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Sample records for laboratory quality control

  1. Analytical laboratory quality control charting

    SciTech Connect

    O'Bryan, Ervin F.

    2001-06-11

    In life the importance of setting goals is stressed. The desired end result must be envisioned to chart a path and determine indicators to provide feedback on the process. Quality does not happen by accident but is achieved through a constant process of setting goals, process development, monitoring process indicators, fine tuning the process, and achieving results. These goals are to be focused and clearly measurable. In industry and life the setting of goals with clear process indicators is often difficult because of the variable end result and scarcity of measurements. Laboratories are fortunate in that they have a plethora of measurements with known or desired end results (controls) to monitor the process and give instantaneous feedback on quality. A key quality tool used by the laboratory to monitor and evaluate the lab processes is control charting. When properly utilized Quality Control (QC) Charts allow labs to be proactive in addressing problems rather than reactive. Several methods are available for control charting and some are listed in the references/information sources. The content for this paper is based on the control-charting program utilized at the Department of Energy's Fernald site. This control-charting program has specific areas of emphasis, simple charts, trend analyses, and effective follow-up.

  2. Quality assurance/quality control manual; National Water Quality Laboratory

    USGS Publications Warehouse

    Pritt, J.W.; Raese, J.W.

    1995-01-01

    Quality-control practices are established for the operation of the U.S. Geological Survey's National Water Quality Laboratory. These practices specify how samples are preserved, shipped, and analyzed in the Laboratory. This manual documents the practices that are currently (1995) used in the Laboratory.

  3. Laboratory quality control based on risk management.

    PubMed

    Nichols, James H

    2011-01-01

    Risk management is the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling and monitoring risk (the effect of uncertainty on objectives). Clinical laboratories conduct a number of activities that could be considered risk management including verification of performance of new tests, troubleshooting instrument problems and responding to physician complaints. Development of a quality control plan for a laboratory test requires a process map of the testing process with consideration for weak steps in the preanalytic, analytic and postanalytic phases of testing where there is an increased probability of errors. Control processes that either prevent or improve the detection of errors can be implemented at these weak points in the testing process to enhance the overall quality of the test result. This manuscript is based on a presentation at the 2nd International Symposium on Point of Care Testing held at King Faisal Specialist Hospital in Riyadh, Saudi Arabia on October 12-13, 2010. Risk management principles will be reviewed and progress towards adopting a new Clinical and Laboratory Standards Institute Guideline for developing laboratory quality control plans based on risk management will be discussed. PMID:21623049

  4. 7 CFR 58.442 - 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. 58.442 Section 58.442 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING... Service 1 Operations and Operating Procedures § 58.442 Laboratory and quality control tests. (a)...

  5. 7 CFR 58.442 - 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. 58.442 Section 58.442 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING... Service 1 Operations and Operating Procedures § 58.442 Laboratory and quality control tests. (a)...

  6. 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 58.442 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING... Service 1 Operations and Operating Procedures § 58.442 Laboratory and quality control tests. (a)...

  7. [Our experience with outside laboratory quality control].

    PubMed

    Dochev, D; Arakasheva, V; Nashkov, A; Tsachev, K

    1979-01-01

    The results from the national outside laboratory qualitative control of the clinical diagnostic laboratory investigations for the period September 1975 -- May 1977 were described. The following interlaboratory discrepancy was found on base of a systematic analysis of the data from the last two ring-like check-ups, November 1976 and May 1977, exressed by the variation coefficient (V.C. %); total protein, sodium, potassium and chlorides -- under 10%; cholesterol, urea and total fats -- between 10 and 20%; calcium, phosphorus, iron and creatinine -- over 20%. The highest per cent of admissible results are found with total protein -- to 85%; cholesterol -- to 70.38%; glucosa -- to 73.17%, urea -- to 69.23%, potassium -- to 59.46%, chlorides -- to 57.9%. With sodium, phosphorus, calcium, iron creatinine and uric acid the "admissibility" fluctuates about or under 50 per cent. The values of the qualitative-control indices discussed are comparable with the values obtained from them in the interlaboratory comparisons of other countries. PMID:494628

  8. HANDBOOK FOR ANALYTICAL QUALITY CONTROL IN WATER AND WASTEWATER LABORATORIES

    EPA Science Inventory

    This handbook is addressed to laboratory directors, leaders of field investigations, and other personnel who bear responsibility for water and wastewater data. Subject matter of the handbook is concerned primarily with quality control (QC) for chemical and biological tests and me...

  9. Quality control of laboratory results in real time.

    PubMed

    Picco, W; Pinna Pintor, L; Baruzzo, G; Pistono, O; Triumbari, F; Pinna Pintor, P

    1992-03-01

    An integrated informatic system may have an important role in identifying and reducing those errors which affect the reliability of laboratory results. The present work reports on the development of a system that, by means of a computer connected with laboratory instrumentation, allows monitoring of global error (bias, random, gross) using classical statistical quality control systems, integrated by auxiliary methods built on a database stored in the computer. These methods succeeded in greatly reducing bias and random error in the most frequent laboratory tests. Further methods to find, quantify, and reduce the gross and extra-analytical errors are under development. PMID:1576336

  10. Quality control for diagnostic oral microbiology laboratories in European countries

    PubMed Central

    Rautemaa-Richardson, Riina; der Reijden Wa, Wil A Van; Dahlen, Gunnar; Smith, Andrew J.

    2011-01-01

    Participation in diagnostic microbiology internal and external quality control (QC) processes is good laboratory practice and an essential component of a quality management system. However, no QC scheme for diagnostic oral microbiology existed until 2009 when the Clinical Oral Microbiology (COMB) Network was created. At the European Oral Microbiology Workshop in 2008, 12 laboratories processing clinical oral microbiological samples were identified. All these were recruited to participate into the study and six laboratories from six European countries completed both the online survey and the first QC round. Three additional laboratories participated in the second round. Based on the survey, European oral microbiology laboratories process a significant (mean per laboratory 4,135) number of diagnostic samples from the oral cavity annually. A majority of the laboratories did not participate in any internal or external QC programme and nearly half of the laboratories did not have standard operating procedures for the tests they performed. In both QC rounds, there was a large variation in the results, interpretation and reporting of antibiotic susceptibility testing among the laboratories. In conclusion, the results of this study demonstrate the need for harmonisation of laboratory processing methods and interpretation of results for oral microbiology specimens. The QC rounds highlighted the value of external QC in evaluating the efficacy and safety of processes, materials and methods used in the laboratory. The use of standardised methods is also a prerequisite for multi-centre epidemiological studies that can provide important information on emerging microbes and trends in anti-microbial susceptibility for empirical prescribing in oro-facial infections. PMID:22084647

  11. [Improvement of routine works and quality control in mycobacterial laboratory].

    PubMed

    Suzuki, Katsuhiro; Higuchi, Takeshi

    2007-03-01

    Many new methods have been introduced into routine laboratory works in microbiology since 1990. Molecular biology, in particular, opened a new era and promoted a technician's skill much. PCR and hybridization technique have been ordinary one in many laboratories. Since old techniques such as smear and culture are still needed, amount of routine works is increasing gradually. Thus, improving efficiency and keeping quality of routine works are becoming more and more important issues. This symposium focused on such points, and four skilled technicians around Japan presented their own tips. 1. Coexistence of M. tuberculosis and M. avium complex (MAC) in the MGIT culture system: Yasushi WATANABE (Clinical Laboratory Division, NHO Nishi-Niigata Chuo National Hospital). Sputum samples of some tuberculosis patients yielded only MAC in the MGIT culture system. Such co-infected cases presented problems to mislead proper treatment and infection control. The detection rate of MAC was significantly high, and the growth speed of MAC was significantly rapid in the MGIT culture system, compared to those of M. tuberculosis. Additionally, M. tuberculosis was not detected with even more quantity than MAC in the small amount of mixed samples. Higher sensitivity and growth speed of MAC are the important characteristics of the MGIT system. 2. Internal quality control with ordinary examination results: Akio AONO (Department of Clinical Examination, Double-Barred Cross Hospital, Japan Anti-Tuberculosis Association). Our laboratory utilizes ordinary examination results as the internal quality control for specimen pretreatment, culture, and drug susceptibility testing. The contamination rate of MGIT culture system is useful for the evaluation of the decontamination process. It was 6.3% on average in our laboratory in 2005. The number of drug resistant strains is also useful to assess the performance of drug susceptibility testing. The incidence of each anti-tuberculosis drug resistance

  12. A suite of RS/1 procedures for chemical laboratory statistical quality control and Shewhart control charting

    SciTech Connect

    Shanahan, K.L.

    1990-09-01

    A suite of RS/1 procedures for Shewhart control charting in chemical laboratories is described. The suite uses the RS series product QCA (Quality Control Analysis) for chart construction and analysis. The suite prompts users for data in a user friendly fashion and adds the data to or creates the control charts. All activities are time stamped. Facilities for generating monthly or contiguous time segment summary charts are included. The suite is currently in use at Westinghouse Savannah River Company.

  13. 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…

  14. Complement analysis 2016: Clinical indications, laboratory diagnostics and quality control.

    PubMed

    Prohászka, Zoltán; Nilsson, Bo; Frazer-Abel, Ashley; Kirschfink, Michael

    2016-11-01

    (e.g. anti-C1inhibitor, anti-factor H) are important in defining autoimmune processes and diseases based on complement dysregulation. To improve the quality of complement laboratory analysis a standardization commmittee of the International Complement Society (ICS) and the International Union of Immunological Societies (IUIS) was formed to provide guidelines for modern complement analysis and standards for the development of international testing programs. PMID:27475991

  15. Computerized real-time quality control program for analytical chemistry laboratories

    SciTech Connect

    Dill, M.S.; Floyd, M.A.; Morrow, R.W.

    1985-10-01

    A unique computer program has been developed for complete quality control/quality assurance of the operation and statistical control of the testing in the analytical laboratory. The system operates similar to a scanner on a production line with effective checkpoints and furnishes immediate feedback by automatically generated mail messages to appropriate personnel when any non-conformance is encountered. Corrective action is required by the technician prior to proceeding with the analysis.

  16. 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...

  17. 21 CFR 111.110 - What quality control operations are required for laboratory operations associated with the...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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...

  18. The development of systematic quality control method using laboratory information system and unity program.

    PubMed

    Min, Won-Ki; Lee, Woochang; Park, Hyosoon

    2002-01-01

    Quality control (QC) process is performed to detect and correct errors in the laboratory, of which systematic errors are repeated and affect all the laboratory process thereafter. This makes it necessary for all the laboratories to detect and correct errors effectively and efficiently. We developed an on-line quality assurance system for detection and correction of systematic error, and linked it to the Unity Plus/Pro (Bio-Rad Laboratories, Irvine, USA), a commercially available quality management system. The laboratory information system based on the client-server paradigm was developed using NCR3600 (NCR, West Columbia, USA) as the server and database for server was Oracle 7.2 (Oracle, Belmont, USA) and development tool was Powerbuilder (Powersoft Burlignton, UK). Each QC material is registered and gets its own identification number and tested the same way as patient sample. The resulting QC data is entered into the Unity Plus/Pro program by in-house data entering program or by manual input. With the implementation of in-house laboratory information system (LIS) and linking it to Unity Plus/Pro, we could apply Westgard's multi-rule for higher error detection rate, resulting in more systematic and precise quality assurance for laboratory product, as well as complementary to conventional external quality assessment. PMID:12755272

  19. Air quality control in the ART laboratory is a major determinant of IVF success

    PubMed Central

    Esteves, Sandro C; Bento, Fabiola C

    2016-01-01

    A recently published article described how a fertility center in the United States implemented air quality control to newly designed in vitro fertilization (IVF) laboratory.1 A highly-efficient air filtration was achieved by installing a centered system supplying filtered air to the IVF laboratory and related critical areas, combining air particulate and volatile organic compound (VOC) filtration. As a consequence, live birth rates were increased by improvements in air quality. This article highlights the key aspects of air contamination in the IVF context. The topic is important not only to IVF specialists but also to Andrologists due to the great number of male infertility patients referred to assisted reproductive technology (ART) treatments. The evidence is growing that laboratory air quality is paramount importance for improved IVF outcome. PMID:26585700

  20. Evaluation of controls for the assurance of quality data in a radiochemistry laboratory

    SciTech Connect

    Morton, J.S.

    1993-12-31

    The paper describes the controls implemented by the U.S. Department of Energy (DOE) at the Radiological and Environmental Sciences Laboratory (RESL) to secure data quality. A description of the analytical instrumentation and methodology employed by RESL is provided. The results of the intercomparison program with the National Institute of Standards and Technology (NIST) are provided to demonstrate traceability to a primary source. A description of the methods and techniques used to ensure quality control on a daily basis is given. The techniques used to evaluate the sources of uncertainty are reviewed and specific examples cited. The intercomparison programs operated by RESL are discussed.

  1. Quality in Teaching Laboratories.

    ERIC Educational Resources Information Center

    Stubington, John F.

    1995-01-01

    Describes a Japanese process-oriented approach called KAIZEN for improving the quality of existing teaching laboratories. It provides relevant quality measurements and indicates how quality can be improved. Use of process criteria sidesteps the difficulty of defining quality for laboratory experiments and allows separation of student assessment…

  2. Analytical laboratory quality audits

    SciTech Connect

    Kelley, William D.

    2001-06-11

    Analytical Laboratory Quality Audits are designed to improve laboratory performance. The success of the audit, as for many activities, is based on adequate preparation, precise performance, well documented and insightful reporting, and productive follow-up. Adequate preparation starts with definition of the purpose, scope, and authority for the audit and the primary standards against which the laboratory quality program will be tested. The scope and technical processes involved lead to determining the needed audit team resources. Contact is made with the auditee and a formal audit plan is developed, approved and sent to the auditee laboratory management. Review of the auditee's quality manual, key procedures and historical information during preparation leads to better checklist development and more efficient and effective use of the limited time for data gathering during the audit itself. The audit begins with the opening meeting that sets the stage for the interactions between the audit team and the laboratory staff. Arrangements are worked out for the necessary interviews and examination of processes and records. The information developed during the audit is recorded on the checklists. Laboratory management is kept informed of issues during the audit so there are no surprises at the closing meeting. The audit report documents whether the management control systems are effective. In addition to findings of nonconformance, positive reinforcement of exemplary practices provides balance and fairness. Audit closure begins with receipt and evaluation of proposed corrective actions from the nonconformances identified in the audit report. After corrective actions are accepted, their implementation is verified. Upon closure of the corrective actions, the audit is officially closed.

  3. Quality in pathology laboratory practice.

    PubMed

    Weinstein, S

    1995-06-01

    Quality refers not only to analytical quality control, a traditional area of laboratory excellence, but to the entire science of quality management. As measures of quality, structural indicators refer to staffing and physical facilities, process indicators to the institutions operations and, perhaps most importantly, outcome indicators address the ultimate patient care uses that pathology information is put to. Comparison of performance to peer laboratories, external quality control, is a practical, if limited, yardstick of performance. Customer satisfaction and turn-around-time of tests are receiving more recent attention as quality measures. Blood banking, because of its inherently complex cycle from donor phlebotomy to product infusion, requires special considerations with regard to quality management. Reporting of anatomical pathology, where the only gold standard is a consensus of experts, also does not lend itself to classical numerical quality assessment. PMID:7670717

  4. 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…

  5. [System of internal laboratory control over the quality of clinical biochemical research].

    PubMed

    Marinov, S; Tsvetkova, R; Parashkevova, E

    1987-01-01

    An analysis and testing of the system of on-laboratory control on the quality of biochemical investigations with the use of control cards, has been performed. The system provides for the working out of control cards, the carrying out of control investigations, the evaluation of the results, and the correction of the control cards. Data for the built-up of the cards has been obtained with the practice of as many as 30 replications with one and the same sample, under the same conditions, the values of the average quadratic deviation (S) being in compliance with Tonks criterion. The action of control is substantiated through doubling the study of 10 per cent of the samples of each batch for each analysis and evaluation of the differences with regard to S by a two-mark system. An average mark from 0.00 to 2.00 per batch of samples is formed for each analysis. Filled in control cards for the total calcium and inorganic phosphorus are presented as an example. The changes in the S values are followed up after the introduction of control cards for 9 indices. With 7 indices reproducibility has proved higher. A total of 90 series of analyses have been controlled and evaluated--54 series (60 per cent) have proved 'good' (from 1.5 to 2.00), 22 series (24.44 per cent)--'satisfactory' (from 1.00 to 1.49), and 14 series (15.56 per cent)--'bad' (from 0.00 to 1.00 or at differences greater than 2.5 S) which implied that the respective analyses of the series of samples had to be replicated. A total of 24 control cards for various indices have been built up. PMID:3617472

  6. 21 CFR 111.110 - What quality control operations are required for laboratory operations associated with the...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What quality control operations are required for laboratory operations associated with the production and process control system? 111.110 Section 111.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT...

  7. Reliability of nucleic acid amplification for detection of Mycobacterium tuberculosis: an international collaborative quality control study among 30 laboratories.

    PubMed Central

    Noordhoek, G T; van Embden, J D; Kolk, A H

    1996-01-01

    Nucleic acid amplification to detect Mycobacterium tuberculosis in clinical specimens is increasingly used as a laboratory tool for the diagnosis of tuberculosis. However, the specificity and sensitivity of these tests may be questioned, and no standardized reagents for quality control assessment are available. To estimate the performance of amplification tests for routine diagnosis, we initiated an interlaboratory study involving 30 laboratories in 18 countries. We prepared blinded panels of 20 sputum samples containing no, 100, or 1,000 mycobacterial cells. Each laboratory was asked to detect M. tuberculosis by their routine method of nucleic acid amplification. Only five laboratories correctly identified the presence or absence of mycobacterial DNA in all 20 samples. Seven laboratories detected mycobacterial DNA in all positive samples, and 13 laboratories correctly reported the absence of DNA in the negative samples. Lack of specificity was more of a problem than lack of sensitivity. Reliability was not found to be associated with the use of any particular method. Reliable detection of M. tuberculosis in clinical samples by nucleic acid amplification techniques is possible, but many laboratories do not use adequate quality controls. This study underlines the need for good laboratory practice and reference reagents to monitor the performance of the whole assay, including pretreatment of clinical samples. PMID:8880513

  8. QUALITY CONTROLS FOR PCR

    EPA Science Inventory

    The purpose of this presentation is to present an overview of the quality control (QC) sections of a draft EPA document entitled, "Quality Assurance/Quality Control Guidance for Laboratories Performing PCR Analyses on Environmental Samples." This document has been prepared by th...

  9. A pilot study on the quality control of film processing in medical radiology laboratories in Greece.

    PubMed

    Hourdakis CJ-; Delakis, J; Kamenopoulou, V; Balougias, H; Papageorgiou, E

    2000-01-01

    The results of a pilot study on the quality of film processing in 80 medical diagnostic radiology laboratories all over Greece are presented. The sensitometric technique for the evaluation of processing has been used to calculate film's base + fog, maximum optical density, speed and contrast, parameters which describe the performance characteristics of automatic film processors and films. The mean values of the base + fog and the maximum optical density were well within the acceptance limits. The film speed was almost constant while the film contrast showed significant variation. PMID:10674786

  10. Commonly Practiced Quality Control and Quality Assurance Procedures for Gas Chromatography-Mass Spectrometry Analysis in Forensic Urine Drug-Testing Laboratories.

    PubMed

    Goldberger, B A; Huestis, M A; Wilkins, D G

    1997-12-01

    Forensic urine drug-testing laboratories operate in a prescribed scientific and administrative manner to ensure accurate test results. All specimens positive by an initial immunoassay test must be confirmed by gas chromatography/mass spectrometry (GC/MS). To provide adequate control and verification of these analytical processes, laboratories must implement appropriate policies and procedures to be used in routine practice. This review describes the following topics regarding GC/MS analyses: method validation, instrument performance, assay calibration, quality control, criteria for designating a positive test result, sample and batch acceptance criteria, and GC/MS data review. PMID:26269941

  11. The Newborn Screening Quality Assurance Program at the Centers for Disease Control and Prevention: Thirty-five Year Experience Assuring Newborn Screening Laboratory Quality

    PubMed Central

    De Jesús, Víctor R.; Mei, Joanne V.; Cordovado, Suzanne K.; Cuthbert, Carla D.

