Internal quality control indicators of cervical cytopathology exams performed in laboratories monitored by the External Quality Control Laboratory.

PubMed

Ázara, Cinara Zago Silveira; Manrique, Edna Joana Cláudio; Tavares, Suelene Brito do Nascimento; de Souza, Nadja Lindany Alves; Amaral, Rita Goreti

2014-09-01

To evaluate the impact of continued education provided by an external quality control laboratory on the indicators of internal quality control of cytopathology exams. The internal quality assurance indicators for cytopathology exams from 12 laboratories monitored by the External Quality Control Laboratory were evaluated. Overall, 185,194 exams were included, 98,133 of which referred to the period preceding implementation of a continued education program, while 87,061 referred to the period following this intervention. Data were obtained from the Cervical Cancer Database of the Brazilian National Health Service. Following implementation of the continued education program, the positivity index (PI) remained within recommended limits in four laboratories. In another four laboratories, the PI progressed from below the limits to within the recommended standards. In one laboratory, the PI remained low, in two laboratories, it remained very low, and in one, it increased from very low to low. The percentage of exams compatible with a high-grade squamous intraepithelial lesion (HSIL) remained within the recommended limits in five laboratories, while in three laboratories it progressed from below the recommended levels to >0.4% of the total number of satisfactory exams, and in four laboratories it remained below the standard limit. Both the percentage of atypical squamous cells of undetermined significance (ASC-US) in relation to abnormal exams, and the ratio between ASC-US and intraepithelial lesions remained within recommended levels in all the laboratories investigated. An improvement was found in the indicators represented by the positivity index and the percentage of exams compatible with a high-grade squamous intraepithelial lesion, showing that the role played by the external quality control laboratory in providing continued education contributed towards improving laboratory staff skills in detecting cervical cancer precursor lesions.

[External quality assessment in clinical biochemistry laboratories: pilot study in 11 laboratories of Lomé (Togo)].

PubMed

Kouassi, Kafui; Fétéké, Lochina; Assignon, Selom; Dorkenoo, Ameyo; Napo-Koura, Gado

2015-01-01

This study aims to evaluate the performance of a few biochemistry analysis and make recommendations to the place of the stakeholders. It is a cross-sectional study conducted between the October 1(st), 2012 and the July 31, 2013 bearing on the results of 5 common examinations of clinical biochemistry, provided by 11 laboratories volunteers opening in the public and private sectors. These laboratories have analysed during the 3 cycles, 2 levels (medium and high) of serum concentration of urea, glucose, creatinine and serum aminotransferases. The performance of laboratories have been determined from the acceptable limits corresponding to the limits of total errors, defined by the French Society of Clinical Biology (SFBC). A system of internal quality control is implemented by all laboratories and 45% of them participated in international programs of external quality assessment (EQA). The rate of acceptable results for the entire study was of 69%. There was a significant difference (p<0.002) between the performance of the group of laboratories engaged in a quality approach and the group with default implementation of the quality approach. Also a significant difference was observed between the laboratories of the central level and those of the peripheral level of our health system (p<0.047). The performance of the results provided by the laboratories remains relatively unsatisfactory. It is important that the Ministry of Health put in place a national program of EQA with mandatory participation.

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.

[Study of quality of a branch laboratory--an opinion of a laboratory manager].

PubMed

Yazawa, Naoyuki

2006-11-01

At the stage of establishing a branch laboratory, quality evaluation is extremely difficult. Even the results of a control survey by the headquarters of the branch laboratory are unhelpful. For a clinical laboratory, the most important function is to provide reliable data all the time, and to maintain the reliability of clinical doctors with informed responses. We mostly refer to control surveys and daily quality control data to evaluate a clinical laboratory, but we rarely check its fundamental abilities, such as planning events, preserving statistical data about the standard range, using the right method for quality control and others. This is generally disregarded and it is taken for granted that they will be correct the first time. From my six years of experience working with X's branch laboratory, I realized that there might be some relation between the quality of a branch laboratory and the fundamental abilities of the company itself. I would never argue that all branch laboratories are ineffective, but they should be conscious of fundamental activities. The referring laboratory, not the referral laboratory, should be responsible for ensuring that the referral laboratory's examination results and findings are correct.

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.

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

Quality-assurance plan for the analysis of fluvial sediment by laboratories of the U.S. Geological Survey

USGS Publications Warehouse

Matthes, Wilbur J.; Sholar, Clyde J.; George, John R.

1992-01-01

This report describes procedures used by the Iowa District sediment laboratory of the U.S. Geological Survey to assure the quality of sediment-laboratory data. These procedures can be used by other U.S. Geological Survey laboratories regardless of size and type of operation for quality assurance and quality control of specific sediment-laboratory processes. Also described are the equipment, specifications, calibration and maintenance, and the protocol for methods used in the analyses of fluvial sediment for concentration or particle size.

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.

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.

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.

[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.

Clinical pharmacology quality assurance program: models for longitudinal analysis of antiretroviral proficiency testing for international laboratories.

PubMed

DiFrancesco, Robin; Rosenkranz, Susan L; Taylor, Charlene R; Pande, Poonam G; Siminski, Suzanne M; Jenny, Richard W; Morse, Gene D

2013-10-01

Among National Institutes of Health HIV Research Networks conducting multicenter trials, samples from protocols that span several years are analyzed at multiple clinical pharmacology laboratories (CPLs) for multiple antiretrovirals. Drug assay data are, in turn, entered into study-specific data sets that are used for pharmacokinetic analyses, merged to conduct cross-protocol pharmacokinetic analysis, and integrated with pharmacogenomics research to investigate pharmacokinetic-pharmacogenetic associations. The CPLs participate in a semiannual proficiency testing (PT) program implemented by the Clinical Pharmacology Quality Assurance program. Using results from multiple PT rounds, longitudinal analyses of recovery are reflective of accuracy and precision within/across laboratories. The objectives of this longitudinal analysis of PT across multiple CPLs were to develop and test statistical models that longitudinally: (1) assess the precision and accuracy of concentrations reported by individual CPLs and (2) determine factors associated with round-specific and long-term assay accuracy, precision, and bias using a new regression model. A measure of absolute recovery is explored as a simultaneous measure of accuracy and precision. Overall, the analysis outcomes assured 97% accuracy (±20% of the final target concentration of all (21) drug concentration results reported for clinical trial samples by multiple CPLs). Using the Clinical Laboratory Improvement Act acceptance of meeting criteria for ≥2/3 consecutive rounds, all 10 laboratories that participated in 3 or more rounds per analyte maintained Clinical Laboratory Improvement Act proficiency. Significant associations were present between magnitude of error and CPL (Kruskal-Wallis P < 0.001) and antiretroviral (Kruskal-Wallis P < 0.001).

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.

Comparability of river suspended-sediment sampling and laboratory analysis methods

USGS Publications Warehouse

Groten, Joel T.; Johnson, Gregory D.

2018-03-06

Accurate measurements of suspended sediment, a leading water-quality impairment in many Minnesota rivers, are important for managing and protecting water resources; however, water-quality standards for suspended sediment in Minnesota are based on grab field sampling and total suspended solids (TSS) laboratory analysis methods that have underrepresented concentrations of suspended sediment in rivers compared to U.S. Geological Survey equal-width-increment or equal-discharge-increment (EWDI) field sampling and suspended sediment concentration (SSC) laboratory analysis methods. Because of this underrepresentation, the U.S. Geological Survey, in collaboration with the Minnesota Pollution Control Agency, collected concurrent grab and EWDI samples at eight sites to compare results obtained using different combinations of field sampling and laboratory analysis methods.Study results determined that grab field sampling and TSS laboratory analysis results were biased substantially low compared to EWDI sampling and SSC laboratory analysis results, respectively. Differences in both field sampling and laboratory analysis methods caused grab and TSS methods to be biased substantially low. The difference in laboratory analysis methods was slightly greater than field sampling methods.Sand-sized particles had a strong effect on the comparability of the field sampling and laboratory analysis methods. These results indicated that grab field sampling and TSS laboratory analysis methods fail to capture most of the sand being transported by the stream. The results indicate there is less of a difference among samples collected with grab field sampling and analyzed for TSS and concentration of fines in SSC. Even though differences are present, the presence of strong correlations between SSC and TSS concentrations provides the opportunity to develop site specific relations to address transport processes not captured by grab field sampling and TSS laboratory analysis methods.

Review and comparison of quality standards, guidelines and regulations for laboratories.

PubMed

Datema, Tjeerd A M; Oskam, Linda; Klatser, Paul R

2012-01-01

The variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents) makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system. There is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories. We reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services . Differences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents. Each laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory processes.

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

Quality-assurance data for routine water analysis in the National Water-Quality Laboratory of the US Geological Survey for water year 1988

USGS Publications Warehouse

Lucey, K.J.

1989-01-01

The US Geological Survey maintains a quality assurance program based on the analysis of reference samples for its National Water Quality Laboratory located in Denver, Colorado. Reference samples containing selected inorganic, nutrient, and precipitation (low-level concentration) constituents are prepared at the Survey 's Water Quality Services Unit in Ocala, Florida, disguised as routine samples, and sent daily or weekly, as appropriate, to the laboratory through other Survey offices. The results are stored permanently in the National Water Data Storage and Retrieval System (WATSTORE), the Survey 's database for all water data. These data are analyzed statistically for precision and bias. An overall evaluation of the inorganic major ion and trace metal constituent data for water year 1988 indicated a lack of precision in the National Water Quality Laboratory for the determination of 8 out of 58 constituents: calcium (inductively coupled plasma emission spectrometry), fluoride, iron (atomic absorption spectrometry), iron (total recoverable), magnesium (atomic absorption spectrometry), manganese (total recoverable), potassium, and sodium (inductively coupled plasma emission spectrometry). The results for 31 constituents had positive or negative bias during water year 1988. A lack of precision was indicated in the determination of three of the six nutrient constituents: nitrate plus nitrite nitrogen as nitrogen, nitrite nitrogen as nitrogen, and orthophosphate as phosphorus. A biased condition was indicated in the determination of ammonia nitrogen as nitrogen, ammonia plus organic nitrogen as nitrogen, and nitrate plus nitrite nitrogen as nitrogen. There was acceptable precision in the determination of all 10 constituents contained in precipitation samples. Results for ammonia nitrogen as nitrogen, sodium, and fluoride indicated a biased condition. (Author 's abstract)

42 CFR 493.1239 - Standard: General laboratory systems quality assessment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... of general laboratory systems quality assessment reviews with appropriate staff. (c) The laboratory must document all general laboratory systems quality assessment activities. [68 FR 3703, Jan. 24, 2003... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: General laboratory systems quality...

Implementation of Quality Management in Core Service Laboratories

PubMed Central

Creavalle, T.; Haque, K.; Raley, C.; Subleski, M.; Smith, M.W.; Hicks, B.

2010-01-01

CF-28 The Genetics and Genomics group of the Advanced Technology Program of SAIC-Frederick exists to bring innovative genomic expertise, tools and analysis to NCI and the scientific community. The Sequencing Facility (SF) provides next generation short read (Illumina) sequencing capacity to investigators using a streamlined production approach. The Laboratory of Molecular Technology (LMT) offers a wide range of genomics core services including microarray expression analysis, miRNA analysis, array comparative genome hybridization, long read (Roche) next generation sequencing, quantitative real time PCR, transgenic genotyping, Sanger sequencing, and clinical mutation detection services to investigators from across the NIH. As the technology supporting this genomic research becomes more complex, the need for basic quality processes within all aspects of the core service groups becomes critical. The Quality Management group works alongside members of these labs to establish or improve processes supporting operations control (equipment, reagent and materials management), process improvement (reengineering/optimization, automation, acceptance criteria for new technologies and tech transfer), and quality assurance and customer support (controlled documentation/SOPs, training, service deficiencies and continual improvement efforts). Implementation and expansion of quality programs within unregulated environments demonstrates SAIC-Frederick's dedication to providing the highest quality products and services to the NIH community.

Laboratory Innovation Towards Quality Program Sustainability.

PubMed

Abimiku, Alash'le; Timperi, Ralph; Blattner, William

2016-08-01

Laboratory innovation significantly affects program sustainability of HIV programs in low and middle income countries (LMICs) far beyond its immediate sphere of impact. Innovation in rapid development of diagnostic technologies, improved quality management systems, strengthened laboratory management, affordable external quality assurance and accreditation schemes, and building local capacity have reduced costs, brought quality improvement to point-of-care testing, increased access to testing services, reduced treatment and prevention costs and opened the door to the real possibility of ending the AIDS epidemic. However, for effectively implemented laboratory innovation to contribute to HIV quality program sustainability, it must be implemented within the overall context of the national strategic plan and HIV treatment programs. The high quality of HIV rapid diagnostic test was a breakthrough that made it possible for more persons to learn their HIV status, receive counseling, and if infected to receive treatment. Likewise, the use of dried blood spots made the shipment of samples easier for the assessment of different variables of HIV infection-molecular diagnosis, CD4+ cell counts, HIV antibodies, drug resistance surveillance, and even antiretroviral drug level measurements. Such advancement is critical for to reaching the UNAIDS target of 90-90-90 and for bringing the AIDS epidemic to an end, especially in LMICs.

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

What's to Be Done About Laboratory Quality? Process Indicators, Laboratory Stewardship, the Outcomes Problem, Risk Assessment, and Economic Value: Responding to Contemporary Global Challenges.

PubMed

Meier, Frederick A; Badrick, Tony C; Sikaris, Kenneth A

2018-02-17

For 50 years, structure, process, and outcomes measures have assessed health care quality. For clinical laboratories, structural quality has generally been assessed by inspection. For assessing process, quality indicators (QIs), statistical monitors of steps in the clinical laboratory total testing, have proliferated across the globe. Connections between structural and process laboratory measures and patient outcomes, however, have rarely been demonstrated. To inform further development of clinical laboratory quality systems, we conducted a selective but worldwide review of publications on clinical laboratory quality assessment. Some QIs, like seven generic College of American Pathologists Q-Tracks monitors, have demonstrated significant process improvement; other measures have uncovered critical opportunities to improve test selection and result management. The College of Pathologists of Australasia Key Indicator Monitoring and Management System has deployed risk calculations, introduced from failure mode effects analysis, as surrogate measures for outcomes. Showing economic value from clinical laboratory testing quality is a challenge. Clinical laboratories should converge on fewer (7-14) rather than more (21-35) process monitors; monitors should cover all steps of the testing process under laboratory control and include especially high-risk specimen-quality QIs. Clinical laboratory stewardship, the combination of education interventions among clinician test orderers and report consumers with revision of test order formats and result reporting schemes, improves test ordering, but improving result reception is more difficult. Risk calculation reorders the importance of quality monitors by balancing three probabilities: defect frequency, weight of potential harm, and detection difficulty. The triple approach of (1) a more focused suite of generic consensus quality indicators, (2) more active clinical laboratory testing stewardship, and (3) integration of formal

ISO 15189 accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory I.

PubMed

Guzel, Omer; Guner, Ebru Ilhan

2009-03-01

Medical laboratories are the key partners in patient safety. Laboratory results influence 70% of medical diagnoses. Quality of laboratory service is the major factor which directly affects the quality of health care. The clinical laboratory as a whole has to provide the best patient care promoting excellence. International Standard ISO 15189, based upon ISO 17025 and ISO 9001 standards, provides requirements for competence and quality of medical laboratories. Accredited medical laboratories enhance credibility and competency of their testing services. Our group of laboratories, one of the leading institutions in the area, had previous experience with ISO 9001 and ISO 17025 Accreditation at non-medical sections. We started to prepared for ISO 15189 Accreditation at the beginning of 2006 and were certified in March, 2007. We spent more than a year to prepare for accreditation. Accreditation scopes of our laboratory were as follows: clinical chemistry, hematology, immunology, allergology, microbiology, parasitology, molecular biology of infection serology and transfusion medicine. The total number of accredited tests is 531. We participate in five different PT programs. Inter Laboratory Comparison (ILC) protocols are performed with reputable laboratories. 82 different PT Program modules, 277 cycles per year for 451 tests and 72 ILC program organizations for remaining tests have been performed. Our laboratory also organizes a PT program for flow cytometry. 22 laboratories participate in this program, 2 cycles per year. Our laboratory has had its own custom made WEB based LIS system since 2001. We serve more than 500 customers on a real time basis. Our quality management system is also documented and processed electronically, Document Management System (DMS), via our intranet. Preparatory phase for accreditation, data management, external quality control programs, personnel related issues before, during and after accreditation process are presented. Every laboratory has

Implementing a Quality Management System in the Medical Microbiology Laboratory.

PubMed

Carey, Roberta B; Bhattacharyya, Sanjib; Kehl, Sue C; Matukas, Larissa M; Pentella, Michael A; Salfinger, Max; Schuetz, Audrey N

2018-07-01

This document outlines a comprehensive practical approach to a laboratory quality management system (QMS) by describing how to operationalize the management and technical requirements described in the ISO 15189 international standard. It provides a crosswalk of the ISO requirements for quality and competence for medical laboratories to the 12 quality system essentials delineated by the Clinical and Laboratory Standards Institute. The quality principles are organized under three main categories: quality infrastructure, laboratory operations, and quality assurance and continual improvement. The roles and responsibilities to establish and sustain a QMS are outlined for microbiology laboratory staff, laboratory management personnel, and the institution's leadership. Examples and forms are included to assist in the real-world implementation of this system and to allow the adaptation of the system for each laboratory's unique environment. Errors and nonconforming events are acknowledged and embraced as an opportunity to improve the quality of the laboratory, a culture shift from blaming individuals. An effective QMS encourages "systems thinking" by providing a process to think globally of the effects of any type of change. Ultimately, a successful QMS is achieved when its principles are adopted as part of daily practice throughout the total testing process continuum. Copyright © 2018 American Society for Microbiology.

Quality assessment of malaria laboratory diagnosis in South Africa.

PubMed

Dini, Leigh; Frean, John

2003-01-01

To assess the quality of malaria diagnosis in 115 South African laboratories participating in the National Health Laboratory Service Parasitology External Quality Assessment Programme we reviewed the results from 7 surveys from January 2000 to August 2002. The mean percentage incorrect result rate was 13.8% (95% CI 11.3-16.9%), which is alarmingly high, with about 1 in 7 blood films being incorrectly interpreted. Most participants with incorrect blood film interpretations had acceptable Giemsa staining quality, indicating that there is less of a problem with staining technique than with blood film interpretation. Laboratories in provinces in which malaria is endemic did not necessarily perform better than those in non-endemic areas. The results clearly suggest that malaria laboratory diagnosis throughout South Africa needs strengthening by improving laboratory standardization and auditing, training, quality assurance and referral resources.

[The external evaluation of study quality: the role in maintaining the reliability of laboratory information].

PubMed

Men'shikov, V V

2013-08-01

The external evaluation of quality of clinical laboratory examinations was gradually introduced in USSR medical laboratories since 1970s. In Russia, in the middle of 1990 a unified all-national system of external evaluation quality was organized known as the Federal center of external evaluation of quality at the basis of laboratory of the state research center of preventive medicine. The main positions of policy in this area were neatly formulated in the guidance documents of ministry of Health. Nowadays, the center of external evaluation of quality proposes 100 and more types of control studies and permanently extends their specter starting from interests of different disciplines of clinical medicine. The consistent participation of laboratories in the cycles of external evaluation of quality intrinsically promotes improvement of indicators of properness and precision of analysis results and increases reliability of laboratory information. However, a significant percentage of laboratories does not participate at all in external evaluation of quality or takes part in control process irregularly and in limited number of tests. The managers of a number of medical organizations disregard the application of the proposed possibilities to increase reliability of laboratory information and limit financing of studies in the field of quality control. The article proposes to adopt the national standard on the basis of ISO 17043 "Evaluation of compliance. The common requirements of professional competence testing".

Exploring the links between quality assurance and laboratory resources. An audit-based study.

PubMed

Singh, Navjeevan; Panwar, Aru; Masih, Vipin Fazal; Arora, Vinod K; Bhatia, Arati

2003-01-01

To investigate and rectify the problems related to Ziehl-Neelsen (Z-N) staining in a cytology laboratory in the context of quality assurance. An audit based quality assurance study of 1,421 patients with clinical diagnoses of tubercular lymphadenopathy who underwent fine needle aspiration cytology. Data from 8 months were audited (group 1). Laboratory practices related to selection of smears for Z-N staining were studied. A 2-step corrective measure based on results of the audit was introduced for 2 months (group 2). Results were subjected to statistical analysis using the chi 2 test. Of 1,172 patients in group 1,368 had diagnoses other than tuberculosis. Overall acid-fast bacillus (AFB) positivity was 42%. AFB positivity in 249 patients in group 2 was 89% (P < .0001). Several issues in the laboratory are linked to quality assurance. Solving everyday problems can have far-reaching benefits for the performance of laboratory personnel, resources and work flow.

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 3 2014-01-01 2014-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 3 2013-01-01 2013-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

7 CFR 58.523 - Laboratory and quality control tests.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 3 2012-01-01 2012-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

The economic impact of poor sample quality in clinical chemistry laboratories: results from a global survey.

PubMed

Erdal, Erik P; Mitra, Debanjali; Khangulov, Victor S; Church, Stephen; Plokhoy, Elizabeth

2017-03-01

Background Despite advances in clinical chemistry testing, poor blood sample quality continues to impact laboratory operations and the quality of results. While previous studies have identified the preanalytical causes of lower sample quality, few studies have examined the economic impact of poor sample quality on the laboratory. Specifically, the costs associated with workarounds related to fibrin and gel contaminants remain largely unexplored. Methods A quantitative survey of clinical chemistry laboratory stakeholders across 10 international regions, including countries in North America, Europe and Oceania, was conducted to examine current blood sample testing practices, sample quality issues and practices to remediate poor sample quality. Survey data were used to estimate costs incurred by laboratories to mitigate sample quality issues. Results Responses from 164 participants were included in the analysis, which was focused on three specific issues: fibrin strands, fibrin masses and gel globules. Fibrin strands were the most commonly reported issue, with an overall incidence rate of ∼3%. Further, 65% of respondents indicated that these issues contribute to analyzer probe clogging, and the majority of laboratories had visual inspection and manual remediation practices in place to address fibrin- and gel-related quality problems (55% and 70%, respectively). Probe maintenance/replacement, visual inspection and manual remediation were estimated to carry significant costs for the laboratories surveyed. Annual cost associated with lower sample quality and remediation related to fibrin and/or gel globules for an average US laboratory was estimated to be $100,247. Conclusions Measures to improve blood sample quality present an important step towards improved laboratory operations.

The quality of veterinary in-clinic and reference laboratory biochemical testing.

PubMed

Rishniw, Mark; Pion, Paul D; Maher, Tammy

2012-03-01

Although evaluation of biochemical analytes in blood is common in veterinary practice, studies assessing the global quality of veterinary in-clinic and reference laboratory testing have not been reported. The aim of this study was to assess the quality of biochemical testing in veterinary laboratories using results obtained from analyses of 3 levels of assayed quality control materials over 5 days. Quality was assessed by comparison of calculated total error with quality requirements, determination of sigma metrics, use of a quality goal index to determine factors contributing to poor performance, and agreement between in-clinic and reference laboratory mean results. The suitability of in-clinic and reference laboratory instruments for statistical quality control was determined using adaptations from the computerized program, EZRules3. Reference laboratories were able to achieve desirable quality requirements more frequently than in-clinic laboratories. Across all 3 materials, > 50% of in-clinic analyzers achieved a sigma metric ≥ 6.0 for measurement of 2 analytes, whereas > 50% of reference laboratory analyzers achieved a sigma metric ≥ 6.0 for measurement of 6 analytes. Expanded uncertainty of measurement and ± total allowable error resulted in the highest mean percentages of analytes demonstrating agreement between in-clinic and reference laboratories. Owing to marked variation in bias and coefficient of variation between analyzers of the same and different types, the percentages of analytes suitable for statistical quality control varied widely. These findings reflect the current state-of-the-art with regard to in-clinic and reference laboratory analyzer performance and provide a baseline for future evaluations of the quality of veterinary laboratory testing. © 2012 American Society for Veterinary Clinical Pathology.

Getting started on metrics - Jet Propulsion Laboratory productivity and quality

NASA Technical Reports Server (NTRS)

Bush, M. W.

1990-01-01

A review is presented to describe the effort and difficulties of reconstructing fifteen years of JPL software history. In 1987 the collection and analysis of project data were started with the objective of creating laboratory-wide measures of quality and productivity for software development. As a result of this two-year Software Product Assurance metrics study, a rough measurement foundation for software productivity and software quality, and an order-of-magnitude quantitative baseline for software systems and subsystems are now available.

Quality assurance program for molecular medicine laboratories.

PubMed

Hajia, M; Safadel, N; Samiee, S Mirab; Dahim, P; Anjarani, S; Nafisi, N; Sohrabi, A; Rafiee, M; Sabzavi, F; Entekhabi, B

2013-01-01

Molecular diagnostic methods have played and continuing to have a critical role in clinical laboratories in recent years. Therefore, standardization is an evolutionary process that needs to be upgrade with increasing scientific knowledge, improvement of the instruments and techniques. The aim of this study was to design a quality assurance program in order to have similar conditions for all medical laboratories engaging with molecular tests. We had to design a plan for all four elements; required space conditions, equipments, training, and basic guidelines. Necessary guidelines was prepared and confirmed by the launched specific committee at the Health Reference Laboratory. Several workshops were also held for medical laboratories directors and staffs, quality control manager of molecular companies, directors and nominees from universities. Accreditation of equipments and molecular material was followed parallel with rest of program. Now we are going to accredit medical laboratories and to evaluate the success of the program. Accreditation of medical laboratory will be succeeding if its basic elements are provided in advance. Professional practice guidelines, holding training and performing accreditation the molecular materials and equipments ensured us that laboratories are aware of best practices, proper interpretation, limitations of techniques, and technical issues. Now, active external auditing can improve the applied laboratory conditions toward the defined standard level.

Factors Affecting Quality of Laboratory Services in Public and Private Health Facilities in Addis Ababa, Ethiopia.

PubMed

Mesfin, Eyob Abera; Taye, Binyam; Belay, Getachew; Ashenafi, Aytenew; Girma, Veronica

2017-10-01

Quality laboratory service is an essential component of health care system but in Sub-Saharan Africa such as Ethiopia, laboratories quality system remains weak due to several factors and it needs more attention to strengthen its capacity and quality system. A cross sectional study was conducted using a questionnaire to assess factors affecting the quality of laboratory service at private and public health institutions in Addis Ababa. A total of 213 laboratory professionals participated in the study and 131 (61.5%) participants had bachelor degree. Majority, 133 (62.4%), of the professionals did not attend any work related training. Seventy five (35.2%) respondents believed that their laboratories did not provide quality laboratory services and the major reported factors affecting provision of quality services were shortage of resources (64.3%), poor management support (57.3%), poor equipment quality (53.4%), high workload (41.1%), lack of equipment calibration (38.3%) and lack of knowledge (23.3%). Moreover logistic regression analysis showed that provision of quality laboratory service was significantly associated with result verification (AOR=9.21, 95% CI=2.26, 37.48), internal quality control (AOR= 6.11, 95% CI=2.11, 17.70), turnaround time (AOR=5.11, 95% CI=1.94, 13.46), shortage of equipment (AOR=7.76, 95% CI=2.55, 23.66), communication with clinicians (AOR=3.24, 95% CI=1.25, 8.41) and lack of job description (AOR=3.67, 95% CI=1.319, 10.22). In conclusion, the major factors that affecting the quality of laboratory service were associated with poor human resource management, poor resources provision, poor management commitment, ineffective communication system and lack of well-established quality management system.

Quality assurance and quality improvement in U.S. clinical molecular genetic laboratories.

PubMed

Chen, Bin; Richards, C Sue; Wilson, Jean Amos; Lyon, Elaine

2011-04-01

A robust quality-assurance program is essential for laboratories that perform molecular genetic testing to maintain high-quality testing and be able to address challenges associated with performance or delivery of testing services as the use of molecular genetic tests continues to expand in clinical and public health practice. This unit discusses quality-assurance and quality-improvement considerations that are critical for molecular genetic testing performed for heritable diseases and conditions. Specific discussion is provided on applying regulatory standards and best practices in establishing/verifying test performance, ensuring quality of the total testing process, monitoring and maintaining personnel competency, and continuing quality improvement. The unit provides a practical reference for laboratory professionals to use in recognizing and addressing essential quality-assurance issues in human molecular genetic testing. It should also provide useful information for genetics researchers, trainees, and fellows in human genetics training programs, as well as others who are interested in quality assurance and quality improvement for molecular genetic testing. 2011 by John Wiley & Sons, Inc.

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.

Implementation research: a mentoring programme to improve laboratory quality in Cambodia

PubMed Central

Voeurng, Vireak; Sek, Sophat; Song, Sophanna; Vong, Nora; Tous, Chansamrach; Flandin, Jean-Frederic; Confer, Deborah; Costa, Alexandre; Martin, Robert

2016-01-01

Abstract Objective To implement a mentored laboratory quality stepwise implementation (LQSI) programme to strengthen the quality and capacity of Cambodian hospital laboratories. Methods We recruited four laboratory technicians to be mentors and trained them in mentoring skills, laboratory quality management practices and international standard organization (ISO) 15189 requirements for medical laboratories. Separately, we trained staff from 12 referral hospital laboratories in laboratory quality management systems followed by tri-weekly in-person mentoring on quality management systems implementation using the LQSI tool, which is aligned with the ISO 15189 standard. The tool was adapted from a web-based resource into a software-based spreadsheet checklist, which includes a detailed action plan and can be used to qualitatively monitor each laboratory’s progress. The tool – translated into Khmer – included a set of quality improvement activities grouped into four phases for implementation with increasing complexity. Project staff reviewed the laboratories’ progress and challenges in weekly conference calls and bi-monthly meetings with focal points of the health ministry, participating laboratories and local partners. We present the achievements in implementation from September 2014 to March 2016. Findings As of March 2016, the 12 laboratories have completed 74–90% of the 104 activities in phase 1, 53–78% of the 178 activities in phase 2, and 18–26% of the 129 activities in phase 3. Conclusion Regular on-site mentoring of laboratories using a detailed action plan in the local language allows staff to learn concepts of quality management system and learn on the job without disruption to laboratory service provision. PMID:27843164

Laboratory quality management system: road to accreditation and beyond.

PubMed

Wadhwa, V; Rai, S; Thukral, T; Chopra, M

2012-01-01

This review attempts to clarify the concepts of Laboratory Quality Management System (Lab QMS) for a medical testing and diagnostic laboratory in a holistic way and hopes to expand the horizon beyond quality control (QC) and quality assurance. It provides an insight on accreditation bodies and highlights a glimpse of existing laboratory practices but essentially it takes the reader through the journey of accreditation and during the course of reading and understanding this document, prepares the laboratory for the same. Some of the areas which have not been highlighted previously include: requirement for accreditation consultants, laboratory infrastructure and scope, applying for accreditation, document preparation. This section is well supported with practical illustrations and necessary tables and exhaustive details like preparation of a standard operating procedure and a quality manual. Concept of training and privileging of staff has been clarified and a few of the QC exercises have been dealt with in a novel way. Finally, a practical advice for facing an actual third party assessment and caution needed to prevent post-assessment pitfalls has been dealt with.

Quality Assurance Program for Molecular Medicine Laboratories

PubMed Central

Hajia, M; Safadel, N; Samiee, S Mirab; Dahim, P; Anjarani, S; Nafisi, N; Sohrabi, A; Rafiee, M; Sabzavi, F; Entekhabi, B

2013-01-01

Background: Molecular diagnostic methods have played and continuing to have a critical role in clinical laboratories in recent years. Therefore, standardization is an evolutionary process that needs to be upgrade with increasing scientific knowledge, improvement of the instruments and techniques. The aim of this study was to design a quality assurance program in order to have similar conditions for all medical laboratories engaging with molecular tests. Methods: We had to design a plan for all four elements; required space conditions, equipments, training, and basic guidelines. Necessary guidelines was prepared and confirmed by the launched specific committee at the Health Reference Laboratory. Results: Several workshops were also held for medical laboratories directors and staffs, quality control manager of molecular companies, directors and nominees from universities. Accreditation of equipments and molecular material was followed parallel with rest of program. Now we are going to accredit medical laboratories and to evaluate the success of the program. Conclusion: Accreditation of medical laboratory will be succeeding if its basic elements are provided in advance. Professional practice guidelines, holding training and performing accreditation the molecular materials and equipments ensured us that laboratories are aware of best practices, proper interpretation, limitations of techniques, and technical issues. Now, active external auditing can improve the applied laboratory conditions toward the defined standard level. PMID:23865028

USGS Laboratory Review Program Ensures Analytical Quality

USGS Publications Warehouse

Erdmann, David E.

1995-01-01

The USGS operates a review program for laboratories that analyze samples for USGS environmental investigations. This program has been effective in providing QA feedback to laboratories while ensuring that analytical data are consistent, of satisfactory quality, and meet the data objectives of the investigation.

Factors Affecting Quality of Laboratory Services in Public and Private Health Facilities in Addis Ababa, Ethiopia

PubMed Central

Taye, Binyam; Belay, Getachew; Ashenafi, Aytenew; Girma, Veronica

2017-01-01

Background Quality laboratory service is an essential component of health care system but in Sub-Saharan Africa such as Ethiopia, laboratories quality system remains weak due to several factors and it needs more attention to strengthen its capacity and quality system. Methodology A cross sectional study was conducted using a questionnaire to assess factors affecting the quality of laboratory service at private and public health institutions in Addis Ababa. Results A total of 213 laboratory professionals participated in the study and 131 (61.5%) participants had bachelor degree. Majority, 133 (62.4%), of the professionals did not attend any work related training. Seventy five (35.2%) respondents believed that their laboratories did not provide quality laboratory services and the major reported factors affecting provision of quality services were shortage of resources (64.3%), poor management support (57.3%), poor equipment quality (53.4%), high workload (41.1%), lack of equipment calibration (38.3%) and lack of knowledge (23.3%). Moreover logistic regression analysis showed that provision of quality laboratory service was significantly associated with result verification (AOR=9.21, 95% CI=2.26, 37.48), internal quality control (AOR= 6.11, 95% CI=2.11, 17.70), turnaround time (AOR=5.11, 95% CI=1.94, 13.46), shortage of equipment (AOR=7.76, 95% CI=2.55, 23.66), communication with clinicians (AOR=3.24, 95% CI=1.25, 8.41) and lack of job description (AOR=3.67, 95% CI=1.319, 10.22). Conclusion In conclusion, the major factors that affecting the quality of laboratory service were associated with poor human resource management, poor resources provision, poor management commitment, ineffective communication system and lack of well-established quality management system. PMID:29075171

Has compliance with CLIA requirements really improved quality in US clinical laboratories?

PubMed

Ehrmeyer, Sharon S; Laessig, Ronald H

2004-08-02

The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandate universal requirements for all U.S. clinical laboratory-testing sites. The intent of CLIA'88 is to ensure quality testing through a combination of minimum quality practices that incorporate total quality management concepts. These regulations do not contain established, objective indicators or measures to assess quality. However, there is an implicit assumption that compliance with traditionally accepted good laboratory practices--following manufacturers' directions, routinely analysing quality control materials, applying quality assurance principles, employing and assessing competent testing personnel, and participating in external quality assessment or proficiency testing (PT)--will result in improved test quality. The CLIA'88 regulations do include PT performance standards, which intentionally or unintentionally, define intra-laboratory performance. Passing PT has become a prime motivation for improving laboratory performance; it can also be used as an objective indicator to assess whether compliance to CLIA has improved intra-laboratory quality. Data from 1994 through 2002 indicate that the percentage of laboratories passing PT has increased. In addition to PT performance, subjective indicators of improved quality--frequency of inspection deficiencies, the number of government sanctions for non-compliance, and customer satisfaction--were evaluated. The results from these subjective indicators are more difficult to interpret but also seem to show improved quality in US clinical laboratories eleven years post-CLIA'88.

7 CFR 58.442 - Laboratory and quality control tests.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory and quality control tests. 58.442 Section... Service 1 Operations and Operating Procedures § 58.442 Laboratory and quality control tests. (a) Chemical... Methods or by other methods giving equivalent results. (b) Weight or volume control. Representative...

7 CFR 58.442 - Laboratory and quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Laboratory and quality control tests. 58.442 Section... Service 1 Operations and Operating Procedures § 58.442 Laboratory and quality control tests. (a) Chemical... Methods or by other methods giving equivalent results. (b) Weight or volume control. Representative...

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

Quality assurance practices in Europe: a survey of molecular genetic testing laboratories

PubMed Central

Berwouts, Sarah; Fanning, Katrina; Morris, Michael A; Barton, David E; Dequeker, Elisabeth

2012-01-01

In the 2000s, a number of initiatives were taken internationally to improve quality in genetic testing services. To contribute to and update the limited literature available related to this topic, we surveyed 910 human molecular genetic testing laboratories, of which 291 (32%) from 29 European countries responded. The majority of laboratories were in the public sector (81%), affiliated with a university hospital (60%). Only a minority of laboratories was accredited (23%), and 26% was certified. A total of 22% of laboratories did not participate in external quality assessment (EQA) and 28% did not use reference materials (RMs). The main motivations given for accreditation were to improve laboratory profile (85%) and national recognition (84%). Nearly all respondents (95%) would prefer working in an accredited laboratory. In accredited laboratories, participation in EQA (P<0.0001), use of RMs (P=0.0014) and availability of continuous education (CE) on medical/scientific subjects (P=0.023), specific tasks (P=0.0018), and quality assurance (P<0.0001) were significantly higher than in non-accredited laboratories. Non-accredited laboratories expect higher restriction of development of new techniques (P=0.023) and improvement of work satisfaction (P=0.0002) than accredited laboratories. By using a quality implementation score (QIS), we showed that accredited laboratories (average score 92) comply better than certified laboratories (average score 69, P<0.001), and certified laboratories better than other laboratories (average score 44, P<0.001), with regard to the implementation of quality indicators. We conclude that quality practices vary widely in European genetic testing laboratories. This leads to a potentially dangerous situation in which the quality of genetic testing is not consistently assured. PMID:22739339

A cost benefit analysis of outsourced laboratory services.

PubMed

Bowers, J A

1995-11-01

As healthcare moves toward increased capitation, hospital administrators must be aware of all costs associated with patient services. This article describes the cost benefit analysis process used by northern Indiana hospital consumers during 1994-1995 to evaluate a local laboratory service outsource provider, South Bend Medical Foundation (SBMF). In an effort to meet the best interests of the community at large, three competing hospitals, medical leadership, and the local outsource provider joined forces to ensure that cost effective quality services would be provided. Laboratory utilization patterns for common DRGs were also analyzed. The team created a reconfiguration analysis to help develop benchmark figures for consideration in future contract negotiations.

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.

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.

Introduction to ISO 15189: a blueprint for quality systems in veterinary laboratories.

PubMed

Freeman, Kathleen P; Bauer, Natali; Jensen, Asger L; Thoresen, Stein

2006-06-01

A trend in human and veterinary medical laboratory management is to achieve accreditation based on international standards. The International Organization for Standardization (ISO) 15189 standard is the first developed especially for accreditation of medical laboratories, and emphasizes the laboratory-client interface. European veterinary laboratories seeking to train candidates for the certification examination of the European College of Veterinary Clinical Pathology (ECVCP) require approval by the ECVCP Laboratory Standards Committee, which bases its evaluation in part on adherence to quality systems described in the ISO 15189 standards. The purpose of this article was to introduce the latest ISO quality standard and describe its application to veterinary laboratories in Europe, specifically as pertains to accreditation of laboratories involved in training veterinary clinical pathologists. Between 2003 and 2006, the Laboratory Standards Committee reviewed 12 applications from laboratories (3 commercial and 9 university) involved in training veterinary clinical pathologists. Applicants were asked to provide a description of the facilities for training and testing, current methodology and technology, health and safety policy, quality assurance policy (including internal quality control and participation in an external quality assurance program), written standard operating procedures (SOPs) and policies, a description of the laboratory information system, and personnel and training. Also during this time period multiple informal and formal discussions among ECVCP diplomates took place as to current practices and perceived areas of concern with regard to laboratory accreditation requirements. Areas in which improvement most often was needed in veterinary laboratories applying for ECVCP accreditation were the written quality plan, defined quality requirements for the tests performed, written SOPs and policies, training records, ongoing audits and competency

Iowa Central Quality Fuel Testing Laboratory

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

Heach, Don; Bidieman, Julaine

2013-09-30

The objective of this project is to finalize the creation of an independent quality fuel testing laboratory on the campus of Iowa Central Community College in Fort Dodge, Iowa that shall provide the exploding biofuels industry a timely and cost-effective centrally located laboratory to complete all state and federal fuel and related tests that are required. The recipient shall work with various state regulatory agencies, biofuel companies and state and national industry associations to ensure that training and testing needs of their members and American consumers are met. The recipient shall work with the Iowa Department of Ag and Landmore » Stewardship on the development of an Iowa Biofuel Quality Standard along with the Development of a standard that can be used throughout industry.« less

Convenient and Efficient Method for Quality Control Analysis of 18F-Fluorocholine: For a Small Scale GMP-based Radiopharmaceuticals Laboratory Set-up.

