method), potassium, silicon, sodium, and sulfate. Eight of the analytical procedures were biased throughout the analysis period for the high-concentration sample, but were within control limits; these procedures were: total aluminum, calcium, dissolved organic carbon, chloride, nitrate (ion chromatograph), potassium, silicon, and sulfate. The magnesium and pH procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The acid-neutralizing capacity, total monomeric aluminum, nitrite, and specific conductance procedures were biased for the high-concentration and low-concentration samples, but were within control limits. Results from the filter-blank and analytical-blank analyses indicated that the procedures for 16 of 17 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for dissolved organic carbon. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 18 of the 21 analytes. At least 93 percent of the samples met data-quality objectives for all analytes except acid-neutralizing capacity (85 percent of samples met objectives), total monomeric aluminum (83 percent of samples met objectives), total aluminum (85 percent of samples met objectives), and chloride (85 percent of samples met objectives). The ammonium and total dissolved nitrogen did not meet the data-quality objectives. Results of the USGS interlaboratory Standard Reference Sample (SRS) Project met the Troy Laboratory data-quality objectives for 87 percent of the samples analyzed. The P-sample (low-ionic-strength constituents) analysis had two outliers each in two studies. The T-sample (trace constituents) analysis and the N-sample (nutrient constituents) analysis had one outlier each in two studies. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 85 percent of the samples met data-quality objectives for 11 of the 14 analytes; the exceptions were acid-neutralizing capacity, total aluminum and ammonium. Data-quality objectives were not met in 41 percent of samples analyzed for acid-neutralizing capacity, 50 percent of samples analyzed for total aluminum, and 44 percent of samples analyzed for ammonium. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 86 percent of the samples analyzed for calcium, magnesium, pH, potassium, and sodium. Data-quality objectives were met by 76 percent of the samples analyzed for chloride, 80 percent of the samples analyzed for specific conductance, and 77 percent of the samples analyzed for sulfate.

Guided-inquiry laboratory experiments to improve students' analytical thinking skills

NASA Astrophysics Data System (ADS)

Wahyuni, Tutik S.; Analita, Rizki N.

2017-12-01

This study aims to improve the experiment implementation quality and analytical thinking skills of undergraduate students through guided-inquiry laboratory experiments. This study was a classroom action research conducted in three cycles. The study has been carried out with 38 undergraduate students of the second semester of Biology Education Department of State Islamic Institute (SII) of Tulungagung, as a part of Chemistry for Biology course. The research instruments were lesson plans, learning observation sheets and undergraduate students' experimental procedure. Research data were analyzed using quantitative-descriptive method. The increasing of analytical thinking skills could be measured using gain score normalized and statistical paired t-test. The results showed that guided-inquiry laboratory experiments model was able to improve both the experiment implementation quality and the analytical thinking skills. N-gain score of the analytical thinking skills was increased, in spite of just 0.03 with low increase category, indicated by experimental reports. Some of undergraduate students have had the difficulties in detecting the relation of one part to another and to an overall structure. The findings suggested that giving feedback the procedural knowledge and experimental reports were important. Revising the experimental procedure that completed by some scaffolding questions were also needed.

Environmental Response Laboratory Network (ERLN) Overview

EPA Pesticide Factsheets

The Environmental Response Laboratory Network provides Federal, State, and local decision-makers with reliable, high quality analytical data used to identify chemical, biological, and radiological contaminants collected in support of response and cleanup.

Descriptor Fingerprints and Their Application to WhiteWine Clustering and Discrimination.

NASA Astrophysics Data System (ADS)

Bangov, I. P.; Moskovkina, M.; Stojanov, B. P.

2018-03-01

This study continues the attempt to use the statistical process for a large-scale analytical data. A group of 3898 white wines, each with 11 analytical laboratory benchmarks was analyzed by a fingerprint similarity search in order to be grouped into separate clusters. A characterization of the wine's quality in each individual cluster was carried out according to individual laboratory parameters.

Experience of quality management system in a clinical laboratory in Nigeria

PubMed Central

Sylvester-Ikondu, Ugochukwu; Onwuamah, Chika K.; Salu, Olumuyiwa B.; Ige, Fehintola A.; Meshack, Emily; Aniedobe, Maureen; Amoo, Olufemi S.; Okwuraiwe, Azuka P.; Okhiku, Florence; Okoli, Chika L.; Fasela, Emmanuel O.; Odewale, Ebenezer. O.; Aleshinloye, Roseline O.; Olatunji, Micheal; Idigbe, Emmanuel O.

2012-01-01

Issues Quality-management systems (QMS) are uncommon in clinical laboratories in Nigeria, and until recently, none of the nation’s 5 349 clinical laboratories have been able to attain the certifications necessary to begin the process of attaining international accreditation. Nigeria’s Human Virology Laboratory (HVL), however, began implementation of a QMS in 2006, and in 2008 it was determined that the laboratory conformed to the requirements of ISO 9001:2000 (now 2008), making it the first diagnostic laboratory to be certified in Nigeria. The HVL has now applied for the World Health Organization (WHO) accreditation preparedness scheme. The experience of the QMS implementation process and the lessons learned therein are shared here. Description In 2005, two personnel from the HVL spent time studying quality systems in a certified clinical laboratory in Dakar, Senegal. Following this peer-to-peer technical assistance, several training sessions were undertaken by HVL staff, a baseline assessment was conducted, and processes were established. The HVL has monitored its quality indicators and conducted internal and external audits; these analyses (from 2007 to 2009) are presented herein. Lessons learned Although there was improvement in the pre-analytical and analytical indicators analysed and although data-entry errors decreased in the post-analytical process, the delay in returning laboratory test results increased significantly. There were several factors identified as causes for this delay and all of these have now been addressed except for an identified need for automation of some high-volume assays (currently being negotiated). Internal and external audits showed a trend of increasing non-conformities which could be the result of personnel simply becoming lax over time. Application for laboratory accreditation, however, could provide the renewed vigour needed to correct these non-conformities. Recommendation This experience shows that sustainability of the QMS at present is a cause for concern. However, the tiered system of accreditation being developed by WHO–Afro may act as a driving force to preserve the spirit of continual improvement. PMID:29062734

National continuous surveys on internal quality control for HbA1c in 306 clinical laboratories of China from 2012 to 2016: Continual improvement.

PubMed

Li, Tingting; Wang, Wei; Zhao, Haijian; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

2017-09-01

This study aimed to evaluate whether the quality performance of clinical laboratories in China has been greatly improved and whether Internal Quality Control (IQC) practice of HbA1c has also been changed since National Center for Clinical Laboratories (NCCL) of China organized laboratories to report IQC data for HbA1c in 2012. Internal Quality Control information of 306 External Quality Assessment (EQA) participant laboratories which kept reporting IQC data in February from 2012 to 2016 were collected by Web-based EQA system. Then percentages of laboratories meeting four different imprecision specifications for current coefficient of variations (CVs) of HbA1c measurements were calculated. Finally, we comprehensively analyzed analytical systems and IQC practice of HbA1c measurements. The current CVs of HbA1c tests have decreased significantly from 2012 to 2016. And percentages of laboratories meeting four imprecision specifications for CVs all showed the increasing tendency year by year. As for analytical system, 52.1% (159/306) laboratories changed their systems with the change in principle of assay. And many laboratories began to use cation exchange high-performance liquid chromatography (CE-HPLC) instead of Immunoturbidimetry, because CE-HPLC owed a lower intra-laboratory CVs. The data of IQC practice, such as IQC rules and frequency, also showed significant variability among years with overall tendency of meeting requirements. The imprecision performance of HbA1c tests has been improved in these 5 years with the change in IQC practice, but it is still disappointing in China. Therefore, laboratories should actively find existing problems and take action to promote performance of HbA1c measurements. © 2016 Wiley Periodicals, Inc.

MODULAR ANALYTICS: A New Approach to Automation in the Clinical Laboratory.

PubMed

Horowitz, Gary L; Zaman, Zahur; Blanckaert, Norbert J C; Chan, Daniel W; Dubois, Jeffrey A; Golaz, Olivier; Mensi, Noury; Keller, Franz; Stolz, Herbert; Klingler, Karl; Marocchi, Alessandro; Prencipe, Lorenzo; McLawhon, Ronald W; Nilsen, Olaug L; Oellerich, Michael; Luthe, Hilmar; Orsonneau, Jean-Luc; Richeux, Gérard; Recio, Fernando; Roldan, Esther; Rymo, Lars; Wicktorsson, Anne-Charlotte; Welch, Shirley L; Wieland, Heinrich; Grawitz, Andrea Busse; Mitsumaki, Hiroshi; McGovern, Margaret; Ng, Katherine; Stockmann, Wolfgang

2005-01-01

MODULAR ANALYTICS (Roche Diagnostics) (MODULAR ANALYTICS, Elecsys and Cobas Integra are trademarks of a member of the Roche Group) represents a new approach to automation for the clinical chemistry laboratory. It consists of a control unit, a core unit with a bidirectional multitrack rack transportation system, and three distinct kinds of analytical modules: an ISE module, a P800 module (44 photometric tests, throughput of up to 800 tests/h), and a D2400 module (16 photometric tests, throughput up to 2400 tests/h). MODULAR ANALYTICS allows customised configurations for various laboratory workloads. The performance and practicability of MODULAR ANALYTICS were evaluated in an international multicentre study at 16 sites. Studies included precision, accuracy, analytical range, carry-over, and workflow assessment. More than 700 000 results were obtained during the course of the study. Median between-day CVs were typically less than 3% for clinical chemistries and less than 6% for homogeneous immunoassays. Median recoveries for nearly all standardised reference materials were within 5% of assigned values. Method comparisons versus current existing routine instrumentation were clinically acceptable in all cases. During the workflow studies, the work from three to four single workstations was transferred to MODULAR ANALYTICS, which offered over 100 possible methods, with reduction in sample splitting, handling errors, and turnaround time. Typical sample processing time on MODULAR ANALYTICS was less than 30 minutes, an improvement from the current laboratory systems. By combining multiple analytic units in flexible ways, MODULAR ANALYTICS met diverse laboratory needs and offered improvement in workflow over current laboratory situations. It increased overall efficiency while maintaining (or improving) quality.

MODULAR ANALYTICS: A New Approach to Automation in the Clinical Laboratory

PubMed Central

Zaman, Zahur; Blanckaert, Norbert J. C.; Chan, Daniel W.; Dubois, Jeffrey A.; Golaz, Olivier; Mensi, Noury; Keller, Franz; Stolz, Herbert; Klingler, Karl; Marocchi, Alessandro; Prencipe, Lorenzo; McLawhon, Ronald W.; Nilsen, Olaug L.; Oellerich, Michael; Luthe, Hilmar; Orsonneau, Jean-Luc; Richeux, Gérard; Recio, Fernando; Roldan, Esther; Rymo, Lars; Wicktorsson, Anne-Charlotte; Welch, Shirley L.; Wieland, Heinrich; Grawitz, Andrea Busse; Mitsumaki, Hiroshi; McGovern, Margaret; Ng, Katherine; Stockmann, Wolfgang

2005-01-01

MODULAR ANALYTICS (Roche Diagnostics) (MODULAR ANALYTICS, Elecsys and Cobas Integra are trademarks of a member of the Roche Group) represents a new approach to automation for the clinical chemistry laboratory. It consists of a control unit, a core unit with a bidirectional multitrack rack transportation system, and three distinct kinds of analytical modules: an ISE module, a P800 module (44 photometric tests, throughput of up to 800 tests/h), and a D2400 module (16 photometric tests, throughput up to 2400 tests/h). MODULAR ANALYTICS allows customised configurations for various laboratory workloads. The performance and practicability of MODULAR ANALYTICS were evaluated in an international multicentre study at 16 sites. Studies included precision, accuracy, analytical range, carry-over, and workflow assessment. More than 700 000 results were obtained during the course of the study. Median between-day CVs were typically less than 3% for clinical chemistries and less than 6% for homogeneous immunoassays. Median recoveries for nearly all standardised reference materials were within 5% of assigned values. Method comparisons versus current existing routine instrumentation were clinically acceptable in all cases. During the workflow studies, the work from three to four single workstations was transferred to MODULAR ANALYTICS, which offered over 100 possible methods, with reduction in sample splitting, handling errors, and turnaround time. Typical sample processing time on MODULAR ANALYTICS was less than 30 minutes, an improvement from the current laboratory systems. By combining multiple analytic units in flexible ways, MODULAR ANALYTICS met diverse laboratory needs and offered improvement in workflow over current laboratory situations. It increased overall efficiency while maintaining (or improving) quality. PMID:18924721

Technology to improve quality and accountability.

PubMed

Kay, Jonathan

2006-01-01

A body of evidence has been accumulated to demonstrate that current practice is not sufficiently safe for several stages of central laboratory testing. In particular, while analytical and perianalytical steps that take place within the laboratory are subjected to quality control procedures, this is not the case for several pre- and post-analytical steps. The ubiquitous application of auto-identification technology seems to represent a valuable tool for reducing error rates. A series of projects in Oxford has attempted to improve processes which support several areas of laboratory medicine, including point-of-care testing, blood transfusion, delivery and interpretation of reports, and support of decision-making by clinicians. The key tools are auto-identification, Internet communication technology, process re-engineering, and knowledge management.

LABORATORY CAPACITY NEEDS ASSESSMENT OF DRINKING WATER UTILITIES: A GLOBAL PERSPECTIVE

EPA Science Inventory

Fully-functioning analytical laboratories capable of producing quality data are essential components of well-run drinking water utilities. In Europe and the US, drinking water laboratory performance is closely monitored and regulated; this is not always the case in the less indu...

Reporting unit size and measurement uncertainty: current Australian practice in clinical chemistry and haematology.

PubMed

Hawkins, Robert C; Badrick, Tony

2015-08-01

In this study we aimed to compare the reporting unit size used by Australian laboratories for routine chemistry and haematology tests to the unit size used by learned authorities and in standard laboratory textbooks and to the justified unit size based on measurement uncertainty (MU) estimates from quality assurance program data. MU was determined from Royal College of Pathologists of Australasia (RCPA) - Australasian Association of Clinical Biochemists (AACB) and RCPA Haematology Quality Assurance Program survey reports. The reporting unit size implicitly suggested in authoritative textbooks, the RCPA Manual, and the General Serum Chemistry program itself was noted. We also used published data on Australian laboratory practices.The best performing laboratories could justify their chemistry unit size for 55% of analytes while comparable figures for the 50% and 90% laboratories were 14% and 8%, respectively. Reporting unit size was justifiable for all laboratories for red cell count, >50% for haemoglobin but only the top 10% for haematocrit. Few, if any, could justify their mean cell volume (MCV) and mean cell haemoglobin concentration (MCHC) reporting unit sizes.The reporting unit size used by many laboratories is not justified by present analytical performance. Using MU estimates to determine the reporting interval for quantitative laboratory results ensures reporting practices match local analytical performance and recognises the inherent error of the measurement process.

The Joint Committee for Traceability in Laboratory Medicine (JCTLM) - its history and operation.

PubMed

Jones, Graham R D; Jackson, Craig

2016-01-30

The Joint Committee for Traceability in Laboratory Medicine (JCTLM) was formed to bring together the sciences of metrology, laboratory medicine and laboratory quality management. The aim of this collaboration is to support worldwide comparability and equivalence of measurement results in clinical laboratories for the purpose of improving healthcare. The JCTLM has its origins in the activities of international metrology treaty organizations, professional societies and federations devoted to improving measurement quality in physical, chemical and medical sciences. The three founding organizations, the International Committee for Weights and Measures (CIPM), the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the International Laboratory Accreditation Cooperation (ILAC) are the leaders of this activity. The main service of the JCTLM is a web-based database with a list of reference materials, reference methods and reference measurement services meeting appropriate international standards. This database allows manufacturers to select references for assay traceability and provides support for suppliers of these services. As of mid 2015 the database lists 295 reference materials for 162 analytes, 170 reference measurement procedures for 79 analytes and 130 reference measurement services for 39 analytes. There remains a need for the development and implementation of metrological traceability in many areas of laboratory medicine and the JCTLM will continue to promote these activities into the future. Copyright © 2015 Elsevier B.V. All rights reserved.

Quality-assurance plan for the analysis of fluvial sediment by the U.S. Geological Survey Kentucky Water Science Center Sediment Laboratory

USGS Publications Warehouse

Shreve, Elizabeth A.; Downs, Aimee C.

2005-01-01

This report describes laboratory procedures used by the U.S. Geological Survey Kentucky Water Science Center Sediment Laboratory for the processing and analysis of fluvial-sediment samples for concentration of sand and finer material. The report details the processing of a sediment sample through the laboratory from receiving the sediment sample, through the analytical process, to compiling results of the requested analysis. Procedures for preserving sample integrity, calibrating and maintaining of laboratory and field instruments and equipment, analyzing samples, internal quality assurance and quality control, and validity of the sediment-analysis results also are described. The report includes a list of references cited and a glossary of sediment and quality-assurance terms.

The procedures manual of the Environmental Measurements Laboratory. Volume 1, 28. edition

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chieco, N.A.

1997-02-01

This manual covers procedures and technology currently in use at the Environmental Measurements Laboratory. An attempt is made to be sure that all work carried out will be of the highest quality. Attention is focused on the following areas: quality assurance; sampling; radiation measurements; analytical chemistry; radionuclide data; special facilities; and specifications.

Data analysis considerations for pesticides determined by National Water Quality Laboratory schedule 2437

USGS Publications Warehouse

Shoda, Megan E.; Nowell, Lisa H.; Stone, Wesley W.; Sandstrom, Mark W.; Bexfield, Laura M.

2018-04-02

In 2013, the U.S. Geological Survey National Water Quality Laboratory (NWQL) made a new method available for the analysis of pesticides in filtered water samples: laboratory schedule 2437. Schedule 2437 is an improvement on previous analytical methods because it determines the concentrations of 225 fungicides, herbicides, insecticides, and associated degradates in one method at similar or lower concentrations than previously available methods. Additionally, the pesticides included in schedule 2437 were strategically identified in a prioritization analysis that assessed likelihood of occurrence, prevalence of use, and potential toxicity. When the NWQL reports pesticide concentrations for analytes in schedule 2437, the laboratory also provides supplemental information useful to data users for assessing method performance and understanding data quality. That supplemental information is discussed in this report, along with an initial analysis of analytical recovery of pesticides in water-quality samples analyzed by schedule 2437 during 2013–2015. A total of 523 field matrix spike samples and their paired environmental samples and 277 laboratory reagent spike samples were analyzed for this report (1,323 samples total). These samples were collected in the field as part of the U.S. Geological Survey National Water-Quality Assessment groundwater and surface-water studies and as part of the NWQL quality-control program. This report reviews how pesticide samples are processed by the NWQL, addresses how to obtain all the data necessary to interpret pesticide concentrations, explains the circumstances that result in a reporting level change or the occurrence of a raised reporting level, and describes the calculation and assessment of recovery. This report also discusses reasons why a data user might choose to exclude data in an interpretive analysis and outlines the approach used to identify the potential for decreased data quality in the assessment of method recovery. The information provided in this report is essential to understanding pesticide data determined by schedule 2437 and should be reviewed before interpretation of these data.

About Region 3's Laboratory and Field Services at EPA's Environmental Science Center

EPA Pesticide Factsheets

Mission & contact information for EPA Region 3's Laboratory and Field Services located at EPA's Environmental Science Center: the Office of Analytical Services and Quality Assurance & Field Inspection Program

Evaluation of analytical errors in a clinical chemistry laboratory: a 3 year experience.

PubMed

Sakyi, As; Laing, Ef; Ephraim, Rk; Asibey, Of; Sadique, Ok

2015-01-01

Proficient laboratory service is the cornerstone of modern healthcare systems and has an impact on over 70% of medical decisions on admission, discharge, and medications. In recent years, there is an increasing awareness of the importance of errors in laboratory practice and their possible negative impact on patient outcomes. We retrospectively analyzed data spanning a period of 3 years on analytical errors observed in our laboratory. The data covered errors over the whole testing cycle including pre-, intra-, and post-analytical phases and discussed strategies pertinent to our settings to minimize their occurrence. We described the occurrence of pre-analytical, analytical and post-analytical errors observed at the Komfo Anokye Teaching Hospital clinical biochemistry laboratory during a 3-year period from January, 2010 to December, 2012. Data were analyzed with Graph Pad Prism 5(GraphPad Software Inc. CA USA). A total of 589,510 tests was performed on 188,503 outpatients and hospitalized patients. The overall error rate for the 3 years was 4.7% (27,520/58,950). Pre-analytical, analytical and post-analytical errors contributed 3.7% (2210/58,950), 0.1% (108/58,950), and 0.9% (512/58,950), respectively. The number of tests reduced significantly over the 3-year period, but this did not correspond with a reduction in the overall error rate (P = 0.90) along with the years. Analytical errors are embedded within our total process setup especially pre-analytical and post-analytical phases. Strategic measures including quality assessment programs for staff involved in pre-analytical processes should be intensified.

Analytical Chemistry Division annual progress report for period ending December 31, 1985

DOE Office of Scientific and Technical Information (OSTI.GOV)

Shultz, W.D.

1986-05-01

Progress reports are presented for the four major sections of the division: analytical spectroscopy, radioactive materials laboratories, inorganic chemistry, and organic chemistry. A brief discussion of the division's role in the Laboratory's Environmental Restoration and Facilities Upgrade is given. Information about quality assurance and safety programs is presented, along with a tabulation of analyses rendered. Publications, oral presentations, professional activities, educational programs, and seminars are cited.

External Standards or Standard Addition? Selecting and Validating a Method of Standardization

NASA Astrophysics Data System (ADS)

Harvey, David T.

2002-05-01

A common feature of many problem-based laboratories in analytical chemistry is a lengthy independent project involving the analysis of "real-world" samples. Students research the literature, adapting and developing a method suitable for their analyte, sample matrix, and problem scenario. Because these projects encompass the complete analytical process, students must consider issues such as obtaining a representative sample, selecting a method of analysis, developing a suitable standardization, validating results, and implementing appropriate quality assessment/quality control practices. Most textbooks and monographs suitable for an undergraduate course in analytical chemistry, however, provide only limited coverage of these important topics. The need for short laboratory experiments emphasizing important facets of method development, such as selecting a method of standardization, is evident. The experiment reported here, which is suitable for an introductory course in analytical chemistry, illustrates the importance of matrix effects when selecting a method of standardization. Students also learn how a spike recovery is used to validate an analytical method, and obtain a practical experience in the difference between performing an external standardization and a standard addition.

Quality Assurance of RNA Expression Profiling in Clinical Laboratories

PubMed Central

Tang, Weihua; Hu, Zhiyuan; Muallem, Hind; Gulley, Margaret L.

2012-01-01

RNA expression profiles are increasingly used to diagnose and classify disease, based on expression patterns of as many as several thousand RNAs. To ensure quality of expression profiling services in clinical settings, a standard operating procedure incorporates multiple quality indicators and controls, beginning with preanalytic specimen preparation and proceeding thorough analysis, interpretation, and reporting. Before testing, histopathological examination of each cellular specimen, along with optional cell enrichment procedures, ensures adequacy of the input tissue. Other tactics include endogenous controls to evaluate adequacy of RNA and exogenous or spiked controls to evaluate run- and patient-specific performance of the test system, respectively. Unique aspects of quality assurance for array-based tests include controls for the pertinent outcome signatures that often supersede controls for each individual analyte, built-in redundancy for critical analytes or biochemical pathways, and software-supported scrutiny of abundant data by a laboratory physician who interprets the findings in a manner facilitating appropriate medical intervention. Access to high-quality reagents, instruments, and software from commercial sources promotes standardization and adoption in clinical settings, once an assay is vetted in validation studies as being analytically sound and clinically useful. Careful attention to the well-honed principles of laboratory medicine, along with guidance from government and professional groups on strategies to preserve RNA and manage large data sets, promotes clinical-grade assay performance. PMID:22020152

National Water Quality Laboratory Profile

USGS Publications Warehouse

Raese, Jon W.

1994-01-01

The National Water Quality Laboratory determines organic and inorganic constituents in samples of surface and ground water, river and lake sediment, aquatic plant and animal material, and precipitation collected throughout the United States and its territories by the U.S. Geological Survey. In water year 1994, the Laboratory produced more than 900,000 analytical results for about 65,000 samples. The Laboratory also coordinates an extensive network of contract laboratories for the determination of radiochemical and stable isotopes and work for the U.S. Department of Defense Environmental Contamination Hydrology Program. Heightened concerns about water quality and about the possible effects of toxic chemicals at trace and ultratrace levels have contributed to an increased demand for impartial, objective, and independent data.

The "hospital central laboratory": automation, integration and clinical usefulness.

PubMed

Zaninotto, Martina; Plebani, Mario

2010-07-01

Recent technological developments in laboratory medicine have led to a major challenge, maintaining a close connection between the search of efficiency through automation and consolidation and the assurance of effectiveness. The adoption of systems that automate most of the manual tasks characterizing routine activities has significantly improved the quality of laboratory performance; total laboratory automation being the paradigm of the idea that "human-less" robotic laboratories may allow for better operation and insuring less human errors. Furthermore, even if ongoing technological developments have considerably improved the productivity of clinical laboratories as well as reducing the turnaround time of the entire process, the value of qualified personnel remains a significant issue. Recent evidence confirms that automation allows clinical laboratories to improve analytical performances only if trained staff operate in accordance with well-defined standard operative procedures, thus assuring continuous monitoring of the analytical quality. In addition, laboratory automation may improve the appropriateness of test requests through the use of algorithms and reflex testing. This should allow the adoption of clinical and biochemical guidelines. In conclusion, in laboratory medicine, technology represents a tool for improving clinical effectiveness and patient outcomes, but it has to be managed by qualified laboratory professionals.

A New Approach to Standardize Multicenter Studies: Mobile Lab Technology for the German Environmental Specimen Bank

PubMed Central

Lermen, Dominik; Schmitt, Daniel; Bartel-Steinbach, Martina; Schröter-Kermani, Christa; Kolossa-Gehring, Marike; von Briesen, Hagen; Zimmermann, Heiko

2014-01-01

Technical progress has simplified tasks in lab diagnosis and improved quality of test results. Errors occurring during the pre-analytical phase have more negative impact on the quality of test results than errors encountered during the total analytical process. Different infrastructures of sampling sites can highly influence the quality of samples and therewith of analytical results. Annually the German Environmental Specimen Bank (ESB) collects, characterizes, and stores blood, plasma, and urine samples of 120–150 volunteers each on four different sampling sites in Germany. Overarching goal is to investigate the exposure to environmental pollutants of non-occupational exposed young adults combining human biomonitoring with questionnaire data. We investigated the requirements of the study and the possibility to realize a highly standardized sampling procedure on a mobile platform in order to increase the required quality of the pre-analytical phase. The results lead to the development of a mobile epidemiologic laboratory (epiLab) in the project “Labor der Zukunft” (future’s lab technology). This laboratory includes a 14.7 m2 reception area to record medical history and exposure-relevant behavior, a 21.1 m2 examination room to record dental fillings and for blood withdrawal, a 15.5 m2 biological safety level 2 laboratory to process and analyze samples on site including a 2.8 m2 personnel lock and a 3.6 m2 cryofacility to immediately freeze samples. Frozen samples can be transferred to their final destination within the vehicle without breaking the cold chain. To our knowledge, we herewith describe for the first time the implementation of a biological safety laboratory (BSL) 2 lab and an epidemiologic unit on a single mobile platform. Since 2013 we have been collecting up to 15.000 individual human samples annually under highly standardized conditions using the mobile laboratory. Characterized and free of alterations they are kept ready for retrospective analyses in their final archive, the German ESB. PMID:25141120

A new approach to standardize multicenter studies: mobile lab technology for the German Environmental Specimen Bank.

PubMed

Lermen, Dominik; Schmitt, Daniel; Bartel-Steinbach, Martina; Schröter-Kermani, Christa; Kolossa-Gehring, Marike; von Briesen, Hagen; Zimmermann, Heiko

2014-01-01

Technical progress has simplified tasks in lab diagnosis and improved quality of test results. Errors occurring during the pre-analytical phase have more negative impact on the quality of test results than errors encountered during the total analytical process. Different infrastructures of sampling sites can highly influence the quality of samples and therewith of analytical results. Annually the German Environmental Specimen Bank (ESB) collects, characterizes, and stores blood, plasma, and urine samples of 120-150 volunteers each on four different sampling sites in Germany. Overarching goal is to investigate the exposure to environmental pollutants of non-occupational exposed young adults combining human biomonitoring with questionnaire data. We investigated the requirements of the study and the possibility to realize a highly standardized sampling procedure on a mobile platform in order to increase the required quality of the pre-analytical phase. The results lead to the development of a mobile epidemiologic laboratory (epiLab) in the project "Labor der Zukunft" (future's lab technology). This laboratory includes a 14.7 m(2) reception area to record medical history and exposure-relevant behavior, a 21.1 m(2) examination room to record dental fillings and for blood withdrawal, a 15.5 m(2) biological safety level 2 laboratory to process and analyze samples on site including a 2.8 m(2) personnel lock and a 3.6 m2 cryofacility to immediately freeze samples. Frozen samples can be transferred to their final destination within the vehicle without breaking the cold chain. To our knowledge, we herewith describe for the first time the implementation of a biological safety laboratory (BSL) 2 lab and an epidemiologic unit on a single mobile platform. Since 2013 we have been collecting up to 15.000 individual human samples annually under highly standardized conditions using the mobile laboratory. Characterized and free of alterations they are kept ready for retrospective analyses in their final archive, the German ESB.

7 CFR 91.4 - Kinds of services.

Code of Federal Regulations, 2014 CFR

2014-01-01

... in performing commodity testing services. (c) Quality assurance reviews. The Science and Technology..., Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS.... Analytical laboratory testing services under the regulations in this subchapter consist of microbiological...

7 CFR 91.4 - Kinds of services.

Code of Federal Regulations, 2011 CFR

2011-01-01

... in performing commodity testing services. (c) Quality assurance reviews. The Science and Technology..., Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS.... Analytical laboratory testing services under the regulations in this subchapter consist of microbiological...

7 CFR 91.4 - Kinds of services.

Code of Federal Regulations, 2012 CFR

2012-01-01

... in performing commodity testing services. (c) Quality assurance reviews. The Science and Technology..., Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS.... Analytical laboratory testing services under the regulations in this subchapter consist of microbiological...

7 CFR 91.4 - Kinds of services.

Code of Federal Regulations, 2013 CFR

2013-01-01

... in performing commodity testing services. (c) Quality assurance reviews. The Science and Technology..., Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS.... Analytical laboratory testing services under the regulations in this subchapter consist of microbiological...

Quality performance of laboratory testing in pharmacies: a collaborative evaluation.

PubMed

Zaninotto, Martina; Miolo, Giorgia; Guiotto, Adriano; Marton, Silvia; Plebani, Mario

2016-11-01

The quality performance and the comparability between results of pharmacies point-of-care-testing (POCT) and institutional laboratories have been evaluated. Eight pharmacies participated in the project: a capillary specimen collected by the pharmacist and, simultaneously, a lithium-heparin sample drawn by a physician of laboratory medicine for the pharmacy customers (n=106) were analyzed in the pharmacy and in the laboratory, respectively. Glucose, cholesterol, HDL-cholesterol, triglycerides, creatinine, uric acid, aspartate aminotransferase, alanine aminotransferase, were measured using: Reflotron, n=5; Samsung, n=1; Cardiocheck PA, n=1; Cholestech LDX, n=1 and Cobas 8000. The POCT analytical performance only (phase 2) were evaluated testing, in pharmacies and in the laboratory, the lithium heparin samples from a female drawn fasting daily in a week, and a control sample containing high concentrations of glucose, cholesterol and triglycerides. For all parameters, except triglycerides, the slopes showed a satisfactory correlation. For triglycerides, a median value higher in POCT in comparison to the laboratory (1.627 mmol/L vs. 0.950 mmol/L) has been observed. The agreement in the subjects classification, demonstrates that for glucose, 70% of the subjects show concentrations below the POCT recommended level (5.8-6.1 mmol/L), while 56% are according to the laboratory limit (<5.6 mmol/L). Total cholesterol exhibits a similar trend while POCT triglycerides show a greater percentage of increased values (21% vs. 9%). The reduction in triglycerides bias (phase 2) suggests that differences between POCT and central laboratory is attributable to a pre-analytical problem. The results confirm the acceptable analytical performance of POCT pharmacies and specific criticisms in the pre- and post-analytical phases.

Implementation of a new 'community' laboratory CD4 service in a rural health district in South Africa extends laboratory services and substantially improves local reporting turnaround time.

PubMed

Coetzee, L M; Cassim, N; Glencross, D K

2015-12-16

The CD4 integrated service delivery model (ITSDM) provides for reasonable access to pathology services across South Africa (SA) by offering three new service tiers that extend services into remote, under-serviced areas. ITSDM identified Pixley ka Seme as such an under-serviced district. To address the poor service delivery in this area, a new ITSDM community (tier 3) laboratory was established in De Aar, SA. Laboratory performance and turnaround time (TAT) were monitored post implementation to assess the impact on local service delivery. Using the National Health Laboratory Service Corporate Data Warehouse, CD4 data were extracted for the period April 2012-July 2013 (n=11,964). Total mean TAT (in hours) was calculated and pre-analytical and analytical components assessed. Ongoing testing volumes, as well as external quality assessment performance across ten trials, were used to indicate post-implementation success. Data were analysed using Stata 12. Prior to the implementation of CD4 testing at De Aar, the total mean TAT was 20.5 hours. This fell to 8.2 hours post implementation, predominantly as a result of a lower pre-analytical mean TAT reducing from a mean of 18.9 to 1.8 hours. The analytical testing TAT remained unchanged after implementation and monthly test volumes increased by up to 20%. External quality assessment indicated adequate performance. Although subjective, questionnaires sent to facilities reported improved service delivery. Establishing CD4 testing in a remote community laboratory substantially reduces overall TAT. Additional community CD4 laboratories should be established in under-serviced areas, especially where laboratory infrastructure is already in place.

Internal quality control: best practice.

PubMed

Kinns, Helen; Pitkin, Sarah; Housley, David; Freedman, Danielle B

2013-12-01

There is a wide variation in laboratory practice with regard to implementation and review of internal quality control (IQC). A poor approach can lead to a spectrum of scenarios from validation of incorrect patient results to over investigation of falsely rejected analytical runs. This article will provide a practical approach for the routine clinical biochemistry laboratory to introduce an efficient quality control system that will optimise error detection and reduce the rate of false rejection. Each stage of the IQC system is considered, from selection of IQC material to selection of IQC rules, and finally the appropriate action to follow when a rejection signal has been obtained. The main objective of IQC is to ensure day-to-day consistency of an analytical process and thus help to determine whether patient results are reliable enough to be released. The required quality and assay performance varies between analytes as does the definition of a clinically significant error. Unfortunately many laboratories currently decide what is clinically significant at the troubleshooting stage. Assay-specific IQC systems will reduce the number of inappropriate sample-run rejections compared with the blanket use of one IQC rule. In practice, only three or four different IQC rules are required for the whole of the routine biochemistry repertoire as assays are assigned into groups based on performance. The tools to categorise performance and assign IQC rules based on that performance are presented. Although significant investment of time and education is required prior to implementation, laboratories have shown that such systems achieve considerable reductions in cost and labour.

External quality assurance performance of clinical research laboratories in sub-saharan Africa.

PubMed

Amukele, Timothy K; Michael, Kurt; Hanes, Mary; Miller, Robert E; Jackson, J Brooks

2012-11-01

Patient Safety Monitoring in International Laboratories (JHU-SMILE) is a resource at Johns Hopkins University that supports and monitors laboratories in National Institutes of Health-funded international clinical trials. To determine the impact of the JHU-SMILE quality assurance scheme in sub-Saharan African laboratories, we reviewed 40 to 60 months of external quality assurance (EQA) results of the College of American Pathologists (CAP) in these laboratories. We reviewed the performance of 8 analytes: albumin, alanine aminotransferase, creatinine, sodium, WBC, hemoglobin, hematocrit, and the human immunodeficiency virus antibody rapid test. Over the 40- to 60-month observation period, the sub-Saharan laboratories had a 1.63% failure rate, which was 40% lower than the 2011 CAP-wide rate of 2.8%. Seventy-six percent of the observed EQA failures occurred in 4 of the 21 laboratories. These results demonstrate that a system of remote monitoring, feedback, and audits can support quality in low-resource settings, even in places without strong regulatory support for laboratory quality.

Quality-Assurance Data for Routine Water Analyses by the U.S. Geological Survey Laboratory in Troy, New York--July 1999 through June 2001

USGS Publications Warehouse

Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

2006-01-01

The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's LabMaster data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality-control samples analyzed from July 1999 through June 2001. Results for the quality-control samples for 18 analytical procedures were evaluated for bias and precision. Control charts indicate that data for eight of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, total aluminum, calcium, chloride and nitrate (ion chromatography and colormetric method) and sulfate. The total aluminum and dissolved organic carbon procedures were biased throughout the analysis period for the high-concentration sample, but were within control limits. The calcium and specific conductance procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The magnesium procedure was biased for the high-concentration and low concentration samples, but was within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 14 of 15 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for dissolved organic carbon. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 17 of the 18 analytes. At least 90 percent of the samples met data-quality objectives for all analytes except ammonium (81 percent of samples met objectives), chloride (75 percent of samples met objectives), and sodium (86 percent of samples met objectives). Results of the USGS interlaboratory Standard Reference Sample (SRS) Project indicated good data quality over the time period, with most ratings for each sample in the good to excellent range. The P-sample (low-ionic-strength constituents) analysis had one satisfactory rating for the specific conductance procedure in one study. The T-sample (trace constituents) analysis had one satisfactory rating for the aluminum procedure in one study and one unsatisfactory rating for the sodium procedure in another. The remainder of the samples had good or excellent ratings for each study. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 89 percent of the samples met data-quality objectives for 10 of the 14 analytes; the exceptions were ammonium, total aluminum, dissolved organic carbon, and sodium. Results indicate a positive bias for the ammonium procedure in all studies. Data-quality objectives were not met in 50 percent of samples analyzed for total aluminum, 38 percent of samples analyzed for dissolved organic carbon, and 27 percent of samples analyzed for sodium. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 91 percent of the samples analyzed for calcium, chloride, fluoride, magnesium, pH, potassium, and sulfate. Data-quality objectives were met by 75 percent of the samples analyzed for sodium and 58 percent of the samples analyzed for specific conductance.

External quality assessment programs in the context of ISO 15189 accreditation.

PubMed

Sciacovelli, Laura; Secchiero, Sandra; Padoan, Andrea; Plebani, Mario

2018-05-23

Effective management of clinical laboratories participating in external quality assessment schemes (EQAS) is of fundamental importance in ensuring reliable analytical results. The International Standard ISO 15189:2012 requires participation in interlaboratory comparison [e.g. external quality assessment (EQA)] for all tests provided by an individual laboratory. If EQAS is not commercially available, alternative approaches should be identified, although clinical laboratories may find it challenging to choose the EQAS that comply with the international standards and approved guidelines. Great competence is therefore required, as well as knowledge of the characteristics and key elements affecting the reliability of an EQAS, and the analytical quality specifications stated in approved documents. Another skill of fundamental importance is the ability to identify an alternative approach when the available EQAS are inadequate or missing. Yet the choice of the right EQA program alone does not guarantee its effectiveness. In fact, the fundamental steps of analysis of the information provided in EQA reports and the ability to identify improvement actions to be undertaken call for the involvement of all laboratory staff playing a role in the specific activity. The aim of this paper was to describe the critical aspects that EQA providers and laboratory professionals should control in order to guarantee effective EQAS management and compliance with ISO 15189 accreditation requirements.

Prevalence of Pre-Analytical Errors in Clinical Chemistry Diagnostic Labs in Sulaimani City of Iraqi Kurdistan

PubMed Central

2017-01-01

Background Laboratory testing is roughly divided into three phases: a pre-analytical phase, an analytical phase and a post-analytical phase. Most analytical errors have been attributed to the analytical phase. However, recent studies have shown that up to 70% of analytical errors reflect the pre-analytical phase. The pre-analytical phase comprises all processes from the time a laboratory request is made by a physician until the specimen is analyzed at the lab. Generally, the pre-analytical phase includes patient preparation, specimen transportation, specimen collection and storage. In the present study, we report the first comprehensive assessment of the frequency and types of pre-analytical errors at the Sulaimani diagnostic labs in Iraqi Kurdistan. Materials and Methods Over 2 months, 5500 venous blood samples were observed in 10 public diagnostic labs of Sulaimani City. The percentages of rejected samples and types of sample inappropriateness were evaluated. The percentage of each of the following pre-analytical errors were recorded: delay in sample transportation, clotted samples, expired reagents, hemolyzed samples, samples not on ice, incorrect sample identification, insufficient sample, tube broken in centrifuge, request procedure errors, sample mix-ups, communication conflicts, misinterpreted orders, lipemic samples, contaminated samples and missed physician’s request orders. The difference between the relative frequencies of errors observed in the hospitals considered was tested using a proportional Z test. In particular, the survey aimed to discover whether analytical errors were recorded and examine the types of platforms used in the selected diagnostic labs. Results The analysis showed a high prevalence of improper sample handling during the pre-analytical phase. In appropriate samples, the percentage error was as high as 39%. The major reasons for rejection were hemolyzed samples (9%), incorrect sample identification (8%) and clotted samples (6%). Most quality control schemes at Sulaimani hospitals focus only on the analytical phase, and none of the pre-analytical errors were recorded. Interestingly, none of the labs were internationally accredited; therefore, corrective actions are needed at these hospitals to ensure better health outcomes. Internal and External Quality Assessment Schemes (EQAS) for the pre-analytical phase at Sulaimani clinical laboratories should be implemented at public hospitals. Furthermore, lab personnel, particularly phlebotomists, need continuous training on the importance of sample quality to obtain accurate test results. PMID:28107395

Prevalence of Pre-Analytical Errors in Clinical Chemistry Diagnostic Labs in Sulaimani City of Iraqi Kurdistan.

PubMed

Najat, Dereen

2017-01-01

Laboratory testing is roughly divided into three phases: a pre-analytical phase, an analytical phase and a post-analytical phase. Most analytical errors have been attributed to the analytical phase. However, recent studies have shown that up to 70% of analytical errors reflect the pre-analytical phase. The pre-analytical phase comprises all processes from the time a laboratory request is made by a physician until the specimen is analyzed at the lab. Generally, the pre-analytical phase includes patient preparation, specimen transportation, specimen collection and storage. In the present study, we report the first comprehensive assessment of the frequency and types of pre-analytical errors at the Sulaimani diagnostic labs in Iraqi Kurdistan. Over 2 months, 5500 venous blood samples were observed in 10 public diagnostic labs of Sulaimani City. The percentages of rejected samples and types of sample inappropriateness were evaluated. The percentage of each of the following pre-analytical errors were recorded: delay in sample transportation, clotted samples, expired reagents, hemolyzed samples, samples not on ice, incorrect sample identification, insufficient sample, tube broken in centrifuge, request procedure errors, sample mix-ups, communication conflicts, misinterpreted orders, lipemic samples, contaminated samples and missed physician's request orders. The difference between the relative frequencies of errors observed in the hospitals considered was tested using a proportional Z test. In particular, the survey aimed to discover whether analytical errors were recorded and examine the types of platforms used in the selected diagnostic labs. The analysis showed a high prevalence of improper sample handling during the pre-analytical phase. In appropriate samples, the percentage error was as high as 39%. The major reasons for rejection were hemolyzed samples (9%), incorrect sample identification (8%) and clotted samples (6%). Most quality control schemes at Sulaimani hospitals focus only on the analytical phase, and none of the pre-analytical errors were recorded. Interestingly, none of the labs were internationally accredited; therefore, corrective actions are needed at these hospitals to ensure better health outcomes. Internal and External Quality Assessment Schemes (EQAS) for the pre-analytical phase at Sulaimani clinical laboratories should be implemented at public hospitals. Furthermore, lab personnel, particularly phlebotomists, need continuous training on the importance of sample quality to obtain accurate test results.

A Lean Six Sigma approach to the improvement of the selenium analysis method.

PubMed

Cloete, Bronwyn C; Bester, André

2012-11-02

Reliable results represent the pinnacle assessment of quality of an analytical laboratory, and therefore variability is considered to be a critical quality problem associated with the selenium analysis method executed at Western Cape Provincial Veterinary Laboratory (WCPVL). The elimination and control of variability is undoubtedly of significant importance because of the narrow margin of safety between toxic and deficient doses of the trace element for good animal health. A quality methodology known as Lean Six Sigma was believed to present the most feasible solution for overcoming the adverse effect of variation, through steps towards analytical process improvement. Lean Six Sigma represents a form of scientific method type, which is empirical, inductive and deductive, and systematic, which relies on data, and is fact-based. The Lean Six Sigma methodology comprises five macro-phases, namely Define, Measure, Analyse, Improve and Control (DMAIC). Both qualitative and quantitative laboratory data were collected in terms of these phases. Qualitative data were collected by using quality-tools, namely an Ishikawa diagram, a Pareto chart, Kaizen analysis and a Failure Mode Effect analysis tool. Quantitative laboratory data, based on the analytical chemistry test method, were collected through a controlled experiment. The controlled experiment entailed 13 replicated runs of the selenium test method, whereby 11 samples were repetitively analysed, whilst Certified Reference Material (CRM) was also included in 6 of the runs. Laboratory results obtained from the controlled experiment was analysed by using statistical methods, commonly associated with quality validation of chemistry procedures. Analysis of both sets of data yielded an improved selenium analysis method, believed to provide greater reliability of results, in addition to a greatly reduced cycle time and superior control features. Lean Six Sigma may therefore be regarded as a valuable tool in any laboratory, and represents both a management discipline, and a standardised approach to problem solving and process optimisation.

7 CFR 91.1 - General.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES... administrative rules of the Science and Technology of the Agricultural Marketing Service for conducting the analytical testing and laboratory audits with quality assurance reviews. It also contains the fees, charges...

7 CFR 91.1 - General.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES... administrative rules of the Science and Technology of the Agricultural Marketing Service for conducting the analytical testing and laboratory audits with quality assurance reviews. It also contains the fees, charges...

7 CFR 91.1 - General.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES... administrative rules of the Science and Technology of the Agricultural Marketing Service for conducting the analytical testing and laboratory audits with quality assurance reviews. It also contains the fees, charges...

7 CFR 91.1 - General.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES... administrative rules of the Science and Technology of the Agricultural Marketing Service for conducting the analytical testing and laboratory audits with quality assurance reviews. It also contains the fees, charges...

Development of a framework of quality assurance practices for a radon passive dosemeter service.

PubMed

D'Alessandro, M; Leonardi, F; Tonnarini, S; Trevisi, R; Veschetti, M

2010-06-01

Etched track detectors are widely used for the detection of radon and its decay products. The reliability of radon measurement performed with such devices requires that laboratories producing analytical data are able to provide results of the required quality. The need for uniform results from laboratories at an international level therefore requires the implementation of a quality assurance programme, the harmonization of criteria, sampling procedures, calculations and the reporting of results, agreed on the basis of fundamental principles and international standards. The quality assurance programme described here is the first step on the way to ISO/IEC 17025 certification for the RI-RN (ISPESL) laboratory.

Variability in baseline laboratory measurements of the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil).

PubMed

Ladwig, R; Vigo, A; Fedeli, L M G; Chambless, L E; Bensenor, I; Schmidt, M I; Vidigal, P G; Castilhos, C D; Duncan, B B

2016-08-01

Multi-center epidemiological studies must ascertain that their measurements are accurate and reliable. For laboratory measurements, reliability can be assessed through investigation of reproducibility of measurements in the same individual. In this paper, we present results from the quality control analysis of the baseline laboratory measurements from the ELSA-Brasil study. The study enrolled 15,105 civil servants at 6 research centers in 3 regions of Brazil between 2008-2010, with multiple biochemical analytes being measured at a central laboratory. Quality control was ascertained through standard laboratory evaluation of intra- and inter-assay variability and test-retest analysis in a subset of randomly chosen participants. An additional sample of urine or blood was collected from these participants, and these samples were handled in the same manner as the original ones, locally and at the central laboratory. Reliability was assessed with the intraclass correlation coefficient (ICC), estimated through a random effects model. Coefficients of variation (CV) and Bland-Altman plots were additionally used to assess measurement variability. Laboratory intra and inter-assay CVs varied from 0.86% to 7.77%. From test-retest analyses, the ICCs were high for the majority of the analytes. Notably lower ICCs were observed for serum sodium (ICC=0.50; 95%CI=0.31-0.65) and serum potassium (ICC=0.73; 95%CI=0.60-0.83), due to the small biological range of these analytes. The CVs ranged from 1 to 14%. The Bland-Altman plots confirmed these results. The quality control analyses showed that the collection, processing and measurement protocols utilized in the ELSA-Brasil produced reliable biochemical measurements.

Quality Manual

NASA Astrophysics Data System (ADS)

Koch, Michael

The quality manual is the “heart” of every management system related to quality. Quality assurance in analytical laboratories is most frequently linked with ISO/IEC 17025, which lists the standard requirements for a quality manual. In this chapter examples are used to demonstrate, how these requirements can be met. But, certainly, there are many other ways to do this.

Evaluation of Analytical Errors in a Clinical Chemistry Laboratory: A 3 Year Experience

PubMed Central

Sakyi, AS; Laing, EF; Ephraim, RK; Asibey, OF; Sadique, OK

2015-01-01

Background: Proficient laboratory service is the cornerstone of modern healthcare systems and has an impact on over 70% of medical decisions on admission, discharge, and medications. In recent years, there is an increasing awareness of the importance of errors in laboratory practice and their possible negative impact on patient outcomes. Aim: We retrospectively analyzed data spanning a period of 3 years on analytical errors observed in our laboratory. The data covered errors over the whole testing cycle including pre-, intra-, and post-analytical phases and discussed strategies pertinent to our settings to minimize their occurrence. Materials and Methods: We described the occurrence of pre-analytical, analytical and post-analytical errors observed at the Komfo Anokye Teaching Hospital clinical biochemistry laboratory during a 3-year period from January, 2010 to December, 2012. Data were analyzed with Graph Pad Prism 5(GraphPad Software Inc. CA USA). Results: A total of 589,510 tests was performed on 188,503 outpatients and hospitalized patients. The overall error rate for the 3 years was 4.7% (27,520/58,950). Pre-analytical, analytical and post-analytical errors contributed 3.7% (2210/58,950), 0.1% (108/58,950), and 0.9% (512/58,950), respectively. The number of tests reduced significantly over the 3-year period, but this did not correspond with a reduction in the overall error rate (P = 0.90) along with the years. Conclusion: Analytical errors are embedded within our total process setup especially pre-analytical and post-analytical phases. Strategic measures including quality assessment programs for staff involved in pre-analytical processes should be intensified. PMID:25745569

[Laboratory accreditation and proficiency testing].

PubMed

Kuwa, Katsuhiko

2003-05-01

ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.

Do new concepts for deriving permissible limits for analytical imprecision and bias have any advantages over existing consensus?

PubMed

Petersen, Per Hyltoft; Sandberg, Sverre; Fraser, Callum G

2011-04-01

The Stockholm conference held in 1999 on "Strategies to set global analytical quality specifications (AQS) in laboratory medicine" reached a consensus and advocated the ubiquitous application of a hierarchical structure of approaches to setting AQS. This approach has been widely used over the last decade, although several issues remain unanswered. A number of new suggestions have been recently proposed for setting AQS. One of these recommendations is described by Haeckel and Wosniok in this issue of Clinical Chemistry and Laboratory Medicine. Their concept is to estimate the increase in false-positive results using conventional population-based reference intervals, the delta false-positive rate due to analytical imprecision and bias, and relate the results directly to the current analytical quality attained. Thus, the actual estimates in the laboratory for imprecision and bias are compared to the AQS. These values are classified in a ranking system according to the closeness to the AQS, and this combination is the new idea of the proposal. Other new ideas have been proposed recently. We wait, with great interest, as should others, to see if these newer approaches become widely used and worthy of incorporation into the hierarchy.

Quality-control materials in the USDA National Food and Nutrient Analysis Program (NFNAP).

PubMed

Phillips, Katherine M; Patterson, Kristine Y; Rasor, Amy S; Exler, Jacob; Haytowitz, David B; Holden, Joanne M; Pehrsson, Pamela R

2006-03-01

The US Department of Agriculture (USDA) Nutrient Data Laboratory (NDL) develops and maintains the USDA National Nutrient Databank System (NDBS). Data are released from the NDBS for scientific and public use through the USDA National Nutrient Database for Standard Reference (SR) ( http://www.ars.usda.gov/ba/bhnrc/ndl ). In 1997 the NDL initiated the National Food and Nutrient Analysis Program (NFNAP) to update and expand its food-composition data. The program included: 1) nationwide probability-based sampling of foods; 2) central processing and archiving of food samples; 3) analysis of food components at commercial, government, and university laboratories; 4) incorporation of new analytical data into the NDBS; and 5) dissemination of these data to the scientific community. A key feature and strength of the NFNAP was a rigorous quality-control program that enabled independent verification of the accuracy and precision of analytical results. Custom-made food-control composites and/or commercially available certified reference materials were sent to the laboratories, blinded, with the samples. Data for these materials were essential to ongoing monitoring of analytical work, to identify and resolve suspected analytical problems, to ensure the accuracy and precision of results for the NFNAP food samples.

What information on measurement uncertainty should be communicated to clinicians, and how?

PubMed

Plebani, Mario; Sciacovelli, Laura; Bernardi, Daniela; Aita, Ada; Antonelli, Giorgia; Padoan, Andrea

2018-02-02

The communication of laboratory results to physicians and the quality of reports represent fundamental requirements of the post-analytical phase in order to assure the right interpretation and utilization of laboratory information. Accordingly, the International Standard for clinical laboratories accreditation (ISO 15189) requires that "laboratory reports shall include the information necessary for the interpretation of the examination results". Measurement uncertainty (MU) is an inherent property of any quantitative measurement result which express the lack of knowledge of the true value and quantify the uncertainty of a result, incorporating the factors known to influence it. Even if the MU is not included in the report attributes of ISO 15189 and cannot be considered a post-analytical requirement, it is suggested as an information which should facilitate an appropriate interpretation of quantitative results (quantity values). Therefore, MU has two intended uses: for laboratory professionals, it gives information about the quality of measurements, providing evidence of the compliance with analytical performance characteristics; for physicians (and patients) it may help in interpretation of measurement results, especially when values are compared with reference intervals or clinical decision limits, providing objective information. Here we describe the way that MU should be added to laboratory reports in order to facilitate the interpretation of laboratory results and connecting efforts performed within laboratory to provide more accurate and reliable results with a more objective tool for their interpretation by physicians. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Green, D.W.; Boparai, A.S.; Bowers, D.L.

This report summarizes the activities of the Analytical Chemistry Laboratory (ACL) at Argonne National Laboratory (ANL) for Fiscal Year (FY) 2000 (October 1999 through September 2000). This annual progress report, which is the seventeenth in this series for the ACL, describes effort on continuing projects, work on new projects, and contributions of the ACL staff to various programs at ANL. The ACL operates within the ANL system as a full-cost-recovery service center, but it has a mission that includes a complementary research and development component: The Analytical Chemistry Laboratory will provide high-quality, cost-effective chemical analysis and related technical support tomore » solve research problems of our clients--Argonne National Laboratory, the Department of Energy, and others--and will conduct world-class research and development in analytical chemistry and its applications. The ACL handles a wide range of analytical problems that reflects the diversity of research and development (R&D) work at ANL. Some routine or standard analyses are done, but the ACL operates more typically in a problem-solving mode in which development of methods is required or adaptation of techniques is needed to obtain useful analytical data. The ACL works with clients and commercial laboratories if a large number of routine analyses are required. Much of the support work done by the ACL is very similar to applied analytical chemistry research work.« less

Quality-assurance data for routine water analyses by the U.S. Geological Survey laboratory in Troy, New York - July 2003 through June 2005

USGS Publications Warehouse

Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

2009-01-01

The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's Lab Master data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality control samples analyzed from July 2003 through June 2005. Results for the quality-control samples for 20 analytical procedures were evaluated for bias and precision. Control charts indicate that data for five of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, pH, silicon, and sodium. Seven of the analytical procedures were biased throughout the analysis period for the high-concentration sample, but were within control limits; these procedures were: dissolved organic carbon, chloride, nitrate (ion chromatograph), nitrite, silicon, sodium, and sulfate. The calcium and magnesium procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The total aluminum and specific conductance procedures were biased for the high-concentration and low-concentration samples, but were within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 17 of 18 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for dissolved organic carbon. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 18 of the 22 analytes. At least 85 percent of the samples met data-quality objectives for all analytes except total monomeric aluminum (82 percent of samples met objectives), total aluminum (77 percent of samples met objectives), chloride (80 percent of samples met objectives), fluoride (76 percent of samples met objectives), and nitrate (ion chromatograph) (79 percent of samples met objectives). The ammonium and total dissolved nitrogen did not meet the data-quality objectives. Results of the USGS interlaboratory Standard Reference Sample (SRS) Project indicated good data quality over the time period, with ratings for each sample in the satisfactory, good, and excellent ranges or less than 10 percent error. The P-sample (low-ionic-strength constituents) analysis had one marginal and two unsatisfactory ratings for the chloride procedure. The T-sample (trace constituents)analysis had two unsatisfactory ratings and one high range percent error for the aluminum procedure. The N-sample (nutrient constituents) analysis had one marginal rating for the nitrate procedure. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 84 percent of the samples met data-quality objectives for 11 of the 14 analytes; the exceptions were ammonium, total aluminum, and acid-neutralizing capacity. The ammonium procedure did not meet data quality objectives in all studies. Data-quality objectives were not met in 23 percent of samples analyzed for total aluminum and 45 percent of samples analyzed acid-neutralizing capacity. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 86 percent of the samples analyzed for calcium, chloride, fluoride, magnesium, pH, potassium, sodium, and sulfate. Data-quality objectives were not met by samples analyzed for fluoride. 

QA/QC in the laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hood, F.C.

1992-05-01

Quality assurance and quality control (QA/QC) of analytical chemistry laboratory activities are essential to the validity and usefulness of resultant data. However, in themselves, conventional QA/QC measures will not always ensure that fraudulent data are not generated. Conventional QA/QC measures are based on the assumption that work will be done in good faith; to assure against fraudulent practices, QA/QC measures must be tailored to specific analyses protocols in anticipation of intentional misapplication of those protocols. Application of specific QA/QC measures to ensure against fraudulent practices result in an increased administrative burden being placed on the analytical process; accordingly, in keepingmore » with graded QA philosophy, data quality objectives must be used to identify specific points of concern for special control to minimize the administrative impact.« less

QA/QC in the laboratory. Session F

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hood, F.C.

1992-05-01

Quality assurance and quality control (QA/QC) of analytical chemistry laboratory activities are essential to the validity and usefulness of resultant data. However, in themselves, conventional QA/QC measures will not always ensure that fraudulent data are not generated. Conventional QA/QC measures are based on the assumption that work will be done in good faith; to assure against fraudulent practices, QA/QC measures must be tailored to specific analyses protocols in anticipation of intentional misapplication of those protocols. Application of specific QA/QC measures to ensure against fraudulent practices result in an increased administrative burden being placed on the analytical process; accordingly, in keepingmore » with graded QA philosophy, data quality objectives must be used to identify specific points of concern for special control to minimize the administrative impact.« less

Quality systems in veterinary diagnostics laboratories.

PubMed

de Branco, Freitas Maia L M

2007-01-01

Quality assurance of services provided by veterinary diagnostics laboratories is a fundamental element promoted by international animal health organizations to establish trust, confidence and transparency needed for the trade of animals and their products at domestic and international levels. It requires, among other things, trained personnel, consistent and rigorous methodology, choice of suitable methods as well as appropriate calibration and traceability procedures. An important part of laboratory quality management is addressed by ISO/IEC 17025, which aims to facilitate cooperation among laboratories and their associated parties by assuring the generation of credible and consistent information derived from analytical results. Currently, according to OIE recommendation, veterinary diagnostics laboratories are only subject to voluntary compliance with standard ISO/IEC 17025; however, it is proposed here that OIE reference laboratories and collaboration centres strongly consider its adoption.

Analytical methods manual for the Mineral Resource Surveys Program, U.S. Geological Survey

USGS Publications Warehouse

Arbogast, Belinda F.

1996-01-01

The analytical methods validated by the Mineral Resource Surveys Program, Geologic Division, is the subject of this manual. This edition replaces the methods portion of Open-File Report 90-668 published in 1990. Newer methods may be used which have been approved by the quality assurance (QA) project and are on file with the QA coordinator.This manual is intended primarily for use by laboratory scientists; this manual can also assist laboratory users to evaluate the data they receive. The analytical methods are written in a step by step approach so that they may be used as a training tool and provide detailed documentation of the procedures for quality assurance. A "Catalog of Services" is available for customer (submitter) use with brief listings of:the element(s)/species determined,method of determination,reference to cite,contact person,summary of the technique,and analyte concentration range.For a copy please contact the Branch office at (303) 236-1800 or fax (303) 236-3200.

Fifteen years of external quality assessment in leukemia/lymphoma immunophenotyping in The Netherlands and Belgium: A way forward.

PubMed

Preijers, Frank W M B; van der Velden, Vincent H J; Preijers, Tim; Brooimans, Rik A; Marijt, Erik; Homburg, Christa; van Montfort, Kees; Gratama, Jan W

2016-05-01

In 1985, external quality assurance was initiated in the Netherlands to reduce the between-laboratory variability of leukemia/lymphoma immunophenotyping and to improve diagnostic conclusions. This program consisted of regular distributions of test samples followed by biannual plenary participant meetings in which results were presented and discussed. A scoring system was developed in which the quality of results was rated by systematically reviewing the pre-analytical, analytical, and post-analytical assay stages using three scores, i.e., correct (A), minor fault (B), and major fault (C). Here, we report on 90 consecutive samples distributed to 40-61 participating laboratories between 1998 and 2012. Most samples contained >20% aberrant cells, mainly selected from mature lymphoid malignancies (B or T cell) and acute leukemias (myeloid or lymphoblastic). In 2002, minimally required monoclonal antibody (mAb) panels were introduced, whilst methodological guidelines for all three assay stages were implemented. Retrospectively, we divided the study into subsequent periods of 4 ("initial"), 4 ("learning"), and 7 years ("consolidation") to detect "learning effects." Uni- and multivariate models showed that analytical performance declined since 2002, but that post-analytical performance improved during the entire period. These results emphasized the need to improve technical aspects of the assay, and reflected improved interpretational skills of the participants. A strong effect of participant affiliation in all three assay stages was observed: laboratories in academic and large peripheral hospitals performed significantly better than those in small hospitals. © 2015 International Clinical Cytometry Society. © 2015 International Clinical Cytometry Society.