    2015-01-01

    Newborn screening is the largest genetic testing effort in the United States and is considered one of the ten great public health achievements during the first 10 years of the 21st century. For over 35 years, the Newborn Screening Quality Assurance Program (NSQAP) at the US Centers for Disease Control and Prevention has helped NBS laboratories ensure that their testing does not delay diagnosis, minimizes false-positive reports, and sustains high-quality testing performance. It is a multi-component program that provides comprehensive quality assurance services for dried blood spot testing. The NSQAP, the Biochemical Mass Spectrometry Laboratory (BMSL), the Molecular Quality Improvement Program (MQIP) and the Newborn Screening Translation Research Initiative (NSTRI), aid screening laboratories achieve technical proficiency and maintain confidence in their performance while processing large volumes of specimens daily. The accuracy of screening tests could be the difference between life and death for many babies; in other instances, identifying newborns with a disorder means that they can be treated and thus avoid life-long disability or severe cognitive impairment. Thousands of newborns and their families have benefited from reliable and accurate testing that has been accomplished by a network of screening laboratories and the NSQAP, BMSL, MQIP and NSTRI. PMID:26309908

  12. GMP criteria for retest and failure analysis. Handling out-of-specification results in the pharmaceutical quality control laboratory.

    PubMed

    Klein, A E; Rocci, M L

    1995-12-01

    The Food and Drug Administration's current Good Manufacturing Practices guidelines for the inspection of pharmaceutical quality control laboratories stress the need for explicit standard operating procedure's requirements for retesting criteria and the investigation of specification failures. Out-of-specification results are best handled through a priori procedures for the evaluation of their validity. These procedures should also specify the degree of retesting or resampling permitted. Initial investigations should focus on uncovering apparent laboratory-related or sampling errors. Should this initial investigation prove inconclusive, an expanded investigation should be conducted to uncover any less conspicuous cause, which could include process or operator-dependent as well as analytical errors. A schematic approach to controlling retesting through a rigorous policy of investigating failures, limiting retest analyses, and documenting and reporting all results is described. PMID:8890350

  13. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Laboratory controls. 226.58 Section 226.58 Food... Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test... standards of identity, strength, quality, and purity. Laboratory controls shall include: (a)...

  14. Performance of automated slidemakers and stainers in a working laboratory environment – routine operation and quality control

    PubMed Central

    SIMSON, E; GASCON-LEMA, M G; BROWN, D L

    2010-01-01

    The automated slidemaker/stainers of the four Beckman Coulter LH755 hematology systems in our laboratory are operated as analyzers, with similar requirements for setup, maintenance and quality control. A study was performed to confirm that these slide maker/stainers in routine use produce peripheral blood films that are completely satisfactory for microscopy and without cells, particularly abnormal cells, being pulled to the edges or sides of the film outside the usual working area. One hundred and thirty-nine automated blood films that had been produced during routine operation were compared with well-prepared manual films from the same patients. None of the films was unacceptable for microscopy. The distributions of normal white cell types within the counting areas of automated films compared with manual films, for all 139 samples for WBC from 1.0 to 352.8 × 109/l; for blasts and promyelocytes in the 65 samples in which they occurred and for nucleated red blood cells in the 58 samples in which they occurred all fell within the expected limits of 200 cell differential counts of CLSI H20-A. Red cell morphology and the occurrence of WBC clumps, platelet clumps and smudge cells were comparable between the automated and manual films of all samples. We conclude that automated slidemaker/stainers, as typified by those of the Beckman Coulter LH755 system, are capable of producing blood films comparable with well-prepared manual films in routine laboratory use; and that the maintenance and quality control procedures used in our laboratory ensure consistent high quality performance from these systems. PMID:19220552

  15. Quality in the molecular microbiology laboratory.

    PubMed

    Wallace, Paul S; MacKay, William G

    2013-01-01

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

  16. [Quality management in medical laboratories].

    PubMed

    Fritzer-Szekeres, M

    2010-05-01

    During the 20th century understanding for quality has changed and international and national requirements for quality have been published. Therefore also medical branches started to establish quality management systems. Quality assurance has always been important for medical laboratories. Certification according to the standard ISO 9001 and accreditation according to the standard ISO 17025 have been the proof of fulfilling quality requirements. The relatively new standard ISO 15189 is the first standard for medical laboratories. This standard includes technical and management requirements for the medical laboratory. The main focus is the proof of competence within the personnel. As this standard is accepted throughout the European Union an increase in accreditations of medical laboratories is predictable. PMID:20454753

  17. Instrument Quality Control.

    PubMed

    Jayakody, Chatura; Hull-Ryde, Emily A

    2016-01-01

    Well-defined quality control (QC) processes are used to determine whether a certain procedure or action conforms to a widely accepted standard and/or set of guidelines, and are important components of any laboratory quality assurance program (Popa-Burke et al., J Biomol Screen 14: 1017-1030, 2009). In this chapter, we describe QC procedures useful for monitoring the accuracy and precision of laboratory instrumentation, most notably automated liquid dispensers. Two techniques, gravimetric QC and photometric QC, are highlighted in this chapter. When used together, these simple techniques provide a robust process for evaluating liquid handler accuracy and precision, and critically underpin high-quality research programs. PMID:27316990

  18. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and...

  19. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and...

  20. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and...

  1. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Laboratory controls. 226.58 Section 226.58 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls...

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

    USGS Publications Warehouse

    Coplen, T.B.; Qi, H.

    2009-01-01

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

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

    PubMed

    Coplen, Tyler B; Qi, Haiping

    2009-06-01

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

  4. Effect of leachate recirculation on landfill gas production and leachate quality: A controlled laboratory study

    SciTech Connect

    Bogner, J.; Spokas, K.

    1995-05-01

    This report summarizes the results of a laboratory study conducted during 1992-1994 at Argonne National Laboratory. The study examined biogas production and leachate chemistry in parallel anaerobic assays run under either leachate recycle or leachate drainage regimes over a period of 400 days. A standardized synthetic refuse (paper, grass, food) was used in an experimental design which evaluated two elevated moisture contents and two added soils. All assays were conducted in vitro in 125 mL serum bottles. Four recycle/drainage events were completed during the 400 days of this experiment. Sufficient replicates (10 or 20) for each trial were included in the experimental design to permit destructive sampling of assay solids after each recycle/drainage event. Changes in the chemistry of solid, liquid, and gaseous phases were evaluated during the decomposition process. Analyses included major gases (CH{sub 4}, CO{sub 2}, O{sub 2}, N{sub 2}), selected chemical constituents of leachate (Cl-C5 carboxylic acids, total organic carbon, Kjeldahl nitrogen, total phosphorus, iron, zinc, and chloride), leachate pH and conductivity, and selected solids analysis (gravimetric moisture content, volatile solids, total carbon, cellulose, hemicellulose, and lignin).

  5. A multi-laboratory evaluation of a clinically-validated incurred quality control material for analysis of allergens in food.

    PubMed

    Johnson, Phil E; Rigby, Neil M; Dainty, Jack R; Mackie, Alan R; Immer, Ulrike U; Rogers, Adrian; Titchener, Pauline; Shoji, Masahiro; Ryan, Anne; Mata, Luis; Brown, Helen; Holzhauser, Thomas; Dumont, Valery; Wykes, Jill A; Walker, Michael; Griffin, Jon; White, Jane; Taylor, Glenn; Popping, Bert; Crevel, René; Miguel, Sonia; Lutter, Petra; Gaskin, Ferdelie; Koerner, Terry B; Clarke, Dean; Sherlock, Robin; Flanagan, Andrew; Chan, Chun-Han; Mills, E N Clare

    2014-04-01

    A dessert matrix previously used for diagnosis of food allergies was incurred with pasteurised egg white or skimmed milk powder at 3, 6, 15 and 30 mg allergen protein per kg of dessert matrix and evaluated as a quality control material for allergen analysis in a multi-laboratory trial. Analysis was performed by immunoassay using five kits each for egg and milk (based on casein) and six 'other' milk kits (five based on β-lactoglobulin and one total milk). All kits detected allergen protein at the 3 mg kg(-1) level. Based on ISO criteria only one egg kit accurately determined egg protein at 3 mg kg(-1) (p=0.62) and one milk (casein) kit accurately determined milk at 6 (p=0.54) and 15 mg kg(-1) (p=0.83), against the target value. The milk "other" kits performed least well of all the kits assessed, giving the least precise analyses. The incurred dessert material had the characteristics required for a quality control material for allergen analysis. PMID:24262522

  6. Statistical Methods for Establishing Quality Control Ranges for Antibacterial Agents in Clinical and Laboratory Standards Institute Susceptibility Testing▿

    PubMed Central

    Turnidge, John; Bordash, Gerry

    2007-01-01

    Quality control (QC) ranges for antimicrobial agents against QC strains for both dilution and disk diffusion testing are currently set by the Clinical and Laboratory Standards Institute (CLSI), using data gathered in predefined structured multilaboratory studies, so-called tier 2 studies. The ranges are finally selected by the relevant CLSI subcommittee, based largely on visual inspection and a few simple rules. We have developed statistical methods for analyzing the data from tier 2 studies and applied them to QC strain-antimicrobial agent combinations from 178 dilution testing data sets and 48 disk diffusion data sets, including a method for identifying possible outlier data from individual laboratories. The methods are based on the fact that dilution testing MIC data were log normally distributed and disk diffusion zone diameter data were normally distributed. For dilution testing, compared to QC ranges actually set by CLSI, calculated ranges were identical in 68% of cases, narrower in 7% of cases, and wider in 14% of cases. For disk diffusion testing, calculated ranges were identical to CLSI ranges in 33% of cases, narrower in 8% of cases, and 1 to 2 mm wider in 58% of cases. Possible outliers were detected in 8% of diffusion test data but none of the disk diffusion data. Application of statistical techniques to the analysis of QC tier 2 data and the setting of QC ranges is relatively simple to perform on spreadsheets, and the output enhances the current CLSI methods for setting of QC ranges. PMID:17438045

  7. 10 CFR 26.167 - Quality assurance and quality control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Quality assurance and quality control. 26.167 Section 26.167 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Laboratories Certified by the Department of Health and Human Services § 26.167 Quality assurance and quality control. (a) Quality assurance program. Each HHS-certified laboratory...

  8. 10 CFR 26.167 - Quality assurance and quality control.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Quality assurance and quality control. 26.167 Section 26.167 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Laboratories Certified by the Department of Health and Human Services § 26.167 Quality assurance and quality control. (a) Quality assurance program. Each HHS-certified laboratory...

  9. 10 CFR 26.167 - Quality assurance and quality control.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Quality assurance and quality control. 26.167 Section 26.167 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Laboratories Certified by the Department of Health and Human Services § 26.167 Quality assurance and quality control. (a) Quality assurance program. Each HHS-certified laboratory...

  10. Automation and quality in analytical laboratories

    SciTech Connect

    Valcarcel, M.; Rios, A.

    1994-05-01

    After a brief introduction to the generic aspects of automation in analytical laboratories, the different approaches to quality in analytical chemistry are presented and discussed to establish the following different facets emerging from the combination of quality and automation: automated analytical control of quality of products and systems; quality control of automated chemical analysis; and improvement of capital (accuracy and representativeness), basic (sensitivity, precision, and selectivity), and complementary (rapidity, cost, and personnel factors) analytical features. Several examples are presented to demonstrate the importance of this marriage of convenience in present and future analytical chemistry. 7 refs., 4 figs.

  11. 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.

  12. 10 CFR 26.167 - Quality assurance and quality control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Quality assurance and quality control. 26.167 Section 26... Department of Health and Human Services § 26.167 Quality assurance and quality control. (a) Quality assurance program. Each HHS-certified laboratory shall have a quality assurance program that encompasses all...

  13. 21 CFR 225.58 - Laboratory controls.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure...

  14. 21 CFR 225.58 - Laboratory controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure...

  15. 21 CFR 225.58 - Laboratory controls.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure...

  16. Quality and safety aspects in histopathology laboratory.

    PubMed

    Adyanthaya, Soniya; Jose, Maji

    2013-09-01

    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

  17. 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. PMID:27194689

  18. Helping You Identify Quality Laboratory Services

    MedlinePlus

    Helping You Identify Quality Laboratory Services Selecting quality health care services for yourself, a relative or friend requires special thought and attention. The Joint Commission has prepared ...

  19. Use of prior manufacturer specifications with Bayesian logic eludes preliminary phase issues in quality control: an example in a hemostasis laboratory.

    PubMed

    Tsiamyrtzis, Panagiotis; Sobas, Frédéric; Négrier, Claude

    2015-07-01

    The present study seeks to demonstrate the feasibility of avoiding the preliminary phase, which is mandatory in all conventional approaches for internal quality control (IQC) management. Apart from savings on the resources consumed by the preliminary phase, the alternative approach described here is able to detect any analytic problems during the startup and provide a foundation for subsequent conventional assessment. A new dynamically updated predictive control chart (PCC) is used. Being Bayesian in concept, it utilizes available prior information. The manufacturer's prior quality control target value, the manufacturer's maximum acceptable interassay coefficient of variation value and the interassay standard deviation value defined during method validation in each laboratory, allow online IQC management. An Excel template, downloadable from journal website, allows easy implementation of this alternative approach in any laboratory. In the practical case of prothrombin percentage measurement, PCC gave no false alarms with respect to the 1ks rule (with same 5% false-alarm probability on a single control sample) during an overlap phase between two IQC batches. Moreover, PCCs were as effective as the 1ks rule in detecting increases in both random and systematic error after the minimal preliminary phase required by medical biology guidelines. PCCs can improve efficiency in medical biology laboratories. PMID:25978121

  20. Indoor Air Quality in Chemistry Laboratories.

    ERIC Educational Resources Information Center

    Hays, Steve M.

    This paper presents air quality and ventilation data from an existing chemical laboratory facility and discusses the work practice changes implemented in response to deficiencies in ventilation. General methods for improving air quality in existing laboratories are presented and investigation techniques for characterizing air quality are…

  1. Evaluation of quality assurance/quality control data collected by the US Geological Survey for water-quality activities at the Idaho National Engineering Laboratory, Idaho, 1989 through 1993

    SciTech Connect

    Williams, L.M.

    1996-06-01

    Hundreds of water samples were collected by the US Geological Survey (USGS) from 177 monitoring sites for the water quality monitoring program at the Idaho National Engineering Laboratory from 1989 through 1993. Concurrently, replicate pairs of samples and various types of blank samples were collected as part of the quality assurance/quality control program. Analyses were performed to determine the concentrations of major ions, nutrients, trace elements, gross radioactivity and radionuclides, organic compounds, and total organic carbon in the samples. To evaluate the precision of field and laboratory methods, analytical results of the replicate pairs of samples were compared statistically for equivalence on the basis of the precision associated with each result. Ninety percent or more of the analytical results for each constituent were equivalent, except for ammonia plus organic nitrogen, orthophosphate, iron, manganese, radium-226, total organic carbon, and total phenols. Blank-sample analytical results indicated that the inorganic-free blank water from the USGS Quality of Water Service Unit and the deionized water from the USGS Idaho Falls Field Office were suitable source solutions for blanks. Waters from other sources were found to be unsatisfactory as blank source solutions. Results of the analyses of several equipment blanks were evaluated to determine if a bias had been introduced and the possible sources of the bias. All of the equipment blank analytical results indicated that ammonia concentrations were greater than the reporting level. None of the equipment blanks had measurable concentrations of radioactivity. Eight percent of the analyses for inorganic constituents showed measurable concentrations were present in the blanks, nine percent for radioactive constituents, and less than one percent for organic constituents.

  2. Quality Leadership and Quality Control

    PubMed Central

    Badrick, Tony

    2003-01-01

    Different quality control rules detect different analytical errors with varying levels of efficiency depending on the type of error present, its prevalence and the number of observations. The efficiency of a rule can be gauged by inspection of a power function graph. Control rules are only part of a process and not an end in itself; just as important are the trouble-shooting systems employed when a failure occurs. 'Average of patient normals' may develop as a usual adjunct to conventional quality control serum based programmes. Acceptable error can be based on various criteria; biological variation is probably the most sensible. Once determined, acceptable error can be used as limits in quality control rule systems. A key aspect of an organisation is leadership, which links the various components of the quality system. Leadership is difficult to characterise but its key aspects include trust, setting an example, developing staff and critically setting the vision for the organisation. Organisations also have internal characteristics such as the degree of formalisation, centralisation, and complexity. Medical organisations can have internal tensions because of the dichotomy between the bureaucratic and the shadow medical structures. PMID:18568046

  3. Inclusion of quality controls on leishmaniases molecular tests to increase diagnostic accuracy in research and reference laboratories.

    PubMed

    da C Gonçalves-de-Albuquerque, Suênia; Pessoa-e-Silva, Rômulo; Trajano-Silva, Lays A M; de Morais, Rayana C S; Brandão-Filho, Sinval P; de Paiva-Cavalcanti, Milena

    2015-04-01

    Early detection of leishmaniases and prompt institution of treatment are paramount for individuals and communities affected by these diseases. To overcome the remaining limitations inherent to molecular methods currently used and to ensure the accuracy of results in leishmaniases diagnosis, two triplex polymerase chain reaction (PCR) assays with quality controls for the reactions were developed. Validity indicators were assessed in 186 dog blood samples from endemic areas in Brazil. The level of agreement between the new tools and their singleplex protocols was assessed by kappa analysis. The triplex PCR for visceral leishmaniasis showed sensitivity (S) = 78.68 %, specificity (E) = 85.29 %, and efficiency (e) = 81.05 %. The cutaneous leishmaniasis protocol showed S = 97.29 %, E = 79.16 %, and e = 90.16 %. Both protocols showed good agreement with gold standards. These new tools enable, in a single reaction, the diagnosis of the diseases and the evaluation of the sample quality and DNA extraction process, thus reducing the cost of reagents and avoiding the eventual need for collecting a second sample. PMID:25428552

  4. The effect of empowerment on the self-efficacy, quality of life and clinical and laboratory indicators of patients treated with hemodialysis: a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Hemodialysis patients face numerous physical and psychological stresses that result in reduced health. The aim of this study is to determine the impact of an empowerment program on self-efficacy, quality of life, clinical indicators of blood pressure and interdialytic weight gain, and laboratory results in these patients. Methods This randomized, controlled trial was conducted at Boo Ali Sina Dialysis Center, Shiraz, Iran. A total of 48 hemodialysis patients participated in this study. After acquisition of informed consent, eligible patients were randomly divided into two groups, control and experimental. Pre-test data were obtained by using a demographic data form and two questionnaires for self-efficacy and quality of life. Blood pressure and interdialytic weight gain were measured. We extracted laboratory data from patients’ charts. A six-week empowerment intervention that included four individual and two group counselling sessions was performed for the experimental group. Six weeks after intervention, post-test data were obtained from both groups in the same manner as the pre-test. Data were analyzed by ANCOVA using SPSS v11.5. Results There were no statistically significant differences in demographic variables between the groups. Pre-test mean scores for self-efficacy, quality of life, blood pressure, interdialytic weight gain and laboratory results did not differ between the groups. There was a significant difference between the experimental and control groups in terms of pre-to post-intervention changes in overall self-efficacy scores, stress reduction, and decision making, in addition to overall quality of life and all dimensions included within quality of life based on this questionnaire. Additionally, the pre- to post-intervention changes in systolic/diastolic blood pressures, interdialytic weight gain, hemoglobin and hematocrit levels significantly differed between the groups. Conclusion Our study demonstrates that a combination of

  5. 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., II; 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

  6. 1990 National Water Quality Laboratory Services Catalog

    USGS Publications Warehouse

    Pritt, Jeffrey, (Edited By); Jones, Berwyn E.

    1989-01-01

    PREFACE This catalog provides information about analytical services available from the National Water Quality Laboratory (NWQL) to support programs of the Water Resources Division of the U.S. Geological Survey. To assist personnel in the selection of analytical services, the catalog lists cost, sample volume, applicable concentration range, detection level, precision of analysis, and preservation techniques for samples to be submitted for analysis. Prices for services reflect operationa1 costs, the complexity of each analytical procedure, and the costs to ensure analytical quality control. The catalog consists of five parts. Part 1 is a glossary of terminology; Part 2 lists the bottles, containers, solutions, and other materials that are available through the NWQL; Part 3 describes the field processing of samples to be submitted for analysis; Part 4 describes analytical services that are available; and Part 5 contains indices of analytical methodology and Chemical Abstract Services (CAS) numbers. Nomenclature used in the catalog is consistent with WATSTORE and STORET. The user is provided with laboratory codes and schedules that consist of groupings of parameters which are measured together in the NWQL. In cases where more than one analytical range is offered for a single element or compound, different laboratory codes are given. Book 5 of the series 'Techniques of Water Resources Investigations of the U.S. Geological Survey' should be consulted for more information about the analytical procedures included in the tabulations. This catalog supersedes U.S. Geological Survey Open-File Report 86-232 '1986-87-88 National Water Quality Laboratory Services Catalog', October 1985.

  7. [Quality control dose calibrators].