PubMed

Hassan, Hishar; Abu Bakar, Suharzelim; Halim, Khairul Najah Che A; Idris, Jaleezah; Nordin, Abdul Jalil

2016-01-01

Prostate cancer continues to be the most prevalent cancer in men in Malaysia. As time progresses, the prospect of PET imaging modality in diagnosis of prostate cancer is promising, with on-going improvement on novel tracers. Among all tracers, 18F-Fluorocholine is reported to be a reputable tracer and reliable diagnostic technique for prostate imaging. Nonetheless, only 18F-Fluorodeoxyglucose (18F-FDG) is available and used in most oncology cases in Malaysia. With a small scale GMP-based radiopharmaceuticals laboratory set-up, initial efforts have been taken to put Malaysia on 18F-Fluorocholine map. This article presents a convenient, efficient and reliable method for quality control analysis of 18F-Fluorocholine. Besides, the aim of this research work is to assist local GMP radiopharmaceuticals laboratories and local authority in Malaysia for quality control analysis of 18F-Fluorocholine guideline. In this study, prior to synthesis, quality control analysis method for 18F-Fluorocholine was developed and validated, by adapting the equipment set-up used in 18F-Fluorodeoxyglucose (18FFDG) routine production. Quality control on the 18F-Fluorocholine was performed by means of pH, radionuclidic identity, radio-high performance liquid chromatography equipped with ultraviolet, radio- thin layer chromatography, gas chromatography and filter integrity test. Post-synthesis; the pH of 18F-Fluorocholine was 6.42 ± 0.04, with half-life of 109.5 minutes (n = 12). The radiochemical purity was consistently higher than 99%, both in radio-high performance liquid chromatography equipped with ultraviolet (r-HPLC; SCX column, 0.25 M NaH2PO4: acetonitrile) and radio-thin layer chromatography method (r-TLC). The calculated relative retention time (RRT) in r-HPLC was 1.02, whereas the retention factor (Rf) in r-TLC was 0.64. Potential impurities from 18F-Fluorocholine synthesis such as ethanol, acetonitrile, dimethylethanolamine and dibromomethane were determined in gas chromatography

Reliability on intra-laboratory and inter-laboratory data of hair mineral analysis comparing with blood analysis.

PubMed

Namkoong, Sun; Hong, Seung Phil; Kim, Myung Hwa; Park, Byung Cheol

2013-02-01

Nowadays, although its clinical value remains controversial institutions utilize hair mineral analysis. Arguments about the reliability of hair mineral analysis persist, and there have been evaluations of commercial laboratories performing hair mineral analysis. The objective of this study was to assess the reliability of intra-laboratory and inter-laboratory data at three commercial laboratories conducting hair mineral analysis, compared to serum mineral analysis. Two divided hair samples taken from near the scalp were submitted for analysis at the same time, to all laboratories, from one healthy volunteer. Each laboratory sent a report consisting of quantitative results and their interpretation of health implications. Differences among intra-laboratory and interlaboratory data were analyzed using SPSS version 12.0 (SPSS Inc., USA). All the laboratories used identical methods for quantitative analysis, and they generated consistent numerical results according to Friedman analysis of variance. However, the normal reference ranges of each laboratory varied. As such, each laboratory interpreted the patient's health differently. On intra-laboratory data, Wilcoxon analysis suggested they generated relatively coherent data, but laboratory B could not in one element, so its reliability was doubtful. In comparison with the blood test, laboratory C generated identical results, but not laboratory A and B. Hair mineral analysis has its limitations, considering the reliability of inter and intra laboratory analysis comparing with blood analysis. As such, clinicians should be cautious when applying hair mineral analysis as an ancillary tool. Each laboratory included in this study requires continuous refinement from now on for inducing standardized normal reference levels.

Helping You Identify Quality Laboratory Services

MedlinePlus

... and then discuss specifics about the quality improvement processes the laboratory has in place. General questions  What ... like a printed copy, please call the Customer Service Center at (630) 792-5800. To report information ...

Approaches to quality management and accreditation in a genetic testing laboratory

PubMed Central

Berwouts, Sarah; Morris, Michael A; Dequeker, Elisabeth

2010-01-01

Medical laboratories, and specifically genetic testing laboratories, provide vital medical services to different clients: clinicians requesting a test, patients from whom the sample was collected, public health and medical-legal instances, referral laboratories and authoritative bodies. All expect results that are accurate and obtained in an efficient and effective manner, within a suitable time frame and at acceptable cost. There are different ways of achieving the end results, but compliance with International Organization for Standardization (ISO) 15189, the international standard for the accreditation of medical laboratories, is becoming progressively accepted as the optimal approach to assuring quality in medical testing. We present recommendations and strategies designed to aid genetic testing laboratories with the implementation of a quality management system, including key aspects such as document control, external quality assessment, internal quality control, internal audit, management review, validation, as well as managing the human side of change. The focus is on pragmatic approaches to attain the levels of quality management and quality assurance required for accreditation according to ISO 15189, within the context of genetic testing. Attention is also given to implementing efficient and effective quality improvement. PMID:20720559

ASVCP quality assurance guidelines: control of general analytical factors in veterinary laboratories.

PubMed

Flatland, Bente; Freeman, Kathy P; Friedrichs, Kristen R; Vap, Linda M; Getzy, Karen M; Evans, Ellen W; Harr, Kendal E

2010-09-01

Owing to lack of governmental regulation of veterinary laboratory performance, veterinarians ideally should demonstrate a commitment to self-monitoring and regulation of laboratory performance from within the profession. In response to member concerns about quality management in veterinary laboratories, the American Society for Veterinary Clinical Pathology (ASVCP) formed a Quality Assurance and Laboratory Standards (QAS) committee in 1996. This committee recently published updated and peer-reviewed Quality Assurance Guidelines on the ASVCP website. The Quality Assurance 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 on 1) general analytic factors for veterinary laboratory performance and comparisons, 2) hematology and hemostasis, and 3) clinical chemistry, endocrine assessment, and urinalysis. This report documents recommendations for control of general analytical factors within veterinary clinical laboratories and is based on section 2.1 (Analytical Factors Important In Veterinary Clinical Pathology, General) of the newly revised ASVCP QAS Guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimum guidelines for quality assurance and quality control for veterinary laboratory testing. It is hoped that these guidelines will provide a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. ©2010 American Society for Veterinary Clinical Pathology.

[Assessment of biological sampling's quality in a medical laboratory: case of Côte d' Ivoire Institute Pasteur].

PubMed

Kouassi-M'Bengue, Alphonsine; Koffi, Stephane; Manizan, Pascale; Ouattara, Abdoulaye; N'Douba, Adele Kacou; Dosso, Mireille

2008-01-01

Assurance quality is important in medical laboratory, but in Africa, few laboratories are involved in this process. The aim of this study was to assess biological sampling's quality in a bacteriological laboratory. A cross sectional study was undertaken in medical bacteriological laboratory of Côte d' Ivoire Institute Pasteur during 6 months. All urines, saddles, and bronchial expectorations collected from ambulatory patients during this period were included in the study. The quality of urine's, saddles and bronchial expectorations' sampling for a bacteriological analysis was evaluated. An interview based on Guidelines of good laboratories practices and referential ISO 15189 was used. A total of 300 samples were indexed. On a total of 300 recorded biological samples, 224 (74.7%) were not in conformity. In 87.5% of the cases of nonconformities, an antibiotic's treatment were preliminary instituted before the sampling. Corrective actions were carried in the laboratory on 30 samples with 56.6% for the urines, 26.7% for the saddles and 16.7% for the bronchial expectorations. At the end of this study, it arises that the quality of the biological sampling received at the medical bacteriology laboratory need to be improved.

External quality control for embryology laboratories.

PubMed

Castilla, Jose Antonio; Ruiz de Assín, Rafael; Gonzalvo, Maria Carmen; Clavero, Ana; Ramírez, Juan Pablo; Vergara, Francisco; Martínez, Luis

2010-01-01

Participation in external quality control (EQC) programmes is recommended by various scientific societies. Results from an EQC programme for embryology laboratories are presented. This 5-year programme consisted of the annual delivery of (i) materials to test toxicity and (ii) a DVD/CD-ROM with images of zygotes and embryos on days 2 and 3, on the basis of which the participants were asked to judge the embryo quality and to take a clinical decision. A high degree of agreement was considered achieved when over 75% of the laboratories produced similar classifications. With respect to the materials analysed, the specificity was 68% and the sensitivity was 83%. Concerning embryo classification, the proportion of embryos on which a high degree of agreement was achieved increased during this period from 35% to 55%. No improvement was observed in the degree of agreement on the clinical decision to be taken. Day-3 embryos produced a higher degree of agreement (58%) than did day-2 embryos (32%) (P<0.05). Participation in EQC increased the degree of inter-laboratory agreement on embryo classification, but not the corresponding agreement on clinical decision taking. It is necessary to introduce measures aimed at standardizing decision taking procedures in embryology laboratories. Copyright (c) 2009 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

[Assessment of the quality of laboratory diagnosis of intestinal parasitic diseases by the laboratories participating in the Federal System of External Quality Assessment of Clinical Laboratory Testing].

PubMed

Malakhov, V N; Dovgalev, A S; Astanina, S Iu; Serdiuk, A P

2014-01-01

In 2010-2013, the quality of microscopic detection of the causative agents ofparasitic diseases in the feces has been assessed by the specialists of the laboratories of the therapeutic-and-prophylactic institutions (TPIs) and Hygiene and Epidemiology Centers, Russian Inspectorate for the Protection of Consumer Rights and Human Welfare, which are participants of the Federal System of External Quality Assessment of Clinical Laboratory Testing. Thirty-two specimens containing 16 species of human helminths and 4 species of enteric protozoa in different combinations were examined. The findings suggest that the quality of microscopic detection of the causative agents of parasitic diseases is low in the laboratories of health care facilities and that the specialists of the laboratories of TPIs and Hygiene and Epidemiology Centers, Russian Inspectorate for the Protection of Consumer Rights and Human Welfare, do not not possess the knowledge and skills necessary to make a laboratory diagnosis of helminths and enteric protozoa. The average detection rates of helminths and protozoa were at a level of 64 and 36%, respectively. The correct results showed that the proportion of helminths and protozoa were 94.5 and 5.5%, respectively. According to the biological and epidemiological classification of helminths, there were higher detection rates for contact group parasites (Enterobius vermicularis and Hymenolepis nana) and geohelminths (Ascaris, Trichuris trichiura, and others). Biohelminths (Opisthorchis, tapeworms, and others) Were detectable slightly worse.

Quality assurance in the HIV/AIDS laboratory network of China.

PubMed

Jiang, Yan; Qiu, Maofeng; Zhang, Guiyun; Xing, Wenge; Xiao, Yao; Pan, Pinliang; Yao, Jun; Ou, Chin-Yih; Su, Xueli

2010-12-01

In 2009, there were 8273 local screening laboratories, 254 confirmatory laboratories, 35 provincial confirmatory central laboratories and 1 National AIDS Reference Laboratory (NARL) in China. These laboratories were located in Center for Disease Control and Prevention (CDC) facilities, hospitals, blood donation clinics, maternal and child health (MCH) hospitals and border health quarantine health-care facilities. The NARL and provincial laboratories provide quality assurance through technical, bio-safety and managerial training; periodic proficiency testing; on-site supervisory inspections; and commercial serologic kit evaluations. From 2002 to 2009, more than 220 million HIV antibody tests were performed at screening laboratories, and all reactive and indeterminate samples were confirmed at confirmatory laboratories. The use of highly technically complex tests, including CD4 cell enumeration, viral load, dried blood spot (DBS)-based early infant diagnosis (EID), drug resistance (DR) genotyping, HIV-1 subtyping and incidence assays, have increased in recent years and their performance quality is closely monitored. China has made significant progress in establishing a well-coordinated HIV laboratory network and QA systems. However, the coverage and intensity of HIV testing and quality assurance programmes need to be strengthened so as to ensure that more infected persons are diagnosed and that they receive timely prevention and treatment services.

Quality assurance of laboratory work and clinical use of laboratory tests in general practice in norway: a survey.

PubMed

Thue, Geir; Jevnaker, Marianne; Gulstad, Guri Andersen; Sandberg, Sverre

2011-09-01

Virtually all the general practices in Norway participate in the Norwegian Quality Improvement of Laboratory Services in Primary Care, NOKLUS. In order to assess and develop NOKLUS's services, it was decided to carry out an investigation in the largest participating group, general practices. In autumn 2008 a questionnaire was sent to all Norwegian general practices asking for feedback on different aspects of NOKLUS's main services: contact with medical laboratory technologists, sending of control materials, use and maintenance of practice-specific laboratory binders, courses, and testing of laboratory equipment. In addition, attitudes were elicited towards possible new services directed at assessing other technical equipment and clinical use of tests. Responses were received from 1290 of 1552 practices (83%). The great majority thought that the frequency of sending out control material should continue as at present, and they were pleased with the feedback reports and follow-up by the laboratory technologists in the counties. Even after many years of practical experience, there is still a need to update laboratory knowledge through visits to practices, courses, and written information. Practices also wanted quality assurance of blood pressure meters and spirometers, and many doctors wanted feedback on their use of laboratory tests. Services regarding quality assurance of point-of-care tests, guidance, and courses should be continued. Quality assurance of other technical equipment and of the doctor's clinical use of laboratory tests should be established as part of comprehensive quality assurance.

[Standardization in laboratory hematology by participating in external quality assurance programs].

PubMed

Nazor, Aida; Siftar, Zoran; Flegar-Mestrić, Zlata

2011-09-01

Since 1985, Department of Clinical Chemistry and Laboratory Medicine, Merkur University Hospital, Zagreb, has been participating in the International External Quality Assessment Scheme for Hematology (IEQAS-H) organized by the World Health Organization (WHO). Owing to very good results, in 1987 the Department received a certificate of participation in this control scheme. Department has been cooperating in the external quality assessment program in laboratory hematology which has been continuously performed in Croatia since 1986 by the Committee for External Quality Assessment Schemes under the auspices of the Croatian Society of Medical Biochemists and School of Pharmacy and Biochemistry, University of Zagreb. Nowadays, 186 medical biochemical laboratories are included in the National External Quality Assessment program, which is performed three times per year. Our Department has participated in the international projects of the European Committee for External Quality Assurance Programs in Laboratory Medicine (EQALM).

42 CFR 493.1239 - Standard: General laboratory systems quality assessment.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Standard: General laboratory systems quality... for Nonwaived Testing General Laboratory Systems § 493.1239 Standard: General laboratory systems... laboratory systems requirements specified at §§ 493.1231 through 493.1236. (b) The general laboratory systems...

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

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.

Improving laboratory data entry quality using Six Sigma.

PubMed

Elbireer, Ali; Le Chasseur, Julie; Jackson, Brooks

2013-01-01

The Uganda Makerere University provides clinical laboratory support to over 70 clients in Uganda. With increased volume, manual data entry errors have steadily increased, prompting laboratory managers to employ the Six Sigma method to evaluate and reduce their problems. The purpose of this paper is to describe how laboratory data entry quality was improved by using Six Sigma. The Six Sigma Quality Improvement (QI) project team followed a sequence of steps, starting with defining project goals, measuring data entry errors to assess current performance, analyzing data and determining data-entry error root causes. Finally the team implemented changes and control measures to address the root causes and to maintain improvements. Establishing the Six Sigma project required considerable resources and maintaining the gains requires additional personnel time and dedicated resources. After initiating the Six Sigma project, there was a 60.5 percent reduction in data entry errors from 423 errors a month (i.e. 4.34 Six Sigma) in the first month, down to an average 166 errors/month (i.e. 4.65 Six Sigma) over 12 months. The team estimated the average cost of identifying and fixing a data entry error to be $16.25 per error. Thus, reducing errors by an average of 257 errors per month over one year has saved the laboratory an estimated $50,115 a year. The Six Sigma QI project provides a replicable framework for Ugandan laboratory staff and other resource-limited organizations to promote quality environment. Laboratory staff can deliver excellent care at a lower cost, by applying QI principles. This innovative QI method of reducing data entry errors in medical laboratories may improve the clinical workflow processes and make cost savings across the health care continuum.

[CAP quality management system in clinical laboratory and its issue].

PubMed

Tazawa, Hiromitsu

2004-03-01

The CAP (College of American Pathologists) was established in 1962 and, at present, CAP-accredited laboratories include about 6000 institutions all over the world, mainly in the U.S. The essential purpose of CAP accreditation is high quality reservation and improvement of clinical laboratory services for patient care, and is based on seven points, listed below. (1) Establishment of a laboratory management program and laboratory techniques to assure accuracy and improve overall quality of laboratory services. (2) Maintenance and improvement of accuracy objectively by centering on a CAP survey. (3) Thoroughness in safety and health administration. (4) Reservation of the performance of laboratory services by personnel and proficiency management. (5) Provision of appropriate information to physicians, and contribution to improved quality of patient care by close communication with physicians (improvement in patient care). (6) Reduction of running costs and personnel costs based on evidence by employing the above-mentioned criteria. (7) Reduction of laboratory error. In the future, accreditation and/or certification by organizations such as CAP, ISO, etc., may become a requirement for providing any clinical laboratory services in Japan. Taking the essence of the CAP and the characteristics of the new international standard, ISO151589, into consideration, it is important to choose the best suited accreditation and/or certification depending of the purpose of clinical laboratory.

Clinical Pharmacology Quality Assurance (CPQA) Program: Models for Longitudinal Analysis of Antiretroviral (ARV) Proficiency Testing for International Laboratories

PubMed Central

DiFrancesco, Robin; Rosenkranz, Susan L.; Taylor, Charlene R.; Pande, Poonam G.; Siminski, Suzanne M.; Jenny, Richard W.; Morse, Gene D.

2013-01-01

Among National Institutes of Health (NIH) HIV Research Networks conducting multicenter trials, samples from protocols that span several years are analyzed at multiple clinical pharmacology laboratories (CPLs) for multiple antiretrovirals (ARV). Drug assay data are, in turn, entered into study-specific datasets that are used for pharmacokinetic analyses, merged to conduct cross-protocol pharmacokinetic analysis and integrated with pharmacogenomics research to investigate pharmacokinetic-pharmacogenetic associations. The CPLs participate in a semi-annual proficiency testing (PT) program implemented by the Clinical Pharmacology Quality Assurance (CPQA) program. Using results from multiple PT rounds, longitudinal analyses of recovery are reflective of accuracy and precision within/across laboratories. The objectives of this longitudinal analysis of PT across multiple CPLs were to develop and test statistical models that longitudinally: (1)assess the precision and accuracy of concentrations reported by individual CPLs; (2)determine factors associated with round-specific and long-term assay accuracy, precision and bias using a new regression model. A measure of absolute recovery is explored as a simultaneous measure of accuracy and precision. Overall, the analysis outcomes assured 97% accuracy (±20% of the final target concentration of all (21)drug concentration results reported for clinical trial samples by multiple CPLs).Using the CLIA acceptance of meeting criteria for ≥2/3 consecutive rounds, all ten laboratories that participated in three or more rounds per analyte maintained CLIA proficiency. Significant associations were present between magnitude of error and CPL (Kruskal Wallis [KW]p<0.001), and ARV (KW p<0.001). PMID:24052065

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.

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.

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.

QUALITY ASSURANCE IN RESEARCH LABORATORIES: RULES AND REASON

EPA Science Inventory

Quality Assurance in Research Laboratories: Rules and Reason

Ron Rogers, Quality Assurance and Records Manager, Environmental Carcinogenesis Division, NHEERL/ORD/US EPA, Research Triangle Park, NC, 27709

To anyone who has actively participated in research, as I have...

External quality assessment of medical laboratories in Croatia: preliminary evaluation of post-analytical laboratory testing.

PubMed

Krleza, Jasna Lenicek; Dorotic, Adrijana; Grzunov, Ana

2017-02-15

Proper standardization of laboratory testing requires assessment of performance after the tests are performed, known as the post-analytical phase. A nationwide external quality assessment (EQA) scheme implemented in Croatia in 2014 includes a questionnaire on post-analytical practices, and the present study examined laboratory responses in order to identify current post-analytical phase practices and identify areas for improvement. In four EQA exercises between September 2014 and December 2015, 145-174 medical laboratories across Croatia were surveyed using the Module 11 questionnaire on the post-analytical phase of testing. Based on their responses, the laboratories were evaluated on four quality indicators: turnaround time (TAT), critical values, interpretative comments and procedures in the event of abnormal results. Results were presented as absolute numbers and percentages. Just over half of laboratories (56.3%) monitored TAT. Laboratories varied substantially in how they dealt with critical values. Most laboratories (65-97%) issued interpretative comments with test results. One third of medical laboratories (30.6-33.3%) issued abnormal test results without confirming them in additional testing. Our results suggest that the nationwide post-analytical EQA scheme launched in 2014 in Croatia has yet to be implemented to the full. To close the gaps between existing recommendations and laboratory practice, laboratory professionals should focus on ensuring that TAT is monitored and lists of critical values are established within laboratories. Professional bodies/institutions should focus on clarify and harmonized rules to standardized practices and applied for adding interpretative comments to laboratory test results and for dealing with abnormal test results.

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.

Internal quality assurance in a clinical virology laboratory. II. Internal quality control.

PubMed Central

Gray, J J; Wreghitt, T G; McKee, T A; McIntyre, P; Roth, C E; Smith, D J; Sutehall, G; Higgins, G; Geraghty, R; Whetstone, R

1995-01-01

AIMS--In April 1991 additional quality control procedures were introduced into the virology section of the Clinical Microbiology and Public Health Laboratory, Cambridge. Internal quality control (IQC) samples were gradually included in the serological assays performed in the laboratory and supplemented kit controls and standard sera. METHODS--From April 1991 to December 1993, 2421 IQC procedures were carried out with reference sera. RESULTS--The IQC samples were evaluated according to the Westgard rules. Violations were recorded in 60 of 1808 (3.3%) controls and were highest in the IQC samples of complement fixation tests (25/312 (8%) of controls submitted for complement fixation tests). CONCLUSIONS--The inclusion of IQC samples in the serological assays performed in the laboratory has highlighted batch to batch variation in commercial assays. The setting of acceptable limits for the IQC samples has increased confidence in the validity of assay results. PMID:7730475

Role of a quality management system in improving patient safety - laboratory aspects.

PubMed

Allen, Lynn C

2013-09-01

The aim of this study is to describe how implementation of a quality management system (QMS) based on ISO 15189 enhances patient safety. A literature review showed that several European hospitals implemented a QMS based on ISO 9001 and assessed the impact on patient safety. An Internet search showed that problems affecting patient safety have occurred in a number of laboratories across Canada. The requirements of a QMS based on ISO 15189 are outlined, and the impact of the implementation of each requirement on patient safety is summarized. The Quality Management Program - Laboratory Services in Ontario is briefly described, and the experience of Ontario laboratories with Ontario Laboratory Accreditation, based on ISO 15189, is outlined. Several hospitals that implemented ISO 9001 reported either a positive impact or no impact on patient safety. Patient safety problems in Canadian laboratories are described. Implementation of each requirement of the QMS can be seen to have a positive effect on patient safety. Average laboratory conformance on Ontario Laboratory Accreditation is very high, and laboratories must address and resolve any nonconformities. Other standards, practices, and quality requirements may also contribute to patient safety. Implementation of a QMS based on ISO 15189 provides a solid foundation for quality in the laboratory and enhances patient safety. It helps to prevent patient safety issues; when such issues do occur, effective processes are in place for investigation and resolution. Patient safety problems in Canadian laboratories might have been prevented had effective QMSs been in place. Ontario Laboratory Accreditation has had a positive impact on quality in Ontario laboratories. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Useful measures and models for analytical quality management in medical laboratories.

PubMed

Westgard, James O

2016-02-01

The 2014 Milan Conference "Defining analytical performance goals 15 years after the Stockholm Conference" initiated a new discussion of issues concerning goals for precision, trueness or bias, total analytical error (TAE), and measurement uncertainty (MU). Goal-setting models are critical for analytical quality management, along with error models, quality-assessment models, quality-planning models, as well as comprehensive models for quality management systems. There are also critical underlying issues, such as an emphasis on MU to the possible exclusion of TAE and a corresponding preference for separate precision and bias goals instead of a combined total error goal. This opinion recommends careful consideration of the differences in the concepts of accuracy and traceability and the appropriateness of different measures, particularly TAE as a measure of accuracy and MU as a measure of traceability. TAE is essential to manage quality within a medical laboratory and MU and trueness are essential to achieve comparability of results across laboratories. With this perspective, laboratory scientists can better understand the many measures and models needed for analytical quality management and assess their usefulness for practical applications in medical laboratories.

Preanalytical quality in clinical chemistry laboratory.

PubMed

Ahmad, M Imteyaz; Ramesh, K L; Kumar, Ravi

2014-01-01

Haemolysis is usually caused by inadequate specimen collection or preanalytical handling and is suggested to be a suitable indicator of preanalytical quality. We investigated the prevalence of detectable haemolysis in all routine venous blood samples in OPDs and IPDs to identify differences in preanalytical quality. Haemolysis index (HI) values were obtained from a Vitros 5,1 in the routine clinical chemistry laboratory for samples collected in the outpatient department (OPD) collection centres, a hospital, and inpatient departments (IPD). Haemolysis was defined as a HI > or = 15 (detection limit). Samples from the OPD with the highest prevalence of haemolysis were 6.1 times (95% confidence interval (CI) 4.0 - 9.2) more often haemolysed compared to the center with the lowest prevalence. Of the samples collected in primary health care, 10.4% were haemolysed compared to 31.1% in the IPDs (p = 0.001). A notable difference in haemolysed samples was found between the IPDs section staffed by emergency medicine physicians and the section staffed by primary health care physicians (34.8% vs. 11.3%, p = 0.001). The significant variation in haemolysis indices among the investigated units is likely to reflect varying preanalytical conditions. The HI is a valuable tool for estimation and follow-up of preanalytical quality in the health care laboratory.

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.

The Individualized Quality Control Plan - Coming Soon to Clinical Microbiology Laboratories Everywhere!

PubMed

Anderson, Nancy

2015-11-15

As of January 1, 2016, microbiology laboratories can choose to adopt a new quality control option, the Individualized Quality Control Plan (IQCP), under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This voluntary approach increases flexibility for meeting regulatory requirements and provides laboratories the opportunity to customize QC for their testing in their unique environments and by their testing personnel. IQCP is an all-inclusive approach to quality based on risk management to address potential errors in the total testing process. It includes three main steps, (1) performing a risk assessment, (2) developing a QC plan, and (3) monitoring the plan through quality assessment. Resources are available from the Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, American Society for Microbiology, Clinical and Laboratory Standards Institute, and accrediting organizations, such as the College of American Pathologists and Joint Commission, to assist microbiology laboratories implementing IQCP.

An approach to quality and performance control in a computer-assisted clinical chemistry laboratory.

PubMed Central

Undrill, P E; Frazer, S C

1979-01-01

A locally developed, computer-based clinical chemistry laboratory system has been in operation since 1970. This utilises a Digital Equipment Co Ltd PDP 12 and an interconnected PDP 8/F computer. Details are presented of the performance and quality control techniques incorporated into the system. Laboratory performance is assessed through analysis of results from fixed-level control sera as well as from cumulative sum methods. At a simple level the presentation may be considered purely indicative, while at a more sophisticated level statistical concepts have been introduced to aid the laboratory controller in decision-making processes. PMID:438340

Developing a customised approach for strengthening tuberculosis laboratory quality management systems toward accreditation

PubMed Central

Trollip, Andre; Erni, Donatelle; Kao, Kekeletso

2017-01-01

Background Quality-assured tuberculosis laboratory services are critical to achieve global and national goals for tuberculosis prevention and care. Implementation of a quality management system (QMS) in laboratories leads to improved quality of diagnostic tests and better patient care. The Strengthening Laboratory Management Toward Accreditation (SLMTA) programme has led to measurable improvements in the QMS of clinical laboratories. However, progress in tuberculosis laboratories has been slower, which may be attributed to the need for a structured tuberculosis-specific approach to implementing QMS. We describe the development and early implementation of the Strengthening Tuberculosis Laboratory Management Toward Accreditation (TB SLMTA) programme. Development The TB SLMTA curriculum was developed by customizing the SLMTA curriculum to include specific tools, job aids and supplementary materials specific to the tuberculosis laboratory. The TB SLMTA Harmonized Checklist was developed from the World Health Organisation Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation checklist, and incorporated tuberculosis-specific requirements from the Global Laboratory Initiative Stepwise Process Towards Tuberculosis Laboratory Accreditation online tool. Implementation Four regional training-of-trainers workshops have been conducted since 2013. The TB SLMTA programme has been rolled out in 37 tuberculosis laboratories in 10 countries using the Workshop approach in 32 laboratories in five countries and the Facility-based approach in five tuberculosis laboratories in five countries. Conclusion Lessons learnt from early implementation of TB SLMTA suggest that a structured training and mentoring programme can build a foundation towards further quality improvement in tuberculosis laboratories. Structured mentoring, and institutionalisation of QMS into country programmes, is needed to support tuberculosis laboratories to achieve

Orthodontic soldering techniques: aspects of quality assurance in the dental laboratory.

PubMed

Heidemann, Jutta; Witt, Emil; Feeg, Martin; Werz, Rainer; Pieger, Klaus

2002-07-01

In Germany, the dental technician is required by the Medical Products Act (MPG) to produce workpieces of high safety and quality and to document these properties. Soldering continues to be the prevailing joining technique in the dental laboratory, although problems arise from the susceptibility to corrosion and the low strength of soldered joints. This study aimed to reveal sources of defects in dental laboratory workpieces in order to achieve optimization in terms of quality assurance. The joints were produced by various dental technicians using three different soldering techniques. These joining techniques were investigated for their quality and their corrosion properties during immersion in ferric chloride, orthodontic appliance cleanser, and artificial saliva. Observance of the soldering instructions by the dental technicians was checked. Corrosion attack was confirmed by scanning electron microscopy and by measuring the ion concentrations of copper, silver and zinc in the corrosive agents, using atomic emission spectroscopy with stimulation by inductively coupled plasma (ICP-AES analysis). Incomplete filling of the soldering gap, porosities resulting from the production process, poor corrosion properties, and in particular a high variability of the measured values point to insufficient reliability of two soldering techniques. Variations in quality were also detected among the technicians' modes of operation. The analyses confirm the need for quality assurance of soldering techniques and for increased support for alternative joining techniques such as laser welding in the future. The results of the studies on laser welding are presented in a separate publication.

Integration of Pharmacy Practice and Pharmaceutical Analysis: Quality Assessment of Laboratory Performance.

ERIC Educational Resources Information Center

McGill, Julian E.; Holly, Deborah R.

1996-01-01

Laboratory portions of courses in pharmacy practice and pharmaceutical analysis at the Medical University of South Carolina are integrated and coordinated to provide feedback on student performance in compounding medications. Students analyze the products they prepare, with early exposure to compendia requirements and other references. Student…

Piloting laboratory quality system management in six health facilities in Nigeria.

PubMed

Mbah, Henry; Ojo, Emmanuel; Ameh, James; Musuluma, Humphrey; Negedu-Momoh, Olubunmi Ruth; Jegede, Feyisayo; Ojo, Olufunmilayo; Uwakwe, Nkem; Ochei, Kingsley; Dada, Michael; Udah, Donald; Chiegil, Robert; Torpey, Kwasi

2014-01-01

Achieving accreditation in laboratories is a challenge in Nigeria like in most African countries. Nigeria adopted the World Health Organization Regional Office for Africa Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (WHO/AFRO- SLIPTA) in 2010. We report on FHI360 effort and progress in piloting WHO-AFRO recognition and accreditation preparedness in six health facility laboratories in five different states of Nigeria. Laboratory assessments were conducted at baseline, follow up and exit using the WHO/AFRO- SLIPTA checklist. From the total percentage score obtained, the quality status of laboratories were classified using a zero to five star rating, based on the WHO/AFRO quality improvement stepwise approach. Major interventions include advocacy, capacity building, mentorship and quality improvement projects. At baseline audit, two of the laboratories attained 1- star while the remaining four were at 0- star. At follow up audit one lab was at 1- star, two at 3-star and three at 4-star. At exit audit, four labs were at 4- star, one at 3-star and one at 2-star rating. One laboratory dropped a 'star' at exit audit, while others consistently improved. The two weakest elements at baseline; internal audit (4%) and occurrence/incidence management (15%) improved significantly, with an exit score of 76% and 81% respectively. The elements facility and safety was the major strength across board throughout the audit exercise. This effort resulted in measurable and positive impact on the laboratories. We recommend further improvement towards a formal international accreditation status and scale up of WHO/AFRO- SLIPTA implementation in Nigeria.

Development of a quality assurance program for ionizing radiation secondary calibration laboratories

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

Heaton, H.T. II; Taylor, A.R. Jr.

For calibration laboratories, routine calibrations of instruments meeting stated accuracy goals are important. One method of achieving the accuracy goals is to establish and follow a quality assurance program designed to monitor all aspects of the calibration program and to provide the appropriate feedback mechanism if adjustments are needed. In the United States there are a number of organizations with laboratory accreditation programs. All existing accreditation programs require that the laboratory implement a quality assurance program with essentially the same elements in all of these programs. Collectively, these elements have been designated as a Measurement Quality Assurance (MQA) program. Thismore » paper will briefly discuss the interrelationship of the elements of an MQA program. Using the Center for Devices and Radiological Health (CDRH) X-ray Calibration Laboratory (XCL) as an example, it will focus on setting up a quality control program for the equipment in a Secondary Calibration Laboratory.« less

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

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…

Comparison of laboratory and field remote sensing methods to measure forage quality.

PubMed

Guo, Xulin; Wilmshurst, John F; Li, Zhaoqin

2010-09-01

Recent research in range ecology has emphasized the importance of forage quality as a key indicator of rangeland condition. However, we lack tools to evaluate forage quality at scales appropriate for management. Using canopy reflectance data to measure forage quality has been conducted at both laboratory and field levels separately, but little work has been conducted to evaluate these methods simultaneously. The objective of this study is to find a reliable way of assessing grassland quality through measuring forage chemistry with reflectance. We studied a mixed grass ecosystem in Grasslands National Park of Canada and surrounding pastures, located in southern Saskatchewan. Spectral reflectance was collected at both in-situ field level and in the laboratory. Vegetation samples were collected at each site, sorted into the green grass portion, and then sent to a chemical company for measuring forage quality variables, including protein, lignin, ash, moisture at 135 °C, Neutral Detergent Fiber (NDF), Acid Detergent Fiber (ADF), Total Digestible, Digestible Energy, Net Energy for Lactation, Net Energy for Maintenance, and Net Energy for Gain. Reflectance data were processed with the first derivative transformation and continuum removal method. Correlation analysis was conducted on spectral and forage quality variables. A regression model was further built to investigate the possibility of using canopy spectral measurements to predict the grassland quality. Results indicated that field level prediction of protein of mixed grass species was possible (r² = 0.63). However, the relationship between canopy reflectance and the other forage quality variables was not strong.

Electronic laboratory quality assurance program: A method of enhancing the prosthodontic curriculum and addressing accreditation standards.

PubMed

Moghadam, Marjan; Jahangiri, Leila

2015-08-01

An electronic quality assurance (eQA) program was developed to replace a paper-based system and to address standards introduced by the Commission on Dental Accreditation (CODA) and to improve educational outcomes. This eQA program provides feedback to predoctoral dental students on prosthodontic laboratory steps at New York University College of Dentistry. The purpose of this study was to compare the eQA program of performing laboratory quality assurance with the former paper-based format. Fourth-year predoctoral dental students (n=334) who experienced both the paper-based and the electronic version of the quality assurance program were surveyed about their experiences. Additionally, data extracted from the eQA program were analyzed to identify areas of weakness in the curriculum. The study findings revealed that 73.8% of the students preferred the eQA program to the paper-based version. The average number of treatments that did not pass quality assurance standards was 119.5 per month. This indicated a 6.34% laboratory failure rate. Further analysis of these data revealed that 62.1% of the errors were related to fixed prosthodontic treatment, 27.9% to partial removable dental prostheses, and 10% to complete removable dental prostheses in the first 18 months of program implementation. The eQA program was favored by dental students who have experienced both electronic and paper-based versions of the system. Error type analysis can yield the ability to create customized faculty standardization sessions and refine the didactic and clinical teaching of the predoctoral students. This program was also able to link patient care activity with the student's laboratory activities, thus addressing the latest requirements of the CODA regarding the competence of graduates in evaluating laboratory work related to their patient care. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Quality of the clinical laboratory department in a specialized hospital in Alexandria, Egypt.

PubMed

Elhoseeny, T A; Mohammad, E K

2013-01-01

Assessment and improvement of turnaround times (TAT) as well as customer satisfaction is essential for laboratory quality management. This study in a specialized hospital in Alexandria, Egypt measured the current TAT for outpatient department bilirubin samples and evaluated the satisfaction of physicians with aspects of clinical laboratory services. While the mean TAT for 110 bilirubin tests [58.1 (SD 31.8) min] was within the College of American Pathologists' benchmark, the 90th percentile was long (96.7 min); 62.7% of tests were reported within 60 min. The mean overall satisfaction score of physicians (range 1-5) was 3.46 (SD 0.49). The highest satisfaction rating was for staff courtesy while the lowest ratings were for laboratory management responsiveness, outpatient stat TAT and critical value notification. Quality or reliability of results was judged by physicians as the most important factor (32.3%), followed by routine test TAT (18.5%). Further analysis of the different steps of the TAT would be helpful and follow-up through examining outliers is recommended

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.

Importance of implementing an analytical quality control system in a core laboratory.

PubMed

Marques-Garcia, F; Garcia-Codesal, M F; Caro-Narros, M R; Contreras-SanFeliciano, T

2015-01-01

The aim of the clinical laboratory is to provide useful information for screening, diagnosis and monitoring of disease. The laboratory should ensure the quality of extra-analytical and analytical process, based on set criteria. To do this, it develops and implements a system of internal quality control, designed to detect errors, and compare its data with other laboratories, through external quality control. In this way it has a tool to detect the fulfillment of the objectives set, and in case of errors, allowing corrective actions to be made, and ensure the reliability of the results. This article sets out to describe the design and implementation of an internal quality control protocol, as well as its periodical assessment intervals (6 months) to determine compliance with pre-determined specifications (Stockholm Consensus(1)). A total of 40 biochemical and 15 immunochemical methods were evaluated using three different control materials. Next, a standard operation procedure was planned to develop a system of internal quality control that included calculating the error of the analytical process, setting quality specifications, and verifying compliance. The quality control data were then statistically depicted as means, standard deviations, and coefficients of variation, as well as systematic, random, and total errors. The quality specifications were then fixed and the operational rules to apply in the analytical process were calculated. Finally, our data were compared with those of other laboratories through an external quality assurance program. The development of an analytical quality control system is a highly structured process. This should be designed to detect errors that compromise the stability of the analytical process. The laboratory should review its quality indicators, systematic, random and total error at regular intervals, in order to ensure that they are meeting pre-determined specifications, and if not, apply the appropriate corrective actions

Endorsing good quality assurance practices in molecular pathology: risks and recommendations for diagnostic laboratories and external quality assessment providers.

PubMed

Tembuyser, Lien; Dequeker, Elisabeth M C

2016-01-01

Quality assurance is an indispensable element in a molecular diagnostic laboratory. The ultimate goal is to warrant patient safety. Several risks that can compromise high quality procedures are at stake, from sample collection to the test performed by the laboratory, the reporting of test results to clinicians, and the organization of effective external quality assessment schemes. Quality assurance should therefore be safeguarded at each level and should imply a holistic multidisciplinary approach. This review aims to provide an overview of good quality assurance practices and discusses certain risks and recommendations to promote and improve quality assurance for both diagnostic laboratories and for external quality assessment providers. The number of molecular targets is continuously rising, and new technologies are evolving. As this poses challenges for clinical implementation and increases the demand for external quality assessment, the formation of an international association for improving quality assurance in molecular pathology is called for.