42 CFR 493.1283 - Standard: Test records.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic Systems § 493.1283 Standard: Test records. (a) The laboratory must maintain an information or record system that includes the following: (1) The positive identification of the specimen. (2) The date and...

External quality assessment for laboratory testing of HLA-B*15:02 allele in relation to carbamazepine therapy.

PubMed

Lin, Guigao; Zhang, Kuo; Han, Yanxi; Xie, Jiehong; Li, Jinming

2018-02-01

Due to the significant risk of developing Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), the use of carbamazepine is not recommended in patients carrying the human leukocyte antigen B (HLA-B) *15:02 allele. In an effort to guarantee reliable community-based HLA-B*15:02 testing throughout China, a HLA-B*15:02 genotyping external quality assessment (EQA) program was set up. In 2016, 10 genomic DNA samples with known HLA-B*15:02 allele status were sent to 37 laboratories from 16 provinces with a request for routine HLA-B*15:02 screening. The samples were validated using Sanger sequencing by a reference laboratory. Both genotyping results and clinical written reports were evaluated. Thirty-six of the participating laboratories correctly identified the HLA-B*15:02 allele status for all EQA samples. However, one lab failed to identify any positive challenges. The overall analytical sensitivity was 97.3% (180/185 challenges; 95% confidence interval: 93.8%-99.1%) and the analytic specificity was 100% (185/185; 95% confidence interval: 98.0%-100%). A review of the written reports showed that the clinical reporting for HLA-B*15:02 detection should be improved. Some essential information was missing, most notably laboratory information/contact, therapeutic recommendations, and methodology. External quality assessment is valuable in assessing and improving the quality of laboratory testing of HLA-B*15:02 allele. © 2017 Wiley Periodicals, Inc.

METHOD 544. DETERMINATION OF MICROCYSTINS AND ...

EPA Pesticide Factsheets

Method 544 is an accurate and precise analytical method to determine six microcystins (including MC-LR) and nodularin in drinking water using solid phase extraction and liquid chromatography tandem mass spectrometry (SPE-LC/MS/MS). The advantage of this SPE-LC/MS/MS is its sensitivity and ability to speciate the microcystins. This method development task establishes sample preservation techniques, sample concentration and analytical procedures, aqueous and extract holding time criteria and quality control procedures. Draft Method 544 undergone a multi-laboratory verification to ensure other laboratories can implement the method and achieve the quality control measures specified in the method. It is anticipated that Method 544 may be used in UCMR 4 to collect nationwide occurrence data for selected microcystins in drinking water. The purpose of this research project is to develop an accurate and precise analytical method to concentrate and determine selected MCs and nodularin in drinking water.

Towards European urinalysis guidelines. Introduction of a project under European Confederation of Laboratory Medicine.

PubMed

Kouri, T T; Gant, V A; Fogazzi, G B; Hofmann, W; Hallander, H O; Guder, W G

2000-07-01

Improved standardized performance is needed because urinalysis continues to be one of the most frequently requested laboratory tests. Since 1997, the European Confederation of Laboratory Medicine (ECLM) has been supporting an interdisciplinary project aiming to produce European urinalysis guidelines. More than seventy clinical chemists, microbiologists and ward-based clinicians, as well as representatives of manufacturers are taking part. These guidelines aim to improve the quality and consistency of chemical urinalysis, particle counting and bacterial culture by suggesting optimal investigative processes that could be applied in Europe. The approach is based on medical needs for urinalysis. The importance of the pre-analytical stage for total quality is stressed by detailed illustrative advice for specimen collection. Attention is also given to emerging automated technology. For cost containment reasons, both optimum (ideal) procedures and minimum analytical approaches are suggested. Since urinalysis mostly lacks genuine reference methods (primary reference measurement procedures; Level 4), a novel classification of the methods is proposed: comparison measurement procedures (Level 3), quantitative routine procedures (Level 2), and ordinal scale examinations (Level 1). Stepwise strategies are suggested to save costs, applying different rules for general and specific patient populations. New analytical quality specifications have been created. After a consultation period, the final written text will be published in full as a separate document.

External Quality Assurance Programs Managed by the U.S. Geological Survey in Support of the National Atmospheric Deposition Program/Mercury Deposition Network

USGS Publications Warehouse

Latysh, Natalie E.; Wetherbee, Gregory A.

2007-01-01

The U.S. Geological Survey (USGS) Branch of Quality Systems operates external quality assurance programs for the National Atmospheric Deposition Program/Mercury Deposition Network (NADP/MDN). Beginning in 2004, three programs have been implemented: the system blank program, the interlaboratory comparison program, and the blind audit program. Each program was designed to measure error contributed by specific components in the data-collection process. The system blank program assesses contamination that may result from sampling equipment, field exposure, and routine handling and processing of the wet-deposition samples. The interlaboratory comparison program evaluates bias and precision of analytical results produced by the Mercury Analytical Laboratory (HAL) for the NADP/MDN, operated by Frontier GeoSciences, Inc. The HAL's performance is compared with the performance of five other laboratories. The blind audit program assesses bias and variability of MDN data produced by the HAL using solutions disguised as environmental samples to ascertain true laboratory performance. This report documents the implementation of quality assurance procedures for the NADP/MDN and the operating procedures for each of the external quality assurance programs conducted by the USGS. The USGS quality assurance information provides a measure of confidence to NADP/MDN data users that measurement variability is distinguished from environmental signals.

Analytical performances of food microbiology laboratories - critical analysis of 7 years of proficiency testing results.

PubMed

Abdel Massih, M; Planchon, V; Polet, M; Dierick, K; Mahillon, J

2016-02-01

Based on the results of 19 food microbiology proficiency testing (PT) schemes, this study aimed to assess the laboratory performances, to highlight the main sources of unsatisfactory analytical results and to suggest areas of improvement. The 2009-2015 results of REQUASUD and IPH PT, involving a total of 48 laboratories, were analysed. On average, the laboratories failed to detect or enumerate foodborne pathogens in 3·0% of the tests. Thanks to a close collaboration with the PT participants, the causes of outliers could be identified in 74% of the cases. The main causes of erroneous PT results were either pre-analytical (handling of the samples, timing of analysis), analytical (unsuitable methods, confusion of samples, errors in colony counting or confirmation) or postanalytical mistakes (calculation and encoding of results). PT schemes are a privileged observation post to highlight analytical problems, which would otherwise remain unnoticed. In this perspective, this comprehensive study of PT results provides insight into the sources of systematic errors encountered during the analyses. This study draws the attention of the laboratories to the main causes of analytical errors and suggests practical solutions to avoid them, in an educational purpose. The observations support the hypothesis that regular participation to PT, when followed by feed-back and appropriate corrective actions, can play a key role in quality improvement and provide more confidence in the laboratory testing results. © 2015 The Society for Applied Microbiology.

QADATA user's manual; an interactive computer program for the retrieval and analysis of the results from the external blind sample quality- assurance project of the U.S. Geological Survey

USGS Publications Warehouse

Lucey, K.J.

1990-01-01

The U.S. Geological Survey conducts an external blind sample quality assurance project for its National Water Quality Laboratory in Denver, Colorado, based on the analysis of reference water samples. Reference samples containing selected inorganic and nutrient constituents are disguised as environmental samples at the Survey 's office in Ocala, Florida, and are sent periodically through other Survey offices to the laboratory. The results of this blind sample project indicate the quality of analytical data produced by the laboratory. This report provides instructions on the use of QADATA, an interactive, menu-driven program that allows users to retrieve the results of the blind sample quality- assurance project. The QADATA program, which is available on the U.S. Geological Survey 's national computer network, accesses a blind sample data base that contains more than 50,000 determinations from the last five water years for approximately 40 constituents at various concentrations. The data can be retrieved from the database for any user- defined time period and for any or all available constituents. After the user defines the retrieval, the program prepares statistical tables, control charts, and precision plots and generates a report which can be transferred to the user 's office through the computer network. A discussion of the interpretation of the program output is also included. This quality assurance information will permit users to document the quality of the analytical results received from the laboratory. The blind sample data is entered into the database within weeks after being produced by the laboratory and can be retrieved to meet the needs of specific projects or programs. (USGS)

[Analysis of productivity, quality and cost of first grade laboratories: blood biometry].

PubMed

Avila, L; Hernández, P; Cruz, A; Zurita, B; Terres, A M; Cruz, C

1999-04-01

Assessment of productivity, quality and production costs and determination of the efficiency of top grade clinical laboratories in Mexico. Ten laboratories were selected from among the total number (52) existing in Mexico City, and the Donabedian model of structure, process and results were applied. Blood count was selected as a tracer. The principal problems found were: inadequate distribution of trained human resources, poor glass material, inadequate analytic process and low productivity. These factors are reflected in the unit costs, which exceed reference laboratory costs by 200%. Only 50% of the laboratories analyzed generate reliable results. Only 20% of the laboratories studied operate efficiently. To solve the problems identified requires integral strategies at different levels. A specific recomendation for the improvement of quality and productivity is an assessment of the cost/benefit of creating a central laboratory and using the remaining sites exclusively for the collection of samples.

Participation in Performance-Evaluation Studies by U.S. Geological Survey National Water Quality Laboratory

USGS Publications Warehouse

Glodt, Stephen R.; Pirkey, Kimberly D.

1998-01-01

Performance-evaluation studies provide customers of the U.S. Geological Survey National Water Quality Laboratory (NWQL) with data needed to evaluate performance and to compare of select laboratories for analytical work. The NWQL participates in national and international performance-evaluation (PE) studies that consist of samples of water, sediment, and aquatic biological materials for the analysis of inorganic constituents, organic compounds, and radionuclides. This Fact Sheet provides a summary of PE study results from January 1993 through April 1997. It should be of particular interest to USGS customers and potential customers of the NWQL, water-quality specialists, cooperators, and agencies of the Federal Government.

Evaluation of Quality-Assurance/Quality-Control Data Collected by the U.S. Geological Survey from Wells and Springs between the Southern Boundary of the Idaho National Engineering and Environmental Laboratory and the Hagerman Area, Idaho, 1989 through 1995

DOE Office of Scientific and Technical Information (OSTI.GOV)

Williams, L.M.; Bartholomay, R.C.; Campbell, L.J.

1998-10-01

The U.S. Geological (USGS) and the Idaho Department of Water Resources, in cooperation with the U.S. Department of Energy, collected and analyzed water samples to monitor the water quality of the Snake River Plain aquifer from the southern boundary of the Idaho National Engineering and Environmental Laboratory to the Hagerman area, Idaho. Concurrently, replicate samples and blank samples were collected and analyzed as part of the quality-assurance/quality-control program. Samples were analyzed from inorganic constituents, gross radioactivity and radionuclides, organic constituents, and stable isotopes. To evaluate the precision of field and laboratory methods, analytical results of the water-quality and replicate samplesmore » were compared statistically for equivalence on the basis of the precision associated with each result. Statistical comparisons of the data indicated that 95 percent of the results of the replicate pairs were equivalent. Blank-sample analytical results indicated th at the inorganic blank water and volatile organic compound blank water from the USGS National Water Quality Laboratory and the distilled water from the Idaho Department of Water Resources were suitable for blanks; blank water from other sources was not. Equipment-blank analytical results were evaluated to determine if a bias had been introduced and possible sources of bias. Most equipment blanks were analyzed for trace elements and volatile organic compounds; chloroform was found in one equipment blank. Two of the equipment blanks were prepared after collection and analyses of the water-quality samples to determine whether contamination had been introduced during the sampling process. Results of one blank indicated that a hose used to divert water away from pumps and electrical equipment had contaminated the samples with some volatile organic compounds. Results of the other equipment blank, from the apparatus used to filter dissolved organic carbon samples, indicated that the filtering apparatus did not affect water-quality samples.« less

Evaluation of a reduced centrifugation time and higher centrifugal force on various general chemistry and immunochemistry analytes in plasma and serum.

PubMed

Møller, Mette F; Søndergaard, Tove R; Kristensen, Helle T; Münster, Anna-Marie B

2017-09-01

Background Centrifugation of blood samples is an essential preanalytical step in the clinical biochemistry laboratory. Centrifugation settings are often altered to optimize sample flow and turnaround time. Few studies have addressed the effect of altering centrifugation settings on analytical quality, and almost all studies have been done using collection tubes with gel separator. Methods In this study, we compared a centrifugation time of 5 min at 3000 ×  g to a standard protocol of 10 min at 2200 ×  g. Nine selected general chemistry and immunochemistry analytes and interference indices were studied in lithium heparin plasma tubes and serum tubes without gel separator. Results were evaluated using mean bias, difference plots and coefficient of variation, compared with maximum allowable bias and coefficient of variation used in laboratory routine quality control. Results For all analytes except lactate dehydrogenase, the results were within the predefined acceptance criteria, indicating that the analytical quality was not compromised. Lactate dehydrogenase showed higher values after centrifugation for 5 min at 3000 ×  g, mean bias was 6.3 ± 2.2% and the coefficient of variation was 5%. Conclusions We found that a centrifugation protocol of 5 min at 3000 ×  g can be used for the general chemistry and immunochemistry analytes studied, with the possible exception of lactate dehydrogenase, which requires further assessment.

The Analytical Quality of Point-of-Care Testing in the ‘QAAMS’ Model for Diabetes Management in Australian Aboriginal Medical Services

PubMed Central

Shephard, Mark DS; Gill, Janice P

2006-01-01

Type 2 diabetes mellitus and its major complication, renal disease, represent one of the most significant contemporary health problems facing Australia’s Indigenous Aboriginal People. The Australian Government-funded Quality Assurance for Aboriginal Medical Services Program (QAAMS) provides a framework by which on-site point-of-care testing (POCT) for haemoglobin A1c (HbA1c) and now urine albumin:creatinine ratio (ACR) can be performed to facilitate better diabetes management in Aboriginal medical services. This paper provides updated evidence for the analytical quality of POCT in the QAAMS Program. The median imprecision for point-of-care (POC) HbA1c and urine ACR quality assurance (QA) testing has continually improved over the past six and half years, stabilising at approximately 3% for both analytes and proving analytically sound in Aboriginal hands. For HbA1c, there was no statistical difference between the imprecision achieved by QAAMS and laboratory users of the Bayer DCA 2000 since the QAAMS program commenced (QAAMS CV 3.6% ± 0.52, laboratory CV 3.4% ± 0.42; p = 0.21, paired t-test). The Western Pacific Island of Tonga recently joined the QAAMS HbA1c Program indicating that the QAAMS model can also be applied internationally in other settings where the prevalence of diabetes is high. PMID:17581642

Quality specification in haematology: the automated blood cell count.

PubMed

Buttarello, Mauro

2004-08-02

Quality specifications for automated blood cell counts include topics that go beyond the traditional analytic stage (imprecision, inaccuracy, quality control) and extend to pre- and post-analytic phases. In this review pre-analytic aspects concerning the choice of anticoagulants, maximum conservation times and differences between storage at room temperature or at 4 degrees C are considered. For the analytic phase, goals for imprecision and bias obtained with various approaches (ratio to biologic variation, state of the art, specific clinical situations) are evaluated. For the post-analytic phase, medical review criteria (algorithm, decision limit and delta check) and the structure of the report (general part and comments), which constitutes the formal act through which a laboratory communicates with clinicians, are considered. K2EDTA is considered the anticoagulant of choice for automated cell counts. Regarding storage, specimens should be analyzed as soon as possible. Storage at 4 degrees C may stabilize specimens from 24 to 72 h when complete blood count (CBC) and differential leucocyte count (DLC) is performed. For precision, analytical goals based on the state of the art are acceptable while for bias this is satisfactory only for some parameters. In haematology quality specifications for pre- and analytical phases are important, but the review criteria and the quality of the report play a central role in assuring a definite clinical value.

U.S. Geological Survey external quality-assurance project report to the National Atmospheric Deposition Program / National Trends Network and Mercury Deposition Network, 2007-08

USGS Publications Warehouse

Wetherbee, Gregory A.; Latysh, Natalie E.; Chesney, Tanya A.

2010-01-01

The U.S. Geological Survey (USGS) used six distinct programs to provide external quality-assurance monitoring for the National Atmospheric Deposition Program / National Trends Network (NTN) and Mercury Deposition Network (MDN) during 2007-08. The field-audit program assessed the effects of onsite exposure, sample handling, and shipping on the chemistry of NTN samples, and a system-blank program assessed the same effects for MDN. Two interlaboratory-comparison programs assessed the bias and variability of the chemical analysis data from the Central Analytical Laboratory (CAL), Mercury (Hg) Analytical Laboratory (HAL), and 12 other participating laboratories. A blind-audit program was also implemented for the MDN to evaluate analytical bias in HAL total Hg concentration data. A co-located-sampler program was used to identify and quantify potential shifts in NADP data resulting from replacement of original network instrumentation with new electronic recording rain gages (E-gages) and prototype precipitation collectors. The results indicate that NADP data continue to be of sufficient quality for the analysis of spatial distributions and time trends of chemical constituents in wet deposition across the U.S. NADP data-quality objectives continued to be achieved during 2007-08. Results also indicate that retrofit of the NADP networks with the new E-gages is not likely to create step-function type shifts in NADP precipitation-depth records, except for sites where annual precipitation depth is dominated by snow because the E-gages tend to catch more snow than the original NADP rain gages. Evaluation of prototype precipitation collectors revealed no difference in sample volumes and analyte concentrations between the original NADP collectors and modified, deep-bucket collectors, but the Yankee Environmental Systems, Inc. (YES) collector obtained samples of significantly higher volumes and analyte concentrations than the standard NADP collector.

[Fundamentals of quality control systems in medical-biochemical laboratories--the role of marketing].

PubMed

Topić, E; Turek, S

2000-01-01

The basic criterion for the overall quality system in medical biochemistry laboratories concerning equipment, premises and laboratory staff in primary health care (PHC) (Regulations on quality systems and good laboratory practice of the Croatian Medical Biochemists Chamber, 1995, Regulations on categorization of medical biochemistry laboratories of the Croatian Medical Biochemists Chamber, 1996, EC4: Essential criteria for quality systems in medical laboratories. Eur J Clin Chem Clin Biochem 1997 in medical biochemical laboratories included in the First Croatia health project, Primary health care subproject, has been met by the marketing approach to the project. The equipment ensuring implementation of the complete laboratory program (NN/96), more accurate and precise analytical procedures, and higher reliability of laboratory test results compared with previous equipment, has been purchased by an international tender. Uniform technology and methods of analysis have ensured high standards of good laboratory services, yielding test results than can be transferred from primary to secondary health care level. The new equipment has improved organization between central and detached medical biochemistry laboratory units, while the high quality requirement has led to improvement in the staff structure, e.g., medical biochemists have been employed in laboratories that had previously worked without such a professional. Equipment renewal has been accompanied by proper education for all levels of PHC professionals.

Auditing of chromatographic data.

PubMed

Mabie, J T

1998-01-01

During a data audit, it is important to ensure that there is clear documentation and an audit trail. The Quality Assurance Unit should review all areas, including the laboratory, during the conduct of the sample analyses. The analytical methodology that is developed should be documented prior to sample analyses. This is an important document for the auditor, as it is the instrumental piece used by the laboratory personnel to maintain integrity throughout the process. It is expected that this document will give insight into the sample analysis, run controls, run sequencing, instrument parameters, and acceptance criteria for the samples. The sample analysis and all supporting documentation should be audited in conjunction with this written analytical method and any supporting Standard Operating Procedures to ensure the quality and integrity of the data.

Six Sigma Quality Management System and Design of Risk-based Statistical Quality Control.

PubMed

Westgard, James O; Westgard, Sten A

2017-03-01

Six sigma concepts provide a quality management system (QMS) with many useful tools for managing quality in medical laboratories. This Six Sigma QMS is driven by the quality required for the intended use of a test. The most useful form for this quality requirement is the allowable total error. Calculation of a sigma-metric provides the best predictor of risk for an analytical examination process, as well as a design parameter for selecting the statistical quality control (SQC) procedure necessary to detect medically important errors. Simple point estimates of sigma at medical decision concentrations are sufficient for laboratory applications. Copyright © 2016 Elsevier Inc. All rights reserved.

A Six Sigma Trial For Reduction of Error Rates in Pathology Laboratory.

PubMed

Tosuner, Zeynep; Gücin, Zühal; Kiran, Tuğçe; Büyükpinarbaşili, Nur; Turna, Seval; Taşkiran, Olcay; Arici, Dilek Sema

2016-01-01

A major target of quality assurance is the minimization of error rates in order to enhance patient safety. Six Sigma is a method targeting zero error (3.4 errors per million events) used in industry. The five main principles of Six Sigma are defining, measuring, analysis, improvement and control. Using this methodology, the causes of errors can be examined and process improvement strategies can be identified. The aim of our study was to evaluate the utility of Six Sigma methodology in error reduction in our pathology laboratory. The errors encountered between April 2014 and April 2015 were recorded by the pathology personnel. Error follow-up forms were examined by the quality control supervisor, administrative supervisor and the head of the department. Using Six Sigma methodology, the rate of errors was measured monthly and the distribution of errors at the preanalytic, analytic and postanalytical phases was analysed. Improvement strategies were reclaimed in the monthly intradepartmental meetings and the control of the units with high error rates was provided. Fifty-six (52.4%) of 107 recorded errors in total were at the pre-analytic phase. Forty-five errors (42%) were recorded as analytical and 6 errors (5.6%) as post-analytical. Two of the 45 errors were major irrevocable errors. The error rate was 6.8 per million in the first half of the year and 1.3 per million in the second half, decreasing by 79.77%. The Six Sigma trial in our pathology laboratory provided the reduction of the error rates mainly in the pre-analytic and analytic phases.

Quality-assurance results for field pH and specific-conductance measurements, and for laboratory analysis, National Atmospheric Deposition Program and National Trends Network; January 1980-September 1984

USGS Publications Warehouse

Schroder, L.J.; Brooks, M.H.; Malo, B.A.; Willoughby, T.C.

1986-01-01

Five intersite comparison studies for the field determination of pH and specific conductance, using simulated-precipitation samples, were conducted by the U.S.G.S. for the National Atmospheric Deposition Program and National Trends Network. These comparisons were performed to estimate the precision of pH and specific conductance determinations made by sampling-site operators. Simulated-precipitation samples were prepared from nitric acid and deionized water. The estimated standard deviation for site-operator determination of pH was 0.25 for pH values ranging from 3.79 to 4.64; the estimated standard deviation for specific conductance was 4.6 microsiemens/cm at 25 C for specific-conductance values ranging from 10.4 to 59.0 microsiemens/cm at 25 C. Performance-audit samples with known analyte concentrations were prepared by the U.S.G.S.and distributed to the National Atmospheric Deposition Program 's Central Analytical Laboratory. The differences between the National Atmospheric Deposition Program and national Trends Network-reported analyte concentrations and known analyte concentrations were calculated, and the bias and precision were determined. For 1983, concentrations of calcium, magnesium, sodium, and chloride were biased at the 99% confidence limit; concentrations of potassium and sulfate were unbiased at the 99% confidence limit. Four analytical laboratories routinely analyzing precipitation were evaluated in their analysis of identical natural- and simulated precipitation samples. Analyte bias for each laboratory was examined using analysis of variance coupled with Duncan 's multiple-range test on data produced by these laboratories, from the analysis of identical simulated-precipitation samples. Analyte precision for each laboratory has been estimated by calculating a pooled variance for each analyte. Interlaboratory comparability results may be used to normalize natural-precipitation chemistry data obtained from two or more of these laboratories. (Author 's abstract)

Pre-Analytical Components of Risk in Four Branches of Clinical Laboratory in Romania--Prospective Study.

PubMed

David, Remona E; Dobreanu, Minodora

2016-01-01

Development of quality measurement principles is a strategic point for each clinical laboratory. Preexamination process is the most critical and the most difficult to be managed. The aim of this study is to identify, quantify, and monitor the nonconformities of the pre-analytical process using quality indicators that can affect the patient's health safety in four different locations of a Romanian private clinical laboratory. The study group consisted of all the analysis requests received by the departments of biochemistry, hematology, and coagulation from January through March 2015. In order to collect the pre-analytical nonconformities, we created a "Risk Budget", using the entries from the "Evidence notebook--non-conform samples" from the above mentioned departments. The laboratory established the quality indicators by means of the risk management technique in order to identify and control the sources of errors, FMEA (Failure Modes and Effects Analyses), which had been implemented and monitored for its purposes and special needs. For the assessment of the control level over the processes, the results were transformed on the Six Sigma scale, using the Westgard calculation method and being obtained in this way the frequency with which an error may occur. (https://www.westgard. com/six-sigma-calculators.htm). The obtained results prove that the quantification and monitoring of the indicators can be a control instrument for the pre-analytic activities. The calculation of the Six Sigma value adds extra information to the study because it allows the detection of the processes which need improvement (Sigma value higher than 4 represents a well controlled process). The highest rates were observed for the hemolyzed and the lipemic samples, in the department of biochemistry and hemolyzed, insufficient sample volume, or clotted samples for the department of hematology and coagulation. Significant statistical differences between laboratories participating in the study have been recorded for these indicators. The elaborated study between the four branches of a Romanian private clinical laboratory was a challenge, and it helped in choosing strategic decisions regarding the improvement of the patient's health safety in the institution, corresponding to the accreditation requirements in accordance with ISO 15189:2013.

Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).

PubMed

Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; Sarzotti-Kelsoe, Marcella

2014-07-01

The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines. © 2013.

Microbiological methods for the water recovery systems test, revision 1.1

NASA Technical Reports Server (NTRS)

Rhoads, Tim; Kilgore, M. V., Jr.; Mikell, A. T., Jr.

1990-01-01

Current microbiological parameters specified to verify microbiological quality of Space Station Freedom water quality include the enumeration of total bacteria, anaerobes, aerobes, yeasts and molds, enteric bacteria, gram positives, gram negatives, and E. coli. In addition, other parameters have been identified as necessary to support the Water Recovery Test activities to be conducted at the NASA/MSFC later this year. These other parameters include aerotolerant eutrophic mesophiles, legionellae, and an additional method for heterotrophic bacteria. If inter-laboratory data are to be compared to evaluate quality, analytical methods must be eliminated as a variable. Therefore, each participating laboratory must utilize the same analytical methods and procedures. Without this standardization, data can be neither compared nor validated between laboratories. Multiple laboratory participation represents a conservative approach to insure quality and completeness of data. Invariably, sample loss will occur in transport and analyses. Natural variance is a reality on any test of this magnitude and is further enhanced because biological entities, capable of growth and death, are specific parameters of interest. The large variation due to the participation of human test subjects has been noted with previous testing. The resultant data might be dismissed as 'out of control' unless intra-laboratory control is included as part of the method or if participating laboratories are not available for verification. The purpose of this document is to provide standardized laboratory procedures for the enumeration of certain microorganisms in water and wastewater specific to the water recovery systems test. The document consists of ten separate cultural methods and one direct count procedure. It is not intended nor is it implied to be a complete microbiological methods manual.

EC4 European Syllabus for Post-Graduate Training in Clinical Chemistry and Laboratory Medicine: version 3 - 2005.

PubMed

Zerah, Simone; McMurray, Janet; Bousquet, Bernard; Baum, Hannsjorg; Beastall, Graham H; Blaton, Vic; Cals, Marie-Josèphe; Duchassaing, Danielle; Gaudeau-Toussaint, Marie-Françoise; Harmoinen, Aimo; Hoffmann, Hans; Jansen, Rob T; Kenny, Desmond; Kohse, Klaus P; Köller, Ursula; Gobert, Jean-Gérard; Linget, Christine; Lund, Erik; Nubile, Giuseppe; Opp, Matthias; Pazzagli, Mario; Pinon, Georges; Queralto, José M; Reguengo, Henrique; Rizos, Demetrios; Szekeres, Thomas; Vidaud, Michel; Wallinder, Hans

2006-01-01

The EC4 Syllabus for Postgraduate Training is the basis for the European Register of Specialists in Clinical Chemistry and Laboratory Medicine. The syllabus: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. The syllabus is not primarily meant to be a training guide, but on the basis of the overview given (common minimal programme), national societies should formulate programmes that indicate where knowledge and experience is needed. The main points of this programme are: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. Knowledge in biochemistry, haematology, immunology, etc.; Pre-analytical conditions; Evaluation of results; Interpretations (post-analytical phase); Laboratory management; and Quality insurance management. The aim of this version of the syllabus is to be in accordance with the Directive of Professional Qualifications published on 30 September 2005. To prepare the common platforms planned in this directive, the disciplines are divided into four categories: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. Knowledge in biochemistry, haematology, immunology, etc.; Pre-analytical conditions; Evaluation of results; Interpretations (post-analytical phase); Laboratory management; and Quality insurance management. General chemistry, encompassing biochemistry, endocrinology, chemical (humoral), immunology, toxicology, and therapeutic drug monitoring; Haematology, covering cells, transfusion serology, coagulation, and cellular immunology; Microbiology, involving bacteriology, virology, parasitology, and mycology; Genetics and IVF.

40 CFR 408.61 - Specialized definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... components of a waste water amenable to measurement by the method described in Methods for Chemical Analysis of Water and Wastes, 1971, Environmental Protection Agency, Analytical Quality Control Laboratory...

40 CFR 408.71 - Specialized definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... waste water amenable to measurement by the method described in Methods for Chemical Analysis of Water and Wastes, 1971, Environmental Protection Agency, Analytical Quality Control Laboratory, page 217. (c...

40 CFR 408.81 - Specialized definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... components of a waste water amendable to measurement by the method described in Methods for Chemical Analysis of Water and Wastes, 1971, Environmental Protection Agency, Analytical Quality Control Laboratory...

Recognizing and Reducing Analytical Errors and Sources of Variation in Clinical Pathology Data in Safety Assessment Studies.

PubMed

Schultze, A E; Irizarry, A R

2017-02-01

Veterinary clinical pathologists are well positioned via education and training to assist in investigations of unexpected results or increased variation in clinical pathology data. Errors in testing and unexpected variability in clinical pathology data are sometimes referred to as "laboratory errors." These alterations may occur in the preanalytical, analytical, or postanalytical phases of studies. Most of the errors or variability in clinical pathology data occur in the preanalytical or postanalytical phases. True analytical errors occur within the laboratory and are usually the result of operator or instrument error. Analytical errors are often ≤10% of all errors in diagnostic testing, and the frequency of these types of errors has decreased in the last decade. Analytical errors and increased data variability may result from instrument malfunctions, inability to follow proper procedures, undetected failures in quality control, sample misidentification, and/or test interference. This article (1) illustrates several different types of analytical errors and situations within laboratories that may result in increased variability in data, (2) provides recommendations regarding prevention of testing errors and techniques to control variation, and (3) provides a list of references that describe and advise how to deal with increased data variability.

Point-of-care testing (POCT) and evidence-based laboratory medicine (EBLM) - does it leverage any advantage in clinical decision making?

PubMed

Florkowski, Christopher; Don-Wauchope, Andrew; Gimenez, Nuria; Rodriguez-Capote, Karina; Wils, Julien; Zemlin, Annalise

Point-of-care testing (POCT) is the analysis of patient specimens outside the clinical laboratory, near or at the site of patient care, usually performed by clinical staff without laboratory training, although it also encompasses patient self-monitoring. It is able to provide a rapid result near the patient and which can be acted upon immediately. The key driver is the concept that clinical decision making may be delayed when samples are sent to the clinical laboratory. Balanced against this are considerations of increased costs for purchase and maintenance of equipment, staff training, connectivity to the laboratory information system (LIS), quality control (QC) and external quality assurance (EQA) procedures, all required for accreditation under ISO 22870. The justification for POCT depends upon being able to demonstrate that a more timely result (shorter turnaround times (TATs)) is able to leverage a clinically important advantage in decision making compared with the central laboratory (CL). In the four decades since POCT was adapted for the self-monitoring of blood glucose levels by subjects with diabetes, numerous new POCT methodologies have become available, enabling the clinician to receive results and initiate treatment more rapidly. However, these instruments are often operated by staff not trained in laboratory medicine and hence are prone to errors in the analytical phase (as opposed to laboratory testing where the analytical phase has the least errors). In some environments, particularly remote rural settings, the CL may be at a considerable distance and timely availability of cardiac troponins and other analytes can triage referrals to the main centers, thus avoiding expensive unnecessary patient transportation costs. However, in the Emergency Department, availability of more rapid results with POCT does not always translate into shorter stays due to other barriers to implementation of care. In this review, we apply the principles of evidence-based laboratory medicine (EBLM) looking for high quality systematic reviews and meta-analyses, ideally underpinned by randomized controlled trials (RCTs), looking for evidence of whether POCT confers any advantage in clinical decision making in different scenarios.

Microbial ecology laboratory procedures manual NASA/MSFC

NASA Technical Reports Server (NTRS)

Huff, Timothy L.

1990-01-01

An essential part of the efficient operation of any microbiology laboratory involved in sample analysis is a standard procedures manual. The purpose of this manual is to provide concise and well defined instructions on routine technical procedures involving sample analysis and methods for monitoring and maintaining quality control within the laboratory. Of equal importance is the safe operation of the laboratory. This manual outlines detailed procedures to be followed in the microbial ecology laboratory to assure safety, analytical control, and validity of results.

Quality in the molecular microbiology laboratory.

PubMed

Wallace, Paul S; MacKay, William G

2013-01-01

In the clinical microbiology laboratory advances in nucleic acid detection, quantification, and sequence analysis have led to considerable improvements in the diagnosis, management, and monitoring of infectious diseases. Molecular diagnostic methods are routinely used to make clinical decisions based on when and how to treat a patient as well as monitor the effectiveness of a therapeutic regime and identify any potential drug resistant strains that may impact on the long term patient treatment program. Therefore, confidence in the reliability of the result provided by the laboratory service to the clinician is essential for patient treatment. Hence, suitable quality assurance and quality control measures are important to ensure that the laboratory methods and service meet the necessary regulatory requirements both at the national and international level. In essence, the modern clinical microbiology laboratory ensures the appropriateness of its services through a quality management system that monitors all aspects of the laboratory service pre- and post-analytical-from patient sample receipt to reporting of results, from checking and upholding staff competency within the laboratory to identifying areas for quality improvements within the service offered. For most European based clinical microbiology laboratories this means following the common International Standard Organization (ISO9001) framework and ISO15189 which sets out the quality management requirements for the medical laboratory (BS EN ISO 15189 (2003) Medical laboratories-particular requirements for quality and competence. British Standards Institute, Bristol, UK). In the United States clinical laboratories performing human diagnostic tests are regulated by the Centers for Medicare and Medicaid Services (CMS) following the requirements within the Clinical Laboratory Improvement Amendments document 1988 (CLIA-88). This chapter focuses on the key quality assurance and quality control requirements within the modern microbiology laboratory providing molecular diagnostics.

Physical Property Analysis and Report for Sediments at 100-BC-5 Operable Unit, Boreholes C7505, C7506, C7507, and C7665

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lindberg, Michael J.

2010-09-28

Between October 14, 2009 and February 22, 2010 sediment samples were received from 100-BC Decision Unit for geochemical studies. This is an analytical data report for sediments received from CHPRC at the 100 BC 5 OU. The analyses for this project were performed at the 325 building located in the 300 Area of the Hanford Site. The analyses were performed according to Pacific Northwest National Laboratory (PNNL) approved procedures and/or nationally recognized test procedures. The data sets include the sample identification numbers, analytical results, estimated quantification limits (EQL), and quality control data. The preparatory and analytical quality control requirements, calibrationmore » requirements, acceptance criteria, and failure actions are defined in the on-line QA plan 'Conducting Analytical Work in Support of Regulatory Programs' (CAW). This QA plan implements the Hanford Analytical Services Quality Assurance Requirements Documents (HASQARD) for PNNL.« less

National survey on intra-laboratory turnaround time for some most common routine and stat laboratory analyses in 479 laboratories in China.

PubMed

Fei, Yang; Zeng, Rong; Wang, Wei; He, Falin; Zhong, Kun; Wang, Zhiguo

2015-01-01

To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones. 479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires. The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479/1307), 38% (228/598), and 36% (449/1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories. Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them.

National survey on intra-laboratory turnaround time for some most common routine and stat laboratory analyses in 479 laboratories in China

PubMed Central

Fei, Yang; Zeng, Rong; Wang, Wei; He, Falin; Zhong, Kun

2015-01-01

Introduction To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones. Materials and methods 479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires. Results The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479 / 1307), 38% (228 / 598), and 36% (449 / 1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories. Conclusions Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them. PMID:26110033

40 CFR 417.191 - Specialized definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... methylene blue active substances amenable to measurement by the method described in “Methods for Chemical Analysis of Water and Wastes,” 1971, Environmental Protection Agency, Analytical Quality Control Laboratory...

Organic Analyses in Water Quality Control Programs. Training Manual.

ERIC Educational Resources Information Center

Office of Water Program Operations (EPA), Cincinnati, OH. National Training and Operational Technology Center.

This document is a lecture/laboratory manual dealing with the analysis of selected organic pollutants. It is intended for use by those having little or no experience in the field, but having one year (or equivalent) of college organic chemistry, and having basic laboratory skills (volumetric glassware, titration, analytical and trip balances).…

Analytical difficulties facing today's regulatory laboratories: issues in method validation.

PubMed

MacNeil, James D

2012-08-01

The challenges facing analytical laboratories today are not unlike those faced in the past, although both the degree of complexity and the rate of change have increased. Challenges such as development and maintenance of expertise, maintenance and up-dating of equipment, and the introduction of new test methods have always been familiar themes for analytical laboratories, but international guidelines for laboratories involved in the import and export testing of food require management of such changes in a context which includes quality assurance, accreditation, and method validation considerations. Decisions as to when a change in a method requires re-validation of the method or on the design of a validation scheme for a complex multi-residue method require a well-considered strategy, based on a current knowledge of international guidance documents and regulatory requirements, as well the laboratory's quality system requirements. Validation demonstrates that a method is 'fit for purpose', so the requirement for validation should be assessed in terms of the intended use of a method and, in the case of change or modification of a method, whether that change or modification may affect a previously validated performance characteristic. In general, method validation involves method scope, calibration-related parameters, method precision, and recovery. Any method change which may affect method scope or any performance parameters will require re-validation. Some typical situations involving change in methods are discussed and a decision process proposed for selection of appropriate validation measures. © 2012 John Wiley & Sons, Ltd.

Impact of Educational Activities in Reducing Pre-Analytical Laboratory Errors: A quality initiative.

PubMed

Al-Ghaithi, Hamed; Pathare, Anil; Al-Mamari, Sahimah; Villacrucis, Rodrigo; Fawaz, Naglaa; Alkindi, Salam

2017-08-01

Pre-analytic errors during diagnostic laboratory investigations can lead to increased patient morbidity and mortality. This study aimed to ascertain the effect of educational nursing activities on the incidence of pre-analytical errors resulting in non-conforming blood samples. This study was conducted between January 2008 and December 2015. All specimens received at the Haematology Laboratory of the Sultan Qaboos University Hospital, Muscat, Oman, during this period were prospectively collected and analysed. Similar data from 2007 were collected retrospectively and used as a baseline for comparison. Non-conforming samples were defined as either clotted samples, haemolysed samples, use of the wrong anticoagulant, insufficient quantities of blood collected, incorrect/lack of labelling on a sample or lack of delivery of a sample in spite of a sample request. From 2008 onwards, multiple educational training activities directed at the hospital nursing staff and nursing students primarily responsible for blood collection were implemented on a regular basis. After initiating corrective measures in 2008, a progressive reduction in the percentage of non-conforming samples was observed from 2009 onwards. Despite a 127.84% increase in the total number of specimens received, there was a significant reduction in non-conforming samples from 0.29% in 2007 to 0.07% in 2015, resulting in an improvement of 75.86% ( P <0.050). In particular, specimen identification errors decreased by 0.056%, with a 96.55% improvement. Targeted educational activities directed primarily towards hospital nursing staff had a positive impact on the quality of laboratory specimens by significantly reducing pre-analytical errors.

Selecting clinical quality indicators for laboratory medicine.

PubMed

Barth, Julian H

2012-05-01

Quality in laboratory medicine is often described as doing the right test at the right time for the right person. Laboratory processes currently operate under the oversight of an accreditation body which gives confidence that the process is good. However, there are aspects of quality that are not measured by these processes. These are largely focused on ensuring that the most clinically appropriate test is performed and interpreted correctly. Clinical quality indicators were selected through a two-phase process. Firstly, a series of focus groups of clinical scientists were held with the aim of developing a list of quality indicators. These were subsequently ranked in order by an expert panel of primary and secondary care physicians. The 10 top indicators included the communication of critical results, comprehensive education to all users and adequate quality assurance for point-of-care testing. Laboratories should ensure their tests are used to national standards, that they have clinical utility, are calibrated to national standards and have long-term stability for chronic disease management. Laboratories should have error logs and demonstrate evidence of measures introduced to reduce chances of similar future errors. Laboratories should make a formal scientific evaluation of analytical quality. This paper describes the process of selection of quality indicators for laboratory medicine that have been validated sequentially by deliverers and users of the service. They now need to be converted into measureable variables related to outcome and validated in practice.

Utility perspective on USEPA analytical methods program redirection

DOE Office of Scientific and Technical Information (OSTI.GOV)

Koch, B.; Davis, M.K.; Krasner, S.W.

1996-11-01

The Metropolitan Water District of Southern California (Metropolitan) is a public, municipal corporation, created by the State of California, which wholesales supplemental water trough 27 member agencies (cities and water districts). Metropolitan serves nearly 16 million people in an area along the coastal plain of Southern California that covers approximately 5200 square miles. Water deliveries have averaged up to 2.5 million acre-feet per year. Metropolitan`s Water Quality Laboratory (WQL) conducts compliance monitoring of its source and finished drinking waters for chemical and microbial constituents. The laboratory maintains certification of a large number and variety of analytical procedures. The WQL operatesmore » in a 17,000-square-foot facility. The equipment is state-of-the-art analytical instrumentation. The staff consists of 40 professional chemists and microbiologists whose experience and expertise are extensive and often highly specialized. The staff turnover is very low, and the laboratory is consistently, efficiently, and expertly run.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hu, T.A.

This is the final sample analysis report for tank 241-BX-104 (BX-104), cores 126 and 127. Two segments from each core yielded a total of 11 samples which were analyzed. The data quality objectives (DQOs) applicable to this sampling event were the Safety Screening DQO (Dukelow et al. 1995) and the Organic Safety DQO (Turner et al. 1995). The samples were received, extruded and analyzed at PNNL 325 Analytical Chemistry Laboratory (ACL). The analyses were performed in accordance with the Sample Analysis Plan (Gretsinger 1996) and indicated that the tank is safe with respect to the criteria in the Safety Screeningmore » and Organic DQO. Detailed analytical results were described in the analytical laboratory 45-day Report (Attachment 1, WHC-SD-WM-DP-171, REV. 0) and final report (Attachment 2, PNL-BX-104 REV.1) prepared by PNNL, 325 Laboratory. Corrections and/or exceptions to the PNNL final report are provided.« less

Results of continuous monitoring of the performance of rubella virus IgG and hepatitis B virus surface antibody assays using trueness controls in a multicenter trial.

PubMed

Kruk, Tamara; Ratnam, Sam; Preiksaitis, Jutta; Lau, Allan; Hatchette, Todd; Horsman, Greg; Van Caeseele, Paul; Timmons, Brian; Tipples, Graham

2012-10-01

We conducted a multicenter trial in Canada to assess the value of using trueness controls (TC) for rubella virus IgG and hepatitis B virus surface antibody (anti-HBs) serology to determine test performance across laboratories over time. TC were obtained from a single source with known international units. Seven laboratories using different test systems and kit lots included the TC in routine assay runs of the analytes. TC measurements of 1,095 rubella virus IgG and 1,195 anti-HBs runs were plotted on Levey-Jennings control charts for individual laboratories and analyzed using a multirule quality control (MQC) scheme as well as a single three-standard-deviation (3-SD) rule. All rubella virus IgG TC results were "in control" in only one of the seven laboratories. Among the rest, "out-of-control" results ranged from 5.6% to 10% with an outlier at 20.3% by MQC and from 1.1% to 5.6% with an outlier at 13.4% by the 3-SD rule. All anti-HBs TC results were "in control" in only two laboratories. Among the rest, "out-of-control" results ranged from 3.3% to 7.9% with an outlier at 19.8% by MQC and from 0% to 3.3% with an outlier at 10.5% by the 3-SD rule. In conclusion, through the continuous monitoring of assay performance using TC and quality control rules, our trial detected significant intra- and interlaboratory, test system, and kit lot variations for both analytes. In most cases the assay rejections could be attributable to the laboratories rather than to kit lots. This has implications for routine diagnostic screening and clinical practice guidelines and underscores the value of using an approach as described above for continuous quality improvement in result reporting and harmonization for these analytes.

Quality-Assurance Data for Routine Water Analyses by the U.S. Geological Survey Laboratory in Troy, New York - July 2001 Through June 2003

USGS Publications Warehouse

Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

2009-01-01

The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's Lab Master data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality control samples analyzed from July 2001 through June 2003. Results for the quality-control samples for 19 analytical procedures were evaluated for bias and precision. Control charts indicate that data for six of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, chloride, magnesium, nitrate (ion chromatography), potassium, and sodium. The calcium procedure was biased throughout the analysis period for the high-concentration sample, but was within control limits. The total monomeric aluminum and fluoride procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The total aluminum, pH, specific conductance, and sulfate procedures were biased for the high-concentration and low-concentration samples, but were within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 16 of 18 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for the dissolved organic carbon or specific conductance procedures. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 18 of the 21 analytes. At least 90 percent of the samples met data-quality objectives for all procedures except total monomeric aluminum (83 percent of samples met objectives), total aluminum (76 percent of samples met objectives), ammonium (73 percent of samples met objectives), dissolved organic carbon (86 percent of samples met objectives), and nitrate (81 percent of samples met objectives). The data-quality objective was not met for the nitrite procedure. Results of the USGS interlaboratory Standard Reference Sample (SRS) Project indicated satisfactory or above data quality over the time period, with most performance ratings for each sample in the good-to-excellent range. The N-sample (nutrient constituents) analysis had one unsatisfactory rating for the ammonium procedure in one study. The T-sample (trace constituents) analysis had one unsatisfactory rating for the magnesium procedure and one marginal rating for the potassium procedure in one study and one unsatisfactory rating for the sodium procedure in another. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 90 percent of the samples met data-quality objectives for 10 of the 14 analytes; the exceptions were acid-neutralizing capacity, ammonium, dissolved organic carbon, and sodium. Data-quality objectives were not met in 37 percent of samples analyzed for acid-neutralizing capacity, 28 percent of samples analyzed for dissolved organic carbon, and 30 percent of samples analyzed for sodium. Results indicate a positive bias for the ammonium procedure in one study and a negative bias in another. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 90 percent of the samples analyzed for calcium, chloride, magnesium, pH, potassium, and sodium. Data-quality objectives were met by 78 percent of

Water-quality data of soil water from three watersheds, Shenandoah National Park, Virginia, 1999-2000

USGS Publications Warehouse

Rice, Karen C.; Maben, Suzanne W.; Webb, James R.

2001-01-01

Data on the chemical composition of soil-water samples were collected quarterly from three watersheds in Shenandoah National Park, Virginia, from September 1999 through July 2000. The soil-water samples were analyzed for specific conductance and concentrations of sodium, potassium, calcium, magnesium, ammonium, chloride, nitrate, sulfate, acid-neutralizing capacity, silica, and total monomeric aluminum. The soil-water data presented in this report can be used to support water-quality modeling of the response of streams to episodic acidification. Laboratory analytical data as well as laboratory quality-assurance information also are presented.

Analysis of Carbamate Pesticides: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS666

DOE Office of Scientific and Technical Information (OSTI.GOV)

Owens, J; Koester, C

The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method for analysis of aldicarb, bromadiolone, carbofuran, oxamyl, and methomyl in water by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS), titled Method EPA MS666. This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to validate and verify the analytical procedures described in MS666 for analysis of carbamatemore » pesticides in aqueous samples. The gathered data from this validation study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of Method EPA MS666 can be determined.« less

Analysis of Ethanolamines: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS888

DOE Office of Scientific and Technical Information (OSTI.GOV)

Owens, J; Vu, A; Koester, C

The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method titled 'Analysis of Diethanolamine, Triethanolamine, n-Methyldiethanolamine, and n-Ethyldiethanolamine in Water by Single Reaction Monitoring Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS): EPA Method MS888'. This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to validate and verify the analytical procedures described in 'EPA Method MS888' for analysis of themore » listed ethanolamines in aqueous samples. The gathered data from this validation study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of 'EPA Method MS888' can be determined.« less

Analysis of Thiodiglycol: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS777

DOE Office of Scientific and Technical Information (OSTI.GOV)

Owens, J; Koester, C

The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method for the analysis of thiodiglycol, the breakdown product of the sulfur mustard HD, in water by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS), titled Method EPA MS777 (hereafter referred to as EPA CRL SOP MS777). This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to verifymore » the analytical procedures described in MS777 for analysis of thiodiglycol in aqueous samples. The gathered data from this study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of Method EPA MS777 can be determined.« less

Cotinine analytical workshop report: consideration of analytical methods for determining cotinine in human body fluids as a measure of passive exposure to tobacco smoke.

PubMed Central

Watts, R R; Langone, J J; Knight, G J; Lewtas, J

1990-01-01

A two-day technical workshop was convened November 10-11, 1986, to discuss analytical approaches for determining trace amounts of cotinine in human body fluids resulting from passive exposure to environmental tobacco smoke (ETS). The workshop, jointly sponsored by the U.S. Environmental Protection Agency and Centers for Disease Control, was attended by scientists with expertise in cotinine analytical methodology and/or conduct of human monitoring studies related to ETS. The workshop format included technical presentations, separate panel discussions on chromatography and immunoassay analytical approaches, and group discussions related to the quality assurance/quality control aspects of future monitoring programs. This report presents a consensus of opinion on general issues before the workshop panel participants and also a detailed comparison of several analytical approaches being used by the various represented laboratories. The salient features of the chromatography and immunoassay analytical methods are discussed separately. PMID:2190812

Overview of mycotoxin methods, present status and future needs.

PubMed

Gilbert, J

1999-01-01

This article reviews current requirements for the analysis for mycotoxins in foods and identifies legislative as well as other factors that are driving development and validation of new methods. New regulatory limits for mycotoxins and analytical quality assurance requirements for laboratories to only use validated methods are seen as major factors driving developments. Three major classes of methods are identified which serve different purposes and can be categorized as screening, official and research. In each case the present status and future needs are assessed. In addition to an overview of trends in analytical methods, some other areas of analytical quality assurance such as participation in proficiency testing and reference materials are identified.

Analysis of serum angiotensin-converting enzyme.

PubMed

Muller, B R

2002-09-01

Serum angiotensin-converting enzyme (SACE) levels are influenced by genetic polymorphism. Interpretation of serum levels with the appropriate genotypic reference range improves the diagnostic sensitivity of the assay for sarcoidosis. SACE assays are performed by a large number of routine clinical laboratories. However, there is no external quality assessment (EQA) for SACE other than an informal regional scheme. This showed analytical performance of SACE assays to be poor, with a diversity of reference ranges, leading to widely disparate clinical classification of EQA samples. Genetic polymorphism combined with poor analytical performance suggest that perhaps SACE assays should revert to being the province of specialized laboratories.

Laboratory Methods for the Measurement of Pollutants in Water and Waste Effluents

NASA Technical Reports Server (NTRS)

Ballinger, Dwight G.

1971-01-01

The requirement for accurate, precise, and rapid analytical procedures for the examination of water and waste samples requires the use of a variety of instruments. The instrumentation in water laboratories includes atomic absorption, UV-visible. and infrared spectrophotometers, automatic colorimetric analyzers, gas chromatographs and mass spectrometers. Because of the emphasis on regulatory action, attention is being directed toward quality control of analytical results. Among the challenging problems are the differentiation of metallic species in water at nanogram concentrations, rapid measurement of free cyanide and free ammonia, more sensitive methods for arsenic and selenium and improved characterization of organic contaminants.

Purity Analysis of the Pharmaceuticals Naproxen and Propranolol: A Guided-Inquiry Laboratory Experiment in the Analytical Chemistry Laboratory

ERIC Educational Resources Information Center

Fakayode, Sayo O.

2015-01-01

Counterfeiting and adulteration of prescription drugs, herbal products, and food supplements are a global challenge, causing serious economic loss to drug marketers and health implications for humans. Accordingly, accurate determination of the purity of pharmaceuticals is critical for the quality assurance of prescription drugs. Herein, the first…

Creating and Evaluating a Hypertext System of Documenting Analytical Test Methods in a Chemical Plant Quality Assurance Laboratory.

ERIC Educational Resources Information Center

White, Charles E., Jr.

The purpose of this study was to develop and implement a hypertext documentation system in an industrial laboratory and to evaluate its usefulness by participative observation and a questionnaire. Existing word-processing test method documentation was converted directly into a hypertext format or "hyperdocument." The hyperdocument was designed and…

Bias from two analytical laboratories involved in a long-term air monitoring program measuring organic pollutants in the Arctic: a quality assurance/quality control assessment.

PubMed

Su, Yushan; Hung, Hayley; Stern, Gary; Sverko, Ed; Lao, Randy; Barresi, Enzo; Rosenberg, Bruno; Fellin, Phil; Li, Henrik; Xiao, Hang

2011-11-01

Initiated in 1992, air monitoring of organic pollutants in the Canadian Arctic provided spatial and temporal trends in support of Canada's participation in the Stockholm Convention of Persistent Organic Pollutants. The specific analytical laboratory charged with this task was changed in 2002 while field sampling protocols remained unchanged. Three rounds of intensive comparison studies were conducted in 2004, 2005, and 2008 to assess data comparability between the two laboratories. Analysis was compared for organochlorine pesticides (OCPs), polychlorinated biphenyls (PCBs) and polycyclic aromatic hydrocarbons (PAHs) in standards, blind samples of mixed standards and extracts of real air samples. Good measurement accuracy was achieved for both laboratories when standards were analyzed. Variation of measurement accuracy over time was found for some OCPs and PCBs in standards on a random and non-systematic manner. Relatively low accuracy in analyzing blind samples was likely related to the process of sample purification. Inter-laboratory measurement differences for standards (<30%) and samples (<70%) were generally less than or comparable to those reported in a previous inter-laboratory study with 21 participating laboratories. Regression analysis showed inconsistent data comparability between the two laboratories during the initial stages of the study. These inter-laboratory differences can complicate abilities to discern long-term trends of pollutants in a given sampling site. It is advisable to maintain long-term measurements with minimal changes in sample analysis.

Point-of-care urine albumin in general practice offices: effect of participation in an external quality assurance scheme.

PubMed

Bukve, Tone; Røraas, Thomas; Riksheim, Berit Oddny; Christensen, Nina Gade; Sandberg, Sverre

2015-01-01

The Norwegian Quality Improvement of Primary Care Laboratories (Noklus) offers external quality assurance (EQA) schemes (EQASs) for urine albumin (UA) annually. This study analyzed the EQA results to determine how the analytical quality of UA analysis in general practice (GP) offices developed between 1998 (n=473) and 2012 (n=1160). Two EQA urine samples were distributed yearly to the participants by mail. The participants measured the UA of each sample and returned the results together with information about their instrument, the profession and number of employees at the office, frequency of internal quality control (IQC), and number of analyses per month. In the feedback report, they received an assessment of their analytical performance. The number of years that the GP office had participated in Noklus was inversely related to the percentage of "poor" results for quantitative but not semiquantitative instruments. The analytical quality improved for participants using quantitative instruments who received an initial assessment of "poor" and who subsequently changed their instrument. Participants using reagents that had expired or were within 3 months of the expiration date performed worse than those using reagents that were expiring in more than 3 months. Continuous participation in the Noklus program improved the performance of quantitative UA analyses at GP offices. This is probably in part attributable to the complete Noklus quality system, whereby in addition to participating in EQAS, participants are visited by laboratory consultants who examine their procedures and provide practical advice and education regarding the use of different instruments.

External quality assurance programs as a tool for verifying standardization of measurement procedures: Pilot collaboration in Europe.

PubMed

Perich, C; Ricós, C; Alvarez, V; Biosca, C; Boned, B; Cava, F; Doménech, M V; Fernández-Calle, P; Fernández-Fernández, P; García-Lario, J V; Minchinela, J; Simón, M; Jansen, R

2014-05-15

Current external quality assurance schemes have been classified into six categories, according to their ability to verify the degree of standardization of the participating measurement procedures. SKML (Netherlands) is a Category 1 EQA scheme (commutable EQA materials with values assigned by reference methods), whereas SEQC (Spain) is a Category 5 scheme (replicate analyses of non-commutable materials with no values assigned by reference methods). The results obtained by a group of Spanish laboratories participating in a pilot study organized by SKML are examined, with the aim of pointing out the improvements over our current scheme that a Category 1 program could provide. Imprecision and bias are calculated for each analyte and laboratory, and compared with quality specifications derived from biological variation. Of the 26 analytes studied, 9 had results comparable with those from reference methods, and 10 analytes did not have comparable results. The remaining 7 analytes measured did not have available reference method values, and in these cases, comparison with the peer group showed comparable results. The reasons for disagreement in the second group can be summarized as: use of non-standard methods (IFCC without exogenous pyridoxal phosphate for AST and ALT, Jaffé kinetic at low-normal creatinine concentrations and with eGFR); non-commutability of the reference material used to assign values to the routine calibrator (calcium, magnesium and sodium); use of reference materials without established commutability instead of reference methods for AST and GGT, and lack of a systematic effort by manufacturers to harmonize results. Results obtained in this work demonstrate the important role of external quality assurance programs using commutable materials with values assigned by reference methods to correctly monitor the standardization of laboratory tests with consequent minimization of risk to patients. Copyright © 2013 Elsevier B.V. All rights reserved.

Chemical analyses in the World Coal Quality Inventory

USGS Publications Warehouse

Tewalt, Susan J.; Belkin, Harvey E.; SanFilipo, John R.; Merrill, Matthew D.; Palmer, Curtis A.; Warwick, Peter D.; Karlsen, Alexander W.; Finkelman, Robert B.; Park, Andy J.

2010-01-01

The main objective of the World Coal Quality Inventory (WoCQI) was to collect and analyze a global set of samples of mined coal during a time period from about 1995 to 2006 (Finkelman and Lovern, 2001). Coal samples were collected by foreign collaborators and submitted to country specialists in the U.S. Geological Survey (USGS) Energy Program. However, samples from certain countries, such as Afghanistan, India, and Kyrgyzstan, were collected collaboratively in the field with USGS personnel. Samples were subsequently analyzed at two laboratories: the USGS Inorganic Geochemistry Laboratory located in Denver, CO and a commercial laboratory (Geochemical Testing, Inc.) located in Somerset, PA. Thus the dataset, which is in Excel (2003) format and includes 1,580 samples from 57 countries, does not have the inter-laboratory variability that is present in many compilations. Major-, minor-, and trace-element analyses from the USGS laboratory, calculated to a consistent analytical basis (dry, whole-coal) and presented with available sample identification information, are sorted alphabetically by country name. About 70 percent of the samples also have data from the commercial laboratory, which are presented on an as-received analytical basis. The USGS initiated a laboratory review of quality assurance in 2008, covering quality control and methodology used in inorganic chemical analyses of coal, coal power plant ash, water, and sediment samples. This quality control review found that data generated by the USGS Inorganic Geochemistry Laboratory from 1996 through 2006 were characterized by quality practices that did not meet USGS requirements commonly in use at the time. The most serious shortcomings were (1) the adjustment of raw sample data to standards when the instrument values for those standards exceeded acceptable limits or (2) the insufficient use of multiple standards to provide adequate quality assurance. In general, adjustment of raw data to account for instrument 'drift' is an acceptable practice within strictly defined limits. During the denoted period, USGS required that the maximum adjustment of instrument values, guided by calibration standards, was not allowed to exceed 10 percent. However, in some cases, the Inorganic Geochemistry Laboratory released data that were adjusted by more than 10 percent and (or) were not constrained by an adequate number of control standards. Original instrument values no longer exist for about 80 percent of the analyses during this period; therefore, the acceptability of drift corrections for most of the samples analyzed cannot be determined. For these reasons, the WoCQI data from the USGS Inorganic Geochemistry Laboratory should be used with care. For more information, individuals may contact laboratory management at EnergyLabs@usgs.gov with specific questions about particular datasets or analytical attributes. Standard USGS sampling methods were provided and recommended to collaborators, but the analyzed samples may or may not be representative of their locale; for some samples, only limited information is available concerning sample provenance. Single samples cannot represent spatial or temporal variability within a coal area. Geochemical datasets of U.S. coals can be found in the COALQUAL database (Bragg and others, 1997) and the National Coal Quality Inventory (Hatch and others, 2006), as only non-U.S. sample data are presented in the WoCQI. Although the WoCQI does not contain worldwide coverage of coal deposits, it is truly a unique and valuable compilation. The information in the WoCQI should prove useful for identifying possible areas for future global coal research.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gillespie, B.M.; Stromatt, R.W.; Ross, G.A.

This data package contains the results obtained by Pacific Northwest Laboratory (PNL) staff in the characterization of samples for the 101-SY Hydrogen Safety Project. The samples were submitted for analysis by Westinghouse Hanford Company (WHC) under the Technical Project Plan (TPP) 17667 and the Quality Assurance Plan MCS-027. They came from a core taken during Window C'' after the May 1991 gas release event. The analytical procedures required for analysis were defined in the Test Instructions (TI) prepared by the PNL 101-SY Analytical Chemistry Laboratory (ACL) Project Management Office in accordance with the TPP and the QA Plan. The requestedmore » analysis for these samples was volatile organic analysis. The quality control (QC) requirements for each sample are defined in the Test Instructions for each sample. The QC requirements outlined in the procedures and requested in the WHC statement of work were followed.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gillespie, B.M.; Stromatt, R.W.; Ross, G.A.

This data package contains the results obtained by Pacific Northwest Laboratory (PNL) staff in the characterization of samples for the 101-SY Hydrogen Safety Project. The samples were submitted for analysis by Westinghouse Hanford Company (WHC) under the Technical Project Plan (TPP) 17667 and the Quality Assurance Plan MCS-027. They came from a core taken during Window ``C`` after the May 1991 gas release event. The analytical procedures required for analysis were defined in the Test Instructions (TI) prepared by the PNL 101-SY Analytical Chemistry Laboratory (ACL) Project Management Office in accordance with the TPP and the QA Plan. The requestedmore » analysis for these samples was volatile organic analysis. The quality control (QC) requirements for each sample are defined in the Test Instructions for each sample. The QC requirements outlined in the procedures and requested in the WHC statement of work were followed.« less

[The analytical reliability of clinical laboratory information and role of the standards in its support].