    PubMed

    Montoza Aguado, M; Delgado García, A; Ramírez Navarro, A; Salgado García, C; Muros de Fuentes, M A; Ortega Lozano, S; Bellón Guardia, M E; Llamas Elvira, J M

    2004-01-01

    We have reviewed the legislation about the quality control of dose calibrator. The importance of verifying the correct work of these instruments, is fundamental in daily practice of radiopharmacy and nuclear medicine. The Spanish legislation establishes to include these controls as part of the quality control of radiopharmaceuticals, and the program of quality assurance in nuclear medicine. We have reviewed guides and protocols from international eminent organizations, summarizing the recommended tests and periodicity of them. PMID:15625064

  8. Quality control tests of lab-reared Cydia pomonella and Cactoblastis cactorum field performance: Comparison of laboratory and field bioassays.

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Research, operational, and commercial programs which rely on mass-reared insects of high quality and performance, need accurate methods for monitoring quality degradation during each step of production, handling and release. With continued interest in the use of the sterile insect technique (SIT) a...

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

    SciTech Connect

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

    1998-10-01

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

  10. Quality Management of the Immunohistochemistry Laboratory: A Practical Guide.

    PubMed

    Cates, Justin M M; Troutman, K Ashley

    2015-08-01

    Governmental regulations and most published guidelines do not provide specific guidance on implementation of quality management (QM) programs for immunohistochemistry (IHC) assays in Anatomic Pathology. QM of IHC consists of 3 main components: quality control, quality assurance, and quality improvement initiatives, each entailing distinctive but interrelated objectives. Discussion of the principles and some specific practices involved in these phases of QM of the IHC laboratory are therefore offered in this review, with an admitted emphasis on pragmatism. PMID:25203427

  11. National Water Quality Laboratory - A Profile

    USGS Publications Warehouse

    Raese, Jon W.

    2001-01-01

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

  12. LABCON - Laboratory Job Control program

    NASA Technical Reports Server (NTRS)

    Reams, L. T.

    1969-01-01

    Computer program LABCON controls the budget system in a component test laboratory whose workload is made up from many individual budget allocations. A common denominator is applied to an incoming job, to which all effort is charged and accounted for.

  13. Facilitating quality control for spectra assignments of small organic molecules: nmrshiftdb2--a free in-house NMR database with integrated LIMS for academic service laboratories.

    PubMed

    Kuhn, Stefan; Schlörer, Nils E

    2015-08-01

    nmrshiftdb2 supports with its laboratory information management system the integration of an electronic lab administration and management into academic NMR facilities. Also, it offers the setup of a local database, while full access to nmrshiftdb2's World Wide Web database is granted. This freely available system allows on the one hand the submission of orders for measurement, transfers recorded data automatically or manually, and enables download of spectra via web interface, as well as the integrated access to prediction, search, and assignment tools of the NMR database for lab users. On the other hand, for the staff and lab administration, flow of all orders can be supervised; administrative tools also include user and hardware management, a statistic functionality for accounting purposes, and a 'QuickCheck' function for assignment control, to facilitate quality control of assignments submitted to the (local) database. Laboratory information management system and database are based on a web interface as front end and are therefore independent of the operating system in use. PMID:25998807

  14. Preparation and certification of a reference material on PCBs in pig fat and its application in quality control in monitoring laboratories during the Belgian "PCB-crisis".

    PubMed

    Bester, K; de Vos, P; Le Guern, L; Harbeck, S; Hendrickx, F; Kramer, G N; Linsinger, T; Mertens, I; Schimmel, H; Sejerøe-Olsen, B; Pauwels, J; De Poorter, G; Rimkus, G G; Schlabach, M

    2001-08-01

    In this article, the production and validation of a new certified reference material "PCBs in animal fat" for the control of the maximum level of 200 ng/g setup by the European Communities for veterinary products from Belgium is described. Three materials are established: a blank, one material with about 100 ng/g and one with about 200 ng/g (sum of seven PCBs). Data on the production and certification are given. Additionally, this material was used as an unknown test material in the quality assurance program of the Belgium meat monitoring system (before the certification of the material). While the certification was performed with an uncertainty of less than 10%, the round robin exhibited larger deviations. However, these deviations were less than 20% for most of the 30 participating laboratories. Only two had significantly higher deviations. PMID:11482639

  15. 40 CFR 136.7 - Quality assurance and quality control.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 24 2012-07-01 2012-07-01 false Quality assurance and quality control. 136.7 Section 136.7 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER... referred to as a spiked blank, or laboratory control sample (LCS); (v) Matrix spike (MS) and matrix...

  16. Applicability of the Monocyte Activation Test (MAT) for hyperimmune sera in the routine of the quality control laboratory: Comparison with the Rabbit Pyrogen Test (RPT).

    PubMed

    da Silva, Cristiane Caldeira; Presgrave, Octavio Augusto França; Hartung, Thomas; de Moraes, Aurea Maria Lage; Delgado, Isabella Fernandes

    2016-04-01

    Pyrogen tests are safety assays performed during the routine quality control of injectable products required by regulatory agencies. Currently, there are three available testing possibilities: 1) the Rabbit Pyrogen Test (RPT); 2) the Bacterial Endotoxin Test (BET); and 3) test systems using human whole-blood or monocytes, termed Monocyte Activation Test (MAT). Although BET is often considered as a replacement for the animal test, it is unable to detect pyrogens other than endotoxin. MAT is based on the human fever reaction and thus, most closely reflects the human response. The aim of this study was to conduct a parallel comparison of the RPT and MAT for hyperimmune sera (HS) batches analyzed during the routine of a quality control laboratory. MAT was performed in the same 43 batches of HS previously tested using RPT. The results showed that MAT presented 100% sensitivity and approximately 85% specificity as compared to RPT, i.e., no false-negative results were obtained. Few suspicious samples, which were negative in the RPT after retesting, provided divergent positive results suggesting a lower limit of detection of MAT. MAT is thus able to detect contaminants in biological products such as HS batches. PMID:26688320

  17. Laboratory services: regaining and maintaining control.

    PubMed

    Lee, Graham R; Fitzgibbon, Maria C; O'Shea, Paula

    2016-06-13

    Purpose - After implementing an internal quality control (IQC) programme, the purpose of this paper is to maintain the requisite analytical performance for clinical laboratory staff, thereby safeguarding patient test results for their intended medical purpose. Design/methodology/approach - The authors address how quality can be maintained and if lost, how it can be regained. The methodology is based on the experience working in clinical laboratory diagnostics and is in accord with both international accreditation requirements and laboratory best practice guidelines. Findings - Monitoring test performance usually involves both prospective and retrospective IQC data analysis. The authors present a number of different approaches together with software tools currently available and emerging, that permit performance monitoring at the level of the individual analyser, across analysers and laboratories (networks). The authors make recommendations on the appropriate response to IQC rule warnings, failures and metrics that indicate analytical control loss, that either precludes further analysis, or signifies deteriorating performance and eventual unsuitability. The authors provide guidance on systematic troubleshooting, to identify undesirable performance and consider risk assessment preventive measures and continuous quality improvement initiatives; e.g., material acceptance procedures, as tools to help regain and maintain analytical control and minimise potential for patient harm. Practical implications - The authors provide a template for use by laboratory scientific personnel that ensures the optimal monitoring of analytical test performance and response when it changes undesirably. Originality/value - The proposed template has been designed to meet the International Organisation for Standardisation for medical laboratories ISO15189:2012 requirements and therefore includes the use of External Quality Assessment and patient results data, as an adjunct to IQC data. PMID

  18. 222-S Laboratory Quality Assurance Plan. Revision 1

    SciTech Connect

    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 quality 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.

  19. Information systems as a quality management tool in clinical laboratories

    NASA Astrophysics Data System (ADS)

    Schmitz, Vanessa; Rosecler Bez el Boukhari, Marta

    2007-11-01

    This article describes information systems as a quality management tool in clinical laboratories. The quality of laboratory analyses is of fundamental importance for health professionals in aiding appropriate diagnosis and treatment. Information systems allow the automation of internal quality management processes, using standard sample tests, Levey-Jennings charts and Westgard multirule analysis. This simplifies evaluation and interpretation of quality tests and reduces the possibility of human error. This study proposes the development of an information system with appropriate functions and costs for the automation of internal quality control in small and medium-sized clinical laboratories. To this end, it evaluates the functions and usability of two commercial software products designed for this purpose, identifying the positive features of each, so that these can be taken into account during the development of the proposed system.

  20. 40 CFR 136.7 - Quality assurance and quality control.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... PROGRAMS (CONTINUED) GUIDELINES ESTABLISHING TEST PROCEDURES FOR THE ANALYSIS OF POLLUTANTS § 136.7 Quality... referred to as a spiked blank, or laboratory control sample (LCS); (v) Matrix spike (MS) and matrix spike duplicate (MSD), or laboratory fortified matrix (LFM) and LFM duplicate, may be used for suspected...

  1. Measurement quality assurance for radioassay laboratories

    SciTech Connect

    McCurdy, D.E.

    1993-12-31

    Until recently, the quality of U.S. radioassay laboratory services has been evaluated by a limited number of governmental measurement assurance programs (MAPs). The major programs have been limited to the U.S. Department of Energy (DOE), the U.S. Environmental Protection Agency (EPA) and the U.S. Nuclear Regulatory Commission (NRC). In 1988, an industry MAP was established for the nuclear power utility industry through the U.S. Council for Energy Awareness/National Institute of Standards and Technology (USCEA/NIST). This program functions as both a MAP for utility laboratories and/or their commercial contractor laboratories, and as a traceability program for the U.S. radioactive source manufacturers and the utility laboratories. Each of these generic MAPs has been initiated and is maintained to serve the specific needs of the sponsoring agency or organization. As a result, there is diversification in their approach, scope, requirements, and degree of traceability to NIST. In 1987, a writing committee was formed under the American National Standards Institute (ANSI) N42.2 committee to develop a standard to serve as the basis document for the creation of a national measurement quality assurance (MQA) program for radioassay laboratories in the U.S. The standard is entitled, {open_quotes}Measurement Quality Assurance For Radioassay Laboratories.{open_quotes} The document was developed to serve as a guide for MQA programs maintained for the specialized sectors of the radioassay community, such as bioassay, routine environmental monitoring, environmental restoration and waste management, radiopharmaceuticals, and nuclear facilities. It was the intent of the writing committee to develop a guidance document that could be utilized to establish a laboratory`s specific data quality objectives (DQOs) that govern the operational requirements of the radioassay process, including mandated protocols and recommendations.

  2. Japanese Quality Control Circles.

    ERIC Educational Resources Information Center

    Nishiyama, Kazuo

    In recent years, United States scholars with an interest in international business and organizational communication have begun to notice the success of Japanese "quality control circles." These are small groups, usually composed of seven to ten workers, who are organized at the production levels within most large Japanese factories. A typical…

  3. SIMBAD Quality-Control

    NASA Astrophysics Data System (ADS)

    Lesteven, Soizick

    1993-01-01

    Taking into consideration the amount and the complexity of SIMBAD data, it is necessary to use automatic methods to control and assure the quality of the SIMBAD database. One possibility is to apply multivariate data analysis to the content of documents related to astronomical data. The method and first results are presented.

  4. 21 CFR 606.140 - Laboratory controls.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of...

  5. 21 CFR 606.140 - Laboratory controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of...

  6. 21 CFR 606.140 - Laboratory controls.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of...

  7. 21 CFR 606.140 - Laboratory controls.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of...

  8. 21 CFR 606.140 - Laboratory controls.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of...

  9. [The network of official medicines control laboratories].

    PubMed

    Buchheit, K-H; Wanko, R

    2014-10-01

    Licensing, control and surveillance by competent authorities is the basis for ensuring efficacy, safety and quality of medicines in Europe. The control of the quality of medicines by national control laboratories, known as Official Medicines Control Laboratories (OMCLs) is an essential step in this process; it encompasses controls before and after granting a marketing authorisation. For certain groups of biomedical medicines (vaccines for human and veterinary use, medicines derived from human plasma) even each batch is controlled before it can be placed on the market. As single OMCLs would not be able to cope with their task, given the large number and diversity of medicines, in 1994 the OMCL network was founded upon initiative of the European Directorate for the Quality of Medicines & HealthCare, in close collaboration with the Commission of the European Union. Currently 68 OMCLs from 39 countries are part of the network. Prerequisite for the smooth operation of the OMCL network is the harmonisation of the quality management system of the individual OMCLs, based on the ISO 17025 standard, internal guidelines and the European Pharmacopoeia. Compliance with these standards is checked through regular audits, thus creating the basis for mutual recognition of test results. The collaboration in the OMCL network for the surveillance of the medicines market, the official control authority batch release and the fight against counterfeiting and illegal medicines enables OMCLs to keep pace with the developments in the field of medicines and to control the broad spectrum of medicines. In the 20 years since its start, the OMCL network has become a European success story. PMID:25192832

  10. Vgi Quality Control

    NASA Astrophysics Data System (ADS)

    Fonte, C. C.; Bastin, L.; Foody, G.; Kellenberger, T.; Kerle, N.; Mooney, P.; Olteanu-Raimond, A.-M.; See, L.

    2015-08-01

    This paper presents a framework for considering quality control of volunteered geographic information (VGI). Different issues need to be considered during the conception, acquisition and post-acquisition phases of VGI creation. This includes items such as collecting metadata on the volunteer, providing suitable training, giving corrective feedback during the mapping process and use of control data, among others. Two examples of VGI data collection are then considered with respect to this quality control framework, i.e. VGI data collection by National Mapping Agencies and by the most recent Geo-Wiki tool, a game called Cropland Capture. Although good practices are beginning to emerge, there is still the need for the development and sharing of best practice, especially if VGI is to be integrated with authoritative map products or used for calibration and/or validation of land cover in the future.

  11. Quality laboratory issues in bleeding disorders.

    PubMed

    Adcock, D M; Mammen, J; Nair, S C; de Lima Montalvão, S A

    2016-07-01

    Selected quality issues pertinent to the determination of accurate results in the haemostasis laboratory are discussed. Specifically, the implementation of a successful external quality-assessment scheme is described, including its impact on result accuracy as well as the programme's unique challenges and opportunities. Errors in the preanalytical phase of laboratory testing represent the greatest source for reporting incorrect test results. Some of the most common preanalytical errors are described including those that necessitate sample rejection. Analytical means to identify potential sources of error and analytical means to overcome particular interferences are described. Representing the most important clinical complication in the treatment of patients with haemophilia, quality issues related to determination of the presence of inhibitory antibodies against factor VIII (FVIII) are reviewed. Heat treatment of patient plasma prior to testing, particularly in patients receiving replacement FVIII concentrate or during induction of immune tolerance to achieve more accurate results is recommended, while screening activated partial thromboplastin time-based mixing tests to rule out inhibitor presence is discouraged. The initiatives presented in this review can be implemented in robust and resource restricted settings to improve the quality of laboratory testing in patients with bleeding disorders. PMID:27405682

  12. Quality control review: implementing a scientifically based quality control system.

    PubMed

    Westgard, James O; Westgard, Sten A

    2016-01-01

    This review focuses on statistical quality control in the context of a quality management system. It describes the use of a 'Sigma-metric' for validating the performance of a new examination procedure, developing a total quality control strategy, selecting a statistical quality control procedure and monitoring ongoing quality on the sigma scale. Acceptable method performance is a prerequisite to the design and implementation of statistical quality control procedures. Statistical quality control can only monitor performance, and when properly designed, alert analysts to the presence of additional errors that occur because of unstable performance. A new statistical quality control planning tool, called 'Westgard Sigma Rules,' provides a simple and quick way for selecting control rules and the number of control measurements needed to detect medically important errors. The concept of a quality control plan is described, along with alternative adaptations of a total quality control plan and a risk-based individualized quality control plan. Finally, the ongoing monitoring of analytic performance and test quality are discussed, including determination of measurement uncertainty from statistical quality control data collected under intermediate precision conditions and bias determined from proficiency testing/external quality assessment surveys. A new graphical tool, called the Sigma Quality Assessment Chart, is recommended for demonstrating the quality of current examination procedures on the sigma scale. PMID:26150675

  13. Environmental quality control report. [Semiannual] report, July--December 1988

    SciTech Connect

    Bishop, C.T.

    1989-04-14

    This report presents the details of the Mound Laboratory EPA-NPDES Quality Assurance Program, the DOE Quality Assessment Program Results, Proficiency Environmental Testing Program and Plutonium in Urine Quality Control for 1988.

  14. Evaluation of quality-control data collected by the U.S. Geological Survey for routine water-quality activities at the Idaho National Laboratory and vicinity, southeastern Idaho, 2002-08

    USGS Publications Warehouse

    Rattray, Gordon W.

    2014-01-01

    Quality-control (QC) samples were collected from 2002 through 2008 by the U.S. Geological Survey, in cooperation with the U.S. Department of Energy, to ensure data robustness by documenting the variability and bias of water-quality data collected at surface-water and groundwater sites at and near the Idaho National Laboratory. QC samples consisted of 139 replicates and 22 blanks (approximately 11 percent of the number of environmental samples collected). Measurements from replicates were used to estimate variability (from field and laboratory procedures and sample heterogeneity), as reproducibility and reliability, of water-quality measurements of radiochemical, inorganic, and organic constituents. Measurements from blanks were used to estimate the potential contamination bias of selected radiochemical and inorganic constituents in water-quality samples, with an emphasis on identifying any cross contamination of samples collected with portable sampling equipment. The reproducibility of water-quality measurements was estimated with calculations of normalized absolute difference for radiochemical constituents and relative standard deviation (RSD) for inorganic and organic constituents. The reliability of water-quality measurements was estimated with pooled RSDs for all constituents. Reproducibility was acceptable for all constituents except dissolved aluminum and total organic carbon. Pooled RSDs were equal to or less than 14 percent for all constituents except for total organic carbon, which had pooled RSDs of 70 percent for the low concentration range and 4.4 percent for the high concentration range. Source-solution and equipment blanks were measured for concentrations of tritium, strontium-90, cesium-137, sodium, chloride, sulfate, and dissolved chromium. Field blanks were measured for the concentration of iodide. No detectable concentrations were measured from the blanks except for strontium-90 in one source solution and one equipment blank collected in September

  15. Iowa Central Quality Fuel Testing Laboratory

    SciTech Connect

    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 Land Stewardship on the development of an Iowa Biofuel Quality Standard along with the Development of a standard that can be used throughout industry.

  16. USGS Blind Sample Project: monitoring and evaluating laboratory analytical quality

    USGS Publications Warehouse

    Ludtke, Amy S.; Woodworth, Mark T.

    1997-01-01

    The U.S. Geological Survey (USGS) collects and disseminates information about the Nation's water resources. Surface- and ground-water samples are collected and sent to USGS laboratories for chemical analyses. The laboratories identify and quantify the constituents in the water samples. Random and systematic errors occur during sample handling, chemical analysis, and data processing. Although all errors cannot be eliminated from measurements, the magnitude of their uncertainty can be estimated and tracked over time. Since 1981, the USGS has operated an independent, external, quality-assurance project called the Blind Sample Project (BSP). The purpose of the BSP is to monitor and evaluate the quality of laboratory analytical results through the use of double-blind quality-control (QC) samples. The information provided by the BSP assists the laboratories in detecting and correcting problems in the analytical procedures. The information also can aid laboratory users in estimating the extent that laboratory errors contribute to the overall errors in their environmental data.

  17. Radiographic quality control devices.

    PubMed

    2000-04-01

    In this study, we evaluate eight radiographic quality control (QC) devices, which noninvasively measure the output from a variety of diagnostic x-ray production systems. When used as part of a quality assurance (QA) program, radiographic QC devices help ensure that x-ray equipment is working within acceptable limits. This in turn helps ensure that high-quality images are achieved with appropriate radiation doses and that resources are used efficiently (for example, by minimizing the number of repeat exposures required). Our testing focused on the physical performance, ease of use, and service and maintenance characteristics that affect the use of these devices for periodic, routine measurements of x-ray system parameters. We found that all the evaluated models satisfactorily measure all the parameters normally needed for a QA program. However, we did identify a number of differences among the models--particularly in the range of exposure levels that can be effectively measured and the ease of use. Three models perform well for a variety of applications and are very easy to use; we rate them Preferred. Three additional models have minor limitations but otherwise perform well; we rate them Acceptable. We recommend against purchasing two models because, although each performs acceptably for most applications, neither model can measure low levels of radiation. This Evaluation covers devices designed to measure the output of x-ray tubes noninvasively. These devices, called radiographic quality control (QC) devices, or QC meters, are typically used by medical physicists, x-ray engineers, biomedical engineers, and suitably trained radiographic technologists to make QC measurements. We focus on the use of these devices as part of an overall quality assurance (QA) program. We have not evaluated their use for other applications, such as acceptance testing. To be included in this study, a device must be able to measure the exposure- and kVp-related characteristics of most x

  18. 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

  19. Reducing Communication Delays and Improving Quality of Care with a Tuberculosis Laboratory Information System in Resource Poor Environments: A Cluster Randomized Controlled Trial

    PubMed Central

    Blaya, Joaquín A.; Shin, Sonya S.; Yagui, Martin; Contreras, Carmen; Cegielski, Peter; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Bayona, Jaime; Kim, Jihoon; Fraser, Hamish S. F.