7 CFR 160.17 - Laboratory analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Laboratory analysis. 160.17 Section 160.17 Agriculture... STANDARDS FOR NAVAL STORES Methods of Analysis, Inspection, Sampling and Grading § 160.17 Laboratory analysis. The analysis and laboratory testing of naval stores shall be conducted, so far as is practicable...

7 CFR 160.17 - Laboratory analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory analysis. 160.17 Section 160.17 Agriculture... STANDARDS FOR NAVAL STORES Methods of Analysis, Inspection, Sampling and Grading § 160.17 Laboratory analysis. The analysis and laboratory testing of naval stores shall be conducted, so far as is practicable...

[THE VIRTUAL CYTOLOGIC SLIDES FOR EXTERNAL EVALUATION OF QUALITY OF IMPLEMENTATION OF CYTOLOGIC ANALYSES IN CLINICAL DIAGNOSTIC LABORATORIES: POSSIBILITIES AND PERSPECTIVES].

PubMed

Djangirova, T V; Shabalova, I P; Pronichev, A N; Polyakov, E V

2015-08-01

The article considers application of technology of analysis of cytological slides in external quality control of clinical diagnostic laboratories. The advantages of virtual slides are demonstrated against other applied technologies of external evaluation of quality i.e. slide plate and digital micro-photography. The conditions of formation of virtual slides for external evaluation of quality of clinical diagnostic laboratories. The technology of their application is described. The success of practical application of considered technology in the Federal system of external evaluation of quality is emphasized.

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)

DNA decontamination methods for internal quality management in clinical PCR laboratories.

PubMed

Wu, Yingping; Wu, Jianyong; Zhang, Zhihui; Cheng, Chen

2018-03-01

The polymerase chain reaction (PCR) technique, one of the most commonly applied methods in diagnostic and molecular biology, has a frustrating downside: the occurrence of false-positive signals due to contamination. In previous research, various DNA decontamination methods have been developed to overcome this limitation. Unfortunately, the use of random or poorly focused sampling methods for monitoring air and/or object surfaces leads to the incomplete elimination during decontamination procedures. We herein attempted to develop a novel DNA decontamination method (environmental surveillance, including surface and air sampling) and quality management program for clinical molecular diagnostic laboratories (or clinical PCR laboratories). Here, we performed a step-by-step evaluation of current DNA decontamination methods and developed an effective procedure for assessing the presence of decontaminating DNA via PCR analysis. Performing targeted environmental surveillance by sampling, which reached optimal performance over 2 weeks, and the decontamination process had been verified as reliable. Additionally, the process was validated to not affect PCR amplification efficiency based on a comparative study. In this study, effective guidelines for DNA decontamination were developed. The method employed ensured that surface DNA contamination could be effectively identified and eliminated. Furthermore, our study highlighted the importance of overall quality assurance and good clinical laboratory practices for preventing contamination, which are key factors for compliance with regulatory or accreditation requirements. Taken together, we provided the evidence that the presented scheme ranged from troubleshooting to the elimination of surface contamination, could serve as critical foundation for developing regular environmental surveillance guidelines for PCR laboratories. © 2017 Wiley Periodicals, Inc.

Idaho National Laboratory Quarterly Performance Analysis

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

Mitchell, Lisbeth

2014-11-01

This report is published quarterly by the Idaho National Laboratory (INL) Quality and Performance Management Organization. The Department of Energy (DOE) Occurrence Reporting and Processing System (ORPS), as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of 60 reportable events (23 from the 4th Qtr FY14 and 37 from the prior three reporting quarters) as well as 58 other issue reports (including not reportable events and Significant Category A and B conditions) identified at INLmore » from July 2013 through October 2014. Battelle Energy Alliance (BEA) operates the INL under contract DE AC07 051D14517.« less

Idaho National Laboratory Quarterly Occurrence Analysis

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

Mitchell, Lisbeth Ann

This report is published quarterly by the Idaho National Laboratory (INL) Quality and Performance Management Organization. The Department of Energy (DOE) Occurrence Reporting and Processing System (ORPS), as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of 85 reportable events (18 from the 4th Qtr FY-15 and 67 from the prior three reporting quarters), as well as 25 other issue reports (including events found to be not reportable and Significant Category A and B conditions)more » identified at INL during the past 12 months (8 from this quarter and 17 from the prior three quarters).« less

[National External Quality Assessment for medical biology laboratories in Burkina Faso: an overview of three years of activity].

PubMed

Sakande, Jean; Nikièma, Abdoulaye; Kabré, Elie; Nacoulma, Eric; Sawadogo, Charles; Lingani, Virginie; Traoré, Lady Kady; Kouanda, Abdoulaye; Kientéga, Youssouf; Somda, Joseph; Kagambéga, Faustin; Sanou, Mahamoudou; Sangaré, Lassana; Traoré-Ouédraogo, Rasmata

2010-01-01

We report results of the National External Quality Assessment for (NEQA) laboratories in Burkina Faso, a country with limited resources located in West Africa whose epidemiology is dominated by infectious diseases. The national laboratory network consists of 160 laboratories including 40 private. The Government of Burkina Faso has adopted a national laboratory policy. One of the objectives of this policy is to improve the quality of laboratory results. One of the strategies to achieve this objective is the establishment of a NEQA. The NEQA is a panel testing also called proficiency testing. It is mandatory for all laboratories to participate to the NEQA. The NEQA is organized twice a year and covers all areas of laboratories (bacteriology-virology, biochemistry, hematology, parasitology and immunology). The review of three years of activity (2006-2008) shows the following results: (1) for microscopic examination of bacteria after Gram staining, the error rate decreased from 24.7% in 2006 to 13.1% in 2007 and 13% in 2008; (2) errors rate in reading slides for the microscopic diagnosis of malaria were 23.4%, 14.6% and 10.2% respectively in 2006, 2007 and 2008; (3) for biochemistry, the percentages of unsatisfactory results were respectively 12.5%, 14.8% and 13.8% in 2006, 2007 and 2008 for the overall parameters assessed. The analysis of the results generated by the laboratories during these three years shows a quality improvement. However, the NEQA should be strengthened through ongoing training and quality control of reagents and equipment.

Does bacteriology laboratory automation reduce time to results and increase quality management?

PubMed

Dauwalder, O; Landrieve, L; Laurent, F; de Montclos, M; Vandenesch, F; Lina, G

2016-03-01

Due to reductions in financial and human resources, many microbiological laboratories have merged to build very large clinical microbiology laboratories, which allow the use of fully automated laboratory instruments. For clinical chemistry and haematology, automation has reduced the time to results and improved the management of laboratory quality. The aim of this review was to examine whether fully automated laboratory instruments for microbiology can reduce time to results and impact quality management. This study focused on solutions that are currently available, including the BD Kiestra™ Work Cell Automation and Total Lab Automation and the Copan WASPLab(®). Copyright © 2015 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

[Software for illustrating a cost-quality balance carried out by clinical laboratory practice].

PubMed

Nishibori, Masahiro; Asayama, Hitoshi; Kimura, Satoshi; Takagi, Yasushi; Hagihara, Michio; Fujiwara, Mutsunori; Yoneyama, Akiko; Watanabe, Takashi

2010-09-01

We have no proper reference indicating the quality of clinical laboratory practice, which should clearly illustrates that better medical tests require more expenses. Japanese Society of Laboratory Medicine was concerned about recent difficult medical economy and issued a committee report proposing a guideline to evaluate the good laboratory practice. According to the guideline, we developed software that illustrate a cost-quality balance carried out by clinical laboratory practice. We encountered a number of controversial problems, for example, how to measure and weight each quality-related factor, how to calculate costs of a laboratory test and how to consider characteristics of a clinical laboratory. Consequently we finished only prototype software within the given period and the budget. In this paper, software implementation of the guideline and the above-mentioned problems are summarized. Aiming to stimulate these discussions, the operative software will be put on the Society's homepage for trial

Quality management systems for your in vitro fertilization clinic's laboratory: Why bother?

PubMed

Olofsson, Jan I; Banker, Manish R; Sjoblom, Late Peter

2013-01-01

Several countries have in recent years introduced prescribed requirements for treatment and monitoring of outcomes, as well as a licensing or accreditation requirement for in vitro fertilization (IVF) clinics and their laboratories. It is commonplace for Assisted Reproductive Technology (ART) laboratories to be required to have a quality control system. However, more effective Total Quality Management systems are now being implemented by an increasing number of ART clinics. In India, it is now a requirement to have a quality management system in order to be accredited and to help meet customer demand for improved delivery of ART services. This review contains the proceedings a quality management session at the Indian Fertility Experts Meet (IFEM) 2010 and focuses on the creation of a patient-oriented best-in-class IVF laboratory.

Quality management systems for your in vitro fertilization clinic's laboratory: Why bother?

PubMed Central

Olofsson, Jan I; Banker, Manish R; Sjoblom, Late Peter

2013-01-01

Several countries have in recent years introduced prescribed requirements for treatment and monitoring of outcomes, as well as a licensing or accreditation requirement for in vitro fertilization (IVF) clinics and their laboratories. It is commonplace for Assisted Reproductive Technology (ART) laboratories to be required to have a quality control system. However, more effective Total Quality Management systems are now being implemented by an increasing number of ART clinics. In India, it is now a requirement to have a quality management system in order to be accredited and to help meet customer demand for improved delivery of ART services. This review contains the proceedings a quality management session at the Indian Fertility Experts Meet (IFEM) 2010 and focuses on the creation of a patient-oriented best-in-class IVF laboratory. PMID:23869142

Working toward a sustainable laboratory quality improvement programme through country ownership: Mozambique's SLMTA story.

PubMed

Masamha, Jessina; Skaggs, Beth; Pinto, Isabel; Mandlaze, Ana Paula; Simbine, Carolina; Chongo, Patrina; de Sousa, Leonardo; Kidane, Solon; Yao, Katy; Luman, Elizabeth T; Samogudo, Eduardo

2014-01-01

Launched in 2009, the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme has emerged as an innovative approach for the improvement of laboratory quality. In order to ensure sustainability, Mozambique embedded the SLMTA programme within the existing Ministry of Health (MOH) laboratory structure. This article outlines the steps followed to establish a national framework for quality improvement and embedding the SLMTA programme within existing MOH laboratory systems. The MOH adopted SLMTA as the national laboratory quality improvement strategy, hired a dedicated coordinator and established a national laboratory quality technical working group comprising mostly personnel from key MOH departments. The working group developed an implementation framework for advocacy, training, mentorship, supervision and audits. Emphasis was placed on building local capacity for programme activities. After receiving training, a team of 25 implementers (18 from the MOH and seven from partner organisations) conducted baseline audits (using the Stepwise Laboratory Quality Improvement Process Towards Accreditation [SLIPTA] checklist), workshops and site visits in six reference and two central hospital laboratories. Exit audits were conducted in six of the eight laboratories and their results are presented. The six laboratories demonstrated substantial improvement in audit scores; median scores increased from 35% at baseline to 57% at exit. It has been recommended that the National Tuberculosis Reference Laboratory apply for international accreditation. Successful implementation of SLMTA requires partnership between programme implementers, whilst effectiveness and long-term viability depend on country leadership, ownership and commitment. Integration of SLMTA into the existing MOH laboratory system will ensure durability beyond initial investments. The Mozambican model holds great promise that country leadership, ownership and institutionalisation can set the stage for

The impact of SLMTA in improving laboratory quality systems in the Caribbean Region.

PubMed

Guevara, Giselle; Gordon, Floris; Irving, Yvette; Whyms, Ismae; Parris, Keith; Beckles, Songee; Maruta, Talkmore; Ndlovu, Nqobile; Albalak, Rachel; Alemnji, George

Past efforts to improve laboratory quality systems and to achieve accreditation for better patient care in the Caribbean Region have been slow. To describe the impact of the Strengthening of Laboratory Management Toward Accreditation (SLMTA) training programme and mentorship amongst five clinical laboratories in the Caribbean after 18 months. Five national reference laboratories from four countries participated in the SLMTA programme that incorporated classroom teaching and implementation of improvement projects. Mentors were assigned to the laboratories to guide trainees on their improvement projects and to assist in the development of Quality Management Systems (QMS). Audits were conducted at baseline, six months, exit (at 12 months) and post-SLMTA (at 18 months) using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist to measure changes in implementation of the QMS during the period. At the end of each audit, a comprehensive implementation plan was developed in order to address gaps. Baseline audit scores ranged from 19% to 52%, corresponding to 0 stars on the SLIPTA five-star scale. After 18 months, one laboratory reached four stars, two reached three stars and two reached two stars. There was a corresponding decrease in nonconformities and development of over 100 management and technical standard operating procedures in each of the five laboratories. The tremendous improvement in these five Caribbean laboratories shows that SLMTA coupled with mentorship is an effective, user-friendly, flexible and customisable approach to the implementation of laboratory QMS. It is recommended that other laboratories in the region consider using the SLMTA training programme as they engage in quality systems improvement and preparation for accreditation.

The impact of SLMTA in improving laboratory quality systems in the Caribbean Region

PubMed Central

Gordon, Floris; Irving, Yvette; Whyms, Ismae; Parris, Keith; Beckles, Songee; Maruta, Talkmore; Ndlovu, Nqobile; Albalak, Rachel; Alemnji, George

2014-01-01

Background Past efforts to improve laboratory quality systems and to achieve accreditation for better patient care in the Caribbean Region have been slow. Objective To describe the impact of the Strengthening of Laboratory Management Toward Accreditation (SLMTA) training programme and mentorship amongst five clinical laboratories in the Caribbean after 18 months. Method Five national reference laboratories from four countries participated in the SLMTA programme that incorporated classroom teaching and implementation of improvement projects. Mentors were assigned to the laboratories to guide trainees on their improvement projects and to assist in the development of Quality Management Systems (QMS). Audits were conducted at baseline, six months, exit (at 12 months) and post-SLMTA (at 18 months) using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist to measure changes in implementation of the QMS during the period. At the end of each audit, a comprehensive implementation plan was developed in order to address gaps. Results Baseline audit scores ranged from 19% to 52%, corresponding to 0 stars on the SLIPTA five-star scale. After 18 months, one laboratory reached four stars, two reached three stars and two reached two stars. There was a corresponding decrease in nonconformities and development of over 100 management and technical standard operating procedures in each of the five laboratories. Conclusion The tremendous improvement in these five Caribbean laboratories shows that SLMTA coupled with mentorship is an effective, user-friendly, flexible and customisable approach to the implementation of laboratory QMS. It is recommended that other laboratories in the region consider using the SLMTA training programme as they engage in quality systems improvement and preparation for accreditation. PMID:27066396

High variability in results of semen analysis in andrology laboratories in Tuscany (Italy): the experience of an external quality control (EQC) programme.

PubMed

Filimberti, E; Degl'Innocenti, S; Borsotti, M; Quercioli, M; Piomboni, P; Natali, I; Fino, M G; Caglieresi, C; Criscuoli, L; Gandini, L; Biggeri, A; Maggi, M; Baldi, E

2013-05-01

We report the results of the first three trials of an external quality control (EQC) programme performed in 71 laboratories executing semen analysis in Tuscany Region (Italy). At the end of the second trial, participants were invited to attend a teaching course illustrating and inviting to adhere to procedures recommended by WHO (V edition). Results of the first three trials of the EQC documented a huge variability in the procedures and the results. The highest variability was found for morphology (CV above 80% for all the trials), followed by count (CV of about 60% for all the trials) and motility (CV below 30% for all the trials). When results of sperm count and morphology were divided according to the used method, mean CV values did not show significant differences. CV for morphology dropped significantly at the third trial for most methods, indicating the usefulness of the teaching course for morphology assessment. Conversely, no differences were observed after the course for motility and for most methods to evaluate count, although CV values were lower at the second and third trial for the laboratories using the Burker cytometer. When results were divided according to tertiles of activity, the lowest mean bias values (difference between each laboratory result and the median value of the results) for count and morphology were observed for laboratories in the third tertile (performing over 200 semen analysis/year). Of interest, mean bias values for concentration dropped significantly at the third trial for low activity laboratories. In conclusion, lack of agreement of results of semen analysis in Tuscany is mainly because of the activity and the experience of the laboratory. Our study points out the importance of participating in EQC programmes and periodical teaching courses as well as the use of WHO recommended standardized procedures to increase precision and to allow the use of WHO reference values. © 2013 American Society of Andrology and European Academy

[The experience of implementation of system of quality management in the Department of Laboratory Diagnostic of the N.V. Sklifosofskiy Research Institute of Emergency Care of Moscow Health Department: a lecture].

PubMed

Zenina, L P; Godkov, M A

2013-08-01

The article presents the experience of implementation of system of quality management into the practice of multi-field laboratory of emergency medical care hospital. The analysis of laboratory errors is applied and the modes of their prevention are demonstrated. The ratings of department of laboratory diagnostic of the N. V. Sklifosofskiy research institute of emergency care in the program EQAS (USA) Monthly Clinical Chemistry from 2007 are presented. The implementation of the system of quality management of laboratory analysis into department of laboratory diagnostic made it possible to support physicians of clinical departments with reliable information. The confidence of clinicians to received results increased. The effectiveness of laboratory diagnostic increased due to lowering costs of analysis without negative impact to quality of curative process.

Lessons learned from implementing a wet laboratory molecular training workshop for beach water quality monitoring.

PubMed

Verhougstraete, Marc Paul; Brothers, Sydney; Litaker, Wayne; Blackwood, A Denene; Noble, Rachel

2015-01-01

Rapid molecular testing methods are poised to replace many of the conventional, culture-based tests currently used in fields such as water quality and food science. Rapid qPCR methods have the benefit of being faster than conventional methods and provide a means to more accurately protect public health. However, many scientists and technicians in water and food quality microbiology laboratories have limited experience using these molecular tests. To ensure that practitioners can use and implement qPCR techniques successfully, we developed a week long workshop to provide hands-on training and exposure to rapid molecular methods for water quality management. This workshop trained academic professors, government employees, private industry representatives, and graduate students in rapid qPCR methods for monitoring recreational water quality. Attendees were immersed in these new methods with hands-on laboratory sessions, lectures, and one-on-one training. Upon completion, the attendees gained sufficient knowledge and practice to teach and share these new molecular techniques with colleagues at their respective laboratories. Key findings from this workshop demonstrated: 1) participants with no prior experience could be effectively trained to conduct highly repeatable qPCR analysis in one week; 2) participants with different desirable outcomes required exposure to a range of different platforms and sample processing approaches; and 3) the collaborative interaction amongst newly trained practitioners, workshop leaders, and members of the water quality community helped foster a cohesive cohort of individuals which can advocate powerful cohort for proper implementation of molecular methods.

Lessons Learned from Implementing a Wet Laboratory Molecular Training Workshop for Beach Water Quality Monitoring

PubMed Central

Verhougstraete, Marc Paul; Brothers, Sydney; Litaker, Wayne; Blackwood, A. Denene; Noble, Rachel

2015-01-01

Rapid molecular testing methods are poised to replace many of the conventional, culture-based tests currently used in fields such as water quality and food science. Rapid qPCR methods have the benefit of being faster than conventional methods and provide a means to more accurately protect public health. However, many scientists and technicians in water and food quality microbiology laboratories have limited experience using these molecular tests. To ensure that practitioners can use and implement qPCR techniques successfully, we developed a week long workshop to provide hands-on training and exposure to rapid molecular methods for water quality management. This workshop trained academic professors, government employees, private industry representatives, and graduate students in rapid qPCR methods for monitoring recreational water quality. Attendees were immersed in these new methods with hands-on laboratory sessions, lectures, and one-on-one training. Upon completion, the attendees gained sufficient knowledge and practice to teach and share these new molecular techniques with colleagues at their respective laboratories. Key findings from this workshop demonstrated: 1) participants with no prior experience could be effectively trained to conduct highly repeatable qPCR analysis in one week; 2) participants with different desirable outcomes required exposure to a range of different platforms and sample processing approaches; and 3) the collaborative interaction amongst newly trained practitioners, workshop leaders, and members of the water quality community helped foster a cohesive cohort of individuals which can advocate powerful cohort for proper implementation of molecular methods. PMID:25822486

ARL Support and Analysis to the Army Public Health Command Kabul Air Quality Data Collection (Spring 2014)

DTIC Science & Technology

2016-05-01

ARL-TR-7692•MAY 2016 US Army Research Laboratory ARL Support and Analysis to the Army Public Health Command Kabul Air Quality Data Collection (Spring...return it to the originator. ARL-TR-7692•MAY 2016 US Army Research Laboratory ARL Support and Analysis to the Army Public Health Command Kabul Air Quality ...and Analysis to the Army Public Health Command Kabul Air Quality Data Collection (Spring 2014) Alan Wetmore and Thomas DeFelice ARL-TR-7692 Approved

[Analysis on 2011 quality control results on aerobic plate count of microbiology laboratories in China].

PubMed

Han, Haihong; Li, Ning; Li, Yepeng; Fu, Ping; Yu, Dongmin; Li Zhigang; Du, Chunming; Guo, Yunchang

2015-01-01

To test the aerobic plate count examining capability of microbiology laboratories, to ensure the accuracy and comparability of quantitative bacteria examination results, and to improve the quality of monitoring. The 4 different concentration aerobic plate count piece samples were prepared and noted as I, II, III and IV. After homogeneity and stability tests, the samples were delivered to monitoring institutions. The results of I, II, III samples were logarithmic transformed, and evaluated with Z-score method using the robust average and standard deviation. The results of IV samples were evaluated as "satisfactory" when reported as < 10 CFU/piece or as "not satisfactory" otherwise. Pearson χ2 test was used to analyze the ratio results. 309 monitoring institutions, which was 99.04% of the total number, reported their results. 271 institutions reported a satisfactory result, and the satisfactory rate was 87.70%. There was no statistical difference in satisfactory rates of I, II and III samples which were 81.52%, 88.30% and 91.40% respectively. The satisfactory rate of IV samples was 93.33%. There was no statistical difference in satisfactory rates between provincial and municipal CDC. The quality control program has provided scientific data that the aerobic plate count capability of the laboratories meets the requirements of monitoring tasks.

Quality management in European screening laboratories in blood establishments: A view of current approaches and trends.

PubMed

Pereira, Paulo; Westgard, James O; Encarnação, Pedro; Seghatchian, Jerard; de Sousa, Gracinda

2015-04-01

The screening laboratory has a critical role in the post-transfusion safety. The success of its targets and efficiency depends on the management system used. Even though the European Union directive 2002/98/EC requires a quality management system in blood establishments, its requirements for screening laboratories are generic. Complementary approaches are needed to implement a quality management system focused on screening laboratories. This article briefly discusses the current good manufacturing practices and good laboratory practices, as well as the trends in quality management system standards. ISO 9001 is widely accepted in some European Union blood establishments as the quality management standard, however this is not synonymous of its successful application. The ISO "risk-based thinking" is interrelated with the quality risk-management process of the EuBIS "Standards and criteria for the inspection of blood establishments". ISO 15189 should be the next step on the quality assurance of a screening laboratory, since it is focused on medical laboratory. To standardize the quality management systems in blood establishments' screening laboratories, new national and European claims focused on technical requirements following ISO 15189 is needed. Copyright © 2015 Elsevier Ltd. All rights reserved.

An overview of Quality Management System implementation in a research laboratory

NASA Astrophysics Data System (ADS)

Molinéro-Demilly, Valérie; Charki, Abdérafi; Jeoffrion, Christine; Lyonnet, Barbara; O'Brien, Steve; Martin, Luc

2018-02-01

The aim of this paper is to show the advantages of implementing a Quality Management System (QMS) in a research laboratory in order to improve the management of risks specific to research programmes and to increase the reliability of results. This paper also presents experience gained from feedback following the implementation of the Quality process in a research laboratory at INRA, the French National Institute for Agronomic Research and details the various challenges encountered and solutions proposed to help achieve smoother adoption of a QMS process. The 7Ms (Management, Measurement, Manpower, Methods, Materials, Machinery, Mother-nature) methodology based on the Ishikawa `Fishbone' diagram is used to show the effectiveness of the actions considered by a QMS, which involve both the organization and the activities of the laboratory. Practical examples illustrate the benefits and improvements observed in the laboratory.

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.

Exploration Laboratory Analysis - ARC

NASA Technical Reports Server (NTRS)

Krihak, Michael K.; Fung, Paul P.

2012-01-01

The Exploration Laboratory Analysis (ELA) project supports the Exploration Medical Capability (ExMC) risk, Risk of Inability to Adequately Treat an Ill or Injured Crew Member, and ExMC Gap 4.05: Lack of minimally invasive in-flight laboratory capabilities with limited consumables required for diagnosing identified Exploration Medical Conditions. To mitigate this risk, the availability of inflight laboratory analysis instrumentation has been identified as an essential capability in future exploration missions. Mission architecture poses constraints on equipment and procedures that will be available to treat evidence-based medical conditions according to the Space Medicine Exploration Medical Conditions List (SMEMCL). The SMEMCL provided diagnosis and treatment for the evidence-based medical conditions and hence, a basis for developing ELA functional requirements.

Single-Family Quality Control Inspector Job Task Analysis

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

Head, Heather R; Kurnik, Charles W

The National Renewable Energy Laboratory (NREL) is contracted by the U.S. Department of Energy (DOE) Weatherization Assistance Program (WAP) to develop and maintain the resources under the Guidelines for Home Energy Professionals (GHEP) project. As part of the GHEP strategy to increase the quality of work conducted for single-family, residential energy-efficiency retrofits, the Home Energy Professionals Job Task Analysis are used as the foundation for quality training programs and trainers.

Correction of stream quality trends for the effects of laboratory measurement bias

USGS Publications Warehouse

Alexander, Richard B.; Smith, Richard A.; Schwarz, Gregory E.

1993-01-01

We present a statistical model relating measurements of water quality to associated errors in laboratory methods. Estimation of the model allows us to correct trends in water quality for long-term and short-term variations in laboratory measurement errors. An illustration of the bias correction method for a large national set of stream water quality and quality assurance data shows that reductions in the bias of estimates of water quality trend slopes are achieved at the expense of increases in the variance of these estimates. Slight improvements occur in the precision of estimates of trend in bias by using correlative information on bias and water quality to estimate random variations in measurement bias. The results of this investigation stress the need for reliable, long-term quality assurance data and efficient statistical methods to assess the effects of measurement errors on the detection of water quality trends.

Impact of mentorship on WHO-AFRO Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA)

PubMed Central

Motebang, David; Mathabo, Lebina; Rotz, Philip J.; Wanyoike, Joseph; Peter, Trevor

2012-01-01

Background The improvment of the quality of testing services in public laboratories is a high priority in many countries. Consequently, initiatives to train laboratory staff on quality management are being implemented, for example, the World Health Organization Regional Headquarters for Africa (WHO-AFRO) Strengthening Laboratory Management Towards Accreditation (SLMTA). Mentorship may be an effective way to augment these efforts. Methods Mentorship was implemented at four hospital laboratories in Lesotho, three districts and one central laboratory, between June 2009 and December 2010. The mentorship model that was implemented had the mentor fully embedded within the operations of each of the laboratories. It was delivered in a series of two mentoring engagements of six and four week initial and follow-up visits respectively. In total, each laboratory received 10 weeks mentorship that was separated by 6–8 weeks. Quality improvements were measured at baseline and at intervals during the mentorship using the WHO-AFRO Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist and scoring system. Results At the beginning of the mentorship, all laboratories were at the SLIPTA zero star rating. After the initial six weeks of mentorship, two of the three district laboratories had improved from zero to one (out of five) star although the difference between their baseline (107.7) and the end of the six weeks (136.3) average scores was not statistically significant (p = 0.25). After 10 weeks of mentorship there was a significant improvement in average scores (182.3; p = 0.034) with one laboratory achieving WHO-AFRO three out of a possible five star status and the two remaining laboratories achieving a two star status. At Queen Elizabeth II (QE II) Central Laboratory, the average baseline score was 44%, measured using a section-specific checklist. There was a significant improvement by five weeks (57.2%; p = 0.021). Conclusion The

[Study of continuous quality improvement for clinical laboratory processes via the platform of Hospital Group].

PubMed

Song, Wenqi; Shen, Ying; Peng, Xiaoxia; Tian, Jian; Wang, Hui; Xu, Lili; Nie, Xiaolu; Ni, Xin

2015-05-26

The program of continuous quality improvement in clinical laboratory processes for complete blood count (CBC) was launched via the platform of Beijing Children's Hospital Group in order to improve the quality of pediatric clinical laboratories. Fifteen children's hospitals of Beijing Children's Hospital group were investigated using the method of Chinese adapted continuous quality improvement with PDCA (Plan-Do-Check-Action). The questionnaire survey and inter-laboratory comparison was conducted to find the existing problems, to analyze reasons, to set forth quality targets and to put them into practice. Then, targeted training was conducted to 15 children's hospitals and the second questionnaire survey, self examinations by the clinical laboratories was performed. At the same time, the Group's online internal quality control platform was established. Overall effects of the program were evaluated so that lay a foundation for the next stage of PDCA. Both quality of control system documents and CBC internal quality control scheme for all of clinical laboratories were improved through this program. In addition, standardization of performance verification was also improved, especially with the comparable verification rate of precision and internal laboratory results up to 100%. In terms of instrument calibration and mandatory diagnostic rates, only three out of the 15 hospitals (20%) failed to pass muster in 2014 from 46.67% (seven out of the 15 hospitals) in 2013. The abnormal data of intraday precision variance coefficients of the five CBC indicator parameters (WBC, RBC, Hb, Plt and Hct) of all the 15 laboratories accounted for 1.2% (2/165) in 2014, a marked decrease from 9.6% (14/145) in 2013. While the number of the hospitals using only one horizontal quality control object for daily quality control has dropped to three from five. The 15 hospitals organized a total of 263 times of training in 2014 from 101 times in 2013, up 160%. The quality improvement program for

Standardisation of DNA quantitation by image analysis: quality control of instrumentation.

PubMed

Puech, M; Giroud, F

1999-05-01

DNA image analysis is frequently performed in clinical practice as a prognostic tool and to improve diagnosis. The precision of prognosis and diagnosis depends on the accuracy of analysis and particularly on the quality of image analysis systems. It has been reported that image analysis systems used for DNA quantification differ widely in their characteristics (Thunissen et al.: Cytometry 27: 21-25, 1997). This induces inter-laboratory variations when the same sample is analysed in different laboratories. In microscopic image analysis, the principal instrumentation errors arise from the optical and electronic parts of systems. They bring about problems of instability, non-linearity, and shading and glare phenomena. The aim of this study is to establish tools and standardised quality control procedures for microscopic image analysis systems. Specific reference standard slides have been developed to control instability, non-linearity, shading and glare phenomena and segmentation efficiency. Some systems have been controlled with these tools and these quality control procedures. Interpretation criteria and accuracy limits of these quality control procedures are proposed according to the conclusions of a European project called PRESS project (Prototype Reference Standard Slide). Beyond these limits, tested image analysis systems are not qualified to realise precise DNA analysis. The different procedures presented in this work determine if an image analysis system is qualified to deliver sufficiently precise DNA measurements for cancer case analysis. If the controlled systems are beyond the defined limits, some recommendations are given to find a solution to the problem.

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.

Tuberculosis Laboratory Diagnosis Quality Assurance among Public Health Facilities in West Amhara Region, Ethiopia.

PubMed

Shiferaw, Melashu Balew; Hailu, Hiwot Amare; Fola, Abebe Alemu; Derebe, Mulatu Melese; Kebede, Aimro Tadese; Kebede, Abayneh Admas; Emiru, Manamnot Agegne; Gelaw, Zelalem Dessie

2015-01-01

Reliable smear microscopy is an important component of Directly Observed Treatment Scheme (DOTS) strategy for TB control program in countries with limited resources. Despite external quality assessment is established in Ethiopia, there is lower TB detection rate (48%) in Amhara region compared to the World Health Organization (WHO) estimate (70%). This highlights the quality of smear microscopy needs to be evaluated. Therefore, the aim of this study was to assess the quality of sputum smear microscopy performance among health center laboratories in West Amhara region, Ethiopia. A cross sectional study was conducted from July 08, 2013 to July 07, 2014. Data were collected from 201 public health center laboratories using a structured questionnaire. Slides were collected based on Lot Quality Assurance Sampling (LQAS) method and rechecked blindly by trained laboratory technologists. The data were entered into EPI info V.7 and smear quality indicators and AFB results were analyzed by SPSS version 20. Among 201 laboratories enrolled in this study, 47 (23.4%) laboratories had major errors. Forty one (20.4%) laboratories had a total of 67 false negative and 29 (14.4%) laboratories had a total of 68 false positive results. Specimen quality, smear thickness and evenness were found poor in 134 (66.7%), 133 (66.2%) and 126 (62.7%) laboratories, respectively. Unavailability of microscope lens cleaning solution (AOR: 2.90; 95% CI: 1.25-6.75; P: 0.013) and dirty smears (AOR: 2.65; 95% CI: 1.14-6.18; P: 0.024) were correlated with false negative results whereas no previous EQA participation (AOR: 3.43; 95% CI: 1. 39-8.45; P: 0.007) was associated with false positive results. The performance of health facilities for sputum smear microscopy was relatively poor in West Amhara region. Hence, strengthening the EQA program and technical support on sputum smear microscopy are recommended to ensure quality tuberculosis diagnostic service.

Water Quality & Pollutant Source Monitoring: Field and Laboratory Procedures. Training Manual.

ERIC Educational Resources Information Center

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

This training manual presents material on techniques and instrumentation used to develop data in field monitoring programs and related laboratory operations concerned with water quality and pollution monitoring. Topics include: collection and handling of samples; bacteriological, biological, and chemical field and laboratory methods; field…

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

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.

Laboratory animal science: a resource to improve the quality of science.

PubMed

Forni, M

2007-08-01

The contribution of animal experimentation to biomedical research is of undoubted value, nevertheless the real usefulness of animal models is still being hotly debated. Laboratory Animal Science is a multidisciplinary approach to humane animal experimentation that allows the choice of the correct animal model and the collection of unbiased data. Refinement, Reduction and Replacement, the "3Rs rule", are now widely accepted and have a major influence on animal experimentation procedures. Refinement, namely any decrease in the incidence or severity of inhumane procedures applied to animals, has been today extended to the entire lives of the experimental animals. Reduction of the number of animals used to obtain statistically significant data may be achieved by improving experimental design and statistical analysis of data. Replacement refers to the development of validated alternative methods. A Laboratory Animal Science training program in biomedical degrees can promote the 3Rs and improve the welfare of laboratory animals as well as the quality of science with ethical, scientific and economic advantages complying with the European requirement that "persons who carry out, take part in, or supervise procedures on animals, or take care of animals used in procedures, shall have had appropriate education and training".

[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.

Laboratory medicine in Ontario: its downsizing and the consequences on quality.

PubMed

Richardson, H

1999-12-01

Health care in Ontario consumes 35% of provincial government annual revenues. Fiscal constraint mandates restructuring of health services to maintain a fully, publicly-funded universally-accessible health system that is patient-focussed and health-outcome driven. Acute-care hospital restructuring under the authority of the Health Services Restructuring Commission and primary health-care reform characterise present government initiatives. Laboratory medicine services at about Can $1 billion annually account for about 5% of health expenditure. A Laboratory Services Restructuring Secretariat created by the Ministry of Health in 1995 has planned regionally-based integrated laboratory services systems bringing together public and private providers, designed a province-wide laboratory information system, developed a quality management program, reviewed the human resource needs for laboratory physicians, scientists and technologists, and recommended that the legislation be rewritten so as to be enabling - not controlling. Meanwhile both hospital and private laboratories have closed, leaving 296 in 1998 compared to 394 in 1991. Laboratory physician numbers at 39 per million population falls far short of the recommended target of 52 and many are within 10 years of retirement. Renewal of laboratory physicians and scientists to meet the shortfall is not occurring. The numbers of registered laboratory technologists has fallen by 6. 8% over 2 years. Consolidation and downsizing of laboratories with the formation of core laboratories has resulted in multi-discipline and cross discipline tasking of specialist technologists. Senior and middle level management technologists have been declared redundant. As a consequence, quality control practices have been hard hit. Plans to address these deficiencies through regional integration and sharing of resources remain to be implemented.

[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.

Follow-Up of External Quality Controls for PCR-Based Diagnosis of Whooping Cough in a Hospital Laboratory Network (Renacoq) and in Other Hospital and Private Laboratories in France.

PubMed

Guillot, Sophie; Guiso, Nicole

2016-08-01

The French National Reference Centre (NRC) for Whooping Cough carried out an external quality control (QC) analysis in 2010 for the PCR diagnosis of whooping cough. The main objective of the study was to assess the impact of this QC in the participating laboratories through a repeat analysis in 2012. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

National survey on internal quality control for tumour markers in clinical laboratories in China.

PubMed

Wang, Wei; Zhong, Kun; Yuan, Shuai; He, Falin; Du, Yuxuan; Hu, Zhehui; Wang, Zhiguo

2018-06-15

This survey was initiated to obtain knowledge on the current situation of internal quality control (IQC) practice for tumour markers (TMs) in China. Additionally, we tried to acquire the most appropriate quality specifications. This survey was a current status survey. The IQC information had been collected via online questionnaires. All of 1821 clinical laboratories which participated in the 2016 TMs external quality assessment (EQA) programme had been enrolled. The imprecision evaluation criteria were the minimal, desirable, and optimal allowable imprecisions based on biological variations, and 1/3 total allowable error (TEa) and 1/4 TEa. A total of 1628 laboratories answered the questionnaires (89%). The coefficients of variation (CVs) of the IQC of participant laboratories varied greatly from 1% (5 th percentile) to 13% (95 th percentile). More than 82% (82 - 91%) of participant laboratories two types of CVs met 1/3 TEa except for CA 19-9. The percentiles of current CVs were smaller than cumulative CVs. A number of 1240 laboratories (76%) reported their principles and systems used. The electrochemiluminescence was the most used principle (45%) and had the smallest CVs. The performance of laboratories for TMs IQC has yet to be improved. On the basis of the obtained results, 1/3 TEa would be realistic and attainable quality specification for TMs IQC for clinical laboratories in China.

Exploration Laboratory Analysis FY13

NASA Technical Reports Server (NTRS)

Krihak, Michael; Perusek, Gail P.; Fung, Paul P.; Shaw, Tianna, L.

2013-01-01

The Exploration Laboratory Analysis (ELA) project supports the Exploration Medical Capability (ExMC) risk, which is stated as the Risk of Inability to Adequately Treat an Ill or Injured Crew Member, and ExMC Gap 4.05: Lack of minimally invasive in-flight laboratory capabilities with limited consumables required for diagnosing identified Exploration Medical Conditions. To mitigate this risk, the availability of inflight laboratory analysis instrumentation has been identified as an essential capability in future exploration missions. Mission architecture poses constraints on equipment and procedures that will be available to treat evidence-based medical conditions according to the Space Medicine Exploration Medical Conditions List (SMEMCL), and to perform human research studies on the International Space Station (ISS) that are supported by the Human Health and Countermeasures (HHC) element. Since there are significant similarities in the research and medical operational requirements, ELA hardware development has emerged as a joint effort between ExMC and HHC. In 2012, four significant accomplishments were achieved towards the development of exploration laboratory analysis for medical diagnostics. These achievements included (i) the development of high priority analytes for research and medical operations, (ii) the development of Level 1 functional requirements and concept of operations documentation, (iii) the selection and head-to-head competition of in-flight laboratory analysis instrumentation, and (iv) the phase one completion of the Small Business Innovation Research (SBIR) projects under the topic Smart Phone Driven Blood-Based Diagnostics. To utilize resources efficiently, the associated documentation and advanced technologies were integrated into a single ELA plan that encompasses ExMC and HHC development efforts. The requirements and high priority analytes was used in the selection of the four in-flight laboratory analysis performers. Based upon the

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

Development and Implementation of a Quality Improvement Process for Echocardiographic Laboratory Accreditation.