PubMed

Men'shikov, V V

2012-12-01

The article deals with the factors impacting the reliability of clinical laboratory information. The differences of qualities of laboratory analysis tools produced by various manufacturers are discussed. These characteristics are the causes of discrepancy of the results of laboratory analyses of the same analite. The role of the reference system in supporting the comparability of laboratory analysis results is demonstrated. The project of national standard is presented to regulate the requirements to standards and calibrators for analysis of qualitative and non-metrical characteristics of components of biomaterials.

[The Scope, Quality and Safety Requirements of Drug Abuse Testing].

PubMed

Küme, Tuncay; Karakükcü, Çiğdem; Pınar, Aslı; Coşkunol, Hakan

2017-01-01

The aim of this review is to inform about the scopes and requirements of drug abuse testing. Drug abuse testing is one of the tools for determination of drug use. It must fulfill the quality and safety requirements in judgmental legal and administrative decisions. Drug abuse testing must fulfill some requirements like selection of the appropriate test matrix, appropriate screening test panel, sampling in detection window, patient consent, identification of the donor, appropriate collection site, sample collection with observation, identification and control of the sample, specimen custody chain in preanalytical phase; analysis in authorized laboratories, specimen validity tests, reliable testing METHODS, strict quality control, two-step analysis in analytical phase; storage of the split specimen, confirmation of the split specimen in the objection, result custody chain, appropriate cut-off concentration, the appropriate interpretation of the result in postanalytical phase. The workflow and analytical processes of drug abuse testing are explained in last regulation of the Department of Medical Laboratory Services, Ministry of Health in Turkey. The clinical physicians have to know and apply the quality and safety requirements in drug abuse testing according to last regulations in Turkey.

QCloud: A cloud-based quality control system for mass spectrometry-based proteomics laboratories

PubMed Central

Chiva, Cristina; Olivella, Roger; Borràs, Eva; Espadas, Guadalupe; Pastor, Olga; Solé, Amanda

2018-01-01

The increasing number of biomedical and translational applications in mass spectrometry-based proteomics poses new analytical challenges and raises the need for automated quality control systems. Despite previous efforts to set standard file formats, data processing workflows and key evaluation parameters for quality control, automated quality control systems are not yet widespread among proteomics laboratories, which limits the acquisition of high-quality results, inter-laboratory comparisons and the assessment of variability of instrumental platforms. Here we present QCloud, a cloud-based system to support proteomics laboratories in daily quality assessment using a user-friendly interface, easy setup, automated data processing and archiving, and unbiased instrument evaluation. QCloud supports the most common targeted and untargeted proteomics workflows, it accepts data formats from different vendors and it enables the annotation of acquired data and reporting incidences. A complete version of the QCloud system has successfully been developed and it is now open to the proteomics community (http://qcloud.crg.eu). QCloud system is an open source project, publicly available under a Creative Commons License Attribution-ShareAlike 4.0. PMID:29324744

New reporting procedures based on long-term method detection levels and some considerations for interpretations of water-quality data provided by the U.S. Geological Survey National Water Quality Laboratory

USGS Publications Warehouse

Childress, Carolyn J. Oblinger; Foreman, William T.; Connor, Brooke F.; Maloney, Thomas J.

1999-01-01

This report describes the U.S. Geological Survey National Water Quality Laboratory?s approach for determining long-term method detection levels and establishing reporting levels, details relevant new reporting conventions, and provides preliminary guidance on interpreting data reported with the new conventions. At the long-term method detection level concentration, the risk of a false positive detection (analyte reported present at the long-term method detection level when not in sample) is no more than 1 percent. However, at the long-term method detection level, the risk of a false negative occurrence (analyte reported not present when present at the long-term method detection level concentration) is up to 50 percent. Because this false negative rate is too high for use as a default 'less than' reporting level, a more reliable laboratory reporting level is set at twice the determined long-term method detection level. For all methods, concentrations measured between the laboratory reporting level and the long-term method detection level will be reported as estimated concentrations. Non-detections will be censored to the laboratory reporting level. Adoption of the new reporting conventions requires a full understanding of how low-concentration data can be used and interpreted and places responsibility for using and presenting final data with the user rather than with the laboratory. Users must consider that (1) new laboratory reporting levels may differ from previously established minimum reporting levels, (2) long-term method detection levels and laboratory reporting levels may change over time, and (3) estimated concentrations are less certain than concentrations reported above the laboratory reporting level. The availability of uncensored but qualified low-concentration data for interpretation and statistical analysis is a substantial benefit to the user. A decision to censor data after they are reported from the laboratory may still be made by the user, if merited, on the basis of the intended use of the data.

Collection methods and quality assessment for Esche-richia coli, water quality, and microbial source tracking data within Tumacácori National Historical Park and the upper Santa Cruz River, Arizona, 2015-16

USGS Publications Warehouse

Paretti, Nicholas; Coes, Alissa L.; Kephart, Christopher M.; Mayo, Justine

2018-03-05

Tumacácori National Historical Park protects the culturally important Mission, San José de Tumacácori, while also managing a portion of the ecologically diverse riparian corridor of the Santa Cruz River. This report describes the methods and quality assurance procedures used in the collection of water samples for the analysis of Escherichia coli (E. coli), microbial source tracking markers, suspended sediment, water-quality parameters, turbidity, and the data collection for discharge and stage; the process for data review and approval is also described. Finally, this report provides a quantitative assessment of the quality of the E. coli, microbial source tracking, and suspended sediment data.The data-quality assessment revealed that bias attributed to field and laboratory contamination was minimal, with E. coli detections in only 3 out of 33 field blank samples analyzed. Concentrations in the field blanks were several orders of magnitude lower than environmental concentrations. The microbial source tracking (MST) field blank was below the detection limit for all MST markers analyzed. Laboratory blanks for E. coli at the USGS Arizona Water Science Center and laboratory blanks for MST markers at the USGS Ohio Water Microbiology Laboratory were all below the detection limit. Irreplicate data for E. coli and suspended sediment indicated that bias was not introduced to the data by combining samples collected using discrete sampling methods with samples collected using automatic sampling methods.The split and sequential E. coli replicate data showed consistent analytical variability and a single equation was developed to explain the variability of E. coli concentrations. An additional analysis of analytical variability for E. coli indicated analytical variability around 18 percent relative standard deviation and no trend was observed in the concentration during the processing and analysis of multiple split-replicates. Two replicate samples were collected for MST and individual markers were compared for a base flow and flood sample. For the markers found in common between the two types of samples, the relative standard deviation for the base flow sample was more than 3 times greater than the markers in the flood sample. Sequential suspended sediment replicates had a relative standard deviation of about 1.3 percent, indicating that environmental and analytical variability was minimal.A holding time review and laboratory study analysis supported the extended holding times required for this investigation. Most concentrations for flood and base-flow samples were within the theoretical variability specified in the most probable number approach suggesting that extended hold times did not overly influence the final concentrations reported.

Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits.

PubMed

Hyltoft Petersen, Per; Klee, George G

2014-03-20

Diagnostic decisions based on decision limits according to medical guidelines are different from the majority of clinical decisions due to the strict dichotomization of patients into diseased and non-diseased. Consequently, the influence of analytical performance is more critical than for other diagnostic decisions where much other information is included. The aim of this opinion paper is to investigate consequences of analytical quality and other circumstances for the outcome of "Guideline-Driven Medical Decision Limits". Effects of analytical bias and imprecision should be investigated separately and analytical quality specifications should be estimated accordingly. Use of sharp decision limits doesn't consider biological variation and effects of this variation are closely connected with the effects of analytical performance. Such relationships are investigated for the guidelines for HbA1c in diagnosis of diabetes and in risk of coronary heart disease based on serum cholesterol. The effects of a second sampling in diagnosis give dramatic reduction in the effects of analytical quality showing minimal influence of imprecision up to 3 to 5% for two independent samplings, whereas the reduction in bias is more moderate and a 2% increase in concentration doubles the percentage of false positive diagnoses, both for HbA1c and cholesterol. An alternative approach comes from the current application of guidelines for follow-up laboratory tests according to clinical procedure orders, e.g. frequency of parathyroid hormone requests as a function of serum calcium concentrations. Here, the specifications for bias can be evaluated from the functional increase in requests for increasing serum calcium concentrations. In consequence of the difficulties with biological variation and the practical utilization of concentration dependence of frequency of follow-up laboratory tests already in use, a kind of probability function for diagnosis as function of the key-analyte is proposed. Copyright © 2013 Elsevier B.V. All rights reserved.

Reprint of "Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits".

PubMed

Hyltoft Petersen, Per; Klee, George G

2014-05-15

Diagnostic decisions based on decision limits according to medical guidelines are different from the majority of clinical decisions due to the strict dichotomization of patients into diseased and non-diseased. Consequently, the influence of analytical performance is more critical than for other diagnostic decisions where much other information is included. The aim of this opinion paper is to investigate consequences of analytical quality and other circumstances for the outcome of "Guideline-Driven Medical Decision Limits". Effects of analytical bias and imprecision should be investigated separately and analytical quality specifications should be estimated accordingly. Use of sharp decision limits doesn't consider biological variation and effects of this variation are closely connected with the effects of analytical performance. Such relationships are investigated for the guidelines for HbA1c in diagnosis of diabetes and in risk of coronary heart disease based on serum cholesterol. The effects of a second sampling in diagnosis give dramatic reduction in the effects of analytical quality showing minimal influence of imprecision up to 3 to 5% for two independent samplings, whereas the reduction in bias is more moderate and a 2% increase in concentration doubles the percentage of false positive diagnoses, both for HbA1c and cholesterol. An alternative approach comes from the current application of guidelines for follow-up laboratory tests according to clinical procedure orders, e.g. frequency of parathyroid hormone requests as a function of serum calcium concentrations. Here, the specifications for bias can be evaluated from the functional increase in requests for increasing serum calcium concentrations. In consequence of the difficulties with biological variation and the practical utilization of concentration dependence of frequency of follow-up laboratory tests already in use, a kind of probability function for diagnosis as function of the key-analyte is proposed. Copyright © 2014. Published by Elsevier B.V.

Laboratory issues: use of nutritional biomarkers.

PubMed

Blanck, Heidi Michels; Bowman, Barbara A; Cooper, Gerald R; Myers, Gary L; Miller, Dayton T

2003-03-01

Biomarkers of nutritional status provide alternative measures of dietary intake. Like the error and variation associated with dietary intake measures, the magnitude and impact of both biological (preanalytical) and laboratory (analytical) variability need to be considered when one is using biomarkers. When choosing a biomarker, it is important to understand how it relates to nutritional intake and the specific time frame of exposure it reflects as well as how it is affected by sampling and laboratory procedures. Biological sources of variation that arise from genetic and disease states of an individual affect biomarkers, but they are also affected by nonbiological sources of variation arising from specimen collection and storage, seasonality, time of day, contamination, stability and laboratory quality assurance. When choosing a laboratory for biomarker assessment, researchers should try to make sure random and systematic error is minimized by inclusion of certain techniques such as blinding of laboratory staff to disease status and including external pooled standards to which laboratory staff are blinded. In addition analytic quality control should be ensured by use of internal standards or certified materials over the entire range of possible values to control method accuracy. One must consider the effect of random laboratory error on measurement precision and also understand the method's limit of detection and the laboratory cutpoints. Choosing appropriate cutpoints and reducing error is extremely important in nutritional epidemiology where weak associations are frequent. As part of this review, serum lipids are included as an example of a biomarker whereby collaborative efforts have been put forth to both understand biological sources of variation and standardize laboratory results.

Strategies for the Successful Implementation of Viral Laboratory Automation

PubMed Central

Avivar, Cristóbal

2012-01-01

It has been estimated that more than 70% of all medical activity is directly related to information providing analytical data. Substantial technological advances have taken place recently, which have allowed a previously unimagined number of analytical samples to be processed while offering high quality results. Concurrently, yet more new diagnostic determinations have been introduced - all of which has led to a significant increase in the prescription of analytical parameters. This increased workload has placed great pressure on the laboratory with respect to health costs. The present manager of the Clinical Laboratory (CL) has had to examine cost control as well as rationing - meaning that the CL’s focus has not been strictly metrological, as if it were purely a system producing results, but instead has had to concentrate on its efficiency and efficacy. By applying re-engineering criteria, an emphasis has had to be placed on improved organisation and operating practice within the CL, focussing on the current criteria of the Integrated Management Areas where the technical and human resources are brought together. This re-engineering has been based on the concepts of consolidating and integrating the analytical platforms, while differentiating the production areas (CORE Laboratory) from the information areas. With these present concepts in mind, automation and virological treatment, along with serology in general, follow the same criteria as the rest of the operating methodology in the Clinical Laboratory. PMID:23248733

Strategies for the successful implementation of viral laboratory automation.

PubMed

Avivar, Cristóbal

2012-01-01

It has been estimated that more than 70% of all medical activity is directly related to information providing analytical data. Substantial technological advances have taken place recently, which have allowed a previously unimagined number of analytical samples to be processed while offering high quality results. Concurrently, yet more new diagnostic determinations have been introduced - all of which has led to a significant increase in the prescription of analytical parameters. This increased workload has placed great pressure on the laboratory with respect to health costs. The present manager of the Clinical Laboratory (CL) has had to examine cost control as well as rationing - meaning that the CL's focus has not been strictly metrological, as if it were purely a system producing results, but instead has had to concentrate on its efficiency and efficacy. By applying re-engineering criteria, an emphasis has had to be placed on improved organisation and operating practice within the CL, focussing on the current criteria of the Integrated Management Areas where the technical and human resources are brought together. This re-engineering has been based on the concepts of consolidating and integrating the analytical platforms, while differentiating the production areas (CORE Laboratory) from the information areas. With these present concepts in mind, automation and virological treatment, along with serology in general, follow the same criteria as the rest of the operating methodology in the Clinical Laboratory.

Bias and precision of selected analytes reported by the National Atmospheric Deposition Program and National Trends Network, 1984

USGS Publications Warehouse

Brooks, M.H.; Schroder, L.J.; Willoughby, T.C.

1987-01-01

The U.S. Geological Survey operated a blind audit sample program during 1974 to test the effects of the sample handling and shipping procedures used by the National Atmospheric Deposition Program and National Trends Network on the quality of wet deposition data produced by the combined networks. Blind audit samples, which were dilutions of standard reference water samples, were submitted by network site operators to the central analytical laboratory disguised as actual wet deposition samples. Results from the analyses of blind audit samples were used to calculate estimates of analyte bias associated with all network wet deposition samples analyzed in 1984 and to estimate analyte precision. Concentration differences between double blind samples that were submitted to the central analytical laboratory and separate analyses of aliquots of those blind audit samples that had not undergone network sample handling and shipping were used to calculate analyte masses that apparently were added to each blind audit sample by routine network handling and shipping procedures. These calculated masses indicated statistically significant biases for magnesium, sodium , potassium, chloride, and sulfate. Median calculated masses were 41.4 micrograms (ug) for calcium, 14.9 ug for magnesium, 23.3 ug for sodium, 0.7 ug for potassium, 16.5 ug for chloride and 55.3 ug for sulfate. Analyte precision was estimated using two different sets of replicate measures performed by the central analytical laboratory. Estimated standard deviations were similar to those previously reported. (Author 's abstract)

Measurements for 8 common analytes in native sera identify inadequate standardization among 6 routine laboratory assays.

PubMed

Stepman, Hedwig C M; Tiikkainen, Ulla; Stöckl, Dietmar; Vesper, Hubert W; Edwards, Selvin H; Laitinen, Harri; Pelanti, Jonna; Thienpont, Linda M

2014-06-01

External quality assessment (EQA) with commutable samples is essential for assessing the quality of assays performed by laboratories, particularly when the emphasis is on their standardization status and interchangeability of results. We used a panel of 20 fresh-frozen single-donation serum samples to assess assays for the measurement of creatinine, glucose, phosphate, uric acid, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides. The commercial random access platforms included: Abbott Architect, Beckman Coulter AU, Ortho Vitros, Roche Cobas, Siemens Advia, and Thermo Scientific Konelab. The assessment was done at the peer group level and by comparison against the all-method trimmed mean or reference method values, where available. The considered quality indicators were intraassay imprecision, combined imprecision (including sample-matrix interference), bias, and total error. Fail/pass decisions were based on limits reflecting state-of-the-art performance, but also limits related to biological variation. Most assays showed excellent peer performance attributes, except for HDL- and LDL cholesterol. Cases in which individual assays had biases exceeding the used limits were the Siemens Advia creatinine (-4.2%), Ortho Vitros phosphate (8.9%), Beckman Coulter AU triglycerides (5.4%), and Thermo Scientific Konelab uric acid (6.4%), which lead to considerable interassay discrepancies. Additionally, large laboratory effects were observed that caused interlaboratory differences of >30%. The design of the EQA study was well suited for monitoring different quality attributes of assays performed in daily laboratory practice. There is a need for improvement, even for simple clinical chemistry analytes. In particular, the interchangeability of results remains jeopardized both by assay standardization issues and individual laboratory effects. © 2014 The American Association for Clinical Chemistry.

National surveys on internal quality control for blood gas analysis and related electrolytes in clinical laboratories of China.

PubMed

Duan, Min; Wang, Wei; Zhao, Haijian; Zhang, Chuanbao; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

2018-05-01

Internal quality control (IQC) is essential for precision evaluation and continuous quality improvement. This study aims to investigate the IQC status of blood gas analysis (BGA) in clinical laboratories of China from 2014 to 2017. IQC information on BGA (including pH, pCO2, pO2, Na+, K+, Ca2+, Cl-) was submitted by external quality assessment (EQA) participant laboratories and collected through Clinet-EQA reporting system in March from 2014 to 2017. First, current CVs were compared among different years and measurement systems. Then, percentages of laboratories meeting five allowable imprecision specifications for each analyte were calculated, respectively. Finally, laboratories were divided into different groups based on control rules and frequency to compare their variation trend. The current CVs of BGA were significantly decreasing from 2014 to 2017. pH and pCO2 got the highest pass rates when compared with the minimum imprecision specification, whereas pO2, Na+, K+, Ca2+, Cl- got the highest pass rates when 1/3 TEa imprecision specification applied. The pass rates of pH, pO2, Na+, K+, Ca2+, Cl- were significantly increasing during the 4 years. The comparisons of current CVs among different measurement systems showed that the precision performance of different analytes among different measurement systems had no regular distribution from 2014 to 2017. The analysis of IQC practice indicated great progress and improvement among different years. The imprecision performance of BGA has improved from 2014 to 2017, but the status of imprecision performance in China remains unsatisfying. Therefore, further investigation and continuous improvement measures should be taken.

[ISO 15189 accreditation in clinical microbiology laboratory: general concepts and the status in our laboratory].

PubMed

Akyar, Işin

2009-10-01

One important trend in the laboratory profession and quality management is the global convergence of laboratory operations. The goal of an accredited medical laboratory is to continue "offering useful laboratory service for diagnosis and treatment of the patients and also aid to the health of the nation". An accredited clinical laboratory is managed by a quality control system, it is competent technically and the laboratory service meets the needs of all its patients and physicians by taking the responsibility of all the medical tests and therapies. For this purpose, ISO 15189 international standard has been prepared by 2003. ISO 15189 standard is originated from the arrangement of ISO 17025 and ISO 9001:2000 standards. Many countries such as England, Germany, France, Canada and Australia have preferred ISO 15189 as their own laboratory accreditation programme, meeting all the requirements of their medical laboratories. The accreditation performance of a clinical microbiology laboratory is mainly based on five essential points; preanalytical, analytical, postanalytical, quality control programmes (internal, external, interlaboratory) and audits (internal, external). In this review article, general concepts on ISO 15189 accreditation standards for the clinical microbiology laboratories have been summarized and the status of a private laboratory (Acibadem LabMed, Istanbul) in Turkey has been discussed.

Analysis of Phosphonic Acids: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS999

DOE Office of Scientific and Technical Information (OSTI.GOV)

Owens, J; Vu, A; Koester, C

The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method titled Analysis of Diisopropyl Methylphosphonate, Ethyl Hydrogen Dimethylamidophosphate, Isopropyl Methylphosphonic Acid, Methylphosphonic Acid, and Pinacolyl Methylphosphonic Acid in Water by Multiple Reaction Monitoring Liquid Chromatography/Tandem Mass Spectrometry: EPA Version MS999. This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to validate and verify the analytical procedures describedmore » in EPA Method MS999 for analysis of the listed phosphonic acids and surrogates in aqueous samples. The gathered data from this validation study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of EPA Method MS999 can be determined.« less

Quality-assurance data for routine water quality analyses by the U. S. Geological Survey laboratory in Troy, New York; July 1993 through June 1995

USGS Publications Warehouse

Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

2001-01-01

A laboratory for analysis of low-ionic strength water has been developed at the U.S. Geological Survey (USGS) office in Troy, N.Y., to analyze samples collected by USGS projects in the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures developed to ensure proper sample collection, processing, and analysis. The quality-assurance/quality-control data are stored in the laboratory's SAS data-management system, which provides efficient review, compilation, and plotting of quality-assurance/quality-control data. This report presents and discusses samples analyzed from July 1993 through June 1995. Quality-control results for 18 analytical procedures were evaluated for bias and precision. Control charts show that data from seven of the analytical procedures were biased throughout the analysis period for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, dissolved inorganic carbon, dissolved organic carbon (soil expulsions), chloride, magnesium, nitrate (colorimetric method), and pH. Three of the analytical procedures were occasionally biased but were within control limits; they were: calcium (high for high-concentration samples for May 1995), dissolved organic carbon (high for highconcentration samples from January through September 1994), and fluoride (high in samples for April and June 1994). No quality-control sample has been developed for the organic monomeric aluminum procedure. Results from the filter-blank and analytical-blank analyses indicate that all analytical procedures in which blanks were run were within control limits, although values for a few blanks were outside the control limits. Blanks were not analyzed for acid-neutralizing capacity, dissolved inorganic carbon, fluoride, nitrate (colorimetric method), or pH. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in 14 of the 18 procedures. Data-quality objectives were met by more than 90 percent of the samples analyzed in all procedures except total monomeric aluminum (85 percent of samples met objectives), total aluminum (70 percent of samples met objectives), and dissolved organic carbon (85 percent of samples met objectives). Triplicate samples were not analyzed for ammonium, fluoride, dissolved inorganic carbon, or nitrate (colorimetric method). Results of the USGS interlaboratory Standard Reference Sample Program indicated high data quality with a median result of 3.6 of a possible 4.0. Environment Canada's LRTAP interlaboratory study results indicated that more than 85 percent of the samples met data-quality objectives in 6 of the 12 analyses; exceptions were calcium, dissolved organic carbon, chloride, pH, potassium, and sodium. Data-quality objectives were not met for calcium samples in one LRTAP study, but 94 percent of samples analyzed were within control limits for the remaining studies. Data-quality objectives were not met by 35 percent of samples analyzed for dissolved organic carbon, but 94 percent of sample values were within 20 percent of the most probable value. Data-quality objectives were not met for 30 percent of samples analyzed for chloride, but 90 percent of sample values were within 20 percent of the most probable value. Measurements of samples with a pH above 6.0 were biased high in 54 percent of the samples, although 85 percent of the samples met data-quality objectives for pH measurements below 6.0. Data-quality objectives for potassium and sodium were not met in one study (only 33 percent of the samples analyzed met the objectives), although 85 percent of the sample values were within control limits for the other studies. Measured sodium values were above the upper control limit in all studies. Results from blind reference-sample analyses indicated that data

Determination of steroid hormones and related compounds in filtered and unfiltered water by solid-phase extraction, derivatization, and gas chromatography with tandem mass spectrometry

USGS Publications Warehouse

Foreman, William T.; Gray, James L.; ReVello, Rhiannon C.; Lindley, Chris E.; Losche, Scott A.; Barber, Larry B.

2012-01-01

A new analytical method has been developed and implemented at the U.S. Geological Survey National Water Quality Laboratory that determines a suite of 20 steroid hormones and related compounds in filtered water (using laboratory schedule 2434) and in unfiltered water (using laboratory schedule 4434). This report documents the procedures and initial performance data for the method and provides guidance on application of the method and considerations of data quality in relation to data interpretation. The analytical method determines 6 natural and 3 synthetic estrogen compounds, 6 natural androgens, 1 natural and 1 synthetic progestin compound, and 2 sterols: cholesterol and 3--coprostanol. These two sterols have limited biological activity but typically are abundant in wastewater effluents and serve as useful tracers. Bisphenol A, an industrial chemical used primarily to produce polycarbonate plastic and epoxy resins and that has been shown to have estrogenic activity, also is determined by the method. A technique referred to as isotope-dilution quantification is used to improve quantitative accuracy by accounting for sample-specific procedural losses in the determined analyte concentration. Briefly, deuterium- or carbon-13-labeled isotope-dilution standards (IDSs), all of which are direct or chemically similar isotopic analogs of the method analytes, are added to all environmental and quality-control and quality-assurance samples before extraction. Method analytes and IDS compounds are isolated from filtered or unfiltered water by solid-phase extraction onto an octadecylsilyl disk, overlain with a graded glass-fiber filter to facilitate extraction of unfiltered sample matrices. The disks are eluted with methanol, and the extract is evaporated to dryness, reconstituted in solvent, passed through a Florisil solid-phase extraction column to remove polar organic interferences, and again evaporated to dryness in a reaction vial. The method compounds are reacted with activated -methyl--trimethylsilyl trifluoroacetamide at 65 degrees Celsius for 1 hour to form trimethylsilyl or trimethylsilyl-enol ether derivatives that are more amenable to gas chromatographic separation than the underivatized compounds. Analysis is carried out by gas chromatography with tandem mass spectrometry using calibration standards that are derivatized concurrently with the sample extracts. Analyte concentrations are quantified relative to specific IDS compounds in the sample, which directly compensate for procedural losses (incomplete recovery) in the determined and reported analyte concentrations. Thus, reported analyte concentrations (or analyte recoveries for spiked samples) are corrected based on recovery of the corresponding IDS compound during the quantification process. Recovery for each IDS compound is reported for each sample and represents an absolute recovery in a manner comparable to surrogate recoveries for other organic methods used by the National Water Quality Laboratory. Thus, IDS recoveries provide a useful tool for evaluating sample-specific analytical performance from an absolute mass recovery standpoint. IDS absolute recovery will differ and typically be lower than the corresponding analyte’s method recovery in spiked samples. However, additional correction of reported analyte concentrations is unnecessary and inappropriate because the analyte concentration (or recovery) already is compensated for by the isotope-dilution quantification procedure. Method analytes were spiked at 10 and 100 nanograms per liter (ng/L) for most analytes (10 times greater spike levels were used for bisphenol A and 100 times greater spike levels were used for 3--coprostanol and cholesterol) into the following validation-sample matrices: reagent water, wastewater-affected surface water, a secondary-treated wastewater effluent, and a primary (no biological treatment) wastewater effluent. Overall method recovery for all analytes in these matrices averaged 100 percent, with overall relative standard deviation of 28 percent. Mean recoveries of the 20 individual analytes for spiked reagent-water samples prepared along with field samples and analyzed in 2009–2010 ranged from 84–104 percent, with relative standard deviations of 6–36 percent. Concentrations for two analytes, equilin and progesterone, are reported as estimated because these analytes had excessive bias or variability, or both. Additional database coding is applied to other reported analyte data as needed, based on sample-specific IDS recovery performance. Detection levels were derived statistically by fortifying reagent water at six different levels (0.1 to 4 ng/L) and range from about 0.4 to 4 ng/L for 16 analytes. Interim reporting levels applied to analytes in this report range from 0.8 to 8 ng/L. Bisphenol A and the sterols (cholesterol and 3-beta-coprostanol) were consistently detected in laboratory and field blanks. The minimum reporting levels were set at 100 ng/L for bisphenol A and at 200 ng/L for the two sterols to prevent any bias associated with the presence of these compounds in the blanks. A minimum reporting level of 2 ng/L was set for 11-ketotestosterone to minimize false positive risk from an interfering siloxane compound emanating as chromatographic-column bleed, from vial septum material, or from other sources at no more than 1 ng/L.

Coordination and standardization of federal sedimentation activities

USGS Publications Warehouse

Glysson, G. Douglas; Gray, John R.

1997-01-01

- precipitation information critical to water resources management. Memorandum M-92-01 covers primarily freshwater bodies and includes activities, such as "development and distribution of consensus standards, field-data collection and laboratory analytical methods, data processing and interpretation, data-base management, quality control and quality assurance, and water- resources appraisals, assessments, and investigations." Research activities are not included.

Methods for determination of inorganic substances in water and fluvial sediments

USGS Publications Warehouse

Fishman, Marvin J.; Friedman, Linda C.

1989-01-01

Chapter Al of the laboratory manual contains methods used by the U.S. Geological Survey to analyze samples of water, suspended sediments, and bottom material for their content of inorganic constituents. Included are methods for determining the concentration of dissolved constituents in water, the total recoverable and total of constituents in water-suspended sediment samples, and the recoverable and total concentrations of constituents in samples of bottom material. The introduction to the manual includes essential definitions and a brief discussion of the use of significant figures in calculating and reporting analytical results. Quality control in the water-analysis laboratory is discussed, including the accuracy and precision of analyses, the use of standard-reference water samples, and the operation of an effective quality-assurance program. Methods for sample preparation and pretreatment are given also. A brief discussion of the principles of the analytical techniques involved and their particular application to water and sediment analysis is presented. The analytical methods of these techniques are arranged alphabetically by constituent. For each method, the general topics covered are the application, the principle of the method, the interferences, the apparatus and reagents required, a detailed description of the analytical procedure, reporting results, units and significant figures, and analytical precision data, when available. More than 126 methods are given for the determination of 70 inorganic constituents and physical properties of water, suspended sediment, and bottom material.

Methods for determination of inorganic substances in water and fluvial sediments

USGS Publications Warehouse

Fishman, Marvin J.; Friedman, Linda C.

1985-01-01

Chapter Al of the laboratory manual contains methods used by the Geological Survey to analyze samples of water, suspended sediments, and bottom material for their content of inorganic constituents. Included are methods for determining the concentration of dissolved constituents in water, total recoverable and total of constituents in water-suspended sediment samples, and recoverable and total concentrations of constituents in samples of bottom material. Essential definitions are included in the introduction to the manual, along with a brief discussion of the use of significant figures in calculating and reporting analytical results. Quality control in the water-analysis laboratory is discussed, including accuracy and precision of analyses, the use of standard reference water samples, and the operation of an effective quality assurance program. Methods for sample preparation and pretreatment are given also.A brief discussion of the principles of the analytical techniques involved and their particular application to water and sediment analysis is presented. The analytical methods involving these techniques are arranged alphabetically according to constituent. For each method given, the general topics covered are application, principle of the method, interferences, apparatus and reagents required, a detailed description of the analytical procedure, reporting results, units and significant figures, and analytical precision data, when available. More than 125 methods are given for the determination of 70 different inorganic constituents and physical properties of water, suspended sediment, and bottom material.

Historical profile, Quality of Water Laboratories, U. S. Geological Survey

USGS Publications Warehouse

Durum, W.H.

1978-01-01

During the period 1918 to 1973 the U.S. Geological Survey, Water Resources Division, established 22 District-type water quality laboratories. These facilities provided the analytical capability and water-quality information for hydrologic investigations and the national baseline inventory of chemical, physical, fluvial sediment, and biological characteristics of surface and ground waters in the United States. Prior to 1950, most methods used in the laboratory were gravimetric, colorimetric, or titrimetric. Flame photometric equipment was common to most laboratories in the 1950's, and the atomic absorption spectrophotometer was added to larger laboratories in the 1960's. In the late 1960's, the first of the automatic analyzers was installed. Total annual production averaged about 480 adjusted complete analyses during the early years 1919-28, about 7,800 in 1946, and about 50,000 in 1970. Budget estimates for the majority of laboratories ranged from $25,000 to $50,000 (1940-50) and $75,000 to $300,000 (1965-73). Beginning in 1972, major functions of the 22 laboratories have been combined into two comprehensive highly-automated facilities located at Denver (Arvada), Colo., and Atlanta (Doraville), Ga. These laboratories comprise the Central Laboratory System for the U.S. Geological Survey. (Woodard-USGS)

Quality indicators and specifications for strategic and support processes in laboratory medicine.

PubMed

Ricós, Carmen; Biosca, Carme; Ibarz, Mercè; Minchinela, Joana; Llopis, Maantonia; Perich, Carmen; Alsina, Jesus; Alvarez, Virtudes; Doménech, Vicenta; Pastor, Rosa Ma; Sansalvador, Mireia; Isern, Gloria Trujillo; Navarro, Conrad Vilanova

2008-01-01

This work is the second part of a study regarding indicators and quality specifications for the non-analytical processes in laboratory medicine. Five primary care and five hospital laboratories agreed on the indicators for two strategic processes (quality planning and project development) and various support processes (client relationships, instrument and infrastructure maintenance, safety and risk prevention, purchases and storage, personnel training). In the majority of cases, the median values recorded over 1 year is considered to be the state-of-the-art in our setting and proposed as the quality specification for the indicators stated. Values have been stratified according to primary care and hospital laboratory for referred tests and group of personnel for training. In some cases, the specifications have been set equal to zero events, such as serious incidents in the infrastructure maintenance process and number of work accidents in the safety and risk prevention process. In light of this study, an effort is needed to optimize decisions regarding corrective actions and to move from a subjective individual criterion to systematic and comparative management. This preliminary study provides a comprehensive vision of a subject that could motivate further research and advances in the quality of laboratory services.

CSF biomarker variability in the Alzheimer’s Association quality control program

PubMed Central

Mattsson, Niklas; Andreasson, Ulf; Persson, Staffan; Carrillo, Maria C.; Collins, Steven; Chalbot, Sonia; Cutler, Neal; Dufour-Rainfray, Diane; Fagan, Anne M.; Heegaard, Niels H. H.; Hsiung, Ging-Yuek Robin; Hyman, Bradley; Iqbal, Khalid; Lachno, D. Richard; Lleó, Alberto; Lewczuk, Piotr; Molinuevo, José L.; Parchi, Piero; Regeniter, Axel; Rissman, Robert; Rosenmann, Hanna; Sancesario, Giuseppe; Schröder, Johannes; Shaw, Leslie M.; Teunissen, Charlotte E.; Trojanowski, John Q.; Vanderstichele, Hugo; Vandijck, Manu; Verbeek, Marcel M.; Zetterberg, Henrik; Blennow, Kaj; Käser, Stephan A.

2013-01-01

Background The cerebrospinal fluid (CSF) biomarkers amyloid beta 1–42, total tau, and phosphorylated tau are used increasingly for Alzheimer’s disease (AD) research and patient management. However, there are large variations in biomarker measurements among and within laboratories. Methods Data from the first nine rounds of the Alzheimer’s Association quality control program was used to define the extent and sources of analytical variability. In each round, three CSF samples prepared at the Clinical Neurochemistry Laboratory (Mölndal, Sweden) were analyzed by single-analyte enzyme-linked immunosorbent assay (ELISA), a multiplexing xMAP assay, or an immunoassay with electrochemoluminescence detection. Results A total of 84 laboratories participated. Coefficients of variation (CVs) between laboratories were around 20% to 30%; within-run CVs, less than 5% to 10%; and longitudinal within-laboratory CVs, 5% to 19%. Interestingly, longitudinal within-laboratory CV differed between biomarkers at individual laboratories, suggesting that a component of it was assay dependent. Variability between kit lots and between laboratories both had a major influence on amyloid beta 1–42 measurements, but for total tau and phosphorylated tau, between-kit lot effects were much less than between-laboratory effects. Despite the measurement variability, the between-laboratory consistency in classification of samples (using prehoc-derived cutoffs for AD) was high (>90% in 15 of 18 samples for ELISA and in 12 of 18 samples for xMAP). Conclusions The overall variability remains too high to allow assignment of universal biomarker cutoff values for a specific intended use. Each laboratory must ensure longitudinal stability in its measurements and use internally qualified cutoff levels. Further standardization of laboratory procedures and improvement of kit performance will likely increase the usefulness of CSF AD biomarkers for researchers and clinicians. PMID:23622690

Chromatographic multivariate quality control of pharmaceuticals giving strongly overlapped peaks based on the chromatogram profile.

PubMed

Escuder-Gilabert, L; Ruiz-Roch, D; Villanueva-Camañas, R M; Medina-Hernández, M J; Sagrado, S

2004-03-12

In the present paper, the simultaneous quantification of two analytes showing strongly overlapped chromatographic peaks (alpha = 1.02), under the assumption that both available equipment and training of the laboratory staff are basic, is studied. A pharmaceutical preparation (Mutabase) containing two drugs of similar physicochemical properties (amitriptyline and perphenazine) is selected as case of study. The assays are carried out under realistic working conditions (i.e. routine testing laboratories). Uncertainty considerations are introduced in the study. A partial least squares model is directly applied to the chromatographic data (with no previous signal transformation) to perform quality control of the pharmaceutical formulation. Under the adequate protocol, the relative error in prediction of analytes is within the tolerances found in the pharmacopeia (10%). For spiked samples simulating formulation mistakes, the errors found have the same magnitude and sign to those provoked.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Engels, J.

The Environmental Restoration (ER) Program was established for the investigation and remediation of inactive US Department of Energy (DOE) sites and facilities that have been declared surplus in terms of their previous uses. The purpose of this document is to Specify ER requirements for quality control (QC) of analytical data. Activities throughout all phases of the investigation may affect the quality of the final data product, thus are subject to control specifications. Laboratory control is emphasized in this document, and field concerns will be addressed in a companion document Energy Systems, in its role of technical coordinator and at themore » request of DOE-OR, extends the application of these requirements to all participants in ER activities. Because every instance and concern may not be addressed in this document, participants are encouraged to discuss any questions with the ER Quality Assurance (QA) Office, the Analytical Environmental Support Group (AESG), or the Analytical Project Office (APO).« less

Potential sources of analytical bias and error in selected trace element data-quality analyses

USGS Publications Warehouse

Paul, Angela P.; Garbarino, John R.; Olsen, Lisa D.; Rosen, Michael R.; Mebane, Christopher A.; Struzeski, Tedmund M.

2016-09-28

Potential sources of analytical bias and error associated with laboratory analyses for selected trace elements where concentrations were greater in filtered samples than in paired unfiltered samples were evaluated by U.S. Geological Survey (USGS) Water Quality Specialists in collaboration with the USGS National Water Quality Laboratory (NWQL) and the Branch of Quality Systems (BQS).Causes for trace-element concentrations in filtered samples to exceed those in associated unfiltered samples have been attributed to variability in analytical measurements, analytical bias, sample contamination either in the field or laboratory, and (or) sample-matrix chemistry. These issues have not only been attributed to data generated by the USGS NWQL but have been observed in data generated by other laboratories. This study continues the evaluation of potential analytical bias and error resulting from matrix chemistry and instrument variability by evaluating the performance of seven selected trace elements in paired filtered and unfiltered surface-water and groundwater samples collected from 23 sampling sites of varying chemistries from six States, matrix spike recoveries, and standard reference materials.Filtered and unfiltered samples have been routinely analyzed on separate inductively coupled plasma-mass spectrometry instruments. Unfiltered samples are treated with hydrochloric acid (HCl) during an in-bottle digestion procedure; filtered samples are not routinely treated with HCl as part of the laboratory analytical procedure. To evaluate the influence of HCl on different sample matrices, an aliquot of the filtered samples was treated with HCl. The addition of HCl did little to differentiate the analytical results between filtered samples treated with HCl from those samples left untreated; however, there was a small, but noticeable, decrease in the number of instances where a particular trace-element concentration was greater in a filtered sample than in the associated unfiltered sample for all trace elements except selenium. Accounting for the small dilution effect (2 percent) from the addition of HCl, as required for the in-bottle digestion procedure for unfiltered samples, may be one step toward decreasing the number of instances where trace-element concentrations are greater in filtered samples than in paired unfiltered samples.The laboratory analyses of arsenic, cadmium, lead, and zinc did not appear to be influenced by instrument biases. These trace elements showed similar results on both instruments used to analyze filtered and unfiltered samples. The results for aluminum and molybdenum tended to be higher on the instrument designated to analyze unfiltered samples; the results for selenium tended to be lower. The matrices used to prepare calibration standards were different for the two instruments. The instrument designated for the analysis of unfiltered samples was calibrated using standards prepared in a nitric:hydrochloric acid (HNO3:HCl) matrix. The instrument designated for the analysis of filtered samples was calibrated using standards prepared in a matrix acidified only with HNO3. Matrix chemistry may have influenced the responses of aluminum, molybdenum, and selenium on the two instruments. The best analytical practice is to calibrate instruments using calibration standards prepared in matrices that reasonably match those of the samples being analyzed.Filtered and unfiltered samples were spiked over a range of trace-element concentrations from less than 1 to 58 times ambient concentrations. The greater the magnitude of the trace-element spike concentration relative to the ambient concentration, the greater the likelihood spike recoveries will be within data control guidelines (80–120 percent). Greater variability in spike recoveries occurred when trace elements were spiked at concentrations less than 10 times the ambient concentration. Spike recoveries that were considerably lower than 90 percent often were associated with spiked concentrations substantially lower than what was present in the ambient sample. Because the main purpose of spiking natural water samples with known quantities of a particular analyte is to assess possible matrix effects on analytical results, the results of this study stress the importance of spiking samples at concentrations that are reasonably close to what is expected but sufficiently high to exceed analytical variability. Generally, differences in spike recovery results between paired filtered and unfiltered samples were minimal when samples were analyzed on the same instrument.Analytical results for trace-element concentrations in ambient filtered and unfiltered samples greater than 10 and 40 μg/L, respectively, were within the data-quality objective for precision of ±25 percent. Ambient trace-element concentrations in filtered samples greater than the long-term method detection limits but less than 10 μg/L failed to meet the data-quality objective for precision for at least one trace element in about 54 percent of the samples. Similarly, trace-element concentrations in unfiltered samples greater than the long-term method detection limits but less than 40 μg/L failed to meet this data-quality objective for at least one trace-element analysis in about 58 percent of the samples. Although, aluminum and zinc were particularly problematic, limited re-analyses of filtered and unfiltered samples appeared to improve otherwise failed analytical precision.The evaluation of analytical bias using standard reference materials indicate a slight low bias for results for arsenic, cadmium, selenium, and zinc. Aluminum and molybdenum show signs of high bias. There was no observed bias, as determined using the standard reference materials, during the analysis of lead.

Evaluating laboratory key performance using quality indicators in Alexandria University Hospital Clinical Chemistry Laboratories.

PubMed

Rizk, Mostafa M; Zaki, Adel; Hossam, Nermine; Aboul-Ela, Yasmin

2014-12-01

The performance of clinical laboratories plays a fundamental role in the quality and effectiveness of healthcare. To evaluate the laboratory performance in Alexandria University Hospital Clinical Laboratories using key quality indicators and to compare the performance before and after an improvement plan based on ISO 15189 standards. The study was carried out on inpatient samples for a period of 7 months that was divided into three phases: phase I included data collection for evaluation of the existing process before improvement (March-May 2012); an intermediate phase, which included corrective, preventive action, quality initiative and steps for improvement (June 2012); and phase II, which included data collection for evaluation of the process after improvement (July 2012-September 2012). In terms of the preanalytical indicators, incomplete request forms in phase I showed that the total number of received requests were 31 944, with a percentage of defected request of 33.66%; whereas in phase II, there was a significant reduction in all defected request items (P<0.001) with a percentage of defected requests of 9.64%. As for the analytical indicators, the proficiency testing accuracy score in phase I showed poor performance of 10 analytes in which total error (TE) exceeded total error allowable (TEa), with a corresponding sigma value of less than 3, which indicates test problems and an unreliable method. The remaining analytes showed an acceptable performance in which TE did not exceed the TEa, with a sigma value of more than 6. Following an intervention of 3 months, the performance showed marked improvement. Error tracking in phase I showed a TE of (5.11%), whereas in phase II it was reduced to 2.48% (P<0.001).For the postanalytical indicators, our results in phase I showed that the percentage of nonreported critical results was 26.07%. In phase II, there was a significant improvement (P<0.001). The percentage of nonreported results was 11.37%, the reasons were either inability to contact the authorized doctor (8.24%), wrong patient identification (1.0%), lack of reporting by lab doctor (1.11%), and finally, lack of reporting by the lab technician (1.03%). Standardization and monitoring of each step in the total testing process is very important and is associated with the most efficient and well-organized laboratories.

ANALYTICAL CHEMISTRY DIVISION ANNUAL PROGRESS REPORT FOR PERIOD ENDING DECEMBER 31, 1961

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

1962-02-01

Research and development progress is reported on analytlcal instrumentation, dlssolver-solution analyses, special research problems, reactor projects analyses, x-ray and spectrochemical analyses, mass spectrometry, optical and electron microscopy, radiochemical analyses, nuclear analyses, inorganic preparations, organic preparations, ionic analyses, infrared spectral studies, anodization of sector coils for the Analog II Cyclotron, quality control, process analyses, and the Thermal Breeder Reactor Projects Analytical Chemistry Laboratory. (M.C.G.)

Promoting clinical and laboratory interaction by harmonization.

PubMed

Plebani, Mario; Panteghini, Mauro

2014-05-15

The lack of interchangeable results in current practice among clinical laboratories has underpinned greater attention to standardization and harmonization projects. Although the focus was mainly on the standardization and harmonization of measurement procedures and their results, the scope of harmonization goes beyond method and analytical results: it includes all other aspects of laboratory testing, including terminology and units, report formats, reference limits and decision thresholds, as well as test profiles and criteria for the interpretation of results. In particular, as evidence collected in last decades demonstrates that pre-pre- and post-post-analytical steps are more vulnerable to errors, harmonization initiatives should be performed to improve procedures and processes at the laboratory-clinical interface. Managing upstream demand, down-stream interpretation of laboratory results, and subsequent appropriate action through close relationships between laboratorians and clinicians remains a crucial issue of the laboratory testing process. Therefore, initiatives to improve test demand management from one hand and to harmonize procedures to improve physicians' acknowledgment of laboratory data and their interpretation from the other hand are needed in order to assure quality and safety in the total testing process. © 2013.

Exhaled breath condensate – from an analytical point of view

PubMed Central

Dodig, Slavica; Čepelak, Ivana

2013-01-01

Over the past three decades, the goal of many researchers is analysis of exhaled breath condensate (EBC) as noninvasively obtained sample. A total quality in laboratory diagnostic processes in EBC analysis was investigated: pre-analytical (formation, collection, storage of EBC), analytical (sensitivity of applied methods, standardization) and post-analytical (interpretation of results) phases. EBC analysis is still used as a research tool. Limitations referred to pre-analytical, analytical, and post-analytical phases of EBC analysis are numerous, e.g. low concentrations of EBC constituents, single-analyte methods lack in sensitivity, and multi-analyte has not been fully explored, and reference values are not established. When all, pre-analytical, analytical and post-analytical requirements are met, EBC biomarkers as well as biomarker patterns can be selected and EBC analysis can hopefully be used in clinical practice, in both, the diagnosis and in the longitudinal follow-up of patients, resulting in better outcome of disease. PMID:24266297

Blood venous sample collection: Recommendations overview and a checklist to improve quality.

PubMed

Giavarina, Davide; Lippi, Giuseppe

2017-07-01

The extra-analytical phases of the total testing process have substantial impact on managed care, as well as an inherent high risk of vulnerability to errors which is often greater than that of the analytical phase. The collection of biological samples is a crucial preanalytical activity. Problems or errors occurring shortly before, or soon after, this preanalytical step may impair sample quality and characteristics, or else modify the final results of testing. The standardization of fasting requirements, rest, patient position and psychological state of the patient are therefore crucial for mitigating the impact of preanalytical variability. Moreover, the quality of materials used for collecting specimens, along with their compatibility, can guarantee sample quality and persistence of chemical and physical characteristics of the analytes over time, so safeguarding the reliability of testing. Appropriate techniques and sampling procedures are effective to prevent problems such as hemolysis, undue clotting in the blood tube, draw of insufficient sample volume and modification of analyte concentration. An accurate identification of both patient and blood samples is a key priority as for other healthcare activities. Good laboratory practice and appropriate training of operators, by specifically targeting collection of biological samples, blood in particular, may greatly improve this issue, thus lowering the risk of errors and their adverse clinical consequences. The implementation of a simple and rapid check-list, including verification of blood collection devices, patient preparation and sampling techniques, was found to be effective for enhancing sample quality and reducing some preanalytical errors associated with these procedures. The use of this tool, along with implementation of objective and standardized systems for detecting non-conformities related to unsuitable samples, can be helpful for standardizing preanalytical activities and improving the quality of laboratory diagnostics, ultimately helping to reaffirm a "preanalytical" culture founded on knowledge and real risk perception. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Evaluation of chemical data from selected sites in the Surface-Water Ambient Monitoring Program (SWAMP) in Florida

USGS Publications Warehouse

Katz, B.G.; Collins, J.J.

1998-01-01

A cooperative study between the Florida Department of Environmental Protection (FDEP) and the U.S. Geological Survey was conducted to assess the integrity of selected water-quality data collected at 150 sites in the FDEP Surface-Water Ambient Monitoring Program (SWAMP) in Florida. The assessment included determining the consistency of the water-quality data collected statewide, including commonality of monitoring procedures and analytes, screening of the gross validity of a chemical analysis, and quality assurance and quality control (QA/QC) procedures. Four tests were used to screen data at selected SWAMP sites to estimate the gross validity of selected chemical data: (1) the ratio of dissolved solids (in milligrams per liter) to specific conductance (in microsiemens per centimeter); (2) the ratio of total cations (in milliequivalents per liter) multiplied by 100 to specific conductance (in microsiemens per centimeter); (3) the ratio of total anions (in milliequivalents per liter) multiplied by 100 to specific conductance (in microsiemens per centimeter); and (4) the ionic charge-balance error. Although the results of the four screening tests indicate that the chemical data generally are quite reliable, the extremely small number of samples (less than 5 percent of the total number of samples) with sufficient chemical information to run the tests may not provide a representative indication of the analytical accuracy of all laboratories in the program. In addition to the four screening tests, unusually low or high values were flagged for field and laboratory pH (less than 4.0 and greater than 9.0) and specific conductance (less than 10 and greater than 10,000 microsiemens per centimeter). The numbers of flagged data were less than 1 percent of the 19,937 water samples with pH values and less than 0.6 percent of the 16,553 water samples with specific conductance values. Thirty-four agencies responded to a detailed questionnaire that was sent to more than 60 agencies involved in the collection and analysis of surface-water-quality data for SWAMP. The purpose of the survey was to evaluate quality assurance methods and consistency of methods statewide. Information was compiled and summarized on monitoring network design, data review and upload procedures, laboratory and field sampling methods, and data practices. Currently, most agencies that responded to the survey follow FDEP-approved QA/QC protocol for sampling and have quality assurance practices for recording and reporting data. Also, most agencies responded that calibration procedures were followed in the laboratory for analysis of data, but no responses were given about the specific procedures. Approximately 50 percent of the respondents indicated that laboratory analysis methods have changed over time. With so many laboratories involved in analyzing samples for SWAMP, it is difficult to compare water quality from one site to another due to different reporting conventions for chemical constituents and different analytical methods over time. Most agencies responded that calibration methods are followed in the field, but no specific details were provided. Grab samples are the most common method of collection. Other data screening procedures are necessary to further evaluate the validity of chemical data collected at SWAMP sites. High variability in the concentration of targeted constituents may signal analytical problems, but more likely changes in concentration are related to hydrologic conditions. This underscores the need for accurate measurements of discharge, lake stage, tidal stage at the time of sampling so that changes in constituent concentrations can be properly evaluated and fluxes (loads) of nutrients or metals, for example, can be calculated and compared over time.

Target analyte quantification by isotope dilution LC-MS/MS directly referring to internal standard concentrations--validation for serum cortisol measurement.

PubMed

Maier, Barbara; Vogeser, Michael

2013-04-01

Isotope dilution LC-MS/MS methods used in the clinical laboratory typically involve multi-point external calibration in each analytical series. Our aim was to test the hypothesis that determination of target analyte concentrations directly derived from the relation of the target analyte peak area to the peak area of a corresponding stable isotope labelled internal standard compound [direct isotope dilution analysis (DIDA)] may be not inferior to conventional external calibration with respect to accuracy and reproducibility. Quality control samples and human serum pools were analysed in a comparative validation protocol for cortisol as an exemplary analyte by LC-MS/MS. Accuracy and reproducibility were compared between quantification either involving a six-point external calibration function, or a result calculation merely based on peak area ratios of unlabelled and labelled analyte. Both quantification approaches resulted in similar accuracy and reproducibility. For specified analytes, reliable analyte quantification directly derived from the ratio of peak areas of labelled and unlabelled analyte without the need for a time consuming multi-point calibration series is possible. This DIDA approach is of considerable practical importance for the application of LC-MS/MS in the clinical laboratory where short turnaround times often have high priority.

Critical Need for Plutonium and Uranium Isotopic Standards with Lower Uncertainties

DOE PAGES

Mathew, Kattathu Joseph; Stanley, Floyd E.; Thomas, Mariam R.; ...

2016-09-23

Certified reference materials (CRMs) traceable to national and international safeguards database are a critical prerequisite for ensuring that nuclear measurement systems are free of systematic biases. CRMs are used to validate measurement processes associated with nuclear analytical laboratories. Diverse areas related to nuclear safeguards are impacted by the quality of the CRM standards available to analytical laboratories. These include: nuclear forensics, radio-chronometry, national and international safeguards, stockpile stewardship, nuclear weapons infrastructure and nonproliferation, fuel fabrication, waste processing, radiation protection, and environmental monitoring. For the past three decades the nuclear community is confronted with the strange situation that improvements in measurementmore » data quality resulting from the improved accuracy and precision achievable with modern multi-collector mass spectrometers could not be fully exploited due to large uncertainties associated with CRMs available from New Brunswick Laboratory (NBL) that are used for instrument calibration and measurement control. Similar conditions prevail for both plutonium and uranium isotopic standards and for impurity element standards in uranium matrices. Herein, the current status of U and Pu isotopic standards available from NBL is reviewed. Critical areas requiring improvement in the quality of the nuclear standards to enable the U. S. and international safeguards community to utilize the full potential of modern multi-collector mass spectrometer instruments are highlighted.« less

Critical Need for Plutonium and Uranium Isotopic Standards with Lower Uncertainties

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mathew, Kattathu Joseph; Stanley, Floyd E.; Thomas, Mariam R.

Certified reference materials (CRMs) traceable to national and international safeguards database are a critical prerequisite for ensuring that nuclear measurement systems are free of systematic biases. CRMs are used to validate measurement processes associated with nuclear analytical laboratories. Diverse areas related to nuclear safeguards are impacted by the quality of the CRM standards available to analytical laboratories. These include: nuclear forensics, radio-chronometry, national and international safeguards, stockpile stewardship, nuclear weapons infrastructure and nonproliferation, fuel fabrication, waste processing, radiation protection, and environmental monitoring. For the past three decades the nuclear community is confronted with the strange situation that improvements in measurementmore » data quality resulting from the improved accuracy and precision achievable with modern multi-collector mass spectrometers could not be fully exploited due to large uncertainties associated with CRMs available from New Brunswick Laboratory (NBL) that are used for instrument calibration and measurement control. Similar conditions prevail for both plutonium and uranium isotopic standards and for impurity element standards in uranium matrices. Herein, the current status of U and Pu isotopic standards available from NBL is reviewed. Critical areas requiring improvement in the quality of the nuclear standards to enable the U. S. and international safeguards community to utilize the full potential of modern multi-collector mass spectrometer instruments are highlighted.« less

42 CFR 493.1251 - Standard: Procedure manual.

Code of Federal Regulations, 2013 CFR

2013-10-01

... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic... intervals (normal values). (11) Imminently life-threatening test results, or panic or alert values. (12... reporting patient results including, when appropriate, the protocol for reporting imminently life...

42 CFR 493.1251 - Standard: Procedure manual.

Code of Federal Regulations, 2014 CFR

2014-10-01

... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic... intervals (normal values). (11) Imminently life-threatening test results, or panic or alert values. (12... reporting patient results including, when appropriate, the protocol for reporting imminently life...

42 CFR 493.1251 - Standard: Procedure manual.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic... intervals (normal values). (11) Imminently life-threatening test results, or panic or alert values. (12... reporting patient results including, when appropriate, the protocol for reporting imminently life...

The Spanish external quality assessment scheme for mercury in urine.

PubMed

Quintana, M J; Mazarrasa, O

1996-01-01

In 1986 the Instituto Nacional de Seguridad e Higiene en el Trabajo (INSHT), established the "Programa interlaboratorios de control de calidad de mercurio en orina (PICC-HgU)". The operation of this scheme is explained, criteria for evaluation of laboratory performance are defined and some results obtained are reviewed. Since the scheme started, an improvement in the overall performance of laboratories has been observed. The differences in the analytical methods used by laboratories do not seem to have a clear influence on the results.

Preanalytical errors in medical laboratories: a review of the available methodologies of data collection and analysis.

PubMed

West, Jamie; Atherton, Jennifer; Costelloe, Seán J; Pourmahram, Ghazaleh; Stretton, Adam; Cornes, Michael

2017-01-01

Preanalytical errors have previously been shown to contribute a significant proportion of errors in laboratory processes and contribute to a number of patient safety risks. Accreditation against ISO 15189:2012 requires that laboratory Quality Management Systems consider the impact of preanalytical processes in areas such as the identification and control of non-conformances, continual improvement, internal audit and quality indicators. Previous studies have shown that there is a wide variation in the definition, repertoire and collection methods for preanalytical quality indicators. The International Federation of Clinical Chemistry Working Group on Laboratory Errors and Patient Safety has defined a number of quality indicators for the preanalytical stage, and the adoption of harmonized definitions will support interlaboratory comparisons and continual improvement. There are a variety of data collection methods, including audit, manual recording processes, incident reporting mechanisms and laboratory information systems. Quality management processes such as benchmarking, statistical process control, Pareto analysis and failure mode and effect analysis can be used to review data and should be incorporated into clinical governance mechanisms. In this paper, The Association for Clinical Biochemistry and Laboratory Medicine PreAnalytical Specialist Interest Group review the various data collection methods available. Our recommendation is the use of the laboratory information management systems as a recording mechanism for preanalytical errors as this provides the easiest and most standardized mechanism of data capture.

Can a combination of average of normals and "real time" External Quality Assurance replace Internal Quality Control?

PubMed

Badrick, Tony; Graham, Peter

2018-03-28

Internal Quality Control and External Quality Assurance are separate but related processes that have developed independently in laboratory medicine over many years. They have different sample frequencies, statistical interpretations and immediacy. Both processes have evolved absorbing new understandings of the concept of laboratory error, sample material matrix and assay capability. However, we do not believe at the coalface that either process has led to much improvement in patient outcomes recently. It is the increasing reliability and automation of analytical platforms along with improved stability of reagents that has reduced systematic and random error, which in turn has minimised the risk of running less frequent IQC. We suggest that it is time to rethink the role of both these processes and unite them into a single approach using an Average of Normals model supported by more frequent External Quality Assurance samples. This new paradigm may lead to less confusion for laboratory staff and quicker responses to and identification of out of control situations.

Dried blood spot specimen quality and validation of a new pre-analytical processing method for qualitative HIV-1 PCR, KwaZulu-Natal, South Africa

PubMed Central

Parboosing, Raveen; Siyaca, Ntombizandile; Moodley, Pravikrishnen

2016-01-01

Background Poor quality dried blood spot (DBS) specimens are usually rejected by virology laboratories, affecting early infant diagnosis of HIV. The practice of combining two incompletely-filled DBS in one specimen preparation tube during pre-analytical specimen processing (i.e., the two-spot method) has been implemented to reduce the number of specimens being rejected for insufficient volume. Objectives This study analysed laboratory data to describe the quality of DBS specimens and the use of the two-spot method over a one-year period, then validated the two-spot method against the standard (one-spot) method. Methods Data on HIV-1 PCR test requests submitted in 2014 to the Department of Virology at Inkosi Albert Luthuli Central Hospital in KwaZulu-Natal province, South Africa were analysed to describe reasons for specimen rejection, as well as results of the two-spot method. The accuracy, lower limit of detection and precision of the two-spot method were assessed. Results Of the 88 481 specimens received, 3.7% were rejected for pre-analytical problems. Of those, 48.9% were rejected as a result of insufficient specimen volume. Two health facilities had significantly more specimen rejections than other facilities. The two-spot method prevented 10 504 specimen rejections. The Pearson correlation coefficient comparing the standard to the two-spot method was 0.997. Conclusions The two-spot method was comparable with the standard method of pre-analytical specimen processing. Two health facilities were identified for targeted retraining on specimen quality. The two-spot method of DBS specimen processing can be used as an adjunct to retraining, to reduce the number of specimens rejected and improve linkage to care. PMID:28879108

Dried blood spot specimen quality and validation of a new pre-analytical processing method for qualitative HIV-1 PCR, KwaZulu-Natal, South Africa.

PubMed

Govender, Kerusha; Parboosing, Raveen; Siyaca, Ntombizandile; Moodley, Pravikrishnen

2016-01-01

Poor quality dried blood spot (DBS) specimens are usually rejected by virology laboratories, affecting early infant diagnosis of HIV. The practice of combining two incompletely-filled DBS in one specimen preparation tube during pre-analytical specimen processing (i.e., the two-spot method) has been implemented to reduce the number of specimens being rejected for insufficient volume. This study analysed laboratory data to describe the quality of DBS specimens and the use of the two-spot method over a one-year period, then validated the two-spot method against the standard (one-spot) method. Data on HIV-1 PCR test requests submitted in 2014 to the Department of Virology at Inkosi Albert Luthuli Central Hospital in KwaZulu-Natal province, South Africa were analysed to describe reasons for specimen rejection, as well as results of the two-spot method. The accuracy, lower limit of detection and precision of the two-spot method were assessed. Of the 88 481 specimens received, 3.7% were rejected for pre-analytical problems. Of those, 48.9% were rejected as a result of insufficient specimen volume. Two health facilities had significantly more specimen rejections than other facilities. The two-spot method prevented 10 504 specimen rejections. The Pearson correlation coefficient comparing the standard to the two-spot method was 0.997. The two-spot method was comparable with the standard method of pre-analytical specimen processing. Two health facilities were identified for targeted retraining on specimen quality. The two-spot method of DBS specimen processing can be used as an adjunct to retraining, to reduce the number of specimens rejected and improve linkage to care.

[Analysis of the results of the SEIMC External Quality Control Program for HIV-1 and HCV viral loads. Year 2008].