    2014-01-01

    Background Lost, delayed or incorrect laboratory results are associated with delays in initiating treatment. Delays in treatment for Multi-Drug Resistant Tuberculosis (MDR-TB) can worsen patient outcomes and increase transmission. The objective of this study was to evaluate the impact of a laboratory information system in reducing delays and the time for MDR-TB patients to culture convert (stop transmitting). Methods Setting: 78 primary Health Centers (HCs) in Lima, Peru. Participants lived within the catchment area of participating HCs and had at least one MDR-TB risk factor. The study design was a cluster randomized controlled trial with baseline data. The intervention was the e-Chasqui web-based laboratory information system. Main outcome measures were: times to communicate a result; to start or change a patient's treatment; and for that patient to culture convert. Results 1671 patients were enrolled. Intervention HCs took significantly less time to receive drug susceptibility test (DST) (median 11 vs. 17 days, Hazard Ratio 0.67 [0.62–0.72]) and culture (5 vs. 8 days, 0.68 [0.65–0.72]) results. The time to treatment was not significantly different, but patients in intervention HCs took 16 days (20%) less time to culture convert (p = 0.047). Conclusions The eChasqui system reduced the time to communicate results between laboratories and HCs and time to culture conversion. It is now used in over 259 HCs covering 4.1 million people. This is the first randomized controlled trial of a laboratory information system in a developing country for any disease and the only study worldwide to show clinical impact of such a system. Trial Registration ClinicalTrials.gov NCT01201941 PMID:24721980

  20. [Internal Quality Control and External Quality Assessment on POCT].

    PubMed

    Kuwa, Katsuhiko

    2015-02-01

    The quality management (QM) of POCT summarizes its internal quality control (IQC) and external quality assessment (EQA). For QM requirements in POCT, ISO 22870-Point-of-care testing (POCT) -Requirements for quality and competence and ISO 15189-Medical laboratories-Requirements for quality and competence, it is performed under the guidance of the QM committee. The role of the POC coordinator and/or medical technologist of the clinical laboratory is important. On measurement performance of POCT devices, it is necessary to confirm data on measurement performance from the manufacturer other than those in the inserted document. In the IQC program, the checking and control of measurement performance are the targets. On measurements of QC samples by the manufacturer, it is essential to check the function of devices. In addition, regarding the EQA program, in 2 neighboring facilities, there is an effect to confirm the current status of measurement and commutability assessment in these laboratories using whole blood along with residual blood samples from daily examinations in the clinical laboratory. PMID:26529974

  1. 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

  2. SIMBAD quality-control

    NASA Technical Reports Server (NTRS)

    Lesteven, Soizick

    1992-01-01

    The astronomical database SIMBAD developed at the Centre de donnees astronomiques de Strasbourg presently contains 760,000 objects (stellar and non-stellar). It has the unique characteristic of being structured specifically for astronomical objects. All types of heterogeneous data (bibliographic references, measurements, and sets of identification) are connected with each object. The attributes that define quality of the database include the following. Reliability: cross-identification should not rely upon just exact values object coordinates. It also means that information attached to one simple object should be consistent. The existing data must be controlled in order to start with a reliable base and to cross-identify new data assuring the quality as data grows. Exhaustivity: delays between publication of new informations and their inclusion in the database should be as short as possible. The integrity of the database has to be maintained as data accumulates. Taking the amount of data into consideration and the rate of new data production, it is necessary to use automatic methods. One of the possibilities is to use multivariate data analysis. The factor-space is a n-dimensional relevancy space which is described by the n-axes representing a set of n subject matter headings; the words and phrases can be used to scale the axes and the documents are then a vector average of the terms within them. The application reported herein is based on the NASA-STI bibliographical database. The selected data concern astronomy, astrophysics, and space radiation (102,963 references from 1975 to 1991 included 8070 keywords). The F-space is built from this bibliographical data. By comparing the F-space position obtained from the NASA-STI keywords with the F-space position obtained from the SIMBAD references, the authors will be able to show whether it is possible to retrieve information with a restricted set of words only. If the comparison is valid, this will be a way to enter

  3. Quality Control of Trichinella Testing at the Slaughterhouse Laboratory: Evaluation of the Use of a 400-Micrometer-Mesh-Size Sieve in the Magnetic Stirrer Method.

    PubMed

    Franssen, Frits; van Andel, Esther; Swart, Arno; van der Giessen, Joke

    2016-02-01

    The performance of a 400-μm-mesh-size sieve (sieve400) has not previously been compared with that of a 180-μm-mesh-size sieve (sieve180). Using pork samples spiked with 0 to 10 Trichinella muscle larvae and an artificial digestion method, sieve performance was evaluated for control of Trichinella in meat-producing animals. The use of a sieve400 resulted in 12% lower larval counts, 147% more debris, and 28% longer counting times compared with the use of a sieve180. Although no false-negative results were obtained, prolonged counting times with the sieve400 may have an impact on performance in a high-throughput environment such as a slaughterhouse laboratory. Based on our results, the sieve180 remains the sieve of choice for Trichinella control in meat in slaughterhouse laboratories, according to the European Union reference method (European Commission regulation 2075/2005). Furthermore, the results of the present study contribute to the discussion of harmonization of meat inspection requirements among countries. PMID:26818995

  4. General aviation fuel quality control

    NASA Technical Reports Server (NTRS)

    Poitz, H.

    1983-01-01

    Quality control measures for aviation gasoline, and some of the differences between quality control on avgas and mogas are discussed. One thing to keep in mind is that with motor gasoline you can always pull off to the side of the road. It's not so easy to do in an airplane. Consequently, there are reasons for having the tight specifications and the tight quality control measures on avgas as compared to motor gasoline.

  5. Evaluation of quality-control data collected by the U.S. Geological Survey for routine water-quality activities at the Idaho National Laboratory, Idaho, 1996–2001

    USGS Publications Warehouse

    Rattray, Gordon W.

    2012-01-01

    The U.S. Geological Survey, in cooperation with the U.S. Department of Energy, collects surface water and groundwater samples at and near the Idaho National Laboratory as part of a routine, site-wide, water-quality monitoring program. Quality-control samples are collected as part of the program to ensure and document the quality of environmental data. From 1996 to 2001, quality-control samples consisting of 204 replicates and 27 blanks were collected at sampling sites. Paired measurements from replicates were used to calculate variability (as reproducibility and reliability) from sample collection and analysis of radiochemical, chemical, and organic constituents. Measurements from field and equipment blanks were used to estimate the potential contamination bias of constituents. The reproducibility of measurements of constituents was calculated from paired measurements as the normalized absolute difference (NAD) or the relative standard deviation (RSD). The NADs and RSDs, as well as paired measurements with censored or estimated concentrations for which NADs and RSDs were not calculated, were compared to specified criteria to determine if the paired measurements had acceptable reproducibility. If the percentage of paired measurements with acceptable reproducibility for a constituent was greater than or equal to 90 percent, then the reproducibility for that constituent was considered acceptable. The percentage of paired measurements with acceptable reproducibility was greater than or equal to 90 percent for all constituents except orthophosphate (89 percent), zinc (80 percent), hexavalent chromium (53 percent), and total organic carbon (TOC; 38 percent). The low reproducibility for orthophosphate and zinc was attributed to calculation of RSDs for replicates with low concentrations of these constituents. The low reproducibility for hexavalent chromium and TOC was attributed to the inability to preserve hexavalent chromium in water samples and high variability with the

  6. Method of Analysis by the U.S. Geological Survey California District Sacramento Laboratory?Determination of Trihalomethane Formation Potential, Method Validation, and Quality-Control Practices

    USGS Publications Warehouse

    Crepeau, Kathryn L.; Fram, Miranda S.; Bush, Noel

    2004-01-01

    An analytical method for the determination of the trihalomethane formation potential of water samples has been developed. The trihalomethane formation potential is measured by dosing samples with chlorine under specified conditions of pH, temperature, incubation time, darkness, and residual-free chlorine, and then analyzing the resulting trihalomethanes by purge and trap/gas chromatography equipped with an electron capture detector. Detailed explanations of the method and quality-control practices are provided. Method validation experiments showed that the trihalomethane formation potential varies as a function of time between sample collection and analysis, residual-free chlorine concentration, method of sample dilution, and the concentration of bromide in the sample.

  7. Quality control on the frontier

    PubMed Central

    Paszkiewicz, Konrad H.; Farbos, Audrey; O'Neill, Paul; Moore, Karen

    2014-01-01

    In the world of high-throughput sequencing there are numerous challenges to effective data quality control. There are no single quality metrics which are appropriate in all conditions. Here we detail the different open source software used at the Exeter Sequencing Service to provide generic quality control information, as well as more specific metrics for genomic and transcriptomic libraries run on Illumina platforms. PMID:24904650

  8. [Quality Management and Quality Specifications of Laboratory Tests in Clinical Studies--Challenges in Pre-Analytical Processes in Clinical Laboratories].

    PubMed

    Ishibashi, Midori

    2015-01-01

    The cost, speed, and quality are the three important factors recently indicated by the Ministry of Health, Labour and Welfare (MHLW) for the purpose of accelerating clinical studies. Based on this background, the importance of laboratory tests is increasing, especially in the evaluation of clinical study participants' entry and safety, and drug efficacy. To assure the quality of laboratory tests, providing high-quality laboratory tests is mandatory. For providing adequate quality assurance in laboratory tests, quality control in the three fields of pre-analytical, analytical, and post-analytical processes is extremely important. There are, however, no detailed written requirements concerning specimen collection, handling, preparation, storage, and shipping. Most laboratory tests for clinical studies are performed onsite in a local laboratory; however, a part of laboratory tests is done in offsite central laboratories after specimen shipping. As factors affecting laboratory tests, individual and inter-individual variations are well-known. Besides these factors, standardizing the factors of specimen collection, handling, preparation, storage, and shipping, may improve and maintain the high quality of clinical studies in general. Furthermore, the analytical method, units, and reference interval are also important factors. It is concluded that, to overcome the problems derived from pre-analytical processes, it is necessary to standardize specimen handling in a broad sense. PMID:26524888

  9. Method of analysis at the U.S. Geological Survey California Water Science Center, Sacramento Laboratory - determination of haloacetic acid formation potential, method validation, and quality-control practices

    USGS Publications Warehouse

    Zazzi, Barbara C.; Crepeau, Kathryn L.; Fram, Miranda S.; Bergamaschi, Brian A.

    2005-01-01

    An analytical method for the determination of haloacetic acid formation potential of water samples has been developed by the U.S. Geological Survey California Water Science Center Sacramento Laboratory. The haloacetic acid formation potential is measured by dosing water samples with chlorine under specified conditions of pH, temperature, incubation time, darkness, and residual-free chlorine. The haloacetic acids formed are bromochloroacetic acid, bromodichloroacetic acid, dibromochloroacetic acid, dibromoacetic acid, dichloroacetic acid, monobromoacetic acid, monochloroacetic acid, tribromoacetic acid, and trichloroacetic acid. They are extracted, methylated, and then analyzed using a gas chromatograph equipped with an electron capture detector. Method validation experiments were performed to determine the method accuracy, precision, and detection limit for each of the compounds. Method detection limits for these nine haloacetic acids ranged from 0.11 to 0.45 microgram per liter. Quality-control practices include the use of blanks, quality-control samples, calibration verification standards, surrogate recovery, internal standard, matrix spikes, and duplicates.

  10. 21 CFR 225.58 - Laboratory controls.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Laboratory controls. 225.58 Section 225.58 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure...

  11. 21 CFR 225.58 - Laboratory controls.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Laboratory controls. 225.58 Section 225.58 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure...

  12. 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.

  13. 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.

  14. The role of the EPA radiation quality assurance program in the measurement quality assurance accreditation program for radioassay laboratories

    SciTech Connect

    Grady, T.M.

    1993-12-31

    As the nature and extent of radiological contamination becomes better documented and more public, radioanalytical laboratories are faced with a constantly expanding variety of new and difficult analytical requirements. Concurrent with those requirements is the responsibility to provide customers, regulatory officials, or the public with defensible data produced in an environment of verifiable, controlled quality. To meet that need, a quality assurance accreditation program for radioassay laboratories has been proposed by the American National Standards Institute (ANSI). The standard will provide the organizational framework and functional requirements needed to assure the quality of laboratory outputs. Under the proposed program, the U.S. Environmental Protection Agency`s (EPA`s) Laboratory Intercomparison Program plays a key role as a reference laboratory. The current and proposed roles of the EPA Intercomparison Program are discussed, as are the functional relationships between EPA, the accreditating organization, and the service and monitoring laboratories.

  15. Safety in the Chemical Laboratory: Flood Control.

    ERIC Educational Resources Information Center

    Pollard, Bruce D.

    1983-01-01

    Describes events leading to a flood in the Wehr Chemistry Laboratory at Marquette University, discussing steps taken to minimize damage upon discovery. Analyzes the problem of flooding in the chemical laboratory and outlines seven steps of flood control: prevention; minimization; early detection; stopping the flood; evaluation; clean-up; and…

  16. 10 CFR 26.137 - Quality assurance and quality control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Quality assurance and quality control. 26.137 Section 26....137 Quality assurance and quality control. (a) Quality assurance program. Each licensee testing facility shall have a quality assurance program that encompasses all aspects of the testing...

  17. Essential elements of quality control.

    PubMed

    Boylan, J C

    1983-11-01

    The components of quality control in the pharmaceutical industry are discussed as they apply to hospital pharmacy admixture services. The pharmaceutical industry complies with the FDA's Current Good Manufacturing Practices, which require manufacturers to have written procedures for ensuring sterility and nonpyrogenicity of injectable products. Because FDA specifies only what outcome measures must be assessed (rather than specific means of assessment), pharmaceutical companies have developed a multiplicity of quality-control systems. However, each system consists of a master formula (quantitative listing of all ingredients), master manufacturing instructions (the recipe for each product), master packaging instructions, and batch records. Documents used by quality control personnel include the specifications (identification, tests, and limits for products), test methods, and sampling procedures. Hospitals should have similar quality-control programs. These programs should systematically prevent or identify and correct deficiencies, measure overall quality, and provide information for managers. Hospital pharmacists whose departments do not have comprehensive programs should consult colleagues who have developed such procedures. Techniques used in industry should be applied when possible. To protect the integrity of manufacturers' drug products during compounding in hospitals, every hospital admixture service must have its own quality-control system. PMID:6650523

  18. Principles and Practices for Quality Assurance and Quality Control

    USGS Publications Warehouse

    Jones, Berwyn E.

    1999-01-01

    Quality assurance and quality control are vital parts of highway runoff water-quality monitoring projects. To be effective, project quality assurance must address all aspects of the project, including project management responsibilities and resources, data quality objectives, sampling and analysis plans, data-collection protocols, data quality-control plans, data-assessment procedures and requirements, and project outputs. Quality control ensures that the data quality objectives are achieved as planned. The historical development and current state of the art of quality assurance and quality control concepts described in this report can be applied to evaluation of data from prior projects.

  19. Data Acquisition and Control Systems Laboratory

    NASA Technical Reports Server (NTRS)

    Holland, Randy; Jensen, Scott; Burrel, Terrence; Spooner, Richard

    2002-01-01

    The Data Acquisition and Control Systems (DACS) Laboratory is a facility at Stennis Space Center that provides an off test-stand capability to develop data-acquisition and control systems for rocket-engine test stands. It is also used to train new employees in state-of-the-art systems, and provides a controlled environment for troubleshooting existing systems, as well as the ability to evaluate the application of new technologies and process improvements. With the SSC propulsion testing schedules, without the DACS Laboratory, it would have been necessary to perform most of the development work on actual test systems, thereby subjecting both the rocket-engine testing and development programs to substantial interference in the form of delays, restrictions on modifications of equipment, and potentially compromising software configuration control. The DACS Laboratory contains a versatile assortment of computer hardware and software, digital and analog electronic control and data-acquisition equipment, and standard electronic bench test equipment and tools. Recently completed Control System development and software verification projects include support to the joint NASA/Air Force Integrated Powerhead Demonstration (IPD) LOX & LH2 PreBurner and Turbopump ground testing programs. In other recent activities, the DACS Laboratory equipment and expertise have supported the off-stand operation of high-pressure control valves to correct valve leak problems prior to installation on the test stand. Future plans include expanding the Laboratory's capabilities to provide cryogenic control valve characterization prior to installation, thereby reducing test stand activation time.

  20. [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". PMID:26591432

  1. Quality assurance plan for the Close Support Laboratory for the remedial investigation at Oak Ridge National Laboratory, Oak Ridge, Tennessee

    SciTech Connect

    Not Available

    1993-08-01

    The primary purpose of the Close Support Laboratory (CSL) is to provide rapid radiological screening of investigation-derived samples before they are shipped to off-site laboratories for more detailed analyses. Analyses for volatile organic compounds and miscellaneous water quality parameters are also performed at the CSL. CSL data are also used to select samples for off-site laboratory analysis, for rapid qualitative and quantitative determinations, and for other processes when off-site analysis is not needed and/or is impractical. This plan specifies methods of implementing analytical and radiological protocols and procedures for the documentation, handling, control, and analysis of samples and describes the levels of authority and responsibility for laboratory operation. Specific quality control methods used by the CSL for individual analyses are described in project procedures.

  2. Laboratory preparation and evaluation of a multiparameter hemocytometry control.

    PubMed

    Lombarts, A J; Leijnse, B

    1984-05-30

    A protocol for the laboratory preparation of a multiparameter hemocytometry control is given. Human platelets, stabilized by a basically simplified and inexpensive fixation procedure, are added to our previously described white and red blood cell control. Evaluation of this multiparameter control shows good precision characteristics and acceptable mechanical stability for at least 7 weeks, as measured in the Coulter counter Model S Plus-II. The control can basically contribute to the realization of the essence of internal quality control: continuous self-auditing and continuous attempts at improvement of performance. PMID:6733929

  3. [External quality assessment for clinical microbiology and good laboratory management].

    PubMed

    Kumasaka, K

    1998-02-01

    The Tokyo Metropolitan external quality assessment (EQA) program has revealed some serious problems in private independent microbiology laboratories in Tokyo since 1982. The poor performance in the EQA surveys closely related to poor laboratory managements, the type of training, experience of the medical technologists or technicians, and supervisory ability of the consultant physicians in independent laboratories. Social factors impede the reform of the quality assurance of clinical microbiology. Such factors include poor infrastructure of continuing education for small private laboratories, closure of the central clinical laboratories in the hospitals and outsourcing of laboratory tests due to restructuring in response to economic problems, and limited numbers of certified clinical pathologists of the Japan Society of Clinical Pathology (JSCP). Therefore, the Tokyo Metropolitan EQA Scheme is still confidential and its main role is educational. Good two way communication between participants and the organizers' clinical pathologists is essential, if the quality of laboratory tests is to be improved. The new JSCP edition of the postgraduate training requirement in clinical pathology includes "Laboratory Administration and Management". Good laboratory management(GLM) is an increasingly important component of good laboratory practice. The practice activities of clinical pathologists must include general management in addition to exercising there specialized knowledge in medicine and technology. Whereas leadership of a good clinical pathologist provides the direction of where a good laboratory is going, good management provides the steps of how to get there. And I believe quality system models from business and industry may provide us with strong guidance to build a quality system for the good laboratory that will endure into the next century. PMID:9528335

  4. Quality control programme in mammography: second level quality controls.

    PubMed

    Nassivera, E; Nardin, L

    1997-06-01

    Mammography is the most reliable method by which to detect lesions in the breast. Since contrast between normal and pathological areas in the breast is extremely low, mammographic image quality should reach high standards without exceeding acceptable exposure levels for the breast. A quality control programme in mammography has been implemented. This programme is subdivided into two levels. The first consists of simple daily checks of image quality and film processing, while the second deals with more complex checks of mammographic unit, screen-film system, darkroom, illuminators, viewing conditions and reference dose determination. The values of all the parameters undergoing measurement are compared with the limiting values given by National and International Protocols. This paper describes the second level controls carried out every 6 months by the medical physicist. The parameters described are only those which have been studied and analysed in detail since the quality control programme in mammography was implemented. Such parameters (kilovoltage, focal spot dimension, half value layer, tube output, automatic exposure control system, screen-film characteristic curve and mean glandular dose) were measured during the period 1991-1995 and the results summarised. The values obtained prove the constant correct functioning of the equipment. PMID:9227255

  5. 10 CFR 26.137 - Quality assurance and quality control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Quality assurance and quality control. 26.137 Section 26.137 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Licensee Testing Facilities § 26.137 Quality assurance and quality control. (a) Quality assurance program. Each licensee...