PubMed

Gilliland, Yvonne E; Lavie, Carl J; Ahmad, Homaa; Bernal, Jose A; Cash, Michael E; Dinshaw, Homeyar; Milani, Richard V; Shah, Sangeeta; Bienvenu, Lisa; White, Christopher J

2016-03-01

We describe our process for quality improvement (QI) for a 3-year accreditation cycle in echocardiography by the Intersocietal Accreditation Commission (IAC) for a large group practice. Echocardiographic laboratory accreditation by the IAC was introduced in 1996, which is not required but could impact reimbursement. To ensure high-quality patient care and community recognition as a facility committed to providing high-quality echocardiographic services, we applied for IAC accreditation in 2010. Currently, there is little published data regarding the IAC process to meet echocardiography standards. We describe our approach for developing a multicampus QI process for echocardiographic laboratory accreditation during the 3-year cycle of accreditation by the IAC. We developed a quarterly review assessing (1) the variability of the interpretations, (2) the quality of the examinations, (3) a correlation of echocardiographic studies with other imaging modalities, (4) the timely completion of reports, (5) procedure volume, (6) maintenance of Continuing Medical Education credits by faculty, and (7) meeting Appropriate Use Criteria. We developed and implemented a multicampus process for QI during the 3-year accreditation cycle by the IAC for Echocardiography. We documented both the process and the achievement of those metrics by the Echocardiography Laboratories at the Ochsner Medical Institutions. We found the QI process using IAC standards to be a continuous educational experience for our Echocardiography Laboratory physicians and staff. We offer our process as an example and guide for other echocardiography laboratories who wish to apply for such accreditation or reaccreditation. © 2016, Wiley Periodicals, Inc.

Exploration Laboratory Analysis

NASA Technical Reports Server (NTRS)

Krihak, M.; Ronzano, K.; Shaw, T.

2016-01-01

The Exploration Laboratory Analysis (ELA) project supports the Exploration Medical Capability (ExMC) risk to minimize or reduce the risk of adverse health outcomes and decrements in performance due to in-flight medical capabilities on human exploration missions. To mitigate this risk, the availability of inflight laboratory analysis instrumentation has been identified as an essential capability for manned exploration missions. Since a single, compact space-ready laboratory analysis capability to perform all exploration clinical measurements is not commercially available, the ELA project objective is to demonstrate the feasibility of emerging operational and analytical capability as a biomedical diagnostics precursor to long duration manned exploration missions. The initial step towards ground and flight demonstrations in fiscal year (FY) 2015 was the down selection of platform technologies for demonstrations in the space environment. The technologies selected included two Small Business Innovation Research (SBIR) performers: DNA Medicine Institutes rHEALTH X and Intelligent Optical Systems later flow assays combined with Holomics smartphone analyzer. The selection of these technologies were based on their compact size, breadth of analytical capability and favorable ability to process fluids in a space environment, among several factors. These two technologies will be advanced to meet ground and flight demonstration success criteria and requirements that will be finalized in FY16. Also, the down selected performers will continue the technology development phase towards meeting prototype deliverables in either late 2016 or 2017.

Exploration Laboratory Analysis

NASA Technical Reports Server (NTRS)

Krihak, M.; Ronzano, K.; Shaw, T.

2016-01-01

The Exploration Laboratory Analysis (ELA) project supports the Exploration Medical Capability (ExMC) risk to minimize or reduce the risk of adverse health outcomes and decrements in performance due to in-flight medical capabilities on human exploration missions. To mitigate this risk, the availability of inflight laboratory analysis instrumentation has been identified as an essential capability for manned exploration missions. Since a single, compact space-ready laboratory analysis capability to perform all exploration clinical measurements is not commercially available, the ELA project objective is to demonstrate the feasibility of emerging operational and analytical capability as a biomedical diagnostics precursor to long duration manned exploration missions. The initial step towards ground and flight demonstrations in fiscal year (FY) 2015 was the downselection of platform technologies for demonstrations in the space environment. The technologies selected included two Small Business Innovation Research (SBIR) performers: DNA Medicine Institute's rHEALTH X and Intelligent Optical System's lateral flow assays combined with Holomic's smartphone analyzer. The selection of these technologies were based on their compact size, breadth of analytical capability and favorable ability to process fluids in a space environment, among several factors. These two technologies will be advanced to meet ground and flight demonstration success criteria and requirements. The technology demonstrations and metrics for success will be finalized in FY16. Also, the downselected performers will continue the technology development phase towards meeting prototype deliverables in either late 2016 or 2017.

Live births achieved via IVF are increased by improvements in air quality and laboratory environment.

PubMed

Heitmann, Ryan J; Hill, Micah J; James, Aidita N; Schimmel, Tim; Segars, James H; Csokmay, John M; Cohen, Jacques; Payson, Mark D

2015-09-01

Infertility is a common disease, which causes many couples to seek treatment with assisted reproduction techniques. Many factors contribute to successful assisted reproduction technique outcomes. One important factor is laboratory environment and air quality. Our facility had the unique opportunity to compare consecutively used, but separate assisted reproduction technique laboratories, as a result of a required move. Environmental conditions were improved by strategic engineering designs. All other aspects of the IVF laboratory, including equipment, physicians, embryologists, nursing staff and protocols, were kept constant between facilities. Air quality testing showed improved air quality at the new IVF site. Embryo implantation (32.4% versus 24.3%; P < 0.01) and live birth (39.3% versus 31.8%, P < 0.05) were significantly increased in the new facility compared with the old facility. More patients met clinical criteria and underwent mandatory single embryo transfer on day 5 leading to both a reduction in multiple gestation pregnancies and increased numbers of vitrified embryos per patient with supernumerary embryos available. Improvements in IVF laboratory conditions and air quality had profound positive effects on laboratory measures and patient outcomes. This study further strengthens the importance of the laboratory environment and air quality in the success of an IVF programme. Published by Elsevier Ltd.

Student laboratory reports: an approach to improving feedback and quality

NASA Astrophysics Data System (ADS)

Ellingsen, Pål Gunnar; Støvneng, Jon Andreas

2018-05-01

We present an ongoing effort in improving the quality of laboratory reports written by first and second year physics students. The effort involves a new approach where students are given the opportunity to submit reports at intermediate deadlines, receive feedback, and then resubmit for the final deadline. In combination with a differential grading system, instead of pass/fail, the improved feedback results in higher quality reports. Improvement in the quality of the reports is visible through the grade statistics.

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

Quality management for the international transport of laboratory animals.

PubMed

Leary, Steven L

2008-01-01

Increased collaboration between investigators at different institutions has increased the number of laboratory animals being transported. The current system of laws and regulations governing animal shipments is inconsistent and government agencies often have areas of overlapping regulatory management. Furthermore, the lack of industry-wide shipping standards and good practices contributes to confusion among those responsible for shipment. One answer to these quality control issues would be the establishment of independent, industry-regulated 'good practices' for animal transport, similar to those used in laboratories for experimental design. These good practices could be based on the existing International Air Transport Association Live Animals Regulations, with contributions from representatives of the specialties involved. Additionally, quality control under the current system of patchwork regulations could be improved if each institution, both academic and commercial, would designate a single point of contact to follow each shipment from start to finish.

Practical, transparent prospective risk analysis for the clinical laboratory.

PubMed

Janssens, Pim Mw

2014-11-01

Prospective risk analysis (PRA) is an essential element in quality assurance for clinical laboratories. Practical approaches to conducting PRA in laboratories, however, are scarce. On the basis of the classical Failure Mode and Effect Analysis method, an approach to PRA was developed for application to key laboratory processes. First, the separate, major steps of the process under investigation are identified. Scores are then given for the Probability (P) and Consequence (C) of predefined types of failures and the chances of Detecting (D) these failures. Based on the P and C scores (on a 10-point scale), an overall Risk score (R) is calculated. The scores for each process were recorded in a matrix table. Based on predetermined criteria for R and D, it was determined whether a more detailed analysis was required for potential failures and, ultimately, where risk-reducing measures were necessary, if any. As an illustration, this paper presents the results of the application of PRA to our pre-analytical and analytical activities. The highest R scores were obtained in the stat processes, the most common failure type in the collective process steps was 'delayed processing or analysis', the failure type with the highest mean R score was 'inappropriate analysis' and the failure type most frequently rated as suboptimal was 'identification error'. The PRA designed is a useful semi-objective tool to identify process steps with potential failures rated as risky. Its systematic design and convenient output in matrix tables makes it easy to perform, practical and transparent. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Laboratory automation of high-quality and efficient ligand-binding assays for biotherapeutic drug development.

PubMed

Wang, Jin; Patel, Vimal; Burns, Daniel; Laycock, John; Pandya, Kinnari; Tsoi, Jennifer; DeSilva, Binodh; Ma, Mark; Lee, Jean

2013-07-01

Regulated bioanalytical laboratories that run ligand-binding assays in support of biotherapeutics development face ever-increasing demand to support more projects with increased efficiency. Laboratory automation is a tool that has the potential to improve both quality and efficiency in a bioanalytical laboratory. The success of laboratory automation requires thoughtful evaluation of program needs and fit-for-purpose strategies, followed by pragmatic implementation plans and continuous user support. In this article, we present the development of fit-for-purpose automation of total walk-away and flexible modular modes. We shared the sustaining experience of vendor collaboration and team work to educate, promote and track the use of automation. The implementation of laboratory automation improves assay performance, data quality, process efficiency and method transfer to CRO in a regulated bioanalytical laboratory environment.

Implementation of a laboratory quality assurance program: the Louisville experience.

PubMed

Metz, Michael J; Abdel-Azim, Tamer; Miller, Cynthia J; Lin, Wei-Shao; ZandiNejad, Amirali; Oliveira, Gustavo M; Morton, Dean

2014-02-01

Remakes, or the refabrication of dental prostheses, can occur as a result of inherent inaccuracies in both clinical and laboratory procedures. Because dental schools manage large numbers of predoctoral dental students with limited familiarity and expertise as related to clinical prosthodontic techniques, it is likely these schools will experience an elevated incidence of laboratory remakes and their ramifications. The University of Louisville School of Dentistry, not unlike other dental schools, has experienced remakes associated with both fixed and removable prosthodontic procedures. Limitations in faculty standardization and variable enforcement of established preclinical protocols have been identified as variables associated with the high percentage of remakes documented. The purpose of this study was to introduce the implementation of a new multidepartmental quality assurance program designed to increase consistency and quality in both information provided to commercial dental laboratories and the prostheses returned. The program has shown to be advantageous in terms of cost-effectiveness and treatment outcomes. A statistically significant decrease in remake percentages has been recorded from inception of this program in December 2010 until December 2012. Furthermore, this program has resulted in more consistent communication between the dental school and commercial dental laboratories, among faculty members, and between faculty and students.

ASVCP quality assurance guidelines: external quality assessment and comparative testing for reference and in-clinic laboratories.

PubMed

Camus, Melinda S; Flatland, Bente; Freeman, Kathleen P; Cruz Cardona, Janice A

2015-12-01

The purpose of this document is to educate providers of veterinary laboratory diagnostic testing in any setting about comparative testing. These guidelines will define, explain, and illustrate the importance of a multi-faceted laboratory quality management program which includes comparative testing. The guidelines will provide suggestions for implementation of such testing, including which samples should be tested, frequency of testing, and recommendations for result interpretation. Examples and a list of vendors and manufacturers supplying control materials and services to veterinary laboratories are also included. © 2015 American Society for Veterinary Clinical Pathology.

USDA, ARS Soft Wheat Quality Laboratory, Annual Report 2011

USDA-ARS?s Scientific Manuscript database

The report describes new activities for the lab including the a transitions in the laboratory and activites on the USDA, NIFA-funded Triticeae CAP project. Recent research on milling and quality evaluations, data management, molecular evaluations, stem rust resistance from the lab are highlighted, ...

Sunway Medical Laboratory Quality Control Plans Based on Six Sigma, Risk Management and Uncertainty.

PubMed

Jairaman, Jamuna; Sakiman, Zarinah; Li, Lee Suan

2017-03-01

Sunway Medical Centre (SunMed) implemented Six Sigma, measurement uncertainty, and risk management after the CLSI EP23 Individualized Quality Control Plan approach. Despite the differences in all three approaches, each implementation was beneficial to the laboratory, and none was in conflict with another approach. A synthesis of these approaches, built on a solid foundation of quality control planning, can help build a strong quality management system for the entire laboratory. Copyright © 2016 Elsevier Inc. All rights reserved.

Association Between Echocardiography Laboratory Accreditation and the Quality of Imaging and Reporting for Valvular Heart Disease.

PubMed

Thaden, Jeremy J; Tsang, Michael Y; Ayoub, Chadi; Padang, Ratnasari; Nkomo, Vuyisile T; Tucker, Stephen F; Cassidy, Cynthia S; Bremer, Merri; Kane, Garvan C; Pellikka, Patricia A

2017-08-01

It is presumed that echocardiographic laboratory accreditation leads to improved quality, but there are few data. We sought to compare the quality of echocardiographic examinations performed at accredited versus nonaccredited laboratories for the evaluation of valvular heart disease. We enrolled 335 consecutive valvular heart disease subjects who underwent echocardiography at our institution and an external accredited or nonaccredited institution within 6 months. Completeness and quality of echocardiographic reports and images were assessed by investigators blinded to the external laboratory accreditation status and echocardiographic results. Compared with nonaccredited laboratories, accredited sites more frequently reported patient sex (94% versus 78%; P <0.001), height and weight (96% versus 63%; P <0.001), blood pressure (86% versus 39%; P <0.001), left ventricular size (96% versus 83%; P <0.001), right ventricular size (94% versus 80%; P =0.001), and right ventricular function (87% versus 73%; P =0.006). Accredited laboratories had higher rates of complete and diagnostic color (58% versus 35%; P =0.002) and spectral Doppler imaging (45% versus 21%; P <0.0001). Concordance between external and internal grading of external studies was improved when diagnostic quantification was performed (85% versus 69%; P =0.003), and in patients with mitral regurgitation, reproducibility was improved with higher quality color Doppler imaging. Accredited echocardiographic laboratories had more complete reporting and better image quality, while echocardiographic quantification and color Doppler image quality were associated with improved concordance in grading valvular heart disease. Future quality improvement initiatives should highlight the importance of high-quality color Doppler imaging and echocardiographic quantification to improve the accuracy, reproducibility, and quality of echocardiographic studies for valvular heart disease. © 2017 American Heart Association, Inc.

Situation analysis of occupational and environmental health laboratory accreditation in Thailand.

PubMed

Sithisarankul, Pornchai; Santiyanont, Rachana; Wongpinairat, Chongdee; Silva, Panadda; Rojanajirapa, Pinnapa; Wangwongwatana, Supat; Srinetr, Vithet; Sriratanaban, Jiruth; Chuntutanon, Swanya

2002-06-01

The objective of this study was to analyze the current situation of laboratory accreditation (LA) in Thailand, especially on occupational and environmental health. The study integrated both quantitative and qualitative approaches. The response rate of the quantitative questionnaires was 54.5% (226/415). The majority of the responders was environmental laboratories located outside hospital and did not have proficiency testing. The majority used ISO 9000, ISO/IEC 17025 or ISO/ EEC Guide 25, and hospital accreditation (HA) as their quality system. However, only 30 laboratories were currently accredited by one of these systems. Qualitative research revealed that international standard for laboratory accreditation for both testing laboratory and calibration laboratory was ISO/IEC Guide 25, which has been currently revised to be ISO/IEC 17025. The National Accreditation Council (NAC) has authorized 2 organizations as Accreditation Bodies (ABs) for LA: Thai Industrial Standards Institute, Ministry of Industry, and Bureau of Laboratory Quality Standards, Department of Medical Sciences, Ministry of Public Health. Regarding LA in HA, HA considered clinical laboratory as only 1 of 31 items for accreditation. Obtaining HA might satisfy the hospital director and his management team, and hence might actually be one of the obstacles for the hospital to further improve their laboratory quality system and apply for ISO/IEC 17025 which was more technically oriented. On the other hand, HA may be viewed as a good start or even a pre-requisite for laboratories in the hospitals to further improve their quality towards ISO/IEC 17025. Interviewing the director of NAC and some key men in some large laboratories revealed several major problems of Thailand's LA. Both Thai Industrial Standards Institute and Bureau of Laboratory Quality Standards did not yet obtain Mutual Recognition Agreement (MRA) with other international ABs. Several governmental bodies had their own standards and

Assessment of analytical quality in Nordic clinical chemistry laboratories using data from contemporary national programs.

PubMed

Aronsson, T; Bjørnstad, P; Leskinen, E; Uldall, A; de Verdier, C H

1984-01-01

The aim of this investigation was primarily to assess analytical quality expressed as between-laboratory, within-laboratory, and total imprecision, not in order to detect laboratories with poor performance, but in the positive sense to provide data for improving critical steps in analytical methodology. The aim was also to establish the present state of the art in comparison with earlier investigations to see if improvement in analytical quality could be observed.

Quality-assurance results for routine water analyses in U.S. Geological Survey laboratories, water year 1998

USGS Publications Warehouse

Ludtke, Amy S.; Woodworth, Mark T.; Marsh, Philip S.

2000-01-01

The U.S. Geological Survey operates a quality-assurance program based on the analyses of reference samples for two laboratories: the National Water Quality Laboratory and the Quality of Water Service Unit. Reference samples that contain selected inorganic, nutrient, and low-level constituents are prepared and submitted to the laboratory as disguised routine samples. The program goal is to estimate precision and bias for as many analytical methods offered by the participating laboratories as possible. Blind reference samples typically are submitted at a rate of 2 to 5 percent of the annual environmental-sample load for each constituent. The samples are distributed to the laboratories throughout the year. The reference samples are subject to the identical laboratory handling, processing, and analytical procedures as those applied to environmental samples and, therefore, have been used as an independent source to verify bias and precision of laboratory analytical methods and ambient water-quality measurements. The results are stored permanently in the National Water Information System and the Blind Sample Project's data base. During water year 1998, 95 analytical procedures were evaluated at the National Water Quality Laboratory and 63 analytical procedures were evaluated at the Quality of Water Service Unit. An overall evaluation of the inorganic and low-level constituent data for water year 1998 indicated 77 of 78 analytical procedures at the National Water Quality Laboratory met the criteria for precision. Silver (dissolved, inductively coupled plasma-mass spectrometry) was determined to be imprecise. Five of 78 analytical procedures showed bias throughout the range of reference samples: chromium (dissolved, inductively coupled plasma-atomic emission spectrometry), dissolved solids (dissolved, gravimetric), lithium (dissolved, inductively coupled plasma-atomic emission spectrometry), silver (dissolved, inductively coupled plasma-mass spectrometry), and zinc

Cost analysis in the toxicology laboratory.

PubMed

Travers, E M

1990-09-01

The process of determining laboratory sectional and departmental costs and test costs for instrument-generated and manually generated reportable results for toxicology laboratories has been outlined in this article. It is hoped that the basic principles outlined in the preceding text will clarify and elucidate one of the most important areas needed for laboratory fiscal integrity and its survival in these difficult times for health care providers. The following general principles derived from this article are helpful aids for managers of toxicology laboratories. 1. To manage a cost-effective, efficient toxicology laboratory, several factors must be considered: the laboratory's instrument configuration, test turnaround time needs, the test menu offered, the analytic methods used, the cost of labor based on time expended and the experience and educational level of the staff, and logistics that determine specimen delivery time and costs. 2. There is a wide variation in costs for toxicologic methods, which requires that an analysis of capital (equipment) purchase and operational (test performance) costs be performed to avoid waste, purchase wisely, and determine which tests consume the majority of the laboratory's resources. 3. Toxicologic analysis is composed of many complex steps. Each step must be individually cost-accounted. Screening test results must be confirmed, and the cost for both steps must be included in the cost per reportable result. 4. Total costs will vary in the same laboratory and between laboratories based on differences in salaries paid to technical staff, differences in reagent/supply costs, the number of technical staff needed to operate the analyzer or perform the method, and the inefficient use of highly paid staff to operate the analyzer or perform the method. 5. Since direct test costs vary directly with the type and number of analyzers or methods and are dependent on the operational mode designed by the manufacturer, laboratory managers

External quality assessment studies for laboratory performance of molecular and serological diagnosis of Chikungunya virus infection.

PubMed

Jacobsen, Sonja; Patel, Pranav; Schmidt-Chanasit, Jonas; Leparc-Goffart, Isabelle; Teichmann, Anette; Zeller, Herve; Niedrig, Matthias

2016-03-01

Since the re-emergence of Chikungunya virus (CHIKV) in Reunion in 2005 and the recent outbreak in the Caribbean islands with an expansion to the Americas the CHIK diagnostic became very important. We evaluate the performance of laboratories regarding molecular and serological diagnostic of CHIK worldwide. A panel of 12 samples for molecular and 13 samples for serology were provided to 60 laboratories in 40 countries for evaluating the sensitivity and specificity of molecular and serology testing. The panel for molecular diagnostic testing was analysed by 56 laboratories returning 60 data sets of results whereas the 56 and 60 data sets were returned for IgG and IgM diagnostic from the participating laboratories. Twenty-three from 60 data sets performed optimal, 7 acceptable and 30 sets of results require improvement. From 50 data sets only one laboratory shows an optimal performance for IgM detection, followed by 9 data sets with acceptable and the rest need for improvement. From 46 IgG serology data sets 20 provide an optimal, 2 an acceptable and 24 require improvement performance. The evaluation of some of the diagnostic performances allows linking the quality of results to the in-house methods or commercial assays used. The external quality assurance for CHIK diagnostics provides a good overview on the laboratory performance regarding sensitivity and specificity for the molecular and serology diagnostic required for the quick and reliable analysis of suspected CHIK patients. Nearly half of the laboratories have to improve their diagnostic profile to achieve a better performance. Copyright © 2016 Z. Published by Elsevier B.V. All rights reserved.

European external quality control study on the competence of laboratories to recognize rare sequence variants resulting in unusual genotyping results.

PubMed

Márki-Zay, János; Klein, Christoph L; Gancberg, David; Schimmel, Heinz G; Dux, László

2009-04-01

Depending on the method used, rare sequence variants adjacent to the single nucleotide polymorphism (SNP) of interest may cause unusual or erroneous genotyping results. Because such rare variants are known for many genes commonly tested in diagnostic laboratories, we organized a proficiency study to assess their influence on the accuracy of reported laboratory results. Four external quality control materials were processed and sent to 283 laboratories through 3 EQA organizers for analysis of the prothrombin 20210G>A mutation. Two of these quality control materials contained sequence variants introduced by site-directed mutagenesis. One hundred eighty-nine laboratories participated in the study. When samples gave a usual result with the method applied, the error rate was 5.1%. Detailed analysis showed that more than 70% of the failures were reported from only 9 laboratories. Allele-specific amplification-based PCR had a much higher error rate than other methods (18.3% vs 2.9%). The variants 20209C>T and [20175T>G; 20179_20180delAC] resulted in unusual genotyping results in 67 and 85 laboratories, respectively. Eighty-three (54.6%) of these unusual results were not recognized, 32 (21.1%) were attributed to technical issues, and only 37 (24.3%) were recognized as another sequence variant. Our findings revealed that some of the participating laboratories were not able to recognize and correctly interpret unusual genotyping results caused by rare SNPs. Our study indicates that the majority of the failures could be avoided by improved training and careful selection and validation of the methods applied.

Bio-Oil Analysis Laboratory Procedures | Bioenergy | NREL

Science.gov Websites

Bio-Oil Analysis Laboratory Procedures Bio-Oil Analysis Laboratory Procedures NREL develops standard procedures have been validated and allow for reliable bio-oil analysis. Procedures Determination different hydroxyl groups (-OH) in pyrolysis bio-oil: aliphatic-OH, phenolic-OH, and carboxylic-OH. Download

Effect of clinical and laboratory parameters on quality of life in celiac patients using celiac disease-specific quality of life scores.

PubMed

Lee, Jungmin; Clarke, Kofi

2017-11-01

Health-related quality of life (HR-QOL) in patients with celiac disease is reduced compared to the general population. We investigated the association between HR-QOL and clinical, laboratory findings using the previously validated CD-QOL (celiac disease-specific quality of life) instrument in patients with celiac disease. To our knowledge, no study has previously explored the relationship between HR-QOL and clinical, laboratory parameters in celiac patients. Patients who received care at the Allegheny Health Network Celiac Center, Pittsburgh, PA were asked to complete the CD-QOL questionnaire. A cross sectional study with predetermined clinical and laboratory parameters was performed. Data collected included IgA anti-tissue transglutaminase (tTG) antibody titers, iron studies, calcium, vitamin A, B12, 25 OH vitamin D, and E levels. Correlation between clinical findings and CD-QOL was also assessed. Seventy-eight out of 124 patients who completed the questionnaire was included in the analysis. Patients with concomitant irritable bowel syndrome (IBS) had significantly reduced HR-QOL with CD-QOL score of 52.4 ± 11.3 vs. 44.6 ± 12.9 in those without IBS (p = .009). There was no difference in HR-QOL in relation to IgA tTG titers or vitamin D levels. Of note, there was a trend towards correlation between higher level of vitamin E and better QOL (r = -0.236, p = .074). Celiac patients with concomitant IBS have reduced HR-QOL. There was no statistically significant association between HR-QOL and laboratory parameters or levels of micronutrients.

Quest for quality: department of laboratory medicine and pathology, Mayo Clinic.

PubMed

Arney, Kris R; Hopper, Mary H; Tran, Sheryl A; Ward, Melissa M; Hanson, Curtis A

2004-01-01

This article describes our journey for quality in the Department of Laboratory Medicine and Pathology (DLMP) at Mayo Clinic. It provides the background of the department and the process for the development and implementation of the quality program. In addition, a quality conference and the development of a quality school are outlined. Throughout the course of this process, valuable lessons were learned and are discussed. We are pleased with the success of the quality journey. However, we realize that the quest has just begun. We look forward to the future and the challenges that lie ahead.

Idaho National Laboratory Quarterly Performance Analysis for the 2nd Quarter FY 2015

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

Mitchell, Lisbeth A.

2015-04-01

This report is published quarterly by the Idaho National Laboratory (INL) Quality and Performance Management Organization. The Department of Energy (DOE) Occurrence Reporting and Processing System (ORPS), as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of events for the 2nd Qtr FY-15.

A primer on the cost of quality for improvement of laboratory and pathology specimen processes.

PubMed

Carlson, Richard O; Amirahmadi, Fazlollaah; Hernandez, James S

2012-09-01

In today's environment, many laboratories and pathology practices are challenged to maintain or increase their quality while simultaneously lowering their overall costs. The cost of improving specimen processes is related to quality, and we demonstrate that actual costs can be reduced by designing "quality at the source" into the processes. Various costs are hidden along the total testing process, and we suggest ways to identify opportunities to reduce cost by improving quality in laboratories and pathology practices through the use of Lean, Six Sigma, and industrial engineering.

Development and implementation of the Caribbean Laboratory Quality Management Systems Stepwise Improvement Process (LQMS-SIP) Towards Accreditation.

PubMed

Alemnji, George; Edghill, Lisa; Guevara, Giselle; Wallace-Sankarsingh, Sacha; Albalak, Rachel; Cognat, Sebastien; Nkengasong, John; Gabastou, Jean-Marc

2017-01-01

Implementing quality management systems and accrediting laboratories in the Caribbean has been a challenge. We report the development of a stepwise process for quality systems improvement in the Caribbean Region. The Caribbean Laboratory Stakeholders met under a joint Pan American Health Organization/US Centers for Disease Control and Prevention initiative and developed a user-friendly framework called 'Laboratory Quality Management System - Stepwise Improvement Process (LQMS-SIP) Towards Accreditation' to support countries in strengthening laboratory services through a stepwise approach toward fulfilling the ISO 15189: 2012 requirements. This approach consists of a three-tiered framework. Tier 1 represents the minimum requirements corresponding to the mandatory criteria for obtaining a licence from the Ministry of Health of the participating country. The next two tiers are quality improvement milestones that are achieved through the implementation of specific quality management system requirements. Laboratories that meet the requirements of the three tiers will be encouraged to apply for accreditation. The Caribbean Regional Organisation for Standards and Quality hosts the LQMS-SIP Secretariat and will work with countries, including the Ministry of Health and stakeholders, including laboratory staff, to coordinate and implement LQMS-SIP activities. The Caribbean Public Health Agency will coordinate and advocate for the LQMS-SIP implementation. This article presents the Caribbean LQMS-SIP framework and describes how it will be implemented among various countries in the region to achieve quality improvement.

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

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

Assuring the Quality of Next-Generation Sequencing in Clinical Microbiology and Public Health Laboratories.

PubMed

Gargis, Amy S; Kalman, Lisa; Lubin, Ira M

2016-12-01

Clinical microbiology and public health laboratories are beginning to utilize next-generation sequencing (NGS) for a range of applications. This technology has the potential to transform the field by providing approaches that will complement, or even replace, many conventional laboratory tests. While the benefits of NGS are significant, the complexities of these assays require an evolving set of standards to ensure testing quality. Regulatory and accreditation requirements, professional guidelines, and best practices that help ensure the quality of NGS-based tests are emerging. This review highlights currently available standards and guidelines for the implementation of NGS in the clinical and public health laboratory setting, and it includes considerations for NGS test validation, quality control procedures, proficiency testing, and reference materials. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Quality Evaluation of Zirconium Dioxide Frameworks Produced in Five Dental Laboratories from Different Countries.

PubMed

Schneebeli, Esther; Brägger, Urs; Scherrer, Susanne S; Keller, Andrea; Wittneben, Julia G; Hicklin, Stefan P

2017-07-01

The aim of this study was to assess and compare quality as well as economic aspects of CAD/CAM high strength ceramic three-unit FDP frameworks ordered from dental laboratories located in emerging countries and Switzerland. The master casts of six cases were sent to five dental laboratories located in Thailand (Bangkok), China (Peking and Shenzhen), Turkey (Izmir), and Switzerland (Bern). Each laboratory was using a different CAD/CAM system. The clinical fit of the frameworks was qualitatively assessed, and the thickness of the framework material, the connector height, the width, and the diameter were evaluated using a measuring sensor. The analysis of the internal fit of the frameworks was performed by means of a replica technique, whereas the inner and outer surfaces of the frameworks were evaluated for traces of postprocessing and damage to the intaglio surface with light and electronic microscopes. Groups (dental laboratories and cases) were compared for statistically significant differences using Mann-Whitney U-tests after Bonferroni correction. An acceptable clinical fit was found at 97.9% of the margins produced in laboratory E, 87.5% in B, 93.7% in C, 79.2% in A, and 62.5% in D. The mean framework thicknesses were not statistically significantly different for the premolar regions; however, for the molar area 4/8 of the evaluated sites were statistically significantly different. Circumference, surface, and width of the connectors produced in the different laboratories were statistically significantly different but not the height. There were great differences in the designs for the pontic and connector regions, and some of the frameworks would not be recommended for clinical use. Traces of heavy postprocessing were found in frameworks from some of the laboratories. The prices per framework ranged from US$177 to US$896. By ordering laboratory work in developing countries, a considerable price reduction was obtained compared to the price level in Switzerland

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

NETL - Thermogravimetric Analysis Laboratory

ScienceCinema

Richards, George

2018-06-22

Researchers in NETL's Thermal Analysis Laboratory are investigating chemical looping combustion. As a clean and efficient fossil fuel technology, chemical looping combustion controls CO2 emissions and offers a promising alternative to traditional combustion.

21 CFR 111.110 - What quality control operations are required for laboratory operations associated with the...

Code of Federal Regulations, 2010 CFR

2010-04-01

... laboratory operations associated with the production and process control system? 111.110 Section 111.110 Food... OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for Quality Control... production and process control system? Quality control operations for laboratory operations associated with...

An overview of the European Organization for External Quality Assurance Providers in Laboratory Medicine (EQALM)

PubMed Central

Stavelin, Anne; Albe, Xavier; Meijer, Piet; Sarkany, Erika; MacKenzie, Finlay

2017-01-01

The European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM) was founded in 1996 and currently has members from 29 European countries and 6 countries from outside Europe. EQALM provides a forum for co-operation and exchange of knowledge on quality-related matters in laboratory medicine, especially with regard to external quality assessment (EQA) programs in Europe. In addition, EQALM represent the EQA providers in laboratory medicine at European level vis-ŕ-vis political, professional, scientific and other bodies, including patients’ organisations. To this end EQALM promotes activities such as organizing meetings with scientific and practical themes for members and other interested parties, issuing scientific publications, developing EQA projects and representing laboratory medicine EQA activities within other organisations and networks. EQALM is active in scientific and educational activity in different fields such as survey frequency, haematology, haemostasis, microbiology, nomenclature, virtual microscopy, traceability, accreditation, and quality assurance of the total testing process. The aim of this paper is to give an overview of the EQALM organisation. PMID:28392724

Development and implementation of the Caribbean Laboratory Quality Management Systems Stepwise Improvement Process (LQMS-SIP) Towards Accreditation

PubMed Central

Alemnji, George; Edghill, Lisa; Wallace-Sankarsingh, Sacha; Albalak, Rachel; Cognat, Sebastien; Nkengasong, John; Gabastou, Jean-Marc

2017-01-01

Background Implementing quality management systems and accrediting laboratories in the Caribbean has been a challenge. Objectives We report the development of a stepwise process for quality systems improvement in the Caribbean Region. Methods The Caribbean Laboratory Stakeholders met under a joint Pan American Health Organization/US Centers for Disease Control and Prevention initiative and developed a user-friendly framework called ‘Laboratory Quality Management System – Stepwise Improvement Process (LQMS-SIP) Towards Accreditation’ to support countries in strengthening laboratory services through a stepwise approach toward fulfilling the ISO 15189: 2012 requirements. Results This approach consists of a three-tiered framework. Tier 1 represents the minimum requirements corresponding to the mandatory criteria for obtaining a licence from the Ministry of Health of the participating country. The next two tiers are quality improvement milestones that are achieved through the implementation of specific quality management system requirements. Laboratories that meet the requirements of the three tiers will be encouraged to apply for accreditation. The Caribbean Regional Organisation for Standards and Quality hosts the LQMS-SIP Secretariat and will work with countries, including the Ministry of Health and stakeholders, including laboratory staff, to coordinate and implement LQMS-SIP activities. The Caribbean Public Health Agency will coordinate and advocate for the LQMS-SIP implementation. Conclusion This article presents the Caribbean LQMS-SIP framework and describes how it will be implemented among various countries in the region to achieve quality improvement. PMID:28879149

External quality assessment on detection of hepatitis C virus RNA in clinical laboratories of China.

PubMed

Wang, Lu-nan; Zhang, Rui; Shen, Zi-yu; Chen, Wen-xiang; Li, Jin-ming

2008-06-05

As with many studies carried out in European countries, a quality assurance program has been established by the National Center for Clinical Laboratories in China (NCCL). The results showed that the external quality assessment significantly improves laboratory performance for quantitative evaluation of hepatitis C virus (HCV) RNA. Serum panels were delivered twice annually to the clinical laboratories which performed HCV RNA detection in China. Each panel made up of 5 coded samples. All laboratories were requested to carry out the detection within the required time period and report on testing results which contained qualitative and/or quantitative test findings, reagents used and relevant information about apparatus. All the positive samples were calibrated against the first International Standard for HCV RNA in a collaborative study and the range of comparison target value (TG) designated as +/- 0.5 log. The numbers of laboratories reporting on qualitative testing results for the first and second time external quality assessment were 168 and 167 in the year of 2003 and increased to 209 and 233 in 2007; the numbers of laboratories reporting on quantitative testing results were 134 and 147 in 2003 and rose to 340 and 339 in 2007. Deviation between the mean value for quantitative results at home in 2003 and the target value was above 0.5 log, which was comparatively high. By 2007, the target value was close to the national average except for the low concentrated specimens (10(3) IU/ml). The percentage of results within the range of GM +/- 0.5 log(10) varied from 8.2% to 93.5%. Some laboratories had some difficulties in the exact quantification of the lowest (3.00 log IU/ml) as well as of the highest viral levels (6.37 log IU/ml) values, very near to the limits of the dynamic range of the assays. The comparison of these results with the previous study confirms that a regular participation in external quality assessment (EQA) assures the achievement of a high

Implementation of quality management systems and progress towards accreditation of National Tuberculosis Reference Laboratories in Africa

PubMed Central

de Dieu Iragena, Jean; Kao, Kekeletso; Erni, Donatelle; Mekonen, Teferi

2017-01-01

Background Laboratory services are essential at all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment. Enabling access to quality services is a challenge in low-resource settings. Implementation of a strong quality management system (QMS) and laboratory accreditation are key to improving patient care. Objectives The study objective was to determine the status of QMS implementation and progress towards accreditation of National Tuberculosis Reference Laboratories (NTRLs) in the African Region. Method An online questionnaire was administered to NTRL managers in 47 World Health Organization Regional Office for Africa member states in the region, between February and April 2015, regarding the knowledge of QMS tools and progress toward implementation to inform strategies for tuberculosis diagnostic services strengthening in the region. Results A total of 21 laboratories (43.0%) had received SLMTA/TB-SLMTA training, of which 10 had also used the Global Laboratory Initiative accreditation tool. However, only 36.7% of NTRLs had received a laboratory audit, a first step in quality improvement. Most NTRLs participated in acid-fast bacilli microscopy external quality assurance (95.8%), although external quality assurance for other techniques was lower (60.4% for first-line drug susceptibility testing, 25.0% for second-line drug susceptibility testing, and 22.9% for molecular testing). Barriers to accreditation included lack of training and accreditation programmes. Only 28.6% of NTRLs had developed strategic plans and budgets which included accreditation. Conclusion Good foundations are in place on the continent from which to scale up accreditation efforts. Laboratory audits should be conducted as a first step in developing quality improvement action plans. Political commitment and strong leadership are needed to drive accreditation efforts; advocacy will require clear evidence of patient impact and cost

Gait Analysis Laboratory

NASA Technical Reports Server (NTRS)

1976-01-01

Complete motion analysis laboratory has evolved out of analyzing walking patterns of crippled children at Stanford Children's Hospital. Data is collected by placing tiny electrical sensors over muscle groups of child's legs and inserting step-sensing switches in soles of shoes. Miniature radio transmitters send signals to receiver for continuous recording of abnormal walking pattern. Engineers are working to apply space electronics miniaturization techniques to reduce size and weight of telemetry system further as well as striving to increase signal bandwidth so analysis can be performed faster and more accurately using a mini-computer.

Service Quality and Patient Satisfaction: An Exploratory Study of Pathology Laboratories in Jaipur.

PubMed

Agarwal, Anuradha; Singh, Maithili R P

2016-01-01

One of the most important parts of healthcare system is diagnostics. Nowadays, Indians have become more aware of their health, due to improved and better availability of health related information, increase in medical tourism, and expanding health insurance. The demand for better diagnostic facilities have increased with the increase in lifestyle related diseases, excesses use of chemicals in agriculture practices and change in food habits. It is expected that the Indian diagnostic market will grow from USD $5 billion in the year 2012 to USD $32 billion by the year 2020 with 20% CAGR (India Brand Equity Foundation 2015 ). Today patients have easy access of information regarding the health services and they have become more concerned about it as they look forward to receiving the maximum value for their money. To win the confidence of the patients and to maintain that trust, it is required to deliver the right services to the right person at the right time. The purpose of this study was to develop a scale to measure the service quality at pathology laboratory. A thorough review of literature revealed that there are studies related to healthcare service quality but there is no such established scale to measure service quality of pathology laboratory. Thus, the authors strived to develop a reliable and valid instrument to measure the patients' perception toward pathology laboratory service quality. For this exploratory study was conducted on the sample of 80 patients of the laboratories in Jaipur city. The reliability and factor structures were tested to purify the scale. The findings revealed 13 items, comprising of three dimensions of service quality: responsiveness, tangibility, and reliability.

Water-quality data-collection activities in Colorado and Ohio; Phase II, Evaluation of 1984 field and laboratory quality-assurance practices

USGS Publications Warehouse

Childress, Carolyn J. Oblinger; Chaney, Thomas H.; Myers, Donna; Norris, J. Michael; Hren, Janet

1987-01-01

Serious questions have been raised by Congress about the usefulness of water-quality data for addressing issues of regional and national scope and, especially, for characterizing the current quality of the Nation's streams and ground water. In response, the U.S. Geological Survey has undertaken a pilot study in Colorado and Ohio to (1) determine the characteristics of current (1984) water-quality data-collection activities of Federal, regional, State, and local agencies, and academic institutions; and (2) determine how well the data from these activities, collected for various purposes and using different procedures, can be used to improve our ability to answer major broad-scope questions, such as:A. What are (or were) natural or near-natural water-quality conditions?B. What are existing water-quality conditions?C. How has water quality changed, and how do the changes relate to human activities?Colorado and Ohio were chosen for the pilot study largely because they represent regions with different types of waterquality concerns and programs. The study has been divided into three phases, the objectives of which are: Phase I--Inventory water-quality data-collection programs, including costs, and identify those programs that met a set of broad criteria for producing data that are potentially appropriate for water-quality assessments of regional and national scope. Phase II--Evaluate the quality assurance of field and laboratory procedures used in producing the data from programs that met the broad criteria of Phase I. Phase III--Compile the qualifying data and evaluate the adequacy of this data base for addressing selected water-quality questions of regional and national scope.Water-quality data are collected by a large number of organizations for diverse purposes ranging from meeting statutory requirements to research on water chemistry. Combining these individual data bases is an appealing and potentially cost-effective way to attempt to develop a data base adequate

LABORATORY AND FIELD AUDITS AS PART OF THE EPA (ENVIRONMENTAL PROTECTION AGENCY) HAZARDOUS WASTE ENGINEERING RESEARCH LABORATORY (HWERL) QUALITY ASSURANCE PROGRAM

EPA Science Inventory

Audits are an important and integral part of the EPA Hazardous Waste Engineering Research Laboratory (HWERL) Quality Assurance (QA) Program. As part of the overall QA program, audits are used to determine contractor compliance with quality assurance plans and to assess the overal...