PubMed

Mira, Nieves Orta; Serrano, María del Remedio Guna; Martínez, José Carlos Latorre; Ovies, María Rosario; Pérez, José L; Cardona, Concepción Gimeno

2010-01-01

Human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarized the results obtained from the 2008 SEIMC External Quality Control Program for HIV-1 and HCV viral loads. In the HIV-1 program, a total of five standards were sent. One standard consisted in seronegative human plasma, while the remaining four contained plasma from 3 different viremic patients, in the range of 2-5 log(10) copies/mL; two of these standards were identical aiming to determine repeatability. The specificity was complete for all commercial methods, and no false positive results were reported by the participants. A significant proportion of the laboratories (24% on average) obtained values out of the accepted range (mean +/- 0.2 log(10) copies/mL), depending on the standard and on the method used for quantification. Repeatability was very good, with up to 95% of laboratories reporting results within the limits (D < 0.5 log(10) copias/mL). The HCV program consisted of two standards with different viral load contents. Most of the participants (88,7%) obtained results within the accepted range (mean +/- 1.96 SD log(10) UI/mL). Post-analytical errors due to mistranscription of the results were detected for HCV, but not for the HIV-1 program. Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up. 2010 Elsevier España S.L. All rights reserved.

Implementing self sustained quality control procedures in a clinical laboratory.

PubMed

Khatri, Roshan; K C, Sanjay; Shrestha, Prabodh; Sinha, J N

2013-01-01

Quality control is an essential component in every clinical laboratory which maintains the excellence of laboratory standards, supplementing to proper disease diagnosis, patient care and resulting in overall strengthening of health care system. Numerous quality control schemes are available, with combinations of procedures, most of which are tedious, time consuming and can be "too technical" whereas commercially available quality control materials can be expensive especially for laboratories in developing nations like Nepal. Here, we present a procedure performed at our centre with self prepared control serum and use of simple statistical tools for quality assurance. The pooled serum was prepared as per guidelines for preparation of stabilized liquid quality control serum from human sera. Internal Quality Assessment was performed on this sample, on a daily basis which included measurement of 12 routine biochemical parameters. The results were plotted on Levey-Jennings charts and analysed with quality control rules, for a period of one month. The mean levels of biochemical analytes in self prepared control serum were within normal physiological range. This serum was evaluated every day along with patients' samples. The results obtained were plotted on control charts and analysed using common quality control rules to identify possible systematic and random errors. Immediate mitigation measures were taken and the dispatch of erroneous reports was avoided. In this study we try to highlight on a simple internal quality control procedure which can be performed by laboratories, with minimum technology, expenditure, and expertise and improve reliability and validity of the test reports.

[Proposed recommendations for the practical use of internal quality controls (IQC) in a medical biology laboratory].

PubMed

Giannoli, Jean-Marc; Szymanowicz, Anton

2011-01-01

We propose a set of recommendations and practices to optimize the use of quality control of medical biology examinations. The fundamentals are reviewed: definition of a series of analysis, IQC at one or more level, Westgard alert rules and rejection, practical remedial actions to take for the technician, corrective and preventive actions to be implemented by the biologist. We have also formalized three flowcharts to guide the technician in their daily practice to ensure analytical quality of investigations carried out. These decision trees are the result of the experience submitted by an accredited and professional laboratory attentive to the ongoing improvement of IQC. This article can provide useful assistance to biologists for accreditation but also aims to foster collaboration reliable medical biology laboratory at the appropriate management of patients.

Clinical implementation of RNA signatures for pharmacogenomic decision-making

PubMed Central

Tang, Weihua; Hu, Zhiyuan; Muallem, Hind; Gulley, Margaret L

2011-01-01

RNA profiling is increasingly used to predict drug response, dose, or toxicity based on analysis of drug pharmacokinetic or pharmacodynamic pathways. Before implementing multiplexed RNA arrays in clinical practice, validation studies are carried out to demonstrate sufficient evidence of analytic and clinical performance, and to establish an assay protocol with quality assurance measures. Pathologists assure quality by selecting input tissue and by interpreting results in the context of the input tissue as well as the technologies that were used and the clinical setting in which the test was ordered. A strength of RNA profiling is the array-based measurement of tens to thousands of RNAs at once, including redundant tests for critical analytes or pathways to promote confidence in test results. Instrument and reagent manufacturers are crucial for supplying reliable components of the test system. Strategies for quality assurance include careful attention to RNA preservation and quality checks at pertinent steps in the assay protocol, beginning with specimen collection and proceeding through the various phases of transport, processing, storage, analysis, interpretation, and reporting. Specimen quality is checked by probing housekeeping transcripts, while spiked and exogenous controls serve as a check on analytic performance of the test system. Software is required to manipulate abundant array data and present it for interpretation by a laboratory physician who reports results in a manner facilitating therapeutic decision-making. Maintenance of the assay requires periodic documentation of personnel competency and laboratory proficiency. These strategies are shepherding genomic arrays into clinical settings to provide added value to patients and to the larger health care system. PMID:23226056

Core components of a comprehensive quality assurance program in anatomic pathology.

PubMed

Nakhleh, Raouf E

2009-11-01

In this article the core components of a comprehensive quality assurance and improvement plan are outlined. Quality anatomic pathology work comes with focus on accurate, timely, and complete reports. A commitment to continuous quality improvement and a systems approach with a persistent effort helps to achieve this end. Departments should have a quality assurance and improvement plan that includes a risk assessment of real and potential problems facing the laboratory. The plan should also list the individuals responsible for carrying out the program with adequate resources, a defined timetable, and annual assessment for progress and future directions. Quality assurance monitors should address regulatory requirements and be organized by laboratory division (surgical pathology, cytology, etc) as well as 5 segments (preanalytic, analytic, postanalytic phases of the test cycle, turn-around-time, and customer satisfaction). Quality assurance data can also be used to evaluate individual pathologists using multiple parameters with peer group comparison.

Development of collaborative-creative learning model using virtual laboratory media for instrumental analytical chemistry lectures

NASA Astrophysics Data System (ADS)

Zurweni, Wibawa, Basuki; Erwin, Tuti Nurian

2017-08-01

The framework for teaching and learning in the 21st century was prepared with 4Cs criteria. Learning providing opportunity for the development of students' optimal creative skills is by implementing collaborative learning. Learners are challenged to be able to compete, work independently to bring either individual or group excellence and master the learning material. Virtual laboratory is used for the media of Instrumental Analytical Chemistry (Vis, UV-Vis-AAS etc) lectures through simulations computer application and used as a substitution for the laboratory if the equipment and instruments are not available. This research aims to design and develop collaborative-creative learning model using virtual laboratory media for Instrumental Analytical Chemistry lectures, to know the effectiveness of this design model adapting the Dick & Carey's model and Hannafin & Peck's model. The development steps of this model are: needs analyze, design collaborative-creative learning, virtual laboratory media using macromedia flash, formative evaluation and test of learning model effectiveness. While, the development stages of collaborative-creative learning model are: apperception, exploration, collaboration, creation, evaluation, feedback. Development of collaborative-creative learning model using virtual laboratory media can be used to improve the quality learning in the classroom, overcome the limitation of lab instruments for the real instrumental analysis. Formative test results show that the Collaborative-Creative Learning Model developed meets the requirements. The effectiveness test of students' pretest and posttest proves significant at 95% confidence level, t-test higher than t-table. It can be concluded that this learning model is effective to use for Instrumental Analytical Chemistry lectures.

Performance of laboratories analysing welding fume on filter samples: results from the WASP proficiency testing scheme.

PubMed

Stacey, Peter; Butler, Owen

2008-06-01

This paper emphasizes the need for occupational hygiene professionals to require evidence of the quality of welding fume data from analytical laboratories. The measurement of metals in welding fume using atomic spectrometric techniques is a complex analysis often requiring specialist digestion procedures. The results from a trial programme testing the proficiency of laboratories in the Workplace Analysis Scheme for Proficiency (WASP) to measure potentially harmful metals in several different types of welding fume showed that most laboratories underestimated the mass of analyte on the filters. The average recovery was 70-80% of the target value and >20% of reported recoveries for some of the more difficult welding fume matrices were <50%. This level of under-reporting has significant implications for any health or hygiene studies of the exposure of welders to toxic metals for the types of fumes included in this study. Good laboratories' performance measuring spiked WASP filter samples containing soluble metal salts did not guarantee good performance when measuring the more complex welding fume trial filter samples. Consistent rather than erratic error predominated, suggesting that the main analytical factor contributing to the differences between the target values and results was the effectiveness of the sample preparation procedures used by participating laboratories. It is concluded that, with practice and regular participation in WASP, performance can improve over time.

The need for accurate total cholesterol measurement. Recommended analytical goals, current state of reliability, and guidelines for better determinations.

PubMed

Naito, H K

1989-03-01

We have approached a dawn of a new era in detection, evaluation, treatment, and monitoring of individuals with elevated blood cholesterol levels who are at increased risk for CHD. The NHLBI's National Cholesterol Education Program will be the major force underlying this national awareness program, which is dependent on the clinical laboratories providing reliable data. Precision or reproducibility of results is not a problem for most of the laboratories, but accuracy is a major concern. Both the manufacturers and laboratorians need to standardize the measurement for cholesterol so that the accuracy base is traceable to the NCCLS NRS/CHOL. The manufacturers need to adopt a uniform policy that will ensure that the values assigned to calibration, quality control, and quality assurance or survey materials are accurate and traceable to the NCCLS/CHOL. Since, at present, there are some limitations of these materials caused by matrix effects, laboratories are encouraged to use the CDC-NHLBI National Reference Laboratory Network to evaluate and monitor their ability to measure patient blood cholesterol levels accurately. Major areas of analytical problems are identified and general, as well as specific, recommendations are provided to help ensure reliable measurement of cholesterol in patient specimens.

[Enzymatic analysis of the quality of foodstuffs].

PubMed

Kolesnov, A Iu

1997-01-01

Enzymatic analysis is an independent and separate branch of enzymology and analytical chemistry. It has become one of the most important methodologies used in food analysis. Enzymatic analysis allows the quick, reliable determination of many food ingredients. Often these contents cannot be determined by conventional methods, or if methods are available, they are determined only with limited accuracy. Today, methods of enzymatic analysis are being increasingly used in the investigation of foodstuffs. Enzymatic measurement techniques are used in industry, scientific and food inspection laboratories for quality analysis. This article describes the requirements of an optimal analytical method: specificity, sample preparation, assay performance, precision, sensitivity, time requirement, analysis cost, safety of reagents.

Harmonization of urine albumin/creatinine ratio (ACR) results: a study based on an external quality assessment program in Polish laboratories.

PubMed

Ćwiklińska, Agnieszka; Dąbrowska, Hanna; Kowalski, Robert; Kuchta, Agnieszka; Kortas-Stempak, Barbara; Fijałkowska, Aleksandra; Bednarczuk, Gabriela; Jankowski, Maciej

2018-05-11

The ratio of albumin to creatinine (ACR) is an important parameter used for detection of albuminuria in patients with early kidney damage. The aim of the study was to evaluate the harmonization of ACR results among Polish participants in an international external quality assessment (EQA) program, and to evaluate the impact of albumin and creatinine analytical performance on the harmonization of ACR results. We analyzed 182 results of albumin, 202 of creatinine, and 180 of ACR obtained from Polish laboratories in an EQA program organized by Labquality. The dispersion of the results in surveys and percentage differences between the results and target values were calculated. Moreover, differences between method groups were assessed. The inter-laboratory coefficient of variation (CV) for ACR was 36%. Only 74% of results of Polish laboratories were within the target limits; for 11% of the results, an incorrect albuminuria category would have been reported. The inter-laboratory CV for albumin was 20%, 2.6-fold higher than for creatinine. Significant differences between method groups for albumin determination have been observed, even when the same measurement technique was used. The greatest difference between two groups was 23%, 2.5-fold greater in comparison to creatinine. There is an insufficient harmonization of ACR values among Polish laboratories, caused mainly by urine albumin analytical performance. Given the important role of ACR in the classification, monitoring and treatment of kidney damage, the harmonization of albumin measurements is crucial and urgently needed.

Combining ISO/IEC 17025:2005 and European Commission Decision 2002/657 audit requirements: a practical way forward.

PubMed

Kay, Jack F

2012-08-01

Laboratories involved in the analyses of veterinary drug residues are under increasing pressure to demonstrate that they produce meaningful and reliable data. Quality assurance and quality control systems are implemented in laboratories to provide evidence of this and these are subject to external assessment to ensure that they are effective. Audits to ISO/IEC 17025:2005, an internationally accepted standard, and subsequent accreditation provide laboratories and their customers with a degree of assurance that the laboratories are operating in control and the data they report can be relied on. However, national or regional authorities may place additional requirements on laboratories to ensure quality data are reported. For example, in the European Union, all official control laboratories involved in veterinary drug residue analyses must also meet the requirements of European Commission Decision 2002/657/EC which sets performance criteria for analytical methods used in this area and these are subject to additional audits by national or regional authorities. All audits place considerable time and resource demands on laboratories and this paper discusses the burden audits place on laboratories and describes a UK initiative to combine these audits to the benefit of both the regulatory authority and the laboratory. © 2012 John Wiley & Sons, Ltd.

Harmonization in laboratory medicine: Requests, samples, measurements and reports.

PubMed

Plebani, Mario

2016-01-01

In laboratory medicine, the terms "standardization" and "harmonization" are frequently used interchangeably as the final goal is the same: the equivalence of measurement results among different routine measurement procedures over time and space according to defined analytical and clinical quality specifications. However, the terms define two distinct, albeit closely linked, concepts based on traceability principles. The word "standardization" is used when results for a measurement are equivalent and traceable to the International System of Units (SI) through a high-order primary reference material and/or a reference measurement procedure (RMP). "Harmonization" is generally used when results are equivalent, but neither a high-order primary reference material nor a reference measurement procedure is available. Harmonization is a fundamental aspect of quality in laboratory medicine as its ultimate goal is to improve patient outcomes through the provision of accurate and actionable laboratory information. Patients, clinicians and other healthcare professionals assume that clinical laboratory tests performed by different laboratories at different times on the same sample and specimen can be compared, and that results can be reliably and consistently interpreted. Unfortunately, this is not necessarily the case, because many laboratory test results are still highly variable and poorly standardized and harmonized. Although the initial focus was mainly on harmonizing and standardizing analytical processes and methods, the scope of harmonization now also includes all other aspects of the total testing process (TTP), such as terminology and units, report formats, reference intervals and decision limits as well as tests and test profiles, requests and criteria for interpretation. Several projects and initiatives aiming to improve standardization and harmonization in the testing process are now underway. Laboratory professionals should therefore step up their efforts to provide interchangeable and comparable laboratory information in order to ultimately assure better diagnosis and treatment in patient care.

External quality-assurance programs managed by the U.S. Geological Survey in support of the National Atmospheric Deposition Program/National Trends Network

USGS Publications Warehouse

Latysh, Natalie E.; Wetherbee, Gregory A.

2005-01-01

The U.S. Geological Survey, Branch of Quality Systems, operates the external quality-assurance programs for the National Atmospheric Deposition Program/National Trends Network (NADP/NTN). Beginning in 1978, six different programs have been implemented?the intersite-comparison program, the blind-audit program, the sample-handling evaluation program, the field-audit program, the interlaboratory-comparison program, and the collocated-sampler program. Each program was designed to measure error contributed by specific components in the data-collection process. The intersite-comparison program, which was discontinued in 2004, was designed to assess the accuracy and reliability of field pH and specific-conductance measurements made by site operators. The blind-audit and sample-handling evaluation programs, which also were discontinued in 2002 and 2004, respectively, assessed contamination that may result from sampling equipment and routine handling and processing of the wet-deposition samples. The field-audit program assesses the effects of sample handling, processing, and field exposure. The interlaboratory-comparison program evaluates bias and precision of analytical results produced by the contract laboratory for NADP, the Illinois State Water Survey, Central Analytical Laboratory, and compares its performance with the performance of international laboratories. The collocated-sampler program assesses the overall precision of wet-deposition data collected by NADP/NTN. This report documents historical operations and the operating procedures for each of these external quality-assurance programs. USGS quality-assurance information allows NADP/NTN data users to discern between actual environmental trends and inherent measurement variability.

An approach for estimating measurement uncertainty in medical laboratories using data from long-term quality control and external quality assessment schemes.

PubMed

Padoan, Andrea; Antonelli, Giorgia; Aita, Ada; Sciacovelli, Laura; Plebani, Mario

2017-10-26

The present study was prompted by the ISO 15189 requirements that medical laboratories should estimate measurement uncertainty (MU). The method used to estimate MU included the: a) identification of quantitative tests, b) classification of tests in relation to their clinical purpose, and c) identification of criteria to estimate the different MU components. Imprecision was estimated using long-term internal quality control (IQC) results of the year 2016, while external quality assessment schemes (EQAs) results obtained in the period 2015-2016 were used to estimate bias and bias uncertainty. A total of 263 measurement procedures (MPs) were analyzed. On the basis of test purpose, in 51 MPs imprecision only was used to estimate MU; in the remaining MPs, the bias component was not estimable for 22 MPs because EQAs results did not provide reliable statistics. For a total of 28 MPs, two or more MU values were calculated on the basis of analyte concentration levels. Overall, results showed that uncertainty of bias is a minor factor contributing to MU, the bias component being the most relevant contributor to all the studied sample matrices. The model chosen for MU estimation allowed us to derive a standardized approach for bias calculation, with respect to the fitness-for-purpose of test results. Measurement uncertainty estimation could readily be implemented in medical laboratories as a useful tool in monitoring the analytical quality of test results since they are calculated using a combination of both the long-term imprecision IQC results and bias, on the basis of EQAs results.

40 CFR 408.121 - Specialized definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... those components of a waste water amenable to measurement by the method described in Methods for Chemical Analysis of Water and Wastes, 1971, Environmental Protection Agency, Analytical Quality Control Laboratory, page 217. (c) The term seafood shall mean the raw material, including freshwater and saltwater...

10 CFR 830.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... research and experimental and analytical laboratory activities, electron microscopes, and X-ray machines... research, test, and power reactors, and critical and pulsed assemblies and any assembly that is designed to... covering a topic such as: quality assurance; maintenance of safety systems; personnel training; conduct of...

PCB Analysis Plan for Tank Archive Samples

DOE Office of Scientific and Technical Information (OSTI.GOV)

NGUYEN, D.M.

2001-03-22

This analysis plan specifies laboratory analysis, quality assurance/quality control (QA/QC), and data reporting requirements for analyzing polychlorinated biphenyls (PCB) concentrations in archive samples. Tank waste archive samples that are planned for PCB analysis are identified in Nguyen 2001. The tanks and samples are summarized in Table 1-1. The analytical data will be used to establish a PCB baseline inventory in Hanford tanks.

Quality Control in Clinical Laboratory Samples

DTIC Science & Technology

2015-01-01

is able to find and correct flaws in the analytical processes of a lab before potentially incorrect patient resu lts are released. According to...verifi es that the results produced are accurate and precise . Clinical labs use management of documentation as well as inco rporation of a continuous...improvement process to streamline the overall quality control process . QC samples are expected to be identical and tested identically to patient

Monitoring and reporting of preanalytical errors in laboratory medicine: the UK situation.

PubMed

Cornes, Michael P; Atherton, Jennifer; Pourmahram, Ghazaleh; Borthwick, Hazel; Kyle, Betty; West, Jamie; Costelloe, Seán J

2016-03-01

Most errors in the clinical laboratory occur in the preanalytical phase. This study aimed to comprehensively describe the prevalence and nature of preanalytical quality monitoring practices in UK clinical laboratories. A survey was sent on behalf of the Association for Clinical Biochemistry and Laboratory Medicine Preanalytical Working Group (ACB-WG-PA) to all heads of department of clinical laboratories in the UK. The survey captured data on the analytical platform and Laboratory Information Management System in use; which preanalytical errors were recorded and how they were classified and gauged interest in an external quality assurance scheme for preanalytical errors. Of the 157 laboratories asked to participate, responses were received from 104 (66.2%). Laboratory error rates were recorded per number of specimens, rather than per number of requests in 51% of respondents. Aside from serum indices for haemolysis, icterus and lipaemia, which were measured in 80% of laboratories, the most common errors recorded were booking-in errors (70.1%) and sample mislabelling (56.9%) in laboratories who record preanalytical errors. Of the laboratories surveyed, 95.9% expressed an interest in guidance on recording preanalytical error and 91.8% expressed interest in an external quality assurance scheme. This survey observes a wide variation in the definition, repertoire and collection methods for preanalytical errors in the UK. Data indicate there is a lot of interest in improving preanalytical data collection. The ACB-WG-PA aims to produce guidance and support for laboratories to standardize preanalytical data collection and to help establish and validate an external quality assurance scheme for interlaboratory comparison. © The Author(s) 2015.

National Survey on Internal Quality Control for HbA(1c) Analytical Instruments in 331 Hospital Laboratories of China.

PubMed

Zeng, Rong; Wang, Wei; Zhao, Haijian; Fei, Yang; Wang, Zhiguo

2015-01-01

The narrow gap of HbA1 value of mass fraction between "normal" (< 6.0%) and "diabetes" (≥ 6.5%) necessitates tight control of inter-assay standardization, assay precision, and trueness. This survey was initiated to obtain knowledge of the current situation of internal quality control (IQC) practice for HbA(1c) in China and find out the most appropriate quality specifications. Data of IQC for HbA(1c) in 331 institutions participating in the national proficiency testing (PT) programs in China were evaluated using four levels of quality specifications, and the percentages of laboratories meeting the quality requirement were calculated to find out the most appropriate quality specifications for control materials of HbA(1c) in China. The IQC data varied vastly among 331 clinical laboratories in China. The measurement of control materials covered a wide range from 4.52% to 12.24% (inter-quartile range) and there were significant differences among the CVs of different methods, including LPLC, CE-HPLC, AC-HPLC, immunoturbidimetry, and others. Among the four main methods, CE-HPLC and AC-HPLC achieved a better precision. As we can see, the performance of laboratories for HbA(1c) has yet to be improved. Clinical laboratories in China should improve their performance with a stricter imprecision criteria.

Quality assurance and quality control in light stable isotope laboratories: A case study of Rio Grande, Texas, water samples

USGS Publications Warehouse

Coplen, T.B.; Qi, H.

2009-01-01

New isotope laboratories can achieve the goal of reporting the same isotopic composition within analytical uncertainty for the same material analysed decades apart by (1) writing their own acceptance testing procedures and putting them into their mass spectrometric or laser-based isotope-ratio equipment procurement contract, (2) requiring a manufacturer to demonstrate acceptable performance using all sample ports provided with the instrumentation, (3) for each medium to be analysed, prepare two local reference materials substantially different in isotopic composition to encompass the range in isotopic composition expected in the laboratory and calibrated them with isotopic reference materials available from the International Atomic Energy Agency (IAEA) or the US National Institute of Standards and Technology (NIST), (4) using the optimum storage containers (for water samples, sealing in glass ampoules that are sterilised after sealing is satisfactory), (5) interspersing among sample unknowns local laboratory isotopic reference materials daily (internationally distributed isotopic reference materials can be ordered at three-year intervals, and can be used for elemental analyser analyses and other analyses that consume less than 1 mg of material) - this process applies to H, C, N, O, and S isotope ratios, (6) calculating isotopic compositions of unknowns by normalising isotopic data to that of local reference materials, which have been calibrated to internationally distributed isotopic reference materials, (7) reporting results on scales normalised to internationally distributed isotopic reference materials (where they are available) and providing to sample submitters the isotopic compositions of internationally distributed isotopic reference materials of the same substance had they been analysed with unknowns, (8) providing an audit trail in the laboratory for analytical results - this trail commonly will be in electronic format and might include a laboratory information management system, (9) making at regular intervals a complete backup of laboratory analytical data (both of samples logged into the laboratory and of mass spectrometric analyses), being sure to store one copy of this backup offsite, and (10) participating in interlaboratory comparison exercises sponsored by the IAEA and other agencies at regular intervals. ?? Taylor & Francis.

Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population.

PubMed

Flegar-Meštrić, Zlata; Perkov, Sonja; Radeljak, Andrea

2016-03-26

Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients' care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine.

Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population

PubMed Central

Flegar-Meštrić, Zlata; Perkov, Sonja; Radeljak, Andrea

2016-01-01

Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients’ care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine. PMID:27019800

Can Unmanned Aerial Systems (Drones) Be Used for the Routine Transport of Chemistry, Hematology, and Coagulation Laboratory Specimens?

PubMed

Amukele, Timothy K; Sokoll, Lori J; Pepper, Daniel; Howard, Dana P; Street, Jeff

2015-01-01

Unmanned Aerial Systems (UAS or drones) could potentially be used for the routine transport of small goods such as diagnostic clinical laboratory specimens. To the best of our knowledge, there is no published study of the impact of UAS transportation on laboratory tests. Three paired samples were obtained from each one of 56 adult volunteers in a single phlebotomy event (336 samples total): two tubes each for chemistry, hematology, and coagulation testing respectively. 168 samples were driven to the flight field and held stationary. The other 168 samples were flown in the UAS for a range of times, from 6 to 38 minutes. After the flight, 33 of the most common chemistry, hematology, and coagulation tests were performed. Statistical methods as well as performance criteria from four distinct clinical, academic, and regulatory bodies were used to evaluate the results. Results from flown and stationary sample pairs were similar for all 33 analytes. Bias and intercepts were <10% and <13% respectively for all analytes. Bland-Altman comparisons showed a mean difference of 3.2% for Glucose and <1% for other analytes. Only bicarbonate did not meet the strictest (Royal College of Pathologists of Australasia Quality Assurance Program) performance criteria. This was due to poor precision rather than bias. There were no systematic differences between laboratory-derived (analytic) CV's and the CV's of our flown versus terrestrial sample pairs however CV's from the sample pairs tended to be slightly higher than analytic CV's. The overall concordance, based on clinical stratification (normal versus abnormal), was 97%. Length of flight had no impact on the results. Transportation of laboratory specimens via small UASs does not affect the accuracy of routine chemistry, hematology, and coagulation tests results from selfsame samples. However it results in slightly poorer precision for some analytes.

[Pre-analytical stage for biomarker assessment in breast cancer: 2014 update of the GEFPICS' guidelines in France].

PubMed

MacGrogan, Gaëtan; Mathieu, Marie-Christine; Poulet, Bruno; Penault-Llorca, Frédérique; Vincent-Salomon, Anne; Roger, Pascal; Treilleux, Isabelle; Valent, Alexander; Antoine, Martine; Becette, Véronique; Bor, Catherine; Brabencova, Eva; Charafe-Jauffret, Emmanuelle; Chenard, Marie-Pierre; Dauplat, Marie-Mélanie; Delrée, Paul; Devouassoux, Mojgan; Fiche, Maryse; Fondrevelle, Marie-Eve; Fridman, Viviana; Garbar, Christian; Genin, Pascal; Ghnassia, Jean-Pierre; Haudebourg, Juliette; Laberge-Le Couteulx, Sophie; Loussouarn, Delphine; Maran-Gonzalez, Aurélie; Marcy, Myriam; Michenet, Patrick; Sagan, Christine; Trassard, Martine; Verriele, Véronique; Arnould, Laurent; Lacroix-Triki, Magali

2014-10-01

Biomarker assessment of breast cancer tumor samples is part of the routine workflow of pathology laboratories. International guidelines have recently been updated, with special regards to the pre-analytical steps that are critical for the quality of immunohistochemical and in situ hybridization procedures, whatever the biomarker analyzed. Fixation and specimen handling protocols must be standardized, validated and carefully tracked. Cooperation and training of the personnel involved in the specimen workflow (e.g. radiologists, surgeons, nurses, technicians and pathologists) are of paramount importance. The GEFPICS' update of the recommendations herein details and comments the different steps of the pre-analytical process. Application of these guidelines and participation to quality insurance programs are mandatory to ensure the correct evaluation of oncotheranostic biomarkers. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Keeping the Momentum and Nuclear Forensics at Los Alamos National Laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Steiner, Robert Ernest; Dion, Heather M.; Dry, Donald E.

LANL has 70 years of experience in nuclear forensics and supports the community through a wide variety of efforts and leveraged capabilities: Expanding the understanding of nuclear forensics, providing training on nuclear forensics methods, and developing bilateral relationships to expand our understanding of nuclear forensic science. LANL remains highly supportive of several key organizations tasked with carrying forth the Nuclear Security Summit messages: IAEA, GICNT, and INTERPOL. Analytical chemistry measurements on plutonium and uranium matrices are critical to numerous programs including safeguards accountancy verification measurements. Los Alamos National Laboratory operates capable actinide analytical chemistry and material science laboratories suitable formore » nuclear material and environmental forensic characterization. Los Alamos National Laboratory uses numerous means to validate and independently verify that measurement data quality objectives are met. Numerous LANL nuclear facilities support the nuclear material handling, preparation, and analysis capabilities necessary to evaluate samples containing nearly any mass of an actinide (attogram to kilogram levels).« less

A FMEA clinical laboratory case study: how to make problems and improvements measurable.

PubMed

Capunzo, Mario; Cavallo, Pierpaolo; Boccia, Giovanni; Brunetti, Luigi; Pizzuti, Sante

2004-01-01

The authors have experimented the application of the Failure Mode and Effect Analysis (FMEA) technique in a clinical laboratory. FMEA technique allows: a) to evaluate and measure the hazards of a process malfunction, b) to decide where to execute improvement actions, and c) to measure the outcome of those actions. A small sample of analytes has been studied: there have been determined the causes of the possible malfunctions of the analytical process, calculating the risk probability index (RPI), with a value between 1 and 1,000. Only for the cases of RPI > 400, improvement actions have been implemented that allowed a reduction of RPI values between 25% to 70% with a costs increment of < 1%. FMEA technique can be applied to the processes of a clinical laboratory, even if of small dimensions, and offers a high potential of improvement. Nevertheless, such activity needs a thorough planning because it is complex, even if the laboratory already operates an ISO 9000 Quality Management System.

Evaluation of Cobas Integra 800 under simulated routine conditions in six laboratories.

PubMed

Redondo, Francisco L; Bermudez, Pilar; Cocco, Claudio; Colella, Francesca; Graziani, Maria Stella; Fiehn, Walter; Hierla, Thomas; Lemoël, Gisèle; Belliard, AnneMarie; Manene, Dieudonne; Meziani, Mourad; Liebel, Maryann; McQueen, Matthew J; Stockmann, Wolfgang

2003-03-01

The new selective access analyser Cobas Integra 800 from Roche Diagnostics was evaluated in an international multicentre study at six sites. Routine simulation experiments showed good performance and full functionality of the instrument and provocation of anomalous situations generated no problems. The new features on Cobas Integra 800, namely clot detection and dispensing control, worked according to specifications. The imprecision of Cobas Integra 800 fulfilled the proposed quality specifications regarding imprecision of analytical systems for clinical chemistry with few exceptions. Claims for linearity, drift, and carry-over were all within the defined specifications, except urea linearity. Interference exists in some cases, as could be expected due to the chemistries applied. Accuracy met the proposed quality specifications, except in some special cases. Method comparisons with Cobas Integra 700 showed good agreement; comparisons with other analysis systems yielded in several cases explicable deviations. Practicability of Cobas Integra 800 met or exceeded the requirements for more than 95% of all attributes rated. The strong points of the new analysis system were reagent handling, long stability of calibration curves, high number of tests on board, compatibility of the sample carrier to other Roche systems, and the sample integrity check for more reliable analytical results. The improvement of the workflow offered by the 5-position rack and STAT handling like on Cobas Integra 800 makes the instrument attractive for further consolidation in the medium-sized laboratory, for dedicated use of special analytes, and/or as back-up in the large routine laboratory.

Laboratory sample stability. Is it possible to define a consensus stability function? An example of five blood magnitudes.

PubMed

Gómez Rioja, Rubén; Martínez Espartosa, Débora; Segovia, Marta; Ibarz, Mercedes; Llopis, María Antonia; Bauça, Josep Miquel; Marzana, Itziar; Barba, Nuria; Ventura, Monserrat; García Del Pino, Isabel; Puente, Juan José; Caballero, Andrea; Gómez, Carolina; García Álvarez, Ana; Alsina, María Jesús; Álvarez, Virtudes

2018-05-05

The stability limit of an analyte in a biological sample can be defined as the time required until a measured property acquires a bias higher than a defined specification. Many studies assessing stability and presenting recommendations of stability limits are available, but differences among them are frequent. The aim of this study was to classify and to grade a set of bibliographic studies on the stability of five common blood measurands and subsequently generate a consensus stability function. First, a bibliographic search was made for stability studies for five analytes in blood: alanine aminotransferase (ALT), glucose, phosphorus, potassium and prostate specific antigen (PSA). The quality of every study was evaluated using an in-house grading tool. Second, the different conditions of stability were uniformly defined and the percent deviation (PD%) over time for each analyte and condition were scattered while unifying studies with similar conditions. From the 37 articles considered as valid, up to 130 experiments were evaluated and 629 PD% data were included (106 for ALT, 180 for glucose, 113 for phosphorus, 145 for potassium and 85 for PSA). Consensus stability equations were established for glucose, potassium, phosphorus and PSA, but not for ALT. Time is the main variable affecting stability in medical laboratory samples. Bibliographic studies differ in recommedations of stability limits mainly because of different specifications for maximum allowable error. Definition of a consensus stability function in specific conditions can help laboratories define stability limits using their own quality specifications.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sailer, S.J.

This Quality Assurance Project Plan (QAPJP) specifies the quality of data necessary and the characterization techniques employed at the Idaho National Engineering Laboratory (INEL) to meet the objectives of the Department of Energy (DOE) Waste Isolation Pilot Plant (WIPP) Transuranic Waste Characterization Quality Assurance Program Plan (QAPP) requirements. This QAPJP is written to conform with the requirements and guidelines specified in the QAPP and the associated documents referenced in the QAPP. This QAPJP is one of a set of five interrelated QAPjPs that describe the INEL Transuranic Waste Characterization Program (TWCP). Each of the five facilities participating in the TWCPmore » has a QAPJP that describes the activities applicable to that particular facility. This QAPJP describes the roles and responsibilities of the Idaho Chemical Processing Plant (ICPP) Analytical Chemistry Laboratory (ACL) in the TWCP. Data quality objectives and quality assurance objectives are explained. Sample analysis procedures and associated quality assurance measures are also addressed; these include: sample chain of custody; data validation; usability and reporting; documentation and records; audits and 0385 assessments; laboratory QC samples; and instrument testing, inspection, maintenance and calibration. Finally, administrative quality control measures, such as document control, control of nonconformances, variances and QA status reporting are described.« less

Harmonization activities of Noklus - a quality improvement organization for point-of-care laboratory examinations.

PubMed

Stavelin, Anne; Sandberg, Sverre

2018-05-16

Noklus is a non-profit quality improvement organization that focuses to improve all elements in the total testing process. The aim is to ensure that all medical laboratory examinations are ordered, performed and interpreted correctly and in accordance with the patients' needs for investigation, treatment and follow-up. For 25 years, Noklus has focused on point-of-care (POC) testing in primary healthcare laboratories and has more than 3100 voluntary participants. The Noklus quality system uses different tools to obtain harmonization and improvement: (1) external quality assessment for the pre-examination, examination and postexamination phase to monitor the harmonization process and to identify areas that need improvement and harmonization, (2) manufacturer-independent evaluations of the analytical quality and user-friendliness of POC instruments and (3) close interactions and follow-up of the participants through site visits, courses, training and guidance. Noklus also recommends which tests that should be performed in the different facilities like general practitioner offices, nursing homes, home care, etc. About 400 courses with more than 6000 delegates are organized annually. In 2017, more than 21,000 e-learning programs were completed.

Large-Scale Interlaboratory Study to Develop, Analytically Validate and Apply Highly Multiplexed, Quantitative Peptide Assays to Measure Cancer-Relevant Proteins in Plasma*

PubMed Central

Abbatiello, Susan E.; Schilling, Birgit; Mani, D. R.; Zimmerman, Lisa J.; Hall, Steven C.; MacLean, Brendan; Albertolle, Matthew; Allen, Simon; Burgess, Michael; Cusack, Michael P.; Gosh, Mousumi; Hedrick, Victoria; Held, Jason M.; Inerowicz, H. Dorota; Jackson, Angela; Keshishian, Hasmik; Kinsinger, Christopher R.; Lyssand, John; Makowski, Lee; Mesri, Mehdi; Rodriguez, Henry; Rudnick, Paul; Sadowski, Pawel; Sedransk, Nell; Shaddox, Kent; Skates, Stephen J.; Kuhn, Eric; Smith, Derek; Whiteaker, Jeffery R.; Whitwell, Corbin; Zhang, Shucha; Borchers, Christoph H.; Fisher, Susan J.; Gibson, Bradford W.; Liebler, Daniel C.; MacCoss, Michael J.; Neubert, Thomas A.; Paulovich, Amanda G.; Regnier, Fred E.; Tempst, Paul; Carr, Steven A.

2015-01-01

There is an increasing need in biology and clinical medicine to robustly and reliably measure tens to hundreds of peptides and proteins in clinical and biological samples with high sensitivity, specificity, reproducibility, and repeatability. Previously, we demonstrated that LC-MRM-MS with isotope dilution has suitable performance for quantitative measurements of small numbers of relatively abundant proteins in human plasma and that the resulting assays can be transferred across laboratories while maintaining high reproducibility and quantitative precision. Here, we significantly extend that earlier work, demonstrating that 11 laboratories using 14 LC-MS systems can develop, determine analytical figures of merit, and apply highly multiplexed MRM-MS assays targeting 125 peptides derived from 27 cancer-relevant proteins and seven control proteins to precisely and reproducibly measure the analytes in human plasma. To ensure consistent generation of high quality data, we incorporated a system suitability protocol (SSP) into our experimental design. The SSP enabled real-time monitoring of LC-MRM-MS performance during assay development and implementation, facilitating early detection and correction of chromatographic and instrumental problems. Low to subnanogram/ml sensitivity for proteins in plasma was achieved by one-step immunoaffinity depletion of 14 abundant plasma proteins prior to analysis. Median intra- and interlaboratory reproducibility was <20%, sufficient for most biological studies and candidate protein biomarker verification. Digestion recovery of peptides was assessed and quantitative accuracy improved using heavy-isotope-labeled versions of the proteins as internal standards. Using the highly multiplexed assay, participating laboratories were able to precisely and reproducibly determine the levels of a series of analytes in blinded samples used to simulate an interlaboratory clinical study of patient samples. Our study further establishes that LC-MRM-MS using stable isotope dilution, with appropriate attention to analytical validation and appropriate quality control measures, enables sensitive, specific, reproducible, and quantitative measurements of proteins and peptides in complex biological matrices such as plasma. PMID:25693799

Doubling immunochemistry laboratory testing efficiency with the cobas e 801 module while maintaining consistency in analytical performance.

PubMed

Findeisen, P; Zahn, I; Fiedler, G M; Leichtle, A B; Wang, S; Soria, G; Johnson, P; Henzell, J; Hegel, J K; Bendavid, C; Collet, N; McGovern, M; Klopprogge, K

2018-06-04

The new immunochemistry cobas e 801 module (Roche Diagnostics) was developed to meet increasing demands on routine laboratories to further improve testing efficiency, while maintaining high quality and reliable data. During a non-interventional multicenter evaluation study, the overall performance, functionality and reliability of the new module was investigated under routine-like conditions. It was tested as a dedicated immunochemistry system at four sites and as a consolidator combined with clinical chemistry at three sites. We report on testing efficiency and analytical performance of the new module. Evaluation of sample workloads with site-specific routine request patterns demonstrated increased speed and almost doubled throughput (maximal 300 tests per h), thus revealing that one cobas e 801 module can replace two cobas e 602 modules while saving up to 44% floor space. Result stability was demonstrated by QC analysis per assay throughout the study. Precision testing over 21 days yielded excellent results within and between labs, and, method comparison performed versus the cobas e 602 module routine results showed high consistency of results for all assays under study. In a practicability assessment related to performance and handling, 99% of graded features met (44%) or even exceeded (55%) laboratory expectations, with enhanced reagent management and loading during operation being highlighted. By nearly doubling immunochemistry testing efficiency on the same footprint as a cobas e 602 module, the new module has a great potential to further consolidate and enhance laboratory testing while maintaining high quality analytical performance with Roche platforms. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory; determination of inorganic and organic constituents in water and fluvial sediments

USGS Publications Warehouse

Fishman, M. J.

1993-01-01

Methods to be used to analyze samples of water, suspended sediment and bottom material for their content of inorganic and organic constituents are presented. Technology continually changes, and so this laboratory manual includes new and revised methods for determining the concentration of dissolved constituents in water, whole water recoverable constituents in water-suspended sediment samples, and recoverable concentration of constit- uents in bottom material. For each method, the general topics covered are the application, the principle of the method, interferences, the apparatus and reagents required, a detailed description of the analytical procedure, reporting results, units and significant figures, and analytical precision data. Included in this manual are 30 methods.

Selected quality assurance data for water samples collected by the US Geological Survey, Idaho National Engineering Laboratory, Idaho, 1980 to 1988

USGS Publications Warehouse

Wegner, S.J.

1989-01-01

Multiple water samples from 115 wells and 3 surface water sites were collected between 1980 and 1988 for the ongoing quality assurance program at the Idaho National Engineering Laboratory. The reported results from the six laboratories involved were analyzed for agreement using descriptive statistics. The constituents and properties included: tritium, plutonium-238, plutonium-239, -240 (undivided), strontium-90, americium-241, cesium-137, total dissolved chromium, selected dissolved trace metals, sodium, chloride, nitrate, selected purgeable organic compounds, and specific conductance. Agreement could not be calculated for purgeable organic compounds, trace metals, some nitrates and blank sample analyses because analytical uncertainties were not consistently reported. However, differences between results for most of these data were calculated. The blank samples were not analyzed for differences. The laboratory results analyzed using descriptive statistics showed a median agreement between all useable data pairs of 95%. (USGS)

A Simple Sonication Improves Protein Signal in Matrix-Assisted Laser Desorption Ionization Imaging

NASA Astrophysics Data System (ADS)

Lin, Li-En; Su, Pin-Rui; Wu, Hsin-Yi; Hsu, Cheng-Chih

2018-02-01

Proper matrix application is crucial in obtaining high quality matrix-assisted laser desorption ionization (MALDI) mass spectrometry imaging (MSI). Solvent-free sublimation was essentially introduced as an approach of homogeneous coating that gives small crystal size of the organic matrix. However, sublimation has lower extraction efficiency of analytes. Here, we present that a simple sonication step after the hydration in standard sublimation protocol significantly enhances the sensitivity of MALDI MSI. This modified procedure uses a common laboratory ultrasonicator to immobilize the analytes from tissue sections without noticeable delocalization. Improved imaging quality with additional peaks above 10 kDa in the spectra was thus obtained upon sonication treatment. [Figure not available: see fulltext.

40 CFR 408.141 - Specialized definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... apply to this subpart. (b) The term oil and grease shall mean those components of a waste water amenable to measurement by the method described in Methods for Chemical Analysis of Water and Wastes, 1971, Environmental Protection Agency, Analytical Quality Control Laboratory, page 217. (c) The term seafood shall...

40 CFR 408.11 - Specialized definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... apply to this subpart. (b) The term oil and grease shall mean those components of a waste water amenable to measurement by the method described in Methods for Chemical Analysis of Water and Wastes, 1971, Environmental Protection Agency, Analytical Quality Control Laboratory, page 217. (c) The term seafood shall...

40 CFR 408.51 - Specialized definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... apply to this subpart. (b) The term oil and grease shall mean those components of a waste water amenable to measurement by the method described in Methods for Chemical Analysis of Water and Wastes, 1971, Environmental Protection Agency, Analytical Quality Control Laboratory, page 217. (c) The term seafood shall...

Laboratory testing of extravascular body fluids in Croatia: a survey of the Working group for extravascular body fluids of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

PubMed

Kopcinovic, Lara Milevoj; Vogrinc, Zeljka; Kocijan, Irena; Culej, Jelena; Aralica, Merica; Jokic, Anja; Antoncic, Dragana; Bozovic, Marija

2016-10-15

We hypothesized that extravascular body fluid (EBF) analysis in Croatia is not harmonized and aimed to investigate preanalytical, analytical and postanalytical procedures used in EBF analysis in order to identify key aspects that should be addressed in future harmonization attempts. An anonymous online survey created to explore laboratory testing of EBF was sent to secondary, tertiary and private health care Medical Biochemistry Laboratories (MBLs) in Croatia. Statements were designed to address preanalytical, analytical and postanalytical procedures of cerebrospinal, pleural, peritoneal (ascites), pericardial, seminal, synovial, amniotic fluid and sweat. Participants were asked to declare the strength of agreement with proposed statements using a Likert scale. Mean scores for corresponding separate statements divided according to health care setting were calculated and compared. The survey response rate was 0.64 (58 / 90). None of the participating private MBLs declared to analyse EBF. We report a mean score of 3.45 obtained for all statements evaluated. Deviations from desirable procedures were demonstrated in all EBF testing phases. Minor differences in procedures used for EBF analysis comparing secondary and tertiary health care MBLs were found. The lowest scores were obtained for statements regarding quality control procedures in EBF analysis, participation in proficiency testing programmes and provision of interpretative comments on EBF's test reports. Although good laboratory EBF practice is present in Croatia, procedures for EBF analysis should be further harmonized to improve the quality of EBF testing and patient safety.

Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference.

PubMed

Panteghini, Mauro; Ceriotti, Ferruccio; Jones, Graham; Oosterhuis, Wytze; Plebani, Mario; Sandberg, Sverre

2017-10-26

Measurements in clinical laboratories produce results needed in the diagnosis and monitoring of patients. These results are always characterized by some uncertainty. What quality is needed and what measurement errors can be tolerated without jeopardizing patient safety should therefore be defined and specified for each analyte having clinical use. When these specifications are defined, the total examination process will be "fit for purpose" and the laboratory professionals should then set up rules to control the measuring systems to ensure they perform within specifications. The laboratory community has used different models to set performance specifications (PS). Recently, it was felt that there was a need to revisit different models and, at the same time, to emphasize the presuppositions for using the different models. Therefore, in 2014 the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) organized a Strategic Conference in Milan. It was felt that there was a need for more detailed discussions on, for instance, PS for EQAS, which measurands should use which models to set PS and how to set PS for the extra-analytical phases. There was also a need to critically evaluate the quality of data on biological variation studies and further discussing the use of the total error (TE) concept. Consequently, EFLM established five Task Finish Groups (TFGs) to address each of these topics. The TFGs are finishing their activity on 2017 and the content of this paper includes deliverables from these groups.

Quality and future of clinical laboratories: the Vico's whole cyclical theory of the recurring cycles.

PubMed

Plebani, Mario

2018-05-24

In the last few decades, laboratory medicine has undergone monumental changes, and laboratory technology, which has made enormous advances, now has new clinical applications thanks to the identification of a growing number of biomarkers and risk factors conducive to the promotion of predictive and preventive interventions that have enhanced the role of laboratory medicine in health care delivering. However, the paradigm shift in the past 50 years has led to a gap between laboratory and clinic, with an increased risk of inappropriateness in test request and interpretation, as well as the consolidation of analytical work in focused factories and megastructurers oriented only toward achieving greater volumes, decreasing cost per test and generating a vision of laboratory services as simple commodities. A careful historical revision of the changing models for delivering laboratory services in the United States leads to the prediction that there are several reasons for counteracting the vision of clinical laboratory as a commodity, and restoring the true nature of laboratory services as an integral part of the diagnosis and therapy process. The present study, which reports on internal and external drivers for change, proposes an integrated vision of quality in laboratory medicine.

Steroid hormone analysis in diagnosis and treatment of DSD: position paper of EU COST Action BM 1303 'DSDnet'.

PubMed

Kulle, A; Krone, N; Holterhus, P M; Schuler, G; Greaves, R F; Juul, A; de Rijke, Y B; Hartmann, M F; Saba, A; Hiort, O; Wudy, S A

2017-05-01

Disorders or differences in sex development (DSD) comprise a heterogeneous group of conditions with an atypical sex development. For optimal diagnosis, highly specialised laboratory analyses are required across European countries. Working group 3 of EU COST (European Cooperation in Science and Technology) Action BM 1303 'DSDnet' 'Harmonisation of Laboratory Assessment' has developed recommendations on laboratory assessment for DSD regarding the use of technologies and analytes to be investigated. This position paper on steroid hormone analysis in diagnosis and treatment of DSD was compiled by a group of specialists in DSD and/or hormonal analysis, either from participating European countries or international partner countries. The topics discussed comprised analytical methods (immunoassay/mass spectrometry-based methods), matrices (urine/serum/saliva) and harmonisation of laboratory tests. The following positions were agreed upon: support of the appropriate use of immunoassay- and mass spectrometry-based methods for diagnosis and monitoring of DSD. Serum/plasma and urine are established matrices for analysis. Laboratories performing analyses for DSD need to operate within a quality framework and actively engage in harmonisation processes so that results and their interpretation are the same irrespective of the laboratory they are performed in. Participation in activities of peer comparison such as sample exchange or when available subscribing to a relevant external quality assurance program should be achieved. The ultimate aim of the guidelines is the implementation of clinical standards for diagnosis and appropriate treatment of DSD to achieve the best outcome for patients, no matter where patients are investigated or managed. © 2017 The authors.

Expressing analytical performance from multi-sample evaluation in laboratory EQA.

PubMed

Thelen, Marc H M; Jansen, Rob T P; Weykamp, Cas W; Steigstra, Herman; Meijer, Ron; Cobbaert, Christa M

2017-08-28

To provide its participants with an external quality assessment system (EQAS) that can be used to check trueness, the Dutch EQAS organizer, Organization for Quality Assessment of Laboratory Diagnostics (SKML), has innovated its general chemistry scheme over the last decade by introducing fresh frozen commutable samples whose values were assigned by Joint Committee for Traceability in Laboratory Medicine (JCTLM)-listed reference laboratories using reference methods where possible. Here we present some important innovations in our feedback reports that allow participants to judge whether their trueness and imprecision meet predefined analytical performance specifications. Sigma metrics are used to calculate performance indicators named 'sigma values'. Tolerance intervals are based on both Total Error allowable (TEa) according to biological variation data and state of the art (SA) in line with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Milan consensus. The existing SKML feedback reports that express trueness as the agreement between the regression line through the results of the last 12 months and the values obtained from reference laboratories and calculate imprecision from the residuals of the regression line are now enriched with sigma values calculated from the degree to which the combination of trueness and imprecision are within tolerance limits. The information and its conclusion to a simple two-point scoring system are also graphically represented in addition to the existing difference plot. By adding sigma metrics-based performance evaluation in relation to both TEa and SA tolerance intervals to its EQAS schemes, SKML provides its participants with a powerful and actionable check on accuracy.

Application of indices Cp and Cpk to improve quality control capability in clinical biochemistry laboratories.

PubMed

Chen, Ming-Shu; Wu, Ming-Hsun; Lin, Chih-Ming

2014-04-30

The traditional criteria for acceptability of analytic quality may not be objective in clinical laboratories. To establish quality control procedures intended to enhance Westgard multi-rules for improving the quality of clinical biochemistry tests, we applied the Cp and Cpk quality-control indices to monitor tolerance fitting and systematic variation of clinical biochemistry test results. Daily quality-control data of a large Taiwanese hospital in 2009 were analyzed. The test items were selected based on an Olympus biochemistry machine and included serum albumin, aspartate aminotransferase, cholesterol, glucose and potassium levels. Cp and Cpk values were calculated for normal and abnormal levels, respectively. The tolerance range was estimated with data from 50 laboratories using the same instruments and reagents. The results showed a monthly trend of variation for the five items under investigation. The index values of glucose were lower than those of the other items, and their values were usually <2. In contrast to the Cp value for cholesterol, Cpk of cholesterol was lower than 2, indicating a systematic error that should be further investigated. This finding suggests a degree of variation or failure to meet specifications that should be corrected. The study indicated that Cp and Cpk could be applied not only for monitoring variations in quality control, but also for revealing inter-laboratory qualitycontrol capability differences.

An interlaboratory transfer of a multi-analyte assay between continents.

PubMed

Georgiou, Alexandra; Dong, Kelly; Hughes, Stephen; Barfield, Matthew

2015-01-01

Alex has worked at GlaxoSmithKline for the past 15 years and currently works within the bioanalytical and toxicokinetic group in the United Kingdom. Alex's role in previous years has been the in-house support of preclinical and clinical bioanalysis, from method development through to sample analysis activities as well as acting as PI for GLP bioanalysis and toxicokinetics. For the past two years, Alex has applied this analytical and regulatory experience to focus on the outsourcing of preclinical bioanalysis, toxicokinetics and clinical bioanalysis, working closely with multiple bioanalytical and in-life CRO partners worldwide. Alex works to support DMPK and Safety Assessment outsourcing activities for GSK across multiple therapeutic areas, from the first GLP study through to late stage clinical PK studies. Transfer and cross-validation of an existing analytical assay between a laboratory providing current analytical support, and a laboratory needed for new or additional support, can present the bioanalyst with numerous challenges. These challenges can be technical or logistical in nature and may prove to be significant when transferring an assay between laboratories in different continents. Part of GlaxoSmithKline's strategy to improve confidence in providing quality data, is to cross-validate between laboratories. If the cross-validation fails predefined acceptance criteria, then a subsequent investigation would follow. This may also prove to be challenging. The importance of thorough planning and good communication throughout assay transfer, cross-validation and any subsequent investigations is illustrated in this case study.

The microINR portable coagulometer: analytical quality and user-friendliness of a PT (INR) point-of-care instrument.

PubMed

Larsen, Pia Bükmann; Storjord, Elin; Bakke, Åsne; Bukve, Tone; Christensen, Mikael; Eikeland, Joakim; Haugen, Vegar Engeland; Husby, Kristin; McGrail, Rie; Mikaelsen, Solveig Meier; Monsen, Grete; Møller, Mette Fogh; Nybo, Jan; Revsholm, Jesper; Risøy, Aslaug Johanne; Skålsvik, Unni Marie; Strand, Heidi; Teruel, Reyes Serrano; Theodorsson, Elvar

2017-04-01

Regular measurement of prothrombin time as an international normalized ratio PT (INR) is mandatory for optimal and safe use of warfarin. Scandinavian evaluation of laboratory equipment for primary health care (SKUP) evaluated the microINR portable coagulometer (microINR ® ) (iLine Microsystems S.L., Spain) for measurement of PT (INR). Analytical quality and user-friendliness were evaluated under optimal conditions at an accredited hospital laboratory and at two primary health care centres (PHCCs). Patients were recruited at the outpatient clinic of the Laboratory of Medical Biochemistry, St Olav's University Hospital, Trondheim, Norway (n = 98) and from two PHCCs (n = 88). Venous blood samples were analyzed under optimal conditions on the STA-R ® Evolution with STA-SPA + reagent (Stago, France) (Owren method), and the results were compared to capillary measurements on the microINR ® . The imprecision of the microINR ® was 6% (90% CI: 5.3-7.0%) and 6.3% (90% CI: 5.1-8.3) in the outpatient clinic and PHCC2, respectively for INR ≥2.5. The microINR ® did not meet the SKUP quality requirement for imprecision ≤5.0%. For INR <2.5 at PHCC2 and at both levels in PHCC1, CV% was ≤5.0. The accuracy fulfilled the SKUP quality goal in both outpatient clinic and PHCCs. User-friendliness of the operation manual was rated as intermediate, defined by SKUP as neutral ratings assessed as neither good nor bad. Operation facilities was rated unsatisfactory, and time factors satisfactory. In conclusion, quality requirements for imprecision were not met. The SKUP criteria for accuracy was fulfilled both at the hospital and at the PHCCs. The user-friendliness was rated intermediate.

External quality assurance project report for the National Atmospheric Deposition Program’s National Trends Network and Mercury Deposition Network, 2013–14

USGS Publications Warehouse

Wetherbee, Gregory A.; Martin, RoseAnn

2016-07-05

The Mercury Deposition Network programs include the system blank program and an interlaboratory comparison program. System blank results indicated that maximum total mercury contamination concentrations in samples were less than the third percentile of all Mercury Deposition Network sample concentrations. The Mercury Analytical Laboratory produced chemical concentration results with low bias and variability compared with other domestic and international laboratories that support atmospheric-deposition monitoring.

Verification of out-of-control situations detected by "average of normal" approach.

PubMed

Liu, Jiakai; Tan, Chin Hon; Loh, Tze Ping; Badrick, Tony

2016-11-01

"Average of normal" (AoN) or "moving average" is increasingly used as an adjunct quality control tool in laboratory practice. Little guidance exists on how to verify if an out-of-control situation in the AoN chart is due to a shift in analytical performance, or underlying patient characteristics. Through simulation based on clinical data, we examined 1) the location of the last apparently stable period in the AoN control chart after an analytical shift, and 2) an approach to verify if the observed shift is related to an analytical shift by repeat testing of archived patient samples from the stable period for 21 common analytes. The number of blocks of results to look back for the stable period increased with the duration of the analytical shift, and was larger when smaller AoN block sizes were used. To verify an analytical shift, 3 archived samples from the analytically stable period should be retested. In particular, the process is deemed to have shifted if a difference of >2 analytical standard deviations (i.e. 1:2s rejection rule) between the original and retested results are observed in any of the 3 samples produced. The probability of Type-1 error (i.e., false rejection) and power (i.e., detecting true analytical shift) of this rule are <0.1 and >0.9, respectively. The use of appropriately archived patient samples to verify an apparent analytical shift is preferred to quality control materials. Nonetheless, the above findings may also apply to quality control materials, barring matrix effects. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

[Analysis of the results of the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology for HIV-1, HCV, and HBV viral loads].

PubMed

Orta Mira, Nieves; Serrano, María del Remedio Guna; Martínez, José-Carlos Latorre; Ovies, María Rosario; Poveda, Marta; de Gopegui, Enrique Ruiz; Cardona, Concepción Gimeno

2011-12-01

Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most important markers for the follow-up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of the results obtained by microbiology laboratories. This article summarized the results obtained in the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology for HIV-1, HCV, and HBV viral loads and HCV genotyping. In the HIV-1 program, a total of five standards were sent. One standard consisted of seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in the range of 3-5 log(10) copies/mL; two of these standards were identical, with the aim of determining repeatability. A significant proportion of the laboratories (22.6% on average) obtained values out of the accepted range (mean ± 0.2 log(10)copies/mL), depending on the standard and on the method used for quantification. Repeatability was very good, with up to 95% of laboratories reporting results within the limits (Δ<0.5 log(10)copies/mL). The HBV and HCV program consisted of two standards with different viral load contents. Most of the participants, 86.1% in the case of HCV and 87.1% in HBV, obtained all the results within the accepted range (mean ± 1.96 SD log(10)UI/mL). Post-analytical errors due to mistranscription of the results were detected in these controls. Data from this analysis reinforce the utility of proficiency programs to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase in overall quality. Due to interlaboratory variability, use of the same method and the same laboratory for patient follow-up is advisable. Copyright © 2011 Elsevier España S.L. All rights reserved.

Irregular analytical errors in diagnostic testing - a novel concept.

PubMed

Vogeser, Michael; Seger, Christoph

2018-02-23

In laboratory medicine, routine periodic analyses for internal and external quality control measurements interpreted by statistical methods are mandatory for batch clearance. Data analysis of these process-oriented measurements allows for insight into random analytical variation and systematic calibration bias over time. However, in such a setting, any individual sample is not under individual quality control. The quality control measurements act only at the batch level. Quantitative or qualitative data derived for many effects and interferences associated with an individual diagnostic sample can compromise any analyte. It is obvious that a process for a quality-control-sample-based approach of quality assurance is not sensitive to such errors. To address the potential causes and nature of such analytical interference in individual samples more systematically, we suggest the introduction of a new term called the irregular (individual) analytical error. Practically, this term can be applied in any analytical assay that is traceable to a reference measurement system. For an individual sample an irregular analytical error is defined as an inaccuracy (which is the deviation from a reference measurement procedure result) of a test result that is so high it cannot be explained by measurement uncertainty of the utilized routine assay operating within the accepted limitations of the associated process quality control measurements. The deviation can be defined as the linear combination of the process measurement uncertainty and the method bias for the reference measurement system. Such errors should be coined irregular analytical errors of the individual sample. The measurement result is compromised either by an irregular effect associated with the individual composition (matrix) of the sample or an individual single sample associated processing error in the analytical process. Currently, the availability of reference measurement procedures is still highly limited, but LC-isotope-dilution mass spectrometry methods are increasingly used for pre-market validation of routine diagnostic assays (these tests also involve substantial sets of clinical validation samples). Based on this definition/terminology, we list recognized causes of irregular analytical error as a risk catalog for clinical chemistry in this article. These issues include reproducible individual analytical errors (e.g. caused by anti-reagent antibodies) and non-reproducible, sporadic errors (e.g. errors due to incorrect pipetting volume due to air bubbles in a sample), which can both lead to inaccurate results and risks for patients.

External quality-assurance results for the National Atmospheric Deposition Program/National Trends Network during 1991

USGS Publications Warehouse

Nilles, M.A.; Gordon, J.D.; Schroder, L.J.; Paulin, C.E.

1995-01-01

The U.S. Geological Survey used four programs in 1991 to provide external quality assurance for the National Atmospheric Deposition Program/National Trends Network (NADP/NTN). An intersite-comparison program was used to evaluate onsite pH and specific-conductance determinations. The effects of routine sample handling, processing, and shipping of wet-deposition samples on analyte determinations and an estimated precision of analyte values and concentrations were evaluated in the blind-audit program. Differences between analytical results and an estimate of the analytical precision of four laboratories routinely measuring wet deposition were determined by an interlaboratory-comparison program. Overall precision estimates for the precipitation-monitoring system were determined for selected sites by a collocated-sampler program. Results of the intersite-comparison program indicated that 93 and 86 percent of the site operators met the NADP/NTN accuracy goal for pH determinations during the two intersite-comparison studies completed during 1991. The results also indicated that 96 and 97 percent of the site operators met the NADP/NTN accuracy goal for specific-conductance determinations during the two 1991 studies. The effects of routine sample handling, processing, and shipping, determined in the blind-audit program indicated significant positive bias (a=.O 1) for calcium, magnesium, sodium, potassium, chloride, nitrate, and sulfate. Significant negative bias (or=.01) was determined for hydrogen ion and specific conductance. Only ammonium determinations were not biased. A Kruskal-Wallis test indicated that there were no significant (*3t=.01) differences in analytical results from the four laboratories participating in the interlaboratory-comparison program. Results from the collocated-sampler program indicated the median relative error for cation concentration and deposition exceeded eight percent at most sites, whereas the median relative error for sample volume, sulfate, and nitrate concentration at all sites was less than four percent. The median relative error for hydrogen ion concentration and deposition ranged from 4.6 to 18.3 percent at the four sites and as indicated in previous years of the study, was inversely proportional to the acidity of the precipitation at a given site. Overall, collocated-sampling error typically was five times that of laboratory error estimates for most analytes.