  6. 10 CFR 26.137 - Quality assurance and quality control.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Quality assurance and quality control. 26.137 Section 26.137 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Licensee Testing Facilities § 26.137 Quality assurance and quality control. (a) Quality assurance program. Each licensee...

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

    SciTech Connect

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

    1993-12-31

    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. This 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.

  8. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 2 2010-07-01 2010-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is... quality control frequencies by using statistical process control to monitor equipment performance on...

  9. NASA Laboratory telerobotic manipulator control system architecture

    NASA Technical Reports Server (NTRS)

    Rowe, J. C.; Butler, P. L.; Glassell, R. L.; Herndon, J. N.

    1991-01-01

    In support of the National Aeronautics and Space Administration (NASA) goals to increase the utilization of dexterous robotic systems in space, the Oak Ridge National Laboratory (ORNL) has developed the Laboratory Telerobotic Manipulator (LTM) system. It is a dexterous, dual-arm, force reflecting teleoperator system with robotic features for NASA ground-based research. This paper describes the overall control system architecture, including both the hardware and software. The control system is a distributed, modular, and hierarchical design with flexible expansion capabilities for future enhancements of both the hardware and software.

  10. 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...

  11. Process for controlling accidents in chemical laboratories

    SciTech Connect

    Delvin, W.L.

    1980-10-01

    Most laboratory safety programs include inspections to identify hazards and thereby control accidents. There are certain elements that must be a part of a successful inspection and control process. These are a systematic and consistent inspection procedure, a reliable evaluation of identified hazards, and effective follow-up actions. Laboratory management, through its responsibility for the total system, has a key role in the inspection and control process for follow-up actions and accepting risks. If any of the above requirements are missing, the process will be less than adequate. Understanding the relationship between accidents, hazards, and risks is important in establishing an effective inspection and control program. Hazards are potential sources of accidents (accidents waiting to happen). Associated with each is a risk, which has two components: probability and consequence. Probability refers to the likelihood that a hazard will turn into an accident and consequence is the result of such an accident. In assessing the seriousness of a hazard, both probability and consequence must be considered in terms of risk level and acceptability. This paper presents a process that can be used by laboratory management to establish an effective inspection and control program for the laboratory. A discussion of safety concepts and their relationships that affect the process is included.

  12. Testing a Constrained MPC Controller in a Process Control Laboratory

    ERIC Educational Resources Information Center

    Ricardez-Sandoval, Luis A.; Blankespoor, Wesley; Budman, Hector M.

    2010-01-01

    This paper describes an experiment performed by the fourth year chemical engineering students in the process control laboratory at the University of Waterloo. The objective of this experiment is to test the capabilities of a constrained Model Predictive Controller (MPC) to control the operation of a Double Pipe Heat Exchanger (DPHE) in real time.…

  13. Quality control of EUVE databases

    NASA Technical Reports Server (NTRS)

    John, L. M.; Drake, J.

    1992-01-01

    The publicly accessible databases for the Extreme Ultraviolet Explorer include: the EUVE Archive mailserver; the CEA ftp site; the EUVE Guest Observer Mailserver; and the Astronomical Data System node. The EUVE Performance Assurance team is responsible for verifying that these public EUVE databases are working properly, and that the public availability of EUVE data contained therein does not infringe any data rights which may have been assigned. In this poster, we describe the Quality Assurance (QA) procedures we have developed from the approach of QA as a service organization, thus reflecting the overall EUVE philosophy of Quality Assurance integrated into normal operating procedures, rather than imposed as an external, post facto, control mechanism.

  14. A Laboratory Testbed for Embedded Fuzzy Control

    ERIC Educational Resources Information Center

    Srivastava, S.; Sukumar, V.; Bhasin, P. S.; Arun Kumar, D.

    2011-01-01

    This paper presents a novel scheme called "Laboratory Testbed for Embedded Fuzzy Control of a Real Time Nonlinear System." The idea is based upon the fact that project-based learning motivates students to learn actively and to use their engineering skills acquired in their previous years of study. It also fosters initiative and focuses students'…

  15. Mars Science Laboratory thermal control architecture

    NASA Technical Reports Server (NTRS)

    Bhandari, Pradeep; Birur, Gajanana; Pauken, Michael; Paris, Anthony; Novak, Keith; Prina, Mauro; Ramirez, Brenda; Bame, David

    2005-01-01

    The Mars Science Laboratory (MSL) mission to land a large rover on Mars is being planned for launch in 2009. This paper will describe the basic architecture of the thermal control system, the challenges and the methods used to overcome them by the use of an innovative architecture to maximize the use of heritage from past projects while meeting the requirements for the design.

  16. 40 CFR 136.7 - Quality assurance and quality control.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 23 2014-07-01 2014-07-01 false Quality assurance and quality control. 136.7 Section 136.7 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) GUIDELINES ESTABLISHING TEST PROCEDURES FOR THE ANALYSIS OF POLLUTANTS § 136.7 Quality assurance and quality control. The...

  17. Approaches to quality management and accreditation in a genetic testing laboratory.

    PubMed

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

    2010-09-01

    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

  18. 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

  19. 23 CFR 1340.8 - Quality control.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... OBSERVATIONAL SURVEYS OF SEAT BELT USE Survey Design Requirements § 1340.8 Quality control. (a) Quality control... control monitors involved in seat belt use surveys shall have received training in data...

  20. 23 CFR 1340.8 - Quality control.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... OBSERVATIONAL SURVEYS OF SEAT BELT USE Survey Design Requirements § 1340.8 Quality control. (a) Quality control... control monitors involved in seat belt use surveys shall have received training in data...

  1. 23 CFR 1340.8 - Quality control.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... OBSERVATIONAL SURVEYS OF SEAT BELT USE Survey Design Requirements § 1340.8 Quality control. (a) Quality control... control monitors involved in seat belt use surveys shall have received training in data...

  2. Quality Control of Meteorological Observations

    NASA Technical Reports Server (NTRS)

    Collins, William; Dee, Dick; Rukhovets, Leonid

    1999-01-01

    For the first time, a problem of the meteorological observation quality control (QC) was formulated by L.S. Gandin at the Main Geophysical Observatory in the 70's. Later in 1988 L.S. Gandin began adapting his ideas in complex quality control (CQC) to the operational environment at the National Centers for Environmental Prediction. The CQC was first applied by L.S.Gandin and his colleagues to detection and correction of errors in rawinsonde heights and temperatures using a complex of hydrostatic residuals.Later, a full complex of residuals, vertical and horizontal optimal interpolations and baseline checks were added for the checking and correction of a wide range of meteorological variables. some other of Gandin's ideas were applied and substantially developed at other meteorological centers. A new statistical QC was recently implemented in the Goddard Data Assimilation System. The central component of any quality control is a buddy check which is a test of individual suspect observations against available nearby non-suspect observations. A novel feature of this test is that the error variances which are used for QC decision are re-estimated on-line. As a result, the allowed tolerances for suspect observations can depend on local atmospheric conditions. The system is then better able to accept extreme values observed in deep cyclones, jet streams and so on. The basic statements of this adaptive buddy check are described. Some results of the on-line QC including moisture QC are presented.

  3. 7 CFR 930.44 - Quality control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Quality control. 930.44 Section 930.44 Agriculture... MICHIGAN, NEW YORK, PENNSYLVANIA, OREGON, UTAH, WASHINGTON, AND WISCONSIN Order Regulating Handling Quality Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of...

  4. 7 CFR 981.42 - Quality control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Quality control. 981.42 Section 981.42 Agriculture... Regulating Handling Quality Control § 981.42 Quality control. (a) Incoming. Except as provided in this... establish, with the approval of the Secretary, such minimum quality and inspection requirements...

  5. Laboratory system strengthening and quality improvement in Ethiopia

    PubMed Central

    Hiwotu, Tilahun M.; Ayana, Gonfa; Mulugeta, Achamyeleh; Kassa, Getachew B.; Kebede, Yenew; Fonjungo, Peter N.; Tibesso, Gudeta; Desale, Adino; Kebede, Adisu; Kassa, Wondwossen; Mekonnen, Tesfaye; Yao, Katy; Luman, Elizabeth T.; Kebede, Amha; Linde, Mary K.

    2015-01-01

    Background In 2010, a National Laboratory Strategic Plan was set forth in Ethiopia to strengthen laboratory quality systems and set the stage for laboratory accreditation. As a result, the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme was initiated in 45 Ethiopian laboratories. Objectives This article discusses the implementation of the programme, the findings from the evaluation process and key challenges. Methods The 45 laboratories were divided into two consecutive cohorts and staff from each laboratory participated in SLMTA training and improvement projects. The average amount of supportive supervision conducted in the laboratories was 68 hours for cohort I and two hours for cohort II. Baseline and exit audits were conducted in 44 of the laboratories and percent compliance was determined using a checklist with scores divided into zero- to five-star rating levels. Results Improvements, ranging from < 1 to 51 percentage points, were noted in 42 laboratories, whilst decreases were recorded in two. The average scores at the baseline and exit audits were 40% and 58% for cohort I (p < 0.01); and 42% and 53% for cohort II (p < 0.01), respectively. The p-value for difference between cohorts was 0.07. At the exit audit, 61% of the first and 48% of the second cohort laboratories achieved an increase in star rating. Poor awareness, lack of harmonisation with other facility activities and the absence of a quality manual were challenges identified. Conclusion Improvements resulting from SLMTA implementation are encouraging. Continuous advocacy at all levels of the health system is needed to ensure involvement of stakeholders and integration with other improvement initiatives and routine activities. PMID:26753129

  6. Quality assurance programs at the PNL calibrations laboratory

    SciTech Connect

    Piper, R.K.; McDonald, J.C.; Fox, R.A.; Eichner, F.N.

    1993-03-01

    The calibrations laboratory at Pacific Northwest Laboratory (PNL) serves as a radiological standardization facility for personnel and environmental dosimetry and radiological survey instruments. As part of this function, the calibrations laboratory must maintain radiological reference fields with calibrations traceable to the National Institute of Standards and Technology (NIST). This task is accomplished by a combination of (1) sources or reference instruments calibrated at or by NIST, (2) measurement quality assurance (MQA) interactions with NIST, and (3) rigorous internal annual and quarterly calibration verifications. This paper describes a representative sample of the facilities, sources, and actions used to maintain accurate and traceable fields.

  7. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 2 2011-07-01 2011-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is calibrated and maintained properly, and that inspection, calibration records, and control charts...

  8. Laboratory cost control and financial management software.

    PubMed

    Mayer, M

    1998-02-01

    Economical constraints within the health care system advocate the introduction of tighter control of costs in clinical laboratories. Detailed cost information forms the basis for cost control and financial management. Based on the cost information, proper decisions regarding priorities, procedure choices, personnel policies and investments can be made. This presentation outlines some principles of cost analysis, describes common limitations of cost analysis, and exemplifies use of software to achieve optimized cost control. One commercially available cost analysis software, LabCost, is described in some detail. In addition to provision of cost information, LabCost also serves as a general management tool for resource handling, accounting, inventory management and billing. The application of LabCost in the selection process of a new high throughput analyzer for a large clinical chemistry service is taken as an example for decisions that can be assisted by cost evaluation. It is concluded that laboratory management that wisely utilizes cost analysis to support the decision-making process will undoubtedly have a clear advantage over those laboratories that fail to employ cost considerations to guide their actions. PMID:9541753

  9. Total Quality Management at an Oak Ridge laboratory and the establishment of an internal quality program

    SciTech Connect

    Dorsey, J.G.

    1993-11-01

    In order for any laboratory to be successful today, it is imperative that a total commitment to quality management be the keystone of that laboratory. Modern industry has begun to recognize that it must reach beyond traditional Quality Assurance methods and enlist the participation of all members of the organization for their unique contributions to make their organizations truly excellent. This report discusses Total Quality Management in the Analytical Services Organization at Oak Ridge, Tennessee. Laboratories are in the Y-12 Plant, which is one of three government sites located in Oak Ridge that are managed by Martin Marietta Energy Systems for the Department of Energy (DOE).

  10. [Quality control in clinical trials].

    PubMed

    Fukushima, M

    1996-01-01

    Quality control (QC) in clinical trials means the procedures which insure protection of human subjects from research risk, reliability of the data, and thereby assures internal consistency. This has been developed since 1970s in the US, by establishing various regulations which are now called GCP. From the viewpoint of total QC, it should be emphasized that rigorous review of protocol by the Institutional Review Board and obtaining Informed Consent are prerequisites for insuring the quality of the given trial at high scientific level. When pursuing a clinical trial, first of all, facilities of the institutions and the ability of investigators must be of high quality. For this reason, at each institution previous data related to trials should be thoroughly reviewed and analyzed prior to developing a protocol. Educational courses in QC in clinical practice are invaluable. QC of diagnosis means, for example, central pathology review and standardization of diagnostic procedures and process. Secondly, at each institution, data managers collect the data and submit them to the central office at the indicated time. In order to evolve clinical trial, continuous education for data managers and expansion of their job are encouraged. Thirdly, at the statistical center independent from the research group office, subject-specific data managers, the biostatistical staff, must check submitted forms for completeness, consistency and accuracy. Finally, at the data analysis, quality evaluation of the research should also be carried out. Throughout the trial, monitoring and audit are particularly important to assure quality. The sponsor has the responsibility of monitoring the trial and make rigorous onsite visits, and the individual study group also have a monitoring program, while the FDA and the NCI audit by themselves. The purpose of audit is not only to assure data reliability but also to check out patient compliance to drug, education as to regulations and rules of clinical

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

    PubMed Central

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

    2014-01-01

    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. PMID:24120573

  12. Research of data quality control based on quality grading

    NASA Astrophysics Data System (ADS)

    Liu, Shuang Hong; Yu, Jian Guo; Yu, Yong Ling

    2012-01-01

    To solve the problem of data quality in data warehouse, the process of data stream in data warehouse and the factors influencing data quality were analyzed; a method for controlling data quality based on quality grading was proposed and the frame of data quality grading system was established. In each process of ETL, the data quality grading system would execute script to calculate values, such as total, component and standard measures in accordance with the definition of Unit Measure, so as to get representation indexes; and then the quality report would be generated according to the indexes and the quality would be graded. The method is applicable to various data warehouse systems.

  13. Research of data quality control based on quality grading

    NASA Astrophysics Data System (ADS)

    Liu, Shuang Hong; Yu, Jian Guo; Yu, Yong Ling

    2011-12-01

    To solve the problem of data quality in data warehouse, the process of data stream in data warehouse and the factors influencing data quality were analyzed; a method for controlling data quality based on quality grading was proposed and the frame of data quality grading system was established. In each process of ETL, the data quality grading system would execute script to calculate values, such as total, component and standard measures in accordance with the definition of Unit Measure, so as to get representation indexes; and then the quality report would be generated according to the indexes and the quality would be graded. The method is applicable to various data warehouse systems.

  14. Controlled Space Physics Experiments using Laboratory Magnetospheres

    NASA Astrophysics Data System (ADS)

    Mauel, M. E.; Kesner, J.; Garnier, D.

    2013-12-01

    Modern society's reliance on space-based platforms for a variety of economic and geopolitical purposes makes understanding the physics of the magnetosphere and "space weather'' one of the most important applications of plasma science. During the past decade, results from the CTX and LDX laboratory magnetospheres and from the RT-1 device at University of Tokyo, we have developed techniques to explore space physics using controlled experiments in laboratory magnetospheres. This presentation briefly reviews observations from the laboratory magnetospheres at Columbia University and MIT, including adiabatic drift-resonant transport, low-frequency MHD turbulence, and the formation of high-beta plasmas with profiles similar to Earth's inner magnetosphere. First principle validation of ``whole plasma'' space weather models have been completed in relevant magnetic geometry, including the spectrum and dynamics of turbulence successfully modeled with nonlinear bounce-averaged gyrokinetic simulations. Plans to explore Alfvénic dynamics and whistler wave trapping are discussed through the achievement of higher-density plasmas using radio-frequency heating. Photographs of the laboratory magnetospheres located at MIT (top) and Columbia University (bottom).

  15. Idaho National Laboratory (INL) Sitewide Institutional Controls Plan

    SciTech Connect

    W. L. Jolley

    2006-07-27

    On November 9, 2002, the U.S. Environmental Protection Agency (EPA), the U.S. Department of Energy (DOE), and the Idaho Department of Environmental Quality approved the Record of Decision Experimental Breeder Reactor-I/Boiling Water Reactor Experiment Area and Miscellaneous Sites, which requires a Sitewide Institutional Controls Plan for the then Idaho National Engineering and Environmental Laboratory (now known as the Idaho National Laboratory). This document, first issued in June 2004, fulfilled that requirement. The revision is needed to provide an update as remedial actions are completed and new areas of concern are found. This Sitewide Institutional Controls Plan is based on guidance in the May 3, 1999, EPA Region 10 Final Policy on the Use of Institutional Controls at Federal Facilities; the September 29, 2000, EPA guidance Institutional Controls: A Site Manager's Guide to Identifying, Evaluating, and Selecting Institutional Controls at Superfund and RCRA Corrective Action Cleanups; and the April 9, 2003, DOE Policy 454.1, "Use of Institutional Controls." These policies establish measures that ensure short- and long-term effectiveness of institutional controls that protect human health and the environment at federal facility sites undergoing remedial action pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and/or corrective action pursuant to the Resource Conservation and Recovery Act (RCRA). The site-specific institutional controls currently in place at the Idaho National Laboratory are documented in this Sitewide Institutional Controls Plan. This plan is being updated, along with the Idaho National Engineering and Environmental Laboratory Comprehensive Facilities and Land Use Plan, to reflect the progress of remedial activities and changes in CERCLA sites.

  16. Gradient algorithm applied to laboratory quantum control

    SciTech Connect

    Roslund, Jonathan; Rabitz, Herschel

    2009-05-15

    The exploration of a quantum control landscape, which is the physical observable as a function of the control variables, is fundamental for understanding the ability to perform observable optimization in the laboratory. For high control variable dimensions, trajectory-based methods provide a means for performing such systematic explorations by exploiting the measured gradient of the observable with respect to the control variables. This paper presents a practical, robust, easily implemented statistical method for obtaining the gradient on a general quantum control landscape in the presence of noise. In order to demonstrate the method's utility, the experimentally measured gradient is utilized as input in steepest-ascent trajectories on the landscapes of three model quantum control problems: spectrally filtered and integrated second harmonic generation as well as excitation of atomic rubidium. The gradient algorithm achieves efficiency gains of up to approximately three times that of the standard genetic algorithm and, as such, is a promising tool for meeting quantum control optimization goals as well as landscape analyses. The landscape trajectories directed by the gradient should aid in the continued investigation and understanding of controlled quantum phenomena.

  17. USDA, ARS Soft Wheat Quality Laboratory, Annual Report 2011

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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, ...

  18. 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. PMID:23869142

  19. Analytical Chemistry Laboratory Quality Assurance Project Plan for the Transuranic Waste Characterization Program

    SciTech Connect

    Sailer, S.J.

    1996-08-01

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

  20. 7 CFR 930.44 - Quality control.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 8 2013-01-01 2013-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of...

  1. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ....359 Quality control. Quality control measures shall insure that emission testing equipment is... 40 Protection of Environment 2 2013-07-01 2013-07-01 false Quality control. 51.359 Section 51.359... of tests) which fall into the testing categories identified. Alternatives or exceptions to...

  2. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ....359 Quality control. Quality control measures shall insure that emission testing equipment is... 40 Protection of Environment 2 2014-07-01 2014-07-01 false Quality control. 51.359 Section 51.359... of tests) which fall into the testing categories identified. Alternatives or exceptions to...

  3. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ....359 Quality control. Quality control measures shall insure that emission testing equipment is... 40 Protection of Environment 2 2012-07-01 2012-07-01 false Quality control. 51.359 Section 51.359... of tests) which fall into the testing categories identified. Alternatives or exceptions to...

  4. 14 CFR 21.139 - Quality control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Quality control. 21.139 Section 21.139... PROCEDURES FOR PRODUCTS AND PARTS Production Certificates § 21.139 Quality control. The applicant must show that he has established and can maintain a quality control system for any product, for which...

  5. 7 CFR 981.42 - Quality control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Quality control. 981.42 Section 981.42 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Regulating Handling Quality Control § 981.42 Quality control. (a) Incoming. Except as provided in...

  6. 7 CFR 930.44 - Quality control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of...

  7. 33 CFR 385.21 - Quality control.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Quality control. 385.21 Section... Processes § 385.21 Quality control. (a) The Corps of Engineers and the non-Federal sponsor shall prepare a quality control plan, in accordance with applicable Corps of Engineers regulations, for each product...