[Quality control assessments of feces examination for schistosomiasis in province-level laboratories of Zhejiang Province].

PubMed

Chen, Wen; Zhu, Ming-Dong; Yan, Xiao-Lan; Lin, Li-Jun; Zhang, Jian-Feng; Li, Li; Wen, Li-Yong

2011-06-01

To understand and evaluate the quality of feces examination for schistosomiasis in province-level laboratories of Zhejiang Province. With the single-blind method, the stool samples were detected by the stool hatching method and sediment detection method. In the 3 quality control assessments in 2006, 2008 and 2009, most laboratories finished the examinations on time. The accordance rates of detections were 88.9%, 100% and 93.9%, respectively. The province-level laboratories for schistosomiasis feces examination of Zhejiang Province is coming into standardization, and the techniques of schistosomiasis feces examination are optimized gradually.

Assessment of three medical and research laboratories using WHO AFRO_SLIPTA Quality Standards in Southwestern Uganda: a long way to go.

PubMed

Taremwa, Ivan Mugisha; Ampaire, Lucas; Iramiot, Jacob; Muhwezi, Obed; Matte, Aloysius; Itabangi, Herbert; Mbabazi, Hope; Atwebembeire, Jeninah; Kamwine, Monicah; Katawera, Victoria; Mbalibulha, Yona; Orikiriza, Patrick; Boum, Yap

2017-01-01

While the laboratory represents more than 70% of clinical diagnosis and patient management, access to reliable and quality laboratory diagnostics in sub-Saharan Africa remains a challenge. To gain knowledge and suggest evidence based interventions towards laboratory improvement in Southwestern Uganda, we assessed the baseline laboratory quality standards in three medical and research laboratories in Southwestern Uganda. We conducted a cross sectional survey from October, 2013 to April, 2014. Selected laboratories, including one private research, one private for profit and one public laboratory, were assessed using the WHO AFRO_SLIPTA checklist and baseline scores were determined. The three laboratories assessed met basic facility requirements, had trained personnel, and safety measures in place. Sample reception was properly designed and executed with a well designated chain of custody. All laboratories had sufficient equipment for the nature of work they were involved in. However, we found that standard operating procedures were incomplete in all three laboratories, lack of quality audit schemes by two laboratories and only one laboratory enrolled into external quality assurance schemes. The SLIPTA scores were one star for the research laboratory and no star for both the public and private-for-profit laboratories. While most of the laboratory systems were in place, the low scores obtained by the assessed laboratories reflect the need for improvement to reach standards of quality assured diagnostics in the region. Therefore, routine mentorship and regional supportive supervision are necessary to increase the quality of laboratory services.

Impact of Nuclear Laboratory Personnel Credentials & Continuing Education on Nuclear Cardiology Laboratory Quality Operations.

PubMed

Malhotra, Saurabh; Sobieraj, Diana M; Mann, April; Parker, Matthew W

2017-12-22

Background/Objectives: The specific credentials and continuing education (CME/CE) of nuclear cardiology laboratory medical and technical staff are important factors in the delivery of quality imaging services that have not been systematically evaluated. Methods: Nuclear cardiology accreditation application data from the Intersocietal Accreditation Commission (IAC) was used to characterize facilities performing myocardial perfusion imaging by setting, size, previous accreditation and credentials of the medical and technical staff. Credentials and CME/CE were compared against initial accreditation decisions (grant or delay) using multivariable logistic regression. Results: Complete data were available for 1913 nuclear cardiology laboratories from 2011-2014. Laboratories with initial positive accreditation decisions had a greater prevalence of Certification Board in Nuclear Cardiology (CBNC) certified medical directors and specialty credentialed technical directors. Certification and credentials of the medical and technical directors, respectively, staff CME/CE compliance, and assistance of a consultant with the application were positively associated with accreditation decisions. Conclusion: Nuclear cardiology laboratories directed by CBNC-certified physicians and NCT- or PET-credentialed technologists were less likely to receive delay decisions for MPI. CME/CE compliance of both the medical and technical directors was associated with accreditation decision. Medical and technical directors' years of experience were not associated with accreditation decision. Copyright © 2017 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

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.

International External Quality Assurance for Laboratory Diagnosis of Diphtheria ▿

PubMed Central

Neal, S. E.; Efstratiou, A.

2009-01-01

The diphtheria surveillance network (DIPNET) encompassing National Diphtheria Reference Centers from 25 European countries is a Dedicated Surveillance Network recognized by the European Commission. A key DIPNET objective is the quality assessment of microbiological procedures for diphtheria across the European Union and beyond. A detailed questionnaire on the level of reference laboratory services and an external quality assessment (EQA) panel comprising six simulated throat specimens were sent to 34 centers. Twenty-three centers are designated National Diphtheria Reference Centers, with the laboratory in the United Kingdom being the only WHO Collaborating Centre. A variety of screening and identification tests were used, including the cysteinase test (20/34 centers), pyrazinamidase test (17/34 centers), and commercial kits (25/34 centers). The classic Elek test for toxigenicity testing is mostly used (28/34 centers), with variations in serum sources and antitoxin concentrations. Many laboratories reported problems obtaining Elek reagents or media. Only six centers produced acceptable results for all six specimens. Overall, 21% of identification and 13% of toxigenicity reports were unacceptable. Many centers could not isolate the target organism, and most found difficulties with the specimens that contained Corynebacterium striatum as a commensal contaminant. Nineteen centers generated either false-positive or negative toxigenic results, which may have caused inappropriate medical management. The discrepancies in this diphtheria diagnostics EQA alarmingly reflect the urgent need to improve laboratory performance in diphtheria diagnostics in Europe, standardize feasible and robust microbiological methods, and build awareness among public health authorities. Therefore, DIPNET recommends that regular workshops and EQA distributions for diphtheria diagnostics should be supported and maintained. PMID:19828749

Quality assurance and quality control for thermal/optical analysis of aerosol samples for organic and elemental carbon.

PubMed

Chow, Judith C; Watson, John G; Robles, Jerome; Wang, Xiaoliang; Chen, L-W Antony; Trimble, Dana L; Kohl, Steven D; Tropp, Richard J; Fung, Kochy K

2011-12-01

Accurate, precise, and valid organic and elemental carbon (OC and EC, respectively) measurements require more effort than the routine analysis of ambient aerosol and source samples. This paper documents the quality assurance (QA) and quality control (QC) procedures that should be implemented to ensure consistency of OC and EC measurements. Prior to field sampling, the appropriate filter substrate must be selected and tested for sampling effectiveness. Unexposed filters are pre-fired to remove contaminants and acceptance tested. After sampling, filters must be stored in the laboratory in clean, labeled containers under refrigeration (<4 °C) to minimize loss of semi-volatile OC. QA activities include participation in laboratory accreditation programs, external system audits, and interlaboratory comparisons. For thermal/optical carbon analyses, periodic QC tests include calibration of the flame ionization detector with different types of carbon standards, thermogram inspection, replicate analyses, quantification of trace oxygen concentrations (<100 ppmv) in the helium atmosphere, and calibration of the sample temperature sensor. These established QA/QC procedures are applicable to aerosol sampling and analysis for carbon and other chemical components.

Analysis of ground water by different laboratories: a comparison of chloride and nitrate data, Nassau and Suffolk counties, New York

USGS Publications Warehouse

Katz, Brian G.; Krulikas, Richard K.

1979-01-01

Water samples from wells in Nassau and Suffolk Counties were analyzed for chloride and nitrate. Two samples were collected at each well; one was analyzed by the U.S. Geological Survey, the other by a laboratory in the county from which the sample was taken. Results were compared statistically by paired-sample t-test to indicate the degree of uniformity among laboratory results. Chloride analyses from one of the three county laboratories differed significantly (0.95 confidence level) from that of a Geological Survey laboratory. For nitrate analyses, a significant difference (0.95 confidence level) was noted between results from two of the three county laboratories and the Geological Survey laboratory. The lack of uniformity among results reported by the participating laboratories indicates a need for continuing participation in a quality-assurance program and exercise of strong quality control from time of sample collection through analysis so that differences can be evaluated. (Kosco-USGS)

Assessing the outcome of Strengthening Laboratory Management Towards Accreditation (SLMTA) on laboratory quality management system in city government of Addis Ababa, Ethiopia

PubMed Central

Sisay, Abay; Mindaye, Tedla; Tesfaye, Abrham; Abera, Eyob; Desale, Adino

2015-01-01

Introduction Strengthening Laboratory Management Toward Accreditation (SLMTA) is a competency-based management training programme designed to bring about immediate and measurable laboratory improvement. The aim of this study is to assess the outcome of SLMTA on laboratory quality management system in Addis Ababa, Ethiopia. Methods The study used an Institutional based cross sectional study design that employed a secondary and primary data collection approach on the participated institution of medical laboratory in SLMTA. The study was conducted in Addis Ababa city government and the data was collected from February ‘April 2014 and data was entered in to EPI-data version 3.1 and was analyzed by SPSS version 20. Results The assessment finding indicate that there was a significant improvement in average scores (141.4; range of 65-196, 95%CI =86.275-115.5, p = 0.000) at final with 3 laboratories become 3 star, 6 laboratories were at 2 star, 11 were 1 star. Laboratory facilities respondents which thought getting adequate and timely manner mentorship were found 2.5 times more likely to get good success in the final score(AOR= 2.501, 95% CI= 1.109-4.602) than which did not get it. Conclusion At the end of SLMTA implementation,3 laboratories score 3 star, 6 laboratories were at 2 star, 11 were at 1 star. The most important contributing factor for not scoring star in the final outcome of SLMTA were not conducting their customer satisfaction survey, poor staff motivation, and lack of regular equipment service maintenance. Mentorship, onsite and offsite coaching and training activities had shown a great improvement on laboratory quality management system in most laboratories. PMID:26175805

Assessing the outcome of Strengthening Laboratory Management Towards Accreditation (SLMTA) on laboratory quality management system in city government of Addis Ababa, Ethiopia.

PubMed

Sisay, Abay; Mindaye, Tedla; Tesfaye, Abrham; Abera, Eyob; Desale, Adino

2015-01-01

Strengthening Laboratory Management Toward Accreditation (SLMTA) is a competency-based management training programme designed to bring about immediate and measurable laboratory improvement. The aim of this study is to assess the outcome of SLMTA on laboratory quality management system in Addis Ababa, Ethiopia. The study used an Institutional based cross sectional study design that employed a secondary and primary data collection approach on the participated institution of medical laboratory in SLMTA. The study was conducted in Addis Ababa city government and the data was collected from February 'April 2014 and data was entered in to EPI-data version 3.1 and was analyzed by SPSS version 20. The assessment finding indicate that there was a significant improvement in average scores (141.4; range of 65-196, 95%CI=86.275-115.5, p=0.000) at final with 3 laboratories become 3 star, 6 laboratories were at 2 star, 11 were 1 star. Laboratory facilities respondents which thought getting adequate and timely manner mentorship were found 2.5 times more likely to get good success in the final score(AOR=2.501, 95% CI=1.109-4.602) than which did not get it. At the end of SLMTA implementation,3 laboratories score 3 star, 6 laboratories were at 2 star, 11 were at 1 star. The most important contributing factor for not scoring star in the final outcome of SLMTA were not conducting their customer satisfaction survey, poor staff motivation, and lack of regular equipment service maintenance. Mentorship, onsite and offsite coaching and training activities had shown a great improvement on laboratory quality management system in most laboratories.

External Quality Assessment Scheme for reference laboratories - review of 8 years' experience.

PubMed

Kessler, Anja; Siekmann, Lothar; Weykamp, Cas; Geilenkeuser, Wolf Jochen; Dreazen, Orna; Middle, Jonathan; Schumann, Gerhard

2013-05-01

We describe an External Quality Assessment Scheme (EQAS) intended for reference (calibration) laboratories in laboratory medicine and supervised by the Scientific Division of the International Federation of Clinical Chemistry and Laboratory Medicine and the responsible Committee on Traceability in Laboratory Medicine. The official EQAS website, RELA (www.dgkl-rfb.de:81), is open to interested parties. Information on all requirements for participation and results of surveys are published annually. As an additional feature, the identity of every participant in relation to the respective results is disclosed. The results of various groups of measurands (metabolites and substrates, enzymes, electrolytes, glycated hemoglobins, proteins, hormones, thyroid hormones, therapeutic drugs) are discussed in detail. The RELA system supports reference measurement laboratories preparing for accreditation according to ISO 17025 and ISO 15195. Participation in a scheme such as RELA is one of the requirements for listing of the services of a calibration laboratory by the Joint Committee on Traceability in Laboratory Medicine.

Molecular genetics external quality assessment pilot scheme for KRAS analysis in metastatic colorectal cancer.

PubMed

Deans, Zandra C; Tull, Justyna; Beighton, Gemma; Abbs, Stephen; Robinson, David O; Butler, Rachel

2011-11-01

Laboratories are increasingly required to perform molecular tests for the detection of mutations in the KRAS gene in metastatic colorectal cancers to allow better clinical management and more effective treatment for these patients. KRAS mutation status predicts a patient's likely response to the monoclonal antibody cetuximab. To provide a high standard of service, these laboratories require external quality assessment (EQA) to monitor the level of laboratory output and measure the performance of the laboratory against other service providers. National External Quality Assurance Services for Molecular Genetics provided a pilot EQA scheme for KRAS molecular analysis in metastatic colorectal cancers during 2009. Very few genotyping errors were reported by participating laboratories; however, the reporting nomenclature of the genotyping results varied considerably between laboratories. The pilot EQA scheme highlighted the need for continuing EQA in this field which will assess the laboratories' ability not only to obtain accurate, reliable results but also to interpret them safely and correctly ensuring that the referring clinician has the correct information to make the best clinical therapeutic decision for their patient.

[Inter-and intra-operator variability in the analysis of semen parameters: results from a quality control program].

PubMed

Daoud, Salima; Chakroun-Feki, Nozha; Sellami, Afifa; Ammar-Keskes, Leila; Rebai, Tarek

2016-01-01

Semen analysis is a key part of male infertility investigation. The necessity of quality management implementation in the andrology laboratory has been recognized in order to ensure the reliability of its results. The aim of this study was to evaluate intra- and inter-individual variability in the assessment of semen parameters in our laboratory through a quality control programme. Four participants from the laboratory with different experience levels have participated in this study. Semen samples of varying quality were assessed for sperm motility, concentration and morphology and the results were used to evaluate inter-participant variability. In addition, replicates of each semen sample were analyzed to determine intra-individual variability for semen parameters analysis. The average values of inter-participant coefficients of variation for sperm motility, concentration and morphology were 12.8%, 19.8% and 48.9% respectively. The mean intra-participant coefficients of variation were, respectively, 6.9%, 12.3% and 42.7% for sperm motility, concentration and morphology. Despite some random errors of under- or overestimation, the overall results remained within the limits of acceptability for all participants. Sperm morphology assessment was particularly influenced by the participant's level of experience. The present data emphasize the need for appropriate training of the laboratory staff and for regular participation in internal quality control programmes in order to improve the reliability of laboratory results.

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.

The quality of sputum smear microscopy in public-private mix directly observed treatment laboratories in West Amhara region, Ethiopia.

PubMed

Manalebh, Almaw; Demissie, Meaza; Mekonnen, Daniel; Abera, Bayeh

2015-01-01

Ethiopia adopted Public-Private Mix Directly Observed Treatment Short Course Chemotherapy (PPM-DOTS) strategy for tuberculosis (TB) control program. Quality of sputum smear microscopy has paramount importance for tuberculosis control program in resource-poor countries like Ethiopia. A cross-sectional study was conducted to assess the quality of sputum smear microscopy in 37 Public-Private Mix laboratories in West Amhara, Ethiopia. The three external quality assessment methods (onsite evaluation, panel testing and blind rechecking) were employed. Onsite assessment revealed that 67.6% of PPM-DOTS laboratories were below the standard physical space (5 X 6) m2. The average monthly workload per laboratory technician was 19.5 (SD±2.9) slides with 12.8% positivity rate. The quality of Acid Fast Bacilli (AFB) staining reagents was sub-standard. The overall agreement for blind rechecking of 1,123 AFB slides was 99.4% (Kappa = 0.97). Reading of 370 AFB panel slides showed 3.5% false reading (Kappa = 0.92). Moreover, the consistency of reading scanty bacilli slides was lower (93%) compared to 1+, 2+ and 3+ bacilli. Based on blind rechecking and panel testing results, PPM-DOTS site laboratories showed good agreement with the reference laboratory. Physical space and qualities of AFB reagents would be areas of intervention to sustain the quality of sputum smear microscopy. Therefore, regular external quality assessment and provision of basic laboratory supplies for TB diagnosis would be the way forward to improve the quality of sputum smear microscopy services in PPM-DOTS laboratories.

The Quality of Sputum Smear Microscopy in Public-Private Mix Directly Observed Treatment Laboratories in West Amhara Region, Ethiopia

PubMed Central

Manalebh, Almaw; Demissie, Meaza; Mekonnen, Daniel; Abera, Bayeh

2015-01-01

Ethiopia adopted Public-Private Mix Directly Observed Treatment Short Course Chemotherapy (PPM-DOTS) strategy for tuberculosis (TB) control program. Quality of sputum smear microscopy has paramount importance for tuberculosis control program in resource-poor countries like Ethiopia. A cross-sectional study was conducted to assess the quality of sputum smear microscopy in 37 Public-Private Mix laboratories in West Amhara, Ethiopia. The three external quality assessment methods (onsite evaluation, panel testing and blind rechecking) were employed. Onsite assessment revealed that 67.6% of PPM-DOTS laboratories were below the standard physical space (5 X 6) m2. The average monthly workload per laboratory technician was 19.5 (SD±2.9) slides with 12.8% positivity rate. The quality of Acid Fast Bacilli (AFB) staining reagents was sub-standard. The overall agreement for blind rechecking of 1,123 AFB slides was 99.4% (Kappa = 0.97). Reading of 370 AFB panel slides showed 3.5% false reading (Kappa = 0.92). Moreover, the consistency of reading scanty bacilli slides was lower (93%) compared to 1+, 2+ and 3+ bacilli. Based on blind rechecking and panel testing results, PPM-DOTS site laboratories showed good agreement with the reference laboratory. Physical space and qualities of AFB reagents would be areas of intervention to sustain the quality of sputum smear microscopy. Therefore, regular external quality assessment and provision of basic laboratory supplies for TB diagnosis would be the way forward to improve the quality of sputum smear microscopy services in PPM-DOTS laboratories. PMID:25849516

[Quality assessment of microscopic examination in tuberculosis diagnostic laboratories: a preliminary study].

PubMed

Simşek, Hülya; Ceyhan, Ismail; Tarhan, Gülnur; Güner, Uğur

2010-10-01

Recently, the diagnosis of pulmonary tuberculosis (TB) has based on smear microscopy in the Direct Observed Treatment Strategy (DOTS) programme which provides the basis of treatment worldwide. Microscopic detection of AFB (Acid-Fast Bacilli) is one of the main components in the National TB Control Programmes (NTCP). Precision level in microscopy procedures and evaluations are the most important steps for accurate diagnosis of the disease and to initiate proper treatment. Therefore, the external quality assessment (EQA) is the most important implement to provide the reliability and validity of tests. In countries where NTCP are performed, this task is fulfilled by the National Reference Laboratories (NRL) according to the guidelines of the World Health Organization (WHO). For this purpose a pilot study was initiated by the central NRL of Turkey for EQA of AFB smear microscopy as part of the NTCP on January 1, 2005. A total of 5 laboratories of which 2 were district TB laboratories (A, B), 2 were tuberculosis control dispensaries (C, D), 1 was a national reference laboratory (E), participated in this study. Blind re-checking method (re-examination of randomly selected slides) was used for the evaluation, and the slides were sent to the central NRL with 3 months interval, four times a year, selected according to LQAS (Lot Quality Assurance Sampling) guides. In the re-evaluation of the slides, false positivity (FP), false negativity (FN) and quantification errors (QE) were noted. Laboratory A, sent totally 525 slides between January 1, 2005 and April 1, 2008. In the result of re-checking, 514 (97.9%) slides were found concordant, and 11 (2.1%) were discordant (10 FP, 1 FN). Laboratory B, participated in the study between October 1, 2005 and July 1, 2006 and of the 67 re-examined slides, 60 (89.5%) were concordant and 7 (10.5%) were discordant (2 FP, 0 FN, 5 QE). Laboratory C, sent 235 slides between January 1, 2005 and April 1, 2006; of them 218 (92.8%) were detected

Importance/performance analysis: a tool for service quality control by clinical laboratories.

PubMed

Scammon, D L; Weiss, R

1991-01-01

A study of customer satisfaction with clinical laboratory service is used as the basis for identifying potential improvements in service and more effectively targeting marketing activities to enhance customer satisfaction. Data on customer satisfaction are used to determine the aspects of service most critical to customers, how well the organization is doing in delivery of service, and how consistent service delivery is. Importance-performance analysis is used to highlight areas for future resource reallocation and strategic emphasis. Suggestions include the establishment of performance guidelines for customer contact personnel, the enhancement of timely delivery of reports via electronic transmission (computer and fax), and the development of standardized graphics for request and report forms to facilitate identification of appropriate request forms and guide clients to key items of information on reports.

Comparative Study in Laboratory Rats to Validate Sperm Quality Methods and Endpoints

NASA Technical Reports Server (NTRS)

Price, W. A.; Briggs, G. B.; Alexander, W. K.; Still, K. R.; Grasman, K. A.

2000-01-01

Abstract The Naval Health Research Center, Detachment (Toxicology) performs toxicity studies in laboratory animals to characterize the risk of exposure to chemicals of Navy interest. Research was conducted at the Toxicology Detachment at WPAFB, OH in collaboration with Wright State University, Department of Biological Sciences for the validation of new bioassay methods for evaluating reproductive toxicity. The Hamilton Thorne sperm analyzer was used to evaluate sperm damage produced by exposure to a known testicular toxic agent, methoxyacetic acid and by inhalation exposure to JP-8 and JP-5 in laboratory rats. Sperm quality parameters were evaluated (sperm concentration, motility, and morphology) to provide evidence of sperm damage. The Hamilton Thorne sperm analyzer utilizes a DNA specific fluorescent stain (similar to flow cytometry) and digitized optical computer analysis to detect sperm cell damage. The computer assisted sperm analysis (CASA) is a more rapid, robust, predictive and sensitive method for characterizing reproductive toxicity. The results presented in this poster report validation information showing exposure to methoxyacetic acid causes reproductive toxicity and inhalation exposure to JP-8 and JP-5 had no significant effects. The CASA method detects early changes that result in reproductive deficits and these data will be used in a continuing program to characterize the toxicity of chemicals, and combinations of chemicals, of military interest to formulate permissible exposure limits.

Instrument Synthesis and Analysis Laboratory

NASA Technical Reports Server (NTRS)

Wood, H. John

2004-01-01

The topics addressed in this viewgraph presentation include information on 1) Historic instruments at Goddard; 2) Integrated Design Capability at Goddard; 3) The Instrument Synthesis and Analysis Laboratory (ISAL).

Use of Web-based training for quality improvement between a field immunohistochemistry laboratory in Nigeria and its United States-based partner institution.

PubMed

Oluwasola, Abideen O; Malaka, David; Khramtsov, Andrey Ilyich; Ikpatt, Offiong Francis; Odetunde, Abayomi; Adeyanju, Oyinlolu Olorunsogo; Sveen, Walmy Elisabeth; Falusi, Adeyinka Gloria; Huo, Dezheng; Olopade, Olufunmilayo Ibironke

2013-12-01

The importance of hormone receptor status in assigning treatment and the potential use of human epidermal growth factor receptor 2 (HER2)-targeted therapy have made it beneficial for laboratories to improve detection techniques. Because interlaboratory variability in immunohistochemistry (IHC) tests may also affect studies of breast cancer subtypes in different countries, we undertook a Web-based quality improvement training and a comparative study of accuracy of immunohistochemical tests of breast cancer biomarkers between a well-established laboratory in the United States (University of Chicago) and a field laboratory in Ibadan, Nigeria. Two hundred and thirty-two breast tumor blocks were evaluated for estrogen receptors (ERs), progesterone receptors (PRs), and HER2 status at both laboratories using tissue microarray technique. Initially, concordance analysis revealed κ scores of 0.42 (moderate agreement) for ER, 0.41 (moderate agreement) for PR, and 0.39 (fair agreement) for HER2 between the 2 laboratories. Antigen retrieval techniques and scoring methods were identified as important reasons for discrepancy. Web-based conferences using Web conferencing tools such as Skype and WebEx were then held periodically to discuss IHC staining protocols and standard scoring systems and to resolve discrepant cases. After quality assurance and training, the agreement improved to 0.64 (substantial agreement) for ER, 0.60 (moderate agreement) for PR, and 0.75 (substantial agreement) for HER2. We found Web-based conferences and digital microscopy useful and cost-effective tools for quality assurance of IHC, consultation, and collaboration between distant laboratories. Quality improvement exercises in testing of tumor biomarkers will reduce misclassification in epidemiologic studies of breast cancer subtypes and provide much needed capacity building in resource-poor countries. © 2013.

[Implementation of the technical requirements of the UNE-EN-ISO 15189 quality standard in a mycobacterial laboratory].

PubMed

Guna Serrano, M del Remedio; Ocete Mochón, M Dolores; Lahiguera, M José; Bresó, M Carmen; Gimeno Cardona, Concepción

2013-02-01

The UNE-EN-ISO 15189:2007 standard defines the requirements for quality and competence that must be met by medical laboratories. These laboratories should use this international standard to develop their own quality management systems and to evaluate their own competencies; in turn, this standard will be used by accreditation bodies to confirm or recognize the laboratories' competence. In clinical microbiology laboratories, application of the standard implies the implementation of the technical and specific management requirements that must be met to achieve optimal quality when carrying out microbiological tests. In Spain, accreditation is granted by the Spanish Accreditation Body (Entidad Nacional de Acreditación). This review aims to discuss the practical application of the standard's technical requirements in mycobacterial laboratory. Firstly, we define the scope of accreditation. Secondly, we specify how the items of the standard on personnel management, control of equipment, environmental facilities, method validation, internal controls and customer satisfaction surveys were developed and implemented in our laboratory. Copyright © 2013 Elsevier España, S.L. All rights reserved.

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

The WHO AFRO external quality assessment programme (EQAP): Linking laboratory networks through EQA programmes.

PubMed

Boeras, Debrah I; Peeling, Rosanna W; Onyebujoh, Philip; Yahaya, Ali A; Gumede-Moeletsi, Hieronyma N; Ndihokubwayo, Jean B

2016-01-01

External Quality Assessment (EQA) surveys performed by the World Health Organization Regional Office for Africa (WHO AFRO) revealed the need for the strengthening of public health microbiology laboratories, particularly for testing of epidemic-prone diseases in the African Region. These surveys revealed common issues such as supply chain management, skilled personnel, logistical support and overall lack of quality standards. For sustainable improvements to health systems as well as global health security, deficiencies identified need to be actively corrected through robust quality assurance programmes and implementation of laboratory quality management systems. Given all the pathogens of public health importance, an external quality assessment programme with a focus on vaccine-preventable diseases and emerging and re-emerging dangerous pathogens is important, and should not be stand-alone, but integrated within laboratory networks as seen in polio, measles, yellow fever and rubella. In 2015, WHO AFRO collaborated with the US Centers for Disease Control and Prevention, the London School of Hygiene & Tropical Medicine and partners in a series of consultations with countries and national and regional EQA providers for the development of quality assurance models to support HIV point-of-care testing and monitoring. These consultations revealed similar challenges as seen in the WHO AFRO surveys. WHO AFRO brought forth its experience in implementing quality standards for health programmes, and also opened discussions on how lessons learned through such established programmes can be utilised to supporting and strengthening the introduction of early infant diagnosis of HIV and viral load point-of-care testing. An optimised external quality assessment programme will impact the ability of countries to meet core capacities, providing improved quality management systems, improving the confidence of diagnostic network services in Africa, and including capacities to detect events

The WHO AFRO external quality assessment programme (EQAP): Linking laboratory networks through EQA programmes

PubMed Central

Yahaya, Ali A.; Gumede-Moeletsi, Hieronyma N.

2016-01-01

External Quality Assessment (EQA) surveys performed by the World Health Organization Regional Office for Africa (WHO AFRO) revealed the need for the strengthening of public health microbiology laboratories, particularly for testing of epidemic-prone diseases in the African Region. These surveys revealed common issues such as supply chain management, skilled personnel, logistical support and overall lack of quality standards. For sustainable improvements to health systems as well as global health security, deficiencies identified need to be actively corrected through robust quality assurance programmes and implementation of laboratory quality management systems. Given all the pathogens of public health importance, an external quality assessment programme with a focus on vaccine-preventable diseases and emerging and re-emerging dangerous pathogens is important, and should not be stand-alone, but integrated within laboratory networks as seen in polio, measles, yellow fever and rubella. In 2015, WHO AFRO collaborated with the US Centers for Disease Control and Prevention, the London School of Hygiene & Tropical Medicine and partners in a series of consultations with countries and national and regional EQA providers for the development of quality assurance models to support HIV point-of-care testing and monitoring. These consultations revealed similar challenges as seen in the WHO AFRO surveys. WHO AFRO brought forth its experience in implementing quality standards for health programmes, and also opened discussions on how lessons learned through such established programmes can be utilised to supporting and strengthening the introduction of early infant diagnosis of HIV and viral load point-of-care testing. An optimised external quality assessment programme will impact the ability of countries to meet core capacities, providing improved quality management systems, improving the confidence of diagnostic network services in Africa, and including capacities to detect events

National Survey on Internal Quality Control Practice for Lipid Parameters in Laboratories of China from 2014 to 2016.

PubMed

Ye, Yuanyuan; Wang, Wei; Zhao, Haijian; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

2017-09-01

To investigate the situation of Internal Quality Control (IQC) practice for total cholesterol, triglycerides, HDL-cholesterol and LDL-cholesterol from 2014 to 2016 in laboratories in China and provide improvement measurements. A web-based External Quality Assessment (EQA) system was used to collect IQC data of lipid parameters in laboratories which continuously participated in the national EQA programs in China from 2014 to 2016. Pass rate of the coefficients of variation (CVs) of two level quality controls in four lipid parameters were calculated according to six quality specifications for precision to evaluate the current status of precision level of the four lipid parameters and their change over time in China. 533, 512, 504, and 466 laboratories continuously reported the data of level one for total cholesterol, triglyceride, HDL-cholesterol and LDL-cholesterol, and 212, 210, 208 and 198 laboratories reported the level two, respectively. The percentage of laboratories meeting the quality specification varied based on different criteria. Non-significant change can be found in the pass rate of CVs over time. The number of laboratories using a closed system increased over time, but still only accounted for a small proportion. There is no significant difference in the pass rate of CVs between closed and open systems. Triglycerides currently have a fairly good performance in China. While the performance of laboratories on total cholesterol, HDL-cholesterol and LDL-cholesterol has yet to be improved.

External quality assessment of national public health laboratories in Africa, 2002–2009

PubMed Central

Perovic, Olga; Fensham, Vivian; McCarthy, Kerrigan; von Gottberg, Anne; de Gouveia, Linda; Poonsamy, Bhavani; Dini, Leigh; Rossouw, Jenny; Keddy, Karen; Alemu, Wondimagegnehu; Yahaya, Ali; Pierson, Antoine; Dolmazon, Virginie; Cognat, Sébastien; Ndihokubwayo, Jean Bosco

2012-01-01

Abstract Objective To describe findings from an external quality assessment programme involving laboratories in Africa that routinely investigate epidemic-prone diseases. Methods Beginning in 2002, the Regional Office for Africa of the World Health Organization (WHO) invited national public health laboratories and related facilities in Africa to participate in the programme. Three surveys comprising specimens and questionnaires associated with bacterial enteric diseases, bacterial meningitis, plague, tuberculosis and malaria were sent annually to test participants’ diagnostic proficiency. Identical surveys were sent to referee laboratories for quality control. Materials were prepared, packaged and shipped in accordance with standard protocols. Findings and reports were due within 30 days. Key methodological decisions and test results were categorized as acceptable or unacceptable on the basis of consensus feedback from referees, using established grading schemes. Findings Between 2002 and 2009, participation increased from 30 to 48 Member States of the WHO and from 39 to 78 laboratories. Each survey was returned by 64–93% of participants. Mean turnaround time was 25.9 days. For bacterial enteric diseases and meningitis components, bacterial identification was acceptable in 65% and 69% of challenges, respectively, but serotyping and antibiotic susceptibility testing and reporting were frequently unacceptable. Microscopy was acceptable for 73% of plague challenges. Tuberculosis microscopy was satisfactorily performed, with 87% of responses receiving acceptable scores. In the malaria component, 82% of responses received acceptable scores for species identification but only 51% of parasite quantitation scores were acceptable. Conclusion The external quality assessment programme consistently identified certain functional deficiencies requiring strengthening that were present in African public health microbiology laboratories. PMID:22461714

Impact of external haematology proficiency testing programme on quality of laboratories.

PubMed

Saxena, Renu; Katoch, S C; Srinivas, Upendra; Rao, Seema; Anand, Hema

2007-11-01

A reliable and reproducible report from a laboratory needs internal quality control within the laboratory and participation in external proficiency testing programmes (EPTP). This study conducted at the Department of Haematology, All India Institute of Medical Sciences (AIIMS), New Delhi, which has been conducting an EPTP since 1992, was undertaken to assess the efficacy of this programme in improving the performance of participating laboratories in reporting test samples sent for Hb, total leucocyte count (TLC), reticulocyte count and assessment of peripheral blood smear (PBS). The samples were prepared in our laboratory according to the International Standards Organization (ISO) guidelines. The performance of individual laboratories was assessed using robust Z score, which is an indicator of acceptability of the test result. An improvement in the overall percentage of laboratories with acceptable reports was seen during the study period. It has increased from 38,40,40 per cent in 1992 to 85, 90,94.7 per cent in 2006 for Hb, TLC, reticulocyte count, respectively. However, the results for peripheral smear assessment improved only marginally. The external haematology proficiency testing programme run by our department for Hb, TLC, reticulocyte count, and peripheral blood smear assessment, has helped in improving the reporting standards of these parameters in Indian laboratories.

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.

A survey of coagulation laboratory practices and satisfaction ratings of member laboratories of the Thailand National External Quality Assessment Scheme for blood coagulation.

PubMed

Chuntarut, A; Tientadakul, P; Wongkrajang, P

2016-06-01

The Thailand National External Quality Assessment Scheme (NEQAS) for blood coagulation was established in 2005. The objective of this study was to collect data of coagulation laboratory practices and satisfaction of NEQAS member. Two hundred seventy-six questionnaires were sent to laboratories that are members of NEQAS to obtain data relating to coagulation laboratory practice and satisfaction in 2014. Data from this survey were compared with data from the survey conducted in 2005 to evaluate levels of improvement. Of 276 questionnaires sent, 212 (76.8%) were returned. Improvements were characterized by the number of laboratories that (i) decreased use of 3.8% sodium citrate as anticoagulant; (ii) implemented use of at least two control levels for internal quality control; and (iii) implemented reporting of reference values with results, as well as establishing their own reference range and using geometric mean as the denominator for international normalized ratio calculation. For overall satisfaction, 179 of 206 (86.9%) participant laboratories reported being satisfied or very satisfied. Improvements in coagulation laboratory practices in Thailand were observed in every step of the total testing process. However, additional improvements are still needed, such as determination and use of a local reference range. © 2016 John Wiley & Sons Ltd.

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

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.

Reproducibility of cervical cytopathology following an intervention by an external quality control laboratory.

PubMed

Ázara, Cinara Zago Silveira; Manrique, Edna Joana Claudio; Tavares, Suelene Brito do Nascimento; Alves de Souza, Nadja Lindany; Magalhães, Juliana Cristina; Amaral, Rita Goreti

2016-04-01

This study assessed the effects of a continued education program on the agreement between cervical cytopathology exams interpreted by local laboratories and interpretation made by an external quality control laboratory (LabMEQ). Overall, 9,798 exams were analyzed between 2007 and 2008, prior to implementation of a continued education program, and 10,028 between 2010 and 2011, following implementation. Continued education consisted of theoretical and practical classes held every two months. The chi-square test and the kappa coefficient were used in the statistical analysis. Following implementation of continued education, the rate of false-negative results, and those leading to delays in clinical management fell in eight laboratories and the rate of false-positive results in five. Agreement between the results reported by the laboratories and the findings of LabMEQ, evaluated according to clinical management, remained excellent in three laboratories (kappa >0.80 and <1.0), went from good (kappa >0.60 and <0.80) to excellent in seven and from excellent to good in two. Agreement regarding the identification of metaplastic epithelium was poor (kappa = 0.25) but progressed to excellent following the implementation of continued education (kappa = 0.950). Agreement between cytopathology results improved significantly following implementation of continued education in cases reported as unsatisfactory (P < 0.001), atypical squamous cells of undetermined significance, cannot exclude high-grade squamous intraepithelial lesion (P < 0.001), low-grade squamous intraepithelial lesion (P < 0.001), and glandular atypia (P < 0.001). Continued education contributed towards improving the reproducibility of cervical cytopathology, decreased the rates of false-negative and false-positive results, and reduced delays in clinical management. © 2016 Wiley Periodicals, Inc.

Launching a Laboratory Testing Process Quality Improvement Toolkit: From the Shared Networks of Colorado Ambulatory Practices and Partners (SNOCAP).

PubMed

Fernald, Douglas; Hamer, Mika; James, Kathy; Tutt, Brandon; West, David

2015-01-01

Family medicine and internal medicine physicians order diagnostic laboratory tests for nearly one-third of patient encounters in an average week, yet among medical errors in primary care, an estimated 15% to 54% are attributed to laboratory testing processes. From a practice improvement perspective, we (1) describe the need for laboratory testing process quality improvements from the perspective of primary care practices, and (2) describe the approaches and resources needed to implement laboratory testing process quality improvements in practice. We applied practice observations, process mapping, and interviews with primary care practices in the Shared Networks of Colorado Ambulatory Practices and Partners (SNOCAP)-affiliated practice-based research networks that field-tested in 2013 a laboratory testing process improvement toolkit. From the data collected in each of the 22 participating practices, common testing quality issues included, but were not limited to, 3 main testing process steps: laboratory test preparation, test tracking, and patient notification. Three overarching qualitative themes emerged: practices readily acknowledge multiple laboratory testing process problems; practices know that they need help addressing the issues; and practices face challenges with finding patient-centered solutions compatible with practice priorities and available resources. While practices were able to get started with guidance and a toolkit to improve laboratory testing processes, most did not seem able to achieve their quality improvement aims unassisted. Providing specific guidance tools with practice facilitation or other rapid-cycle quality improvement support may be an effective approach to improve common laboratory testing issues in primary care. © Copyright 2015 by the American Board of Family Medicine.

Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice.

PubMed

McCarty, Lynn S; Borgert, Christopher J; Mihaich, Ellen M

2012-07-01

There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.

Evaluation of the implementation of a quality system in a basic research laboratory: viability and impacts.

PubMed

Fraga, Hilda Carolina de Jesus Rios; Fukutani, Kiyoshi Ferreira; Celes, Fabiana Santana; Barral, Aldina Maria Prado; Oliveira, Camila Indiani de

2012-01-01

To evaluate the process of implementing a quality management system in a basic research laboratory of a public institution, particularly considering the feasibility and impacts of this improvement. This was a prospective and qualitative study. We employed the norm "NIT DICLA 035--Princípios das Boas Práticas de Laboratório (BPL)" and auxiliary documents of Organisation for Economic Co-operation and Development to complement the planning and implementation of a Quality System, in a basic research laboratory. In parallel, we used the PDCA tool to define the goals of each phase of the implementation process. This study enabled the laboratory to comply with the NIT DICLA 035 norm and to implement this norm during execution of a research study. Accordingly, documents were prepared and routines were established such as the registration of non-conformities, traceability of research data and equipment calibration. The implementation of a quality system, the setting of a laboratory focused on basic research is feasible once certain structural changes are made. Importantly, impacts were noticed during the process, which could be related to several improvements in the laboratory routine.