NATIONAL PERFORMANCE AUDIT PROGRAM: 1979 PROFICIENCY SURVEYS FOR SULFUR DIOXIDE, NITROGEN DIOXIDE, CARBON MONOXIDE, SULFATE, NITRATE, LEAD AND HIGH VOLUME FLOW

EPA Science Inventory

The Quality Assurance Division of the Environmental Monitoring Systems Laboratory, Research Triangle Park, North Carolina, administers semiannual Surveys of Analytical Proficiency for sulfur dioxide, nitrogen dioxide, carbon monoxide, sulfate, nitrate and lead. Sample material, s...

42 CFR 493.1283 - Standard: Test records.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Standard: Test records. 493.1283 Section 493.1283 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic Systems § 493.1283 Standard: Test records. (...

40 CFR 408.41 - Specialized definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... shall apply to this subpart. (b) The term oil and grease shall mean those components of a waste water amenable to measurement by the method described in Methods for Chemical Analysis of Water and Wastes, 1971, Environmental Protection Agency, Analytical Quality Control Laboratory, page 217. (c) The term seafood shall...

Synergistic relationships between Analytical Chemistry and written standards.

PubMed

Valcárcel, Miguel; Lucena, Rafael

2013-07-25

This paper describes the mutual impact of Analytical Chemistry and several international written standards (norms and guides) related to knowledge management (CEN-CWA 14924:2004), social responsibility (ISO 26000:2010), management of occupational health and safety (OHSAS 18001/2), environmental management (ISO 14001:2004), quality management systems (ISO 9001:2008) and requirements of the competence of testing and calibration laboratories (ISO 17025:2004). The intensity of this impact, based on a two-way influence, is quite different depending on the standard considered. In any case, a new and fruitful approach to Analytical Chemistry based on these relationships can be derived. Copyright © 2013 Elsevier B.V. All rights reserved.

Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory; determination of pesticides in water by Carbopak-B solid-phase extraction and high-preformance liquid chromatography

USGS Publications Warehouse

Werner, Stephen L.; Burkhardt, Mark R.; DeRusseau, Sabrina N.

1996-01-01

In accordance with the needs of the National Water-Quality Assessment Program (NAWQA), the U.S. Geological Survey has developed and implemented a graphitized carbon-based solid-phase extraction and high-performance liquid chromatographic analytical method. The method is used to determine 41 pesticides and pesticide metabolites that are not readily amenable to gas chromatography or other high-temperature analytical techniques. Pesticides are extracted from filtered environmental water samples using a 0.5-gram graphitized carbon-based solid-phase cartridge, eluted from the cartridge into two analytical fractions, and analyzed using high-performance liquid chromatography with photodiode-array detection. The upper concentration limit is 1.6 micrograms per liter (=B5g/L) for most compounds. Single-operator method detection limits in organic-free water samples ranged from 0.006 to 0.032 =B5g/L= Recoveries in organic-free water samples ranged from 37 to 88 percent. Recoveries in ground- and surface-water samples ranged from 29 to 94 percent. An optional on-site extraction procedure allows for samples to be collected and processed at remote sites where it is difficult to ship samples to the laboratory within the recommended pre-extraction holding time of 7 days.

Pre-analytical phase: The automated ProTube device supports quality assurance in the phlebotomy process.

PubMed

Piva, Elisa; Tosato, Francesca; Plebani, Mario

2015-12-07

Most errors in laboratory medicine occur in the pre-analytical phase of the total testing process. Phlebotomy, a crucial step in the pre-analytical phase influencing laboratory results and patient outcome, calls for quality assurance procedures and automation in order to prevent errors and ensure patient safety. We compared the performance of a new small, automated device, the ProTube Inpeco, designed for use in phlebotomy with a complete traceability of the process, with a centralized automated system, BC ROBO. ProTube was used for 15,010 patients undergoing phlebotomy with 48,776 tubes being labeled. The mean time and standard deviation (SD) for blood sampling was 3:03 (min:sec; SD ± 1:24) when using ProTube, against 5:40 (min:sec; SD ± 1:57) when using BC ROBO. The mean number of patients per hour managed at each phlebotomy point was 16 ± 3 with ProTube, and 10 ± 2 with BC ROBO. No tubes were labeled erroneously or incorrectly, even if process failure occurred in 2.8% of cases when ProTube was used. Thanks to its cutting edge technology, the ProTube has many advantages over BC ROBO, above all in verifying patient identity, and in allowing a reduction in both identification error and tube mislabeling.

Implementation of biological variation-based analytical performance specifications in the laboratory: Stringent evaluation of Improvacutor blood collection tubes.

PubMed

Chung, Hee-Jung; Song, Yoon Kyung; Hong, Sung Kuk; Hwang, Sang-Hyun; Seo, Hee Seung; Whang, Dong Hee; Nam, Myung-Hyun; Lee, Do Hoon

2017-01-01

Recently, because the quality of laboratory analyses has increased along with the need for quality improvement, several external quality control bodies have adapted performance specifications using the Desirable Biological Variation Database, termed "Ricos goals"; these criteria are more stringent than those presented in CLIA 88. In this study, we aimed to validate newly introduced serum separator tubes, Improvacutor, for routine clinical chemistry testing in accordance with Ricos goals and CLIA 88. Blood samples were collected from 100 volunteers into three types of serum vacuum tubes: Greiner Vacuette, Becton Dickinson (BD) Vacutainer, and Improve Improvacutor. The samples were subjected to 16 routine chemistry tests using a TBA-200fr NEO chemistry autoanalyzer. In the comparison analysis, all 16 test results were acceptable according to CLIA 88. However, in the comparison of Improve and BD tubes, creatinine showed 4.31% (+0.08 μmol/L) bias. This slightly exceeded the Desirable Specification for Inaccuracy Ricos limit of ±3.96%, but still satisfied the CLIS88 limit of ±26.52 μmol/L. The remaining 15 analytes performed acceptably according to the Desirable Specifications of Ricos. The correlation coefficient of 12 analytes was greater than 0.95 in Passing-Bablok regression analysis among the three tubes, but was lower for four analytes: calcium, sodium, potassium, and chloride. In the stability assay, only potassium tested in the Greiner tube revealed a larger positive bias (2.18%) than the Ricos Desirable Specification for Inaccuracy based on biologic variation (1.8%). The BD tube also showed a positive bias of 1.74%, whereas the new Improve tube showed the smallest positive bias of 1.17% in potassium level after 72 h storage. Thus, the results of this study demonstrate that recently introduced analytical performance specifications based on components of biological variation (Rico's goal) could be extended to criterion for performance evaluation and applied.

The effects of total laboratory automation on the management of a clinical chemistry laboratory. Retrospective analysis of 36 years.

PubMed

Sarkozi, Laszlo; Simson, Elkin; Ramanathan, Lakshmi

2003-03-01

Thirty-six years of data and history of laboratory practice at our institution has enabled us to follow the effects of analytical automation, then recently pre-analytical and post-analytical automation on productivity, cost reduction and enhanced quality of service. In 1998, we began the operation of a pre- and post-analytical automation system (robotics), together with an advanced laboratory information system to process specimens prior to analysis, deliver them to various automated analytical instruments, specimen outlet racks and finally to refrigerated stockyards. By the end of 3 years of continuous operation, we compared the chemistry part of the system with the prior 33 years and quantitated the financial impact of the various stages of automation. Between 1965 and 2000, the Consumer Price Index increased by a factor of 5.5 in the United States. During the same 36 years, at our institution's Chemistry Department the productivity (indicated as the number of reported test results/employee/year) increased from 10,600 to 104,558 (9.3-fold). When expressed in constant 1965 dollars, the total cost per test decreased from 0.79 dollars to 0.15 dollars. Turnaround time for availability of results on patient units decreased to the extent that Stat specimens requiring a turnaround time of <1 h do not need to be separately prepared or prioritized on the system. Our experience shows that the introduction of a robotics system for perianalytical automation has brought a large improvement in productivity together with decreased operational cost. It enabled us to significantly increase our workload together with a reduction of personnel. In addition, stats are handled easily and there are benefits such as safer working conditions and improved sample identification, which are difficult to quantify at this stage.

Guidelines for point-of-care testing: haematology.

PubMed

Briggs, Carol; Guthrie, David; Hyde, Keith; Mackie, Ian; Parker, Norman; Popek, Mary; Porter, Neil; Stephens, Clare

2008-09-01

This guideline provides a framework for the arrangement of point-of-care testing (POCT) services, previously known as near patient testing (patient self-testing not covered). POCT is defined as any analytical test performed outside the laboratory. Primary users are often non-laboratory healthcare workers. The guidance applies to units within hospitals as well as general practioner surgeries, community clinics and pharmacies. The head of the haematology laboratory or a point of care coordinator must take responsibility for all aspects of the POCT service, including quality and training. Depending on the size and nature of the POCT practice, a local POCT manager may also be required. Equipment selected should have received a successful independent performance evaluation. If an independent evaluation has not been performed the purchaser should assess the device according to the protocol in this document. POCT devices should generate results that are comparable to those of the local laboratory. An accredited external quality assessment programme and internal quality control system must be established. Manufacturers promoting POCT devices designed for non-laboratory sites, e.g. pharmacies, should undertake training and annual competency assessment, perhaps using a web-based system. A diagram to illustrate the stages for the implementation of a POCT service is illustrated.

40 CFR Appendix G to Subpart A of... - UNEP Recommendations for Conditions Applied to Exemption for Essential Laboratory and Analytical...

Code of Federal Regulations, 2013 CFR

2013-07-01

... and laboratory purposes. Pursuant to Decision XI/15 of the Parties to the Montreal Protocol, effective... laboratory and analytical purposes is authorized provided that these laboratory and analytical chemicals..., restricted to laboratory use and analytical purposes and specifying that used or surplus substances should be...

40 CFR Appendix G to Subpart A of... - UNEP Recommendations for Conditions Applied to Exemption for Essential Laboratory and Analytical...

Code of Federal Regulations, 2010 CFR

2010-07-01

... and laboratory purposes. Pursuant to Decision XI/15 of the Parties to the Montreal Protocol, effective... laboratory and analytical purposes is authorized provided that these laboratory and analytical chemicals..., restricted to laboratory use and analytical purposes and specifying that used or surplus substances should be...

40 CFR Appendix G to Subpart A of... - UNEP Recommendations for Conditions Applied to Exemption for Essential Laboratory and Analytical...

Code of Federal Regulations, 2014 CFR

2014-07-01

... and laboratory purposes. Pursuant to Decision XI/15 of the Parties to the Montreal Protocol, effective... laboratory and analytical purposes is authorized provided that these laboratory and analytical chemicals..., restricted to laboratory use and analytical purposes and specifying that used or surplus substances should be...

40 CFR Appendix G to Subpart A of... - UNEP Recommendations for Conditions Applied to Exemption for Essential Laboratory and Analytical...

Code of Federal Regulations, 2012 CFR

2012-07-01

... and laboratory purposes. Pursuant to Decision XI/15 of the Parties to the Montreal Protocol, effective... laboratory and analytical purposes is authorized provided that these laboratory and analytical chemicals..., restricted to laboratory use and analytical purposes and specifying that used or surplus substances should be...

40 CFR Appendix G to Subpart A of... - UNEP Recommendations for Conditions Applied to Exemption for Essential Laboratory and Analytical...

Code of Federal Regulations, 2011 CFR

2011-07-01

... and laboratory purposes. Pursuant to Decision XI/15 of the Parties to the Montreal Protocol, effective... laboratory and analytical purposes is authorized provided that these laboratory and analytical chemicals..., restricted to laboratory use and analytical purposes and specifying that used or surplus substances should be...

Clinical laboratory analytics: Challenges and promise for an emerging discipline.

PubMed

Shirts, Brian H; Jackson, Brian R; Baird, Geoffrey S; Baron, Jason M; Clements, Bryan; Grisson, Ricky; Hauser, Ronald George; Taylor, Julie R; Terrazas, Enrique; Brimhall, Brad

2015-01-01

The clinical laboratory is a major source of health care data. Increasingly these data are being integrated with other data to inform health system-wide actions meant to improve diagnostic test utilization, service efficiency, and "meaningful use." The Academy of Clinical Laboratory Physicians and Scientists hosted a satellite meeting on clinical laboratory analytics in conjunction with their annual meeting on May 29, 2014 in San Francisco. There were 80 registrants for the clinical laboratory analytics meeting. The meeting featured short presentations on current trends in clinical laboratory analytics and several panel discussions on data science in laboratory medicine, laboratory data and its role in the larger healthcare system, integrating laboratory analytics, and data sharing for collaborative analytics. One main goal of meeting was to have an open forum of leaders that work with the "big data" clinical laboratories produce. This article summarizes the proceedings of the meeting and content discussed.

Clinical laboratory analytics: Challenges and promise for an emerging discipline

PubMed Central

Shirts, Brian H.; Jackson, Brian R.; Baird, Geoffrey S.; Baron, Jason M.; Clements, Bryan; Grisson, Ricky; Hauser, Ronald George; Taylor, Julie R.; Terrazas, Enrique; Brimhall, Brad

2015-01-01

The clinical laboratory is a major source of health care data. Increasingly these data are being integrated with other data to inform health system-wide actions meant to improve diagnostic test utilization, service efficiency, and “meaningful use.” The Academy of Clinical Laboratory Physicians and Scientists hosted a satellite meeting on clinical laboratory analytics in conjunction with their annual meeting on May 29, 2014 in San Francisco. There were 80 registrants for the clinical laboratory analytics meeting. The meeting featured short presentations on current trends in clinical laboratory analytics and several panel discussions on data science in laboratory medicine, laboratory data and its role in the larger healthcare system, integrating laboratory analytics, and data sharing for collaborative analytics. One main goal of meeting was to have an open forum of leaders that work with the “big data” clinical laboratories produce. This article summarizes the proceedings of the meeting and content discussed. PMID:25774320

The impact of automation on organizational changes in a community hospital clinical microbiology laboratory.

PubMed

Camporese, Alessandro

2004-06-01

The diagnosis of infectious diseases and the role of the microbiology laboratory are currently undergoing a process of change. The need for overall efficiency in providing results is now given the same importance as accuracy. This means that laboratories must be able to produce quality results in less time with the capacity to interpret the results clinically. To improve the clinical impact of microbiology results, the new challenge facing the microbiologist has become one of process management instead of pure analysis. A proper project management process designed to improve workflow, reduce analytical time, and provide the same high quality results without losing valuable time treating the patient, has become essential. Our objective was to study the impact of introducing automation and computerization into the microbiology laboratory, and the reorganization of the laboratory workflow, i.e. scheduling personnel to work shifts covering both the entire day and the entire week. In our laboratory, the introduction of automation and computerization, as well as the reorganization of personnel, thus the workflow itself, has resulted in an improvement in response time and greater efficiency in diagnostic procedures.

Global harmonization of food safety regulations: perspectives from Japan after the Fukushima nuclear accident.

PubMed

Yoshida, Mitsuru

2014-08-01

Japanese food self-sufficiency was only 39% on the basis of kcal in 2012, so Japan relies heavily on imported food. Hence the necessity of having international rules on the regulation of food contaminants is important especially for countries like Japan that depend on food imports. A One-Stop-Testing system is desired, in which the test result obtained from a single testing laboratory is accepted as valid worldwide. To establish this system, laboratory accreditation under international standards is a necessary step. Furthermore, the importance of supply of reference materials for internal quality control and proficiency testing for external quality control of each laboratory's analytical system is reviewed in connection with the experience of radioactive nuclide contamination resulting from the Fukushima nuclear power plant accident in March 2011. © 2013 Society of Chemical Industry.

[Domestic and international trends concerning allowable limits of error in external quality assessment scheme].

PubMed

Hosogaya, Shigemi; Ozaki, Yukio

2005-06-01

Many external quality assessment schemes (EQAS) are performed to support quality improvement of the services provided by participating laboratories for the benefits of patients. The EQAS organizer shall be responsible for ensuring that the method of evaluation is appropriate for maintenance of the credibility of the schemes. Procedures to evaluate each participating laboratory are gradually being standardized. In most cases of EQAS, the peer group mean is used as a target of accuracy, and the peer group standard deviation is used as a criterion for inter-laboratory variation. On the other hand, Fraser CG, et al. proposed desirable quality specifications for any imprecision and inaccuracies, which were derived from inter- and intra-biologic variations. We also proposed allowable limits of analytical error, being less than one-half of the average intra-individual variation for evaluation of imprecision, and less than one-quarter of the inter- plus intra-individual variation for evaluation of inaccuracy. When expressed in coefficient of variation terms, these allowable limits may be applied at a wide range of levels of quantity.

Monitoring and root cause analysis of clinical biochemistry turn around time at an academic hospital.

PubMed

Chauhan, Kiran P; Trivedi, Amit P; Patel, Dharmik; Gami, Bhakti; Haridas, N

2014-10-01

Quality can be defined as the ability of a product or service to satisfy the needs and expectations of the customer. Laboratories are more focusing on technical and analytical quality for reliability and accuracy of test results. Patients and clinicians however are interested in rapid, reliable and efficient service from laboratory. Turn around time (TAT), the timeliness with which laboratory personnel deliver test results, is one of the most noticeable signs of laboratory service and is often used as a key performance indicator of laboratory performance. This study is aims to provide clue for laboratory TAT monitoring and root cause analysis. In a 2 year period a total of 75,499 specimens of outdoor patient department were monitor, of this a total of 4,142 specimens exceeded TAT. With consistent efforts to monitor, root cause analysis and corrective measures, we are able to decreased the specimens exceeding TAT from 7-8 to 3.7 %. Though it is difficult task to monitor TAT with the help of laboratory information system, real time documentation and authentic data retrievable, along with identification of causes for delays and its remedial measures, improve laboratory TAT and thus patient satisfaction.

Mistakes in a stat laboratory: types and frequency.

PubMed

Plebani, M; Carraro, P

1997-08-01

Application of Total Quality Management concepts to laboratory testing requires that the total process, including preanalytical and postanalytical phases, be managed so as to reduce or, ideally, eliminate all defects within the process itself. Indeed a "mistake" can be defined as any defect during the entire testing process, from ordering tests to reporting results. We evaluated the frequency and types of mistakes found in the "stat" section of the Department of Laboratory Medicine of the University-Hospital of Padova by monitoring four different departments (internal medicine, nephrology, surgery, and intensive care unit) for 3 months. Among a total of 40490 analyses, we identified 189 laboratory mistakes, a relative frequency of 0.47%. The distribution of mistakes was: preanalytical 68.2%, analytical 13.3%, and postanalytical 18.5%. Most of the laboratory mistakes (74%) did not affect patients' outcome. However, in 37 patients (19%), laboratory mistakes were associated with further inappropriate investigations, thus resulting in an unjustifiable increase in costs. Moreover, in 12 patients (6.4%) laboratory mistakes were associated with inappropriate care or inappropriate modification of therapy. The promotion of quality control and continuous improvement of the total testing process, including pre- and postanalytical phases, seems to be a prerequisite for an effective laboratory service.

Developing an analytical toxicology service: principles and guidance.

PubMed

Flanagan, Robert J

2004-01-01

Many acutely poisoned patients are treated with no laboratory help other than general clinical chemistry and haematology. Emergency toxicological analyses (24-hour availability) that could influence immediate patient management such as iron, lithium and paracetamol (acetaminophen), are relatively few in number and are remarkably similar worldwide. These assays should be provided at hospitals with large accident and emergency departments. More complex, less frequently needed clinical toxicological assays that can often be offered on a less urgent basis are usually provided from regional or national centres because of the need to make best use of resources. Recommendations as to the assays that should be provided locally and at regional centres are available for the UK and US, and are generally applicable. Regional centres normally diversify into specialised therapeutic drug monitoring, urine screening for drugs of abuse, metals analysis and sometimes forensic work in order to widen the repertoire of tests available and to increase funding. Whatever the type and quantity of work undertaken and the instrumentation used, guidelines are now available delineating staff training, method validation, assay operation, quality control/quality assurance, and indeed virtually all other aspects of laboratory operation. These considerations notwithstanding, clinical interpretation of analytical results remains a difficult area and is the responsibility of the reporting laboratory, at least in the first instance.

Evaluation of Performance of Laboratories and Manufacturers Within the Framework of the IFCC model for Quality Targets of HbA1c.

PubMed

Weykamp, Cas; Siebelder, Carla

2017-11-01

HbA1c is a key parameter in diabetes management. For years the test has been used exclusively for monitoring of long-term diabetic control. However, due to improvement of the performance, HbA1c is considered more and more for diagnosis and screening. With this new application, quality demands further increase. A task force of the International Federation of Clinical Chemistry and Laboratory Medicine developed a model to set and evaluate quality targets for HbA1c. The model is based on the concept of total error and takes into account the major sources of analytical errors in the medical laboratory: bias and imprecision. Performance criteria are derived from sigma-metrics and biological variation. This review shows 2 examples of the application of the model: at the level of single laboratories, and at the level of a group of laboratories. In the first example data of 125 individual laboratories of a recent external quality assessment program in the Netherlands are evaluated. Differences between laboratories as well as their relation to method principles are shown. The second example uses recent and 3-year-old data of the proficiency test of the College of American Pathologists. The differences in performance between 26 manufacturer-related groups of laboratories are shown. Over time these differences are quite consistent although some manufacturers improved substantially either by better standardization or by replacing a test. The IFCC model serves all who are involved in HbA1c testing in the ongoing process of better performance and better patient care.

Managing laboratory automation in a changing pharmaceutical industry

PubMed Central

Rutherford, Michael L.

1995-01-01

The health care reform movement in the USA and increased requirements by regulatory agencies continue to have a major impact on the pharmaceutical industry and the laboratory. Laboratory management is expected to improve effciency by providing more analytical results at a lower cost, increasing customer service, reducing cycle time, while ensuring accurate results and more effective use of their staff. To achieve these expectations, many laboratories are using robotics and automated work stations. Establishing automated systems presents many challenges for laboratory management, including project and hardware selection, budget justification, implementation, validation, training, and support. To address these management challenges, the rationale for project selection and implementation, the obstacles encountered, project outcome, and learning points for several automated systems recently implemented in the Quality Control Laboratories at Eli Lilly are presented. PMID:18925014

Results of external quality-assurance program for the National Atmospheric Deposition Program and National Trends Network during 1985

USGS Publications Warehouse

Brooks, M.H.; Schroder, L.J.; Willoughby, T.C.

1988-01-01

External quality assurance monitoring of the National Atmospheric Deposition Program (NADP) and National Trends Network (NTN) was performed by the U.S. Geological Survey during 1985. The monitoring consisted of three primary programs: (1) an intersite comparison program designed to assess the precision and accuracy of onsite pH and specific conductance measurements made by NADP and NTN site operators; (2) a blind audit sample program designed to assess the effect of routine field handling on the precision and bias of NADP and NTN wet deposition data; and (3) an interlaboratory comparison program designed to compare analytical data from the laboratory processing NADP and NTN samples with data produced by other laboratories routinely analyzing wet deposition samples and to provide estimates of individual laboratory precision. An average of 94% of the site operators participated in the four voluntary intersite comparisons during 1985. A larger percentage of participating site operators met the accuracy goal for specific conductance measurements (average, 87%) than for pH measurements (average, 67%). Overall precision was dependent on the actual specific conductance of the test solution and independent of the pH of the test solution. Data for the blind audit sample program indicated slight positive biases resulting from routine field handling for all analytes except specific conductance. These biases were not large enough to be significant for most data users. Data for the blind audit sample program also indicated that decreases in hydrogen ion concentration were accompanied by decreases in specific conductance. Precision estimates derived from the blind audit sample program indicate that the major source of uncertainty in wet deposition data is the routine field handling that each wet deposition sample receives. Results of the interlaboratory comparison program were similar to results of previous years ' evaluations, indicating that the participating laboratories produced comparable data when they analyzed identical wet deposition samples, and that the laboratory processing NADP and NTN samples achieved the best analyte precision of the participating laboratories. (Author 's abstract)

[Comparability study of analytical results between a group of clinical laboratories].

PubMed

Alsius-Serra, A; Ballbé-Anglada, M; López-Yeste, M L; Buxeda-Figuerola, M; Guillén-Campuzano, E; Juan-Pereira, L; Colomé-Mallolas, C; Caballé-Martín, I

2015-01-01

To describe the study of the comparability of the measurements levels of biological tests processed in biochemistry in Catlab's 4 laboratories. Quality requirements, coefficients of variation and total error (CV% and TE %) were established. Controls were verified with the precision requirements (CV%) in each test and each individual laboratory analyser. Fresh serum samples were used for the comparability study. The differences were analysed using a Microsoft Access® application that produces modified Bland-Altman plots. The comparison of 32 biological parameters that are performed in more than one laboratory and/or analyser generated 306 Bland-Altman graphs. Of these, 101 (33.1%) fell within the accepted range of values based on biological variability, and 205 (66.9%) required revision. Data were re-analysed based on consensus minimum specifications for analytical quality (consensus of the Asociación Española de Farmacéuticos Analistas (AEFA), the Sociedad Española de Bioquímica Clínica y Patología Molecular (SEQC), the Asociación Española de Biopatología Médica (AEBM) and the Sociedad Española de Hematología y Hemoterapia (SEHH), October 2013). With the new specifications, 170 comparisons (56%) fitted the requirements and 136 (44%) required additional review. Taking into account the number of points that exceeded the requirement, random errors, range of results in which discrepancies were detected, and range of clinical decision, it was shown that the 44% that required review were acceptable, and the 32 tests were comparable in all laboratories and analysers. The analysis of the results showed that the consensus requirements of the 4 scientific societies were met. However, each laboratory should aim to meet stricter criteria for total error. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Position Statement Executive Summary: Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

PubMed Central

Arnold, Mark; Bakris, George L.; Bruns, David E.; Horvath, Andrea Rita; Kirkman, M. Sue; Lernmark, Ake; Metzger, Boyd E.; Nathan, David M.

2011-01-01

BACKGROUND Multiple laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. APPROACH An expert committee compiled evidence-based recommendations for the use of laboratory analysis in patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. A draft of the guidelines was posted on the Internet, and the document was modified in response to comments. The guidelines were reviewed by the joint Evidence-Based Laboratory Medicine Committee of the AACC and the National Academy of Clinical Biochemistry and were accepted after revisions by the Professional Practice Committee and subsequent approval by the Executive Committee of the American Diabetes Association. CONTENT In addition to the long-standing criteria based on measurement of venous plasma glucose, diabetes can be diagnosed by demonstrating increased hemoglobin A1c (HbA1c) concentrations in the blood. Monitoring of glycemic control is performed by the patients measuring their own plasma or blood glucose with meters and by laboratory analysis of HbA1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. SUMMARY The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended. PMID:21617111

Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus.

PubMed

Sacks, David B; Arnold, Mark; Bakris, George L; Bruns, David E; Horvath, Andrea Rita; Kirkman, M Sue; Lernmark, Ake; Metzger, Boyd E; Nathan, David M

2011-06-01

Multiple laboratory tests are used to diagnose and manage patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these tests varies substantially. An expert committee compiled evidence-based recommendations for the use of laboratory testing for patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. Draft guidelines were posted on the Internet and presented at the 2007 Arnold O. Beckman Conference. The document was modified in response to oral and written comments, and a revised draft was posted in 2010 and again modified in response to written comments. The National Academy of Clinical Biochemistry and the Evidence-Based Laboratory Medicine Committee of the American Association for Clinical Chemistry jointly reviewed the guidelines, which were accepted after revisions by the Professional Practice Committee and subsequently approved by the Executive Committee of the American Diabetes Association. In addition to long-standing criteria based on measurement of plasma glucose, diabetes can be diagnosed by demonstrating increased blood hemoglobin A(1c) (HbA(1c)) concentrations. Monitoring of glycemic control is performed by self-monitoring of plasma or blood glucose with meters and by laboratory analysis of HbA(1c). The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. The guidelines provide specific recommendations that are based on published data or derived from expert consensus. Several analytes have minimal clinical value at present, and their measurement is not recommended.

Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus.

PubMed

Sacks, David B; Arnold, Mark; Bakris, George L; Bruns, David E; Horvath, Andrea Rita; Kirkman, M Sue; Lernmark, Ake; Metzger, Boyd E; Nathan, David M

2011-06-01

Multiple laboratory tests are used to diagnose and manage patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these tests varies substantially. An expert committee compiled evidence-based recommendations for the use of laboratory testing for patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. Draft guidelines were posted on the Internet and presented at the 2007 Arnold O. Beckman Conference. The document was modified in response to oral and written comments, and a revised draft was posted in 2010 and again modified in response to written comments. The National Academy of Clinical Biochemistry and the Evidence Based Laboratory Medicine Committee of the AACC jointly reviewed the guidelines, which were accepted after revisions by the Professional Practice Committee and subsequently approved by the Executive Committee of the American Diabetes Association. In addition to long-standing criteria based on measurement of plasma glucose, diabetes can be diagnosed by demonstrating increased blood hemoglobin A(1c) (Hb A(1c)) concentrations. Monitoring of glycemic control is performed by self-monitoring of plasma or blood glucose with meters and by laboratory analysis of Hb A(1c). The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. The guidelines provide specific recommendations that are based on published data or derived from expert consensus. Several analytes have minimal clinical value at present, and their measurement is not recommended.

Position statement executive summary: guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus.

PubMed

Sacks, David B; Arnold, Mark; Bakris, George L; Bruns, David E; Horvath, Andrea Rita; Kirkman, M Sue; Lernmark, Ake; Metzger, Boyd E; Nathan, David M

2011-06-01

Multiple laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. An expert committee compiled evidence-based recommendations for the use of laboratory analysis in patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. A draft of the guidelines was posted on the Internet, and the document was modified in response to comments. The guidelines were reviewed by the joint Evidence-Based Laboratory Medicine Committee of the AACC and the National Academy of Clinical Biochemistry and were accepted after revisions by the Professional Practice Committee and subsequent approval by the Executive Committee of the American Diabetes Association. In addition to the long-standing criteria based on measurement of venous plasma glucose, diabetes can be diagnosed by demonstrating increased hemoglobin A(1c) (HbA(1c)) concentrations in the blood. Monitoring of glycemic control is performed by the patients measuring their own plasma or blood glucose with meters and by laboratory analysis of HbA(1c). The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended.

Laboratory testing of extravascular body fluids in Croatia: a survey of the Working group for extravascular body fluids of the Croatian Society of Medical Biochemistry and Laboratory Medicine

PubMed Central

Kopcinovic, Lara Milevoj; Vogrinc, Zeljka; Kocijan, Irena; Culej, Jelena; Aralica, Merica; Jokic, Anja; Antoncic, Dragana; Bozovic, Marija

2016-01-01

Introduction We hypothesized that extravascular body fluid (EBF) analysis in Croatia is not harmonized and aimed to investigate preanalytical, analytical and postanalytical procedures used in EBF analysis in order to identify key aspects that should be addressed in future harmonization attempts. Materials and methods An anonymous online survey created to explore laboratory testing of EBF was sent to secondary, tertiary and private health care Medical Biochemistry Laboratories (MBLs) in Croatia. Statements were designed to address preanalytical, analytical and postanalytical procedures of cerebrospinal, pleural, peritoneal (ascites), pericardial, seminal, synovial, amniotic fluid and sweat. Participants were asked to declare the strength of agreement with proposed statements using a Likert scale. Mean scores for corresponding separate statements divided according to health care setting were calculated and compared. Results The survey response rate was 0.64 (58 / 90). None of the participating private MBLs declared to analyse EBF. We report a mean score of 3.45 obtained for all statements evaluated. Deviations from desirable procedures were demonstrated in all EBF testing phases. Minor differences in procedures used for EBF analysis comparing secondary and tertiary health care MBLs were found. The lowest scores were obtained for statements regarding quality control procedures in EBF analysis, participation in proficiency testing programmes and provision of interpretative comments on EBF’s test reports. Conclusions Although good laboratory EBF practice is present in Croatia, procedures for EBF analysis should be further harmonized to improve the quality of EBF testing and patient safety. PMID:27812307

NATIONAL PERFORMANCE AUDIT PROGRAM: 1980 PROFICIENCY SURVEY FOR SULFUR DIOXIDE, NITROGEN DIOXIDE, CARBON MONOXIDE, SULFATE, NITRATE, LEAD AND HIGH VOLUME FLOW

EPA Science Inventory

Based on authority granted by provisions of the Clean Air Act (42 U.S.C 7410, et seq.), the Quality Assurance Division of the Environmental Monitoring Systems Laboratory, Research Triangle Park, NC administers periodic surveys of analytical proficiency for sulfur dioxide, nitroge...

ISO 9000 Quality Management System

NASA Astrophysics Data System (ADS)

Hadjicostas, Evsevios

The ISO 9000 series describes a quality management system applicable to any organization. In this chapter we present the requirements of the standard in a way that is as close as possible to the needs of analytical laboratories. The sequence of the requirements follows that in the ISO 9001:2008 standard. In addition, the guidelines for performance improvement set out in the ISO 9004 are reviewed. Both standards should be used as a reference as well as the basis for further elaboration.

Development of an evidence-based approach to external quality assurance for breast cancer hormone receptor immunohistochemistry: comparison of reference values.

PubMed

Makretsov, Nikita; Gilks, C Blake; Alaghehbandan, Reza; Garratt, John; Quenneville, Louise; Mercer, Joel; Palavdzic, Dragana; Torlakovic, Emina E

2011-07-01

External quality assurance and proficiency testing programs for breast cancer predictive biomarkers are based largely on traditional ad hoc design; at present there is no universal consensus on definition of a standard reference value for samples used in external quality assurance programs. To explore reference values for estrogen receptor and progesterone receptor immunohistochemistry in order to develop an evidence-based analytic platform for external quality assurance. There were 31 participating laboratories, 4 of which were previously designated as "expert" laboratories. Each participant tested a tissue microarray slide with 44 breast carcinomas for estrogen receptor and progesterone receptor and submitted it to the Canadian Immunohistochemistry Quality Control Program for analysis. Nuclear staining in 1% or more of the tumor cells was a positive score. Five methods for determining reference values were compared. All reference values showed 100% agreement for estrogen receptor and progesterone receptor scores, when indeterminate results were excluded. Individual laboratory performance (agreement rates, test sensitivity, test specificity, positive predictive value, negative predictive value, and κ value) was very similar for all reference values. Identification of suboptimal performance by all methods was identical for 30 of 31 laboratories. Estrogen receptor assessment of 1 laboratory was discordant: agreement was less than 90% for 3 of 5 reference values and greater than 90% with the use of 2 other reference values. Various reference values provide equivalent laboratory rating. In addition to descriptive feedback, our approach allows calculation of technical test sensitivity and specificity, positive and negative predictive values, agreement rates, and κ values to guide corrective actions.

Impact of Educational Activities in Reducing Pre-Analytical Laboratory Errors

PubMed Central

Al-Ghaithi, Hamed; Pathare, Anil; Al-Mamari, Sahimah; Villacrucis, Rodrigo; Fawaz, Naglaa; Alkindi, Salam

2017-01-01

Objectives Pre-analytic errors during diagnostic laboratory investigations can lead to increased patient morbidity and mortality. This study aimed to ascertain the effect of educational nursing activities on the incidence of pre-analytical errors resulting in non-conforming blood samples. Methods This study was conducted between January 2008 and December 2015. All specimens received at the Haematology Laboratory of the Sultan Qaboos University Hospital, Muscat, Oman, during this period were prospectively collected and analysed. Similar data from 2007 were collected retrospectively and used as a baseline for comparison. Non-conforming samples were defined as either clotted samples, haemolysed samples, use of the wrong anticoagulant, insufficient quantities of blood collected, incorrect/lack of labelling on a sample or lack of delivery of a sample in spite of a sample request. From 2008 onwards, multiple educational training activities directed at the hospital nursing staff and nursing students primarily responsible for blood collection were implemented on a regular basis. Results After initiating corrective measures in 2008, a progressive reduction in the percentage of non-conforming samples was observed from 2009 onwards. Despite a 127.84% increase in the total number of specimens received, there was a significant reduction in non-conforming samples from 0.29% in 2007 to 0.07% in 2015, resulting in an improvement of 75.86% (P <0.050). In particular, specimen identification errors decreased by 0.056%, with a 96.55% improvement. Conclusion Targeted educational activities directed primarily towards hospital nursing staff had a positive impact on the quality of laboratory specimens by significantly reducing pre-analytical errors. PMID:29062553

Interlaboratory comparability, bias, and precision for four laboratories measuring constituents in precipitation, November 1982-August 1983

USGS Publications Warehouse

Brooks, M.H.; Schroder, L.J.; Malo, B.A.

1985-01-01

Four laboratories were evaluated in their analysis of identical natural and simulated precipitation water samples. Interlaboratory comparability was evaluated using analysis of variance coupled with Duncan 's multiple range test, and linear-regression models describing the relations between individual laboratory analytical results for natural precipitation samples. Results of the statistical analyses indicate that certain pairs of laboratories produce different results when analyzing identical samples. Analyte bias for each laboratory was examined using analysis of variance coupled with Duncan 's multiple range test on data produced by the laboratories from the analysis of identical simulated precipitation samples. Bias for a given analyte produced by a single laboratory has been indicated when the laboratory mean for that analyte is shown to be significantly different from the mean for the most-probable analyte concentrations in the simulated precipitation samples. Ion-chromatographic methods for the determination of chloride, nitrate, and sulfate have been compared with the colorimetric methods that were also in use during the study period. Comparisons were made using analysis of variance coupled with Duncan 's multiple range test for means produced by the two methods. Analyte precision for each laboratory has been estimated by calculating a pooled variance for each analyte. Analyte estimated precisions have been compared using F-tests and differences in analyte precisions for laboratory pairs have been reported. (USGS)

The impact of repeat-testing of common chemistry analytes at critical concentrations.

PubMed

Onyenekwu, Chinelo P; Hudson, Careen L; Zemlin, Annalise E; Erasmus, Rajiv T

2014-12-01

Early notification of critical values by the clinical laboratory to the treating physician is a requirement for accreditation and is essential for effective patient management. Many laboratories automatically repeat a critical value before reporting it to prevent possible misdiagnosis. Given today's advanced instrumentation and quality assurance practices, we questioned the validity of this approach. We performed an audit of repeat-testing in our laboratory to assess for significant differences between initial and repeated test results, estimate the delay caused by repeat-testing and to quantify the cost of repeating these assays. A retrospective audit of repeat-tests for sodium, potassium, calcium and magnesium in the first quarter of 2013 at Tygerberg Academic Laboratory was conducted. Data on the initial and repeat-test values and the time that they were performed was extracted from our laboratory information system. The Clinical Laboratory Improvement Amendment criteria for allowable error were employed to assess for significant difference between results. A total of 2308 repeated tests were studied. There was no significant difference in 2291 (99.3%) of the samples. The average delay ranged from 35 min for magnesium to 42 min for sodium and calcium. At least 2.9% of laboratory running costs for the analytes was spent on repeating them. The practice of repeating a critical test result appears unnecessary as it yields similar results, delays notification to the treating clinician and increases laboratory running costs.

An overview of quality control practices in Ontario with particular reference to cholesterol analysis.

PubMed

Krishnan, S; Webb, S; Henderson, A R; Cheung, C M; Nazir, D J; Richardson, H

1999-03-01

The Laboratory Proficiency Testing Program (LPTP) assesses the analytical performance of all licensed laboratories in Ontario. The LPTP Enzymes, Cardiac Markers, and Lipids Committee conducted a "Patterns of Practice" survey to assess the in-house quality control (QC) practices of laboratories in Ontario using cholesterol as the QC paradigm. The survey was questionnaire-based seeking information on statistical calculations, software rules, review process and data retention, and so on. Copies of the in-house cholesterol QC graphs were requested. A total of 120 of 210 laboratories were randomly chosen to receive the questionnaires during 1995 and 1996; 115 laboratories responded, although some did not answer all questions. The majority calculate means and standard deviations (SD) every month, using anywhere from 4 to >100 data points. 65% use a fixed mean and SD, while 17% use means calculated from the previous month. A few use a floating or cumulative mean. Some laboratories that do not use fixed means use a fixed SD. About 90% use some form of statistical quality control rules. The most common rules used to detect random error are 1(3s)/R4s while 2(2s)/4(1s)/10x are used for systematic errors. About 20% did not assay any QC at levels >5.5 mmol/L. Quality control data are reviewed daily (technologists), weekly and monthly (supervisors/directors). Most laboratories retain their QC records for up to 3 years on paper and magnetic media. On some QC graphs the mean and SD, QC product lot number, or reference to action logs are not apparent. Quality control practices in Ontario are, therefore, disappointing. Improvement is required in the use of clinically appropriate concentrations of QC material and documentation on QC graphs.

Utilizing global data to estimate analytical performance on the Sigma scale: A global comparative analysis of methods, instruments, and manufacturers through external quality assurance and proficiency testing programs.

PubMed

Westgard, Sten A

2016-06-01

To assess the analytical performance of instruments and methods through external quality assessment and proficiency testing data on the Sigma scale. A representative report from five different EQA/PT programs around the world (2 US, 1 Canadian, 1 UK, and 1 Australasian) was accessed. The instrument group standard deviations were used as surrogate estimates of instrument imprecision. Performance specifications from the US CLIA proficiency testing criteria were used to establish a common quality goal. Then Sigma-metrics were calculated to grade the analytical performance. Different methods have different Sigma-metrics for each analyte reviewed. Summary Sigma-metrics estimate the percentage of the chemistry analytes that are expected to perform above Five Sigma, which is where optimized QC design can be implemented. The range of performance varies from 37% to 88%, exhibiting significant differentiation between instruments and manufacturers. Median Sigmas for the different manufacturers in three analytes (albumin, glucose, sodium) showed significant differentiation. Chemistry tests are not commodities. Quality varies significantly from manufacturer to manufacturer, instrument to instrument, and method to method. The Sigma-assessments from multiple EQA/PT programs provide more insight into the performance of methods and instruments than any single program by itself. It is possible to produce a ranking of performance by manufacturer, instrument and individual method. Laboratories seeking optimal instrumentation would do well to consult this data as part of their decision-making process. To confirm that these assessments are stable and reliable, a longer term study should be conducted that examines more results over a longer time period. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Concentrations of tritium and strontium-90 in water from selected wells at the Idaho National Engineering Laboratory after purging one, two, and three borehole volumes

USGS Publications Warehouse

Bartholomay, R.C.

1993-01-01

Water from 11 wells completed in the Snake River Plain aquifer at the Idaho National Engineering Laboratory was sampled as part of the U.S. Geological Survey's quality assurance program to determine the effect of purging different borehole volumes on tritium and strontium-90 concentrations. Wells were selected for sampling on the basis of the length of time it took to purge a borehole volume of water. Samples were collected after purging one, two, and three borehole volumes. The U.S. Department of Energy's Radiological and Environmental Sciences Laboratory provided analytical services. Statistics were used to determine the reproducibility of analytical results. The comparison between tritium and strontium-90 concentrations after purging one and three borehole volumes and two and three borehole volumes showed that all but two sample pairs with defined numbers were in statistical agreement. Results indicate that concentrations of tritium and strontium-90 are not affected measurably by the number of borehole volumes purged.

[Modal failure analysis and effects in the detection of errors in the transport of samples to the clinical laboratory].

PubMed

Parés-Pollán, L; Gonzalez-Quintana, A; Docampo-Cordeiro, J; Vargas-Gallego, C; García-Álvarez, G; Ramos-Rodríguez, V; Diaz Rubio-García, M P

2014-01-01

Owing to the decrease in values of biochemical glucose parameter in some samples from external extraction centres, and the risk this implies to patient safety; it was decided to apply an adaptation of the «Health Services Failure Mode and Effects Analysis» (HFMEA) to manage risk during the pre-analytical phase of sample transportation from external centres to clinical laboratories. A retrospective study of glucose parameter was conducted during two consecutive months. The analysis was performed in its different phases: to define the HFMEA topic, assemble the team, graphically describe the process, conduct a hazard analysis, design the intervention and indicators, and identify a person to be responsible for ensuring completion of each action. The results of glucose parameter in one of the transport routes, were significantly lower (P=.006). The errors and potential causes of this problem were analysed, and criteria of criticality and detectability were applied (score≥8) in the decision tree. It was decided to: develop a document management system; reorganise extractions and transport routes in some centres; quality control of the sample container ice-packs, and the time and temperature during transportation. This work proposes quality indicators for controlling time and temperature of transported samples in the pre-analytical phase. Periodic review of certain laboratory parameters can help to detect problems in transporting samples. The HFMEA technique is useful for the clinical laboratory. Copyright © 2013 SECA. Published by Elsevier Espana. All rights reserved.

Chemicals of emerging concern in water and bottom sediment in the Great Lakes Basin, 2012: collection methods, analytical methods, quality assurance, and study data

USGS Publications Warehouse

Lee, Kathy E.; Langer, Susan K.; Menheer, Michael A.; Hansen, Donald S.; Foreman, William T.; Furlong, Edward T.; Jorgenson, Zachary G.; Choy, Steven J.; Moore, Jeremy N.; Banda, JoAnn; Gefell, Daniel J.

2015-01-01

During this study, 53 environmental samples, 4 field duplicate samples, and 8 field spike samples of bottom sediment and laboratory matrix-spike samples were analyzed for a wide variety of CECs at the USGS National Water Quality Laboratory using laboratory schedule 5433 for wastewater indicators; research method 6434 for steroid hormones, sterols, and bisphenol A; and research method 9008 for human-use pharmaceuticals and antidepressants. Forty of the 57 chemicals analyzed using laboratory schedule 5433 had detectable concentrations ranging from 1 to 49,000 micrograms per kilogram. Fourteen of the 20 chemicals analyzed using research method 6434 had detectable concentrations ranging from 0.04 to 24,940 nanograms per gram. Ten of the 20 chemicals analyzed using research method 9008 had detectable concentrations ranging from 0.59 to 197.5 micrograms per kilogram. Five of the 11 chemicals analyzed using research method 9008 had detectable concentrations ranging from 1.16 to 25.0 micrograms per kilogram.

Clinical Laboratory Practice Recommendations for the Use of Cardiac Troponin in Acute Coronary Syndrome: Expert Opinion from the Academy of the American Association for Clinical Chemistry and the Task Force on Clinical Applications of Cardiac Bio-Markers of the International Federation of Clinical Chemistry and Laboratory Medicine.

PubMed

Wu, Alan H B; Christenson, Robert H; Greene, Dina N; Jaffe, Allan S; Kavsak, Peter A; Ordonez-Llanos, Jordi; Apple, Fred S

2018-04-01

This document is an essential companion to the third iteration of the National Academy of Clinical Biochemistry [NACB, 8 now the American Association for Clinical Chemistry (AACC) Academy] Laboratory Medicine Practice Guidelines (LMPG) on cardiac markers. The expert consensus recommendations were drafted in collaboration with the International Federation of Clinical Chemistry and Laboratory Medicine Task Force on Clinical Applications of Bio-Markers (IFCC TF-CB). We determined that there is sufficient clinical guidance on the use of cardiac troponin (cTn) testing from clinical practice groups. Thus, in this expert consensus document, we focused on clinical laboratory practice recommendations for high-sensitivity (hs)-cTn assays. This document utilized the expert opinion class of evidence to focus on the following 10 topics: ( a ) quality control (QC) utilization, ( b ) validation of the lower reportable analytical limits, ( c ) units to be used in reporting measurable concentrations for patients and QC materials, ( d ) 99th percentile sex-specific upper reference limits to define the reference interval; ( e ) criteria required to define hs-cTn assays, ( f ) communication with clinicians and the laboratory's role in educating clinicians regarding the influence of preanalytic and analytic problems that can confound assay results, ( g ) studies on hs-cTn assays and how authors need to document preanalytical and analytical variables, ( h ) harmonizing and standardizing assay results and the role of commutable materials, ( i ) time to reporting of results from sample receipt and sample collection, and ( j ) changes in hs-cTn concentrations over time and the role of both analytical and biological variabilities in interpreting results of serial blood collections. © 2017 American Association for Clinical Chemistry.

Clinical laboratory: bigger is not always better.

PubMed

Plebani, Mario

2018-06-27

Laboratory services around the world are undergoing substantial consolidation and changes through mechanisms ranging from mergers, acquisitions and outsourcing, primarily based on expectations to improve efficiency, increasing volumes and reducing the cost per test. However, the relationship between volume and costs is not linear and numerous variables influence the end cost per test. In particular, the relationship between volumes and costs does not span the entire platter of clinical laboratories: high costs are associated with low volumes up to a threshold of 1 million test per year. Over this threshold, there is no linear association between volumes and costs, as laboratory organization rather than test volume more significantly affects the final costs. Currently, data on laboratory errors and associated diagnostic errors and risk for patient harm emphasize the need for a paradigmatic shift: from a focus on volumes and efficiency to a patient-centered vision restoring the nature of laboratory services as an integral part of the diagnostic and therapy process. Process and outcome quality indicators are effective tools to measure and improve laboratory services, by stimulating a competition based on intra- and extra-analytical performance specifications, intermediate outcomes and customer satisfaction. Rather than competing with economic value, clinical laboratories should adopt a strategy based on a set of harmonized quality indicators and performance specifications, active laboratory stewardship, and improved patient safety.

Second NBL measurement evaluation program meeting: A summary

DOE Office of Scientific and Technical Information (OSTI.GOV)

Spaletto, M.I.; Clapper, M.; Tolbert, M.E.M.

New Brunswick Laboratory (NBL), the US government`s nuclear materials measurements and reference materials laboratory, administers interlaboratory measurement evaluation programs to evaluate the quality and adequacy of safeguards measurements. The NBL Measurement Evaluation Program covers several types of safeguards analytical measurements. The Safeguards Measurement Evaluation (SME) program distributes test materials destructive measurements of uranium for both elemental concentration and isotopic abundances, and of plutonium for isotopic abundances. The Calorimetry Exchange (CalEx) Program tests the quality of nondestructive measurements of plutonium isotopic abundances by gamma spectroscopy and plutonium concentration by calorimetry. In May 1997, more than 30 representatives from the Department ofmore » Energy (DOE), its contractor laboratories, and Nuclear Regulatory Commission licensees met at NBL in Argonne, Illinois, for the annual meeting of the Measurement Evaluation Program. The summary which follows details key points that were discussed or presented at the meeting.« less

Point-of-care test (POCT) INR: hope or illusion?

PubMed

Dusse, Luci Maria Sant'Ana; Oliveira, Nataly Carvalho; Rios, Danyelle Romana Alves; Marcolino, Milena Soriano

2012-01-01

In the last decade, point-of-care tests were developed to provide rapid generation of test results. These tests have increasingly broad applications. In the area of hemostasis, the international normalized ratio, INR point-of-care test (POCT INR), is the main test of this new proposal. This test has great potential benefit in situations where the quick INR results influences clinical decision making, as in acute ischemic stroke, before surgical procedures and during cardiac surgery. The INR POCT has the potential to be used for self-monitoring of oral anticoagulation in patients under anticoagulant therapy. However, the precision and accuracy of INR POCT still need to be enhanced to increase effectiveness and efficiency of the test. Additionally, the RDC / ANVISA Number 302 makes clear that the POCT testing must be supervised by the technical manager of the Clinical Laboratory in the pre-analytical, analytical and post-analytical. In practice, the Clinical Laboratory does not participate in the implementation of POCT testing or release of the results. Clinicians have high expectation with the incorporation of INR POCT in clinical practice, despite the limitations of this method. These professionals are willing to train the patient to perform the test, but are not legally responsible for the quality of it and are not prepared for the maintenance of equipment. The definition of who is in charge for the test must be one to ensure the quality control.

Method of Analysis by the U.S. Geological Survey California District Sacramento Laboratory-- Determination of Dissolved Organic Carbon in Water by High Temperature Catalytic Oxidation, Method Validation, and Quality-Control Practices

USGS Publications Warehouse

Bird, Susan M.; Fram, Miranda S.; Crepeau, Kathryn L.

2003-01-01

An analytical method has been developed for the determination of dissolved organic carbon concentration in water samples. This method includes the results of the tests used to validate the method and the quality-control practices used for dissolved organic carbon analysis. Prior to analysis, water samples are filtered to remove suspended particulate matter. A Shimadzu TOC-5000A Total Organic Carbon Analyzer in the nonpurgeable organic carbon mode is used to analyze the samples by high temperature catalytic oxidation. The analysis usually is completed within 48 hours of sample collection. The laboratory reporting level is 0.22 milligrams per liter.

Water-quality data at amphibian research sites in Maryland, Washington, D.C., and Virginia, 2005-2007

USGS Publications Warehouse

Rice, Karen C.

2008-01-01

Data on the chemical composition of water were collected at least once from 47 amphibian research sites in Maryland, Washington, D.C., and Virginia, from 2005 through 2007. One hundred twenty-five water samples were collected from vernal pools and streams and analyzed as part of long-term monitoring projects of the U.S. Geological Survey Amphibian Research and Monitoring Initiative in the Northeast Region. Field measurements of water temperature, specific conductance, and pH were made. Laboratory analyses of the water samples included acid-neutralizing capacity, total Kjeldahl nitrogen (ammonium plus organic nitrogen), nitrite plus nitrate, total nitrogen, and total phosphorus concentrations. Field and laboratory analytical results of water samples and quality-assurance data are presented.

Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory; determination of selected carbamate pesticides in water by high-performance liquid chromatography

USGS Publications Warehouse

Werner, S.L.; Johnson, S.M.

1994-01-01

As part of its primary responsibility concerning water as a national resource, the U.S. Geological Survey collects and analyzes samples of ground water and surface water to determine water quality. This report describes the method used since June 1987 to determine selected total-recoverable carbamate pesticides present in water samples. High- performance liquid chromatography is used to separate N-methyl carbamates, N-methyl carbamoyloximes, and an N-phenyl carbamate which have been extracted from water and concentrated in dichloromethane. Analytes, surrogate compounds, and reference compounds are eluted from the analytical column within 25 minutes. Two modes of analyte detection are used: (1) a photodiode-array detector measures and records ultraviolet-absorbance profiles, and (2) a fluorescence detector measures and records fluorescence from an analyte derivative produced when analyte hydrolysis is combined with chemical derivatization. Analytes are identified and confirmed in a three-stage process by use of chromatographic retention time, ultraviolet (UV) spectral comparison, and derivatization/fluorescence detection. Quantitative results are based on the integration of single-wavelength UV-absorbance chromatograms and on comparison with calibration curves derived from external analyte standards that are run with samples as part of an instrumental analytical sequence. Estimated method detection limits vary for each analyte, depending on the sample matrix conditions, and range from 0.5 microgram per liter to as low as 0.01 microgram per liter. Reporting levels for all analytes have been set at 0.5 microgram per liter for this method. Corrections on the basis of percentage recoveries of analytes spiked into distilled water are not applied to values calculated for analyte concentration in samples. These values for analyte concentrations instead indicate the quantities recovered by the method from a particular sample matrix.

[The external quality assessment schemes for lead in blood organized by the French national agency for medicine and health product safety: a synthesis of 15 years of activity].

PubMed

Pineau, Alain; Otz, Jocelyne; Guillard, Olivier; Fauconneau, Bernard; Dumont, Gilles; François-Burg, Elisabeth

2014-01-01

In 1992, at the request of the French labor ministry following questions on the ability of medical biology laboratories to satisfactorily measure blood lead level (PbB), a national PbB quality control came into being. Only in 1996 did this external quality control include a number of laboratories sufficient to allow for a significant retrospective evaluation. After fifteen years (1996-2011), The French National Agency for Medicines and Health Products Safety wished to exploit the database collected. The number of participating laboratories went down from 73 to 41. On the other hand, the key finding pertained to the highly improved performance of the laboratories, which was associated with a spread decrease of the results over the entire range of tested PbBs (9 to 700 μg/L). Since 2006, we have observed increasing use of the inductively coupled plasma with mass spectrometry and decreasing use of electrothermal atomic absorption spectrometry. Provided that they rely on identical metrology expertise, the two analytical techniques lead to results on all the tested concentrations that are not statistically different.

Good laboratory practices for biochemical genetic testing and newborn screening for inherited metabolic disorders.

PubMed

2012-04-06

Biochemical genetic testing and newborn screening are essential laboratory services for the screening, detection, diagnosis, and monitoring of inborn errors of metabolism or inherited metabolic disorders. Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, laboratory testing is categorized on the basis of the level of testing complexity as either waived (i.e., from routine regulatory oversight) or nonwaived testing (which includes tests of moderate and high complexity). Laboratories that perform biochemical genetic testing are required by CLIA regulations to meet the general quality systems requirements for nonwaived testing and the personnel requirements for high-complexity testing. Laboratories that perform public health newborn screening are subject to the same CLIA regulations and applicable state requirements. As the number of inherited metabolic diseases that are included in state-based newborn screening programs continues to increase, ensuring the quality of performance and delivery of testing services remains a continuous challenge not only for public health laboratories and other newborn screening facilities but also for biochemical genetic testing laboratories. To help ensure the quality of laboratory testing, CDC collaborated with the Centers for Medicare & Medicaid Services, the Food and Drug Administration, the Health Resources and Services Administration, and the National Institutes of Health to develop guidelines for laboratories to meet CLIA requirements and apply additional quality assurance measures for these areas of genetic testing. This report provides recommendations for good laboratory practices that were developed based on recommendations from the Clinical Laboratory Improvement Advisory Committee, with additional input from the Secretary's Advisory Committee on Genetics, Health, and Society; the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; and representatives of newborn screening laboratories. The recommended practices address the benefits of using a quality management system approach, factors to consider before introducing new tests, establishment and verification of test performance specifications, the total laboratory testing process (which consists of the preanalytic, analytic, and postanalytic phases), confidentiality of patient information and test results, and personnel qualifications and responsibilities for laboratory testing for inherited metabolic diseases. These recommendations are intended for laboratories that perform biochemical genetic testing to improve the quality of laboratory services and for newborn screening laboratories to ensure the quality of laboratory practices for inherited metabolic disorders. These recommendations also are intended as a resource for medical and public health professionals who evaluate laboratory practices, for users of laboratory services to facilitate their collaboration with newborn screening systems and use of biochemical genetic tests, and for standard-setting organizations and professional societies in developing future laboratory quality standards and practice recommendations. This report complements Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions (CDC. Good laboratory practices for molecular genetic testing for heritable diseases and conditions. MMWR 2009;58 [No. RR-6]) to provide guidance for ensuring and improving the quality of genetic laboratory services and public health outcomes. Future recommendations for additional areas of genetic testing will be considered on the basis of continued monitoring and evaluation of laboratory practices, technology advancements, and the development of laboratory standards and guidelines.

External quality assurance project report for the National Atmospheric Deposition Program’s National Trends Network and Mercury Deposition Network, 2015–16

USGS Publications Warehouse

Wetherbee, Gregory A.; Martin, RoseAnn

2018-06-29

The U.S. Geological Survey Precipitation Chemistry Quality Assurance project operated five distinct programs to provide external quality assurance monitoring for the National Atmospheric Deposition Program’s (NADP) National Trends Network and Mercury Deposition Network during 2015–16. The National Trends Network programs include (1) a field audit program to evaluate sample contamination and stability, (2) an interlaboratory comparison program to evaluate analytical laboratory performance, and (3) a colocated sampler program to evaluate bias and variability attributed to automated precipitation samplers. The Mercury Deposition Network programs include the (4) system blank program and (5) an interlaboratory comparison program. The results indicate that NADP data continue to be of sufficient quality for the analysis of spatial distributions and time trends for chemical constituents in wet deposition.The field audit program results indicate increased sample contamination for calcium, magnesium, and potassium relative to 2010 levels, and slight fluctuation in sodium contamination. Nitrate contamination levels dropped slightly during 2014–16, and chloride contamination leveled off between 2007 and 2016. Sulfate contamination is similar to the 2000 level. Hydrogen ion contamination has steadily decreased since 2012. Losses of ammonium and nitrate resulting from potential sample instability were negligible.The NADP Central Analytical Laboratory produced interlaboratory comparison results with low bias and variability compared to other domestic and international laboratories that support atmospheric deposition monitoring. Significant absolute bias above the magnitudes of the detection limits was observed for nitrate and sulfate concentrations, but no analyte determinations exceeded the detection limits for blanks.Colocated sampler program results from dissimilar colocated collectors indicate that the retrofit of the National Trends Network with N-CON Systems Company, Inc. precipitation collectors could cause substantial shifts in NADP annual deposition (concentration multiplied by depth) values. Median weekly relative percent differences for analyte concentrations ranged from -4 to +76 percent for cations, from 5 to 6 percent for ammonium, from +14 to +25 percent for anions, and from -21 to +8 percent for hydrogen ion contamination. By comparison, weekly absolute concentration differences for paired identical N-CON Systems Company, Inc., collectors ranged from 4–22 percent for cations; 2–9 percent for anions; 4–5 percent for ammonium; and 13–14 percent for hydrogen ion contamination. The N-CON Systems Company, Inc. collector caught more precipitation than the Aerochem Metrics Model 301 collector (ACM) at the WA99/99WA sites, but it typically caught slightly less precipitation than the ACM at ND11/11ND, sites which receive more wind and snow than WA99/99WA.Paired, identical OTT Pluvio-2 and ETI Noah IV precipitation gages were operated at the same sites. Median absolute percent differences for daily measured precipitation depths ranged from 0 to 7 percent. Annual absolute differences ranged from 0.08 percent (ETI Noah IV precipitation gages) to 11 percent (OTT Pluvio-2 precipitation gages).The Mercury Deposition Network programs include the system blank program and an interlaboratory comparison program. System blank results indicate that maximum total mercury contamination concentrations in samples were less than the third percentile of all Mercury Deposition Network sample concentrations (1.098 nanograms per liter; ng/L). The Mercury Analytical Laboratory produced chemical concentration results with low bias and variability compared with other domestic and international laboratories that support atmospheric-deposition monitoring. The laboratory’s performance results indicate a +1-ng/L shift in bias between 2015 (-0.4 ng/L) and 2016 (+0.5 ng/L).

Study design and percent recoveries of anthropogenic organic compounds with and without the addition of ascorbic acid to preserve water samples containing free chlorine, 2004-06

USGS Publications Warehouse

Valder, Joshua F.; Delzer, Gregory C.; Price, Curtis V.; Sandstrom, Mark W.