  8. 14 CFR 21.139 - Quality control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Quality control. 21.139 Section 21.139... PROCEDURES FOR PRODUCTS AND PARTS Production Certificates § 21.139 Quality control. The applicant must show that he has established and can maintain a quality control system for any product, for which...

  9. Quality assurance and quality control in monitoring programs

    USGS Publications Warehouse

    Shampine, W.J.

    1993-01-01

    There are three general characteristics of the data to be collected in a monitoring program that should be met in order to maximize the use and value of the data: the data quality should be known the data type and quality should be consistent and comparable, and the data should be available and accessible. Potential problems with each of these characteristics are addressed effectively by quality assurance and quality control. One of the most important aspects of quality assurance in a monitoring program is the development of a quality assurance plan, which should identify clearly the quality of the data needed and describe in detail the planned actions to provide confidence that the program will meet its stated objectives. Quality control data, which allow for the quality and suitability of the environmental data to be evaluated and ascertained, should be collected and utilized as an integral part of the QA effort associated with a monitoring program.

  10. Quality Control by Artificial Vision

    SciTech Connect

    Lam, Edmond Y.; Gleason, Shaun Scott; Niel, Kurt S.

    2010-01-01

    Computational technology has fundamentally changed many aspects of our lives. One clear evidence is the development of artificial-vision systems, which have effectively automated many manual tasks ranging from quality inspection to quantitative assessment. In many cases, these machine-vision systems are even preferred over manual ones due to their repeatability and high precision. Such advantages come from significant research efforts in advancing sensor technology, illumination, computational hardware, and image-processing algorithms. Similar to the Special Section on Quality Control by Artificial Vision published two years ago in Volume 17, Issue 3 of the Journal of Electronic Imaging, the present one invited papers relevant to fundamental technology improvements to foster quality control by artificial vision, and fine-tuned the technology for specific applications. We aim to balance both theoretical and applied work pertinent to this special section theme. Consequently, we have seven high-quality papers resulting from the stringent peer-reviewing process in place at the Journal of Electronic Imaging. Some of the papers contain extended treatment of the authors work presented at the SPIE Image Processing: Machine Vision Applications conference and the International Conference on Quality Control by Artificial Vision. On the broad application side, Liu et al. propose an unsupervised texture image segmentation scheme. Using a multilayer data condensation spectral clustering algorithm together with wavelet transform, they demonstrate the effectiveness of their approach on both texture and synthetic aperture radar images. A problem related to image segmentation is image extraction. For this, O'Leary et al. investigate the theory of polynomial moments and show how these moments can be compared to classical filters. They also show how to use the discrete polynomial-basis functions for the extraction of 3-D embossed digits, demonstrating superiority over Fourier

  11. Business quality control in issuing life insurance.

    PubMed

    Roberts, N K

    1999-01-01

    Fraud investigation and fraud control are entirely different processes. Similarly the auditing of a life insurance company and the issuing of life insurance policies and business quality control are not the same. Business quality control and fraud control have much in common. In this article, these similarities are explored and a case is made that companies issuing life insurance policies should consider the business quality control approach rather than the more traditional investigatory methods. PMID:10539385

  12. Los Alamos National Laboratory Yucca Mountain Site Characterization Project 1994 quality program status report

    SciTech Connect

    Bolivar, S.L.

    1996-03-01

    This status report is for calendar year 1994. It summarizes the annual activities and accomplishments of the Los Alamos National Laboratory Yucca Mountain Site Characterization Project (YMP or Project) quality assurance program. By identifying the accomplishments of the quality program, a baseline is established that will assist in decision making, improve administrative controls and predictability, and allow us to annually identify adverse trends and to evaluate improvements. This is the fourth annual status report.

  13. Quality in the clinical laboratory--the paradigm shift has arrived.

    PubMed

    2004-01-01

    Whether we practice laboratory medicine in a physician office laboratory or a university hospital laboratory, we find ourselves in the midst of the new focus on total quality, that of quality management of systems. For many decades, manufacturing has placed an emphasis on not just quality control of a process but quality as an expected outcome of their system. Now is the time for laboratory professionals to focus on the future by beginning to develop systems thinking and pursue quality as an outcome. We may not realize it, but we are in the midst of a shift in our Paradigm of Quality. In his book, From Quality to Business Excellence, Charles G. Cobb, states: "The organization, like the human body, is a system; to make it healthy you must consider the whole as well as the parts. That requires looking at the 'system' from a broad cross-functional perspective, just as in a medical analogy, a general practitioner provides an overall view and integrates a team of other specialists as needed". PMID:15493110

  14. Quality Control of EUVE Databases

    NASA Astrophysics Data System (ADS)

    John, Linda M.

    1993-01-01

    The publicly accessible databases for the Extreme Ultraviolet Explorer (EUVE) include: the EUVE Archive Mailserver, the Center for EUV Astrophysics ftp site, the EUVE Guest Observer Mailserver, and the Astronomical Data System node. The EUVE Performance Assurance team is responsible for verifying that these public databases are working properly and that the public availability of EUVE data contained therein does not infringe any data rights which may have been assigned. In this paper, we describe the quality assurance (QA) procedures we have developed from approaching QA as a service organization; this approach reflects the overall EUVE philosophy of QA integrated into normal operating procedures, rather than imposed as an external, post-facto, control mechanism.

  15. 78 FR 54643 - Proposed Information Collection Request; Comment Request; Laboratory Quality Assurance Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-05

    ...The Environmental Protection Agency is planning to submit an information collection request (ICR), ``Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium Under the Safe Drinking Water Act'' (EPA ICR No. 2067.05, OMB Control No. 2040-0246) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C.......

  16. [Introduction of quality systems into laboratory medicine: methodological aspects].

    PubMed

    Ivanov, G A; Émanuél', A V

    2011-05-01

    The paper considers the problems of introducing the quality management systems (QMS) according to GOST R ISO 9001-2001 in the health care facilities of different forms of property and departmental subordination. It gives examples of successfully putting QMS into practice in the companies that manufacture products for laboratory diagnosis in accordance with the Russian and international standardization principles. Methods are presented for training the staff of the facilities in the QMS principles and making a dialogue between laboratories and customers. PMID:21786620

  17. Atmospheric Cloud Physics Laboratory thermal control

    NASA Technical Reports Server (NTRS)

    Moses, J. L.; Fogal, G. L.; Scollon, T. R., Jr.

    1978-01-01

    The paper presents the development background and the present status of the Atmospheric Cloud Physics Laboratory (ACPL) thermal control capability. The ACPL, a Spacelab payload, is currently in the initial flight hardware development phase for a first flight scheduled in June 1981. The ACPL is intended as a facility for conducting a wide variety of cloud microphysics experimentation under zero gravity conditions. The cloud chambers, which are key elements of the ACPL, have stringent thermal requirements. Thus the expansion chamber inner walls must be uniform to within + or - 0.1 C during both steady-state and transient operation over a temperature range of +30 to -25 C. Design progression of the expansion chamber, from early in-house NASA-MSFC concepts (including test results of a prototype chamber) to a thermal control concept currently under development, is discussed.

  18. 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.

  19. QUALITY CONTROL - VARIABILITY IN PROTOCOLS

    EPA Science Inventory

    The EPA Risk Reduction Engineering Laboratory’s Quality Assurance Office, which published the popular pocket guide Preparing Perfect Project Plans, is now introducing another quality assurance reference aid. The document Variability in Protocols (VIP) was initially designed as a ...

  20. Computers and quality control in nuclear medicine.

    PubMed

    Brookeman, V A

    1978-04-01

    The general topic of computers and nuclear medicine quality control may be approached from two main areas; controlling the quality of computerized studies, and computer applications in general nuclear medicine quality control. Overlap occurs when quality control of computer studies is performed by the computer itself. The uses of computers in record-keeping and in quality control of imaging instrumentation and in vitro studies, including radioimmunoassay, are discussed in this review. Aspects of quality control for computerized clinical cardiovascular, cerebral, and renal studies and emission computed tomography are reviewed, including consideration of difficulties and inaccuracies involved in the studies. Any automatic computer analysis program should incorporate adequate checks and error detection protocols and should illustrate results for verification. Current routine quality control procedures using the computer unfortunately are few. Quality control criteria are needed for camera/computer systems in high count rate clinical applications, and increasing emphasis should be aimed at quality control of those computerized dynamic and function studies in current clinical use. The computer has a valuable potential for nuclear medicine quality control. In vitro and computerized in vivo studies can be analyzed by readily available statistical programs, and variances can be monitored continuously. Computers can calibrate and monitor instrument performance regularly, and can handle managerial and clerical duties such as bookkeeping. PMID:684439

  1. Laboratory tests of sludge-control additives

    SciTech Connect

    Tatnall, R.E.

    1996-07-01

    Laboratory {open_quotes}jar{close_quotes} tests compared eleven different fuel oil and diesel fuel sludge-control additives. Factors studied included (1) ability to disperse and prevent buildup of sludge deposits on surfaces, (2) ability to protect steel from corrosion, (3) ability to inhibit growth and proliferation of bacteria, and (4) ability to disperse water. Results varied greatly, and it was found that many commercial products do not do what they claim. It is concluded that fuel retailers should not believe manufacturers` claims for their additive products, but rather should test such products themselves to be sure that the benefits of treatment are real. A simplified form of the procedure used here is proposed as one way for dealers to do such testing.

  2. [Critical role of clinical laboratories in hospital infection control].

    PubMed

    Yagi, Tetsuya

    2010-11-01

    The hospital infection control and prevention is recognized to be more and more important according to the advances in modern medical treatment and care. Clinical microbiology laboratory play critical roles in the hospital infection control as a member of infection control team (ICT). They are the first in a hospital to identify outbreak of MRSA in NICU and molecular epidemiological analysis of the isolates lead proper intervention of ICT to the concerned ward. From a viewpoint of infectious disease specialist, rapid and precise microbiological information is essential for the appropriate diagnosis and treatment of infectious diseases. Each medical technologist need to make efforts to understand the characteristics of the examinations for infectious diseases and send out information useful for clinical practices. In our hospital, with the participation of all members of medical technologists, rapid reporting system was developed for blood culture examinations, which greatly contribute to the appropriate treatment of bloodstream infections. Collaborations of clinical microbiology laboratory with other members of ICT realize high quality hospital infection control. They also need to be aware of themselves as good practitioners of infection control measures to prevent hospital infections. PMID:21229708

  3. 30 CFR 74.6 - Quality control.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA...

  4. 30 CFR 74.6 - Quality control.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA...

  5. DEVELOPMENT OF SUSPENDED SOLIDS QUALITY CONTROL AND PERFORMANCE EVALUATION SAMPLES

    EPA Science Inventory

    A two phase study was conducted to develop a synthetic suspended solids sample for use as quality control check and performance evaluation within environmental monitoring laboratories. The first phase consisted of a feasibility study to determine compounds that exhibited the opti...

  6. Can external quality control improve pig AI efficiency?

    PubMed

    Waberski, D; Petrunkina, A M; Töpfer-Petersen, E

    2008-11-01

    External quality control programmes carried out by central laboratories have been long established in human andrology with the aim of enhancing the accuracy and reproducibility of semen assessment. Compared to human, demands on boar semen assessment in AI stations are more complex, with the need both to identify boars with poor ejaculate quality and to monitor individual boar differences for semen storage. Additionally, appropriate assessment serves as a control instrument to ensure the security and efficiency of semen processing. Despite current limitations regarding the ability of sperm assays to estimate the potential fertility of males, it is evident that boar fertility is related to certain conventional semen tests, e.g. sperm morphology. In central studies carried out on stored semen from 11 AI stations, flow cytometric assessment of plasma and acrosome membrane integrity proved to be more sensitive in detecting sperm damage associated with ageing and temperature stress as compared to light microscopy. Membrane integrity of stored semen differed between AI stations indicating significant influences of semen processing on sperm quality. Thus external control of semen quality in reference laboratories may be useful to monitor the efficiency of internal semen quality control in individual AI stations, to identify males with lower semen quality and/or poor response to semen storage, and to verify the precision of sperm counting. The possibility that central laboratories with sufficient resources may be able to identify functionally different responding sperm subpopulations for better estimation of fertility is discussed. Ideally, external quality control schemes for AI stations would comprise application of validated tests with high relevance for fertility (including bacterial status), analysis of semen processing on the AI station, and training courses for laboratory personnel. PMID:18656253

  7. Sponsor/contract laboratory communication: a team approach to quality.

    PubMed

    Caulfield, M; Franklin, W; Muncie, J A; Nelson, J; Ross, T; Russo, A S; Schulte, M C; Sottolano, L A; Vincifora, C J; Pappacena, B M

    1993-01-01

    The true measure of any successful quality endeavor is the final product. The final product generated at contract facilities conducting nonclinical studies is the final report. This should be accurate, complete, and consistent with regard to the raw data, and in compliance itself. The final report resulting from studies conducted at contract laboratories should be reflective of the collaborative efforts of sponsor and laboratory staffs. The dual interaction of the respective Quality Assurance Units (QAUs) in ensuring that optimal study performance is maintained from initiation through final report submission is of paramount importance. Key to any productive sponsor/contract laboratory relationship is communication. The multidirectional flow of information inherent in the conduct of nonclinical studies must be managed to maximize the strengths of the principals involved, while at the same time assuring that consistent emphasis is placed on team focus. Although the role of the QAUs representing the contract facilities and the sponsor both ensure the quality of study conduct, and ultimately the final product, their respective approaches may be from different perspectives. The contract QAU's primary focus is the specific study conduct, including appropriate inspections of ongoing critical phases and audits of raw data and reports, along with compliance to site Standard Operating Procedures (SOPs), protocols and sponsor requirements. On the other hand, sponsor QAUs focus mainly on overall study conduct, assurance that contract QAUs are operating effectively, and ensuring that sponsor monitors are communicating adequately with contract facility personnel. Open communication between the respective QAUs is the most productive and useful way of ensuring that all quality criteria are met.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:8156212

  8. Quality Control in Small Groups

    NASA Astrophysics Data System (ADS)

    Lemmens, L. F.

    2008-11-01

    The smallness of some groups in a set up to control the quality of a service using questionnaires limits the size of the samples, this limitation has several consequences. Indeed the common approach used for relatively large groups, based on the central limit theorem and the law of large numbers, cannot be used anymore to construct estimators for the parameters of the model. Using an inverse probability will lift these restrictions. A questionnaire is a collection of items. In an item the respondent indicates on a Likert scale his or her agreement with a statement. Dimensions are a set of items dealing with one aspect of the service. In a questionnaire several dimensions are addressed but usually the items are presented in a random sequence. The model for an item is hierarchical with following components: a multivariate hypergeometric model takes the sampling in a finite population into account, the multinomial serves as a prior for the sampling and the Dirichlet-distribution serves as a prior for the multinomials. The composition of dimensions allows to use the posterior for one of the items as a prior for another item of that dimension and so on. After analysis of several questionnaires using this model, the reliability of the responses from some respondents turned out to be a key-problem, in the sense the responses can be classified into at least two classes and a decision rule had to be developed to neglect some of them. The influence of rejecting some answers, on the confidence for the most plausible statement can be estimated. This leads often to the result that there is only minimal evidence for the most probable statement.

  9. Colorado Air Quality Control Regulations and Ambient Air Quality Standards.

    ERIC Educational Resources Information Center

    Colorado State Dept. of Health, Denver. Div. of Air Pollution Control.

    Regulations and standards relative to air quality control in Colorado are defined in this publication. Presented first are definitions of terms, a statement of intent, and general provisions applicable to all emission control regulations adopted by the Colorado Air Pollution Control Commission. Following this, three regulations are enumerated: (1)…

  10. [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. PMID:25812407

  11. Laboratory facility design and microbial indoor air quality in selected hospital laboratories.

    PubMed

    Luksamijarulkul, Pipat; Kiennukul, Nuchanard; Vatthanasomboon, Pisit

    2014-05-01

    Hospital laboratory is one of workplace areas contaminated with a variety of biohazards. A cross sectional study was conducted to assess the microbial air quality and facility design in the laboratories of four selected governmental hospitals (Hospitals A, B, C, and D) in Bangkok, Thailand. One hundred eighty-eight indoor air samples were collected from 40 laboratory rooms to investigate bacterial and fungal counts using the Millipore air tester. Forty air samples were collected from the waiting areas of those laboratories, and 16 outdoor air samples were collected to use for comparison. Additionally, those laboratory facilities were assessed following biosafety facility design (10 items). Results indicated that the facility design of laboratory in the Hospital A met most of items of the biosafety facility criteria. The rest met only seven items of the criteria. Means +/- standard deviation (SD) of bacterial counts of 253.1 +/- 247.7 cfu/m3, 236.8 +/- 200.1 cfu/m3, 304.4 +/- 264.2 cfu/m3, and 146.7 +/- 127.0 cfu/m3, and fungal counts of 500.8 +/- 64.2 cfu/ m3, 425.0 +/- 21.2 cfu/m3, 357.0 +/- 121.2 cfu/m3, and 355.7 +/- 86.8 cfu/m3 were found in hospital laboratories A, B, C and D, respectively. The isolated colonies of bacteria and fungi were identified as group or genus. It was found that the most common bacteria was Staphylococcus spp (84.1%, 76.0%, 72.1% and 80.5%, respectively), whereas, the most common fungi were Aspergillus spp and septate hyphae fungi (42.0%, 37.5%, 39.5%, and 45.7%; vs 38.6%, 56.2%, 52.1%, and 37.2%, respectively). These data may be valuable to develop interventions to improve the microbial indoor air quality among hospital laboratories and for preventing the laboratory-acquired infections. PMID:24974659

  12. 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

  13. Factors associated with the quality of laboratory performance in the United Kingdom external quality assessment scheme for serum growth hormone.

    PubMed

    Seth, J; Hanning, I

    1988-05-31

    A search was made for associations between poor performance in the UK External Quality Assessment Scheme (EQAS) for serum growth hormone (GH), and a range of factors including assay method, laboratory workload and staffing, and Internal Quality Control (IQC) procedures. On the basis of the factors identified as being associated with poor performance we recommend the following. 1. Laboratories using RIA for GH should routinely analyse samples at two dilutions and report a mean result. 2. The use of 125I-GH which is 5 or more weeks old should be avoided. Tracer should also be chromatographed to remove aggregate before use. 3. Laboratories using RIA should avoid using a standard curve which covers too wide a range concentration; a curve midpoint (ie GH concentration to reduce the zero standard binding by 50%) of about 8 mU/l or less is probably acceptable. 4. It should be noted that high workloads present a risk of some loss in quality of responsible for checking IQC data. 6. Laboratories which do not have the resources to maintain fully their own RIA as outlined above should carefully consider use of an unbiased, precise IRMA. The UK EQAS has identified two assays (Boots-Celltech Sucrosep, NETRIA) that appear to meet these criteria [2]. The above observations may also be relevant to immunoassays for other peptide hormones. PMID:3383443

  14. 30 CFR 74.6 - Quality control.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality control. 74.6 Section 74.6 Mineral... DUST SAMPLING DEVICES Approval Requirements for Coal Mine Dust Personal Sampler Unit § 74.6 Quality... to maintain its quality prior to assembly of each sampler unit. In order to assure that the...

  15. Handling qualities requirements for control configured vehicles

    NASA Technical Reports Server (NTRS)

    Woodcock, R. J.; George, F. L.

    1976-01-01

    The potential effects of fly by wire and control configured vehicle concepts on flying qualities are considered. Failure mode probabilities and consequences, controllability, and dynamics of highly augmented aircraft are among the factors discussed in terms of design criteria.

  16. Quality control education in the community college

    NASA Technical Reports Server (NTRS)

    Greene, J. Griffen; Wilson, Steve

    1966-01-01

    This paper describes the Quality Control Program at Daytona Beach Junior College, including course descriptions. The program in quality control required communication between the college and the American Society for Quality Control (ASQC). The college has machinery established for certification of the learning process, and the society has the source of teachers who are competent in the technical field and who are the employers of the educational products. The associate degree for quality control does not have a fixed program, which can serve all needs, any more than all engineering degrees have identical programs. The main ideas which would be common to all quality control programs are the concept of economic control of a repetitive process and the concept of developing individual potentialities into individuals who are needed and productive.

  17. Sandia National Laboratories ASCI Applications Software Quality Engineering Practices

    SciTech Connect

    ZEPPER, JOHN D.; ARAGON, KATHRYN MARY; ELLIS, MOLLY A.; BYLE, KATHLEEN A.; EATON, DONNA SUE

    2003-04-01

    This document provides a guide to the deployment of the software verification activities, software engineering practices, and project management principles that guide the development of Accelerated Strategic Computing Initiative (ASCI) applications software at Sandia National Laboratories (Sandia). The goal of this document is to identify practices and activities that will foster the development of reliable and trusted products produced by the ASCI Applications program. Document contents include an explanation of the structure and purpose of the ASCI Quality Management Council, an overview of the software development lifecycle, an outline of the practices and activities that should be followed, and an assessment tool.