Quality-assurance plan and field methods for quality-of-water activities, U.S. Geological Survey, Idaho National Engineering Laboratory, Idaho

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

Mann, L.J.

1996-10-01

Water-quality activities at the Idaho National Engineering Laboratory (INEL) Project Office are part of the US Geological Survey`s (USGS) Water Resources Division (WRD) mission of appraising the quantity and quality of the Nation`s water resources. The purpose of the Quality Assurance Plan (QAP) for water-quality activities performed by the INEL Project Office is to maintain and improve the quality of technical products, and to provide a formal standardization, documentation, and review of the activities that lead to these products. The principles of this plan are as follows: (1) water-quality programs will be planned in a competent manner and activities willmore » be monitored for compliance with stated objectives and approaches; (2) field, laboratory, and office activities will be performed in a conscientious and professional manner in accordance with specified WRD practices and procedures by qualified and experienced employees who are well trained and supervised, if or when, WRD practices and procedures are inadequate, data will be collected in a manner that its quality will be documented; (3) all water-quality activities will be reviewed for completeness, reliability, credibility, and conformance to specified standards and guidelines; (4) a record of actions will be kept to document the activity and the assigned responsibility; (5) remedial action will be taken to correct activities that are deficient.« less

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.

Laboratory quality improvement in Tanzania.

PubMed

Andiric, Linda R; Massambu, Charles G

2015-04-01

The article describes the implementation and improvement in the first groups of medical laboratories in Tanzania selected to participate in the training program on Strengthening Laboratory Management Toward Accreditation (SLMTA). As in many other African nations, the selected improvement plan consisted of formalized hands-on training (SLMTA) that teaches the tasks and skills of laboratory management and provides the tools for implementation of best laboratory practice. Implementation of the improvements learned during training was verified before and after SLMTA with the World Health Organization African Region Stepwise Laboratory Improvement Process Towards Accreditation checklist. During a 4-year period, the selected laboratories described in this article demonstrated improvement with a range of 2% to 203% (cohort I) and 12% to 243% (cohort II) over baseline scores. The article describes the progress made in Tanzania's first cohorts, the obstacles encountered, and the lessons learned during the pilot and subsequent implementations. Copyright© by the American Society for Clinical Pathology.

Creating a sustainable culture of quality through the SLMTA programme in a district hospital laboratory in Kenya.

PubMed

Maruti, Phidelis M; Mulianga, Ekesa A; Wambani, Lorna N; Wafula, Melda N; Mambo, Fidelis A; Mutisya, Shadrack M; Wakaria, Eric N; Mbati, Erick M; Amayo, Angela A; Majani, Jonathan M; Nyary, Bryan; Songwe, Kilian A

2014-01-01

Bungoma District Hospital Laboratory (BDHL), which supports a 200-bed referral facility, began its Strengthening Laboratory Management Toward Accreditation (SLMTA) journey in 2011 together with eight other laboratories in the second round of SLMTA rollout in Kenya. To describe how the SLMTA programme and enhanced quality interventions changed the culture and management style at BDHL and instilled a quality system designed to sustain progress for years to come. SLMTA implementation followed the standard three-workshop series, mentorship site visits and audits. In order to build sustainability of progress, BDHL integrated quality improvement processes into its daily operations. The lab undertook a process of changing its internal culture to align all hospital stakeholders - including upper management, clinicians, laboratory staff and maintenance staff - to the mission of sustainable quality practices at BDHL. After 16 months in the SLMTA programme, BDHL improved from zero stars (38%) to four stars (89%). Over a period of two to three years, external quality assessment results improved from 47% to 87%; staff punctuality increased from 49% to 82%; clinician complaints decreased from 83% to 16; rejection rates decreased from 12% to 3%; and annual equipment repairs decreased from 40 to 15. Twelve months later the laboratory scored three stars (81%) in an external surveillance audit conducted by Kenya Accreditation Service (KENAS). Management buy-in, staff participation, use of progress-monitoring tools and feedback systems, as well as incorporation of improvement processes into routine daily activities, were vital in developing and sustaining a culture of quality improvement.

College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference on good laboratory practices in gynecologic cytology: background, rationale, and organization.

PubMed

Tworek, Joseph A; Henry, Michael R; Blond, Barbara; Jones, Bruce Allen

2013-02-01

Gynecologic cytopathology is a heavily regulated field, with Clinical Laboratory Improvement Amendments of 1988 mandating the collection of many quality metrics. There is a lack of consensus regarding methods to collect, monitor, and benchmark these data and how these data should be used in a quality assurance program. Furthermore, the introduction of human papilloma virus testing and proficiency testing has provided more data to monitor. To determine good laboratory practices in quality assurance of gynecologic cytopathology. Data were collected through a written survey consisting of 98 questions submitted to 1245 Clinical Laboratory Improvement Amendments-licensed or Department of Defense laboratories. There were 541 usable responses. Additional input was sought through a Web posting of results and questions on the College of American Pathologists Web site. Four senior authors who authored the survey and 28 cytopathologists and cytotechnologists were assigned to 5 working groups to analyze data and present statements on good laboratory practices in gynecologic cytopathology at the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference. Ninety-eight attendees at the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference discussed and voted on good laboratory practice statements to obtain consensus. This paper describes the rationale, background, process, and strengths and limitations of a series of papers that summarize good laboratory practice statements in quality assurance in gynecologic cytopathology.

Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory; processing, taxonomy, and quality control of benthic macroinvertebrate samples

USGS Publications Warehouse

Moulton, Stephen R.; Carter, James L.; Grotheer, Scott A.; Cuffney, Thomas F.; Short, Terry M.

2000-01-01

Qualitative and quantitative methods to process benthic macroinvertebrate (BMI) samples have been developed and tested by the U.S. Geological Survey?s National Water Quality Laboratory Biological Group. The qualitative processing method is based on visually sorting a sample for up to 2 hours. Sorting focuses on attaining organisms that are likely to result in taxonomic identifications to lower taxonomic levels (for example, Genus or Species). Immature and damaged organisms are also sorted when they are likely to result in unique determinations. The sorted sample remnant is scanned briefly by a second person to determine if obvious taxa were missed. The quantitative processing method is based on a fixed-count approach that targets some minimum count, such as 100 or 300 organisms. Organisms are sorted from randomly selected 5.1- by 5.1-centimeter parts of a gridded subsampling frame. The sorted remnant from each sample is resorted by a second individual for at least 10 percent of the original sort time. A large-rare organism search is performed on the unsorted remnant to sort BMI taxa that were not likely represented in the sorted grids. After either qualitatively or quantitatively sorting the sample, BMIs are identified by using one of three different types of taxonomic assessment. The Standard Taxonomic Assessment is comparable to the U.S. Environmental Protection Agency Rapid Bioassessment Protocol III and typically provides Genus- or Species-level taxonomic resolution. The Rapid Taxonomic Assessment is comparable to the U.S. Environmental Protection Agency Rapid Bioassessment Protocol II and provides Familylevel and higher taxonomic resolution. The Custom Taxonomic Assessment provides Species-level resolution whenever possible for groups identified to higher taxonomic levels by using the Standard Taxonomic Assessment. The consistent use of standardized designations and notes facilitates the interpretation of BMI data within and among water-quality studies

Quality Indicators in Laboratory Medicine: the status of the progress of IFCC Working Group "Laboratory Errors and Patient Safety" project.

PubMed

Sciacovelli, Laura; Lippi, Giuseppe; Sumarac, Zorica; West, Jamie; Garcia Del Pino Castro, Isabel; Furtado Vieira, Keila; Ivanov, Agnes; Plebani, Mario

2017-03-01

The knowledge of error rates is essential in all clinical laboratories as it enables them to accurately identify their risk level, and compare it with those of other laboratories in order to evaluate their performance in relation to the State-of-the-Art (i.e. benchmarking) and define priorities for improvement actions. Although no activity is risk free, it is widely accepted that the risk of error is minimized by the use of Quality Indicators (QIs) managed as a part of laboratory improvement strategy and proven to be suitable monitoring and improvement tools. The purpose of QIs is to keep the error risk at a level that minimizes the likelihood of patients. However, identifying a suitable State-of-the-Art is challenging, because it calls for the knowledge of error rates measured in a variety of laboratories throughout world that differ in their organization and management, context, and the population they serve. Moreover, it also depends on the choice of the events to keep under control and the individual procedure for measurement. Although many laboratory professionals believe that the systemic use of QIs in Laboratory Medicine may be effective in decreasing errors occurring throughout the total testing process (TTP), to improve patient safety as well as to satisfy the requirements of International Standard ISO 15189, they find it difficult to maintain standardized and systematic data collection, and to promote continued high level of interest, commitment and dedication in the entire staff. Although many laboratories worldwide express a willingness to participate to the Model of QIs (MQI) project of IFCC Working Group "Laboratory Errors and Patient Safety", few systematically enter/record their own results and/or use a number of QIs designed to cover all phases of the TTP. Many laboratories justify their inadequate participation in data collection of QIs by claiming that the number of QIs included in the MQI is excessive. However, an analysis of results suggests

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.

European specialist porphyria laboratories: diagnostic strategies, analytical quality, clinical interpretation, and reporting as assessed by an external quality assurance program.

PubMed

Aarsand, Aasne K; Villanger, Jørild H; Støle, Egil; Deybach, Jean-Charles; Marsden, Joanne; To-Figueras, Jordi; Badminton, Mike; Elder, George H; Sandberg, Sverre

2011-11-01

The porphyrias are a group of rare metabolic disorders whose diagnosis depends on identification of specific patterns of porphyrin precursor and porphyrin accumulation in urine, blood, and feces. Diagnostic tests for porphyria are performed by specialized laboratories in many countries. Data regarding the analytical and diagnostic performance of these laboratories are scarce. We distributed 5 sets of multispecimen samples from different porphyria patients accompanied by clinical case histories to 18-21 European specialist porphyria laboratories/centers as part of a European Porphyria Network organized external analytical and postanalytical quality assessment (EQA) program. The laboratories stated which analyses they would normally have performed given the case histories and reported results of all porphyria-related analyses available, interpretative comments, and diagnoses. Reported diagnostic strategies initially showed considerable diversity, but the number of laboratories applying adequate diagnostic strategies increased during the study period. We found an average interlaboratory CV of 50% (range 12%-152%) for analytes in absolute concentrations. Result normalization by forming ratios to the upper reference limits did not reduce this variation. Sixty-five percent of reported results were within biological variation-based analytical quality specifications. Clinical interpretation of the obtained analytical results was accurate, and most laboratories established the correct diagnosis in all distributions. Based on a case-based EQA scheme, variations were apparent in analytical and diagnostic performance between European specialist porphyria laboratories. Our findings reinforce the use of EQA schemes as an essential tool to assess both analytical and diagnostic processes and thereby to improve patient care in rare diseases.

In-Flight Laboratory Analysis

NASA Technical Reports Server (NTRS)

Baumann, David; Perusek, Gail; Nelson, Emily; Krihak, Michael; Brown, Dan

2012-01-01

One-year study objectives align with HRP requirements. HRP requirements include measurement panels for research and medical operations - These measurement panels are distinctly different. Instrument requirements are defined - Power, volume and mass not quite a critical limitation as for medical operations (deep space exploration missions). One-year evaluation goals will lead HHC towards in-flight laboratory analysis capability.

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

The changing face of clinical laboratories.

PubMed

Plebani, M

1999-07-01

Laboratory medicine has undergone a sea change, and medical laboratories must now adapt to, and meet new, customer-supplier needs springing from shifts in the patterns of disease prevalence, medical practice, and demographics. Managed care and other cost-containment processes have forced those involved in health care to cooperate to develop a full picture of patient care, and this has affected clinical laboratory objectives, the main focus now being on improvement in medical outcomes. More recently, the resource shortages in health care and results of cost/effectiveness analysis have demonstrated that the value of a laboratory test must be ascertained not only on the basis of its chemical or clinical performance characteristics, but also by its impact on patient management, the only true assessment of the quality of testing being quality of patient outcomes. The time is ripe for changing the vision of laboratory medicine, and some of the reasons for this are the availability of results in real-time, the introduction of more specific tests, and the trend to prevent diseases rather than cure them. The information from laboratory tests designed to evaluate biochemical or genetic risk and/or prognostic factors cannot be replaced either by physical examination and/or the assessment of symptoms. Today, the importance of laboratory scientists must be proven in three broad areas: a) guaranteeing the quality of tests, irrespective of where they are performed; b) improving the quality of the service; c) maximizing the impact of laboratory information on patient management.

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

HPV testing for primary cervical screening: Laboratory issues and evolving requirements for robust quality assurance.

PubMed

Carozzi, Francesca Maria; Del Mistro, Annarosa; Cuschieri, Kate; Frayle, Helena; Sani, Cristina; Burroni, Elena

2016-03-01

This review aims to highlight the importance of Quality Assurance for Laboratories performing HPV test for Cervical Cancer Screening. An HPV test, to be used as primary screening test, must be validated according to international criteria, based on comparison of its clinical accuracy to HC2 or GP5+/6+ PCR-EIA tests. The number of validated platforms is increasing and appropriate Quality Assurance Programs (QAPs) which can interrogate longitudinal robustness and quality are paramount. This document describes the following topics: (1) the characteristics of an HPV laboratory and the personnel training needs, to ensure an elevated quality of the entire process and the optimal use of the resources; (2) the Quality Assurance, as both internal (IQA) and external quality assessment (EQA) systems, to be implemented and performed, and the description of the existing EQAs, including limitations; (3) general considerations for an optimal EQA program for hrHPV primary screening Due to the importance of Quality Assurance for this field, international efforts are necessary to improve QA International Collaboration. Copyright © 2015 Elsevier B.V. All rights reserved.

Performance indicators for quality in surgical and laboratory services at Muhimbili National Hospital (MNH) in Tanzania.

PubMed

Mbembati, Naboth A; Mwangu, Mugwira; Muhondwa, Eustace P Y; Leshabari, Melkizedek M

2008-04-01

Muhimbili National Hospital (MNH), a teaching and national referral hospital, is undergoing major reforms to improve the quality of health care. We performed a retrospective descriptive study using a set of performance indicators for the surgical and laboratory services of MNH in years 2001 and 2002, to help monitor and evaluate the impact of reforms on the quality of health care during and after the reform process. Hospital records were reviewed and information recorded for planned and postponed operations, laboratory equipment, reagents, laboratory tests and quality assurance programmes. In the year 2001 a total of 4332 non-emergency operations were planned, 3313 operations were performed and 1019 (23.5%) operations were postponed. In the year 2002, 4301 non-emergency operations were planned, 3046 were performed and 1255 (29%) were postponed. The most common reasons for operation postponement were "time-barred", interference by emergency operations, no show of patients and inoperable anaesthetic machines. Equipment problems and supply and staff shortages together accounted for one quarter of postponements. In the laboratory, a lack of equipment prevented some tests, but quality assurance was performed for most tests. Current surgical services at MNH are inadequate; operating theatres require modern, functioning equipment and adequate supplies of consumables to provide satisfactory care.

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 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

Key performance indicators score (KPIs-score) based on clinical and laboratorial parameters can establish benchmarks for internal quality control in an ART program.

PubMed

Franco, José G; Petersen, Claudia G; Mauri, Ana L; Vagnini, Laura D; Renzi, Adriana; Petersen, Bruna; Mattila, M C; Comar, Vanessa A; Ricci, Juliana; Dieamant, Felipe; Oliveira, João Batista A; Baruffi, Ricardo L R

2017-06-01

KPIs have been employed for internal quality control (IQC) in ART. However, clinical KPIs (C-KPIs) such as age, AMH and number of oocytes collected are never added to laboratory KPIs (L-KPIs), such as fertilization rate and morphological quality of the embryos for analysis, even though the final endpoint is the evaluation of clinical pregnancy rates. This paper analyzed if a KPIs-score strategy with clinical and laboratorial parameters could be used to establish benchmarks for IQC in ART cycles. In this prospective cohort study, 280 patients (36.4±4.3years) underwent ART. The total KPIs-score was obtained by the analysis of age, AMH (AMH Gen II ELISA/pre-mixing modified, Beckman Coulter Inc.), number of metaphase-II oocytes, fertilization rates and morphological quality of the embryonic lot. The total KPIs-score (C-KPIs+L-KPIs) was correlated with the presence or absence of clinical pregnancy. The relationship between the C-KPIs and L-KPIs scores was analyzed to establish quality standards, to increase the performance of clinical and laboratorial processes in ART. The logistic regression model (LRM), with respect to pregnancy and total KPIs-score (280 patients/102 clinical pregnancies), yielded an odds ratio of 1.24 (95%CI = 1.16-1.32). There was also a significant difference (p<0.0001) with respect to the total KPIs-score mean value between the group of patients with clinical pregnancies (total KPIs-score=20.4±3.7) and the group without clinical pregnancies (total KPIs-score=15.9±5). Clinical pregnancy probabilities (CPP) can be obtained using the LRM (prediction key) with the total KPIs-score as a predictor variable. The mean C-KPIs and L-KPIs scores obtained in the pregnancy group were 11.9±2.9 and 8.5±1.7, respectively. Routinely, in all cases where the C-KPIs score was ≥9, after the procedure, the L-KPIs score obtained was ≤6, a revision of the laboratory procedure was performed to assess quality standards. This total KPIs-score could set up

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.

RIPOSTE: a framework for improving the design and analysis of laboratory-based research

PubMed Central

Masca, Nicholas GD; Hensor, Elizabeth MA; Cornelius, Victoria R; Buffa, Francesca M; Marriott, Helen M; Eales, James M; Messenger, Michael P; Anderson, Amy E; Boot, Chris; Bunce, Catey; Goldin, Robert D; Harris, Jessica; Hinchliffe, Rod F; Junaid, Hiba; Kingston, Shaun; Martin-Ruiz, Carmen; Nelson, Christopher P; Peacock, Janet; Seed, Paul T; Shinkins, Bethany; Staples, Karl J; Toombs, Jamie; Wright, Adam KA; Teare, M Dawn

2015-01-01

Lack of reproducibility is an ongoing problem in some areas of the biomedical sciences. Poor experimental design and a failure to engage with experienced statisticians at key stages in the design and analysis of experiments are two factors that contribute to this problem. The RIPOSTE (Reducing IrreProducibility in labOratory STudiEs) framework has been developed to support early and regular discussions between scientists and statisticians in order to improve the design, conduct and analysis of laboratory studies and, therefore, to reduce irreproducibility. This framework is intended for use during the early stages of a research project, when specific questions or hypotheses are proposed. The essential points within the framework are explained and illustrated using three examples (a medical equipment test, a macrophage study and a gene expression study). Sound study design minimises the possibility of bias being introduced into experiments and leads to higher quality research with more reproducible results. DOI: http://dx.doi.org/10.7554/eLife.05519.001 PMID:25951517

RIPOSTE: a framework for improving the design and analysis of laboratory-based research.

PubMed

Masca, Nicholas Gd; Hensor, Elizabeth Ma; Cornelius, Victoria R; Buffa, Francesca M; Marriott, Helen M; Eales, James M; Messenger, Michael P; Anderson, Amy E; Boot, Chris; Bunce, Catey; Goldin, Robert D; Harris, Jessica; Hinchliffe, Rod F; Junaid, Hiba; Kingston, Shaun; Martin-Ruiz, Carmen; Nelson, Christopher P; Peacock, Janet; Seed, Paul T; Shinkins, Bethany; Staples, Karl J; Toombs, Jamie; Wright, Adam Ka; Teare, M Dawn

2015-05-07

Lack of reproducibility is an ongoing problem in some areas of the biomedical sciences. Poor experimental design and a failure to engage with experienced statisticians at key stages in the design and analysis of experiments are two factors that contribute to this problem. The RIPOSTE (Reducing IrreProducibility in labOratory STudiEs) framework has been developed to support early and regular discussions between scientists and statisticians in order to improve the design, conduct and analysis of laboratory studies and, therefore, to reduce irreproducibility. This framework is intended for use during the early stages of a research project, when specific questions or hypotheses are proposed. The essential points within the framework are explained and illustrated using three examples (a medical equipment test, a macrophage study and a gene expression study). Sound study design minimises the possibility of bias being introduced into experiments and leads to higher quality research with more reproducible results.

Implementation of the World Health Organization Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation.

PubMed

Ndihokubwayo, Jean-Bosco; Maruta, Talkmore; Ndlovu, Nqobile; Moyo, Sikhulile; Yahaya, Ali Ahmed; Coulibaly, Sheick Oumar; Kasolo, Francis; Turgeon, David; Abrol, Angelii P

2016-01-01

The increase in disease burden has continued to weigh upon health systems in Africa. The role of the laboratory has become increasingly critical in the improvement of health for diagnosis, management and treatment of diseases. In response, the World Health Organization Regional Office for Africa (WHO AFRO) and its partners created the WHO AFRO Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program. WHO AFRO defined a governance structure with roles and responsibilities for six main stakeholders. Laboratories were evaluated by auditors trained and certified by the African Society for Laboratory Medicine. Laboratory performance was measured using the WHO AFRO SLIPTA scoring checklist and recognition certificates rated with 1-5 stars were issued. By March 2015, 27 of the 47 (57%) WHO AFRO member states had appointed a SLIPTA focal point and 14 Ministers of Health had endorsed SLIPTA as the desired programme for continuous quality improvement. Ninety-eight auditors from 17 African countries, competent in the Portuguese (3), French (12) and English (83) languages, were trained and certified. The mean score for the 159 laboratories audited between May 2013 and March 2015 was 69% (median 70%; SD 11.5; interquartile range 62-77). Of these audited laboratories, 70% achieved 55% compliance or higher (2 or more stars) and 1% scored at least 95% (5 stars). The lowest scoring sections of the WHO AFRO SLIPTA checklist were sections 6 (Internal Audit) and 10 (Corrective Action), which both had mean scores below 50%. The WHO AFRO SLIPTA is a process that countries with limited resources can adopt for effective implementation of quality management systems. Political commitment, ownership and investment in continuous quality improvement are integral components of the process.

The Albuquerque Seismological Laboratory Data Quality Analyzer

NASA Astrophysics Data System (ADS)

Ringler, A. T.; Hagerty, M.; Holland, J.; Gee, L. S.; Wilson, D.

2013-12-01

The U.S. Geological Survey's Albuquerque Seismological Laboratory (ASL) has several efforts underway to improve data quality at its stations. The Data Quality Analyzer (DQA) is one such development. The DQA is designed to characterize station data quality in a quantitative and automated manner. Station quality is based on the evaluation of various metrics, such as timing quality, noise levels, sensor coherence, and so on. These metrics are aggregated into a measurable grade for each station. The DQA consists of a website, a metric calculator (Seedscan), and a PostgreSQL database. The website allows the user to make requests for various time periods, review specific networks and stations, adjust weighting of the station's grade, and plot metrics as a function of time. The website dynamically loads all station data from a PostgreSQL database. The database is central to the application; it acts as a hub where metric values and limited station descriptions are stored. Data is stored at the level of one sensor's channel per day. The database is populated by Seedscan. Seedscan reads and processes miniSEED data, to generate metric values. Seedscan, written in Java, compares hashes of metadata and data to detect changes and perform subsequent recalculations. This ensures that the metric values are up to date and accurate. Seedscan can be run in a scheduled task or on demand by way of a config file. It will compute metrics specified in its configuration file. While many metrics are currently in development, some are completed and being actively used. These include: availability, timing quality, gap count, deviation from the New Low Noise Model, deviation from a station's noise baseline, inter-sensor coherence, and data-synthetic fits. In all, 20 metrics are planned, but any number could be added. ASL is actively using the DQA on a daily basis for station diagnostics and evaluation. As Seedscan is scheduled to run every night, data quality analysts are able to then use the

Cairo consensus on the IVF laboratory environment and air quality: report of an expert meeting.

PubMed

Mortimer, D; Cohen, J; Mortimer, S T; Fawzy, M; McCulloh, D H; Morbeck, D E; Pollet-Villard, X; Mansour, R T; Brison, D R; Doshi, A; Harper, J C; Swain, J E; Gilligan, A V

2018-03-02

This proceedings report presents the outcomes from an international Expert Meeting to establish a consensus on the recommended technical and operational requirements for air quality within modern assisted reproduction technology (ART) laboratories. Topics considered included design and construction of the facility, as well as its heating, ventilation and air conditioning system; control of particulates, micro-organisms (bacteria, fungi and viruses) and volatile organic compounds (VOCs) within critical areas; safe cleaning practices; operational practices to optimize air quality while minimizing physicochemical risks to gametes and embryos (temperature control versus air flow); and appropriate infection-control practices that minimize exposure to VOC. More than 50 consensus points were established under the general headings of assessing site suitability, basic design criteria for new construction, and laboratory commissioning and ongoing VOC management. These consensus points should be considered as aspirational benchmarks for existing ART laboratories, and as guidelines for the construction of new ART laboratories. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

External quality assessment for arbovirus diagnostics in the World Health Organization Western Pacific Region, 2013–2016: improving laboratory quality over the years

PubMed Central

Abdad, Mohammad Yazid; Squires, Raynal C; Cognat, Sebastien; Oxenford, Christopher John

2017-01-01

Arboviruses continue to pose serious public health threats in the World Health Organization (WHO) Western Pacific Region. As such, laboratories need to be equipped for their accurate detection. In 2011, to ensure test proficiency, the WHO Regional Office for the Western Pacific piloted an external quality assessment (EQA) programme for arbovirus diagnostics. By 2016, it had grown into a global programme with participation of 96 laboratories worldwide, including 25 laboratories from 19 countries, territories and areas in the Region. The test performance of the 25 laboratories in the Region in 2016 was high with 23 (92%) reporting correct results in all specimens for dengue and chikungunya viruses. For Zika virus, 18 (72%) of the 25 laboratories reported correct results in all specimens, while seven (28%) demonstrated at least one error. When comparing iterations of this EQA programme in the Region between 2013 and 2016, the number of participating laboratories increased from 18 to 25. The first round only included dengue virus, while the latest round additionally included chikungunya, Zika and yellow fever viruses. Proficiency for molecular detection of dengue virus remained high (83–94%) over the four-year period. The observed proficiency for arbovirus diagnostics between 2013 and 2016 is an indicator of laboratory quality improvement in the Region. PMID:29051839

Sandia National Laboratories Advanced Simulation and Computing (ASC) software quality plan. Part 1: ASC software quality engineering practices, Version 2.0.

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

Sturtevant, Judith E.; Heaphy, Robert; Hodges, Ann Louise

2006-09-01

The purpose of the Sandia National Laboratories Advanced Simulation and Computing (ASC) Software Quality Plan is to clearly identify the practices that are the basis for continually improving the quality of ASC software products. The plan defines the ASC program software quality practices and provides mappings of these practices to Sandia Corporate Requirements CPR 1.3.2 and 1.3.6 and to a Department of Energy document, ASCI Software Quality Engineering: Goals, Principles, and Guidelines. This document also identifies ASC management and software project teams responsibilities in implementing the software quality practices and in assessing progress towards achieving their software quality goals.

Quality assurance of reference standards from nine European solar-ultraviolet monitoring laboratories.

PubMed

Gröbner, Julian; Rembges, Diana; Bais, Alkiviadis F; Blumthaler, Mario; Cabot, Thierry; Josefsson, Weine; Koskela, Tapani; Thorseth, Trond M; Webb, Ann R; Wester, Ulf

2002-07-20

A program for quality assurance of reference standards has been initiated among nine solar-UV monitoring laboratories. By means of a traveling lamp package that comprises several 1000-W ANSI code DXW-type quartz-halogen lamps, a 0.1-ohm shunt, and a 6-1/2 digit voltmeter, the irradiance scales used by the nine laboratories were compared with one another; a relative uncertainty of 1.2% was found. The comparison of 15 reference standards yielded differences of as much as 9%; the average difference was less than 3%.

[Establishment of Quality Control System of Nucleic Acid Detection for Ebola Virus in Sierra Leone-China Friendship Biological Safety Laboratory].

PubMed

Wang, Qin; Zhang, Yong; Nie, Kai; Wang, Huanyu; Du, Haijun; Song, Jingdong; Xiao, Kang; Lei, Wenwen; Guo, Jianqiang; Wei, Hejiang; Cai, Kun; Wang, Yanhai; Wu, Jiang; Gerald, Bangura; Kamara, Idrissa Laybohr; Liang, Mifang; Wu, Guizhen; Dong, Xiaoping

2016-03-01

The quality control process throughout the Ebola virus nucleic acid detection in Sierra Leone-China Friendship Biological Safety Laboratory (SLE-CHN Biosafety Lab) was described in detail, in order to comprehensively display the scientific, rigorous, accurate and efficient practice in detection of Ebola virus of first batch detection team in SLE-CHN Biosafety Lab. Firstly, the key points of laboratory quality control system was described, including the managements and organizing, quality control documents and information management, instrument, reagents and supplies, assessment, facilities design and space allocation, laboratory maintenance and biosecurity. Secondly, the application of quality control methods in the whole process of the Ebola virus detection, including before the test, during the test and after the test, was analyzed. The excellent and professional laboratory staffs, the implementation of humanized management are the cornerstone of the success; High-level biological safety protection is the premise for effective quality control and completion of Ebola virus detection tasks. And professional logistics is prerequisite for launching the laboratory diagnosis of Ebola virus. The establishment and running of SLE-CHN Biosafety Lab has landmark significance for the friendship between Sierra Leone and China, and the lab becomes the most important base for Ebola virus laboratory testing in Sierra Leone.

Systematic reviews: I. The correlation between laboratory tests on marginal quality and bond strength. II. The correlation between marginal quality and clinical outcome.

PubMed

Heintze, Siegward D

2007-01-01

An accepted principle in restorative dentistry states that restorations should be placed with the best marginal quality possible to avoid postoperative sensitivity, marginal discoloration, and secondary caries. Different laboratory methods claim to predict the clinical performance of restorative materials, for example, tests of bond strength and microleakage and gap analysis. The purpose of this review was twofold: (1) find studies that correlated the results of bond strength tests with either microleakage or gap analysis for the same materials, and (2) find studies that correlated the results of microleakage and/or gaps with the clinical parameters for the same materials. Furthermore, influencing factors on the results of the laboratory tests were reviewed and assessed. For the first question, searches for studies were conducted in the MEDLINE database and IADR/AADR abtracts online with specific search and inclusion criteria. The outcome for each study was assessed on the basis of the statistical test applied in the study, and finally the number of studies with or without correlation was compiled. For the second question, results of the quantitative marginal analysis of Class V restorations published by the University of Zürich with the same test protocol and prospective clinical trials were searched that investigated the same materials for at least 2 years in Class V cavities. Pearson correlation coefficients were calculated for pooled data of materials and clinical outcome parameters such as retention loss, marginal discoloration, marginal integrity, and secondary caries. For the correlation of dye penetration and clinical outcome, studies on Class V restorations published by the same research institute were searched in MEDLINE that examined the same adhesive systems as the selected clinical trials. For the correlation bond strength/microleakage, 30 studies were included into the review, and for the correlation bond strength/gap analysis 18 studies. For both

Roles of laboratories and laboratory systems in effective tuberculosis programmes.

PubMed

Ridderhof, John C; van Deun, Armand; Kam, Kai Man; Narayanan, P R; Aziz, Mohamed Abdul

2007-05-01

Laboratories and laboratory networks are a fundamental component of tuberculosis (TB) control, providing testing for diagnosis, surveillance and treatment monitoring at every level of the health-care system. New initiatives and resources to strengthen laboratory capacity and implement rapid and new diagnostic tests for TB will require recognition that laboratories are systems that require quality standards, appropriate human resources, and attention to safety in addition to supplies and equipment. To prepare the laboratory networks for new diagnostics and expanded capacity, we need to focus efforts on strengthening quality management systems (QMS) through additional resources for external quality assessment programmes for microscopy, culture, drug susceptibility testing (DST) and molecular diagnostics. QMS should also promote development of accreditation programmes to ensure adherence to standards to improve both the quality and credibility of the laboratory system within TB programmes. Corresponding attention must be given to addressing human resources at every level of the laboratory, with special consideration being given to new programmes for laboratory management and leadership skills. Strengthening laboratory networks will also involve setting up partnerships between TB programmes and those seeking to control other diseases in order to pool resources and to promote advocacy for quality standards, to develop strategies to integrate laboratories functions and to extend control programme activities to the private sector. Improving the laboratory system will assure that increased resources, in the form of supplies, equipment and facilities, will be invested in networks that are capable of providing effective testing to meet the goals of the Global Plan to Stop TB.

Use of a systematic risk analysis method (FMECA) to improve quality in a clinical laboratory procedure.

PubMed

Serafini, A; Troiano, G; Franceschini, E; Calzoni, P; Nante, N; Scapellato, C

2016-01-01

Risk management is a set of actions to recognize or identify risks, errors and their consequences and to take the steps to counter it. The aim of our study was to apply FMECA (Failure Mode, Effects and Criticality Analysis) to the Activated Protein C resistance (APCR) test in order to detect and avoid mistakes in this process. We created a team and the process was divided in phases and sub phases. For each phase we calculated the probability of occurrence (O) of an error, the detectability score (D) and the severity (S). The product of these three indexes yields the RPN (Risk Priority Number). Phases with a higher RPN need corrective actions with a higher priority. The calculation of RPN showed that more than 20 activities have a score higher than 150 and need important preventive actions; 8 have a score between 100 and 150. Only 23 actions obtained an acceptable score lower than 100. This was one of the first experience of application of FMECA analysis to a laboratory process, and the first one which applies this technique to the identification of the factor V Leiden, and our results confirm that FMECA could be a simple, powerful and useful tool in risk management and helps to identify quickly the criticality in a laboratory process.

This Is not Participatory Design - A Critical Analysis of Eight Living Laboratories.

PubMed

Bygholm, Ann; Kanstrup, Anne Marie

2017-01-01

Design of Health Technology for elderly and care personnel has a high priority because of a severe increase of elderly citizens in need of health care combined with a decrease of resources in the health care sector. Desires for maintaining and improving the quality of care while reducing costs has resulted in a search for approaches that support co-operation between technology designers, elderly persons and health care professionals on innovating future care technology. Living laboratories, where areas of a care environment are transformed into a so-called platform for technology innovation, are popular. Expectations for living laboratories are high but examinations of how such laboratories support the intended participatory innovation are few. This paper presents and examines eight living laboratories set up in Danish nursing homes for technology innovation. We present the notion of a living laboratory and explicate the aspirations and expectations of this approach, and discuss why these expectations are hard to meet both on a general level and in the investigated labs. We question the basic assumptions of the possibility of reconciling the different interests of the stakeholders involved. In our analysis we focus on users in the living laboratories. We use guiding principles developed within Participatory Design to reveal the role and participation of the users - the health care professionals and the elderly - in the eight living laboratories. In general, these users played a minor role, in the labs where technical problems turned out to be main activity. We conclude that living laboratories do not nullify different/conflicting interests and that a real-life setting by itself is no guarantee for user participation.

Challenges of a negative work load and implications on morale, productivity and quality of service delivered in NHS laboratories in England

PubMed Central

Osaro, Erhabor; Chima, Njemanze

2014-01-01

The National Health Service (NHS) is a term used to describe the publicly funded healthcare delivery system providing quality healthcare services in the United Kingdom. There are several challenges militating against the effective laboratory service delivery in the NHS in England. Biomedical scientists work in healthcare to diagnose disease and evaluate the effectiveness of treatment through the analysis of body fluids and tissue samples from patients. They provide the “engine room” of modern medicine with 70% of diagnosis based on the laboratory results generated by them. This review involved the search of literature for information on working condition of biomedical scientist in the NHS in England. Laboratory service delivery in the NHS in England faces numerous daunting challenges; staffing levels in the last few years have become dangerously low, less remunerated, relatively less experienced and predominantly band 5's, multidisciplinary rather than specialty based, associated with working more unsocial hours without adequate recovery time, de-banding of staff, high staff turnaround, profit and cost driven rather than quality. These factors has resulted in burn out, low morale, high sickness absences, increased error rate, poor team spirit, diminished productivity and suboptimal laboratory service delivery. There is the urgent need to retract our steps on unpopular policies to ensure that patient care is not compromised by ensuring adequate staffing level and mix, ensuring adequate remuneration of laboratory staff, implementing evidenced-based specialty oriented service, determining the root cause/s for the high staff turnover and implementing corrective action, identifying other potential sources of waste in the system rather than pruning the already dangerously low staffing levels and promoting a quality delivery side by side cost effectiveness. PMID:25182941

Challenges of a negative work load and implications on morale, productivity and quality of service delivered in NHS laboratories in England.

PubMed

Osaro, Erhabor; Chima, Njemanze

2014-06-01

The National Health Service (NHS) is a term used to describe the publicly funded healthcare delivery system providing quality healthcare services in the United Kingdom. There are several challenges militating against the effective laboratory service delivery in the NHS in England. Biomedical scientists work in healthcare to diagnose disease and evaluate the effectiveness of treatment through the analysis of body fluids and tissue samples from patients. They provide the "engine room" of modern medicine with 70% of diagnosis based on the laboratory results generated by them. This review involved the search of literature for information on working condition of biomedical scientist in the NHS in England. Laboratory service delivery in the NHS in England faces numerous daunting challenges; staffing levels in the last few years have become dangerously low, less remunerated, relatively less experienced and predominantly band 5's, multidisciplinary rather than specialty based, associated with working more unsocial hours without adequate recovery time, de-banding of staff, high staff turnaround, profit and cost driven rather than quality. These factors has resulted in burn out, low morale, high sickness absences, increased error rate, poor team spirit, diminished productivity and suboptimal laboratory service delivery. There is the urgent need to retract our steps on unpopular policies to ensure that patient care is not compromised by ensuring adequate staffing level and mix, ensuring adequate remuneration of laboratory staff, implementing evidenced-based specialty oriented service, determining the root cause/s for the high staff turnover and implementing corrective action, identifying other potential sources of waste in the system rather than pruning the already dangerously low staffing levels and promoting a quality delivery side by side cost effectiveness.

Laboratory theory and methods for sediment analysis

USGS Publications Warehouse

Guy, Harold P.

1969-01-01

The diverse character of fluvial sediments makes the choice of laboratory analysis somewhat arbitrary and the pressing of sediment samples difficult. This report presents some theories and methods used by the Water Resources Division for analysis of fluvial sediments to determine the concentration of suspended-sediment samples and the particle-size distribution of both suspended-sediment and bed-material samples. Other analyses related to these determinations may include particle shape, mineral content, and specific gravity, the organic matter and dissolved solids of samples, and the specific weight of soils. The merits and techniques of both the evaporation and filtration methods for concentration analysis are discussed. Methods used for particle-size analysis of suspended-sediment samples may include the sieve pipet, the VA tube-pipet, or the BW tube-VA tube depending on the equipment available, the concentration and approximate size of sediment in the sample, and the settling medium used. The choice of method for most bed-material samples is usually limited to procedures suitable for sand or to some type of visual analysis for large sizes. Several tested forms are presented to help insure a well-ordered system in the laboratory to handle the samples, to help determine the kind of analysis required for each, to conduct the required processes, and to assist in the required computations. Use of the manual should further 'standardize' methods of fluvial sediment analysis among the many laboratories and thereby help to achieve uniformity and precision of the data.

Implementation of the World Health Organization Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation

PubMed Central

Maruta, Talkmore; Ndlovu, Nqobile; Moyo, Sikhulile; Yahaya, Ali Ahmed; Coulibaly, Sheick Oumar; Kasolo, Francis; Turgeon, David; Abrol, Angelii P.