2008-01-01

The National Water-Quality Assessment (NAWQA) Program of the U.S. Geological Survey (USGS) began implementing Source Water-Quality Assessments (SWQAs) in 2002 that focus on characterizing the quality of source water and finished water of aquifers and major rivers used by some of the larger community water systems in the United States. As used for SWQA studies, source water is the raw (ambient) water collected at the supply well prior to water treatment (for ground water) or the raw (ambient) water collected from the river near the intake (for surface water). Finished water is the water that is treated, which typically involves, in part, the addition of chlorine or other disinfection chemicals to remove pathogens, and is ready to be delivered to consumers. Finished water is collected before the water enters the distribution system. This report describes the study design and percent recoveries of anthropogenic organic compounds (AOCs) with and without the addition of ascorbic acid to preserve water samples containing free chlorine. The percent recoveries were determined by using analytical results from a laboratory study conducted in 2004 by the USGS's National Water Quality Laboratory (NWQL) and from data collected during 2004-06 for a field study currently (2008) being conducted by the USGS's NAWQA Program. The laboratory study was designed to determine if preserving samples with ascorbic acid (quenching samples) adversely affects analytical performance under controlled conditions. During the laboratory study, eight samples of reagent water were spiked for each of five analytical schedules evaluated. Percent recoveries from these samples were then compared in two ways: (1) four quenched reagent spiked samples analyzed on day 0 were compared with four quenched reagent spiked samples analyzed on day 7 or 14, and (2) the combined eight quenched reagent spiked samples analyzed on day 0, 7, or 14 were compared with eight laboratory reagent spikes (LRSs). Percent recoveries from the quenched reagent spiked samples that were analyzed at two different times (day 0 and day 7 or 14) can be used to determine the stability of the quenched samples held for an amount of time representative of the normal amount of time between sample collection and analysis. The comparison between the quenched reagent spiked samples and the LRSs can be used to determine if quenching samples adversely affects the analytical performance under controlled conditions. The field study began in 2004 and is continuing today (February 2008) to characterize the effect of quenching on field-matrix spike recoveries and to better understand the potential oxidation and transformation of 277 AOCs. Three types of samples were collected from 11 NAWQA Study Units across the Nation: (1) quenched finished-water samples (not spiked), (2) quenched finished-water spiked samples, and (3) nonquenched finished-water spiked samples. Percent recoveries of AOCs in quenched and nonquenched finished-water spiked samples collected during 2004-06 are presented. Comparisons of percent recoveries between quenched and nonquenched spiked samples can be used to show how quenching affects finished-water samples. A maximum of 6 surface-water and 7 ground-water quenched finished-water spiked samples paired with nonquenched finished-water spiked samples were analyzed. Analytical results for the field study are presented in two ways: (1) by surface-water supplies or ground-water supplies, and (2) by use (or source) group category for surface-water and ground-water supplies. Graphical representations of percent recoveries for the quenched and nonquenched finished-water spiked samples also are presented.

An Undergraduate Experiment for the Measurement of Perfluorinated Surfactants in Fish Liver by Liquid Chromatography-Tandem Mass Spectrometry

ERIC Educational Resources Information Center

Stock, Naomi L.; Martin, Jonathan W.; Ye, Yun; Mabury, Scott A.

2007-01-01

A laboratory experiment that provides students a hands-on introduction to the specific techniques of liquid chromatography-tandem mass spectrometry (LC-MS/MS) and electrospray ionization is presented. The students can thus practice the analytical principles of sample extraction, detection, quantification, and quality control using a fresh fish…

Investigating Arsenic Contents in Surface and Drinking Water by Voltammetry and the Method of Standard Additions

ERIC Educational Resources Information Center

Cheng, Anran; Tyne, Rebecca; Kwok, Yu Ting; Rees, Louis; Craig, Lorraine; Lapinee, Chaipat; D'Arcy, Mitch; Weiss, Dominik J.; Salau¨n, Pascal

2016-01-01

Testing water samples for arsenic contamination has become an important water quality issue worldwide. Arsenic usually occurs in very small concentrations, and a sensitive analytical method is needed. We present here a 1-day laboratory module developed to introduce Earth Sciences and/or Chemistry student undergraduates to key aspects of this…

Freezing Point of Milk: A Natural Way to Understand Colligative Properties

ERIC Educational Resources Information Center

Novo, Mercedes; Reija, Belen; Al-Soufi, Wajih

2007-01-01

A laboratory experiment is presented in which the freezing point depression is analyzed using milk as solution. The nature of milk as a mixture of different solutes makes it a suitable probe to learn about colligative properties. The first part of the experiment illustrates the analytical use of freezing point measurements to control milk quality,…

NHEXAS PHASE I REGION 5 STUDY--STANDARD OPERATING PROCEDURE--NHEXAS FILTER HANDLING, WEIGHING AND ARCHIVING PROCEDURES FOR AEROSOL SAMPLES (RTI/ACS-AP-209-011)

EPA Science Inventory

This protocol describes the procedures for weighing, handling, and archiving aerosol filters and for managing the associated analytical and quality assurance data. Filter samples were weighed for aerosol mass at RTI laboratory, with only the automated field sampling data transfer...

Phosphorus Concentrations in Stream-Water and Reference Samples - An Assessment of Laboratory Comparability

USGS Publications Warehouse

McHale, Michael R.; McChesney, Dennis

2007-01-01

In 2003, a study was conducted to evaluate the accuracy and precision of 10 laboratories that analyze water-quality samples for phosphorus concentrations in the Catskill Mountain region of New York State. Many environmental studies in this region rely on data from these different laboratories for water-quality analyses, and the data may be used in watershed modeling and management decisions. Therefore, it is important to determine whether the data reported by these laboratories are of comparable accuracy and precision. Each laboratory was sent 12 samples for triplicate analysis for total phosphorus, total dissolved phosphorus, and soluble reactive phosphorus. Eight of these laboratories reported results that met comparability criteria for all samples; the remaining two laboratories met comparability criteria for only about half of the analyses. Neither the analytical method used nor the sample concentration ranges appeared to affect the comparability of results. The laboratories whose results were comparable gave consistently comparable results throughout the concentration range analyzed, and the differences among methods did not diminish comparability. All laboratories had high data precision as indicated by sample triplicate results. In addition, the laboratories consistently reported total phosphorus values greater than total dissolved phosphorus values, and total dissolved phosphorus values greater than soluble reactive phosphorus values, as would be expected. The results of this study emphasize the importance of regular laboratory participation in sample-exchange programs.

The detection of problem analytes in a single proficiency test challenge in the absence of the Health Care Financing Administration rule violations.

PubMed

Cembrowski, G S; Hackney, J R; Carey, N

1993-04-01

The Clinical Laboratory Improvement Act of 1988 (CLIA 88) has dramatically changed proficiency testing (PT) practices having mandated (1) satisfactory PT for certain analytes as a condition of laboratory operation, (2) fixed PT limits for many of these "regulated" analytes, and (3) an increased number of PT specimens (n = 5) for each testing cycle. For many of these analytes, the fixed limits are much broader than the previously employed Standard Deviation Index (SDI) criteria. Paradoxically, there may be less incentive to identify and evaluate analytically significant outliers to improve the analytical process. Previously described "control rules" to evaluate these PT results are unworkable as they consider only two or three results. We used Monte Carlo simulations of Kodak Ektachem analyzers participating in PT to determine optimal control rules for the identification of PT results that are inconsistent with those from other laboratories using the same methods. The analysis of three representative analytes, potassium, creatine kinase, and iron was simulated with varying intrainstrument and interinstrument standard deviations (si and sg, respectively) obtained from the College of American Pathologists (Northfield, Ill) Quality Assurance Services data and Proficiency Test data, respectively. Analytical errors were simulated in each of the analytes and evaluated in terms of multiples of the interlaboratory SDI. Simple control rules for detecting systematic and random error were evaluated with power function graphs, graphs of probability of error detected vs magnitude of error. Based on the simulation results, we recommend screening all analytes for the occurrence of two or more observations exceeding the same +/- 1 SDI limit. For any analyte satisfying this condition, the mean of the observations should be calculated. For analytes with sg/si ratios between 1.0 and 1.5, a significant systematic error is signaled by the mean exceeding 1.0 SDI. Significant random error is signaled by one observation exceeding the +/- 3-SDI limit or the range of the observations exceeding 4 SDIs. For analytes with higher sg/si, significant systematic or random error is signaled by violation of the screening rule (having at least two observations exceeding the same +/- 1 SDI limit). Random error can also be signaled by one observation exceeding the +/- 1.5-SDI limit or the range of the observations exceeding 3 SDIs. We present a practical approach to the workup of apparent PT errors.

Status of internal quality control for thyroid hormones immunoassays from 2011 to 2016 in China.

PubMed

Zhang, Shishi; Wang, Wei; Zhao, Haijian; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

2018-01-01

Internal quality control (IQC) plays a key role in the evaluation of precision performance in clinical laboratories. This report aims to present precision status of thyroid hormones immunoassays from 2011 to 2016 in China. Through Clinet-EQA reporting system, IQC information of Triiodothyronine and Thyroxine in the form of free and total (FT3, TT3, FT4, TT4), as well as Thyroid Stimulating Hormone (TSH) were collected from participant laboratories submitting IQC data in February, 2011-2016. For each analyte, current CVs were compared among different years and measurement systems. Percentages of laboratories meeting five allowable imprecision specifications (pass rates) were also calculated. Analysis of IQC practice was conducted to constitute a complete report. Current CVs were decreasing significantly but pass rates increasing only for FT3 during 6 years. FT3, TT3, FT4, and TT4 had the highest pass rates comparing with 1/3TEa imprecision specification but TSH had this comparing with minimum imprecision specification derived from biological variation. Constituent ratios of four mainstream measurement systems changed insignificantly. In 2016, precision performance of Abbott and Roche systems were better than Beckman and Siemens systems for all analytes except FT3 had Siemens also better than Beckman. Analysis of IQC practice demonstrated wide variation and great progress in aspects of IQC rules and control frequency. With change of IQC practice, only FT3 had precision performance improved in 6 years. However, precision status of five analytes in China was still unsatisfying. Ongoing investigation and improvement of IQC have yet to be achieved. © 2017 Wiley Periodicals, Inc.

A comparison of analytical laboratory and optical in situ methods for the measurement of nitrate in north Florida water bodies

NASA Astrophysics Data System (ADS)

Rozin, A. G.; Clark, M. W.

2013-12-01

Assessing the impact of nutrient concentrations on aquatic ecosystems requires an in depth understanding of dynamic biogeochemical cycles that are often a challenge to monitor at the high spatial and temporal resolution necessary to understand these complex processes. Traditional sampling approaches involving discrete samples and laboratory analyses can be constrained by analytical costs, field time, and logistical details that can fail to accurately capture both spatial and temporal changes. Optical in situ instruments may provide the opportunity to continuously monitor a variety of water quality parameters at a high spatial or temporal resolution. This work explores the suitability of a Submersible Ultraviolet Nitrate Analyzer (SUNA), produced by Satlantic, to accurately assess in situ nitrate concentration in several freshwater systems in north Florida. The SUNA was deployed to measure nitrate at five different water bodies selected to represent a range of watershed land uses and water chemistry in the region. In situ nitrate measurements were compared to standard laboratory methods to evaluate the effectiveness of the SUNA's operation. Other optical sensors were used to measure the spectral properties of absorbance, fluorescence, and turbidity (scatter) in the same Florida water bodies. Data from these additional sensors were collected to quantify possible interferences that may affect SUNA performance. In addition, data from the SUNA and other sensors are being used to infer information about the quality and quantity of aqueous constituents besides nitrate. A better understanding of the capabilities and possible limitations of these relatively new analytical instruments will allow researchers to more effectively investigate biogeochemical processes and nutrient transport and enhance decision-making to protect our water bodies.

Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal

PubMed Central

Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M. Juliana; Hural, John

2014-01-01

The HIV Vaccine Trials Network (HVTN) is a global network of 28 clinical trial sites dedicated to identifying an effective HIV vaccine. Cryopreservation of high-quality peripheral blood mononuclear cells (PBMC) is critical for the assessment of vaccine-induced cellular immune functions. The HVTN PBMC Quality Management Program is designed to ensure viable PBMC are processed, stored and shipped for clinical trial assays from all HVTN clinical trial sites. The program has evolved by developing and incorporating best practices for laboratory and specimen quality and implementing automated, web-based tools. These tools allow the site-affiliated processing laboratories and the central Laboratory Operations Unit to rapidly collect, analyze and report PBMC quality data. The HVTN PBMC Quality Management Program includes five key components: 1) Laboratory Assessment, 2) PBMC Training and Certification, 3) Internal Quality Control, 4) External Quality Control (EQC), and 5) Assay Specimen Quality Control. Fresh PBMC processing data is uploaded from each clinical site processing laboratory to a central HVTN Statistical and Data Management Center database for access and analysis on a web portal. Samples are thawed at a central laboratory for assay or specimen quality control and sample quality data is uploaded directly to the database by the central laboratory. Four year cumulative data covering 23,477 blood draws reveals an average fresh PBMC yield of 1.45×106 ±0.48 cells per milliliter of useable whole blood. 95% of samples were within the acceptable range for fresh cell yield of 0.8–3.2×106 cells/ml of usable blood. Prior to full implementation of the HVTN PBMC Quality Management Program, the 2007 EQC evaluations from 10 international sites showed a mean day 2 thawed viability of 83.1% and recovery of 67.5%. Since then, four year cumulative data covering 3338 specimens used in immunologic assays shows that 99.88% had acceptable viabilities (>66%) for use in cellular assays (mean, 91.46% ±4.5%), and 96.2% had acceptable recoveries (50%–130%) with a mean of recovery of 85.8% ±19.12% of the originally cryopreserved cells. EQC testing revealed that since August 2009, failed recoveries dropped from 4.1% to 1.6% and failed viabilities dropped from 1.0% to 0.3%. The HVTN PBMC quality program provides for laboratory assessment, training and tools for identifying problems, implementing corrective action and monitoring for improvements. These data support the benefits of implementing a comprehensive, web-based PBMC quality program for large clinical trials networks. PMID:24709391

Evaluation of Preanalytical Quality Indicators by Six Sigma and Pareto`s Principle.

PubMed

Kulkarni, Sweta; Ramesh, R; Srinivasan, A R; Silvia, C R Wilma Delphine

2018-01-01

Preanalytical steps are the major sources of error in clinical laboratory. The analytical errors can be corrected by quality control procedures but there is a need for stringent quality checks in preanalytical area as these processes are done outside the laboratory. Sigma value depicts the performance of laboratory and its quality measures. Hence in the present study six sigma and Pareto principle was applied to preanalytical quality indicators to evaluate the clinical biochemistry laboratory performance. This observational study was carried out for a period of 1 year from November 2015-2016. A total of 1,44,208 samples and 54,265 test requisition forms were screened for preanalytical errors like missing patient information, sample collection details in forms and hemolysed, lipemic, inappropriate, insufficient samples and total number of errors were calculated and converted into defects per million and sigma scale. Pareto`s chart was drawn using total number of errors and cumulative percentage. In 75% test requisition forms diagnosis was not mentioned and sigma value of 0.9 was obtained and for other errors like sample receiving time, stat and type of sample sigma values were 2.9, 2.6, and 2.8 respectively. For insufficient sample and improper ratio of blood to anticoagulant sigma value was 4.3. Pareto`s chart depicts out of 80% of errors in requisition forms, 20% is contributed by missing information like diagnosis. The development of quality indicators, application of six sigma and Pareto`s principle are quality measures by which not only preanalytical, the total testing process can be improved.

Quality specification and status of internal quality control of cardiac biomarkers in China from 2011 to 2016.

PubMed

Li, Tingting; Wang, Wei; Zhao, Haijian; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

2017-09-07

This study aimed to investigate the status of internal quality control (IQC) for cardiac biomarkers from 2011 to 2016 so that we can have overall knowledge of the precision level of measurements in China and set appropriate precision specifications. Internal quality control data of cardiac biomarkers, including creatinine kinase MB (CK-MB) (μg/L), CK-MB(U/L), myoglobin (Mb), cardiac troponin I (cTnI), cardiac troponin T (cTnT), and homocysteines (HCY), were collected by a web-based external quality assessment (EQA) system. Percentages of laboratories meeting five precision quality specifications for current coefficient of variations (CVs) were calculated. Then, appropriate precision specifications were chosen for these six analytes. Finally, the CVs and IQC practice were further analyzed with different grouping methods. The current CVs remained nearly constant for 6 years. cTnT had the highest pass rates every year against five specifications, whereas HCY had the lowest pass rates. Overall, most analytes had a satisfactory performance (pass rates >80%), except for HCY, if one-third TEa or the minimum specification were employed. When the optimal specification was applied, the performance of most analytes was frustrating (pass rates < 60%) except for cTnT. The appropriate precision specifications of Mb, cTnI, cTnT and HCY were set as current CVs less than 9.20%, 9.90%, 7.50%, 10.54%, 7.63%, and 6.67%, respectively. The data of IQC practices indicated wide variation and substantial progress. The precision performance of cTnT was already satisfying, while the other five analytes, especially HCY, were still frustrating; thus, ongoing investigation and continuous improvement for IQC are still needed. © 2017 Wiley Periodicals, Inc.

Transfer of analytical procedures: a panel of strategies selected for risk management, with emphasis on an integrated equivalence-based comparative testing approach.

PubMed

Agut, C; Caron, A; Giordano, C; Hoffman, D; Ségalini, A

2011-09-10

In 2001, a multidisciplinary team made of analytical scientists and statisticians at Sanofi-aventis has published a methodology which has governed, from that time, the transfers from R&D sites to Manufacturing sites of the release monographs. This article provides an overview of the recent adaptations brought to this original methodology taking advantage of our experience and the new regulatory framework, and, in particular, the risk management perspective introduced by ICH Q9. Although some alternate strategies have been introduced in our practices, the comparative testing one, based equivalence testing as statistical approach, remains the standard for assays lying on very critical quality attributes. This is conducted with the concern to control the most important consumer's risk involved at two levels in analytical decisions in the frame of transfer studies: risk, for the receiving laboratory, to take poor release decisions with the analytical method and risk, for the sending laboratory, to accredit such a receiving laboratory on account of its insufficient performances with the method. Among the enhancements to the comparative studies, the manuscript presents the process settled within our company for a better integration of the transfer study into the method life-cycle, just as proposals of generic acceptance criteria and designs for assay and related substances methods. While maintaining rigor and selectivity of the original approach, these improvements tend towards an increased efficiency in the transfer operations. Copyright © 2011 Elsevier B.V. All rights reserved.

An intercomparison study of analytical methods used for quantification of levoglucosan in ambient aerosol filter samples

NASA Astrophysics Data System (ADS)

Yttri, K. E.; Schnelle-Kreiss, J.; Maenhaut, W.; Alves, C.; Bossi, R.; Bjerke, A.; Claeys, M.; Dye, C.; Evtyugina, M.; García-Gacio, D.; Gülcin, A.; Hillamo, R.; Hoffer, A.; Hyder, M.; Iinuma, Y.; Jaffrezo, J.-L.; Kasper-Giebl, A.; Kiss, G.; López-Mahia, P. L.; Pio, C.; Piot, C.; Ramirez-Santa-Cruz, C.; Sciare, J.; Teinilä, K.; Vermeylen, R.; Vicente, A.; Zimmermann, R.

2014-07-01

The monosaccharide anhydrides (MAs) levoglucosan, galactosan and mannosan are products of incomplete combustion and pyrolysis of cellulose and hemicelluloses, and are found to be major constituents of biomass burning aerosol particles. Hence, ambient aerosol particle concentrations of levoglucosan are commonly used to study the influence of residential wood burning, agricultural waste burning and wild fire emissions on ambient air quality. A European-wide intercomparison on the analysis of the three monosaccharide anhydrides was conducted based on ambient aerosol quartz fiber filter samples collected at a Norwegian urban background site during winter. Thus, the samples' content of MAs is representative for biomass burning particles originating from residential wood burning. The purpose of the intercomparison was to examine the comparability of the great diversity of analytical methods used for analysis of levoglucosan, mannosan and galactosan in ambient aerosol filter samples. Thirteen laboratories participated, of which three applied High-Performance Anion-Exchange Chromatography (HPAEC), four used High-Performance Liquid Chromatography (HPLC) or Ultra-Performance Liquid Chromatography (UPLC), and six resorted to Gas Chromatography (GC). The analytical methods used were of such diversity that they should be considered as thirteen different analytical methods. All of the thirteen laboratories reported levels of levoglucosan, whereas nine reported data for mannosan and/or galactosan. Eight of the thirteen laboratories reported levels for all three isomers. The accuracy for levoglucosan, presented as the mean percentage error (PE) for each participating laboratory, varied from -63 to 23%; however, for 62% of the laboratories the mean PE was within ±10%, and for 85% the mean PE was within ±20%. For mannosan, the corresponding range was -60 to 69%, but as for levoglucosan, the range was substantially smaller for a subselection of the laboratories; i.e., for 33% of the laboratories the mean PE was within ±10%. For galactosan, the mean PE for the participating laboratories ranged from -84 to 593%, and as for mannosan 33% of the laboratories reported a mean PE within ±10%. The variability of the various analytical methods, as defined by their minimum and maximum PE value, was typically better for levoglucosan than for mannosan and galactosan, ranging from 3.2 to 41% for levoglucosan, from 10 to 67% for mannosan, and from 6 to 364% for galactosan. For the levoglucosan to mannosan ratio, which may be used to assess the relative importance of softwood vs. hardwood burning, the variability only ranged from 3.5 to 24%. To our knowledge, this is the first major intercomparison on analytical methods used to quantify monosaccharide anhydrides in ambient aerosol filter samples conducted and reported in the scientific literature. The results show that for levoglucosan the accuracy is only slightly lower than that reported for analysis of SO42- on filter samples, a constituent that has been analyzed by numerous laboratories for several decades, typically by ion chromatography, and which is considered a fairly easy constituent to measure. Hence, the results obtained for levoglucosan with respect to accuracy are encouraging and suggest that levels of levoglucosan, and to a lesser extent mannosan and galactosan, obtained by most of the analytical methods currently used to quantify monosaccharide anhydrides in ambient aerosol filter samples, are comparable. Finally, the various analytical methods used in the current study should be tested for other aerosol matrices and concentrations as well, the most obvious being summertime aerosol samples affected by wild fires and/or agricultural fires.

An intercomparison study of analytical methods used for quantification of levoglucosan in ambient aerosol filter samples

NASA Astrophysics Data System (ADS)

Yttri, K. E.; Schnelle-Kreis, J.; Maenhaut, W.; Abbaszade, G.; Alves, C.; Bjerke, A.; Bonnier, N.; Bossi, R.; Claeys, M.; Dye, C.; Evtyugina, M.; García-Gacio, D.; Hillamo, R.; Hoffer, A.; Hyder, M.; Iinuma, Y.; Jaffrezo, J.-L.; Kasper-Giebl, A.; Kiss, G.; López-Mahia, P. L.; Pio, C.; Piot, C.; Ramirez-Santa-Cruz, C.; Sciare, J.; Teinilä, K.; Vermeylen, R.; Vicente, A.; Zimmermann, R.

2015-01-01

The monosaccharide anhydrides (MAs) levoglucosan, galactosan and mannosan are products of incomplete combustion and pyrolysis of cellulose and hemicelluloses, and are found to be major constituents of biomass burning (BB) aerosol particles. Hence, ambient aerosol particle concentrations of levoglucosan are commonly used to study the influence of residential wood burning, agricultural waste burning and wildfire emissions on ambient air quality. A European-wide intercomparison on the analysis of the three monosaccharide anhydrides was conducted based on ambient aerosol quartz fiber filter samples collected at a Norwegian urban background site during winter. Thus, the samples' content of MAs is representative for BB particles originating from residential wood burning. The purpose of the intercomparison was to examine the comparability of the great diversity of analytical methods used for analysis of levoglucosan, mannosan and galactosan in ambient aerosol filter samples. Thirteen laboratories participated, of which three applied high-performance anion-exchange chromatography (HPAEC), four used high-performance liquid chromatography (HPLC) or ultra-performance liquid chromatography (UPLC) and six resorted to gas chromatography (GC). The analytical methods used were of such diversity that they should be considered as thirteen different analytical methods. All of the thirteen laboratories reported levels of levoglucosan, whereas nine reported data for mannosan and/or galactosan. Eight of the thirteen laboratories reported levels for all three isomers. The accuracy for levoglucosan, presented as the mean percentage error (PE) for each participating laboratory, varied from -63 to 20%; however, for 62% of the laboratories the mean PE was within ±10%, and for 85% the mean PE was within ±20%. For mannosan, the corresponding range was -60 to 69%, but as for levoglucosan, the range was substantially smaller for a subselection of the laboratories; i.e. for 33% of the laboratories the mean PE was within ±10%. For galactosan, the mean PE for the participating laboratories ranged from -84 to 593%, and as for mannosan 33% of the laboratories reported a mean PE within ±10%. The variability of the various analytical methods, as defined by their minimum and maximum PE value, was typically better for levoglucosan than for mannosan and galactosan, ranging from 3.2 to 41% for levoglucosan, from 10 to 67% for mannosan and from 6 to 364% for galactosan. For the levoglucosan to mannosan ratio, which may be used to assess the relative importance of softwood versus hardwood burning, the variability only ranged from 3.5 to 24 . To our knowledge, this is the first major intercomparison on analytical methods used to quantify monosaccharide anhydrides in ambient aerosol filter samples conducted and reported in the scientific literature. The results show that for levoglucosan the accuracy is only slightly lower than that reported for analysis of SO42- (sulfate) on filter samples, a constituent that has been analysed by numerous laboratories for several decades, typically by ion chromatography and which is considered a fairly easy constituent to measure. Hence, the results obtained for levoglucosan with respect to accuracy are encouraging and suggest that levels of levoglucosan, and to a lesser extent mannosan and galactosan, obtained by most of the analytical methods currently used to quantify monosaccharide anhydrides in ambient aerosol filter samples, are comparable. Finally, the various analytical methods used in the current study should be tested for other aerosol matrices and concentrations as well, the most obvious being summertime aerosol samples affected by wildfires and/or agricultural fires.

Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

PubMed Central

Arnold, Mark; Bakris, George L.; Bruns, David E.; Horvath, Andrea Rita; Kirkman, M. Sue; Lernmark, Ake; Metzger, Boyd E.; Nathan, David M.

2011-01-01

BACKGROUND Multiple laboratory tests are used to diagnose and manage patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these tests varies substantially. APPROACH An expert committee compiled evidence-based recommendations for the use of laboratory testing for patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. Draft guidelines were posted on the Internet and presented at the 2007 Arnold O. Beckman Conference. The document was modified in response to oral and written comments, and a revised draft was posted in 2010 and again modified in response to written comments. The National Academy of Clinical Biochemistry and the Evidence-Based Laboratory Medicine Committee of the American Association for Clinical Chemistry jointly reviewed the guidelines, which were accepted after revisions by the Professional Practice Committee and subsequently approved by the Executive Committee of the American Diabetes Association. CONTENT In addition to long-standing criteria based on measurement of plasma glucose, diabetes can be diagnosed by demonstrating increased blood hemoglobin A1c (HbA1c) concentrations. Monitoring of glycemic control is performed by self-monitoring of plasma or blood glucose with meters and by laboratory analysis of HbA1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. SUMMARY The guidelines provide specific recommendations that are based on published data or derived from expert consensus. Several analytes have minimal clinical value at present, and their measurement is not recommended. PMID:21617108

Interest and limits of the six sigma methodology in medical laboratory.

PubMed

Scherrer, Florian; Bouilloux, Jean-Pierre; Calendini, Ors'Anton; Chamard, Didier; Cornu, François

2017-02-01

The mandatory accreditation of clinical laboratories in France provides an incentive to develop real tools to measure performance management methods and to optimize the management of internal quality controls. Six sigma methodology is an approach commonly applied to software quality management and discussed in numerous publications. This paper discusses the primary factors that influence the sigma index (the choice of the total allowable error, the approach used to address bias) and compares the performance of different analyzers on the basis of the sigma index. Six sigma strategy can be applied to the policy management of internal quality control in a laboratory and demonstrates through a comparison of four analyzers that there is no single superior analyzer in clinical chemistry. Similar sigma results are obtained using approaches toward bias based on the EQAS or the IQC. The main difficulty in using the six sigma methodology lies in the absence of official guidelines for the definition of the total error acceptable. Despite this drawback, our comparison study suggests that difficulties with defined analytes do not vary with the analyzer used.

Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE).

PubMed

Lippi, Giuseppe; Baird, Geoffrey S; Banfi, Giuseppe; Bölenius, Karin; Cadamuro, Janne; Church, Stephen; Cornes, Michael P; Dacey, Anna; Guillon, Antoine; Hoffmann, Georg; Nybo, Mads; Premawardhana, Lakdasa Devananda; Salinas, María; Sandberg, Sverre; Slingerland, Robbert; Stankovic, Ana; Sverresdotter, Sylte Marit; Vermeersch, Pieter; Simundic, Ana-Maria

2017-03-01

It is now undeniable that laboratory testing is vital for the diagnosis, prognostication and therapeutic monitoring of human disease. Despite the many advances made for achieving a high degree of quality and safety in the analytical part of diagnostic testing, many hurdles in the total testing process remain, especially in the preanalytical phase ranging from test ordering to obtaining and managing the biological specimens. The Working Group for the Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has planned many activities aimed at mitigating the vulnerability of the preanalytical phase, including the organization of three European meetings in the past 7 years. Hence, this collective article follows the previous three opinion papers that were published by the EFLM WGPRE on the same topic, and brings together the summaries of the presentations that will be given at the 4th EFLM-BD meeting "Improving quality in the preanalytical phase through innovation" in Amsterdam, 24-25 March, 2017.

Analysis of environmental contamination resulting from catastrophic incidents: part 2. Building laboratory capability by selecting and developing analytical methodologies.

PubMed

Magnuson, Matthew; Campisano, Romy; Griggs, John; Fitz-James, Schatzi; Hall, Kathy; Mapp, Latisha; Mullins, Marissa; Nichols, Tonya; Shah, Sanjiv; Silvestri, Erin; Smith, Terry; Willison, Stuart; Ernst, Hiba

2014-11-01

Catastrophic incidents can generate a large number of samples of analytically diverse types, including forensic, clinical, environmental, food, and others. Environmental samples include water, wastewater, soil, air, urban building and infrastructure materials, and surface residue. Such samples may arise not only from contamination from the incident but also from the multitude of activities surrounding the response to the incident, including decontamination. This document summarizes a range of activities to help build laboratory capability in preparation for sample analysis following a catastrophic incident, including selection and development of fit-for-purpose analytical methods for chemical, biological, and radiological contaminants. Fit-for-purpose methods are those which have been selected to meet project specific data quality objectives. For example, methods could be fit for screening contamination in the early phases of investigation of contamination incidents because they are rapid and easily implemented, but those same methods may not be fit for the purpose of remediating the environment to acceptable levels when a more sensitive method is required. While the exact data quality objectives defining fitness-for-purpose can vary with each incident, a governing principle of the method selection and development process for environmental remediation and recovery is based on achieving high throughput while maintaining high quality analytical results. This paper illustrates the result of applying this principle, in the form of a compendium of analytical methods for contaminants of interest. The compendium is based on experience with actual incidents, where appropriate and available. This paper also discusses efforts aimed at adaptation of existing methods to increase fitness-for-purpose and development of innovative methods when necessary. The contaminants of interest are primarily those potentially released through catastrophes resulting from malicious activity. However, the same techniques discussed could also have application to catastrophes resulting from other incidents, such as natural disasters or industrial accidents. Further, the high sample throughput enabled by the techniques discussed could be employed for conventional environmental studies and compliance monitoring, potentially decreasing costs and/or increasing the quantity of data available to decision-makers. Published by Elsevier Ltd.

[The taking and transport of biological samples].

PubMed

Kerwat, Klaus; Kerwat, Martina; Eberhart, Leopold; Wulf, Hinnerk

2011-05-01

The results of microbiological tests are the foundation for a targetted therapy and the basis for monitoring infections. The quality of each and every laboratory finding depends not only on an error-free analytical process. The pre-analysis handling procedures are of particular importance. They encompass all factors and influences prior to the actual analysis. These include the correct timepoint for sample taking, the packaging and the rapid transport of the material to be investigated. Errors in the pre-analytical processing are the most frequent reasons for inappropriate findings. © Georg Thieme Verlag Stuttgart · New York.

Experimental design of an interlaboratory study for trace metal analysis of liquid fluids. [for aerospace vehicles

NASA Technical Reports Server (NTRS)

Greenbauer-Seng, L. A.

1983-01-01

The accurate determination of trace metals and fuels is an important requirement in much of the research into and development of alternative fuels for aerospace applications. Recognizing the detrimental effects of certain metals on fuel performance and fuel systems at the part per million and in some cases part per billion levels requires improved accuracy in determining these low concentration elements. Accurate analyses are also required to ensure interchangeability of analysis results between vendor, researcher, and end use for purposes of quality control. Previous interlaboratory studies have demonstrated the inability of different laboratories to agree on the results of metal analysis, particularly at low concentration levels, yet typically good precisions are reported within a laboratory. An interlaboratory study was designed to gain statistical information about the sources of variation in the reported concentrations. Five participant laboratories were used on a fee basis and were not informed of the purpose of the analyses. The effects of laboratory, analytical technique, concentration level, and ashing additive were studied in four fuel types for 20 elements of interest. The prescribed sample preparation schemes (variations of dry ashing) were used by all of the laboratories. The analytical data were statistically evaluated using a computer program for the analysis of variance technique.

Uptake of recommended common reference intervals for chemical pathology in Australia.

PubMed

Jones, Graham Rd; Koetsier, Sabrina

2017-05-01

Background Reference intervals are a vital part of reporting numerical pathology results. It is known, however, that variation in reference intervals between laboratories is common, even when analytical methods support common reference intervals. In response to this, in Australia, the Australasian Association of Clinical Biochemists together with the Royal College of Pathologists of Australasia published in 2014 a set of recommended common reference intervals for 11 common serum analytes (sodium, potassium, chloride, bicarbonate, creatinine male, creatinine female, calcium, calcium adjusted for albumin, phosphate, magnesium, lactate dehydrogenase, alkaline phosphatase and total protein). Methods Uptake of recommended common reference intervals in Australian laboratories was assessed using data from four annual cycles of the RCPAQAP reference intervals external quality assurance programme. Results Over three years, from 2013 to 2016, the use of the recommended upper and lower reference limits has increased from 40% to 83%. Nearly half of the intervals in use by enrolled laboratories in 2016 have been changed in this time period, indicating an active response to the guidelines. Conclusions These data support the activities of the Australasian Association of Clinical Biochemists and Royal College of Pathologists of Australasia in demonstrating a change in laboratory behaviour to reduce unnecessary variation in reference intervals and thus provide a consistent message to doctor and patients irrespective of the laboratory used.

Pilot proficiency testing study for second tier congenital adrenal hyperplasia newborn screening.

PubMed

De Jesús, Víctor R; Simms, David A; Schiffer, Jarad; Kennedy, Meredith; Mei, Joanne V; Hannon, W Harry

2010-11-11

Congenital adrenal hyperplasia (CAH) is caused by inherited defects in steroid biosynthesis. The Newborn Screening Quality Assurance Program (NSQAP) initiated a pilot, dried-blood spot (DBS)-based proficiency testing program designed to investigate materials and laboratory performance for second tier CAH screening by tandem mass spectrometry (MS/MS). The ratio of 17-α-hydroxyprogesterone (17-OHP), androstenedione (4-AD) and cortisol is used as an indicator of CAH in laboratory protocols for second tier analysis of DBS specimens. DBS prepared by NSQAP contained a range of steroid concentrations resulting in different clinical ratios. Laboratories received blind-coded DBS specimens and reported results to NSQAP for evaluation. Quantitative values reported by participants for 17-OHP, 4-AD, and cortisol, reflected small differences in their analytical methods. Average quantitative values for 17-OHP increased from 81% to 107% recovery over the 3.5-year period; cortisol recoveries increased from 61.9% to 89.5%; and 4-AD recoveries decreased from 184% to 68%. Laboratory participation in the CAH second tier proficiency testing program has resulted in improved analyte recoveries and enhanced sample preparation methodologies. NSQAP services for the second tier CAH analysis in DBS demonstrate the need for surveillance to ensure harmonization and continuous improvements, and to achieve sustained high-performance of newborn screening laboratories worldwide. Published by Elsevier B.V.

[The requirements of standard and conditions of interchangeability of medical articles].

PubMed

Men'shikov, V V; Lukicheva, T I

2013-11-01

The article deals with possibility to apply specific approaches under evaluation of interchangeability of medical articles for laboratory analysis. The development of standardized analytical technologies of laboratory medicine and formulation of requirements of standards addressed to manufacturers of medical articles the clinically validated requirements are to be followed. These requirements include sensitivity and specificity of techniques, accuracy and precision of research results, stability of reagents' quality in particular conditions of their transportation and storage. The validity of requirements formulated in standards and addressed to manufacturers of medical articles can be proved using reference system, which includes master forms and standard samples, reference techniques and reference laboratories. This approach is supported by data of evaluation of testing systems for measurement of level of thyrotrophic hormone, thyroid hormones and glycated hemoglobin HB A1c. The versions of testing systems can be considered as interchangeable only in case of results corresponding to the results of reference technique and comparable with them. In case of absence of functioning reference system the possibilities of the Joined committee of traceability in laboratory medicine make it possible for manufacturers of reagent sets to apply the certified reference materials under development of manufacturing of sets for large listing of analytes.

Analysis of Environmental Contamination resulting from ...

EPA Pesticide Factsheets

Catastrophic incidents can generate a large number of samples with analytically diverse types including forensic, clinical, environmental, food, and others. Environmental samples include water, wastewater, soil, air, urban building and infrastructure materials, and surface residue. Such samples may arise not only from contamination from the incident but also from the multitude of activities surrounding the response to the incident, including decontamination. This document summarizes a range of activities to help build laboratory capability in preparation for analysis following a catastrophic incident, including selection and development of fit-for-purpose analytical methods for chemical, biological, and radiological contaminants. Fit-for-purpose methods are those which have been selected to meet project specific data quality objectives. For example, methods could be fit for screening contamination in the early phases of investigation of contamination incidents because they are rapid and easily implemented, but those same methods may not be fit for the purpose of remediating the environment to safe levels when a more sensitive method is required. While the exact data quality objectives defining fitness-for-purpose can vary with each incident, a governing principle of the method selection and development process for environmental remediation and recovery is based on achieving high throughput while maintaining high quality analytical results. This paper illu

Laboratory Medicine Best Practice Guideline: Vitamins A, E and the Carotenoids in Blood

PubMed Central

Greaves, Ronda F; Woollard, Gerald A; Hoad, Kirsten E; Walmsley, Trevor A; Johnson, Lambro A; Briscoe, Scott; Koetsier, Sabrina; Harrower, Tamantha; Gill, Janice P

2014-01-01

Despite apparent method similarities between laboratories there appear to be confounding factors inhibiting uniform reporting and standardisation of vitamin assays. The Australasian Association of Clinical Biochemists (AACB) Vitamins Working Party, in conjunction with The Royal College of Pathologists of Australasia Quality Assurance Programs, has formulated a guideline to improve performance, reproducibility and accuracy of fat-soluble vitamin results. The aim of the guideline is to identify critical pre-analytical, analytical and post-analytical components of the analysis of vitamins A, E and carotenoids in blood to promote best practice and harmonisation. This best practice guideline has been developed with reference to the Centers for Disease Control and Prevention (CDC) “Laboratory Medicine Best Practices: Developing an Evidence-Based Review and Evaluation Process”. The CDC document cites an evaluation framework for generating best practice recommendations that are specific to laboratory medicine. These 50 recommendations proposed herein, were generated from a comprehensive literature search and the extensive combined experience of the AACB Vitamins Working Party members. They were formulated based on comparison between an impact assessment rating and strength of evidence and were classified as either: (1) strongly recommend, (2) recommend, (3) no recommendation for or against, or (4) recommend against. These best practice recommendations represent the consensus views, in association with peer reviewed evidence of the AACB Vitamins Working Party, towards best practice for the collection, analysis and interpretation of vitamins A, E and carotenoids in blood. PMID:25210208

Results of the U. S. Geological Survey's analytical evaluation program for standard reference samples distributed in April 2001

USGS Publications Warehouse

Woodworth, M.T.; Connor, B.F.

2001-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-165 (trace constituents), M-158 (major constituents), N-69 (nutrient constituents), N-70 (nutrient constituents), P-36 (low ionic-strength constituents), and Hg-32 (mercury) -- that were distributed in April 2001 to laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 73 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U. S. Geological Survey's Analytical Evaluation Program for Standard Reference Samples Distributed in March 2002

USGS Publications Warehouse

Woodworth, M.T.; Conner, B.F.

2002-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T- 169 (trace constituents), M- 162 (major constituents), N-73 (nutrient constituents), N-74 (nutrient constituents), P-38 (low ionic-strength constituents), and Hg-34 (mercury) -- that were distributed in March 2002 to laboratories enrolled in the U.S. Geological Survey sponsored intedaboratory testing program. Analytical data received from 93 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U.S. Geological Survey's analytical evaluation program for standard reference samples distributed in September 2002

USGS Publications Warehouse

Woodworth, Mark T.; Connor, Brooke F.

2003-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-171 (trace constituents), M-164 (major constituents), N-75 (nutrient constituents), N-76 (nutrient constituents), P-39 (low ionic-strength constituents), and Hg-35 (mercury) -- that were distributed in September 2002 to laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 102 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U.S. Geological Survey's analytical evaluation program for standard reference samples distributed in September 2001

USGS Publications Warehouse

Woodworth, Mark T.; Connor, Brooke F.

2002-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-167 (trace constituents), M-160 (major constituents), N-71 (nutrient constituents), N-72 (nutrient constituents), P-37 (low ionic-strength constituents), and Hg-33 (mercury) -- that were distributed in September 2001 to laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 98 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U.S. Geological Survey's Analytical Evaluation Program for Standard Reference Samples Distributed in March 2000

USGS Publications Warehouse

Farrar, Jerry W.; Copen, Ashley M.

2000-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-161 (trace constituents), M-154 (major constituents), N-65 (nutrient constituents), N-66 nutrient constituents), P-34 (low ionic strength constituents), and Hg-30 (mercury) -- that were distributed in March 2000 to 144 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 132 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U.S. Geological Survey's analytical evaluation program for standard reference samples distributed in October 1999

USGS Publications Warehouse

Farrar, T.W.

2000-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-159 (trace constituents), M-152 (major constituents), N-63 (nutrient constituents), N-64 (nutrient constituents), P-33 (low ionic strength constituents), and Hg-29 (mercury) -- that were distributed in October 1999 to 149 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 131 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U.S. Geological Survey's analytical evaluation program for standard reference samples distributed in March 2003

USGS Publications Warehouse

Woodworth, Mark T.; Connor, Brooke F.

2003-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-173 (trace constituents), M-166 (major constituents), N-77 (nutrient constituents), N-78 (nutrient constituents), P-40 (low ionic-strength constituents), and Hg-36 (mercury) -- that were distributed in March 2003 to laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 110 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of the U. S. Geological Survey's analytical evaluation program for standard reference samples distributed in October 2000

USGS Publications Warehouse

Connor, B.F.; Currier, J.P.; Woodworth, M.T.

2001-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-163 (trace constituents), M-156 (major constituents), N-67 (nutrient constituents), N-68 (nutrient constituents), P-35 (low ionic strength constituents), and Hg-31 (mercury) -- that were distributed in October 2000 to 126 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 122 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Molecular genetic testing for cystic fibrosis: laboratory performance on the College of American Pathologists external proficiency surveys.

PubMed

Lyon, Elaine; Schrijver, Iris; Weck, Karen E; Ferreira-Gonzalez, Andrea; Richards, C Sue; Palomaki, Glenn E

2015-03-01

Molecular testing for cystic fibrosis mutations is widespread and routine in reproductive decision making and diagnosis. Our objective was to assess the level of performance of laboratories for this test. The College of American Pathologists administers external proficiency testing with multiple DNA samples distributed biannually. RESULTS are analyzed, reviewed, and graded by the joint College of American Pathologists/American College of Medical Genetics and Genomics Biochemical and Molecular Genetics Committee. Assessment is based on genotype and associated clinical interpretation. Overall, 357 clinical laboratories participated in the proficiency testing survey between 2003 and 2013 (322 in the United States and 35 international). In 2013, US participants reported performing nearly 120,000 tests monthly. Analytical sensitivity and specificity of US laboratories were 98.8% (95% confidence interval: 98.4-99.1%) and 99.6% (95% confidence interval: 99.4-99.7%), respectively. Analytical sensitivity improved between 2003 and 2008 (from 97.9 to 99.3%; P = 0.007) and remained steady thereafter. Clinical interpretation matched the intended response for 98.8, 86.0, and 91.0% of challenges with no, one, or two mutations, respectively. International laboratories performed similarly. Laboratory testing for cystic fibrosis in the United States has improved since 2003, and these data demonstrate a high level of quality. Neither the number of samples tested nor test methodology affected performance.

External quality-assurance project report for the National Atmospheric Deposition Program/National Trends Network and Mercury Deposition Network, 2009-2010

USGS Publications Warehouse

Wetherbee, Gregory A.; Martin, RoseAnn; Rhodes, Mark F.; Chesney, Tanya A.

2014-01-01

The U.S. Geological Survey operated six distinct programs to provide external quality-assurance monitoring for the National Atmospheric Deposition Program/National Trends Network (NTN) and Mercury Deposition Network (MDN) during 2009–2010. The field-audit program assessed the effects of onsite exposure, sample handling, and shipping on the chemistry of NTN samples; a system-blank program assessed the same effects for MDN. Two interlaboratory-comparison programs assessed the bias and variability of the chemical analysis data from the Central Analytical Laboratory (CAL) and Mercury (Hg) Analytical Laboratory (HAL). The blind-audit program was also implemented for the MDN to evaluate analytical bias in total Hg concentration data produced by the HAL. The co-located-sampler program was used to identify and quantify potential shifts in NADP data resulting from replacement of original network instrumentation with new electronic recording rain gages (E-gages) and precipitation collectors that use optical sensors. The results indicate that NADP data continue to be of sufficient quality for the analysis of spatial distributions and time trends of chemical constituents in wet deposition across the United States. Results also suggest that retrofit of the NADP networks with the new precipitation collectors could cause –8 to +14 percent shifts in NADP annual precipitation-weighted mean concentrations and total deposition values for ammonium, nitrate, sulfate, and hydrogen ion, and larger shifts (+13 to +74 percent) for calcium, magnesium, sodium, potassium, and chloride. The prototype N-CON Systems bucket collector is more efficient in the catch of precipitation in winter than Aerochem Metrics Model 301 collector, especially for light snowfall.

U.S. Geological Survey external quality-assurance project report for the National Atmospheric Deposition Program / National Trends Network and Mercury Deposition Network, 2011-2012

USGS Publications Warehouse

Wetherbee, Gregory A.; Martin, RoseAnn

2014-01-01

The U.S. Geological Survey operated six distinct programs to provide external quality-assurance monitoring for the National Atmospheric Deposition Program (NADP) / National Trends Network (NTN) and Mercury Deposition Network (MDN) during 2011–2012. The field-audit program assessed the effects of onsite exposure, sample handling, and shipping on the chemistry of NTN samples; a system-blank program assessed the same effects for MDN. Two interlaboratory-comparison programs assessed the bias and variability of the chemical analysis data from the Central Analytical Laboratory and Mercury Analytical Laboratory (HAL). A blind-audit program was implemented for the MDN during 2011 to evaluate analytical bias in HAL total mercury concentration data. The co-located–sampler program was used to identify and quantify potential shifts in NADP data resulting from the replacement of original network instrumentation with new electronic recording rain gages and precipitation collectors that use optical precipitation sensors. The results indicate that NADP data continue to be of sufficient quality for the analysis of spatial distributions and time trends of chemical constituents in wet deposition across the United States. Co-located rain gage results indicate -3.7 to +6.5 percent bias in NADP precipitation-depth measurements. Co-located collector results suggest that the retrofit of the NADP networks with the new precipitation collectors could cause +10 to +36 percent shifts in NADP annual deposition values for ammonium, nitrate, and sulfate; -7.5 to +41 percent shifts for hydrogen-ion deposition; and larger shifts (-51 to +52 percent) for calcium, magnesium, sodium, potassium, and chloride. The prototype N-CON Systems bucket collector typically catches more precipitation than the NADP-approved Aerochem Metrics Model 301 collector.

PFLOTRAN Verification: Development of a Testing Suite to Ensure Software Quality

NASA Astrophysics Data System (ADS)

Hammond, G. E.; Frederick, J. M.

2016-12-01

In scientific computing, code verification ensures the reliability and numerical accuracy of a model simulation by comparing the simulation results to experimental data or known analytical solutions. The model is typically defined by a set of partial differential equations with initial and boundary conditions, and verification ensures whether the mathematical model is solved correctly by the software. Code verification is especially important if the software is used to model high-consequence systems which cannot be physically tested in a fully representative environment [Oberkampf and Trucano (2007)]. Justified confidence in a particular computational tool requires clarity in the exercised physics and transparency in its verification process with proper documentation. We present a quality assurance (QA) testing suite developed by Sandia National Laboratories that performs code verification for PFLOTRAN, an open source, massively-parallel subsurface simulator. PFLOTRAN solves systems of generally nonlinear partial differential equations describing multiphase, multicomponent and multiscale reactive flow and transport processes in porous media. PFLOTRAN's QA test suite compares the numerical solutions of benchmark problems in heat and mass transport against known, closed-form, analytical solutions, including documentation of the exercised physical process models implemented in each PFLOTRAN benchmark simulation. The QA test suite development strives to follow the recommendations given by Oberkampf and Trucano (2007), which describes four essential elements in high-quality verification benchmark construction: (1) conceptual description, (2) mathematical description, (3) accuracy assessment, and (4) additional documentation and user information. Several QA tests within the suite will be presented, including details of the benchmark problems and their closed-form analytical solutions, implementation of benchmark problems in PFLOTRAN simulations, and the criteria used to assess PFLOTRAN's performance in the code verification procedure. References Oberkampf, W. L., and T. G. Trucano (2007), Verification and Validation Benchmarks, SAND2007-0853, 67 pgs., Sandia National Laboratories, Albuquerque, NM.

Harmonisation of serum dihydrotestosterone analysis: establishment of an external quality assurance program.

PubMed

Greaves, Ronda F; Jolly, Lisa; Hartmann, Michaela F; Ho, Chung Shun; Kam, Richard K T; Joseph, John; Boyder, Conchita; Wudy, Stefan A

2017-03-01

Serum dihydrotestosterone (DHT) is an important analyte for the clinical assessment of disorders of sex development. It is also reportedly a difficult analyte to measure. Currently, there are significant gaps in the standardisation of this analyte, including no external quality assurance (EQA) program available worldwide to allow for peer review performance of DHT. We therefore proposed to establish a pilot EQA program for serum DHT. DHT was assessed in the 2015 Royal College of Pathologists of Australasia Quality Assurance Programs' Endocrine program material. The material's target (i.e. "true") values were established using a measurement procedure based on isotope dilution gas chromatography (GC) tandem mass spectrometry (MS/MS). DHT calibrator values were based on weighed values of pure DHT material (>97.5% purity) from Sigma. The allowable limits of performance (ALP) were established as ±0.1 up to 0.5 nmol/L and ±15% for targets >0.5 nmol/L. Target values for the six levels of RCPAQAP material for DHT ranged from 0.02 to 0.43 nmol/L (0.01-0.12 ng/mL). The material demonstrated linearity across the six levels. There were seven participating laboratories for this pilot study. Results of the liquid chromatography (LC) MS/MS methods were within the ALP; whereas the results from the immunoassay methods were consistently higher than the target values and outside the ALP. This report provides the first peer comparison of serum DHT measured by mass spectrometry (MS) and immunoassay laboratories. Establishment of this program provides one of the pillars to achieve method harmonisation. This supports accurate clinical decisions where DHT measurement is required.

Response to comment on “Persistence of pharmaceutical compounds and other organic wastewater contaminants in a conventional drinking-water-treatment plant”

USGS Publications Warehouse

Stackelberg, Paul E.; Furlong, Edward T.; Meyer, Michael T.; Zaugg, Steven D.; Henderson, Alden K.; Reissman, Dori B.

2006-01-01

The U.S. Geological Survey (USGS) and the Centers for Disease Control thank Dr. Till for her comments concerning our research (Till, 2005) and welcome the opportunity to respond. The primary objective of our study was to evaluate the potential for organic wastewater-related contaminants (OWCs), including pharmaceuticals, to survive a conventional drinking-water-treatment process and persist in potable-water supplies (Stackelberg et al., 2004). Our study was supported by two USGS laboratories: the National Water Quality Laboratory (NWQL), which provided the HPLC/ESI-MS and CLLE GC/MS data and the Ocala Water Quality and Research Laboratory (OWQRL), which provided the LC/MS data (Stackelberg et al., 2004). Although discussed as distinct techniques by Dr. Till and indicated by differing acronyms to distinguish the laboratories producing the data, as described in our paper, the two LC/MS methods are very similar; they consist of a solid-phase extraction method with analysis of the extract produced using high-performance liquid chromatography coupled to an electrospray ionization mass spectrometer operated in the positive mode. The NWQL and OWQRL report ‘trace’ and ‘ultratrace’ determinations of analytes that provide significant benefit for describing the presence and fate of low-level contaminants. For mass spectral methods, an analyte is qualitatively identified by its retention time on the chromatographic column as well as the presence of two or more confirming ions with area ratios that match that of the reference standard compounds. Because of a recognized increased risk of false positives, these qualitative identification criteria are used in conjunction with abundant quality-control samples (detailed below) to confirm detection prior to making an estimate of the concentration. These qualitative identification criteria must be met before a compound is considered present (or detected) in a sample (Oblinger Childress et al., 1999). When a compound has been qualitatively identified in an environmental sample (whether above or below its reporting level [RL]), it is assessed in context with associated field and laboratory blanks, field and laboratory replicates, and other data, such as appropriate laboratory reagent spikes. An environmental concentration is calculated only after determining that field and laboratory procedures did not contaminate the samples. The concentrations are then calculated from 5- to 8-point calibration curves using internal standard quantitation. Our lowest calibration standard is intentionally much lower than the RL, typically 10 times lower. The most abundant molecular or fragment ion is used for quantitation, and, for the two LC/MS methods, at least one, and where possible two, qualifier ions are used for confirmation. For the GC/MS method, with its greater degree of fragmentation, one quantitation and two qualifier ions are used. When any of the abovementioned qualitative identification criteria are not met, the analyte is considered not present and is reported as “less than” the RL.

QUALITY ASSURANCE PROGRAM FOR WET DEPOSITION SAMPLING AND CHEMICAL ANALYSES FOR THE NATIONAL TRENDS NETWORK.

USGS Publications Warehouse

Schroder, LeRoy J.; Malo, Bernard A.; ,

1985-01-01

The purpose of the National Trends Network is to delineate the major inorganic constituents in the wet deposition in the United States. The approach chosen to monitor the Nation's wet deposition is to install approximately 150 automatic sampling devices with at least one collector in each state. Samples are collected at one week intervals, removed from collectors, and transported to an analytical laboratory for chemical analysis. The quality assurance program has divided wet deposition monitoring into 5 parts: (1) Sampling site selection, (2) sampling device, (3) sample container, (4) sample handling, and (5) laboratory analysis. Each of these five components is being examined using existing designs or new designs. Each existing or proposed sampling site is visited and a criteria audit is performed.

Application of Six Sigma Model to Evaluate the Analytical Quality of Four HbA1c Analyzers.

PubMed

Maesa, Jos Eacute M; Fern Aacute Ndez-Riejos, Patricia; S Aacute Nchez-Mora, Catalina; Toro-Crespo, Mar Iacute A De; Gonz Aacute Lez-Rodriguez, Concepci Oacute N

2017-01-01

The Six Sigma Model is a global quality management system applicable to the determination of glycated hemoglobin (HbA1c). In addition, this model can ensure the three characteristics influencing the patient risk: the correct performance of the analytical method with low inaccuracy and bias, the quality control strategy used by the laboratory, and the necessary quality of the analyte. The aim of this study is to use the Six Sigma Model for evaluating quality criteria in the determination of glycated hemoglobin HbA1c and its application to assess four different HbA1c analyzers. Four HbA1c analyzers were evaluated: HA-8180V®, D-100®, G8®, and Variant II Turbo®. For 20 consecutive days, two levels of quality control (high and low) provided by the manufacturers were measured in each of the instruments. Imprecision (CV), bias, and Sigma values (σ) were calculated with the data obtained and a method decision chart was developed considering a range of quality requirements (allowable total error, TEa). For a TEa = 3%, HA-8180V = 1.54 σ, D-100 = 1.63 σ, G8 = 2.20 σ, and Variant II Turbo = -0.08 σ. For a TEa = 4%, HA-8180V = 2.34 σ, D-100 = 2.32 σ, G8 = 3.74 σ, and Variant II Turbo = 0.16 σ. For a TEa = 10%, HA8180V = 7.12 σ, D-100 = 6.46 σ, G8 = 13.0 σ, and Variant II Turbo = 1.56 σ. Applying the Stockholm consensus and its subsequent Milan review to the results: the maximum level in quality requirements for HbA1c is an allowable total error (TEa) = 3%, G8 is located in region 2 σ (2.20), which is a poor result, and HA-8180V and D-100 are both in region 1 σ (1.54 and 1.63, respectively), which is an unacceptable analytical performance.

The role of light microscopy in aerospace analytical laboratories

NASA Technical Reports Server (NTRS)

Crutcher, E. R.

1977-01-01

Light microscopy has greatly reduced analytical flow time and added new dimensions to laboratory capability. Aerospace analytical laboratories are often confronted with problems involving contamination, wear, or material inhomogeneity. The detection of potential problems and the solution of those that develop necessitate the most sensitive and selective applications of sophisticated analytical techniques and instrumentation. This inevitably involves light microscopy. The microscope can characterize and often identify the cause of a problem in 5-15 minutes with confirmatory tests generally less than one hour. Light microscopy has and will make a very significant contribution to the analytical capabilities of aerospace laboratories.

Manganese recycling in the United States in 1998

USGS Publications Warehouse

Jones, Thomas S.

2003-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-163 (trace constituents), M-156 (major constituents), N-67 (nutrient constituents), N-68 (nutrient constituents), P-35 (low ionic strength constituents), and Hg-31 (mercury) -- that were distributed in October 2000 to 126 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 122 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Concentrations of tritium and strontium-90 in water from selected wells at the Idaho National Engineering Laboratory after purging one, two, and three borehole volumes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bartholomay, R.C.

1993-12-31

Water from 11 wells completed in the Snake River Plain aquifer at the Idaho National Engineering Laboratory was sampled as Part of the US. Geological Survey`s quality assurance program to determine the effect of Purging different borehole volumes on tritium and strontium-90 concentrations. Wells were selected for sampling on the basis of the length of time it took to purge a borehole volume of water. Samples were collected after purging one, two, and three borehole volumes. The US Department of Energy`s Radiological and Environmental Sciences Laboratory provided analytical services. Statistics were used to determine the reproducibility of analytical results. Themore » comparison between tritium and strontium-90 concentrations after purging one and three borehole volumes and two and three borehole volumes showed that all but two sample pairs with defined numbers were in statistical agreement. Results indicate that concentrations of tritium and strontium-90 are not affected measurably by the number of borehole volumes purged.« less

Benefits of an automated GLP final report preparation software solution.

PubMed

Elvebak, Larry E

2011-07-01

The final product of analytical laboratories performing US FDA-regulated (or GLP) method validation and bioanalysis studies is the final report. Although there are commercial-off-the-shelf (COTS) software/instrument systems available to laboratory managers to automate and manage almost every aspect of the instrumental and sample-handling processes of GLP studies, there are few software systems available to fully manage the GLP final report preparation process. This lack of appropriate COTS tools results in the implementation of rather Byzantine and manual processes to cobble together all the information needed to generate a GLP final report. The manual nature of these processes results in the need for several iterative quality control and quality assurance events to ensure data accuracy and report formatting. The industry is in need of a COTS solution that gives laboratory managers and study directors the ability to manage as many portions as possible of the GLP final report writing process and the ability to generate a GLP final report with the click of a button. This article describes the COTS software features needed to give laboratory managers and study directors such a solution.

USDA's National Food and Nutrient Analysis Program (NFNAP) produces high-quality data for USDA food composition databases: Two decades of collaboration.

PubMed

Haytowitz, David B; Pehrsson, Pamela R

2018-01-01

For nearly 20years, the National Food and Nutrient Analysis Program (NFNAP) has expanded and improved the quantity and quality of data in US Department of Agriculture's (USDA) food composition databases (FCDB) through the collection and analysis of nationally representative food samples. NFNAP employs statistically valid sampling plans, the Key Foods approach to identify and prioritize foods and nutrients, comprehensive quality control protocols, and analytical oversight to generate new and updated analytical data for food components. NFNAP has allowed the Nutrient Data Laboratory to keep up with the dynamic US food supply and emerging scientific research. Recently generated results for nationally representative food samples show marked changes compared to previous database values for selected nutrients. Monitoring changes in the composition of foods is critical in keeping FCDB up-to-date, so that they remain a vital tool in assessing the nutrient intake of national populations, as well as for providing dietary advice. Published by Elsevier Ltd.

Compatibility Grab Sampling and Analysis Plan for FY 2000

DOE Office of Scientific and Technical Information (OSTI.GOV)

SASAKI, L.M.

1999-12-29

This sampling and analysis plan (SAP) identifies characterization objectives pertaining to sample collection, laboratory analytical evaluation, and reporting requirements for grab samples obtained to address waste compatibility. It is written in accordance with requirements identified in Data Quality Objectives for Tank Farms Waste Compatibility Program (Mulkey et al. 1999) and Tank Farm Waste Transfer Compatibility Program (Fowler 1999). In addition to analyses to support Compatibility, the Waste Feed Delivery program has requested that tank samples obtained for Compatibility also be analyzed to confirm the high-level waste and/or low-activity waste envelope(s) for the tank waste (Baldwin 1999). The analytical requirements tomore » confirm waste envelopes are identified in Data Quality Objectives for TWRS Privatization Phase I: Confirm Tank T is an Appropriate Feed Source for Low-Activity Waste Feed Batch X (Nguyen 1999a) and Data Quality Objectives for RPP Privatization Phase I: Confirm Tank T is an Appropriate Feed Source for High-Level Waste Feed Batch X (Nguyen 1999b).« less

Statistical analysis of stream water-quality data and sampling network design near Oklahoma City, central Oklahoma, 1977-1999

USGS Publications Warehouse

Brigham, Mark E.; Payne, Gregory A.; Andrews, William J.; Abbott, Marvin M.

2002-01-01

The sampling network was evaluated with respect to areal coverage, sampling frequency, and analytical schedules. Areal coverage could be expanded to include one additional watershed that is not part of the current network. A new sampling site on the North Canadian River might be useful because of expanding urbanization west of the city, but sampling at some other sites could be discontinued or reduced based on comparisons of data between the sites. Additional real-time or periodic monitoring for dissolved oxygen may be useful to prevent anoxic conditions in pools behind new low-water dams. The sampling schedules, both monthly and quarterly, are adequate to evaluate trends, but additional sampling during flow extremes may be needed to quantify loads and evaluate water-quality during flow extremes. Emerging water-quality issues may require sampling for volatile organic compounds, sulfide, total phosphorus, chlorophyll-a, Esherichia coli, and enterococci, as well as use of more sensitive laboratory analytical methods for determination of cadmium, mercury, lead, and silver.

