Sample records for abacc laboratories quality

  1. Nuclear safeguards in Brazil and Argentina: 25 years of ABACC

    NASA Astrophysics Data System (ADS)

    Kassenova, Togzhan

    2017-11-01

    As possessors of advanced nuclear technology, Brazil and Argentina bear special responsibility for helping the international community and neighbors in their region feel confident that their nuclear programs are peaceful, secure, and safe. Over the past 25 years, the Brazilian-Argentine Agency for Accounting and Control of Nuclear Materials (ABACC) has played an indispensable role in strengthening such confidence by implementing nuclear safeguards in the two countries. Today, ABACC carries out safeguards inspections at a total of 76 nuclear facilities in Brazil and Argentina. This article describes how Brazil and Argentina view trends in the global nonproliferation regime and international nuclear safeguards, and explains how these trends relate to unique challenges and opportunities facing Brazil, Argentina, and ABACC.

  2. 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…

  3. Service quality framework for clinical laboratories.

    PubMed

    Ramessur, Vinaysing; Hurreeram, Dinesh Kumar; Maistry, Kaylasson

    2015-01-01

    The purpose of this paper is to illustrate a service quality framework that enhances service delivery in clinical laboratories by gauging medical practitioner satisfaction and by providing avenues for continuous improvement. The case study method has been used for conducting the exploratory study, with focus on the Mauritian public clinical laboratory. A structured questionnaire based on the SERVQUAL service quality model was used for data collection, analysis and for the development of the service quality framework. The study confirms the pertinence of the following service quality dimensions within the context of clinical laboratories: tangibility, reliability, responsiveness, turnaround time, technology, test reports, communication and laboratory staff attitude and behaviour. The service quality framework developed, termed LabSERV, is vital for clinical laboratories in the search for improving service delivery to medical practitioners. This is a pioneering work carried out in the clinical laboratory sector in Mauritius. Medical practitioner expectations and perceptions have been simultaneously considered to generate a novel service quality framework for clinical laboratories.

  4. 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

  5. Secure Video Surveillance System (SVSS) for unannounced safeguards inspections.

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

    Galdoz, Erwin G.; Pinkalla, Mark

    2010-09-01

    The Secure Video Surveillance System (SVSS) is a collaborative effort between the U.S. Department of Energy (DOE), Sandia National Laboratories (SNL), and the Brazilian-Argentine Agency for Accounting and Control of Nuclear Materials (ABACC). The joint project addresses specific requirements of redundant surveillance systems installed in two South American nuclear facilities as a tool to support unannounced inspections conducted by ABACC and the International Atomic Energy Agency (IAEA). The surveillance covers the critical time (as much as a few hours) between the notification of an inspection and the access of inspectors to the location in facility where surveillance equipment is installed.more » ABACC and the IAEA currently use the EURATOM Multiple Optical Surveillance System (EMOSS). This outdated system is no longer available or supported by the manufacturer. The current EMOSS system has met the project objective; however, the lack of available replacement parts and system support has made this system unsustainable and has increased the risk of an inoperable system. A new system that utilizes current technology and is maintainable is required to replace the aging EMOSS system. ABACC intends to replace one of the existing ABACC EMOSS systems by the Secure Video Surveillance System. SVSS utilizes commercial off-the shelf (COTS) technologies for all individual components. Sandia National Laboratories supported the system design for SVSS to meet Safeguards requirements, i.e. tamper indication, data authentication, etc. The SVSS consists of two video surveillance cameras linked securely to a data collection unit. The collection unit is capable of retaining historical surveillance data for at least three hours with picture intervals as short as 1sec. Images in .jpg format are available to inspectors using various software review tools. SNL has delivered two SVSS systems for test and evaluation at the ABACC Safeguards Laboratory. An additional 'proto-type' system

  6. 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…

  7. Quality in laboratory medicine: 50years on.

    PubMed

    Plebani, Mario

    2017-02-01

    The last 50years have seen substantial changes in the landscape of laboratory medicine: its role in modern medicine is in evolution and the quality of laboratory services is changing. The need to control and improve quality in clinical laboratories has grown hand in hand with the growth in technological developments leading to an impressive reduction of analytical errors over time. An essential cause of this impressive improvement has been the introduction and monitoring of quality indicators (QIs) such as the analytical performance specifications (in particular bias and imprecision) based on well-established goals. The evolving landscape of quality and errors in clinical laboratories moved first from analytical errors to all errors performed within the laboratory walls, subsequently to errors in laboratory medicine (including errors in test requesting and result interpretation), and finally, to a focus on errors more frequently associated with adverse events (laboratory-associated errors). After decades in which clinical laboratories have focused on monitoring and improving internal indicators of analytical quality, efficiency and productivity, it is time to shift toward indicators of total quality, clinical effectiveness and patient outcomes. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  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.