2016-01-01

Background The increase in disease burden has continued to weigh upon health systems in Africa. The role of the laboratory has become increasingly critical in the improvement of health for diagnosis, management and treatment of diseases. In response, the World Health Organization Regional Office for Africa (WHO AFRO) and its partners created the WHO AFRO Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program. SLIPTA implementation process WHO AFRO defined a governance structure with roles and responsibilities for six main stakeholders. Laboratories were evaluated by auditors trained and certified by the African Society for Laboratory Medicine. Laboratory performance was measured using the WHO AFRO SLIPTA scoring checklist and recognition certificates rated with 1–5 stars were issued. Preliminary results By March 2015, 27 of the 47 (57%) WHO AFRO member states had appointed a SLIPTA focal point and 14 Ministers of Health had endorsed SLIPTA as the desired programme for continuous quality improvement. Ninety-eight auditors from 17 African countries, competent in the Portuguese (3), French (12) and English (83) languages, were trained and certified. The mean score for the 159 laboratories audited between May 2013 and March 2015 was 69% (median 70%; SD 11.5; interquartile range 62–77). Of these audited laboratories, 70% achieved 55% compliance or higher (2 or more stars) and 1% scored at least 95% (5 stars). The lowest scoring sections of the WHO AFRO SLIPTA checklist were sections 6 (Internal Audit) and 10 (Corrective Action), which both had mean scores below 50%. Conclusion The WHO AFRO SLIPTA is a process that countries with limited resources can adopt for effective implementation of quality management systems. Political commitment, ownership and investment in continuous quality improvement are integral components of the process. PMID:28879103

Dietary Supplement Laboratory Quality Assurance Program: The First Five Exercises

PubMed Central

Phillips, Melissa M.; Rimmer, Catherine A.; Wood, Laura J.; Lippa, Katrice A.; Sharpless, Katherine E.; Duewer, David L.; Sander, Lane C.; Betz, Joseph M.

2011-01-01

The National Institute of Standards and Technology (NIST) has established a Dietary Supplement Laboratory Quality Assurance Program (DSQAP) in collaboration with the National Institutes of Health Office of Dietary Supplements. Program participants measure concentrations of active and/or marker compounds as well as nutritional and toxic elements in food and dietary supplements distributed by NIST. Data are compiled at NIST, where they are analyzed for accuracy relative to reference values and concordance among the participants. Performance reports and certificates of completion are provided to participants, which can be used to demonstrate compliance with current Good Manufacturing Practices as promulgated by the U.S. Food and Drug Administration. The DSQAP has conducted five exercises to date, with total participation including more than 75 different laboratories and many more individual analysts. PMID:21797008

Idaho National Laboratory Quarterly Occurrence Analysis - 3rd Quarter FY-2016

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

Mitchell, Lisbeth Ann

This report is published quarterly by the Idaho National Laboratory (INL) Quality and Performance Management Organization. The Department of Energy (DOE) Occurrence Reporting and Processing System (ORPS), as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of 73 reportable events (23 from the 3rd Qtr FY-16 and 50 from the prior three reporting quarters), as well as 45 other issue reports (including events found to be not reportable and Significant Category A and B conditions)more » identified at INL during the past 12 months (16 from this quarter and 29 from the prior three quarters).« less

Idaho National Laboratory Quarterly Occurrence Analysis - 1st Quarter FY 2016

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

Mitchell, Lisbeth Ann

This report is published quarterly by the Idaho National Laboratory (INL) Quality and Performance Management Organization. The Department of Energy (DOE) Occurrence Reporting and Processing System (ORPS), as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of 74 reportable events (16 from the 1st Qtr FY-16 and 58 from the prior three reporting quarters), as well as 35 other issue reports (including events found to be not reportable and Significant Category A and B conditions)more » identified at INL during the past 12 months (15 from this quarter and 20 from the prior three quarters).« less

Idaho National Laboratory Quarterly Occurrence Analysis 4th Quarter FY 2016

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

Mitchell, Lisbeth Ann

This report is published quarterly by the Idaho National Laboratory (INL) Quality and Performance Management Organization. The Department of Energy (DOE) Occurrence Reporting and Processing System, as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of 84 reportable events (29 from the 4th quarter fiscal year 2016 and 55 from the prior three reporting quarters), as well as 39 other issue reports (including events found to be not reportable and Significant Category A and Bmore » conditions) identified at INL during the past 12 months (two from this quarter and 37 from the prior three quarters).« less

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.

External quality assessment of clinical laboratories in the United Kingdom

PubMed Central

Whitehead, TP; Woodford, FP

1981-01-01

A review is given of the National External Quality Assessment Schemes (NEQASs) in various pathology disciplines in the United Kingdom, with a discussion of the relative roles of the DHSS, individual laboratory scientists, and the relevant professional bodies. Principles of operation and scientific problems in the design of NEQASs in different disciplines are described and contrasted, and some comparisons with the experience in other European countries and the USA are drawn. PMID:7024326

Roles of laboratories and laboratory systems in effective tuberculosis programmes

PubMed Central

van Deun, Armand; Kam, Kai Man; Narayanan, PR; Aziz, Mohamed Abdul

2007-01-01

Abstract Laboratories and laboratory networks are a fundamental component of tuberculosis (TB) control, providing testing for diagnosis, surveillance and treatment monitoring at every level of the health-care system. New initiatives and resources to strengthen laboratory capacity and implement rapid and new diagnostic tests for TB will require recognition that laboratories are systems that require quality standards, appropriate human resources, and attention to safety in addition to supplies and equipment. To prepare the laboratory networks for new diagnostics and expanded capacity, we need to focus efforts on strengthening quality management systems (QMS) through additional resources for external quality assessment programmes for microscopy, culture, drug susceptibility testing (DST) and molecular diagnostics. QMS should also promote development of accreditation programmes to ensure adherence to standards to improve both the quality and credibility of the laboratory system within TB programmes. Corresponding attention must be given to addressing human resources at every level of the laboratory, with special consideration being given to new programmes for laboratory management and leadership skills. Strengthening laboratory networks will also involve setting up partnerships between TB programmes and those seeking to control other diseases in order to pool resources and to promote advocacy for quality standards, to develop strategies to integrate laboratories’ functions and to extend control programme activities to the private sector. Improving the laboratory system will assure that increased resources, in the form of supplies, equipment and facilities, will be invested in networks that are capable of providing effective testing to meet the goals of the Global Plan to Stop TB. PMID:17639219

Health laboratories in the Tanga region of Tanzania: the quality of diagnostic services for malaria and other communicable diseases.

PubMed

Ishengoma, D R S; Rwegoshora, R T; Mdira, K Y; Kamugisha, M L; Anga, E O; Bygbjerg, I C; Rønn, A M; Magesa, S M

2009-07-01

Although critical for good case management and the monitoring of health interventions, the health-laboratory services in sub-Saharan Africa are grossly compromised by poor infrastructures and a lack of trained personnel, essential reagents and other supplies. The availability and quality of diagnostic services in 37 health laboratories in three districts of the Tanga region of Tanzania have recently been assessed. The results of the survey, which involved interviews with health workers, observations and a documentary review, revealed that malaria accounted for >50% of admissions and out-patient visits. Most (92%) of the laboratories were carrying out malaria diagnosis and 89% were measuring haemoglobin concentrations but only one (3%) was conducting culture and sensitivity tests, and those only on urine and pus samples. Only 14 (17%) of the 84 people found working in the visited laboratories were laboratory technologists with a diploma certificate or higher qualification. Sixteen (43%) of the study laboratories each had five or fewer types of equipment and only seven (19%) had more than 11 types each. Although 11 (30%) of the laboratories reported that they conducted internal quality control, none had standard operating procedures (SOP) on display or evidence of such quality assurance. Although malaria was the main health problem, diagnostic services for malaria and other diseases were inadequate and of poor quality because of the limited human resources, poor equipment and shortage of supplies. If the health services in Tanga are not to be overwhelmed by the progressively increasing burden of HIV/AIDS, malaria, tuberculosis and other emerging and re-emerging diseases, more funding and appropriate policies to improve the availability and quality of the area's diagnostic services will clearly be required.

External quality assessment for CD4 + T-lymphocyte count test: Performance of the Brazilian public health laboratories network.

PubMed

Gaspar, Pâmela Cristina; Wohlke, Bruna Lovizutto Protti; Brunialti, Milena Karina Coló; Pires, Ana Flávia; Kohiyama, Igor Massaki; Salomão, Reinaldo; Alonso Neto, José Boullosa; Júnior, Orlando da Costa Ferreira; Franchini, Miriam; Bazzo, Maria Luiza; Benzaken, Adele Schwartz

2018-05-01

The National Network for CD4+ T-lymphocyte counting of Brazil comprises 93 laboratories. This study reports the laboratory performances achieved in external quality assessment (EQA) rounds provides by Ministry of Health to evaluate the quality of the kits used and the performance of test by the technicians.Ten EQA rounds were analyzed according the EQA criteria aimed to evaluate individual laboratory performance on the basis of the accuracy of their results compared to the general mean obtained by all participating laboratories and the reproducibility of the results obtained between 2 samples from the same donor.The percentage of approved and failed laboratories in the EQAs tends to follow a uniform pattern. Since 2011, approval has remained above 80% and the failure rate has never exceeded 15%.EQA is very important to evaluate the performance of the laboratories, to identify monitor, and to resolve errors as quickly as possible.

Sandia Laboratories technical capabilities: engineering analysis

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

Lundergan, C. D.

1975-12-01

This report characterizes the engineering analysis capabilities at Sandia Laboratories. Selected applications of these capabilities are presented to illustrate the extent to which they can be applied in research and development programs. (auth)

Implementing Laboratory Quality Management Systems in Mozambique: The Becton Dickinson-US President's Emergency Plan for AIDS Relief Public-Private Partnership Initiative.

PubMed

Skaggs, Beth; Pinto, Isabel; Masamha, Jessina; Turgeon, David; Gudo, Eduardo Samo

2016-04-15

Mozambique's ministry of health (MOH) recognized the need to establish a national laboratory quality assurance (NLQA) program to improve the reliability and accuracy of laboratory testing. The Becton Dickinson-US President's Emergency Plan for AIDS Relief Public-Private Partnership (PPP) was used to garner MOH commitment and train a cadre of local auditors and managers to support sustainability and country ownership of a NLQA program. From January 2011 to April 2012, the World Health Organization Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist and the Strengthening Laboratory Management Towards Accreditation (SLMTA) curriculum were used in 6 MOH laboratories. PPP volunteers provided training and mentorship to build the capacity of local auditors and program managers to promote institutionalization and sustainability of the program within the MOH. SLIPTA was launched in 6 MOH laboratories, and final audits demonstrated improvements across the 13 quality system essentials, compared with baseline. Training and mentorship of MOH staff by PPP volunteers resulted in 18 qualified auditors and 28 managers/quality officers capacitated to manage the improvement process in their laboratories. SLIPTA helps laboratories improve the quality and reliability of their service even in the absence of full accreditation. Local capacity building ensures sustainability by creating country buy-in, reducing costs of audits, and institutionalizing program management. Published by Oxford University Press for the Infectious Diseases Society of America 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Quality of Liver and Kidney Function Tests among Public Medical Laboratories in Western Region of Amhara National Regional State of Ethiopia.

PubMed

Teka, Abaynesh; Kibatu, Girma

2012-03-01

Medical laboratories play essential roles in measurements of substances in body fluids for the purpose of diagnosis, treatment, prevention, and for greater understanding of the disease process. Thus, data generated from have to be reliable for which strict quality control, management and assurance are maintained. The aim of this study is to assess the accuracy and precision of clinical chemistry laboratories in western region of Amhara national regional state of Ethiopia in testing liver and kidney functions. Eight laboratories in hospitals and a Regional Health Research Laboratory Center participated in this study from February to March, 2011. Each participant was requested to measure six specimens for six chemistry tests from two control samples. Three hundred twenty four test results to be reported from all participant laboratories, if all measurements can be made, were designed to be collected and statistically evaluated. None of the study subject laboratories could deliver all the six tests for estimation of both liver and renal functions simultaneously during the study period. Only 213 values from the expected 324 values were reported and about 65 % of the 213 values reported fell outside of the allowable limits of errors for the chemistry tests of the control specimen used. This study finding showed that there were lack of accuracy and precision in chemistry measurements. A regular survey on medical laboratories should be conducted questioning the accuracy and precision of their analyses in order to sustain improvements in the quality of services provided by participating laboratories for the benefit of patients. Laboratory Quality Management Systems appreciate the need for regular quality control and quality assessment schemes in medical laboratories.

LANDSAT TM image data quality analysis for energy-related applications

NASA Technical Reports Server (NTRS)

Wukelic, G. E.; Foote, H. P.; Petrie, G. M.; Barnard, J. C.; Eliason, J. R.

1985-01-01

This project represents a no-cost agreement between National Aeronautic Space Administration Goddard Space Flight Center (NASA GSFC) and the Pacific Northwest Laboratory (PNL). PNL is a Department of Energy (DOE) national laboratory operted by Battelle Memorial Institute at its Pacific Northwest Laboratories in Richland, Washington. The objective of this investigation is to evaluate LANDSAT's thematic mapper (TM) data quality and utility characteristics from an energy research and technological perspective. Of main interest is the extent to which repetitive TM data might support DOE efforts relating to siting, developing, and monitoring energy-related facilities, and to basic geoscientific research. The investigation utilizes existing staff and facility capabilities, and ongoing programmatic activities at PNL and other DOE national laboratories to cooperatively assess the potential usefulness of the improved experimental TM data. The investigation involves: (1) both LANDSAT 4 and 5 TM data, (2) qualitative and quantitative use consideration, and 3) NASA P (corrected) and A (uncorrected) CCT analysis for a variety of sites of DOE interest. Initial results were presented at the LANDSAT Investigator's Workshops and at specialized LANDSAT TM sessions at various conferences.

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.

[Tasks and duties of veterinary reference laboratories for food borne zoonoses].

PubMed

Ellerbroek, Lüppo; Alter, T; Johne, R; Nöckler, K; Beutin, L; Helmuth, R

2009-02-01

Reference laboratories are of central importance for consumer protection. Field expertise and high scientific competence are basic requirements for the nomination of a national reference laboratory. To ensure a common approach in the analysis of zoonotic hazards, standards have been developed by the reference laboratories together with national official laboratories on the basis of Art. 33 of Directive (EG) No. 882/2004. Reference laboratories function as arbitrative boards in the case of ambivalent or debatable results. New methods for detection of zoonotic agents are developed and validated to provide tools for analysis, e. g., in legal cases, if results from different parties are disputed. Besides these tasks, national reference laboratories offer capacity building and advanced training courses and control the performance of ring trials to ensure consistency in the quality of analyses in official laboratories. All reference laboratories work according to the ISO standard 17025 which defines the grounds for strict laboratory quality rules and in cooperation with the respective Community Reference Laboratories (CRL). From the group of veterinary reference laboratories for food-borne zoonoses, the national reference laboratories are responsible for Listeria monocytogenes, for Campylobacter, for the surveillance and control of viral and bacterial contamination of bivalve molluscs, for E. coli, for the performance of analysis and tests on zoonoses (Salmonella), and from the group of parasitological zoonotic agents, the national reference laboratory for Trichinella.

Setup, Validation and Quality Control of a Centralized WGS laboratory - Lessons Learned.

PubMed

Arnold, Cath; Edwards, Kirstin; Desai, Meeta; Platt, Steve; Green, Jonathan; Conway, David

2018-04-25

Routine use of Whole Genome analysis for infectious diseases can be used to enlighten various scenarios pertaining to Public Health, including identification of microbial pathogens; relating individual cases to an outbreak of infectious disease; establishing an association between an outbreak of food poisoning and a specific food vehicle; inferring drug susceptibility; source tracing of contaminants and study of variations in the genome affect pathogenicity/virulence. We describe the setup, validation and ongoing verification of a centralised WGS laboratory to carry out the sequencing for these public health functions for the National Infection Services, Public Health England in the UK. The performance characteristics and Quality Control metrics measured during validation and verification of the entire end to end process (accuracy, precision, reproducibility and repeatability) are described and include information regarding the automated pass and release of data to service users without intervention. © Crown copyright 2018.

Web-Based Virtual Laboratory for Food Analysis Course

NASA Astrophysics Data System (ADS)

Handayani, M. N.; Khoerunnisa, I.; Sugiarti, Y.

2018-02-01

Implementation of learning on food analysis course in Program Study of Agro-industrial Technology Education faced problems. These problems include the availability of space and tools in the laboratory that is not comparable with the number of students also lack of interactive learning tools. On the other hand, the information technology literacy of students is quite high as well the internet network is quite easily accessible on campus. This is a challenge as well as opportunities in the development of learning media that can help optimize learning in the laboratory. This study aims to develop web-based virtual laboratory as one of the alternative learning media in food analysis course. This research is R & D (research and development) which refers to Borg & Gall model. The results showed that assessment’s expert of web-based virtual labs developed, in terms of software engineering aspects; visual communication; material relevance; usefulness and language used, is feasible as learning media. The results of the scaled test and wide-scale test show that students strongly agree with the development of web based virtual laboratory. The response of student to this virtual laboratory was positive. Suggestions from students provided further opportunities for improvement web based virtual laboratory and should be considered for further research.

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.

Errors in clinical laboratories or errors in laboratory medicine?

PubMed

Plebani, Mario

2006-01-01

Laboratory testing is a highly complex process and, although laboratory services are relatively safe, they are not as safe as they could or should be. Clinical laboratories have long focused their attention on quality control methods and quality assessment programs dealing with analytical aspects of testing. However, a growing body of evidence accumulated in recent decades demonstrates that quality in clinical laboratories cannot be assured by merely focusing on purely analytical aspects. The more recent surveys on errors in laboratory medicine conclude that in the delivery of laboratory testing, mistakes occur more frequently before (pre-analytical) and after (post-analytical) the test has been performed. Most errors are due to pre-analytical factors (46-68.2% of total errors), while a high error rate (18.5-47% of total errors) has also been found in the post-analytical phase. Errors due to analytical problems have been significantly reduced over time, but there is evidence that, particularly for immunoassays, interference may have a serious impact on patients. A description of the most frequent and risky pre-, intra- and post-analytical errors and advice on practical steps for measuring and reducing the risk of errors is therefore given in the present paper. Many mistakes in the Total Testing Process are called "laboratory errors", although these may be due to poor communication, action taken by others involved in the testing process (e.g., physicians, nurses and phlebotomists), or poorly designed processes, all of which are beyond the laboratory's control. Likewise, there is evidence that laboratory information is only partially utilized. A recent document from the International Organization for Standardization (ISO) recommends a new, broader definition of the term "laboratory error" and a classification of errors according to different criteria. In a modern approach to total quality, centered on patients' needs and satisfaction, the risk of errors and mistakes

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.

Sandia National Laboratories Advanced Simulation and Computing (ASC) software quality plan : ASC software quality engineering practices Version 3.0.

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

Turgeon, Jennifer L.; Minana, Molly A.; Hackney, Patricia

2009-01-01

The purpose of the Sandia National Laboratories (SNL) Advanced Simulation and Computing (ASC) Software Quality Plan is to clearly identify the practices that are the basis for continually improving the quality of ASC software products. Quality is defined in the US Department of Energy/National Nuclear Security Agency (DOE/NNSA) Quality Criteria, Revision 10 (QC-1) as 'conformance to customer requirements and expectations'. This quality plan defines the SNL ASC Program software quality engineering (SQE) practices and provides a mapping of these practices to the SNL Corporate Process Requirement (CPR) 001.3.6; 'Corporate Software Engineering Excellence'. This plan also identifies ASC management's and themore » software project teams responsibilities in implementing the software quality practices and in assessing progress towards achieving their software quality goals. This SNL ASC Software Quality Plan establishes the signatories commitments to improving software products by applying cost-effective SQE practices. This plan enumerates the SQE practices that comprise the development of SNL ASC's software products and explains the project teams opportunities for tailoring and implementing the practices.« less

Field Methods and Quality-Assurance Plan for Quality-of-Water Activities, U.S. Geological Survey, Idaho National Laboratory, Idaho

USGS Publications Warehouse

Knobel, LeRoy L.; Tucker, Betty J.; Rousseau, Joseph P.

2008-01-01

Water-quality activities conducted by the staff of the U.S. Geological Survey (USGS) Idaho National Laboratory (INL) Project Office coincide with the USGS mission of appraising the quantity and quality of the Nation's water resources. The activities are conducted in cooperation with the U.S. Department of Energy's (DOE) Idaho Operations Office. Results of the water-quality investigations are presented in various USGS publications or in refereed scientific journals. The results of the studies are highly regarded, and they are used with confidence by researchers, regulatory and managerial agencies, and interested civic groups. In its broadest sense, quality assurance refers to doing the job right the first time. It includes the functions of planning for products, review and acceptance of the products, and an audit designed to evaluate the system that produces the products. Quality control and quality assurance differ in that quality control ensures that things are done correctly given the 'state-of-the-art' technology, and quality assurance ensures that quality control is maintained within specified limits.

[Statistical approach to evaluate the occurrence of out-of acceptable ranges and accuracy for antimicrobial susceptibility tests in inter-laboratory quality control program].

PubMed

Ueno, Tamio; Matuda, Junichi; Yamane, Nobuhisa

2013-03-01

To evaluate the occurrence of out-of acceptable ranges and accuracy of antimicrobial susceptibility tests, we applied a new statistical tool to the Inter-Laboratory Quality Control Program established by the Kyushu Quality Control Research Group. First, we defined acceptable ranges of minimum inhibitory concentration (MIC) for broth microdilution tests and inhibitory zone diameter for disk diffusion tests on the basis of Clinical and Laboratory Standards Institute (CLSI) M100-S21. In the analysis, more than two out-of acceptable range results in the 20 tests were considered as not allowable according to the CLSI document. Of the 90 participating laboratories, 46 (51%) experienced one or more occurrences of out-of acceptable range results. Then, a binomial test was applied to each participating laboratory. The results indicated that the occurrences of out-of acceptable range results in the 11 laboratories were significantly higher when compared to the CLSI recommendation (allowable rate < or = 0.05). The standard deviation indices(SDI) were calculated by using reported results, mean and standard deviation values for the respective antimicrobial agents tested. In the evaluation of accuracy, mean value from each laboratory was statistically compared with zero using a Student's t-test. The results revealed that 5 of the 11 above laboratories reported erroneous test results that systematically drifted to the side of resistance. In conclusion, our statistical approach has enabled us to detect significantly higher occurrences and source of interpretive errors in antimicrobial susceptibility tests; therefore, this approach can provide us with additional information that can improve the accuracy of the test results in clinical microbiology laboratories.

MICROBIAL LABORATORY GUIDANCE MANUAL FOR THE ...

EPA Pesticide Factsheets

The Long-Term 2 Enhanced Surface Water Treatment Rule Laboratory Instruction Manual will be a compilation of all information needed by laboratories and field personnel to collect, analyze, and report the microbiological data required under the rule. The manual will provide laboratories with a single source of information that currently is available from various sources including the latest versions of Methods 1622 and 1623, including all approved, equivalent modifications; the procedures for E.coli methods approved for use under the LT2ESWTR; lists of vendor sources; data recording forms; data reporting requirements; information on the Laboratory Quality Assurance Evaluation Program for the Analysis of Cryptosporidium in Water; and sample collection procedures. Although most of this information is available elsewhere, a single, comprehensive compendium containing this information is needed to aid utilities and laboratories performing the sampling and analysis activities required under the LT2 rule. This manual will serve as an instruction manual for laboratories to use when collecting data for Crypto, E. coli and turbidity.

Planetary Sample Analysis Laboratory at DLR

NASA Astrophysics Data System (ADS)

Helbert, J.; Maturilli, A.; de Vera, J. P.

2018-04-01

Building on the available infrastructure and the long heritage, DLR is planning to create a Planetary Sample Analysis laboratory (PSA), which can be later extended to a full sample curation facility in collaboration with the Robert-Koch Institute.

Improving patient safety through quality assurance.

PubMed

Raab, Stephen S

2006-05-01

Anatomic pathology laboratories use several quality assurance tools to detect errors and to improve patient safety. To review some of the anatomic pathology laboratory patient safety quality assurance practices. Different standards and measures in anatomic pathology quality assurance and patient safety were reviewed. Frequency of anatomic pathology laboratory error, variability in the use of specific quality assurance practices, and use of data for error reduction initiatives. Anatomic pathology error frequencies vary according to the detection method used. Based on secondary review, a College of American Pathologists Q-Probes study showed that the mean laboratory error frequency was 6.7%. A College of American Pathologists Q-Tracks study measuring frozen section discrepancy found that laboratories improved the longer they monitored and shared data. There is a lack of standardization across laboratories even for governmentally mandated quality assurance practices, such as cytologic-histologic correlation. The National Institutes of Health funded a consortium of laboratories to benchmark laboratory error frequencies, perform root cause analysis, and design error reduction initiatives, using quality assurance data. Based on the cytologic-histologic correlation process, these laboratories found an aggregate nongynecologic error frequency of 10.8%. Based on gynecologic error data, the laboratory at my institution used Toyota production system processes to lower gynecologic error frequencies and to improve Papanicolaou test metrics. Laboratory quality assurance practices have been used to track error rates, and laboratories are starting to use these data for error reduction initiatives.

SLIPTA e-Tool improves laboratory audit process in Vietnam and Cambodia.

PubMed

Nguyen, Thuong T; McKinney, Barbara; Pierson, Antoine; Luong, Khue N; Hoang, Quynh T; Meharwal, Sandeep; Carvalho, Humberto M; Nguyen, Cuong Q; Nguyen, Kim T; Bond, Kyle B

2014-01-01

The Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist is used worldwide to drive quality improvement in laboratories in developing countries and to assess the effectiveness of interventions such as the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme. However, the paper-based format of the checklist makes administration cumbersome and limits timely analysis and communication of results. In early 2012, the SLMTA team in Vietnam developed an electronic SLIPTA checklist tool. The e-Tool was pilot tested in Vietnam in mid-2012 and revised. It was used during SLMTA implementation in Vietnam and Cambodia in 2012 and 2013 and further revised based on auditors' feedback about usability. The SLIPTA e-Tool enabled rapid turn-around of audit results, reduced workload and language barriers and facilitated analysis of national results. Benefits of the e-Tool will be magnified with in-country scale-up of laboratory quality improvement efforts and potential expansion to other countries.

SLIPTA e-Tool improves laboratory audit process in Vietnam and Cambodia

PubMed Central

Nguyen, Thuong T.; McKinney, Barbara; Pierson, Antoine; Luong, Khue N.; Hoang, Quynh T.; Meharwal, Sandeep; Carvalho, Humberto M.; Nguyen, Cuong Q.; Nguyen, Kim T.

2014-01-01

Background The Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist is used worldwide to drive quality improvement in laboratories in developing countries and to assess the effectiveness of interventions such as the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme. However, the paper-based format of the checklist makes administration cumbersome and limits timely analysis and communication of results. Development of e-Tool In early 2012, the SLMTA team in Vietnam developed an electronic SLIPTA checklist tool. The e-Tool was pilot tested in Vietnam in mid-2012 and revised. It was used during SLMTA implementation in Vietnam and Cambodia in 2012 and 2013 and further revised based on auditors’ feedback about usability. Outcomes The SLIPTA e-Tool enabled rapid turn-around of audit results, reduced workload and language barriers and facilitated analysis of national results. Benefits of the e-Tool will be magnified with in-country scale-up of laboratory quality improvement efforts and potential expansion to other countries. PMID:29043190

ASBESTOS CONTAINING MATERIALS IN SCHOOL BUILDINGS: BULK SAMPLE ANALYSIS QUALITY ASSURANCE PROGRAM. BULK SAMPLE ROUNDS 12, 13 AND BLIND ROUND III

EPA Science Inventory

The report presents the results of laboratories participating in the twelveth, thirteenth and third (III) blind round of the bulk sample analysis quality assurance program sponsored by the U.S. Environmental Protection Agency. Three hundred twenty-three, 386 and 51 laboratories w...

Investigation and Analysis of Hemoglobin A1c Measurement Systems’ Performance for 135 Laboratories in China

PubMed Central

Zhao, Hai-Jian; Zhang, Tian-Jiao; Zeng, Jie; Hu, Cui-Hua; Ma, Rong; Zhang, Chuan-Bao

2017-01-01

Background: Hemoglobin A1c (HbA1c) measurement is of great value for the diagnosis and monitoring of diabetes. Many manufacturers have developed various experiments to determine the HbA1c concentration. However, the longitudinal use of these tests requires strict quality management. This study aimed to analyze the quality of HbA1c measurement systems in China using six sigma techniques to help improve their performances. Methods: A total of 135 laboratories were involved in this investigation in 2015. Bias values and coefficients of variation were collected from an HbA1c trueness verification external quality assessment program and an internal quality control program organized by the National Center of Clinical Laboratories in China. The sigma (σ) values and the quality goal index (QGI) were used to evaluate the performances of different groups, which were divided according to principles and instruments. Results: The majority of participants (88, 65.2%) were scored as “improvement needed (σ < 3)”, suggesting that the laboratories needed to improve their measurement performance. Only 8.2% (11/135) of the laboratories were scored as “world class (σ ≥ 6)”. Among all the 88 laboratories whose σ values were below 3, 52 (59.1%) and 23 (26.1%) laboratories needed to improve measurement precision (QGI <8.0) and trueness (QGI >1.2), respectively; the remaining laboratories (13, 14.8%) needed to improve both measurement precision and trueness. In addition, 16.1% (5/31) and 15.0% (3/20) of the laboratories in “TOSOH” and “ARKRAY” groups, respectively, were scored as “world class”, whereas none of the laboratories in “BIO-RAD” group were scored as “world class”. Conclusions: This study indicated that, although participating laboratories were laboratories with better performance in China, the performances were still unsatisfactory. Actions should be taken to improve HbA1c measurement performance before we can include HbA1c assays in diabetes

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.

Importance of the Primary Radioactivity Standard Laboratory and Implementation of its Quality Management

NASA Astrophysics Data System (ADS)

Sahagia, Maria; Razdolescu, Anamaria Cristina; Luca, Aurelian; Ivan, Constantin

2007-04-01

The paper presents some specific aspects of the implementation of the quality management in the Radionuclide Metrology Laboratory, from IFIN-HH, the owner of the primary Romanian standard in radioactivity. The description of the accreditation, according to the EN ISO/IEC 17025:2005, is presented.

Development and operation of a quality assurance system for deviations from standard operating procedures in a clinical cell therapy laboratory.

PubMed

McKenna, D; Kadidlo, D; Sumstad, D; McCullough, J

2003-01-01

Errors and accidents, or deviations from standard operating procedures, other policy, or regulations must be documented and reviewed, with corrective actions taken to assure quality performance in a cellular therapy laboratory. Though expectations and guidance for deviation management exist, a description of the framework for the development of such a program is lacking in the literature. Here we describe our deviation management program, which uses a Microsoft Access database and Microsoft Excel to analyze deviations and notable events, facilitating quality assurance (QA) functions and ongoing process improvement. Data is stored in a Microsoft Access database with an assignment to one of six deviation type categories. Deviation events are evaluated for potential impact on patient and product, and impact scores for each are determined using a 0- 4 grading scale. An immediate investigation occurs, and corrective actions are taken to prevent future similar events from taking place. Additionally, deviation data is collectively analyzed on a quarterly basis using Microsoft Excel, to identify recurring events or developing trends. Between January 1, 2001 and December 31, 2001 over 2500 products were processed at our laboratory. During this time period, 335 deviations and notable events occurred, affecting 385 products and/or patients. Deviations within the 'technical error' category were most common (37%). Thirteen percent of deviations had a patient and/or a product impact score > or = 2, a score indicating, at a minimum, potentially affected patient outcome or moderate effect upon product quality. Real-time analysis and quarterly review of deviations using our deviation management program allows for identification and correction of deviations. Monitoring of deviation trends allows for process improvement and overall successful functioning of the QA program in the cell therapy laboratory. Our deviation management program could serve as a model for other laboratories in

Quantification of histochemical stains using whole slide imaging: development of a method and demonstration of its usefulness in laboratory quality control.

PubMed

Gray, Allan; Wright, Alex; Jackson, Pete; Hale, Mike; Treanor, Darren

2015-03-01

Histochemical staining of tissue is a fundamental technique in tissue diagnosis and research, but it suffers from significant variability. Efforts to address this include laboratory quality controls and quality assurance schemes, but these rely on subjective interpretation of stain quality, are laborious and have low reproducibility. We aimed (1) to develop a method for histochemical stain quantification using whole slide imaging and image analysis and (2) to demonstrate its usefulness in measuring staining variation. A method to quantify the individual stain components of histochemical stains on virtual slides was developed. It was evaluated for repeatability and reproducibility, then applied to control sections of an appendix to quantify H&E staining (H/E intensities and H:E ratio) between automated staining machines and to measure differences between six regional diagnostic laboratories. The method was validated with <0.5% variation in H:E ratio measurement when using the same scanner for a batch of slides (ie, it was repeatable) but was not highly reproducible between scanners or over time, where variation of 7% was found. Application of the method showed H:E ratios between three staining machines varied from 0.69 to 0.93, H:E ratio variation over time was observed. Interlaboratory comparison demonstrated differences in H:E ratio between regional laboratories from 0.57 to 0.89. A simple method using whole slide imaging can be used to quantify and compare histochemical staining. This method could be deployed in routine quality assurance and quality control. Work is needed on whole slide imaging devices to improve reproducibility. 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.

Factoring quality laboratory diagnosis into the malaria control agenda for sub-Saharan Africa.

PubMed

Aidoo, Michael

2013-09-01

Recent progress in malaria control in sub-Saharan Africa has been achieved primarily through provision of insecticide-treated nets, indoor residual spraying, and antimalarial drugs. Although these interventions are important, proper case identification and accurate measurement of their impact depend on quality diagnostic testing. Current availability of diagnostic testing for malaria in sub-Saharan Africa is inadequate to support disease management, prevention programs, and surveillance needs. Challenges faced include a dearth of skilled workforce, inadequate health systems infrastructure, and lack of political will. A coordinated approach to providing pre-service clinical and laboratory training together with systems that support a scale-up of laboratory services could provide means not only for effective malaria case management but also, management of non-malaria febrile illnesses, disease surveillance, and accurate control program evaluation. A synthesis of the challenges faced in ensuring quality malaria testing and how to include this information in the malaria control and elimination agenda are presented.

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 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

Can current analytical quality performance of UK clinical laboratories support evidence-based guidelines for diabetes and ischaemic heart disease?--A pilot study and a proposal.

PubMed

Jassam, Nuthar; Yundt-Pacheco, John; Jansen, Rob; Thomas, Annette; Barth, Julian H

2013-08-01

The implementation of national and international guidelines is beginning to standardise clinical practice. However, since many guidelines have decision limits based on laboratory tests, there is an urgent need to ensure that different laboratories obtain the same analytical result on any sample. A scientifically-based quality control process will be a pre-requisite to provide this level of analytical performance which will support evidence-based guidelines and movement of patients across boundaries while maintaining standardised outcomes. We discuss the finding of a pilot study performed to assess UK clinical laboratories readiness to work to a higher grade quality specifications such as biological variation-based quality specifications. Internal quality control (IQC) data for HbA1c, glucose, creatinine, cholesterol and high density lipoprotein (HDL)-cholesterol were collected from UK laboratories participating in the Bio-Rad Unity QC programme. The median of the coefficient of variation (CV%) of the participating laboratories was evaluated against the CV% based on biological variation. Except creatinine, the other four analytes had a variable degree of compliance with the biological variation-based quality specifications. More than 75% of the laboratories met the biological variation-based quality specifications for glucose, cholesterol and HDL-cholesterol. Slightly over 50% of the laboratories met the analytical goal for HBA1c. Only one analyte (cholesterol) had a performance achieving the higher quality specifications consistent with 5σ. Our data from IQC do not consistently demonstrate that the results from clinical laboratories meet evidence-based quality specifications. Therefore, we propose that a graded scale of quality specifications may be needed at this stage.

Internal Quality Control Practices in Coagulation Laboratories: recommendations based on a patterns-of-practice survey.

PubMed

McFarlane, A; Aslan, B; Raby, A; Moffat, K A; Selby, R; Padmore, R

2015-12-01

Internal quality control (IQC) procedures are crucial for ensuring accurate patient test results. The IQMH Centre for Proficiency Testing conducted a web-based survey to gather information on the current IQC practices in coagulation testing. A questionnaire was distributed to 174 Ontario laboratories licensed to perform prothrombin time (PT) and activated partial thromboplastin time (APTT). All laboratories reported using two levels of commercial QC (CQC); 12% incorporate pooled patient plasma into their IQC program; >68% run CQC at the beginning of each shift; 56% following maintenance, with reagent changes, during a shift, or with every repeat sample; 6% only run CQC at the beginning of the day and 25% when the instruments have been idle for a defined period of time. IQC run frequency was determined by manufacturer recommendations (71%) but also influenced by the stability of test (27%), clinical impact of an incorrect test result (25%), and sample's batch number (10%). IQC was monitored using preset limits based on standard deviation (66%), precision goals (46%), or allowable performance limits (36%). 95% use multirules. Failure actions include repeating the IQC (90%) and reporting patient results; if repeat passes, 42% perform repeat analysis of all patient samples from last acceptable IQC. Variability exists in coagulation IQC practices among Ontario clinical laboratories. The recommendations presented here would be useful in encouraging standardized IQC practices. © 2015 John Wiley & Sons Ltd.

ASBESTOS-CONTAINING MATERIALS IN SCHOOL BUILDINGS: BULK SAMPLE ANALYSIS QUALITY ASSURANCE PROGRAM-BULK SAMPLE ROUNDS 9, 10, 11 AND BLIND ROUND 2

EPA Science Inventory

The report presents the results of laboratories participating in the nineth, tenth, eleventh and second blind round(s) of the bulk sample analysis quality assurance program sponsored by the U.S. Environmental Protection Agency. Two hundred fifty-four, 320, 318, and 50 laboratorie...

Benchmarking and the laboratory

PubMed Central

Galloway, M; Nadin, L

2001-01-01

This article describes how benchmarking can be used to assess laboratory performance. Two benchmarking schemes are reviewed, the Clinical Benchmarking Company's Pathology Report and the College of American Pathologists' Q-Probes scheme. The Clinical Benchmarking Company's Pathology Report is undertaken by staff based in the clinical management unit, Keele University with appropriate input from the professional organisations within pathology. Five annual reports have now been completed. Each report is a detailed analysis of 10 areas of laboratory performance. In this review, particular attention is focused on the areas of quality, productivity, variation in clinical practice, skill mix, and working hours. The Q-Probes scheme is part of the College of American Pathologists programme in studies of quality assurance. The Q-Probes scheme and its applicability to pathology in the UK is illustrated by reviewing two recent Q-Probe studies: routine outpatient test turnaround time and outpatient test order accuracy. The Q-Probes scheme is somewhat limited by the small number of UK laboratories that have participated. In conclusion, as a result of the government's policy in the UK, benchmarking is here to stay. Benchmarking schemes described in this article are one way in which pathologists can demonstrate that they are providing a cost effective and high quality service. Key Words: benchmarking • pathology PMID:11477112

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.

Magnetic resonance imaging in laboratory petrophysical core analysis

NASA Astrophysics Data System (ADS)

Mitchell, J.; Chandrasekera, T. C.; Holland, D. J.; Gladden, L. F.; Fordham, E. J.

2013-05-01

Magnetic resonance imaging (MRI) is a well-known technique in medical diagnosis and materials science. In the more specialized arena of laboratory-scale petrophysical rock core analysis, the role of MRI has undergone a substantial change in focus over the last three decades. Initially, alongside the continual drive to exploit higher magnetic field strengths in MRI applications for medicine and chemistry, the same trend was followed in core analysis. However, the spatial resolution achievable in heterogeneous porous media is inherently limited due to the magnetic susceptibility contrast between solid and fluid. As a result, imaging resolution at the length-scale of typical pore diameters is not practical and so MRI of core-plugs has often been viewed as an inappropriate use of expensive magnetic resonance facilities. Recently, there has been a paradigm shift in the use of MRI in laboratory-scale core analysis. The focus is now on acquiring data in the laboratory that are directly comparable to data obtained from magnetic resonance well-logging tools (i.e., a common physics of measurement). To maintain consistency with well-logging instrumentation, it is desirable to measure distributions of transverse (T2) relaxation time-the industry-standard metric in well-logging-at the laboratory-scale. These T2 distributions can be spatially resolved over the length of a core-plug. The use of low-field magnets in the laboratory environment is optimal for core analysis not only because the magnetic field strength is closer to that of well-logging tools, but also because the magnetic susceptibility contrast is minimized, allowing the acquisition of quantitative image voxel (or pixel) intensities that are directly scalable to liquid volume. Beyond simple determination of macroscopic rock heterogeneity, it is possible to utilize the spatial resolution for monitoring forced displacement of oil by water or chemical agents, determining capillary pressure curves, and estimating

[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.

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.

Quality improvement project in cervical cancer screening: practical measures for monitoring laboratory performance.