[Multisite validation of CDT measurement by the %CDT TIA and the Tina Quant %CDT kits].

PubMed

Boehrer, J L; Cano, Y; Capolaghi, B; Desch, G; Dosbaa, I; Estepa, L; Hennache, B; Schellenberg, F

2007-01-01

The measurement of CDT (Carbohydrate Deficient Transferrin) is an essential biological tool in the diagnosis and follow-up of alcohol abuse. It is also employed as a marker of abstinence for the restitution of driving licences. However, the precision of measurement, and the between laboratory homogeneity of the results are still discussed. The ion exchange followed by immunodetermination of CDT is available in two products, the Tina Quant %CDT (Roche, Mannheim, Germany) and the %CDT TIA (Bio-Rad, Hercules, United States). This multicentre study was undertaken: 1) to evaluate the analytical characteristics of these kits and the homogeneity of the results from one laboratory to another, independently of the method used, 2) to validate the differences between the proposed normal values of both kits, 3) to study the possibility of using commercial control sera as external quality control. Four analytical systems were included in the study (Roche Modular/Hitachi 717, Beckman Coulter Immage and LX20, Dade Behring BNII). Determinations were carried out on pools of sera, commercial control sera, kit controls, and 30 serums of patients. These latter were also analyzed in capillary electrophoresis in order to establish correlations between the techniques. The calibrations were stable over one 2 weeks period. The repeatability of measurements spread out from 3,1% to 24,7%, for a mean value lower than 10%. The commercial control sera provided reliable results, with values adapted to a routine quality control use. The results of the Bio-Rad applications were lower by approximately 20% than those of the Roche application, which justifies the difference of the normal values (2,6% versus 3%), and an identical classification of the patients in at least 27 of the 30 samples. We conclude that the analytical quality of the compared techniques, even if it could be improved, is sufficient to guarantee a good reliability of the results. An external quality control could be proposed by using the control sera that we tested.

Methods of Analysis by the U.S. Geological Survey National Water Quality Laboratory - Determination of Moderate-Use Pesticides and Selected Degradates in Water by C-18 Solid-Phase Extraction and Gas Chromatography/Mass Spectrometry

USGS Publications Warehouse

Sandstrom, Mark W.; Stroppel, Max E.; Foreman, William T.; Schroeder, Michael P.

2001-01-01

A method for the isolation and analysis of 21 parent pesticides and 20 pesticide degradates in natural-water samples is described. Water samples are filtered to remove suspended particulate matter and then are pumped through disposable solid-phase-extraction columns that contain octadecyl-bonded porous silica to extract the analytes. The columns are dried by using nitrogen gas, and adsorbed analytes are eluted with ethyl acetate. Extracted analytes are determined by capillary-column gas chromatography/mass spectrometry with selected-ion monitoring of three characteristic ions. The upper concentration limit is 2 micrograms per liter (?g/L) for most analytes. Single-operator method detection limits in reagent-water samples range from 0.00 1 to 0.057 ?g/L. Validation data also are presented for 14 parent pesticides and 20 degradates that were determined to have greater bias or variability, or shorter holding times than the other compounds. The estimated maximum holding time for analytes in pesticide-grade water before extraction was 4 days. The estimated maximum holding time for analytes after extraction on the dry solid-phase-extraction columns was 7 days. An optional on-site extraction procedure allows for samples to be collected and processed at remote sites where it is difficult to ship samples to the laboratory within the recommended pre-extraction holding time. The method complements existing U.S. Geological Survey Method O-1126-95 (NWQL Schedules 2001 and 2010) by using identical sample preparation and comparable instrument analytical conditions so that sample extracts can be analyzed by either method to expand the range of analytes determined from one water sample.

Analytical methods of the U.S. Geological Survey's New York District Water-Analysis Laboratory

USGS Publications Warehouse

Lawrence, Gregory B.; Lincoln, Tricia A.; Horan-Ross, Debra A.; Olson, Mark L.; Waldron, Laura A.

1995-01-01

The New York District of the U.S. Geological Survey (USGS) in Troy, N.Y., operates a water-analysis laboratory for USGS watershed-research projects in the Northeast that require analyses of precipitation and of dilute surface water and soil water for major ions; it also provides analyses of certain chemical constituents in soils and soil gas samples.This report presents the methods for chemical analyses of water samples, soil-water samples, and soil-gas samples collected in wateshed-research projects. The introduction describes the general materials and technicques for each method and explains the USGS quality-assurance program and data-management procedures; it also explains the use of cross reference to the three most commonly used methods manuals for analysis of dilute waters. The body of the report describes the analytical procedures for (1) solution analysis, (2) soil analysis, and (3) soil-gas analysis. The methods are presented in alphabetical order by constituent. The method for each constituent is preceded by (1) reference codes for pertinent sections of the three manuals mentioned above, (2) a list of the method's applications, and (3) a summary of the procedure. The methods section for each constitutent contains the following categories: instrumentation and equipment, sample preservation and storage, reagents and standards, analytical procedures, quality control, maintenance, interferences, safety considerations, and references. Sufficient information is presented for each method to allow the resulting data to be appropriately used in environmental investigations.

Forensic toxicology.

PubMed

Drummer, Olaf H

2010-01-01

Forensic toxicology has developed as a forensic science in recent years and is now widely used to assist in death investigations, in civil and criminal matters involving drug use, in drugs of abuse testing in correctional settings and custodial medicine, in road and workplace safety, in matters involving environmental pollution, as well as in sports doping. Drugs most commonly targeted include amphetamines, benzodiazepines, cannabis, cocaine and the opiates, but can be any other illicit substance or almost any over-the-counter or prescribed drug, as well as poisons available to the community. The discipline requires high level skills in analytical techniques with a solid knowledge of pharmacology and pharmacokinetics. Modern techniques rely heavily on immunoassay screening analyses and mass spectrometry (MS) for confirmatory analyses using either high-performance liquid chromatography or gas chromatography as the separation technique. Tandem MS has become more and more popular compared to single-stage MS. It is essential that analytical systems are fully validated and fit for the purpose and the assay batches are monitored with quality controls. External proficiency programs monitor both the assay and the personnel performing the work. For a laboratory to perform optimally, it is vital that the circumstances and context of the case are known and the laboratory understands the limitations of the analytical systems used, including drug stability. Drugs and poisons can change concentration postmortem due to poor or unequal quality of blood and other specimens, anaerobic metabolism and redistribution. The latter provides the largest handicap in the interpretation of postmortem results.

External Quality Assessment beyond the analytical phase: an Australian perspective.

PubMed

Badrick, Tony; Gay, Stephanie; McCaughey, Euan J; Georgiou, Andrew

2017-02-15

External Quality Assessment (EQA) is the verification, on a recurring basis, that laboratory results conform to expectations for the quality required for patient care. It is now widely recognised that both the pre- and post-laboratory phase of testing, termed the diagnostic phases, are a significant source of laboratory errors. These errors have a direct impact on both the effectiveness of the laboratory and patient safety. Despite this, Australian laboratories tend to be focussed on very narrow concepts of EQA, primarily surrounding test accuracy, with little in the way of EQA programs for the diagnostic phases. There is a wide range of possibilities for the development of EQA for the diagnostic phases in Australia, such as the utilisation of scenarios and health informatics. Such programs can also be supported through advances in health information and communications technology, including electronic test ordering and clinical decision support systems. While the development of such programs will require consultation and support from the referring doctors, and their format will need careful construction to ensure that the data collected is de-identified and provides education as well as useful and informative data, we believe that there is high value in the development of such programs. Therefore, it is our opinion that all pathology laboratories should strive to be involved in an EQA program in the diagnostic phases to both monitor the diagnostic process and to identify, learn from and reduce errors and near misses in these phases in a timely fashion.

External Quality Assessment beyond the analytical phase: an Australian perspective

PubMed Central

Gay, Stephanie; McCaughey, Euan J.; Georgiou, Andrew

2017-01-01

External Quality Assessment (EQA) is the verification, on a recurring basis, that laboratory results conform to expectations for the quality required for patient care. It is now widely recognised that both the pre- and post-laboratory phase of testing, termed the diagnostic phases, are a significant source of laboratory errors. These errors have a direct impact on both the effectiveness of the laboratory and patient safety. Despite this, Australian laboratories tend to be focussed on very narrow concepts of EQA, primarily surrounding test accuracy, with little in the way of EQA programs for the diagnostic phases. There is a wide range of possibilities for the development of EQA for the diagnostic phases in Australia, such as the utilisation of scenarios and health informatics. Such programs can also be supported through advances in health information and communications technology, including electronic test ordering and clinical decision support systems. While the development of such programs will require consultation and support from the referring doctors, and their format will need careful construction to ensure that the data collected is de-identified and provides education as well as useful and informative data, we believe that there is high value in the development of such programs. Therefore, it is our opinion that all pathology laboratories should strive to be involved in an EQA program in the diagnostic phases to both monitor the diagnostic process and to identify, learn from and reduce errors and near misses in these phases in a timely fashion. PMID:28392728

Method and platform standardization in MRM-based quantitative plasma proteomics.

PubMed

Percy, Andrew J; Chambers, Andrew G; Yang, Juncong; Jackson, Angela M; Domanski, Dominik; Burkhart, Julia; Sickmann, Albert; Borchers, Christoph H

2013-12-16

There exists a growing demand in the proteomics community to standardize experimental methods and liquid chromatography-mass spectrometry (LC/MS) platforms in order to enable the acquisition of more precise and accurate quantitative data. This necessity is heightened by the evolving trend of verifying and validating candidate disease biomarkers in complex biofluids, such as blood plasma, through targeted multiple reaction monitoring (MRM)-based approaches with stable isotope-labeled standards (SIS). Considering the lack of performance standards for quantitative plasma proteomics, we previously developed two reference kits to evaluate the MRM with SIS peptide approach using undepleted and non-enriched human plasma. The first kit tests the effectiveness of the LC/MRM-MS platform (kit #1), while the second evaluates the performance of an entire analytical workflow (kit #2). Here, these kits have been refined for practical use and then evaluated through intra- and inter-laboratory testing on 6 common LC/MS platforms. For an identical panel of 22 plasma proteins, similar concentrations were determined, regardless of the kit, instrument platform, and laboratory of analysis. These results demonstrate the value of the kit and reinforce the utility of standardized methods and protocols. The proteomics community needs standardized experimental protocols and quality control methods in order to improve the reproducibility of MS-based quantitative data. This need is heightened by the evolving trend for MRM-based validation of proposed disease biomarkers in complex biofluids such as blood plasma. We have developed two kits to assist in the inter- and intra-laboratory quality control of MRM experiments: the first kit tests the effectiveness of the LC/MRM-MS platform (kit #1), while the second evaluates the performance of an entire analytical workflow (kit #2). In this paper, we report the use of these kits in intra- and inter-laboratory testing on 6 common LC/MS platforms. This article is part of a Special Issue entitled: Standardization and Quality Control in Proteomics. © 2013.

EMQN/CMGS best practice guidelines for the molecular genetic testing of Huntington disease.

PubMed

Losekoot, Monique; van Belzen, Martine J; Seneca, Sara; Bauer, Peter; Stenhouse, Susan A R; Barton, David E

2013-05-01

Huntington disease (HD) is caused by the expansion of an unstable polymorphic trinucleotide (CAG)n repeat in exon 1 of the HTT gene, which translates into an extended polyglutamine tract in the protein. Laboratory diagnosis of HD involves estimation of the number of CAG repeats. Molecular genetic testing for HD is offered in a wide range of laboratories both within and outside the European community. In order to measure the quality and raise the standard of molecular genetic testing in these laboratories, the European Molecular Genetics Quality Network has organized a yearly external quality assessment (EQA) scheme for molecular genetic testing of HD for over 10 years. EQA compares a laboratory's output with a fixed standard both for genotyping and reporting of the results to the referring physicians. In general, the standard of genotyping is very high but the clarity of interpretation and reporting of the test result varies more widely. This emphasizes the need for best practice guidelines for this disorder. We have therefore developed these best practice guidelines for genetic testing for HD to assist in testing and reporting of results. The analytical methods and the potential pitfalls of molecular genetic testing are highlighted and the implications of the different test outcomes for the consultand and his or her family members are discussed.

Collaborative study on saccharide quantification of the Haemophilus influenzae type b component in liquid vaccine presentations.

PubMed

Rosskopf, U; Daas, A; Terao, E; von Hunolstein, C

2017-01-01

Before release onto the market, it must be demonstrated that the total and free polysaccharide (poly ribosyl-ribitol-phosphate, PRP) content of Haemophilus influenzae type b (Hib) vaccine complies with requirements. However, manufacturers use different methods to assay PRP content: a national control laboratory must establish and validate the relevant manufacturer methodology before using it to determine PRP content. An international study was organised by the World Health Organization (WHO), in collaboration with the Biological Standardisation Programme (BSP) of the Council of Europe/European Directorate for the Quality of Medicines & HealthCare (EDQM) and of the European Union Commission, to verify the suitability of a single method for determining PRP content in liquid pentavalent vaccines (DTwP-HepB-Hib) containing a whole-cell pertussis component. It consists of HCl hydrolysis followed by chromatographic separation and quantification of ribitol on a CarboPac MA1 column using high-performance anion exchange chromatography coupled with pulsed amperometric detection (HPAEC-PAD). The unconjugated, free, PRP is separated from the total PRP using C4 solid-phase extraction cartridges (SPE C4). Ten quality control laboratories performed two independent analyses applying the proposed analytical test protocol to five vaccine samples, including a vaccine lot with sub-potent PRP content and very high free PRP content. Both WHO PRP standard and ribitol reference standard were included as calibrating standards. A significant bias between WHO PRP standard and ribitol reference standard was observed. Study results showed that the proposed analytical method is, in principle, suitable for the intended use provided that a validation is performed as usually expected from quality control laboratories.

Mechanisms and kinetics of cellulose fermentation for protein production

NASA Technical Reports Server (NTRS)

Dunlap, C. A.

1971-01-01

The development of a process (and ancillary processing and analytical techniques) to produce bacterial single-cell protein of good nutritional quality from waste cellulose is discussed. A fermentation pilot plant and laboratory were developed and have been in operation for about two years. Single-cell protein (SCP) can be produced from sugarcane bagasse--a typical agricultural cellulosic waste. The optimization and understanding of this process and its controlling variables are examined. Both batch and continuous fermentation runs have been made under controlled conditions in the 535 liter pilot plant vessel and in the laboratory 14-liter fermenters.

Expert Assessment of Conditions for Accredited Quality Management System Functioning in Testing Laboratories

NASA Astrophysics Data System (ADS)

Mytych, Joanna; Ligarski, Mariusz J.

2018-03-01

The quality management systems compliant with the ISO 9001:2009 have been thoroughly researched and described in detail in the world literature. The accredited management systems used in the testing laboratories and compliant with the ISO/IEC 17025:2005 have been mainly described in terms of the system design and implementation. They have also been investigated from the analytical point of view. Unfortunately, a low number of studies concerned the management system functioning in the accredited testing laboratories. The aim of following study was to assess the management system functioning in the accredited testing laboratories in Poland. On 8 October 2015, 1,213 accredited testing laboratories were present in Poland. They investigated various scientific areas and substances/objects. There are more and more such laboratories that have various problems and different long-term experience when it comes to the implementation, maintenance and improvement of the management systems. The article describes the results of the conducted expert assessment (survey) carried out to examine the conditions for the functioning of a management system in an accredited laboratory. It also focuses on the characteristics of the accredited research laboratories in Poland. The authors discuss the selection of the external and internal conditions that may affect the accredited management system. They show how the experts assessing the selected conditions were chosen. The survey results are also presented.

Results of the U.S. Geological Survey's Analytical Evaluation Program for standard reference samples distributed in March 1999

USGS Publications Warehouse

Farrar, Jerry W.; Chleboun, Kimberly M.

1999-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for 8 standard reference samples -- T-157 (trace constituents), M-150 (major constituents), N-61 (nutrient constituents), N-62 (nutrient constituents), P-32 (low ionic strength constituents), GWT-5 (ground-water trace constituents), GWM- 4 (ground-water major constituents),and Hg-28 (mercury) -- that were distributed in March 1999 to 120 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 111 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the seven reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the 8 standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Critical appraisal in the practice of laboratory medicine.

PubMed

Price, Christopher P; Christenson, Robert H

2016-03-01

Critical appraisal is a key skill employed across the spectrum of laboratory medicine practice. It underpins the use of information that is relevant, of good quality and is meaningful. Relevance is answering the right question for the right patient at the right time, with quality ensuring provision of the right information. Meaningful is making the right decisions in order to deliver the right outcomes. Critical appraisal is about minimizing the risk of bias or 'departures from trueness' in all of the facets of laboratory medicine practice. It can be summarized in four steps: (i) a clear understanding and articulation of the problem being addressed - whether it be an analytical challenge, individual patient care or policymaking; (ii) verifying the methodological approach employed; (iii) assuring the reliability of the results and (iv) ensuring the applicability and implications of the results. Reference is made to a number of checklists that can be used to assist in the process of critical appraisal. © The Author(s) 2015.

Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal.

PubMed

Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M Juliana; Hural, John

2014-07-01

The HIV Vaccine Trials Network (HVTN) is a global network of 28 clinical trial sites dedicated to identifying an effective HIV vaccine. Cryopreservation of high-quality peripheral blood mononuclear cells (PBMC) is critical for the assessment of vaccine-induced cellular immune functions. The HVTN PBMC Quality Management Program is designed to ensure that viable PBMC are processed, stored and shipped for clinical trial assays from all HVTN clinical trial sites. The program has evolved by developing and incorporating best practices for laboratory and specimen quality and implementing automated, web-based tools. These tools allow the site-affiliated processing laboratories and the central Laboratory Operations Unit to rapidly collect, analyze and report PBMC quality data. The HVTN PBMC Quality Management Program includes five key components: 1) Laboratory Assessment, 2) PBMC Training and Certification, 3) Internal Quality Control, 4) External Quality Control (EQC), and 5) Assay Specimen Quality Control. Fresh PBMC processing data is uploaded from each clinical site processing laboratory to a central HVTN Statistical and Data Management Center database for access and analysis on a web portal. Samples are thawed at a central laboratory for assay or specimen quality control and sample quality data is uploaded directly to the database by the central laboratory. Four year cumulative data covering 23,477 blood draws reveals an average fresh PBMC yield of 1.45×10(6)±0.48 cells per milliliter of useable whole blood. 95% of samples were within the acceptable range for fresh cell yield of 0.8-3.2×10(6) cells/ml of usable blood. Prior to full implementation of the HVTN PBMC Quality Management Program, the 2007 EQC evaluations from 10 international sites showed a mean day 2 thawed viability of 83.1% and a recovery of 67.5%. Since then, four year cumulative data covering 3338 specimens used in immunologic assays shows that 99.88% had acceptable viabilities (>66%) for use in cellular assays (mean, 91.46% ±4.5%), and 96.2% had acceptable recoveries (50%-130%) with a mean of recovery of 85.8% ±19.12% of the originally cryopreserved cells. EQC testing revealed that since August 2009, failed recoveries dropped from 4.1% to 1.6% and failed viabilities dropped from 1.0% to 0.3%. The HVTN PBMC quality program provides for laboratory assessment, training and tools for identifying problems, implementing corrective action and monitoring for improvements. These data support the benefits of implementing a comprehensive, web-based PBMC quality program for large clinical trials networks. Copyright © 2014 Elsevier B.V. All rights reserved.

Innovative Technology Development for Comprehensive Air Quality Characterization from Open Burning

DTIC Science & Technology

2012-04-01

Burning/Open Detonation (OB/OD) has been used as a safe, effective , and economic way to demilitarize munitions for energetic material disposal. Field...target analyte i (lb/lb i in ordnance) ERDC-CERL Engineer Research Development Center, Construction Engineering Research Laboratory GC/FID gas ...chromatograph(y) - flame ionization detector GC/MS gas chromatography/mass spectrometry GPS global positioning system ISO International Organization for

Evaluation of quality indicators in a laboratory supporting tertiary cancer care facilities in India.

PubMed

Kumar, Savitha Anil; Jayanna, Prashanth; Prabhudesai, Shilpa; Kumar, Ajai

2014-01-01

To collect and tabulate errors and nonconformities in the preanalytical, analytical, and postanalytical process phases in a diagnostic clinical laboratory that supports a super-specialty cancer center in India, and identify areas of potential improvement in patient services. We collected data from our laboratory during a period of 24 months. Departments in the study included clinical biochemistry, hematology, clinical pathology, microbiology and serology, surgical pathology, and molecular pathology. We had initiated quality assessment based on international standards in our laboratory in 2010, with the aim of obtaining accreditation by national and international governing bodies. We followed the guidelines specified by International Organization for Standardization (ISO) 15189:2007 to identify noncompliant elements of our processes. Among a total of 144,030 specimens that our referral laboratory received during the 2-year period of our study, we uncovered an overall error rate for all 3 process phases of 1.23%; all of our error rates closely approximated the results from our peer institutions. Errors were most common in the preanalytical phase in both years of study; preanalytical- and postanalytical-phase errors constituted more than 90% of all errors. Further improvements are warranted in laboratory services and are contingent on adequate training and interdepartmental communication and cooperation. Copyright© by the American Society for Clinical Pathology (ASCP).

A generalized analytical model for radiative transfer in vacuum thermal insulation of space vehicles

NASA Astrophysics Data System (ADS)

Krainova, Irina V.; Dombrovsky, Leonid A.; Nenarokomov, Aleksey V.; Budnik, Sergey A.; Titov, Dmitry M.; Alifanov, Oleg M.

2017-08-01

The previously developed spectral model for radiative transfer in vacuum thermal insulation of space vehicles is generalized to take into account possible thermal contact between a fibrous spacer and one of the neighboring aluminum foil layers. An approximate analytical solution based on slightly modified two-flux approximation for radiative transfer in a semi-transparent fibrous spacer is derived. It was shown that thermal contact between the spacer and adjacent foil may decrease significantly the quality of thermal insulation because of an increase in radiative flux to/from the opposite aluminum foil. Theoretical predictions are confirmed by comparison with new results of laboratory experiments.

Certification of elements in and use of standard reference material 3280 multivitamin/multielement tablets.

PubMed

Turk, Gregory C; Sharpless, Katherine E; Cleveland, Danielle; Jongsma, Candice; Mackey, Elizabeth A; Marlow, Anthony F; Oflaz, Rabia; Paul, Rick L; Sieber, John R; Thompson, Robert Q; Wood, Laura J; Yu, Lee L; Zeisler, Rolf; Wise, Stephen A; Yen, James H; Christopher, Steven J; Day, Russell D; Long, Stephen E; Greene, Ella; Harnly, James; Ho, I-Pin; Betz, Joseph M

2013-01-01

Standard Reference Material 3280 Multivitamin/ Multielement Tablets was issued by the National Institute of Standards and Technology in 2009, and has certified and reference mass fraction values for 13 vitamins, 26 elements, and two carotenoids. Elements were measured using two or more analytical methods at NIST with additional data contributed by collaborating laboratories. This reference material is expected to serve a dual purpose: to provide quality assurance in support of a database of dietary supplement products and to provide a means for analysts, dietary supplement manufacturers, and researchers to assess the appropriateness and validity of their analytical methods and the accuracy of their results.

ASVCP guidelines: quality assurance for point-of-care testing in veterinary medicine.

PubMed

Flatland, Bente; Freeman, Kathleen P; Vap, Linda M; Harr, Kendal E

2013-12-01

Point-of-care testing (POCT) refers to any laboratory testing performed outside the conventional reference laboratory and implies close proximity to patients. Instrumental POCT systems consist of small, handheld or benchtop analyzers. These have potential utility in many veterinary settings, including private clinics, academic veterinary medical centers, the community (eg, remote area veterinary medical teams), and for research applications in academia, government, and industry. Concern about the quality of veterinary in-clinic testing has been expressed in published veterinary literature; however, little guidance focusing on POCT is available. Recognizing this void, the ASVCP formed a subcommittee in 2009 charged with developing quality assurance (QA) guidelines for veterinary POCT. Guidelines were developed through literature review and a consensus process. Major recommendations include (1) taking a formalized approach to POCT within the facility, (2) use of written policies, standard operating procedures, forms, and logs, (3) operator training, including periodic assessment of skills, (4) assessment of instrument analytical performance and use of both statistical quality control and external quality assessment programs, (5) use of properly established or validated reference intervals, (6) and ensuring accurate patient results reporting. Where possible, given instrument analytical performance, use of a validated 13s control rule for interpretation of control data is recommended. These guidelines are aimed at veterinarians and veterinary technicians seeking to improve management of POCT in their clinical or research setting, and address QA of small chemistry and hematology instruments. These guidelines are not intended to be all-inclusive; rather, they provide a minimum standard for maintenance of POCT instruments in the veterinary setting. © 2013 American Society for Veterinary Clinical Pathology and European Society for Veterinary Clinical Pathology.

Validation of QuEChERS analytical technique for organochlorines and synthetic pyrethroids in fruits and vegetables using GC-ECD.

PubMed

Dubey, J K; Patyal, S K; Sharma, Ajay

2018-03-19

In the present day scenario of increasing awareness and concern about the pesticides, it is very important to ensure the quality of data being generated in pesticide residue analysis. To impart confidence in the products, terms like quality assurance and quality control are used as an integral part of quality management. In order to ensure better quality of results in pesticide residue analysis, validation of analytical methods to be used is extremely important. Keeping in view the importance of validation of method, the validation of QuEChERS (quick, easy, cheap, effective, rugged, and safe) a multiresidue method for extraction of 13 organochlorines and seven synthetic pyrethroids in fruits and vegetables followed by GC ECD for quantification was done so as to use this method for analysis of samples received in the laboratory. The method has been validated as per the Guidelines issued by SANCO (French words Sante for Health and Consommateurs for Consumers) in accordance with their document SANCO/XXXX/2013. Various parameters analyzed, viz., linearity, specificity, repeatability, reproducibility, and ruggedness were found to have acceptable values with a per cent RSD of less than 10%. Limit of quantification (LOQ) for the organochlorines was established to be 0.01 and 0.05 mg kg -1 for the synthetic pyrethroids. The uncertainty of the measurement (MU) for all these compounds ranged between 1 and 10%. The matrix-match calibration was used to compensate the matrix effect on the quantification of the compounds. The overall recovery of the method ranged between 80 and 120%. These results demonstrate the applicability and acceptability of this method in routine estimation of pesticide residues of these 20 pesticides in the fruits and vegetables by the laboratory.

Major advances in testing of dairy products: milk component and dairy product attribute testing.

PubMed

Barbano, D M; Lynch, J M

2006-04-01

Milk component analysis is relatively unusual in the field of quantitative analytical chemistry because an analytical test result determines the allocation of very large amounts of money between buyers and sellers of milk. Therefore, there is high incentive to develop and refine these methods to achieve a level of analytical performance rarely demanded of most methods or laboratory staff working in analytical chemistry. In the last 25 yr, well-defined statistical methods to characterize and validate analytical method performance combined with significant improvements in both the chemical and instrumental methods have allowed achievement of improved analytical performance for payment testing. A shift from marketing commodity dairy products to the development, manufacture, and marketing of value added dairy foods for specific market segments has created a need for instrumental and sensory approaches and quantitative data to support product development and marketing. Bringing together sensory data from quantitative descriptive analysis and analytical data from gas chromatography olfactometry for identification of odor-active compounds in complex natural dairy foods has enabled the sensory scientist and analytical chemist to work together to improve the consistency and quality of dairy food flavors.

Body fluid analysis: clinical utility and applicability of published studies to guide interpretation of today's laboratory testing in serous fluids.

PubMed

Block, Darci R; Algeciras-Schimnich, Alicia

2013-01-01

Requests for testing various analytes in serous fluids (e.g., pleural, peritoneal, pericardial effusions) are submitted daily to clinical laboratories. Testing of these fluids deviates from assay manufacturers' specifications, as most laboratory assays are optimized for testing blood or urine specimens. These requests add a burden to clinical laboratories, which need to validate assay performance characteristics in these fluids to exclude matrix interferences (given the different composition of body fluids) while maintaining regulatory compliance. Body fluid testing for a number of analytes has been reported in the literature; however, understanding the clinical utility of these analytes is critical because laboratories must address the analytic and clinical validation requirements, while educating clinicians on proper test utilization. In this article, we review the published data to evaluate the clinical utility of testing for numerous analytes in body fluid specimens. We also highlight the pre-analytic and analytic variables that need to be considered when reviewing published studies in body fluid testing. Finally, we provide guidance on how published studies might (or might not) guide interpretation of test results in today's clinical laboratories.

External quality-assurance results for the national atmospheric deposition program/national trends network, 2000-2001

USGS Publications Warehouse

Wetherbee, Gregory A.; Latysh, Natalie E.; Gordon, John D.

2004-01-01

Five external quality-assurance programs were operated by the U.S. Geological Survey for the National Atmospheric Deposition Program/National Trends Network (NADP/NTN) from 2000 through 2001 (study period): the intersite-comparison program, the blind-audit program, the field-audit program, the interlaboratory-comparison program, and the collocated-sampler program. Each program is designed to measure specific components of the total error inherent in NADP/NTN wet-deposition measurements. The intersite-comparison program assesses the variability and bias of pH and specific-conductance determinations made by NADP/NTN site operators with respect to accuracy goals. The accuracy goals are statistically based using the median of all of the measurements obtained for each of four intersite-comparison studies. The percentage of site operators responding on time that met the pH accuracy goals ranged from 84.2 to 90.5 percent. In these same four intersite-comparison studies, 88.9 to 99.0 percent of the site operators met the accuracy goals for specific conductance. The blind-audit program evaluates the effects of routine sample handling, processing, and shipping on the chemistry of weekly precipitation samples. The blind-audit data for the study period indicate that sample handling introduced a small amount of sulfate contamination and slight changes to hydrogen-ion content of the precipitation samples. The magnitudes of the paired differences are not environmentally significant to NADP/NTN data users. The field-audit program (also known as the 'field-blank program') was designed to measure the effects of field exposure, handling, and processing on the chemistry of NADP/NTN precipitation samples. The results indicate potential low-level contamination of NADP/NTN samples with calcium, ammonium, chloride, and nitrate. Less sodium contamination was detected by the field-audit data than in previous years. Statistical analysis of the paired differences shows that contaminant ions are entrained into the solutions from the field-exposed buckets, but the positive bias that results from the minor amount of contamination appears to affect the analytical results by less than 6 percent. An interlaboratory-comparison program is used to estimate the analytical variability and bias of participating laboratories, especially the NADP Central Analytical Laboratory (CAL). Statistical comparison of the analytical results of participating laboratories implies that analytical data from the various monitoring networks can be compared. Bias was identified in the CAL data for ammonium, chloride, nitrate, sulfate, hydrogen-ion, and specific-conductance measurements, but the absolute value of the bias was less than analytical minimum reporting limits for all constituents except ammonium and sulfate. Control charts show brief time periods when the CAL's analytical precision for sodium, ammonium, and chloride was not within the control limits. Data for the analysis of ultrapure deionized-water samples indicated that the laboratories are maintaining good control of laboratory contamination. Estimated analytical precision among the laboratories indicates that the magnitudes of chemical-analysis errors are not environmentally significant to NADP data users. Overall precision of the precipitation-monitoring system used by the NADP/NTN was estimated by evaluation of samples from collocated monitoring sites at CA99, CO08, and NH02. Precision defined by the median of the absolute percent difference (MAE) was estimated to be approximately 10 percent or less for calcium, magnesium, sodium, chloride, nitrate, sulfate, specific conductance, and sample volume. The MAE values for ammonium and hydrogen-ion concentrations were estimated to be less than 10 percent for CA99 and NH02 but nearly 20 percent for ammonium concentration and about 17 percent for hydrogen-ion concentration for CO08. As in past years, the variability in the collocated-site data for sam

Medical immunology: two-way bridge connecting bench and bedside.

PubMed

Rijkers, Ger T; Damoiseaux, Jan G M C; Hooijkaas, Herbert

2014-12-01

Medical immunology in The Netherlands is a laboratory specialism dealing with immunological analyses as well as pre- and post-analytical consultation to clinicians (clinical immunologists and other specialists) involved in patients with immune mediated diseases. The scope of medical immunology includes immunodeficiencies, autoimmune diseases, allergy, transfusion and transplantation immunology, and lymphoproliferative disorders plus the monitoring of these patients. The training, professional criteria, quality control of procedures and laboratories is well organized. As examples of the bridge function of medical immunology between laboratory (bench) and patient (bedside) the contribution of medical immunologists to diagnosis and treatment of primary immunodeficiency diseases (in particular: humoral immunodeficiencies) as well as autoantibodies (anti-citrullinated proteins in rheumatoid arthritis) are given. Copyright © 2014 Elsevier B.V. All rights reserved.

Technical requirements for bioassay support services

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hickman, D.P.; Anderson, A.L.

1991-05-01

This document provides the technical basis for the Chem-Nuclear Geotech (Geotech) bioassay program. It includes information and details that can be used as a model in providing technical contents and requirements for bioassay laboratory support, either internally or in solicitations by Geotech to obtain subcontractor laboratory support. It provides a detailed summary and description of the types of bioassay samples to be expected in support of Geotech remedial projects for the US Department of Energy and the bioassay services and analytical requirements necessary to process such samples, including required limits of sensitivity. General responsibilities of the bioassay laboratory are alsomore » addressed, including quality assurance. Peripheral information of importance to the program is included in the appendices of this document. 7 tabs.« less

Multi-Agency Radiological Laboratory Analytical Protocols Manual (MARLAP)

EPA Pesticide Factsheets

The Multi-Agency Radiological Laboratory Analytical Protocols Manual (MARLAP) provides guidance for the planning, implementation and assessment phases of projects that require laboratory analysis of radionuclides.

Gap Analysis for Chinese Drug Control Institutes to Achieve the Standards of World Health Organization Medicine Prequalification.

PubMed

Mao, Xin; Yang, Yue

2017-02-01

The study aims to explore the challenges and the gaps faced by Chinese Drug Control Institutes in achieving the standards of World Health Organization (WHO) Medicine Prequalification. The study was undertaken with 6 Provincial Drug Control Institutes in China from November 2012 to November 2013. The study assessed key elements required to comply with WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL). For GPPQCL, the study found gaps in quality management system, control of documentation, data-processing equipment, premises and equipment, contracts, reagents (water), reference substances and reference materials, calibration, verification of performance and qualification of equipment, instruments and other devices, analytical worksheet, evaluation of test results, personnel, and validation of analytical procedures. The study indicates that gaps are attributed to differences between the standards of Chinese Accreditation Standards and WHO-GPPQCL. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Planned Variation in Preanalytical Conditions to Evaluate Biospecimen Stability in the National Children’s Study (NCS)

PubMed Central

Mechanic, Leah; Mendez, Armando; Merrill, Lori; Rogers, John; Layton, Marnie; Todd, Deborah; Varanasi, Arti; O’Brien, Barbara; Meyer, William A.; Zhang, Ming; Schleicher, Rosemary L.; Moye, Jack

2014-01-01

BACKGROUND Preanalytical conditions encountered during collection, processing, and storage of biospecimens may influence laboratory results. The National Children’s Study (NCS) is a planned prospective cohort study of 100,000 families to examine the influence of a wide variety of exposures on child health. In developing biospecimen collection, processing, and storage procedures for the NCS, we identified several analytes of different biochemical categories for which it was unclear to what extent deviations from NCS procedures could influence measurement results. METHODS A pilot study was performed to examine effects of preanalytic sample handling conditions (delays in centrifugation, freezing delays, delays in separation from cells, additive delay, and tube type) on concentrations of eight different analytes. 2,825 measurements were made to assess 15 unique combinations of analyte and handling conditions in blood collected from 151 women of childbearing age (≥20 individuals per handling condition). RESULTS The majority of analytes were stable under the conditions evaluated. However, levels of plasma interleukin-6 and serum insulin were decreased in response to sample centrifugation delays of up to 5.5 hours post collection (P<0.0001). In addition, delays in freezing centrifuged plasma samples (comparing 24, 48 and 72 hours to immediate freezing) resulted in increased levels of adrenocorticotropic hormone (P=0.0014). CONCLUSIONS Determining stability of proposed analytes in response to preanalytical conditions and handling helps to ensure high-quality specimens for study now and in the future. The results inform development of procedures, plans for measurement of analytes, and interpretation of laboratory results. PMID:23924524

Assessing inter-laboratory comparability and limits of determination for the analysis of cyclic volatile methyl siloxanes in whole Rainbow Trout (Oncorhynchus mykiss).

PubMed

McGoldrick, Daryl J; Durham, Jeremy; Leknes, Henriette; Kierkegaard, Amelie; Gerhards, Reinhard; Powell, David E; McLachlan, Michael S

2011-11-01

Cyclic volatile methyl siloxanes (cVMS) are high volume production chemicals used in a wide range of industrial and consumer products. Three cVMS compounds (D4, D5, and D6) have and are undergoing environmental risk evaluations in several countries and have been proposed for legal regulation in Canada. As interest in monitoring concentrations of these chemicals in the environment increase, there is a need to evaluate the analytical procedures for cVMS in biological matrices in order to assess the quality of data produced. The purpose of this study was to determine laboratory testing performance for measuring residues of D4, D5, and D6 in a standard set of fish homogenate samples and to estimate limits of determination for each substance. The samples sent to each laboratory consisted of homogenized whole body tissues of hatchery raised rainbow trout which were fed food fortified with D4, D5, and D6 (dosed) and trout that were fed standard food rations (control). The participants analyzed each sample using their analytical method of choice using their own standards and procedures for quantification and quality control. With a few exceptions, participating laboratories generated comparable results for D4, D5, and D6 in both the dosed and control samples having z-scores between 2 and -2. Method detection limits for the whole fish matrix were on average 2.4 ng g(-1) ww for D4, 2.3 ng g(-1) ww for D5, and 1.8 ng g(-1) ww for D6. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

Cost effectiveness of adopted quality requirements in hospital laboratories.

PubMed

Hamza, Alneil; Ahmed-Abakur, Eltayib; Abugroun, Elsir; Bakhit, Siham; Holi, Mohamed

2013-01-01

The present study was designed in quasi-experiment to assess adoption of the essential clauses of particular clinical laboratory quality management requirements based on international organization for standardization (ISO 15189) in hospital laboratories and to evaluate the cost effectiveness of compliance to ISO 15189. The quality management intervention based on ISO 15189 was conceded through three phases; pre - intervention phase, Intervention phase and Post-intervention phase. In pre-intervention phase the compliance to ISO 15189 was 49% for study group vs. 47% for control group with P value 0.48, while the post intervention results displayed 54% vs. 79% for study group and control group respectively in compliance to ISO 15189 and statistically significant difference (P value 0.00) with effect size (Cohen's d) of (0.00) in pre-intervention phase and (0.99) in post - intervention phase. The annual average cost per-test for the study group and control group was 1.80 ± 0.25 vs. 1.97 ± 0.39, respectively with P value 0.39 whereas the post-intervention results showed that the annual average total costs per-test for study group and control group was 1.57 ± 0.23 vs 2.08 ± 0.38, P value 0.019 respectively, with cost-effectiveness ratio of (0.88) in pre -intervention phase and (0.52) in post-intervention phase. The planned adoption of quality management requirements (QMS) in clinical laboratories had great effect to increase the compliance percent with quality management system requirement, raise the average total cost effectiveness, and improve the analytical process capability of the testing procedure.

[Evaluation of the quality of clinical practice guidelines published in the Annales de Biologie Clinique with the help of the EFLM checklist].

PubMed

Wils, Julien; Fonfrède, Michèle; Augereau, Christine; Watine, Joseph

2014-01-01

Several tools are available to help evaluate the quality of clinical practice guidelines (CPG). The AGREE instrument (Appraisal of guidelines for research & evaluation) is the most consensual tool but it has been designed to assess CPG methodology only. The European federation of laboratory medicine (EFLM) recently designed a check-list dedicated to laboratory medicine which is supposed to be comprehensive and which therefore makes it possible to evaluate more thoroughly the quality of CPG in laboratory medicine. In the present work we test the comprehensiveness of this check-list on a sample of CPG written in French and published in Annales de biologie clinique (ABC). Thus we show that some work remains to be achieved before a truly comprehensive check-list is designed. We also show that there is some room for improvement for the CPG published in ABC, for example regarding the fact that some of these CPG do not provide any information about allowed durations of transport and of storage of biological samples before analysis, or about standards of minimal analytical performance, or about the sensitivities or the specificities of the recommended tests.

College of American Pathologists' laboratory standards for next-generation sequencing clinical tests.

PubMed

Aziz, Nazneen; Zhao, Qin; Bry, Lynn; Driscoll, Denise K; Funke, Birgit; Gibson, Jane S; Grody, Wayne W; Hegde, Madhuri R; Hoeltge, Gerald A; Leonard, Debra G B; Merker, Jason D; Nagarajan, Rakesh; Palicki, Linda A; Robetorye, Ryan S; Schrijver, Iris; Weck, Karen E; Voelkerding, Karl V

2015-04-01

The higher throughput and lower per-base cost of next-generation sequencing (NGS) as compared to Sanger sequencing has led to its rapid adoption in clinical testing. The number of laboratories offering NGS-based tests has also grown considerably in the past few years, despite the fact that specific Clinical Laboratory Improvement Amendments of 1988/College of American Pathologists (CAP) laboratory standards had not yet been developed to regulate this technology. To develop a checklist for clinical testing using NGS technology that sets standards for the analytic wet bench process and for bioinformatics or "dry bench" analyses. As NGS-based clinical tests are new to diagnostic testing and are of much greater complexity than traditional Sanger sequencing-based tests, there is an urgent need to develop new regulatory standards for laboratories offering these tests. To develop the necessary regulatory framework for NGS and to facilitate appropriate adoption of this technology for clinical testing, CAP formed a committee in 2011, the NGS Work Group, to deliberate upon the contents to be included in the checklist. Results . -A total of 18 laboratory accreditation checklist requirements for the analytic wet bench process and bioinformatics analysis processes have been included within CAP's molecular pathology checklist (MOL). This report describes the important issues considered by the CAP committee during the development of the new checklist requirements, which address documentation, validation, quality assurance, confirmatory testing, exception logs, monitoring of upgrades, variant interpretation and reporting, incidental findings, data storage, version traceability, and data transfer confidentiality.

Evolution of a residue laboratory network and the management tools for monitoring its performance.

PubMed

Lins, E S; Conceição, E S; Mauricio, A De Q

2012-01-01

Since 2005 the National Residue & Contaminants Control Plan (NRCCP) in Brazil has been considerably enhanced, increasing the number of samples, substances and species monitored, and also the analytical detection capability. The Brazilian laboratory network was forced to improve its quality standards in order to comply with the NRCP's own evolution. Many aspects such as the limits of quantification (LOQs), the quality management systems within the laboratories and appropriate method validation are in continuous improvement, generating new scenarios and demands. Thus, efficient management mechanisms for monitoring network performance and its adherence to the established goals and guidelines are required. Performance indicators associated to computerised information systems arise as a powerful tool to monitor the laboratories' activity, making use of different parameters to describe this activity on a day-to-day basis. One of these parameters is related to turnaround times, and this factor is highly affected by the way each laboratory organises its management system, as well as the regulatory requirements. In this paper a global view is presented of the turnaround times related to the type of analysis, laboratory, number of samples per year, type of matrix, country region and period of the year, all these data being collected from a computerised system called SISRES. This information gives a solid background to management measures aiming at the improvement of the service offered by the laboratory network.

Method of analysis at the U.S. Geological Survey California Water Science Center, Sacramento Laboratory - determination of haloacetic acid formation potential, method validation, and quality-control practices

USGS Publications Warehouse

Zazzi, Barbara C.; Crepeau, Kathryn L.; Fram, Miranda S.; Bergamaschi, Brian A.

2005-01-01

An analytical method for the determination of haloacetic acid formation potential of water samples has been developed by the U.S. Geological Survey California Water Science Center Sacramento Laboratory. The haloacetic acid formation potential is measured by dosing water samples with chlorine under specified conditions of pH, temperature, incubation time, darkness, and residual-free chlorine. The haloacetic acids formed are bromochloroacetic acid, bromodichloroacetic acid, dibromochloroacetic acid, dibromoacetic acid, dichloroacetic acid, monobromoacetic acid, monochloroacetic acid, tribromoacetic acid, and trichloroacetic acid. They are extracted, methylated, and then analyzed using a gas chromatograph equipped with an electron capture detector. Method validation experiments were performed to determine the method accuracy, precision, and detection limit for each of the compounds. Method detection limits for these nine haloacetic acids ranged from 0.11 to 0.45 microgram per liter. Quality-control practices include the use of blanks, quality-control samples, calibration verification standards, surrogate recovery, internal standard, matrix spikes, and duplicates.

42 CFR 493.959 - Immunohematology.

Code of Federal Regulations, 2014 CFR

2014-10-01

... challenges per testing event a program must provide for each analyte or test procedure is five. Analyte or... Compatibility testing Antibody identification (d) Evaluation of a laboratory's analyte or test performance. HHS... program must compare the laboratory's response for each analyte with the response that reflects agreement...

42 CFR 493.959 - Immunohematology.

Code of Federal Regulations, 2013 CFR

2013-10-01

... challenges per testing event a program must provide for each analyte or test procedure is five. Analyte or... Compatibility testing Antibody identification (d) Evaluation of a laboratory's analyte or test performance. HHS... program must compare the laboratory's response for each analyte with the response that reflects agreement...

42 CFR 493.959 - Immunohematology.

Code of Federal Regulations, 2012 CFR

2012-10-01

... challenges per testing event a program must provide for each analyte or test procedure is five. Analyte or... Compatibility testing Antibody identification (d) Evaluation of a laboratory's analyte or test performance. HHS... program must compare the laboratory's response for each analyte with the response that reflects agreement...

42 CFR 493.959 - Immunohematology.

Code of Federal Regulations, 2011 CFR

2011-10-01

... challenges per testing event a program must provide for each analyte or test procedure is five. Analyte or... Compatibility testing Antibody identification (d) Evaluation of a laboratory's analyte or test performance. HHS... program must compare the laboratory's response for each analyte with the response that reflects agreement...

Results of the U.S. Geological Survey's Analytical Evaluation Program for standard reference samples: T-155 (trace constituents), M-148 (major constituents), N-59 (nutrient constituents), N-60 (nutrient constituents), P-31 (low ionic strength constituents), GWT-4 (ground-water trace constituents) and Hg-27 (Mercury) distributed in September 1998

USGS Publications Warehouse

Farrar, Jerry W.

1999-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for seven standard reference samples -- T-155 (trace constituents), M-148 (major constituents), N-59 (nutrient constituents), N-60 (nutrient constituents), P-31 (low ionic strength constituents), GWT-4 (ground-water trace constituents), and Hg- 27 (mercury) -- which were distributed in September 1998 to 162 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 136 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the seven reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the seven standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Green, D.W.; Heinrich, R.R.; Graczyk, D.G.

The purpose of this report is to summarize the activities of the Analytical Chemistry Laboratory (ACL) at Argonne National Laboratory (ANL) for fiscal year 1988 (October 1987 through September 1988). The Analytical Chemistry Laboratory is a full-cost recovery service center, with the primary mission of providing a broad range of analytical chemistry support services to the scientific and engineering programs at ANL. In addition, the ACL conducts a research program in analytical chemistry, works on instrumental and methods development, and provides analytical services for governmental, educational, and industrial organizations. The ACL handles a wide range of analytical problems, from routinemore » standard analyses to unique problems that require significant development of methods and techniques.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

Green, D.W.; Heinrich, R.R.; Graczyk, D.G.

The purpose of this report is to summarize the activities of the Analytical Chemistry Laboratory (ACL) at Argonne National Laboratory (ANL) for Fiscal Year 1989 (October 1988 through September 1989). The Analytical Chemistry Laboratory is a full-cost-recovery service center, with the primary mission of providing a broad range of analytical chemistry support services to the scientific and engineering programs at ANL. In addition, the ACL conducts a research program in analytical chemistry, works on instrumental and methods development, and provides analytical services for governmental, educational, and industrial organizations. The ACL handles a wide range of analytical problems, from routine standardmore » analyses to unique problems that require significant development of methods and techniques.« less

Report on the U.S. Geological Survey's Evaluation Program Standard Reference Samples Distributed in October 1995: T-137 (Trace Constituents), M-136 (Major Constituents), N-47 (Nutrient Constituents), N-48 (Nutrient Constituents), P-25 (Low Ionic Strength Constituents), and Hg-21 (Mercury)

USGS Publications Warehouse

Farrar, Jerry W.; Long, H. Keith

1996-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for 6 standard reference samples--T-137 (trace constituents), M-136 (major constituents), N-47 (nutrient constituents), N-48 (nutrient constituents), P-25 (low ionic strength constituents), and Hg-21 (mercury)--that were distributed in October 1995 to 149 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 136 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Report on the U.S. Geological Survey's evaluation program for standard reference samples distributed in April 1994; T-129 (trace constituents), M-130 (major constituents), N-42 (nutrients), P-22 (low ionic strength), and Hg-18 (mercury)

USGS Publications Warehouse

Long, H. Keith; Farrar, Jerry W.

1994-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for five standard reference samples--T-129 (trace constituents), M-130 (major constituents), N-42 (nutrients), P-22 (low ionic strength), Hg-18(mercury),--that were distributed in April 1994 to 157 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 133 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the five reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the five standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Report of the U.S. Geological Survey's evaluation program for standard reference samples distributed in April 1993; T-123 (trace constituents), T-125 (trace constituents), M-126 (major constituents, N-38 (nutrients), N-39 (nutrients), P-20 (low ionic strength, and Hg-16 (mercury)

USGS Publications Warehouse

Long, H.K.; Farrar, J.W.

1993-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for seven standard reference samples--T-123 (trace constituents), T-125 (trace constituents), M-126 (major constituents), N-38 (nutrients), N-39 (Nutrients), P-20 (precipitation-low ionic strength), and Hg-16 (mercury)--that were distributed in April 1993 to 175 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 131 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the 7 reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the seven standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Laboratory performance in the Sediment Laboratory Quality-Assurance Project, 1996-98

USGS Publications Warehouse

Gordon, John D.; Newland, Carla A.; Gagliardi, Shane T.

2000-01-01

Analytical results from all sediment quality-control samples are compiled and statistically summarized by the USGS, Branch of Quality Systems, both on an intra- and interlaboratory basis. When evaluating these data, the reader needs to keep in mind that every measurement has an error component associated with it. It is premature to use the data from the first five SLQA studies to judge any of the laboratories as performing in an unacceptable manner. There were, however, some notable differences in the results for the 12 laboratories that participated in the five SLQA studies. For example, the overall median percent difference for suspended-sediment concentration on an individual laboratory basis ranged from –18.04 to –0.33 percent. Five of the 12 laboratories had an overall median percent difference for suspended-sediment concentration of –2.02 to –0.33 percent. There was less variability in the median difference for the measured fine-size material mass. The overall median percent difference for fine-size material mass ranged from –10.11 to –4.27 percent. Except for one laboratory, the median difference for fine-size material mass was within a fairly narrow range of –6.76 to –4.27 percent. The median percent difference for sand-size material mass differed among laboratories more than any other physical sediment property measured in the study. The overall median percent difference for the sand-size material mass ranged from –1.49 percent to 26.39 percent. Five of the nine laboratories that do sand/fine separations had overall median percent differences that ranged from –1.49 to 2.98 percent for sand-size material mass. Careful review of the data reveals that certain laboratories consistently produced data within statistical control limits for some or all of the physical sediment properties measured in this study, whereas other laboratories occasionally produced data that exceeded the control limits.

Focused Feasibility Study Final Field Sampling Plan

DTIC Science & Technology

1993-10-01

baseline of groundwater chemistry prior to commencing additional environmental investigations of the area. Work for Phase I of the FFS is designed lo...investigations and remedial feasibility investigations at Beach Point. The groundwater data will also be used to aid in the design of any groundwater extraction...approved laboratories. The analytical data will be the equivalent of EPA Level IV data. This level of data quality has been established for environmental

23. VIEW OF THE FIRST FLOOR PLAN. THE FIRST FLOOR ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

23. VIEW OF THE FIRST FLOOR PLAN. THE FIRST FLOOR HOUSED ADMINISTRATIVE OFFICES, THE CENTRAL COMPUTING, UTILITY SYSTEMS, ANALYTICAL LABORATORIES, AND MAINTENANCE SHOPS. THE ORIGINAL DRAWING HAS BEEN ARCHIVED ON MICROFILM. THE DRAWING WAS REPRODUCED AT THE BEST QUALITY POSSIBLE. LETTERS AND NUMBERS IN THE CIRCLES INDICATE FOOTER AND/OR COLUMN LOCATIONS. - Rocky Flats Plant, General Manufacturing, Support, Records-Central Computing, Southern portion of Plant, Golden, Jefferson County, CO

Quality specifications for the extra-analytical phase of laboratory testing: Reference intervals and decision limits.

PubMed

Ceriotti, Ferruccio

2017-07-01

Reference intervals and decision limits are a critical part of the clinical laboratory report. The evaluation of their correct use represents a tool to verify the post analytical quality. Four elements are identified as indicators. 1. The use of decision limits for lipids and glycated hemoglobin. 2. The use, whenever possible, of common reference values. 3. The presence of gender-related reference intervals for at least the following common serum measurands (besides obviously the fertility relate hormones): alkaline phosphatase (ALP), alanine aminotransferase (ALT), creatine kinase (CK), creatinine, gamma-glutamyl transferase (GGT), IgM, ferritin, iron, transferrin, urate, red blood cells (RBC), hemoglobin (Hb) and hematocrit (Hct). 4. The presence of age-related reference intervals. The problem of specific reference intervals for elderly people is discussed, but their use is not recommended; on the contrary it is necessary the presence of pediatric age-related reference intervals at least for the following common serum measurands: ALP, amylase, creatinine, inorganic phosphate, lactate dehydrogenase, aspartate aminotransferase, urate, insulin like growth factor 1, white blood cells, RBC, Hb, Hct, alfa-fetoprotein and fertility related hormones. The lack of such reference intervals may imply significant risks for the patients. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Guidance for laboratories performing molecular pathology for cancer patients

PubMed Central

Cree, Ian A; Deans, Zandra; Ligtenberg, Marjolijn J L; Normanno, Nicola; Edsjö, Anders; Rouleau, Etienne; Solé, Francesc; Thunnissen, Erik; Timens, Wim; Schuuring, Ed; Dequeker, Elisabeth; Murray, Samuel; Dietel, Manfred; Groenen, Patricia; Van Krieken, J Han

2014-01-01

Molecular testing is becoming an important part of the diagnosis of any patient with cancer. The challenge to laboratories is to meet this need, using reliable methods and processes to ensure that patients receive a timely and accurate report on which their treatment will be based. The aim of this paper is to provide minimum requirements for the management of molecular pathology laboratories. This general guidance should be augmented by the specific guidance available for different tumour types and tests. Preanalytical considerations are important, and careful consideration of the way in which specimens are obtained and reach the laboratory is necessary. Sample receipt and handling follow standard operating procedures, but some alterations may be necessary if molecular testing is to be performed, for instance to control tissue fixation. DNA and RNA extraction can be standardised and should be checked for quality and quantity of output on a regular basis. The choice of analytical method(s) depends on clinical requirements, desired turnaround time, and expertise available. Internal quality control, regular internal audit of the whole testing process, laboratory accreditation, and continual participation in external quality assessment schemes are prerequisites for delivery of a reliable service. A molecular pathology report should accurately convey the information the clinician needs to treat the patient with sufficient information to allow for correct interpretation of the result. Molecular pathology is developing rapidly, and further detailed evidence-based recommendations are required for many of the topics covered here. PMID:25012948

Post-standardization of routine creatinine assays: are they suitable for clinical applications.

PubMed

Jassam, Nuthar; Weykamp, Cas; Thomas, Annette; Secchiero, Sandra; Sciacovelli, Laura; Plebani, Mario; Thelen, Marc; Cobbaert, Christa; Perich, Carmen; Ricós, Carmen; Paula, Faria A; Barth, Julian H

2017-05-01

Introduction Reliable serum creatinine measurements are of vital importance for the correct classification of chronic kidney disease and early identification of kidney injury. The National Kidney Disease Education Programme working group and other groups have defined clinically acceptable analytical limits for creatinine methods. The aim of this study was to re-evaluate the performance of routine creatinine methods in the light of these defined limits so as to assess their suitability for clinical practice. Method In collaboration with the Dutch External Quality Assurance scheme, six frozen commutable samples, with a creatinine concentration ranging from 80 to 239  μmol/L and traceable to isotope dilution mass spectrometry, were circulated to 91 laboratories in four European countries for creatinine measurement and estimated glomerular filtration rate calculation. Two out of the six samples were spiked with glucose to give high and low final concentrations of glucose. Results Results from 89 laboratories were analysed for bias, imprecision (%CV) for each creatinine assay and total error for estimated glomerular filtration rate. The participating laboratories used analytical instruments from four manufacturers; Abbott, Beckman, Roche and Siemens. All enzymatic methods in this study complied with the National Kidney Disease Education Programme working group recommended limits of bias of 5% above a creatinine concentration of 100  μmol/L. They also did not show any evidence of interference from glucose. In addition, they also showed compliance with the clinically recommended %CV of ≤4% across the analytical range. In contrast, the Jaffe methods showed variable performance with regard to the interference of glucose and unsatisfactory bias and precision. Conclusion Jaffe-based creatinine methods still exhibit considerable analytical variability in terms of bias, imprecision and lack of specificity, and this variability brings into question their clinical utility. We believe that clinical laboratories and manufacturers should work together to phase out the use of relatively non-specific Jaffe methods and replace them with more specific methods that are enzyme based.

International Space Station Potable Water Characterization for 2013

NASA Technical Reports Server (NTRS)

Straub, John E., II; Plumlee, Debrah K.; Schultz, John R.; Mudgett, Paul D.

2014-01-01

In this post-construction, operational phase of International Space Station (ISS) with an ever-increasing emphasis on its use as a test-bed for future exploration missions, the ISS crews continue to rely on water reclamation systems for the majority of their water needs. The onboard water supplies include U.S. Segment potable water from humidity condensate and urine, Russian Segment potable water from condensate, and ground-supplied potable water, as reserve. In 2013, the cargo returned on the Soyuz 32-35 flights included archival potable water samples collected from Expeditions 34-37. The former Water and Food Analytical Laboratory (now Toxicology and Evironmental Chemistry Laboratory) at the NASA Johnson Space Center continued its long-standing role of performing chemical analyses on ISS return water samples to verify compliance with potable water quality specifications. This paper presents and discusses the analytical results for potable water samples returned from Expeditions 34-37, including a comparison to ISS quality standards. During the summer of 2013, the U.S. Segment potable water experienced a third temporary rise and fall in total organic carbon (TOC) content, as the result of organic contamination breaking through the water system's treatment process. Analytical results for the Expedition 36 archival samples returned on Soyuz 34 confirmed that dimethylsilanediol was once again the responsible contaminant, just as it was for the previous comparable TOC rises in 2010 and 2012. Discussion herein includes the use of the in-flight total organic carbon analyzer (TOCA) as a key monitoring tool for tracking these TOC rises and scheduling appropriate remediation.

Data from selected U.S. Geological Survey National Stream Water Quality Monitoring Networks

USGS Publications Warehouse

Alexander, Richard B.; Slack, James R.; Ludtke, Amy S.; Fitzgerald, Kathleen K.; Schertz, Terry L.

1998-01-01

A nationally consistent and well-documented collection of water quality and quantity data compiled during the past 30 years for streams and rivers in the United States is now available on CD-ROM and accessible over the World Wide Web. The data include measurements from two U.S. Geological Survey (USGS) national networks for 122 physical, chemical, and biological properties of water collected at 680 monitoring stations from 1962 to 1995, quality assurance information that describes the sample collection agencies, laboratories, analytical methods, and estimates of laboratory measurement error (bias and variance), and information on selected cultural and natural characteristics of the station watersheds. The data are easily accessed via user-supplied software including Web browser, spreadsheet, and word processor, or may be queried and printed according to user-specified criteria using the supplied retrieval software on CD-ROM. The water quality data serve a variety of scientific uses including research and educational applications related to trend detection, flux estimation, investigations of the effects of the natural environment and cultural sources on water quality, and the development of statistical methods for designing efficient monitoring networks and interpreting water resources data.

The ideal laboratory information system.

PubMed

Sepulveda, Jorge L; Young, Donald S

2013-08-01

Laboratory information systems (LIS) are critical components of the operation of clinical laboratories. However, the functionalities of LIS have lagged significantly behind the capacities of current hardware and software technologies, while the complexity of the information produced by clinical laboratories has been increasing over time and will soon undergo rapid expansion with the use of new, high-throughput and high-dimensionality laboratory tests. In the broadest sense, LIS are essential to manage the flow of information between health care providers, patients, and laboratories and should be designed to optimize not only laboratory operations but also personalized clinical care. To list suggestions for designing LIS with the goal of optimizing the operation of clinical laboratories while improving clinical care by intelligent management of laboratory information. Literature review, interviews with laboratory users, and personal experience and opinion. Laboratory information systems can improve laboratory operations and improve patient care. Specific suggestions for improving the function of LIS are listed under the following sections: (1) Information Security, (2) Test Ordering, (3) Specimen Collection, Accessioning, and Processing, (4) Analytic Phase, (5) Result Entry and Validation, (6) Result Reporting, (7) Notification Management, (8) Data Mining and Cross-sectional Reports, (9) Method Validation, (10) Quality Management, (11) Administrative and Financial Issues, and (12) Other Operational Issues.

Tank Vapor Characterization Project: Tank 241-S-102 fourth temporal study: Headspace gas and vapor characterization results from samples collected on December 19, 1996

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pool, K.H.; Evans, J.C.; Olsen, K.B.

1997-08-01

This report presents the results from analyses of samples taken from the headspace of waste storage tank 241-S-102 (Tank S-102) at the Hanford Site in Washington State. Tank headspace samples collected by SGN Eurisys Service Corporation (SESC) were analyzed by Pacific Northwest National Laboratory (PNNL) to determine headspace concentrations of selected non-radioactive analytes. Analyses were performed by the Vapor Analytical Laboratory (VAL) at PNNL. Vapor concentrations from sorbent trap samples are based on measured sample volumes provided by SESC. Ammonia was determined to be above the immediate notification limit of 150 ppm as specified by the sampling and analysis planmore » (SAP). Hydrogen was the principal flammable constituent of the Tank S-102 headspace, determined to be present at approximately 2.410% of its lower flammability limit (LFL). Total headspace flammability was estimated to be <2.973% of its lower flammability limit (LFL). Total headspace flammability was estimated to be <2.973% of the LFL. Average measured concentrations of targeted gases, inorganic vapors, and selected organic vapors are provided in Table S.1. A summary of experimental methods, including sampling methodology, analytical procedures, and quality assurance and control methods are presented in Section 2.0. Detailed descriptions of the analytical results are provided in Section 3.0.« less

A 'smart' tube holder enables real-time sample monitoring in a standard lab centrifuge.