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

    PubMed

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

    2014-09-01

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

  10. 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.

  11. Public health laboratory quality management in a developing country.

    PubMed

    Wangkahat, Khwanjai; Nookhai, Somboon; Pobkeeree, Vallerut

    2012-01-01

    The article aims to give an overview of the system of public health laboratory quality management in Thailand and to produce a strengths, weaknesses, opportunities and threats (SWOT) analysis that is relevant to public health laboratories in the country. The systems for managing laboratory quality that are currently employed were described in the first component. The second component was a SWOT analysis, which used the opinions of laboratory professionals to identify any areas that could be improved to meet quality management systems. Various quality management systems were identified and the number of laboratories that met both international and national quality management requirements was different. The SWOT analysis found the opportunities and strengths factors offered the best chance to improve laboratory quality management in the country. The results are based on observations and brainstorming with medical laboratory professionals who can assist laboratories in accomplishing quality management. The factors derived from the analysis can help improve laboratory quality management in the country. This paper provides viewpoints and evidence-based approaches for the development of best possible practice of services in public health laboratories.

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

    PubMed

    Yazawa, Naoyuki

    2006-11-01

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

  13. 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.

  14. Selecting clinical quality indicators for laboratory medicine.

    PubMed

    Barth, Julian H

    2012-05-01

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

  15. Quality systems in veterinary diagnostics laboratories.

    PubMed

    de Branco, Freitas Maia L M

    2007-01-01

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

  16. Extra-analytical quality indicators and laboratory performances.

    PubMed

    Sciacovelli, Laura; Aita, Ada; Plebani, Mario

    2017-07-01

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

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

    PubMed

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

    2012-01-01

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

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

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

    Meznarich, H.K.

    1995-07-31

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

  19. 42 CFR 493.1239 - Standard: General laboratory systems quality assessment.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  20. Laboratory Innovation Towards Quality Program Sustainability.

    PubMed

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

    2016-08-01

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

  1. Quality and safety aspects in histopathology laboratory

    PubMed Central

    Adyanthaya, Soniya; Jose, Maji

    2013-01-01

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

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

    PubMed

    Guzel, Omer; Guner, Ebru Ilhan

    2009-03-01

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

  3. Implementing a Quality Management System in the Medical Microbiology Laboratory.

    PubMed

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

    2018-07-01

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

  4. Quality assessment of malaria laboratory diagnosis in South Africa.

    PubMed

    Dini, Leigh; Frean, John

    2003-01-01

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

  5. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  6. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  7. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  8. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  9. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

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

    PubMed

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

    2012-03-01

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

  11. Quality assurance program for molecular medicine laboratories.

    PubMed

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

    2013-01-01

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

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

    PubMed

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

    2011-04-01

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

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

    PubMed Central

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

    2016-01-01

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

  14. Laboratory quality management system: road to accreditation and beyond.

    PubMed

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

    2012-01-01

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

  15. Quality Assurance Program for Molecular Medicine Laboratories

    PubMed Central

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

    2013-01-01

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

  16. USGS Laboratory Review Program Ensures Analytical Quality

    USGS Publications Warehouse

    Erdmann, David E.

    1995-01-01

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

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

    PubMed

    Ehrmeyer, Sharon S; Laessig, Ronald H

    2004-08-02

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

  18. 7 CFR 58.442 - Laboratory and quality control tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  19. 7 CFR 58.442 - Laboratory and quality control tests.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

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

    PubMed Central

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

    2012-01-01

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

  1. 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.

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

    PubMed

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

    2013-09-01

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

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

    PubMed

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

    2006-06-01

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

  4. Iowa Central Quality Fuel Testing Laboratory

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

    Heach, Don; Bidieman, Julaine

    2013-09-30

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

  5. Helping You Identify Quality Laboratory Services

    MedlinePlus

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

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

    PubMed

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

    2015-01-01

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

  7. 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.