PubMed

Tarkkanen, Jussi; Geagea, Antoine; Nieminen, Pekka; Anttila, Ahti

2003-01-01

We conducted a quality improvement project in a cervical cancer screening programme in Helsinki in order to see if detection of precancerous lesions could be influenced by external (participation rate) and internal (laboratory praxis) quality measures. In order to increase the participation rate, a second personal invitation to Pap-test was mailed to nonparticipants of the first call. In order to improve the quality of screening, the cytotechnicians monitored their performance longitudinally by recording the number of slides reviewed per day, the pick-up rate of abnormal smears, the report of the consulting cytopathologist, and the number of histologically verified lesions detected from the cases that they had screened. Regular sessions were held to compare the histological findings with the cytological findings of all cases referred for colposcopy. No pressure was applied on the cytotechnicians to ensure that they felt comfortable with their daily workload. A total of 110 000 smears were screened for cervical cancer at the Helsinki City Hospital during 1996-99. Initially, the overall participation rate increased from 62% to 71%. The number of histologically confirmed precancerous lesions (CIN 1-3) more than doubled and their detection rate increased from 0.32% to 0.72%. Continuous education and feedback from daily work performance were important, yet rather inexpensive means in increasing laboratory performance. Additional measures are needed to further increase the participation rate. Impact of the quality measures on cancer incidence needs to be assessed later on.

Clinical laboratory as an economic model for business performance analysis.

PubMed

Buljanović, Vikica; Patajac, Hrvoje; Petrovecki, Mladen

2011-08-15

To perform SWOT (strengths, weaknesses, opportunities, and threats) analysis of a clinical laboratory as an economic model that may be used to improve business performance of laboratories by removing weaknesses, minimizing threats, and using external opportunities and internal strengths. Impact of possible threats to and weaknesses of the Clinical Laboratory at Našice General County Hospital business performance and use of strengths and opportunities to improve operating profit were simulated using models created on the basis of SWOT analysis results. The operating profit as a measure of profitability of the clinical laboratory was defined as total revenue minus total expenses and presented using a profit and loss account. Changes in the input parameters in the profit and loss account for 2008 were determined using opportunities and potential threats, and economic sensitivity analysis was made by using changes in the key parameters. The profit and loss account and economic sensitivity analysis were tools for quantifying the impact of changes in the revenues and expenses on the business operations of clinical laboratory. Results of simulation models showed that operational profit of €470 723 in 2008 could be reduced to only €21 542 if all possible threats became a reality and current weaknesses remained the same. Also, operational gain could be increased to €535 804 if laboratory strengths and opportunities were utilized. If both the opportunities and threats became a reality, the operational profit would decrease by €384 465. The operational profit of the clinical laboratory could be significantly reduced if all threats became a reality and the current weaknesses remained the same. The operational profit could be increased by utilizing strengths and opportunities as much as possible. This type of modeling may be used to monitor business operations of any clinical laboratory and improve its financial situation by implementing changes in the next fiscal

Improvement in the performance of external quality assessment in Korean HIV clinical laboratories using unrecalcified human plasma.

PubMed

Wang, Jin-Sook; Kee, Mee-Kyung; Choi, Byeong-Sun; Kim, Chan-Wha; Kim, Hyon-Suk; Kim, Sung Soon

2012-01-01

The external quality assessment schemes (EQAS) organizer provides a suitable program to monitor and improve the quality of human immunodeficiency virus (HIV) testing laboratories with EQAS panels prepared under various conditions. The aim of the current study was to investigate the effects of human plasma samples on the EQAS results of HIV obtained from hospital-based clinical laboratories. From 2007 to 2009, HIV EQAS panels consisted of four to six samples that consisted of undiluted positive and negative samples and were provided to laboratories twice per year. Up until the first half EQAS in 2008, EQAS panel materials were obtained by converting acid citrate dextrose treated plasma to serum via chemical treatment with CaCl2. Beginning with the second EQAS in 2008, all materials were prepared without the defibrination process. Approximately 300 HIV clinical laboratories participated in this program. The overall performance of clinical laboratories was shown to be improved when using unrecalcified plasma panels compared with recalcified panels. Significant differences were observed in EIA analyses of plasma for both positive (p<0.001) and negative (p<0.001) samples between the recalcified and unrecalcified groups. Our finding suggested that defibrination status of EQAS panels might affect the results of anti-HIV EQAS of Korean HIV testing laboratories.

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.

A web-based laboratory information system to improve quality of care of tuberculosis patients in Peru: functional requirements, implementation and usage statistics.

PubMed

Blaya, Joaquin A; Shin, Sonya S; Yagui, Martin J A; Yale, Gloria; Suarez, Carmen Z; Asencios, Luis L; Cegielski, J Peter; Fraser, Hamish S F

2007-10-28

Multi-drug resistant tuberculosis patients in resource-poor settings experience large delays in starting appropriate treatment and may not be monitored appropriately due to an overburdened laboratory system, delays in communication of results, and missing or error-prone laboratory data. The objective of this paper is to describe an electronic laboratory information system implemented to alleviate these problems and its expanding use by the Peruvian public sector, as well as examine the broader issues of implementing such systems in resource-poor settings. A web-based laboratory information system "e-Chasqui" has been designed and implemented in Peru to improve the timeliness and quality of laboratory data. It was deployed in the national TB laboratory, two regional laboratories and twelve pilot health centres. Using needs assessment and workflow analysis tools, e-Chasqui was designed to provide for improved patient care, increased quality control, and more efficient laboratory monitoring and reporting. Since its full implementation in March 2006, 29,944 smear microscopy, 31,797 culture and 7,675 drug susceptibility test results have been entered. Over 99% of these results have been viewed online by the health centres. High user satisfaction and heavy use have led to the expansion of e-Chasqui to additional institutions. In total, e-Chasqui will serve a network of institutions providing medical care for over 3.1 million people. The cost to maintain this system is approximately US$0.53 per sample or 1% of the National Peruvian TB program's 2006 budget. Electronic laboratory information systems have a large potential to improve patient care and public health monitoring in resource-poor settings. Some of the challenges faced in these settings, such as lack of trained personnel, limited transportation, and large coverage areas, are obstacles that a well-designed system can overcome. e-Chasqui has the potential to provide a national TB laboratory network in Peru

A web-based laboratory information system to improve quality of care of tuberculosis patients in Peru: functional requirements, implementation and usage statistics

PubMed Central

Blaya, Joaquin A; Shin, Sonya S; Yagui, Martin JA; Yale, Gloria; Suarez, Carmen Z; Asencios, Luis L; Cegielski, J Peter; Fraser, Hamish SF

2007-01-01

Background Multi-drug resistant tuberculosis patients in resource-poor settings experience large delays in starting appropriate treatment and may not be monitored appropriately due to an overburdened laboratory system, delays in communication of results, and missing or error-prone laboratory data. The objective of this paper is to describe an electronic laboratory information system implemented to alleviate these problems and its expanding use by the Peruvian public sector, as well as examine the broader issues of implementing such systems in resource-poor settings. Methods A web-based laboratory information system "e-Chasqui" has been designed and implemented in Peru to improve the timeliness and quality of laboratory data. It was deployed in the national TB laboratory, two regional laboratories and twelve pilot health centres. Using needs assessment and workflow analysis tools, e-Chasqui was designed to provide for improved patient care, increased quality control, and more efficient laboratory monitoring and reporting. Results Since its full implementation in March 2006, 29,944 smear microscopy, 31,797 culture and 7,675 drug susceptibility test results have been entered. Over 99% of these results have been viewed online by the health centres. High user satisfaction and heavy use have led to the expansion of e-Chasqui to additional institutions. In total, e-Chasqui will serve a network of institutions providing medical care for over 3.1 million people. The cost to maintain this system is approximately US$0.53 per sample or 1% of the National Peruvian TB program's 2006 budget. Conclusion Electronic laboratory information systems have a large potential to improve patient care and public health monitoring in resource-poor settings. Some of the challenges faced in these settings, such as lack of trained personnel, limited transportation, and large coverage areas, are obstacles that a well-designed system can overcome. e-Chasqui has the potential to provide a national

Historical return on investment and improved quality resulting from development and mining of a hospital laboratory relational database.

PubMed

Brimhall, Bradley B; Hall, Timothy E; Walczak, Steven

2006-01-01

A hospital laboratory relational database, developed over eight years, has demonstrated significant cost savings and a substantial financial return on investment (ROI). In addition, the database has been used to measurably improve laboratory operations and the quality of patient care.

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.

[Development of laboratory sequence analysis software based on WWW and UNIX].

PubMed

Huang, Y; Gu, J R

2001-01-01

Sequence analysis tools based on WWW and UNIX were developed in our laboratory to meet the needs of molecular genetics research in our laboratory. General principles of computer analysis of DNA and protein sequences were also briefly discussed in this paper.

Improved Specimen-Referral System and Increased Access to Quality Laboratory Services in Ethiopia: The Role of the Public-Private Partnership

PubMed Central

Kebede, Yenew; Fonjungo, Peter N.; Tibesso, Gudeta; Shrivastava, Ritu; Nkengasong, John N.; Kenyon, Thomas; Kebede, Amha; Gadde, Renuka; Ayana, Gonfa

2016-01-01

Background. Nonstandardized specimen-transport logistics, lack of laboratory personnel to transport specimens, lack of standard specimen containers, and long turnaround time (TAT) hindered access to quality laboratory services. The objective of the Becton, Dickinson, and Company (BD)–US President's Emergency Plan for AIDS Relief (PEPFAR) Public-Private Partnership (PPP) was to support country-specific programs to develop integrated laboratory systems, services, and quality improvement strategies, with an emphasis on strengthening the specimen-referral system (SRS). Methods. In 2007, through the Centers for Disease Control and Prevention (CDC), the Ethiopian Public Health Institute (EPHI) joined with the BD-PEPFAR PPP to strengthen laboratory systems. A joint planning and assessment committee identified gaps in the SRS for prioritization and intervention and piloted the system in Addis Ababa and Amhara Region. Results. The PPP established standardized, streamlined specimen logistics, using the Ethiopian Postal Service Enterprise to support a laboratory network in which 554 facilities referred specimens to 160 laboratories. The PPP supported procuring 400 standard specimen containers and the training of 586 laboratory personnel and 81 postal workers. The average TAT was reduced from 7 days (range, 2–14 days) to 2 days (range, 1–3 days) in Addis Ababa and from 10 days (range, 6–21 days) to 5 days (range, 2–6 days) in Amhara Region. Conclusions. This study highlights the feasibility and untapped potential of PPPs to strengthen laboratory systems. This planned and structured approach to improving specimen referral enhanced access to quality laboratory services. PMID:27025700

[Quality Management System in Pathological Laboratory].

PubMed

Koyatsu, Junichi; Ueda, Yoshihiko

2015-07-01

Even compared to other clinical laboratories, the pathological laboratory conducts troublesome work, and many of the work processes are also manual. Therefore, the introduction of the systematic management of administration is necessary. It will be a shortcut to use existing standards such as ISO 15189 for this purpose. There is no standard specialized for the pathological laboratory, but it is considered to be important to a pathological laboratory in particular. 1. Safety nianagement of the personnel and environmental conditions. Comply with laws and regulations concerning the handling of hazardous materials. 2. Pre-examination processes. The laboratory shall have documented procedures for the proper collection and handling of primary samples. Developed and documented criteria for acceptance or rejection of samples are applied. 3. Examination processes. Selection, verification, and validation of the examination procedures. Devise a system that can constantly monitor the traceability of the sample. 4. Post-examination processes. Storage, retention, and disposal of clinical samples. 5. Release of results. When examination results fall within established alert or critical intervals, immediately notify the physicians. The important point is to recognize the needs of the client and be aware that pathological diagnoses are always "the final diagnoses".

Using Focused Laboratory Management and Quality Improvement Projects to Enhance Resident Training and Foster Scholarship

PubMed Central

Ford, Bradley A.; Klutts, J. Stacey; Jensen, Chris S.; Briggs, Angela S.; Robinson, Robert A.; Bruch, Leslie A.; Karandikar, Nitin J.

2017-01-01

Training in patient safety, quality, and management is widely recognized as an important element of graduate medical education. These concepts have been intertwined in pathology graduate medical education for many years, although training programs face challenges in creating explicit learning opportunities in these fields. Tangibly involving pathology residents in management and quality improvement projects has the potential to teach and reinforce key concepts and further fulfill Accreditation Council for Graduate Medical Education goals for pursuing projects related to patient safety and quality improvement. In this report, we present our experience at a pathology residency program (University of Iowa) in engaging pathology residents in projects related to practical issues of laboratory management, process improvement, and informatics. In this program, at least 1 management/quality improvement project, typically performed during a clinical chemistry/management rotation, was required and ideally resulted in a journal publication. The residency program also initiated a monthly management/informatics series for pathology externs, residents, and fellows that covers a wide range of topics. Since 2010, all pathology residents at the University of Iowa have completed at least 1 management/quality improvement project. Many of the projects involved aspects of laboratory test utilization, with some projects focused on other areas such as human resources, informatics, or process improvement. Since 2012, 31 peer-reviewed journal articles involving effort from 26 residents have been published. Multiple projects resulted in changes in ongoing practice, particularly within the hospital electronic health record. Focused management/quality improvement projects involving pathology residents can result in both meaningful quality improvement and scholarly output. PMID:28913416

Using Focused Laboratory Management and Quality Improvement Projects to Enhance Resident Training and Foster Scholarship.

PubMed

Krasowski, Matthew D; Ford, Bradley A; Klutts, J Stacey; Jensen, Chris S; Briggs, Angela S; Robinson, Robert A; Bruch, Leslie A; Karandikar, Nitin J

2017-01-01

Training in patient safety, quality, and management is widely recognized as an important element of graduate medical education. These concepts have been intertwined in pathology graduate medical education for many years, although training programs face challenges in creating explicit learning opportunities in these fields. Tangibly involving pathology residents in management and quality improvement projects has the potential to teach and reinforce key concepts and further fulfill Accreditation Council for Graduate Medical Education goals for pursuing projects related to patient safety and quality improvement. In this report, we present our experience at a pathology residency program (University of Iowa) in engaging pathology residents in projects related to practical issues of laboratory management, process improvement, and informatics. In this program, at least 1 management/quality improvement project, typically performed during a clinical chemistry/management rotation, was required and ideally resulted in a journal publication. The residency program also initiated a monthly management/informatics series for pathology externs, residents, and fellows that covers a wide range of topics. Since 2010, all pathology residents at the University of Iowa have completed at least 1 management/quality improvement project. Many of the projects involved aspects of laboratory test utilization, with some projects focused on other areas such as human resources, informatics, or process improvement. Since 2012, 31 peer-reviewed journal articles involving effort from 26 residents have been published. Multiple projects resulted in changes in ongoing practice, particularly within the hospital electronic health record. Focused management/quality improvement projects involving pathology residents can result in both meaningful quality improvement and scholarly output.

Intraoral laser welding: ultrastructural and mechanical analysis to compare laboratory laser and dental laser.

PubMed

Fornaini, Carlo; Passaretti, Francesca; Villa, Elena; Rocca, Jean-Paul; Merigo, Elisabetta; Vescovi, Paolo; Meleti, Marco; Manfredi, Maddalena; Nammour, Samir

2011-07-01

The Nd:YAG laser has been used since 1970 in dental laboratories to weld metals on dental prostheses. Recently in several clinical cases, we have suggested that the Nd:YAG laser device commonly utilized in the dental office could be used to repair broken fixed, removable and orthodontic prostheses and to weld metals directly in the mouth. The aim of this work was to evaluate, using scanning electron microscopy (SEM), energy dispersive X-ray spectroscopy (EDS) and dynamic mechanical analysis (DMA), the quality of the weld and its mechanical strength, comparing a device normally used in dental laboratory and a device normally used in the dental office for oral surgery, the same as that described for intraoral welding. Metal plates of a Co-Cr-Mo dental alloy and steel orthodontic wires were subjected to four welding procedures: welding without filler metal using the laboratory laser, welding with filler metal using the laboratory laser, welding without filler metal using the office laser, and welding with filler metal using the office laser. The welded materials were then analysed by SEM, EDS and DMA. SEM analysis did not show significant differences between the samples although the plates welded using the office laser without filler metal showed a greater number of fissures than the other samples. EDS microanalysis of the welding zone showed a homogeneous composition of the metals. Mechanical tests showed similar elastic behaviours of the samples, with minimal differences between the samples welded with the two devices. No wire broke even under the maximum force applied by the analyser. This study seems to demonstrate that the welds produced using the office Nd:YAG laser device and the laboratory Nd:YAG laser device, as analysed by SEM, EDS and DMA, showed minimal and nonsignificant differences, although these findings need to be confirmed using a greater number of samples.

Idaho National Laboratory Quarterly Occurrence Analysis for the 1st Quarter FY2017

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

Mitchell, Lisbeth Ann

This report is published quarterly by the Idaho National Laboratory (INL) Quality and Performance Management Organization. The Department of Energy (DOE) Occurrence Reporting and Processing System (ORPS), as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of 82 reportable events (13 from the 1st quarter (Qtr) of fiscal year (FY) 2017 and 68 from the prior three reporting quarters), as well as 31 other issue reports (including events found to be not reportable and Significantmore » Category A and B conditions) identified at INL during the past 12 months (seven from this quarter and 24 from the prior three quarters).« less

RAS screening in colorectal cancer: a comprehensive analysis of the results from the UK NEQAS colorectal cancer external quality assurance schemes (2009-2016).

PubMed

Richman, Susan D; Fairley, Jennifer; Butler, Rachel; Deans, Zandra C

2017-12-01

Evidence strongly indicates that extended RAS testing should be undertaken in mCRC patients, prior to prescribing anti-EGFR therapies. With more laboratories implementing testing, the requirement for External Quality Assurance schemes increases, thus ensuring high standards of molecular analysis. Data was analysed from 15 United Kingdom National External Quality Assessment Service (UK NEQAS) for Molecular Genetics Colorectal cancer external quality assurance (EQA) schemes, delivered between 2009 and 2016. Laboratories were provided annually with nine colorectal tumour samples for genotyping. Information on methodology and extent of testing coverage was requested, and scores given for genotyping, interpretation and clerical accuracy. There has been a sixfold increase in laboratory participation (18 in 2009 to 108 in 2016). For RAS genotyping, fewer laboratories now use Roche cobas®, pyrosequencing and Sanger sequencing, with more moving to next generation sequencing (NGS). NGS is the most commonly employed technology for BRAF and PIK3CA mutation screening. KRAS genotyping errors were seen in ≤10% laboratories, until the 2014-2015 scheme, when there was an increase to 16.7%, corresponding to a large increase in scheme participants. NRAS genotyping errors peaked at 25.6% in the first 2015-2016 scheme but subsequently dropped to below 5%. Interpretation and clerical accuracy scores have been consistently good throughout. Within this EQA scheme, we have observed that the quality of molecular analysis for colorectal cancer has continued to improve, despite changes in the required targets, the volume of testing and the technologies employed. It is reassuring to know that laboratories clearly recognise the importance of participating in EQA schemes.

Power Supplies for Space Systems Quality Assurance by Sandia Laboratories

DOE R&D Accomplishments Database

Hannigan, R. L.; Harnar, R. R.

1976-07-01

The Sandia Laboratories` participation in Quality Assurance programs for Radioisotopic Thermoelectric Generators which have been used in space systems over the past 10 years is summarized. Basic elements of this QA program are briefly described and recognition of assistance from other Sandia organizations is included. Descriptions of the various systems for which Sandia has had the QA responsibility are presented, including SNAP 19 (Nimbus, Pioneer, Viking), SNAP 27 (Apollo), Transit, Multi Hundred Watt (LES 8/9 and MJS), and a new program, High Performance Generator Mod 3. The outlook for Sandia participation in RTG programs for the next several years is noted.

Clinical laboratory as an economic model for business performance analysis

PubMed Central

Buljanović, Vikica; Patajac, Hrvoje; Petrovečki, Mladen

2011-01-01

Aim To perform SWOT (strengths, weaknesses, opportunities, and threats) analysis of a clinical laboratory as an economic model that may be used to improve business performance of laboratories by removing weaknesses, minimizing threats, and using external opportunities and internal strengths. Methods Impact of possible threats to and weaknesses of the Clinical Laboratory at Našice General County Hospital business performance and use of strengths and opportunities to improve operating profit were simulated using models created on the basis of SWOT analysis results. The operating profit as a measure of profitability of the clinical laboratory was defined as total revenue minus total expenses and presented using a profit and loss account. Changes in the input parameters in the profit and loss account for 2008 were determined using opportunities and potential threats, and economic sensitivity analysis was made by using changes in the key parameters. The profit and loss account and economic sensitivity analysis were tools for quantifying the impact of changes in the revenues and expenses on the business operations of clinical laboratory. Results Results of simulation models showed that operational profit of €470 723 in 2008 could be reduced to only €21 542 if all possible threats became a reality and current weaknesses remained the same. Also, operational gain could be increased to €535 804 if laboratory strengths and opportunities were utilized. If both the opportunities and threats became a reality, the operational profit would decrease by €384 465. Conclusion The operational profit of the clinical laboratory could be significantly reduced if all threats became a reality and the current weaknesses remained the same. The operational profit could be increased by utilizing strengths and opportunities as much as possible. This type of modeling may be used to monitor business operations of any clinical laboratory and improve its financial situation by

Clinical laboratory accreditation in India.

PubMed

Handoo, Anil; Sood, Swaroop Krishan

2012-06-01

Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.

Capability of the Gas Analysis and Testing Laboratory at the NASA Johnson Space Center

NASA Technical Reports Server (NTRS)

Broerman, Craig; Jimenez, Javier; Sweterlitsch, Jeff

2012-01-01

The Gas Analysis and Testing Laboratory is an integral part of the testing performed at the NASA Johnson Space Center. The Gas Analysis and Testing Laboratory is a high performance laboratory providing real time analytical instruments to support manned and unmanned testing. The lab utilizes precision gas chromatographs, gas analyzers and spectrophotometers to support the technology development programs within the NASA community. The Gas Analysis and Testing Laboratory works with a wide variety of customers and provides engineering support for user-specified applications in compressed gas, chemical analysis, general and research laboratory.

Capability of the Gas Analysis and Testing Laboratory at the NASA Johnson Space Center

NASA Technical Reports Server (NTRS)

Broerman, Craig; Jimenez, Javier; Sweterlitsch, Jeff

2011-01-01

The Gas Analysis and Testing Laboratory is an integral part of the testing performed at the NASA Johnson Space Center. The Gas Analysis and Testing Laboratory is a high performance laboratory providing real time analytical instruments to support manned and unmanned testing. The lab utilizes precision gas chromatographs, gas analyzers and spectrophotometers to support the technology development programs within the NASA community. The Gas Analysis and Testing Laboratory works with a wide variety of customers and provides engineering support for user-specified applications in compressed gas, chemical analysis, general and research laboratory

Quality Indexes and Feasibility Analysis of Traditional Dried Anchovy From Buru Island

NASA Astrophysics Data System (ADS)

Krisanta Enda Savitri, Imelda; Sormin, R. B. D.; Silaban, Bernita

2017-10-01

Dried anchovy is a prominent fishery product in Buru Island Maluku. It is produce traditionally in villages Batuboi and Siahoni at Kayeli bay. Drying process was done in open air under the sun directly during two days to produce dried anchovy with a prospective marketable. This preliminary research was aimed to investigated the quality indexes and business feasibility of dried anchovy produced by processor comunity. The quality index was found by laboratory analysis of sample dried anchovy referring to Indonesian National Standard. The data for feasibility analysis was found by interview and by using quesioner list. The average Quality indexes of dried anchovy as follows: Water 14.22 grams percent; Protein 55.68 grams percent; Fat 2.29 grams percent; Ash 9.02 grams percent; Total Bacteri (TPC) 3,5 × 102-; organoleptic value 7.79; E. coli, Salmonella and Mold were unidentified. Total cost of dried anchovy production is 37,050,720 Rupiahs/year with the income was 224,000,000 Rupiahs/year. Total profit is 217,824,880 Rupiahs/year and the Revenue Cost ratio was 6.05. Dried anchovy from Buru Island has a good quality and also has a good business feasibility.

Improved Specimen-Referral System and Increased Access to Quality Laboratory Services in Ethiopia: The Role of the Public-Private Partnership.

PubMed

Kebede, Yenew; Fonjungo, Peter N; Tibesso, Gudeta; Shrivastava, Ritu; Nkengasong, John N; Kenyon, Thomas; Kebede, Amha; Gadde, Renuka; Ayana, Gonfa

2016-04-15

Nonstandardized specimen-transport logistics, lack of laboratory personnel to transport specimens, lack of standard specimen containers, and long turnaround time (TAT) hindered access to quality laboratory services. The objective of the Becton, Dickinson, and Company (BD)-US President's Emergency Plan for AIDS Relief (PEPFAR) Public-Private Partnership (PPP) was to support country-specific programs to develop integrated laboratory systems, services, and quality improvement strategies, with an emphasis on strengthening the specimen-referral system (SRS). In 2007, through the Centers for Disease Control and Prevention (CDC), the Ethiopian Public Health Institute (EPHI) joined with the BD-PEPFAR PPP to strengthen laboratory systems. A joint planning and assessment committee identified gaps in the SRS for prioritization and intervention and piloted the system in Addis Ababa and Amhara Region. The PPP established standardized, streamlined specimen logistics, using the Ethiopian Postal Service Enterprise to support a laboratory network in which 554 facilities referred specimens to 160 laboratories. The PPP supported procuring 400 standard specimen containers and the training of 586 laboratory personnel and 81 postal workers. The average TAT was reduced from 7 days (range, 2-14 days) to 2 days (range, 1-3 days) in Addis Ababa and from 10 days (range, 6-21 days) to 5 days (range, 2-6 days) in Amhara Region. This study highlights the feasibility and untapped potential of PPPs to strengthen laboratory systems. This planned and structured approach to improving specimen referral enhanced access to quality laboratory services. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Improvement of coagulation laboratory practice in Thailand: the first-year experience of the national external quality assessment scheme for blood coagulation.

PubMed

Tientadakul, Panutsaya; Opartkiattikul, Nisarat; Wongtiraporn, Wanida

2009-01-01

In Thailand until 2005 there had been no external quality assessment scheme at the national level for blood coagulation tests. Only a few laboratories had an external quality assessment for these tests. In the year 2005, the Thailand National External Quality Assessment Scheme for Blood Coagulation was founded. To describe the establishment of the Thailand National External Quality Assessment Scheme for Blood Coagulation (including problems encountered and solutions), its progression and expansion, and the improvement of coagulation laboratory practice in Thailand during 2 trial surveys and 4 formal surveys conducted in the first 1 1/2 years. Between 2005 and 2006, the external quality assessment samples for prothrombin time/international normalized ratio and activated partial thromboplastin time were distributed to the participants as well as the instructions and suggestions for the improvement of laboratory practice. From the data collected, the all-method coefficient of variation of the international normalized ratio and activated partial thromboplastin time was calculated for each survey. The number of participants increased during the first 1 1/2 years that the surveys were conducted, from 109 to 127. Survey data demonstrate an improvement in response rate and an increase in the number of laboratories that determine their own reference ranges and repeat this for every change of reagent lot, using the appropriate anticoagulant. The increased precision of tests is indicated by the decrease of the all-method coefficient of variation of the international normalized ratio and activated partial thromboplastin time. Examples of individual laboratory improvement through feedback are also described. The improvement of coagulation laboratory practice both through the instructions provided and liaison with participants was observed during the course of this scheme.

Sandia National Laboratories Advanced Simulation and Computing (ASC) software quality plan. Part 1 : ASC software quality engineering practices version 1.0.

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

Minana, Molly A.; Sturtevant, Judith E.; Heaphy, Robert

2005-01-01

The purpose of the Sandia National Laboratories (SNL) Advanced Simulation and Computing (ASC) Software Quality Plan is to clearly identify the practices that are the basis for continually improving the quality of ASC software products. Quality is defined in DOE/AL Quality Criteria (QC-1) as conformance to customer requirements and expectations. This quality plan defines the ASC program software quality practices and provides mappings of these practices to the SNL Corporate Process Requirements (CPR 1.3.2 and CPR 1.3.6) and the Department of Energy (DOE) document, ASCI Software Quality Engineering: Goals, Principles, and Guidelines (GP&G). This quality plan identifies ASC management andmore » software project teams' responsibilities for cost-effective software engineering quality practices. The SNL ASC Software Quality Plan establishes the signatories commitment to improving software products by applying cost-effective software engineering quality practices. This document explains the project teams opportunities for tailoring and implementing the practices; enumerates the practices that compose the development of SNL ASC's software products; and includes a sample assessment checklist that was developed based upon the practices in this document.« less

Guidelines to implement quality management systems in microbiology laboratories for tissue banking.

PubMed

Vicentino, W; Rodríguez, G; Saldías, M; Alvarez, I

2009-10-01

Human tissues for implants are a biomedical product that is being used more frequently by many medical disciplines. There are infections in the patients related to the implanted tissues. The early detection of infections transmitted by blood and the microbiological study of tissues before their clinical use are strategies in tissue banks to prevent these situations. This work sought to contribute to establish the bases for the operation of a laboratory applied to the microbiological quality control of tissues. Based on classical microbiological principles, we defined the operation of microbiological control and tissues sterilization since 2003. We determine lists of acceptable microorganisms for every tissue, criteria for the interpretation of results, and a diagnostic algorithm of microbiological quality. We observed that the circumstances of donor death can be a determinant of the quality. The environment and the operator should be investigated as probable sources of contamination in outbreaks. The criteria of work based on a solid methodology must help to avoid the transmission of infections between donor and recipient. This is a critical point in the quality management of a tissue bank.

Pathology economic model tool: a novel approach to workflow and budget cost analysis in an anatomic pathology laboratory.

PubMed

Muirhead, David; Aoun, Patricia; Powell, Michael; Juncker, Flemming; Mollerup, Jens

2010-08-01

The need for higher efficiency, maximum quality, and faster turnaround time is a continuous focus for anatomic pathology laboratories and drives changes in work scheduling, instrumentation, and management control systems. To determine the costs of generating routine, special, and immunohistochemical microscopic slides in a large, academic anatomic pathology laboratory using a top-down approach. The Pathology Economic Model Tool was used to analyze workflow processes at The Nebraska Medical Center's anatomic pathology laboratory. Data from the analysis were used to generate complete cost estimates, which included not only materials, consumables, and instrumentation but also specific labor and overhead components for each of the laboratory's subareas. The cost data generated by the Pathology Economic Model Tool were compared with the cost estimates generated using relative value units. Despite the use of automated systems for different processes, the workflow in the laboratory was found to be relatively labor intensive. The effect of labor and overhead on per-slide costs was significantly underestimated by traditional relative-value unit calculations when compared with the Pathology Economic Model Tool. Specific workflow defects with significant contributions to the cost per slide were identified. The cost of providing routine, special, and immunohistochemical slides may be significantly underestimated by traditional methods that rely on relative value units. Furthermore, a comprehensive analysis may identify specific workflow processes requiring improvement.

Methodological considerations for implementation of lymphocyte subset analysis in a clinical reference laboratory.

PubMed

Muirhead, K A; Wallace, P K; Schmitt, T C; Frescatore, R L; Franco, J A; Horan, P K

1986-01-01

As the diagnostic utility of lymphocyte subset analysis has been recognized in the clinical research laboratory, a wide variety of reagents and cell preparation, staining and analysis methods have also been described. Methods that are perfectly suitable for analysis of smaller sample numbers in the biological or clinical research setting are not always appropriate and/or applicable in the setting of a high volume clinical reference laboratory. We describe here some of the specific considerations involved in choosing a method for flow cytometric analysis which minimizes sample preparation and data analysis time while maximizing sample stability, viability, and reproducibility. Monoclonal T- and B-cell reagents from three manufacturers were found to give equivalent results for a reference population of healthy individuals. This was true whether direct or indirect immunofluorescence staining was used and whether cells were prepared by Ficoll-Hypaque fractionation (FH) or by lysis of whole blood. When B cells were enumerated using a polyclonal anti-immunoglobulin reagent, less cytophilic immunoglobulin staining was present after lysis than after FH preparation. However, both preparation methods required additional incubation at 37 degrees C to obtain results concordant with monoclonal B-cell reagents. Standard reagents were chosen on the basis of maximum positive/negative separation and the availability of appropriate negative controls. The effects of collection medium and storage conditions on sample stability and reproducibility of subset analysis were also assessed. Specimens collected in heparin and stored at room temperature in buffered medium gave reproducible results for 3 days after specimen collection, using either FH or lysis as the preparation method. General strategies for instrument optimization, quality control, and biohazard containment are also discussed.

[The quality management in clinical diagnostic laboratory in conditions of the Federal Center of traumatology, orthopedics and endoprosthesis replacement of Minzdrav of Russia (Cheboksary)].

PubMed

Nikolaev, N S; Nazarova, V V; Dobrovol'skaia, N Iu; Orlova, A V; Pchelova, N N

2014-10-01

The article presents experience of clinical diagnostic laboratory of the Federal Center of traumatology, orthopedics and endoprosthesis replacement of Minzdrav of Russia (Cheboksary) in the area of quality management of medical laboratory services on the basis of evaluation of efficacy and effectiveness of processes. The factors effecting quality of functioning of clinical diagnostic laboratory are indicated. The criteria and indicators of efficacy of work of employees of clinical diagnostic laboratory are presented.

Establishment of National Laboratory Standards in Public and Private Hospital Laboratories

PubMed Central

ANJARANI, Soghra; SAFADEL, Nooshafarin; DAHIM, Parisa; AMINI, Rana; MAHDAVI, Saeed; MIRAB SAMIEE, Siamak

2013-01-01

In September 2007 national standard manual was finalized and officially announced as the minimal quality requirements for all medical laboratories in the country. Apart from auditing laboratories, Reference Health Laboratory has performed benchmarking auditing of medical laboratory network (surveys) in provinces. 12th benchmarks performed in Tehran and Alborz provinces, Iran in 2010 in three stages. We tried to compare different processes, their quality and accordance with national standard measures between public and private hospital laboratories. The assessment tool was a standardized checklist consists of 164 questions. Analyzing process show although in most cases implementing the standard requirements are more prominent in private laboratories, there is still a long way to complete fulfillment of requirements, and it takes a lot of effort. Differences between laboratories in public and private sectors especially in laboratory personnel and management process are significant. Probably lack of motivation, plays a key role in obtaining less desirable results in laboratories in public sectors. PMID:23514840

Determining the optimal forensic DNA analysis procedure following investigation of sample quality.

PubMed

Hedell, Ronny; Hedman, Johannes; Mostad, Petter

2018-07-01

Crime scene traces of various types are routinely sent to forensic laboratories for analysis, generally with the aim of addressing questions about the source of the trace. The laboratory may choose to analyse the samples in different ways depending on the type and quality of the sample, the importance of the case and the cost and performance of the available analysis methods. Theoretically well-founded guidelines for the choice of analysis method are, however, lacking in most situations. In this paper, it is shown how such guidelines can be created using Bayesian decision theory. The theory is applied to forensic DNA analysis, showing how the information from the initial qPCR analysis can be utilized. It is assumed the alternatives for analysis are using a standard short tandem repeat (STR) DNA analysis assay, using the standard assay and a complementary assay, or the analysis may be cancelled following quantification. The decision is based on information about the DNA amount and level of DNA degradation of the forensic sample, as well as case circumstances and the cost for analysis. Semi-continuous electropherogram models are used for simulation of DNA profiles and for computation of likelihood ratios. It is shown how tables and graphs, prepared beforehand, can be used to quickly find the optimal decision in forensic casework.

Propagating Water Quality Analysis Uncertainty Into Resource Management Decisions Through Probabilistic Modeling

NASA Astrophysics Data System (ADS)

Gronewold, A. D.; Wolpert, R. L.; Reckhow, K. H.

2007-12-01

Most probable number (MPN) and colony-forming-unit (CFU) are two estimates of fecal coliform bacteria concentration commonly used as measures of water quality in United States shellfish harvesting waters. The MPN is the maximum likelihood estimate (or MLE) of the true fecal coliform concentration based on counts of non-sterile tubes in serial dilution of a sample aliquot, indicating bacterial metabolic activity. The CFU is the MLE of the true fecal coliform concentration based on the number of bacteria colonies emerging on a growth plate after inoculation from a sample aliquot. Each estimating procedure has intrinsic variability and is subject to additional uncertainty arising from minor variations in experimental protocol. Several versions of each procedure (using different sized aliquots or different numbers of tubes, for example) are in common use, each with its own levels of probabilistic and experimental error and uncertainty. It has been observed empirically that the MPN procedure is more variable than the CFU procedure, and that MPN estimates are somewhat higher on average than CFU estimates, on split samples from the same water bodies. We construct a probabilistic model that provides a clear theoretical explanation for the observed variability in, and discrepancy between, MPN and CFU measurements. We then explore how this variability and uncertainty might propagate into shellfish harvesting area management decisions through a two-phased modeling strategy. First, we apply our probabilistic model in a simulation-based analysis of future water quality standard violation frequencies under alternative land use scenarios, such as those evaluated under guidelines of the total maximum daily load (TMDL) program. Second, we apply our model to water quality data from shellfish harvesting areas which at present are closed (either conditionally or permanently) to shellfishing, to determine if alternative laboratory analysis procedures might have led to different

Implementation of a national external quality assessment program for medical laboratories in Burkina Faso: challenges, lessons learned, and perspectives.

PubMed

Sakandé, Jean; Nikièma, Abdoulaye; Kabré, Elie; Sawadogo, Charles; Nacoulma, Eric W; Sanou, Mamadou; Sangaré, Lassana; Traoré-Ouédraogo, Rasmata; Sawadogo, Mamadou; Gershy-Damet, Guy Michel

2014-02-01

The National External Quality Assessment (NEQA) program of Burkina Faso is a proficiency testing program mandatory for all laboratories in the country since 2006. The program runs two cycles per year and covers all areas of laboratories. All panels were validated by the expert committee before dispatch under optimal storage and transport conditions to participating laboratories along with report forms. Performance in the last 5 years varied by panel, with average annual performance of bacteriology panels for all laboratories rising from 75% in 2006 to 81% in 2010 and with a best average performance of 87% in 2007 and 2008. During the same period, malaria microscopy performance varied from 85% to 94%, with a best average performance of 94% in 2010; chemistry performance increased from 87% to 94%, with a best average annual performance of 97% in 2009. Hematology showed more variation in performance, ranging from 61% to 86%, with a best annual average performance of 90% in 2008. Average annual performance for immunology varied less between 2006 and 2010, recording 97%, 90%, and 95%. Except for malaria microscopy, annual performances for enrolled panels varied substantially from year to year, indicating some difficulty in maintaining consistency in quality. The main challenges of the NEQA program observed between 2006 to 2010 were funding, sourcing, and safe transportation of quality panels to all laboratories countrywide.

Internal quality control practice of thyroid disease related tests and imprecision analysis in China.

PubMed

Hu, Li-Tao; Wang, Zhi-Guo

2014-01-01

Internal quality control (IQC) has a long and well-established role in clinical laboratories and the quality of laboratories has achieved great improvement in China. However, the practice of IQC varies significantly between institutions and many problems still exists. Consequently, the Chinese National Center for Clinical Laboratories has been undertaking monthly nation-wide surveys of current IQC practice of tests since 2010 to monitor laboratory quality. Thyroid disease related tests were chosen for this research. Different numbers of laboratories in China participating national external quality assessment (EQA) schemes of Total Thyroxine (TT4), Total Triiodothyronine (TT3), Free Thyroxine (FT4) and Free Triiodothyronine (FT3) tests, and Thyroid Stimulating Hormone (TSH) measurements, were required to report the IQC information though the national external quality assessment (EQA) network platform. Survey data showed significant variability in all aspects of IQC practice. More than half of the laboratories are using a single concentration level of IQC material and up to 28.6% of the laboratories only use 1(2s) or 1(3s) to monitor IQC results for FT3, TT3, FT4, TT4, and TSH. The medians of the average time intervals of two control tests for FT3, TT3, FT4, TT4, and TSH are 33.6, 35.4, 33.6, 35.4, and 33.6 hours, respectively, more or less 1.4 days. When quality specifications based on biological variation are applied to imprecision evaluation, only 46.3%, 52.1%, 31.3%, 12.8%, and 5.86% laboratories meet the minimum performance for FT3, TT3, FT4, and TT4, 24.5%, 23.6%, 12.8%, and 5.86% of the all meet the desirable performance, and 4.4%, 3.9%, 2.5% and 3.0% of the all meet the optimal performance. While it shows a higher percentage of acceptable laboratories (98.1%, 87.9% and 39.0% meeting the minimum, desirable and optimal performance, respectively) for TSH. Not-well-designed IQC practices may affect the effectiveness of laboratory IQC and, thus, the adequacy of a