PubMed

Hoang, Tony; Moskwa, Nicholas; Halvorsen, Ken

2018-01-01

The centrifuge is among the oldest and most widely used pieces of laboratory equipment, with significant applications that include clinical diagnostics and biomedical research. A major limitation of laboratory centrifuges is their "black box" nature, limiting sample observation to before and after centrifugation. Thus, optimized protocols require significant trial and error, while unoptimized protocols waste time by centrifuging longer than necessary or material due to incomplete sedimentation. Here, we developed an instrumented centrifuge tube receptacle compatible with several commercial benchtop centrifuges that can provide real-time sample analysis during centrifugation. We demonstrated the system by monitoring cell separations during centrifugation for different spin speeds, concentrations, buffers, cell types, and temperatures. We show that the collected data are valuable for analytical purposes (e.g. quality control), or as feedback to the user or the instrument. For the latter, we verified an adaptation where complete sedimentation turned off the centrifuge and notified the user by a text message. Our system adds new functionality to existing laboratory centrifuges, saving users time and providing useful feedback. This add-on potentially enables new analytical applications for an instrument that has remained largely unchanged for decades.

A ‘smart’ tube holder enables real-time sample monitoring in a standard lab centrifuge

PubMed Central

Hoang, Tony; Moskwa, Nicholas

2018-01-01

The centrifuge is among the oldest and most widely used pieces of laboratory equipment, with significant applications that include clinical diagnostics and biomedical research. A major limitation of laboratory centrifuges is their “black box” nature, limiting sample observation to before and after centrifugation. Thus, optimized protocols require significant trial and error, while unoptimized protocols waste time by centrifuging longer than necessary or material due to incomplete sedimentation. Here, we developed an instrumented centrifuge tube receptacle compatible with several commercial benchtop centrifuges that can provide real-time sample analysis during centrifugation. We demonstrated the system by monitoring cell separations during centrifugation for different spin speeds, concentrations, buffers, cell types, and temperatures. We show that the collected data are valuable for analytical purposes (e.g. quality control), or as feedback to the user or the instrument. For the latter, we verified an adaptation where complete sedimentation turned off the centrifuge and notified the user by a text message. Our system adds new functionality to existing laboratory centrifuges, saving users time and providing useful feedback. This add-on potentially enables new analytical applications for an instrument that has remained largely unchanged for decades. PMID:29659624

Methodology in diagnostic laboratory test research in clinical chemistry and clinical chemistry and laboratory medicine.

PubMed

Lumbreras-Lacarra, Blanca; Ramos-Rincón, José Manuel; Hernández-Aguado, Ildefonso

2004-03-01

The application of epidemiologic principles to clinical diagnosis has been less developed than in other clinical areas. Knowledge of the main flaws affecting diagnostic laboratory test research is the first step for improving its quality. We assessed the methodologic aspects of articles on laboratory tests. We included articles that estimated indexes of diagnostic accuracy (sensitivity and specificity) and were published in Clinical Chemistry or Clinical Chemistry and Laboratory Medicine in 1996, 2001, and 2002. Clinical Chemistry has paid special attention to this field of research since 1996 by publishing recommendations, checklists, and reviews. Articles were identified through electronic searches in Medline. The strategy combined the Mesh term "sensitivity and specificity" (exploded) with the text words "specificity", "false negative", and "accuracy". We examined adherence to seven methodologic criteria used in the study by Reid et al. (JAMA1995;274:645-51) of papers published in general medical journals. Three observers evaluated each article independently. Seventy-nine articles fulfilled the inclusion criteria. The percentage of studies that satisfied each criterion improved from 1996 to 2002. Substantial improvement was observed in reporting of the statistical uncertainty of indices of diagnostic accuracy, in criteria based on clinical information from the study population (spectrum composition), and in avoidance of workup bias. Analytical reproducibility was reported frequently (68%), whereas information about indeterminate results was rarely provided. The mean number of methodologic criteria satisfied showed a statistically significant increase over the 3 years in Clinical Chemistry but not in Clinical Chemistry and Laboratory Medicine. The methodologic quality of the articles on diagnostic test research published in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine is comparable to the quality observed in the best general medical journals. The methodologic aspects that most need improvement are those linked to the clinical information of the populations studied. Editorial actions aimed to increase the quality of reporting of diagnostic studies could have a relevant positive effect, as shown by the improvement observed in Clinical Chemistry.

Sediment laboratory quality-assurance project: studies of methods and materials

USGS Publications Warehouse

Gordon, J.D.; Newland, C.A.; Gray, J.R.

2001-01-01

In August 1996 the U.S. Geological Survey initiated the Sediment Laboratory Quality-Assurance project. The Sediment Laboratory Quality Assurance project is part of the National Sediment Laboratory Quality-Assurance program. This paper addresses the fmdings of the sand/fme separation analysis completed for the single-blind reference sediment-sample project and differences in reported results between two different analytical procedures. From the results it is evident that an incomplete separation of fme- and sand-size material commonly occurs resulting in the classification of some of the fme-size material as sand-size material. Electron microscopy analysis supported the hypothesis that the negative bias for fme-size material and the positive bias for sand-size material is largely due to aggregation of some of the fine-size material into sand-size particles and adherence of fine-size material to the sand-size grains. Electron microscopy analysis showed that preserved river water, which was low in dissolved solids, specific conductance, and neutral pH, showed less aggregation and adhesion than preserved river water that was higher in dissolved solids and specific conductance with a basic pH. Bacteria were also found growing in the matrix, which may enhance fme-size material aggregation through their adhesive properties. Differences between sediment-analysis methods were also investigated as pan of this study. Suspended-sediment concentration results obtained from one participating laboratory that used a total-suspended solids (TSS) method had greater variability and larger negative biases than results obtained when this laboratory used a suspended-sediment concentration method. When TSS methods were used to analyze the reference samples, the median suspended sediment concentration percent difference was -18.04 percent. When the laboratory used a suspended-sediment concentration method, the median suspended-sediment concentration percent difference was -2.74 percent. The percent difference was calculated as follows: Percent difference = (( reported mass - known mass)/known mass ) X 100.

The Efficacy of Problem-Based Learning in an Analytical Laboratory Course for Pre-Service Chemistry Teachers

ERIC Educational Resources Information Center

Yoon, Heojeong; Woo, Ae Ja; Treagust, David; Chandrasegaran, A. L.

2014-01-01

The efficacy of problem-based learning (PBL) in an analytical chemistry laboratory course was studied using a programme that was designed and implemented with 20 students in a treatment group over 10 weeks. Data from 26 students in a traditional analytical chemistry laboratory course were used for comparison. Differences in the creative thinking…

Standardizing in vitro diagnostics tasks in clinical trials: a call for action.

PubMed

Lippi, Giuseppe; Simundic, Ana-Maria; Rodriguez-Manas, Leocadio; Bossuyt, Patrick; Banfi, Giuseppe

2016-05-01

Translational research is defined as the process of applying ideas, insights and discoveries generated through basic scientific inquiry to treatment or prevention of human diseases. Although precise information is lacking, several lines of evidence attest that up to 95% early-phase studies may not translate into tangible outcomes for improving clinical management. Major theoretical hurdles exist in the translational process, but is it also undeniable that many studies may have failed for practical reasons, such as the use of inappropriate diagnostic testing for evaluating efficacy, effectiveness or safety of a given medical intervention, or poor quality in laboratory testing. This can generate biased test results and result in misconceptions during data interpretation, eventually leading to no clinical benefit, possible harm, and a waste of valuable resources. From a genuine economic perspective, it can be estimated that over 10 million euros of funding may be lost each year in clinical trials in the European Union due to preanalytical and analytical problems. These are mostly attributions to the heterogeneity of current guidelines and recommendations for the testing process, to the poor evidence base for basic pre-analytical, analytical and post-analytical requirements in clinical trials, and to the failure to thoughtfully integrate the perspectives of clinicians, patients, nurses and diagnostic companies in laboratory best practices. The most rational means for filling the gap between what we know and what we practice in clinical trials cannot discount the development of multidisciplinary teams including research scientists, clinicians, nurses, patients associations and representative of in vitro diagnostic (IVD) companies, who should actively interplay and collaborate with laboratory professionals to adapt and disseminate evidence-based recommendations about biospecimen collection and management into the research settings, from preclinical to phase III studies.

Data quality in drug discovery: the role of analytical performance in ligand binding assays

NASA Astrophysics Data System (ADS)

Wätzig, Hermann; Oltmann-Norden, Imke; Steinicke, Franziska; Alhazmi, Hassan A.; Nachbar, Markus; El-Hady, Deia Abd; Albishri, Hassan M.; Baumann, Knut; Exner, Thomas; Böckler, Frank M.; El Deeb, Sami

2015-09-01

Despite its importance and all the considerable efforts made, the progress in drug discovery is limited. One main reason for this is the partly questionable data quality. Models relating biological activity and structures and in silico predictions rely on precisely and accurately measured binding data. However, these data vary so strongly, such that only variations by orders of magnitude are considered as unreliable. This can certainly be improved considering the high analytical performance in pharmaceutical quality control. Thus the principles, properties and performances of biochemical and cell-based assays are revisited and evaluated. In the part of biochemical assays immunoassays, fluorescence assays, surface plasmon resonance, isothermal calorimetry, nuclear magnetic resonance and affinity capillary electrophoresis are discussed in details, in addition radiation-based ligand binding assays, mass spectrometry, atomic force microscopy and microscale thermophoresis are briefly evaluated. In addition, general sources of error, such as solvent, dilution, sample pretreatment and the quality of reagents and reference materials are discussed. Biochemical assays can be optimized to provide good accuracy and precision (e.g. percental relative standard deviation <10 %). Cell-based assays are often considered superior related to the biological significance, however, typically they cannot still be considered as really quantitative, in particular when results are compared over longer periods of time or between laboratories. A very careful choice of assays is therefore recommended. Strategies to further optimize assays are outlined, considering the evaluation and the decrease of the relevant error sources. Analytical performance and data quality are still advancing and will further advance the progress in drug development.

Tank 241-AN-101, grab samples, 1AN-98-1, 1AN-98-2 and 1AN-98-3 analytical results for the final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

FULLER, R.K.

1999-02-24

This document is the final report for tank 241-AN-101 grab samples. Three grab samples 1AN-98-1, 1AN-98-2 and 1AN-98-3 were taken from riser 16 of tank 241-AN-101 on April 8, 1998 and received by the 222-S Laboratory on April 9, 1998. Analyses were performed in accordance with the ''Compatability Grab Sampling and Analysis Plan'' (TSAP) and the ''Data Quality Objectives for Tank Farms Waste Compatability Program'' (DQO). The analytical results are presented in the data summary report. No notification limits were exceeded.

Dioxins, Furans, PCBs, and Congeners Analytical Service within the Superfund Contract Laboratory Program

EPA Pesticide Factsheets

This page contains information about the DLM02.2 analytical service for the analysis of dioxins and furans at hazardous waste sites. The SOW contains the analytical method and contractual requirements for laboratories.

Quality-Assurance/Quality-Control Manual for Collection and Analysis of Water-Quality Data in the Ohio District, US Geological Survey

USGS Publications Warehouse

Francy, D.S.; Jones, A.L.; Myers, Donna N.; Rowe, G.L.; Eberle, Michael; Sarver, K.M.

1998-01-01

The U.S. Geological Survey (USGS), Water Resources Division (WRD), requires that quality-assurance/quality-control (QA/QC) activities be included in any sampling and analysis program. Operational QA/QC procedures address local needs while incorporating national policies. Therefore, specific technical policies were established for all activities associated with water-quality project being done by the Ohio District. The policies described in this report provide Ohio District personnel, cooperating agencies, and others with a reference manual on QA/QC procedures that are followed in collecitng and analyzing water-quality samples and reporting water-quality information in the Ohio District. The project chief, project support staff, District Water-Quality Specialist, and District Laboratory Coordinator are all involved in planning and implementing QA/QC activities at the district level. The District Chief and other district-level managers provide oversight, and the Regional Water-Quality Specialist, Office of Water Quality (USGS headquarters), and the Branch of Quality Systems within the Office of Water Quality create national QA/QC polices and provide assistance to District personnel. In the literature, the quality of all measurement data is expressed in terms of precision, variability, bias, accuracy, completeness, representativeness, and comparability. In the Ohio District, bias and variability will be used to describe quality-control data generated from samples in the field and laboratory. Each project chief must plan for implementation and financing of QA/QC activities necessary to achieve data-quality objectives. At least 15 percent of the total project effort must be directed toward QA/QC activities. Of this total, 5-10 percent will be used for collection and analysis of quality-control samples. This is an absolute minimum, and more may be required based on project objectives. Proper techniques must be followed in the collection and processing of surface-water, ground-water, biological, precipitation, bed-sediment, bedload, suspended-sediment, and solid-phase samples. These techniques are briefly described in this report and are extensively documented. The reference documents listed in this report will be kept by the District librarian and District Water-Quality Specialist and updated regularly so that they are available to all District staff. Proper handling and documentation before, during, and after field activities are essential to ensure the integrity of the sample and to correct erroneous reporting of data results. Field sites are to be properly identified and entered into the data base before field data-collection activities begin. During field activities, field notes are to be completed and sample bottles appropriately labeled a nd stored. After field activities, all paperwork is to be completed promptly and samples transferred to the laboratory within allowable holding times. All equipment used by District personnel for the collection and processing of water-quality samples is to be properly operated, maintained, and calibrated by project personnel. This includes equipment for onsite measurement of water-quality characteristics (temperature, specific conductance, pH, dissolved oxygen, alkalinity, acidity, and turbidity) and equipment and instruments used for biological sampling. The District Water-Quality Specialist and District Laboratory Coordinator are responsible for preventive maintenance and calibration of equipment in the Ohio District laboratory. The USGS National Water Quality Laboratory in Arvada, Colo., is the primary source of analytical services for most project work done by the Ohio District. Analyses done at the Ohio District laboratory are usually those that must be completed within a few hours of sample collection. Contract laboratories or other USGS laboratories are sometimes used instead of the NWQL or the Ohio District laboratory. When a contract laboratory is used, the projec

NOAA national status and trends program eleventh round intercomparison exercise results for trace metals in marine sediments and biological tissues. National status and trends program for marine environmental quality: Technical memo

DOE Office of Scientific and Technical Information (OSTI.GOV)

Willie, S.

1997-12-01

A total of thirty-nine participants were included in the exercise, including OAA, USEPA, state, Australian, Canadian, Mexican and Argentinean laboratories. Two samples were sent by NRC to each participant, and contaminated marine sediment from Esquimalt harbor in British Columbia and a freeze-dried oyster tissue. Laboratories were also asked to analyze two certified reference materials (CRMs) MESS-2 and CRM 2976. The elements to be determined were Al, Cr, Fe, Ni, Cu, Zn, As, Se, Ag, Cd, Sn, Hg and Pb for both matrices, plus Be, Si, Mn, Sb and Tl for the sediments. An accepted mean and confidence interval was calculatedmore » for each analyte in the two unknown samples, laboratory biases were identified and an overall rating of superior, good, fair or others were assigned to each laboratory.« less

Optimization of analytical laboratory work using computer networking and databasing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Upp, D.L.; Metcalf, R.A.

1996-06-01

The Health Physics Analysis Laboratory (HPAL) performs around 600,000 analyses for radioactive nuclides each year at Los Alamos National Laboratory (LANL). Analysis matrices vary from nasal swipes, air filters, work area swipes, liquids, to the bottoms of shoes and cat litter. HPAL uses 8 liquid scintillation counters, 8 gas proportional counters, and 9 high purity germanium detectors in 5 laboratories to perform these analyses. HPAL has developed a computer network between the labs and software to produce analysis results. The software and hardware package includes barcode sample tracking, log-in, chain of custody, analysis calculations, analysis result printing, and utility programs.more » All data are written to a database, mirrored on a central server, and eventually written to CD-ROM to provide for online historical results. This system has greatly reduced the work required to provide for analysis results as well as improving the quality of the work performed.« less

Report on the U.S. Geological Survey's evaluation program for standard reference samples distributed in October 1993 : T-127 (trace constituents), M-128 (major constituents), N-40 (nutrients), N-41 (nutrients), P-21 (low ionic strength), Hg-17 (mercury), AMW-3 (acid mine water), and WW-1 (whole water)

USGS Publications Warehouse

Long, H.K.; Farrar, J.W.

1994-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for eight standard reference samples--T-127 (trace constituents), M-128 (major constituents), N-40 (nutrients), N-41 (nutrients), P-21 (low ionic strength), Hg-17 (mercury), AMW-3 (acid mine water), and WW-1 (whole water)--that were distributed in October 1993 to 158 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 145 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the eight reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the eight standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Report on the U.S. Geological Survey's evaluation program for standard reference samples distributed in October 1994 : T-131 (trace constituents), T-133 (trace constituents), M-132 (major constituents), N-43 (nutrients), N-44 (nutrients), P-23 (low ionic strength) and Hg-19 (mercury)

USGS Publications Warehouse

Long, H. Keith; Farrar, Jerry W.

1995-01-01

This report presents the results of the U.S. Geological Survey's analytical evaluation program for 7 standard reference samples--T-131 (trace constituents), T-133 (trace constituents), M-132 (major constituents), N-43 (nutrients), N-44 (nutrients), P-23 (low ionic strength), and Hg-19 (mercury). The samples were distributed in October 1994 to 131 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 121 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the seven reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the seven standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

Results of quality-control sampling of water, bed sediment, and tissue in the Western Lake Michigan Drainages study unit of the National Water-Quality Assessment Program

USGS Publications Warehouse

Fitzgerald, S.A.

1997-01-01

This report contains the quality control results of the Western Lake Michigan Drainages study unit of the National Water Quality Assessment Program. Quality control samples were collected in the same manner and contemporaneously with environmental samples during the first highintensity study phase in the unit (1992 through 1995) and amounted to approximately 15 percent of all samples collected. The accuracy and precision of hundreds of chemical analyses of surface and ground-water, bed sediment, and tissue was determined through the collection and analysis of field blanks, field replicates and splits, matrix spikes, and surrogates. Despite the several detections of analytes in the field blanks, the concentrations of most constituents in the environmental samples will likely be an order of magnitude or higher than those in the blanks. However, frequent detections, and high concentrations, of dissolved organic carbon (DOC) in several surface and ground-water blanks are probably significant with respect to commonly measured environmental concentrations, and the environmental data will have to be qualified accordingly. The precision of sampling of water on a percent basis, as determined from replicates and splits, was generally proportional to the concentration of the constituents, with constituents present in relatively high concentrations generally having less sampling variability than those with relatively low concentrations. In general, analytes with relatively high variability between replicates were present at concentrations near the reporting limit or were associated with relatively small absolute concentration differences, or both. Precision of replicates compared to that for splits in bed sediment samples was similar, thus eliminating sampling as a major source of variability in analyte concentrations. In the case the phthalates in bed sediment, contamination in either the field or laboratory could have caused the relatively large variability between replicate samples and between split samples.Variability of analyte concentrations in tissue samples was relatively low, being 29 percent or less for all constituents. Recoveries of most laboratory schedule 2001/2010 pesticide spike compounds in surfacewater samples were reasonably good. Low intrinsic method recovery resulted in relatively low recovery forp,p'-DDE, metribuzin, and propargite. In the case of propargite, decomposition with the environmental sample matrices was also indicated. Recoveries of two compounds, cyanazine and thiobencarb, might have been biased high due to interferences. The one laboratory schedule 2050/2051 field matrix pesticide spike indicated numerous operational problems with this method that biased recoveries either low or high. Recoveries of pesticides from both pesticide schedules in field spikes of ground-water samples generally were similar to those of field matrix spikes of surface- water samples. High maximum recoveries were noted for tebuthiuron, disulfoton, DCPA, and permethrin, which indicates the possible presence of interferents in the matrices for these compounds. Problems in the recoveries of pesticides on schedule 2050/2051 from ground-water samples generally were the same as those for surfacewater samples. Recoveries of VOCs in field matrix spikes were reasonable when consideration was given for the use of the micropipettor that delivered only about 80 percent on average of the nominal mass of spiked analytes. Finally, the recoveries of most surrogate compounds in surface and ground-water samples were reasonable. Problems in sample handling (for example, spillage) were likely not the cause of any of the low recoveries of spiked compounds.

Atomic spectrometry and trends in clinical laboratory medicine

NASA Astrophysics Data System (ADS)

Parsons, Patrick J.; Barbosa, Fernando

2007-09-01

Increasing numbers of clinical laboratories are transitioning away from flame and electrothermal AAS methods to those based on ICP-MS. Still, for many laboratories, the choice of instrumentation is based upon (a) the element(s) to be determined, (b) the matrix/matrices to be analyzed, and (c) the expected concentration(s) of the analytes in the matrix. Most clinical laboratories specialize in measuring Se, Zn, Cu, and Al in serum, and/or Pb, Cd, Hg, As, and Cr in blood and/or urine, while other trace elements (e.g., Pt, Au etc.) are measured for therapeutic purposes. Quantitative measurement of elemental species is becoming more widely accepted for nutritional and/or toxicological screening purposes, and ICP-MS interfaced with separation techniques, such as liquid chromatography or capillary electrophoresis, offers the advantage of on-line species determination coupled with very low detection limits. Polyatomic interferences for some key elements such as Se, As, and Cr require instrumentation equipped with dynamic reaction cell or collision cell technologies, or might even necessitate the use of sector field ICP-MS, to assure accurate results. Nonetheless, whatever analytical method is selected for the task, careful consideration must be given both to specimen collection procedures and to the control of pre-analytical variables. Finally, all methods benefit from access to reliable certified reference materials (CRMs). While a variety of reference materials (RMs) are available for trace element measurements in clinical matrices, not all can be classified as CRMs. The major metrological organizations (e.g., NIST, IRMM, NIES) provide a limited number of clinical CRMs, however, secondary reference materials are readily available from commercial organizations and organizers of external quality assessment schemes.

Analytical method for nitroaromatic explosives in radiologically contaminated soil for ISO/IEC 17025 accreditation

DOE PAGES

Boggess, Andrew; Crump, Stephen; Gregory, Clint; ...

2017-12-06

Here, unique hazards are presented in the analysis of radiologically contaminated samples. Strenuous safety and security precautions must be in place to protect the analyst, laboratory, and instrumentation used to perform analyses. A validated method has been optimized for the analysis of select nitroaromatic explosives and degradative products using gas chromatography/mass spectrometry via sonication extraction of radiologically contaminated soils, for samples requiring ISO/IEC 17025 laboratory conformance. Target analytes included 2-nitrotoluene, 4-nitrotoluene, 2,6-dinitrotoluene, and 2,4,6-trinitrotoluene, as well as the degradative product 4-amino-2,6-dinitrotoluene. Analytes were extracted from soil in methylene chloride by sonication. Administrative and engineering controls, as well as instrument automationmore » and quality control measures, were utilized to minimize potential human exposure to radiation at all times and at all stages of analysis, from receiving through disposition. Though thermal instability increased uncertainties of these selected compounds, a mean lower quantitative limit of 2.37 µg/mL and mean accuracy of 2.3% relative error and 3.1% relative standard deviation were achieved. Quadratic regression was found to be optimal for calibration of all analytes, with compounds of lower hydrophobicity displaying greater parabolic curve. Blind proficiency testing (PT) of spiked soil samples demonstrated a mean relative error of 9.8%. Matrix spiked analyses of PT samples demonstrated that 99% recovery of target analytes was achieved. To the knowledge of the authors, this represents the first safe, accurate, and reproducible quantitative method for nitroaromatic explosives in soil for specific use on radiologically contaminated samples within the constraints of a nuclear analytical lab.« less

Analytical method for nitroaromatic explosives in radiologically contaminated soil for ISO/IEC 17025 accreditation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Boggess, Andrew; Crump, Stephen; Gregory, Clint

Here, unique hazards are presented in the analysis of radiologically contaminated samples. Strenuous safety and security precautions must be in place to protect the analyst, laboratory, and instrumentation used to perform analyses. A validated method has been optimized for the analysis of select nitroaromatic explosives and degradative products using gas chromatography/mass spectrometry via sonication extraction of radiologically contaminated soils, for samples requiring ISO/IEC 17025 laboratory conformance. Target analytes included 2-nitrotoluene, 4-nitrotoluene, 2,6-dinitrotoluene, and 2,4,6-trinitrotoluene, as well as the degradative product 4-amino-2,6-dinitrotoluene. Analytes were extracted from soil in methylene chloride by sonication. Administrative and engineering controls, as well as instrument automationmore » and quality control measures, were utilized to minimize potential human exposure to radiation at all times and at all stages of analysis, from receiving through disposition. Though thermal instability increased uncertainties of these selected compounds, a mean lower quantitative limit of 2.37 µg/mL and mean accuracy of 2.3% relative error and 3.1% relative standard deviation were achieved. Quadratic regression was found to be optimal for calibration of all analytes, with compounds of lower hydrophobicity displaying greater parabolic curve. Blind proficiency testing (PT) of spiked soil samples demonstrated a mean relative error of 9.8%. Matrix spiked analyses of PT samples demonstrated that 99% recovery of target analytes was achieved. To the knowledge of the authors, this represents the first safe, accurate, and reproducible quantitative method for nitroaromatic explosives in soil for specific use on radiologically contaminated samples within the constraints of a nuclear analytical lab.« less

Tank 241-AY-101 Privatization Push Mode Core Sampling and Analysis Plan

DOE Office of Scientific and Technical Information (OSTI.GOV)

TEMPLETON, A.M.

2000-01-12

This sampling and analysis plan (SAP) identifies characterization objectives pertaining to sample collection, laboratory analytical evaluation, and reporting requirements for samples obtained from tank 241-AY-101. The purpose of this sampling event is to obtain information about the characteristics of the contents of 241-AY-101 required to satisfy Data Quality Objectives For RPP Privatization Phase I: Confirm Tank T Is An Appropriate Feed Source For High-Level Waste Feed Batch X(HLW DQO) (Nguyen 1999a), Data Quality Objectives For TWRS Privatization Phase I : Confirm Tank T Is An Appropriate Feed Source For Low-Activity Waste Feed Batch X (LAW DQO) (Nguyen 1999b), Low Activitymore » Waste and High-Level Waste Feed Data Quality Objectives (L and H DQO) (Patello et al. 1999), and Characterization Data Needs for Development, Design, and Operation of Retrieval Equipment Developed through the Data Quality Objective Process (Equipment DQO) (Bloom 1996). Special instructions regarding support to the LAW and HLW DQOs are provided by Baldwin (1999). Push mode core samples will be obtained from risers 15G and 150 to provide sufficient material for the chemical analyses and tests required to satisfy these data quality objectives. The 222-S Laboratory will extrude core samples; composite the liquids and solids; perform chemical analyses on composite and segment samples; archive half-segment samples; and provide subsamples to the Process Chemistry Laboratory. The Process Chemistry Laboratory will prepare test plans and perform process tests to evaluate the behavior of the 241-AY-101 waste undergoing the retrieval and treatment scenarios defined in the applicable DQOs. Requirements for analyses of samples originating in the process tests will be documented in the corresponding test plans and are not within the scope of this SAP.« less

Tank 241-AY-101 Privatization Push Mode Core Sampling and Analysis Plan

DOE Office of Scientific and Technical Information (OSTI.GOV)

TEMPLETON, A.M.

2000-05-19

This sampling and analysis plan (SAP) identifies characterization objectives pertaining to sample collection, laboratory analytical evaluation, and reporting requirements for samples obtained from tank 241-AY-101. The purpose of this sampling event is to obtain information about the characteristics of the contents of 241-AY-101 required to satisfy ''Data Quality Objectives For RPP Privatization Phase I: Confirm Tank T Is An Appropriate Feed Source For High-Level Waste Feed Batch X(HLW DQO)' (Nguyen 1999a), ''Data Quality Objectives For TWRS Privatization Phase I: Confirm Tank T Is An Appropriate Feed Source For Low-Activity Waste Feed Butch X (LAW DQO) (Nguyen 1999b)'', ''Low Activity Wastemore » and High-Level Waste Feed Data Quality Objectives (L&H DQO)'' (Patello et al. 1999), and ''Characterization Data Needs for Development, Design, and Operation of Retrieval Equipment Developed through the Data Quality Objective Process (Equipment DQO)'' (Bloom 1996). Special instructions regarding support to the LAW and HLW DQOs are provided by Baldwin (1999). Push mode core samples will be obtained from risers 15G and 150 to provide sufficient material for the chemical analyses and tests required to satisfy these data quality objectives. The 222-S Laboratory will extrude core samples; composite the liquids and solids; perform chemical analyses on composite and segment samples; archive half-segment samples; and provide sub-samples to the Process Chemistry Laboratory. The Process Chemistry Laboratory will prepare test plans and perform process tests to evaluate the behavior of the 241-AY-101 waste undergoing the retrieval and treatment scenarios defined in the applicable DQOs. Requirements for analyses of samples originating in the process tests will be documented in the corresponding test plans and are not within the scope of this SAP.« less

Cost Effectiveness of Adopted Quality Requirements in Hospital Laboratories

PubMed Central

HAMZA, Alneil; AHMED-ABAKUR, Eltayib; ABUGROUN, Elsir; BAKHIT, Siham; HOLI, Mohamed

2013-01-01

Background The present study was designed in quasi-experiment to assess adoption of the essential clauses of particular clinical laboratory quality management requirements based on international organization for standardization (ISO 15189) in hospital laboratories and to evaluate the cost effectiveness of compliance to ISO 15189. Methods: The quality management intervention based on ISO 15189 was conceded through three phases; pre – intervention phase, Intervention phase and Post-intervention phase. Results: In pre-intervention phase the compliance to ISO 15189 was 49% for study group vs. 47% for control group with P value 0.48, while the post intervention results displayed 54% vs. 79% for study group and control group respectively in compliance to ISO 15189 and statistically significant difference (P value 0.00) with effect size (Cohen’s d) of (0.00) in pre-intervention phase and (0.99) in post – intervention phase. The annual average cost per-test for the study group and control group was 1.80 ± 0.25 vs. 1.97 ± 0.39, respectively with P value 0.39 whereas the post-intervention results showed that the annual average total costs per-test for study group and control group was 1.57 ± 0.23 vs 2.08 ± 0.38, P value 0.019 respectively, with cost-effectiveness ratio of (0.88) in pre -intervention phase and (0.52) in post-intervention phase. Conclusion: The planned adoption of quality management requirements (QMS) in clinical laboratories had great effect to increase the compliance percent with quality management system requirement, raise the average total cost effectiveness, and improve the analytical process capability of the testing procedure. PMID:23967422

DOE Office of Scientific and Technical Information (OSTI.GOV)

Green, D.W.; Heinrich, R.R.; Graczyk, D.G.

The purpose of this report is to summarize the activities of the Analytical Chemistry Laboratory (ACL) at Argonne National Laboratory (ANL) for Fiscal Year 1991 (October 1990 through September 1991). This is the eighth annual report for the ACL. The Analytical Chemistry Laboratory is a full-cost-recovery service center, with the primary mission of providing a broad range of analytical chemistry support services to the scientific and engineering programs at ANL. In addition, the ACL conducts a research program in analytical chemistry, works on instrumental and methods development, and provides analytical services for governmental, educational, and industrial organizations. The ACL handlesmore » a wide range of analytical problems, from routine standard analyses to unique problems that require significant development of methods and techniques.« less

Inorganic chemical analysis of environmental materials—A lecture series

USGS Publications Warehouse

Crock, J.G.; Lamothe, P.J.

2011-01-01

At the request of the faculty of the Colorado School of Mines, Golden, Colorado, the authors prepared and presented a lecture series to the students of a graduate level advanced instrumental analysis class. The slides and text presented in this report are a compilation and condensation of this series of lectures. The purpose of this report is to present the slides and notes and to emphasize the thought processes that should be used by a scientist submitting samples for analyses in order to procure analytical data to answer a research question. First and foremost, the analytical data generated can be no better than the samples submitted. The questions to be answered must first be well defined and the appropriate samples collected from the population that will answer the question. The proper methods of analysis, including proper sample preparation and digestion techniques, must then be applied. Care must be taken to achieve the required limits of detection of the critical analytes to yield detectable analyte concentration (above "action" levels) for the majority of the study's samples and to address what portion of those analytes answer the research question-total or partial concentrations. To guarantee a robust analytical result that answers the research question(s), a well-defined quality assurance and quality control (QA/QC) plan must be employed. This QA/QC plan must include the collection and analysis of field and laboratory blanks, sample duplicates, and matrix-matched standard reference materials (SRMs). The proper SRMs may include in-house materials and/or a selection of widely available commercial materials. A discussion of the preparation and applicability of in-house reference materials is also presented. Only when all these analytical issues are sufficiently addressed can the research questions be answered with known certainty.

Realizing the promise of reverse phase protein arrays for clinical, translational, and basic research: a workshop report: the RPPA (Reverse Phase Protein Array) society.

PubMed

Akbani, Rehan; Becker, Karl-Friedrich; Carragher, Neil; Goldstein, Ted; de Koning, Leanne; Korf, Ulrike; Liotta, Lance; Mills, Gordon B; Nishizuka, Satoshi S; Pawlak, Michael; Petricoin, Emanuel F; Pollard, Harvey B; Serrels, Bryan; Zhu, Jingchun

2014-07-01

Reverse phase protein array (RPPA) technology introduced a miniaturized "antigen-down" or "dot-blot" immunoassay suitable for quantifying the relative, semi-quantitative or quantitative (if a well-accepted reference standard exists) abundance of total protein levels and post-translational modifications across a variety of biological samples including cultured cells, tissues, and body fluids. The recent evolution of RPPA combined with more sophisticated sample handling, optical detection, quality control, and better quality affinity reagents provides exquisite sensitivity and high sample throughput at a reasonable cost per sample. This facilitates large-scale multiplex analysis of multiple post-translational markers across samples from in vitro, preclinical, or clinical samples. The technical power of RPPA is stimulating the application and widespread adoption of RPPA methods within academic, clinical, and industrial research laboratories. Advances in RPPA technology now offer scientists the opportunity to quantify protein analytes with high precision, sensitivity, throughput, and robustness. As a result, adopters of RPPA technology have recognized critical success factors for useful and maximum exploitation of RPPA technologies, including the following: preservation and optimization of pre-analytical sample quality, application of validated high-affinity and specific antibody (or other protein affinity) detection reagents, dedicated informatics solutions to ensure accurate and robust quantification of protein analytes, and quality-assured procedures and data analysis workflows compatible with application within regulated clinical environments. In 2011, 2012, and 2013, the first three Global RPPA workshops were held in the United States, Europe, and Japan, respectively. These workshops provided an opportunity for RPPA laboratories, vendors, and users to share and discuss results, the latest technology platforms, best practices, and future challenges and opportunities. The outcomes of the workshops included a number of key opportunities to advance the RPPA field and provide added benefit to existing and future participants in the RPPA research community. The purpose of this report is to share and disseminate, as a community, current knowledge and future directions of the RPPA technology. © 2014 by The American Society for Biochemistry and Molecular Biology, Inc.

SECOND FLOOR PLAN OF REMOTE ANALYTICAL FACILITY (CPP627) WARM LABORATORY ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

SECOND FLOOR PLAN OF REMOTE ANALYTICAL FACILITY (CPP-627) WARM LABORATORY ROOM, DECONTAMINATION ROOM, HOT CHEMISTRY LABORATORY, AND MULTICURIE CELL ROOM. INL DRAWING NUMBER 200-0627-00-098-105066. ALTERNATE ID NUMBER 4272-14-103. - Idaho National Engineering Laboratory, Idaho Chemical Processing Plant, Fuel Reprocessing Complex, Scoville, Butte County, ID

Recommendation for the review of biological reference intervals in medical laboratories.

PubMed

Henny, Joseph; Vassault, Anne; Boursier, Guilaine; Vukasovic, Ines; Mesko Brguljan, Pika; Lohmander, Maria; Ghita, Irina; Andreu, Francisco A Bernabeu; Kroupis, Christos; Sprongl, Ludek; Thelen, Marc H M; Vanstapel, Florent J L A; Vodnik, Tatjana; Huisman, Willem; Vaubourdolle, Michel

2016-12-01

This document is based on the original recommendation of the Expert Panel on the Theory of Reference Values of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), updated guidelines were recently published under the auspices of the IFCC and the Clinical and Laboratory Standards Institute (CLSI). This document summarizes proposals for recommendations on: (i) The terminology, which is often confusing, noticeably concerning the terms of reference limits and decision limits. (ii) The method for the determination of reference limits according to the original procedure and the conditions, which should be used. (iii) A simple procedure allowing the medical laboratories to fulfill the requirements of the regulation and standards. The updated document proposes to verify that published reference limits are applicable to the laboratory involved. Finally, the strengths and limits of the revised recommendations (especially the selection of the reference population, the maintenance of the analytical quality, the choice of the statistical method used…) will be briefly discussed.

Reduction of multi-dimensional laboratory data to a two-dimensional plot: a novel technique for the identification of laboratory error.

PubMed

Kazmierczak, Steven C; Leen, Todd K; Erdogmus, Deniz; Carreira-Perpinan, Miguel A

2007-01-01

The clinical laboratory generates large amounts of patient-specific data. Detection of errors that arise during pre-analytical, analytical, and post-analytical processes is difficult. We performed a pilot study, utilizing a multidimensional data reduction technique, to assess the utility of this method for identifying errors in laboratory data. We evaluated 13,670 individual patient records collected over a 2-month period from hospital inpatients and outpatients. We utilized those patient records that contained a complete set of 14 different biochemical analytes. We used two-dimensional generative topographic mapping to project the 14-dimensional record to a two-dimensional space. The use of a two-dimensional generative topographic mapping technique to plot multi-analyte patient data as a two-dimensional graph allows for the rapid identification of potentially anomalous data. Although we performed a retrospective analysis, this technique has the benefit of being able to assess laboratory-generated data in real time, allowing for the rapid identification and correction of anomalous data before they are released to the physician. In addition, serial laboratory multi-analyte data for an individual patient can also be plotted as a two-dimensional plot. This tool might also be useful for assessing patient wellbeing and prognosis.

Sources and preparation of data for assessing trends in concentrations of pesticides in streams of the United States, 1992–2010

USGS Publications Warehouse

Martin, Jeffrey D.; Eberle, Michael; Nakagaki, Naomi

2011-01-01

This report updates a previously published water-quality dataset of 44 commonly used pesticides and 8 pesticide degradates suitable for a national assessment of trends in pesticide concentrations in streams of the United States. Water-quality samples collected from January 1992 through September 2010 at stream-water sites of the U.S. Geological Survey (USGS) National Water-Quality Assessment (NAWQA) Program and the National Stream Quality Accounting Network (NASQAN) were compiled, reviewed, selected, and prepared for trend analysis. The principal steps in data review for trend analysis were to (1) identify analytical schedule, (2) verify sample-level coding, (3) exclude inappropriate samples or results, (4) review pesticide detections per sample, (5) review high pesticide concentrations, and (6) review the spatial and temporal extent of NAWQA pesticide data and selection of analytical methods for trend analysis. The principal steps in data preparation for trend analysis were to (1) select stream-water sites for trend analysis, (2) round concentrations to a consistent level of precision for the concentration range, (3) identify routine reporting levels used to report nondetections unaffected by matrix interference, (4) reassign the concentration value for routine nondetections to the maximum value of the long-term method detection level (maxLT-MDL), (5) adjust concentrations to compensate for temporal changes in bias of recovery of the gas chromatography/mass spectrometry (GCMS) analytical method, and (6) identify samples considered inappropriate for trend analysis. Samples analyzed at the USGS National Water Quality Laboratory (NWQL) by the GCMS analytical method were the most extensive in time and space and, consequently, were selected for trend analysis. Stream-water sites with 3 or more water years of data with six or more samples per year were selected for pesticide trend analysis. The selection criteria described in the report produced a dataset of 21,988 pesticide samples at 212 stream-water sites. Only 21,144 pesticide samples, however, are considered appropriate for trend analysis.

Recent advances in immunosensor for narcotic drug detection

PubMed Central

Gandhi, Sonu; Suman, Pankaj; Kumar, Ashok; Sharma, Prince; Capalash, Neena; Suri, C. Raman

2015-01-01

Introduction: Immunosensor for illicit drugs have gained immense interest and have found several applications for drug abuse monitoring. This technology has offered a low cost detection of narcotics; thereby, providing a confirmatory platform to compliment the existing analytical methods. Methods: In this minireview, we define the basic concept of transducer for immunosensor development that utilizes antibodies and low molecular mass hapten (opiate) molecules. Results: This article emphasizes on recent advances in immunoanalytical techniques for monitoring of opiate drugs. Our results demonstrate that high quality antibodies can be used for immunosensor development against target analyte with greater sensitivity, specificity and precision than other available analytical methods. Conclusion: In this review we highlight the fundamentals of different transducer technologies and its applications for immunosensor development currently being developed in our laboratory using rapid screening via immunochromatographic kit, label free optical detection via enzyme, fluorescence, gold nanoparticles and carbon nanotubes based immunosensing for sensitive and specific monitoring of opiates. PMID:26929925

LABORATORY MISCONDUCT - WHAT CAN HAPPEN TO YOU?

EPA Science Inventory

Contracted laboratories perform a vast number of routine and special analytical services that are the foundation of decisions upon which rests the fate of the environment. Guiding these laboratories in the generation of environmental data has been the analytical protocols and ...

Quality assurance and quality control of geochemical data—A primer for the research scientist

USGS Publications Warehouse

Geboy, Nicholas J.; Engle, Mark A.

2011-01-01

Geochemistry is a constantly expanding science. More and more, scientists are employing geochemical tools to help answer questions about the Earth and earth system processes. Scientists may assume that the responsibility of examining and assessing the quality of the geochemical data they generate is not theirs but rather that of the analytical laboratories to which their samples have been submitted. This assumption may be partially based on knowledge about internal and external quality assurance and quality control (QA/QC) programs in which analytical laboratories typically participate. Or there may be a perceived lack of time or resources to adequately examine data quality. Regardless of the reason, the lack of QA/QC protocols can lead to the generation and publication of erroneous data. Because the interpretations drawn from the data are primary products to U.S. Geological Survey (USGS) stakeholders, the consequences of publishing erroneous results can be significant. The principal investigator of a scientific study ultimately is responsible for the quality and interpretation of the project's findings, and thus must also play a role in the understanding, implementation, and presentation of QA/QC information about the data. Although occasionally ignored, QA/QC protocols apply not only to procedures in the laboratory but also in the initial planning of a research study and throughout the life of the project. Many of the tenets of developing a sound QA/QC program or protocols also parallel the core concepts of developing a good study: What is the main objective of the study? Will the methods selected provide data of enough resolution to answer the hypothesis? How should samples be collected? Are there known or unknown artifacts or contamination sources in the sampling and analysis methods? Assessing data quality requires communication between the scientists responsible for designing the study and those collecting samples, analyzing samples, treating data, and interpreting results. This primer has been developed to provide basic information and guidance about developing QA/QC protocols for geochemical studies. It is not intended to be a comprehensive guide but rather an introduction to key concepts tied to a list of relevant references for further reading. The guidelines are presented in stepwise order beginning with presampling considerations and continuing through final data interpretation. The goal of this primer is to outline basic QA/QC practices that scientists can use before, during, and after chemical analysis to ensure the validity of the data they collect with the goal of providing defendable results and conclusions.

[Analysis of the results of the HIV-1, HCV and HBV viral load of SEIMC External Quality Control Program. Year 2013].

PubMed

Orta Mira, Nieves; Del Remedio Guna Serrano, María; Latorre Martínez, José-Carlos; Medina González, Rafael; Rosario Ovies, María; Poveda, Marta; Ruiz de Gopegui, Enrique; Gimeno Cardona, Concepción

2015-07-01

Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarized the results obtained from the 2013 SEIMC External Quality Control Programme for HIV-1, HCV, and HBV viral loads. In the HIV-1 program, a total of five standards were sent. One standard consisted in seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in the range of 2-5 log10 copies/mL; two of these standards were identical aiming to determine repeatability. A significant proportion of the laboratories (25% on average) obtained values out of the accepted range (mean ± 0.25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was excellent, with up to 98.9% of laboratories reporting results within the limits (D < 0.5 log10 copies/mL). The HBV and HCV program consisted of two standards with different viral load contents. Most of the participants, 82% in the case of HCV and 78% in the HBV, obtained all the results within the accepted range (mean ± 1.96 SD log10 UI/mL). Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

[Analysis of the results of the HIV-1, HCV and HBV viral load of SEIMC External Quality Control Program. Year 2014].

PubMed

Medina González, Rafael; Orta Mira, Nieves; Guna Serrano, María Del Remedio; Latorre Martínez, José-Carlos; Gopegui, Enrique Ruiz de; Rosario Ovies, María; Poveda, Marta; Gimeno Cardona, Concepción

2016-07-01

Human immunodeficiency virus type 1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarizes the results obtained from the 2014 SEIMC (Spanish Society of Infectious Diseases and Clinical Microbiology) External Quality Control Programme for HIV-1, HCV, and HBV viral loads. In the HIV-1 program, a total of 5 standards were sent. One standard consisted in seronegative human plasma, while the remaining 4 contained plasma from 3 different viremic patients, in the range of 2-5 log10 copies/mL; 2 of these standards were identical aiming to determine repeatability. A significant proportion of the laboratories (30.8% on average) obtained values out of the accepted range (mean ± 0.25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was excellent, with up to 95.8% of laboratories reporting results within the limits (Δ < 0.5 log10 copies/mL). The HBV and HCV program consisted of 2 standards with different viral load contents. Most of the participants, 83.7% in the case of HCV and 87.9% in the HBV, obtained all the results within the accepted range (mean ± 1.96 standard deviations log10 IU/mL). Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

42 CFR 493.807 - Condition: Reinstatement of laboratories performing nonwaived testing.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two... reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or...

42 CFR 493.807 - Condition: Reinstatement of laboratories performing nonwaived testing.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two... reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or...

42 CFR 493.807 - Condition: Reinstatement of laboratories performing nonwaived testing.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two... reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or...

External quality-assurance results for the National Atmospheric Deposition Program / National Trends Network and Mercury Deposition Network, 2004

USGS Publications Warehouse

Wetherbee, Gregory A.; Latysh, Natalie E.; Greene, Shannon M.

2006-01-01

The U.S. Geological Survey (USGS) used five programs to provide external quality-assurance monitoring for the National Atmospheric Deposition Program/National Trends Network (NADP/NTN) and two programs to provide external quality-assurance monitoring for the NADP/Mercury Deposition Network (NADP/MDN) during 2004. An intersite-comparison program was used to estimate accuracy and precision of field-measured pH and specific-conductance. The variability and bias of NADP/NTN data attributed to field exposure, sample handling and shipping, and laboratory chemical analysis were estimated using the sample-handling evaluation (SHE), field-audit, and interlaboratory-comparison programs. Overall variability of NADP/NTN data was estimated using a collocated-sampler program. Variability and bias of NADP/MDN data attributed to field exposure, sample handling and shipping, and laboratory chemical analysis were estimated using a system-blank program and an interlaboratory-comparison program. In two intersite-comparison studies, approximately 89 percent of NADP/NTN site operators met the pH measurement accuracy goals, and 94.7 to 97.1 percent of NADP/NTN site operators met the accuracy goals for specific conductance. Field chemistry measurements were discontinued by NADP at the end of 2004. As a result, the USGS intersite-comparison program also was discontinued at the end of 2004. Variability and bias in NADP/NTN data due to sample handling and shipping were estimated from paired-sample concentration differences and specific conductance differences obtained for the SHE program. Median absolute errors (MAEs) equal to less than 3 percent were indicated for all measured analytes except potassium and hydrogen ion. Positive bias was indicated for most of the measured analytes except for calcium, hydrogen ion and specific conductance. Negative bias for hydrogen ion and specific conductance indicated loss of hydrogen ion and decreased specific conductance from contact of the sample with the collector bucket. Field-audit results for 2004 indicate dissolved analyte loss in more than one-half of NADP/NTN wet-deposition samples for all analytes except chloride. Concentrations of contaminants also were estimated from field-audit data. On the basis of 2004 field-audit results, at least 25 percent of the 2004 NADP/NTN concentrations for sodium, potassium, and chloride were lower than the maximum sodium, potassium, and chloride contamination likely to be found in 90 percent of the samples with 90-percent confidence. Variability and bias in NADP/NTN data attributed to chemical analysis by the NADP Central Analytical Laboratory (CAL) were comparable to the variability and bias estimated for other laboratories participating in the interlaboratory-comparison program for all analytes. Variability in NADP/NTN ammonium data evident in 2002-03 was reduced substantially during 2004. Sulfate, hydrogen-ion, and specific conductance data reported by CAL during 2004 were positively biased. A significant (a = 0.05) bias was identified for CAL sodium, potassium, ammonium, and nitrate data, but the absolute values of the median differences for these analytes were less than the method detection limits. No detections were reported for CAL analyses of deionized-water samples, indicating that contamination was not a problem for CAL. Control charts show that CAL data were within statistical control during at least 90 percent of 2004. Most 2004 CAL interlaboratory-comparison results for synthetic wet-deposition solutions were within ?10 percent of the most probable values (MPVs) for solution concentrations except for chloride, nitrate, sulfate, and specific conductance results from one sample in November and one specific conductance result in December. Overall variability of NADP/NTN wet-deposition measurements was estimated during water year 2004 by the median absolute errors for weekly wet-deposition sample concentrations and precipitation measurements for tw

Guidance for laboratories performing molecular pathology for cancer patients.

PubMed

Cree, Ian A; Deans, Zandra; Ligtenberg, Marjolijn J L; Normanno, Nicola; Edsjö, Anders; Rouleau, Etienne; Solé, Francesc; Thunnissen, Erik; Timens, Wim; Schuuring, Ed; Dequeker, Elisabeth; Murray, Samuel; Dietel, Manfred; Groenen, Patricia; Van Krieken, J Han

2014-11-01

Molecular testing is becoming an important part of the diagnosis of any patient with cancer. The challenge to laboratories is to meet this need, using reliable methods and processes to ensure that patients receive a timely and accurate report on which their treatment will be based. The aim of this paper is to provide minimum requirements for the management of molecular pathology laboratories. This general guidance should be augmented by the specific guidance available for different tumour types and tests. Preanalytical considerations are important, and careful consideration of the way in which specimens are obtained and reach the laboratory is necessary. Sample receipt and handling follow standard operating procedures, but some alterations may be necessary if molecular testing is to be performed, for instance to control tissue fixation. DNA and RNA extraction can be standardised and should be checked for quality and quantity of output on a regular basis. The choice of analytical method(s) depends on clinical requirements, desired turnaround time, and expertise available. Internal quality control, regular internal audit of the whole testing process, laboratory accreditation, and continual participation in external quality assessment schemes are prerequisites for delivery of a reliable service. A molecular pathology report should accurately convey the information the clinician needs to treat the patient with sufficient information to allow for correct interpretation of the result. Molecular pathology is developing rapidly, and further detailed evidence-based recommendations are required for many of the topics covered here. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Mercury Deposition Network Site Operator Training for the System Blank and Blind Audit Programs

USGS Publications Warehouse

Wetherbee, Gregory A.; Lehmann, Christopher M.B.

2008-01-01

The U.S. Geological Survey operates the external quality assurance project for the National Atmospheric Deposition Program/Mercury Deposition Network. The project includes the system blank and blind audit programs for assessment of total mercury concentration data quality for wet-deposition samples. This presentation was prepared to train new site operators and to refresh experienced site operators to successfully process and submit system blank and blind audit samples for chemical analysis. Analytical results are used to estimate chemical stability and contamination levels of National Atmospheric Deposition Program/Mercury Deposition Network samples and to evaluate laboratory variability and bias.

Assessment of Air Quality in the Shuttle and International Space Station (ISS) Based on Samples Returned by STS-104 at the Conclusion of 7A

NASA Technical Reports Server (NTRS)

James, John T.

2001-01-01

The toxicological assessment of air samples returned at the end of the STS-l04 (7 A) flight to the ISS is reported. ISS air samples were taken in June and July 2001 from the Service Module, FGB, and U.S. Laboratory using grab sample canisters (GSCs) and/or formaldehyde badges. Preflight and end-of-mission samples were obtained from Atlantis using GSCs. Solid sorbent air sampler (SSAS) samples were obtained from the ISS in April, June, and July. Analytical methods have not changed from earlier reports, and all quality control measures were met.

Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory; determination of low-level silver by graphite furnace atomic absorption spectrophotometry

USGS Publications Warehouse

Damrau, D.L.

1993-01-01

Increased awareness of the quality of water in the United States has led to the development of a method for determining low levels (0.2-5.0 microg/L) of silver in water samples. Use of graphite furnace atomic absorption spectrophotometry provides a sensitive, precise, and accurate method for determining low-level silver in samples of low ionic-strength water, precipitation water, and natural water. The minimum detection limit determined for low-level silver is 0.2 microg/L. Precision data were collected on natural-water samples and SRWS (Standard Reference Water Samples). The overall percent relative standard deviation for natural-water samples with silver concentrations more than 0.2 microg/L was less than 40 percent throughout the analytical range. For the SRWS with concentrations more than 0.2 microg/L, the overall percent relative standard deviation was less than 25 percent throughout the analytical range. The accuracy of the results was determined by spiking 6 natural-water samples with different known concentrations of the silver standard. The recoveries ranged from 61 to 119 percent at the 0.5-microg/L spike level. At the 1.25-microg/L spike level, the recoveries ranged from 92 to 106 percent. For the high spike level at 3.0 microg/L, the recoveries ranged from 65 to 113 percent. The measured concentrations of silver obtained from known samples were within the Branch of Quality Assurance accepted limits of 1 1/2 standard deviations on the basis of the SRWS program for Inter-Laboratory studies.

Satisfying regulatory and accreditation requirements for quality control.

PubMed

Ehrmeyer, Sharon S

2013-03-01

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) requires all US clinical laboratories that test "materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease..." to be regulated. The CLIA mandates are site neutral; based on test complexity; and focus on the three phases of the testing process (preanalytical, analytical, and postanalytical). Many testing sites choose to meet the CLIA requirements by following the testing standards of a professional accreditation organization deemed by the Centers for Medicare and Medicaid Services. The three principal organizations are The Joint Commission, the College of American Pathologists, and COLA. Copyright © 2013 Elsevier Inc. All rights reserved.

[Point-of-care-testing--the intensive care laboratory].

PubMed

Müller, M M; Hackl, W; Griesmacher, A

1999-01-01

After successful centralization of laboratory analyses since more than 30 years, advances in biosensors, microprocessors, measurement of undiluted whole blood and miniaturization of laboratory analyzers are leading nowadays more and more to a re-decentralization in the laboratory medicine. Point-of-care-testing (POCT), which is defined as any laboratory test performed outside central or decentralized laboratories, is becoming more and more popular. The theoretical advantages of POCT are faster turn-around-times (TAT), more rapid medical decisions, avoidance of sample identification and sample transport problems and the need of only small specimen volumes. These advantages are frequently mentioned, but are not associated with a clear clinical benefit. The disadvantages of POCT such as incorrect handling and/or maintenance of the analyzers by nontrained clinical staff, inadequate or even absent calibrations and/or quality controls, lack of cost-effectiveness because of an increased number of analyzers and more expensive reagents, insufficient documentation and difficult comparability of the obtained POCT-results with routine laboratory results, are strongly evident. According to the authors' opinion the decision for the establishing of POCT has only to be made in a close co-operation between physicians and laboratorians in order to vouch for necessity and high quality of the analyses. Taking the local situation into consideration (24-h-central laboratory, etc.) the spectrum of parameters measured by means of POCT should be rigorously restricted to the vital functions. Such analytes should be: hemoglobin or hematocrit, activated whole blood clotting time, blood gases, sodium, potassium, ionized calcium, glucose, creatinine, ammonia and lactate.

Control of Infectious Diseases in the Era of European Clinical Microbiology Laboratory Consolidation: New Challenges and Opportunities for the Patient and for Public Health Surveillance.

PubMed

Vandenberg, Olivier; Kozlakidis, Zisis; Schrenzel, Jacques; Struelens, Marc Jean; Breuer, Judith

2018-01-01

Many new innovative diagnostic approaches have been made available during the last 10 years with major impact on patient care and public health surveillance. In parallel, to enhance the cost-effectiveness of the clinical microbiology laboratories (CMLs), European laboratory professionals have streamlined their organization leading to amalgamation of activities and restructuring of their professional relationships with clinicians and public health specialists. Through this consolidation process, an operational model has emerged that combines large centralized clinical laboratories performing most tests on one high-throughput analytical platform connected to several distal laboratories dealing locally with urgent analyses at near point of care. The centralization of diagnostic services over a large geographical region has given rise to the concept of regional-scale "microbiology laboratories network." Although the volume-driven cost savings associated with such laboratory networks seem self-evident, the consequence(s) for the quality of patient care and infectious disease surveillance and control remain less obvious. In this article, we describe the range of opportunities that the changing landscape of CMLs in Europe can contribute toward improving the quality of patient care but also the early detection and enhanced surveillance of public health threats caused by infectious diseases. The success of this transformation of health services is reliant on the appropriate preparation in terms of staff, skills, and processes that would be inclusive of stakeholders. In addition, rigorous metrics are needed to set out more concrete laboratory service performance objectives and assess the expected benefits to society in terms of saving lives and preventing diseases.

Audit of clinical-laboratory practices in haematology and blood transfusion at Muhimbili National Hospital in Tanzania.

PubMed

Makubi, Abel N; Meda, Collins; Magesa, Alex; Minja, Peter; Mlalasi, Juliana; Salum, Zubeda; Kweka, Rumisha E; Rwehabura, James; Quaresh, Amrana; Magesa, Pius M; Robert, David; Makani, Julie; Kaaya, Ephata

2012-10-01

In Tanzania, there is paucity of data for monitoring laboratory medicine including haematology. This therefore calls for audits of practices in haematology and blood transfusion in order to provide appraise practice and devise strategies that would result in improved quality of health care services. This descriptive cross-sectional study which audited laboratory practice in haematology and blood transfusion at Muhimbili National Hospital (MNH) aimed at assessing the pre-analytical stage of laboratory investigations including laboratory request forms and handling specimen processing in the haematology laboratory and assessing the chain from donor selection, blood component processing to administration of blood during transfusion. A national standard checklist was used to audit the laboratory request forms (LRF), phlebotomists' practices on handling and assessing the from donor selection to administration 6f blood during transfusion. Both interview and observations were used. A total of 195 LRF were audited and 100% of had incomplete information such as patients' identification numbers, time sample ordered, reason for request, summary of clinical assessment and differential diagnoses. The labelling of specimens was poorly done by phlebotomists/clinicians in 82% of the specimens. Also 65% (132/202) of the blood samples delivered in the haematology laboratory did not contain the recommended volume of blood. There was no laboratory request form specific for ordering blood and there were no guidelines for indication of blood transfusion in the wards/ clinics. The blood transfusion laboratory section was not participating in external quality assessment and the hospital transfusion committee was not in operation. It is recommended that a referral hospital like MNH should have a transfusion committee to provide an active forum to facilitate communication between those involved with transfusion, monitor, coordinate and audit blood transfusion practices as per national guidelines.

Trace analysis of surfactants in Corexit oil dispersant formulations and seawater

NASA Astrophysics Data System (ADS)

Place, Benjamin J.; Perkins, Matt J.; Sinclair, Ewan; Barsamian, Adam L.; Blakemore, Paul R.; Field, Jennifer A.

2016-07-01

After the April 2010 explosion on the Deepwater Horizon oil rig, and subsequent release of millions of barrels of oil, two Corexit oil dispersant formulations were used in unprecedented quantities both on the surface and sub-surface of the Gulf of Mexico. Although the dispersant formulations contain four classes of surfactants, current studies to date focus on the anionic surfactant, bis-(2-ethylhexyl) sulfosuccinate (DOSS). Factors affecting the integrity of environmental and laboratory samples for Corexit analysis have not been systematically investigated. For this reason, a quantitative analytical method was developed for the detection of all four classes of surfactants, as well as the hydrolysis products of DOSS, the enantiomeric mixture of α- and β-ethylhexyl sulfosuccinate (α-/β-EHSS). The analytical method was then used to evaluate which practices for sample collection, storage, and analysis resulted in high quality data. Large volume, direct injection of seawater followed by liquid chromatography tandem mass spectrometry (LC-MS/MS) minimized analytical artifacts, analysis time, and both chemical and solid waste. Concentrations of DOSS in the seawater samples ranged from 71 to 13,000 ng/L, while the nonionic surfactants including Span 80, Tween 80, Tween 85 were detected infrequently (26% of samples) at concentrations from 840 to 9100 ng/L. The enantiomers α-/β-EHSS were detected in seawater, at concentrations from 200 to 1900 ng/L, and in both Corexit dispersant formulations, indicating α-/β-EHSS were applied to the oil spill and may be not unambiguous indicator of DOSS degradation. Best practices are provided to ensure sample integrity and data quality for environmental monitoring studies and laboratory that require the detection and quantification of Corexit-based surfactants in seawater.

Analytical quality by design: a tool for regulatory flexibility and robust analytics.

PubMed

Peraman, Ramalingam; Bhadraya, Kalva; Padmanabha Reddy, Yiragamreddy

2015-01-01

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT).

Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

PubMed Central

Bhadraya, Kalva; Padmanabha Reddy, Yiragamreddy

2015-01-01

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT). PMID:25722723

Middle East food safety perspectives.

PubMed

Idriss, Atef W; El-Habbab, Mohammad S

2014-08-01

Food safety and quality assurance are increasingly a major issue with the globalisation of agricultural trade, on the one hand, and intensification of agriculture, on the other. Consumer protection has become a priority in policy-making amongst the large economies of the Middle East and North Africa (MENA) countries following a number of food safety incidents. To enhance food safety, it is necessary to establish markets underpinned by knowledge and resources, including analysis of international rejections of food products from MENA countries, international laboratory accreditation, improved reporting systems and traceability, continued development and validation of analytical methods, and more work on correlating sensory evaluation with analytical results. MENA countries should develop a national strategy for food safety based on a holistic approach that extends from farm-to-fork and involves all the relevant stakeholders. Accordingly, food safety should be a regional programme, raising awareness among policy- and decision-makers of the importance of food safety and quality for consumer protection, food trade and economic development. © 2014 Society of Chemical Industry.