  18. 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.

  19. Description of the Spacecraft Control Laboratory Experiment (SCOLE) facility

    NASA Technical Reports Server (NTRS)

    Williams, Jeffrey P.; Rallo, Rosemary A.

    1987-01-01

    A laboratory facility for the study of control laws for large flexible spacecraft is described. The facility fulfills the requirements of the Spacecraft Control Laboratory Experiment (SCOLE) design challenge for a laboratory experiment, which will allow slew maneuvers and pointing operations. The structural apparatus is described in detail sufficient for modelling purposes. The sensor and actuator types and characteristics are described so that identification and control algorithms may be designed. The control implementation computer and real-time subroutines are also described.

  20. Description of the Spacecraft Control Laboratory Experiment (SCOLE) facility

    NASA Technical Reports Server (NTRS)

    Williams, Jeffrey P.; Rallo, Rosemary A.

    1987-01-01

    A laboratory facility for the study of control laws for large flexible spacecraft is described. The facility fulfills the requirements of the Spacecraft Control Laboratory Experiment (SCOLE) design challenge for laboratory experiments, which will allow slew maneuvers and pointing operations. The structural apparatus is described in detail sufficient for modelling purposes. The sensor and actuator types and characteristics are described so that identification and control algorithms may be designed. The control implementation computer and real-time subroutines are also described.

  1. Sandia National Laboratories ASCI Applications Software Quality Engineering Practices

    SciTech Connect

    ZEPPER, JOHN D.; ARAGON, KATHRYN MARY; ELLIS, MOLLY A.; BYLE, KATHLEEN A.; EATON, DONNA SUE

    2002-01-01

    This document provides a guide to the deployment of the software verification activities, software engineering practices, and project management principles that guide the development of Accelerated Strategic Computing Initiative (ASCI) applications software at Sandia National Laboratories (Sandia). The goal of this document is to identify practices and activities that will foster the development of reliable and trusted products produced by the ASCI Applications program. Document contents include an explanation of the structure and purpose of the ASCI Quality Management Council, an overview of the software development lifecycle, an outline of the practices and activities that should be followed, and an assessment tool. These sections map practices and activities at Sandia to the ASCI Software Quality Engineering: Goals, Principles, and Guidelines, a Department of Energy document.

  2. DEVELOPMENT OF AN ENVIRONMENTAL QUALITY TEACHING LABORATORY AND SUPPLEMENTARY EXPERIENTIAL LEARNING ACTIVITIES

    Technology Transfer Automated Retrieval System (TEKTRAN)

    In an effort to improve the ability of agriculturally and environmentally oriented graduates to work in interdisciplinary teams to solve problems, an environmental quality teaching laboratory was developed. In this laboratory, virtual, field, and laboratory experiences provide the experiential and ...

  3. 33 CFR 385.21 - Quality control.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... DEFENSE PROGRAMMATIC REGULATIONS FOR THE COMPREHENSIVE EVERGLADES RESTORATION PLAN CERP Implementation... quality control plan, in accordance with applicable Corps of Engineers regulations, for each product that will be produced by a Project Delivery Team. The quality control plan shall be included in the...

  4. Professional Development for Water Quality Control Personnel.

    ERIC Educational Resources Information Center

    Shepard, Clinton Lewis

    This study investigated the availability of professional development opportunities for water quality control personnel in the midwest. The major objective of the study was to establish a listing of educational opportunities for the professional development of water quality control personnel and to compare these with the opportunities technicians…

  5. Quality Control Technician Curriculum. An Elusive Butterfly.

    ERIC Educational Resources Information Center

    Holler, Michael

    Defining and developing a quality control technician curriculum for an associate degree program is a difficult and puzzling job. There are as many definitions of quality control and curriculum ideas as there are educators asked. However, one could start by dividing the field into its major areas--heavy manufacturing, maintenance, research, and…

  6. 30 CFR 74.6 - Quality control.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality control. 74.6 Section 74.6 Mineral... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and... DUST SAMPLING DEVICES Approval Requirements for Coal Mine Dust Personal Sampler Unit § 74.6...

  7. Novel methodology to assess sputum smear microscopy quality in private laboratories

    PubMed Central

    2012-01-01

    Background In South Asia, it is estimated that 80% of patients choose to attend a private facility for their healthcare needs. Although patients generally believe that the private-sector provides high quality services, private diagnostic laboratories are largely unregulated and little is known about the accuracy of results provided. This study assesses the accuracy of sputum smear microscopy for pulmonary tuberculosis diagnosis in private laboratories operating in Karachi, Pakistan. A novel evaluation methodology was designed in which patient-actors submitted sputum specimens spiked with cultured Mycobacterium tuberculosis (Mtb) for testing such that laboratories were not aware that they were being assessed. Methods Smear-negative sputum specimens from Indus Hospital TB Program patients were collected and combined with an attenuated, cultured Mtb strain to create Mtb-spiked samples; for negative standards, no Mtb was added to the smear-negative sputum specimens. Seven of the largest private laboratories across Karachi were chosen for evaluation and were sent six Mtb-spiked and one Mtb-negative sputum specimens. Patient-actors pretending to be laboratory customers submitted these specimens to each laboratory for testing over a three day period. Results Only three laboratories accurately classified all the Mtb-spiked specimens which were submitted. A further three misclassified all the Mtb-spiked specimens as smear-negative, thus providing the ‘patients’ with false negative results. Conclusions TB sputum smear microscopy services are highly variable across private laboratories and are often of extremely poor quality. Engagement, capacity building and rigorous monitoring of standards at private laboratories are of vital importance for the control of TB. Our findings, while specific for TB diagnostic tests, could be symptomatic of other tests performed in private laboratories and warrant further investigation. PMID:23193964

  8. Quality Assessment of Urinary Stone Analysis: Results of a Multicenter Study of Laboratories in Europe.

    PubMed

    Siener, Roswitha; Buchholz, Noor; Daudon, Michel; Hess, Bernhard; Knoll, Thomas; Osther, Palle J; Reis-Santos, José; Sarica, Kemal; Traxer, Olivier; Trinchieri, Alberto

    2016-01-01

    After stone removal, accurate analysis of urinary stone composition is the most crucial laboratory diagnostic procedure for the treatment and recurrence prevention in the stone-forming patient. The most common techniques for routine analysis of stones are infrared spectroscopy, X-ray diffraction and chemical analysis. The aim of the present study was to assess the quality of urinary stone analysis of laboratories in Europe. Nine laboratories from eight European countries participated in six quality control surveys for urinary calculi analyses of the Reference Institute for Bioanalytics, Bonn, Germany, between 2010 and 2014. Each participant received the same blinded test samples for stone analysis. A total of 24 samples, comprising pure substances and mixtures of two or three components, were analysed. The evaluation of the quality of the laboratory in the present study was based on the attainment of 75% of the maximum total points, i.e. 99 points. The methods of stone analysis used were infrared spectroscopy (n = 7), chemical analysis (n = 1) and X-ray diffraction (n = 1). In the present study only 56% of the laboratories, four using infrared spectroscopy and one using X-ray diffraction, fulfilled the quality requirements. According to the current standard, chemical analysis is considered to be insufficient for stone analysis, whereas infrared spectroscopy or X-ray diffraction is mandatory. However, the poor results of infrared spectroscopy highlight the importance of equipment, reference spectra and qualification of the staff for an accurate analysis of stone composition. Regular quality control is essential in carrying out routine stone analysis. PMID:27248840

  9. Quality Assessment of Urinary Stone Analysis: Results of a Multicenter Study of Laboratories in Europe

    PubMed Central

    Siener, Roswitha; Buchholz, Noor; Daudon, Michel; Hess, Bernhard; Knoll, Thomas; Osther, Palle J.; Reis-Santos, José; Sarica, Kemal; Traxer, Olivier; Trinchieri, Alberto

    2016-01-01

    After stone removal, accurate analysis of urinary stone composition is the most crucial laboratory diagnostic procedure for the treatment and recurrence prevention in the stone-forming patient. The most common techniques for routine analysis of stones are infrared spectroscopy, X-ray diffraction and chemical analysis. The aim of the present study was to assess the quality of urinary stone analysis of laboratories in Europe. Nine laboratories from eight European countries participated in six quality control surveys for urinary calculi analyses of the Reference Institute for Bioanalytics, Bonn, Germany, between 2010 and 2014. Each participant received the same blinded test samples for stone analysis. A total of 24 samples, comprising pure substances and mixtures of two or three components, were analysed. The evaluation of the quality of the laboratory in the present study was based on the attainment of 75% of the maximum total points, i.e. 99 points. The methods of stone analysis used were infrared spectroscopy (n = 7), chemical analysis (n = 1) and X-ray diffraction (n = 1). In the present study only 56% of the laboratories, four using infrared spectroscopy and one using X-ray diffraction, fulfilled the quality requirements. According to the current standard, chemical analysis is considered to be insufficient for stone analysis, whereas infrared spectroscopy or X-ray diffraction is mandatory. However, the poor results of infrared spectroscopy highlight the importance of equipment, reference spectra and qualification of the staff for an accurate analysis of stone composition. Regular quality control is essential in carrying out routine stone analysis. PMID:27248840

  10. 42 CFR 493.1239 - Standard: General laboratory systems quality assessment.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: General laboratory systems quality... HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1239 Standard: General laboratory...

  11. Quality-control analytical methods: continuous quality improvement.

    PubMed

    Venti, Eden M

    2006-01-01

    It is vital that all compounding pharmacies have a continuous quality improvement program in place by way of standard operating procedures to assure that patients receive high-quality preparations. The program should take into consideration any federal and state regulatory requirements, as well as professional association expectations. Quality control measurements and regular review of those measurements are the foundations of a good quality plan. All pharmacy personnel should be aware of the importance of reporting potential internal quality concerns or problems and should be encouraged to do so without fear of repercussions. Ideally, an error-free compounding pracitice would be the goal. Since this is not practical, quality issues should not be viewed as problems, but as opportunities to improve compounding practices by correcting, before they become pervasive, the processes used in the preparation of prescriptions. PMID:23974418

  12. Safety in the Chemical Laboratory: Fire Safety and Fire Control in the Chemistry Laboratory.

    ERIC Educational Resources Information Center

    Wilbraham, A. C.

    1979-01-01

    Discusses fire safety and fire control in the chemistry laboratory. The combustion process, extinguishing equipment, extinguisher maintenance and location, and fire safety and practices are included. (HM)

  13. Evolution of a Low Cost Control Engineering Laboratory.

    ERIC Educational Resources Information Center

    El-Shirbeeny, El-Hosseiny Taha

    1986-01-01

    Presents an approach for building an inexpensive control engineering laboratory to support control courses in an undergraduate engineering program. Outlines the use of simple amplifier circuits and small personal computers in performing control experiments. Proposes an optimum configuration of the laboratory for minimum servicing and adequate…

  14. Water Quality Control, Curriculum Guide.

    ERIC Educational Resources Information Center

    Washington City Board of Education, NC.

    Activities which study how water is used, contaminated, and treated or purified are presented in this curriculum guide, culminating in the investigation of a local water quality problem. Designed as a 12 week mini-course for students in grades eight and nine, the guide first presents a review of the content, objectives, major concepts, and sources…

  15. [Internal quality control for antimicrobial susceptibility test: an experience feedback].

    PubMed

    Vedy, Serge

    2012-01-01

    Internal quality control (IQC) position in antimicrobial susceptibility testing must be evaluated attentively before using. Ours S. aureus ATCC 25923 use during year 2011 has given precious information that can be useful for other laboratories. First, IQC should never be used before checking that all the realisation process steps are controlled. It will then appear that reagents are the most susceptible to give false results. That's what happens in 2.74% of antimicrobial susceptibility test. IQC is then useful to limit their clinical's impact. However, IQC use also shows that quality improvement will be difficult without industrial producer's involvement. PMID:22826843

  16. Carcinogen Control in the Chemical Laboratory.

    ERIC Educational Resources Information Center

    Johnson, James S.

    1981-01-01

    Presents general and specific guidelines for handling carcinogens. Additional topics include: definition of potential occupational carcinogens; classification of carcinogens; inventory requirements; signs and labels for materials and laboratories; decontamination and disposal procedures; medical surveillance for employees working with controlled…

  17. Control by quality: proposition of a typology.

    PubMed

    Pujo, P; Pillet, M

    The application of Quality tools and methods in industrial management has always had a fundamental impact on the control of production. It influences the behavior of the actors concerned, while introducing the necessary notions and formalizations, especially for production systems with little or no automation, which constitute a large part of the industrial activity. Several quality approaches are applied in the workshop and are implemented at the level of the control. In this paper, the authors present a typology of the various approaches that have successively influenced control, such as statistical process control, quality assurance, and continuous improvement. First the authors present a parallel between production control and quality organizational structure. They note the duality between control, which is aimed at increasing productivity, and quality, which aims to satisfy the needs of the customer. They also note the hierarchical organizational structure of these two systems of management with, at each level, the notion of a feedback loop. This notion is fundamental to any kind of decision making. The paper is organized around the operational, tactical, and strategic levels, by describing for each level the main methods and tools for control by quality. The overview of these tools and methods starts at the operational level, with the Statistical Process Control, the Taguchi technique, and the "six sigma" approach. On the tactical level, we find a quality system approach, with a documented description of the procedures introduced in the firm. The management system can refer here to Quality Assurance, Total Productive Maintenance, or Management by Total Quality. The formalization through procedures of the rules of decision governing the process control enhances the validity of these rules. This leads to the enhancement of their reliability and to their consolidation. All this counterbalances the human, intrinsically fluctuating, behavior of the control

  18. 11. Interior view of control room in Components Test Laboratory ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    11. Interior view of control room in Components Test Laboratory (T-27), looking north. Photograph shows upgraded instrumentation, piping, and technological modifications installed in 1997-99 to accommodate component testing requirements for the Atlas V missile. - Air Force Plant PJKS, Systems Integration Laboratory, Components Test Laboratory, Waterton Canyon Road & Colorado Highway 121, Lakewood, Jefferson County, CO

  19. [Comparing quality measurements Part 2: control charts].

    PubMed

    Kottner, Jan; Hauss, Armin

    2013-04-01

    Comparative quality measurements and evaluations in nursing play significant roles. Quality measures are affected by systematic and random error. Statistical Process Control (SPC) offers a method to take random variation adequately into account. In this article, control charts are introduced. Those are graphical displays to show quality measures over time. Attribute variables can be displayed by p-, u- and c-control charts. Special cause variations within the processes can be detected by rules. If signs for special cause variations are absent, the process in considered being in statistical control showing common cause variation. A deviation of one data point greater than three standard deviations from the arithmetic mean is considered the strongest signal for non random variation within the process. Within quality improvement contexts control charts outperform traditional comparisons of means and spreads. PMID:23535476

  20. Quality Control Using Optical Probe Arrays

    NASA Astrophysics Data System (ADS)

    Stewart, Robert M.

    1989-01-01

    Low cost, optical probes, can be combined into an inspection array, and the go/no-go outputs can be analyzed by a high speed programmable logic controller (PLC). The PLC can be remotely addressed to change the desired level of quality control. The PLC can provide on-line data for blow-by-blow statistical process control (SPC).

  1. [Quality control of printed patient information].

    PubMed

    Herm, Kerstin; Linden, Michael

    2013-05-01

    Printed material is an important part in patient information and is called bibliotherapy. It is subject to quality control similar to any other types of treatment. This paper presents an outline of important quality criteria and methods of quality control. Important quality criteria are: (a) Correctness and validity of content evaluated by mentioning the expertise of the authors, appraisal through external experts, reference to scientific literature, and empirical tests of the content, (b) Readability in respect to text structure measured by the "Flesch-Reading-Ease-Formula" supported by fair graphical design including fond and structure of text, (c) Comprehensibility tested by feedback of patients or standardized by the Hamburg comprehensibility rating, (d) Utility including securing availability, acceptance, differential indication and use. Writing and publication of patient leaflets must be accompanied by quality control measures. PMID:23446824

  2. Quality Control Systems in Cardiac Aging

    PubMed Central

    Quarles, Ellen K; Dai, Dao-Fu; Tocchi, Autumn; Basisty, Nathan; Gitari, Lemuel; Rabinovitch, Peter S

    2015-01-01

    Cardiac aging is an intrinsic process that results in impaired cardiac function, along with cellular and molecular changes. These degenerative changes are intimately associated with quality control mechanisms. This review provides a general overview of the clinical and cellular changes which manifest in cardiac aging, and the quality control mechanisms involved in maintaining homeostasis and retarding aging. These mechanisms include autophagy, ubiquitin-mediated turnover, apoptosis, mitochondrial quality control and cardiac matrix homeostasis. Finally, we discuss aging interventions that have been observed to impact cardiac health outcomes. These include caloric restriction, rapamycin, resveratrol, GDF11, mitochondrial antioxidants and cardiolipin-targeted therapeutics. A greater understanding of the quality control mechanisms that promote cardiac homeostasis will help to understand the benefits of these interventions, and hopefully lead to further improved therapeutic modalities. PMID:25702865

  3. 10. Interior view of control room in Components Test Laboratory ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    10. Interior view of control room in Components Test Laboratory (T-27), looking east. The control room is located in the center of the building and abuts the Test Cell 8, 9, and 10 and equipment room wings. Photograph shows upgraded instrumentation, piping, and technological modifications installed in 1997-99 to accommodate component testing requirements for the Atlas V missile. - Air Force Plant PJKS, Systems Integration Laboratory, Components Test Laboratory, Waterton Canyon Road & Colorado Highway 121, Lakewood, Jefferson County, CO

  4. Quality assurance plan for Waste Area Grouping 6 at Oak Ridge National Laboratory, Oak Ridge, Tennessee

    SciTech Connect

    Not Available

    1994-01-01

    This Quality Assurance Plan (QAP) is concerned with design and construction (Sect. 2) and characterization and monitoring (Sect. 3). The basis for Sect. 2 is the Quality Assurance Plan for the Design and Construction of Waste Area Grouping 6 Closure at Oak Ridge National Laboratory, Oak Ridge, Tennessee, and the basis for Sect. 3 is the Environmental Restoration Quality Program Plan. Combining the two areas into one plan gives a single, overall document that explains the requirements and from which the individual QAPs and quality assurance project plans can be written. The Waste Area Grouping (WAG) 6 QAP establishes the procedures and requirements to be implemented for control of quality-related activities for the WAG 6 project. Quality Assurance (QA) activities are subject to requirements detailed in the Martin Marietta Energy Systems, Inc. (Energy Systems), QA Program and the Environmental Restoration (ER) QA Program, as well as to other quality requirements. These activities may be performed by Energy Systems organizations, subcontractors to Energy Systems, and architect-engineer (A-E) under prime contract to the US Department of Energy (DOE), or a construction manager under prime contract to DOE. This plan specifies the overall Energy Systems quality requirements for the project. The WAG 6 QAP will be supplemented by subproject QAPs that will identify additional requirements pertaining to each subproject.

  5. Microprocessors: Laboratory Simulation of Industrial Control Applications.

    ERIC Educational Resources Information Center

    Gedeon, David V.

    1981-01-01

    Describes a course to make technical managers more aware of computer technology and how data loggers, programmable controllers, and larger computer systems interact in a hierarchical configuration of manufacturing process control. (SK)

  6. CONTROL ASSAY DEVELOPMENT: METHODOLOGY AND LABORATORY VERIFICATION

    EPA Science Inventory

    The report describes Control Assay Development (CAD), a data acquisition program designed to evaluate the potential applicability of various treatment processes for the control of solid, liquid, and gaseous emissions from coal conversion plants. The CAD program described could be...

  7. Quality control of automated cell counters.

    PubMed

    Cembrowski, George S; Clarke, Gwen

    2015-03-01

    The hematology analyzers of today provide more reproducible analyses compared with those of a few decades ago, necessitating an evolution in hematology quality practices. The improved performance allows use of simple quality control rules. This improved performance also renders the repeat analysis of critical value specimens non value added. Some of the patient averaging techniques have become outmoded and need to be replaced by less complicated calculations but with truncation of predictable outlying populations. The ready availability of comparative peer quality control values helps to improve analyzer precision and accuracy, and simplifies instrument validation and calibration. PMID:25676372

  8. QUALITY CONTROL FOR RESEARCH STUDIES: A CRITICAL PART OF THE QUALITY SYSTEM AT THE U. S. EPA

    EPA Science Inventory

    QUALITY CONTROL FOR RESEARCH STUDIES: A CRITICAL PART OF THE QUALITY SYSTEM AT THE U.S. EPA Mette C.J. Schladweiler, Scientist, and Thomas J. Hughes, QA and Records Manager, Experimental Toxicology Division (ETD), National Health and Environmental Effects Research Laboratory (NHE...

  9. Real-time quality control: the French Minitel system.

    PubMed

    Goguel, A; LeBlanc, A

    1990-01-01

    A prototype system designed to provide real-time response to inter-laboratory proficiency testing results has been developed using the French Minitel telecommunication system. This nationwide computer networking system allows for instantaneous reporting and evaluation of results obtained on external quality assessment (EQA) samples. If a certain test is in error and presumably out of control the problem can be remedied immediately with obvious advantages to patient care. PMID:2282753

  10. [The quality of biological information: standardization and quality control].

    PubMed

    Giampaoli, S; Muti, P

    1992-01-01

    Some procedures and methods for the measurement of cardiovascular risk factor are described; in particular of anthropometric measurements (weight, height, arm circumference, wrist circumference, hip circumference) of blood pressure, of electrocardiogram and of blood samples for the preservation of biological specimens. Some advice for the quality control during screening activities are reported. PMID:1492736

  11. QUALITY ASSURANCE AND QUALITY CONTROL FOR RADIOCHEMICAL ANALYSES AND MEASUREMENTS

    EPA Science Inventory

    Require that each batch of samples analyzed be accompanied by appropriate quality control samples to evaluate accuracy and precision of the results. Require a documented data review and validation process by a minimum of three people before data is released to the client. Requi...

  12. Evaluation of the International Atomic Energy Agency (IAEA) Safeguards Analytical Laboratory quality assurance program

    SciTech Connect

    Pietri, C.E.; Bracey, J.T.

    1985-02-01

    Destructive analysis is used by the International Atomic Energy Agency (IAEA) through its Safeguards Analytical Laboratory (SAL) to verify, in part, the inventory of nuclear materials at nuclear facilities. The reliability and quality of these meassurements must be assured in a systematic manner. The Division of Safeguards Evaluation, IAEA, required assistance in developing and implementing the quality assurance measures for the analytical procedures used in the destructive analysis of these safeguards samples. To meet these needs an ISPO POTAS Task D.53 was instituted in which consultants would review with IAEA staff the procedures used (or proposed) at SAL for the destructive analysis of safeguards samples and the statistical evaluation of the resulting measurement data at Headquarters. The procedures included analytical methods, qualtiy control measures, and the treatment of data from these activities. Based on this review, modifications to the system, if required, would be recommended which would provide routine assurance to management that these procedures are functioning properly to achieve safeguards objectives. In the course of this review, the sample handling procedures, measurement control activities, analytical methods, reference materials, calibration procedures, statistical analysis of data, and data management system were studied and evaluated. The degree to which SAL (as a total system) achieved laboratory quality assurance was assessed by comparison to accepted standards of quality assurance. 22 refs., 1 fig.

  13. Network-based production quality control

    NASA Astrophysics Data System (ADS)

    Kwon, Yongjin; Tseng, Bill; Chiou, Richard

    2007-09-01

    This study investigates the feasibility of remote quality control using a host of advanced automation equipment with Internet accessibility. Recent emphasis on product quality and reduction of waste stems from the dynamic, globalized and customer-driven market, which brings opportunities and threats to companies, depending on the response speed and production strategies. The current trends in industry also include a wide spread of distributed manufacturing systems, where design, production, and management facilities are geographically dispersed. This situation mandates not only the accessibility to remotely located production equipment for monitoring and control, but efficient means of responding to changing environment to counter process variations and diverse customer demands. To compete under such an environment, companies are striving to achieve 100%, sensor-based, automated inspection for zero-defect manufacturing. In this study, the Internet-based quality control scheme is referred to as "E-Quality for Manufacturing" or "EQM" for short. By its definition, EQM refers to a holistic approach to design and to embed efficient quality control functions in the context of network integrated manufacturing systems. Such system let designers located far away from the production facility to monitor, control and adjust the quality inspection processes as production design evolves.

  14. Quality assurance testing of an explosives trace analysis laboratory--further improvements to include peroxide explosives.

    PubMed

    Crowson, Andrew; Cawthorne, Richard

    2012-12-01

    The Forensic Explosives Laboratory (FEL) operates within the Defence Science and Technology Laboratory (DSTL) which is part of the UK Government Ministry of Defence (MOD). The FEL provides support and advice to the Home Office and UK police forces on matters relating to the criminal misuse of explosives. During 1989 the FEL established a weekly quality assurance testing regime in its explosives trace analysis laboratory. The purpose of the regime is to prevent the accumulation of explosives traces within the laboratory at levels that could, if other precautions failed, result in the contamination of samples and controls. Designated areas within the laboratory are swabbed using cotton wool swabs moistened with ethanol:water mixture, in equal amounts. The swabs are then extracted, cleaned up and analysed using Gas Chromatography with Thermal Energy Analyser detectors or Liquid Chromatography with triple quadrupole Mass Spectrometry. This paper follows on from two previous published papers which described the regime and summarised results from approximately 14years of tests. This paper presents results from the subsequent 7years setting them within the context of previous results. It also discusses further improvements made to the systems and procedures and the inclusion of quality assurance sampling for the peroxide explosives TATP and HMTD. Monitoring samples taken from surfaces within the trace laboratories and trace vehicle examination bay have, with few exceptions, revealed only low levels of contamination, predominantly of RDX. Analysis of the control swabs, processed alongside the monitoring swabs, has demonstrated that in this environment the risk of forensic sample contamination, assuming all the relevant anti-contamination procedures have been followed, is so small that it is considered to be negligible. The monitoring regime has also been valuable in assessing the process of continuous improvement, allowing sources of contamination transfer into the trace

  15. In situ bioassay using Chironomus riparius: An intermediate between laboratory and field sediment quality assessments

    SciTech Connect

    Guchte, C. van de; Grootelaar, L.; Naber, A.

    1995-12-31

    Benthic macroinvertebrates like chironomid larvae are important indicators for sediment quality. Both in field surveys and laboratory bioassays effect parameters like abundance, survival, growth, larval development and morphological abnormalities of chironomids are recommended biological endpoints to assess the impact of sediment associated contaminants. Now and then results from field surveys on contaminated sites appeared to differ from results in laboratory bioassays on sediment field samples from the same sites. The impact of so-called modifying factors like temperature, oxygen levels and the availability of food could be studied in the laboratory. However, these factors could not fully explain the observed differences. In situ bioassays have been developed to bridge the gap between laboratory and field derived data with respect to the exposure of cultured Chironomus riparius larvae versus field collected Chironomus sp. larvae. Control survival in the in situ bioassays was within acceptable limits (> 80%). Effects observed during the caged exposure of laboratory cultured first instar larvae at contaminated sites were in agreement with the hypothesis that adequate in-field bioassessment reduces uncertainties inherent in the use of standardized laboratory bioassays. Although relative risk ranking of chemicals or contaminated sites can rely upon standard testing protocols, in situ bioassays can give a better insight in exposure-effect relationships under actual field conditions.

  16. Quality Assurance and Quality Control in Point-of-Care Testing.

    PubMed

    Newman, Ashleigh W; Behling-Kelly, Erica

    2016-03-01

    With advancements in the standard of care in veterinary medicine and instrument technology, performing in-house laboratory work on a variety of point-of-care instruments, ranging from glucometers to benchtop chemistry analyzers, has become increasingly commonplace. However, the ability of an instrument to perform a test does not guarantee that those results are accurate. Ensuring that your in-clinic laboratory is providing reliable data requires a comprehensive plan that encompasses both common sense practices aimed at preventing errors at each stage of the testing process, as well as standard operating procedures to validate and monitor analyzer performance. These 2 arms of the plan are known as quality assurance and quality control. Although these concepts are typically out of the comfort zone for veterinarians, just as the thought of business management may deter some veterinarians from practice ownership, it is not beyond the capabilities of veterinarians to learn, understand, and incorporate them into their practice. The objectives of this article are to convey the importance of quality assurance and quality control, walk you through the American Society for Veterinary Clinical Pathology guidelines on this topic, and provide direction to additional resources for further education on this topic, all with the focus on point-of-care testing in the in-clinic laboratory. PMID:27451043

  17. Quality control ranges for testing broth microdilution susceptibility of Flavobacterium columnare and F. psychrophilium to nine antimicrobials

    Technology Transfer Automated Retrieval System (TEKTRAN)

    A multi-laboratory broth microdilution method trial was performed to standardize the specialized test conditions required for fish pathogens Flavobacterium columnare and F. pyschrophilum. Nine laboratories tested the quality control (QC) strains Escherichia coli ATCC 25922 and Aeromonas salmonicid...

  18. Los Alamos National Laboratory Yucca Mountain Site Characterization Project 1993 Quality Program status report

    SciTech Connect

    Bolivar, S.L.

    1995-05-01

    This status report is for calendar year 1993. It summarizes the annual activities and accomplishments of the Los Alamos National Laboratory (Los Alamos) Yucca Mountain Site Characterization Project (YMP or Project) quality assurance program. By identifying the accomplishments of the quality program, we establish a baseline that will assist in decision making, improve administrative controls and predictability, and allow us to annually identify long term trends and to evaluate improvements. This is the third annual status report (Bolivar, 1992; Bolivar, 1994). This report is divided into two primary sections: Program Activities and Trend Analysis. Under Program Activities, programmatic issues occurring in 1993 are discussed. The goals for 1993 are also listed, followed by a discussion of their status. Lastly, goals for 1994 are identified. The Trend Analysis section is a summary of 1993 quarterly trend reports and provides a good overview of the quality assurance issues of the Los Alamos YMP.

  19. Controlling Laboratory Processes From A Personal Computer

    NASA Technical Reports Server (NTRS)

    Will, H.; Mackin, M. A.

    1991-01-01

    Computer program provides natural-language process control from IBM PC or compatible computer. Sets up process-control system that either runs without operator or run by workers who have limited programming skills. Includes three smaller programs. Two of them, written in FORTRAN 77, record data and control research processes. Third program, written in Pascal, generates FORTRAN subroutines used by other two programs to identify user commands with device-driving routines written by user. Also includes set of input data allowing user to define user commands to be executed by computer. Requires personal computer operating under MS-DOS with suitable hardware interfaces to all controlled devices. Also requires FORTRAN 77 compiler and device drivers written by user.

  20. Quality control of a teleradiology system

    NASA Astrophysics Data System (ADS)

    Lyche, David K.; Willis, Charles E.; Williamson, Morgan P.; Suitor, Charles T.; Romlein, John R.

    1996-04-01

    Teleradiology is being implemented in the U.S. military. Soft-copy reading of computed radiology (CR) images and film-digitizer (FD) images are becoming a common practice. The Medical Diagnostic Imaging Support (MDIS) Office at the Medical Advanced Technology Management Office (MATMO), Fort Detrick, Maryland, installed an 'off-the-shelf' DICOM teleradiology system by which CR images and FD images acquired at Hickam Air Force Base (AFB), Hawaii, are transmitted electronically over a T-1 telecommunications line to Tripler Army Medical Center (TAMC), Hawaii. The goal was to provide a diagnostic quality teleradiology system to the military services to extend the expertise and training of physicians to remote sites. In order to guarantee a diagnostic quality image throughout the system, a rigid set of quality control standards had to be designed and implemented. This poster presents the results of a successful teleradiology implementation where quality control is maintained throughout the imaging chain.

  1. Quality control technique to reduce the variability of longitudinal measurement of hemoglobin mass.

    PubMed

    Gough, C E; Sharpe, K; Ashenden, M J; Anson, J M; Saunders, P U; Garvican, L A; Bonetti, D L; Gore, C J; Prommer, N

    2011-12-01

    The sensitivity of the athlete blood passport to detect blood doping may be improved by the inclusion of total hemoglobin mass (Hb(mass)), but the comparability of Hb(mass) from different laboratories is unknown. To optimize detection sensitivity, the analytical variability associated with Hb(mass) measurement must be minimized. The aim of this study was to investigate the efficacy of using quality controls to minimize the variation in Hb(mass) between laboratories. Three simulated laboratories were set up in one location. Nine participants completed three carbon monoxide (CO) re-breathing tests in each laboratory. One participant completed two CO re-breathing tests in each laboratory. Simultaneously, quality controls containing Low (1-3%) and High (8-11%) concentrations of percent carboxyhemoglobin (%HbCO) were measured to compare hemoximeters in each laboratory. Linear mixed modeling was used to estimate the within-subject variation in Hb(mass), expressed as the coefficient of variation, and to estimate the effect of different laboratories. The analytic variation of Hb(mass) was 2.4% when tests were conducted in different laboratories, which reduced to 1.6% when the model accounted for between-laboratory differences. Adjustment of Hb(mass) values using quality controls achieved a comparable analytic variation of 1.7%. The majority of between-laboratory variation in Hb(mass) originated from the difference between hemoximeters, which could be eliminated using appropriate quality controls. PMID:21535184

  2. Development of Quality Control Procedures for Lepidoptera

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Lepidopteran species are among the most destructive insect pests throughout the world. The sterile insect technique (SIT), within an area-wide integrated pest management (AW-IPM) approach, has proven to be a valuable tactic for controlling and eradicating important moth pests. Improving laboratory...

  3. Quality control by a mobile molecular workshop: Quality versus quantity

    NASA Astrophysics Data System (ADS)

    Sharma, Ajeet K.; Chowdhury, Debashish

    2010-09-01

    Ribosome is a molecular machine that moves on a messenger RNA (mRNA) track while, simultaneously, polymerizing a protein using the mRNA also as the corresponding template. We define, and analytically calculate, two different measures of the efficiency of this machine. However, we argue that its performance is evaluated better in terms of the translational fidelity and the speed with which it polymerizes a protein. We define both these quantities and calculate these analytically. Fidelity is a measure of the quality of the products, while the total quantity of products synthesized in a given interval depends on the speed of polymerization. We show that for synthesizing a large quantity of proteins, it is not necessary to sacrifice the quality. We also explore the effects of the quality control mechanism on the strength of mechanochemical coupling. We suggest experiments for testing some of the ideas presented here.

  4. Harmonisation Initiatives of Copernicus Data Quality Control

    NASA Astrophysics Data System (ADS)

    Vescovi, F. D.; Lankester, T.; Coleman, E.; Ottavianelli, G.

    2015-04-01

    The Copernicus Space Component Data Access system (CSCDA) incorporates data contributions from a wide range of satellite missions. Through EO data handling and distribution, CSCDA serves a set of Copernicus Services related to Land, Marine and Atmosphere Monitoring, Emergency Management and Security and Climate Change. The quality of the delivered EO products is the responsibility of each contributing mission, and the Copernicus data Quality Control (CQC) service supports and complements such data quality control activities. The mission of the CQC is to provide a service of quality assessment on the provided imagery, to support the investigation related to product quality anomalies, and to guarantee harmonisation and traceability of the quality information. In terms of product quality control, the CQC carries out analysis of representative sample products for each contributing mission as well as coordinating data quality investigation related to issues found or raised by Copernicus users. Results from the product analysis are systematically collected and the derived quality reports stored in a searchable database. The CQC service can be seen as a privileged focal point with unique comparison capacities over the data providers. The comparison among products from different missions suggests the need for a strong, common effort of harmonisation. Technical terms, definitions, metadata, file formats, processing levels, algorithms, cal/val procedures etc. are far from being homogeneous, and this may generate inconsistencies and confusion among users of EO data. The CSCDA CQC team plays a significant role in promoting harmonisation initiatives across the numerous contributing missions, so that a common effort can achieve optimal complementarity and compatibility among the EO data from multiple data providers. This effort is done in coordination with important initiatives already working towards these goals (e.g. INSPIRE directive, CEOS initiatives, OGC standards, QA4EO

  5. Post-translational Modification and Quality Control

    PubMed Central

    Wang, Xuejun; Pattison, J. Scott; Su, Huabo

    2013-01-01

    Protein quality control (PQC) functions to minimize the level and toxicity of misfolded proteins in the cell. PQC is performed by intricate collaboration among chaperones and target protein degradation. The latter is carried out primarily by the ubiquitin-proteasome system and perhaps autophagy. Terminally misfolded proteins that are not timely removed tend to form aggregates. Their clearance requires macroautophagy. Macroautophagy serves in intracellular quality control also by selectively segregating defective organelles (e.g., mitochondria) and targeting them for degradation by the lysosome. Inadequate PQC is observed in a large subset of failing human hearts with a variety of etiologies and its pathogenic role has been experimentally demonstrated. Multiple post-translational modifications (PTMs) can occur to substrate proteins and/or PQC machineries, promoting or hindering the removal of the misfolded proteins. This article highlights recent advances in PTMs-mediated regulation of intracellular quality control mechanisms and its known involvement in cardiac pathology. PMID:23329792

  6. Protein quality control in the bacterial periplasm.

    PubMed

    Merdanovic, Melisa; Clausen, Tim; Kaiser, Markus; Huber, Robert; Ehrmann, Michael

    2011-01-01

    Protein quality control involves sensing and treatment of defective or incomplete protein structures. Misfolded or mislocalized proteins trigger dedicated signal transduction cascades that upregulate the production of protein quality-control factors. Corresponding proteases and chaperones either degrade or repair damaged proteins, thereby reducing the level of aggregation-prone molecules. Because the periplasm of gram-negative bacteria is particularly exposed to environmental changes and respective protein-folding stresses connected with the presence of detergents, low or high osmolarity of the medium, elevated temperatures, and the host's immune response, fine-tuned protein quality control systems are essential for survival under these unfavorable conditions. This review discusses recent advances in the identification and characterization of the key cellular factors and the emerging general principles of the underlying molecular mechanisms. PMID:21639788

  7. QUALITY ASSURANCE GUIDELINES FOR LABORATORIES PERFORMING FORENSIC ANALYSIS OF CHEMICAL TERRORISM

    EPA Science Inventory

    The Scientific Working Group on Forensic Analysis of Chemical Terrorism (SWGFACT) has developed the following quality assurance guidelines to provide laboratories engaged in forensic analysis of chemical evidence associated with terrorism a framework to implement a quality assura...

  8. Using checklists in a gross anatomy laboratory improves learning outcomes and dissection quality.

    PubMed

    Hofer, Ryan Engebretson; Nikolaus, O Brant; Pawlina, Wojciech

    2011-01-01

    Checklists have been widely used in the aviation industry ever since aircraft operations became more complex than any single pilot could reasonably remember. More recently, checklists have found their way into medicine, where cognitive function can be compromised by stress and fatigue. The use of checklists in medical education has rarely been reported, especially in the basic sciences. We explored whether the use of a checklist in the gross anatomy laboratory would improve learning outcomes, dissection quality, and students' satisfaction in the first-year Human Structure didactic block at Mayo Medical School. During the second half of a seven-week anatomy course, dissection teams were each day given a hardcopy checklist of the structures to be identified during that day's dissection. The first half of the course was considered the control, as students did not receive any checklists to utilize during dissection. The measured outcomes were scored on four practice practical examinations and four dissection quality assessments, two each from the first half (control) and second half of the course. A student satisfaction survey was distributed at the end of the course. Examination and dissection scores were analyzed for correlations between practice practical examination score and checklist use. Our data suggest that a daily hardcopy list of anatomical structures for active use in the gross anatomy laboratory increases practice practical examination scores and dissection quality. Students recommend the use of these checklists in future anatomy courses. PMID:21786427

  9. HPLC for quality control of polyimides

    NASA Technical Reports Server (NTRS)

    Young, P. R.; Sykes, G. F.

    1979-01-01

    High Pressure Liquid Chromatography (HPLC) as a quality control tool for polyimide resins and prepregs are presented. A data base to help establish accept/reject criteria for these materials was developed. This work is intended to supplement, not replace, standard quality control tests normally conducted on incoming resins and prepregs. To help achieve these objectives, the HPLC separation of LARC-160 polyimide precursor resin was characterized. Room temperature resin aging effects were studied. Graphite reinforced composites made from fresh and aged resin were fabricated and tested to determine if changes observed by HPLC were significant.

  10. Quality control in the secretory assembly line.

    PubMed Central

    Helenius, A

    2001-01-01

    As a rule, only proteins that have reached a native, folded and assembled structure are transported to their target organelles and compartments within the cell. In the secretory pathway of eukaryotic cells, this type of sorting is particularly important. A variety of molecular mechanisms are involved that distinguish between folded and unfolded proteins, modulate their intracellular transport, and induce degradation if they fail to fold. This phenomenon, called quality control, occurs at several levels and involves different types of folding sensors. The quality control system provides a stringent and versatile molecular sorting system that guaranties fidelity of protein expression in the secretory pathway. PMID:11260794