  8. 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

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

    PubMed

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

    2010-09-01

    Owing to lack of governmental regulation of veterinary laboratory performance, veterinarians ideally should demonstrate a commitment to self-monitoring and regulation of laboratory performance from within the profession. In response to member concerns about quality management in veterinary laboratories, the American Society for Veterinary Clinical Pathology (ASVCP) formed a Quality Assurance and Laboratory Standards (QAS) committee in 1996. This committee recently published updated and peer-reviewed Quality Assurance Guidelines on the ASVCP website. The Quality Assurance Guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports on 1) general analytic factors for veterinary laboratory performance and comparisons, 2) hematology and hemostasis, and 3) clinical chemistry, endocrine assessment, and urinalysis. This report documents recommendations for control of general analytical factors within veterinary clinical laboratories and is based on section 2.1 (Analytical Factors Important In Veterinary Clinical Pathology, General) of the newly revised ASVCP QAS Guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimum guidelines for quality assurance and quality control for veterinary laboratory testing. It is hoped that these guidelines will provide a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. ©2010 American Society for Veterinary Clinical Pathology.

  10. 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.

  11. External quality control for embryology laboratories.

    PubMed

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

    2010-01-01

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

  12. [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.

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

    PubMed

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

    2010-12-01

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

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

    PubMed

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

    2011-09-01

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

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

    PubMed

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

    2011-09-01

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

  16. 42 CFR 493.1239 - Standard: General laboratory systems quality assessment.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  17. Improving laboratory data entry quality using Six Sigma.

    PubMed

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

    2013-01-01

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

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

    PubMed

    Tazawa, Hiromitsu

    2004-03-01

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

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

    PubMed

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

    2012-11-01

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

  20. 1990 National Water Quality Laboratory Services Catalog

    USGS Publications Warehouse

    Pritt, Jeffrey; 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.

  1. Implementing self sustained quality control procedures in a clinical laboratory.

    PubMed

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

    2013-01-01

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

  2. 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...

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

    PubMed

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

    2017-02-15

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

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

    PubMed

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

    2014-07-01

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

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

    PubMed Central

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

    1995-01-01

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

  6. New Brunswick Laboratory. Progress report, October 1995--September 1996

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

    NONE

    Fiscal year (FY) 1996 was a very good year for New Brunswick Laboratory (NBL), whose major sponsor is the Office of Safeguards and Security (NN-51) in the US Department of Energy (DOE), Office of Nonproliferation and National Security, Office of Security Affairs. Several projects pertinent to the NBL mission were completed, and NBL`s interactions with partners and customers were encouraging. Among the partners with which NBL interacted in this report period were the International Atomic Energy Agency (IAEA), NN-51. Environmental Program Group of the DOE Chicago Operations Office, International Safeguards Project Office, Waste Isolation Pilot Plant (WIPP), Ukraine Working Group,more » Fissile Materials Assurance Working Group, National Institute of Standards and Technology (NIST), Nuclear Regulatory Commission (NRC), Institute for Reference Materials and Measurements (IRMM) in Belgium, Brazilian/Argentine Agency for Accounting and Control of Nuclear Materials (ABACC), Lockheed Idaho Technologies Company, and other DOE facilities and laboratories. NBL staff publications, participation in safeguards assistance and other nuclear programs, development of new reference materials, involvement in the updating and refinement of DOE documents, service in enhancing the science education of others, and other related activities enhanced NBL`s status among DOE laboratories and facilities. Noteworthy are the facts that NBL`s small inventory of nuclear materials is accurately accounted for, and, as in past years, its materials and human resources were used in peaceful nuclear activities worldwide.« less

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

    PubMed

    Allen, Lynn C

    2013-09-01

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

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

    PubMed

    Westgard, James O

    2016-02-01

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

  9. Preanalytical quality in clinical chemistry laboratory.

    PubMed

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

    2014-01-01

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

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

    PubMed

    Anderson, Nancy

    2015-11-15

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

  11. National Water Quality Laboratory, 1995 services catalog

    USGS Publications Warehouse

    Timme, P.J.

    1995-01-01

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

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

    PubMed Central

    Trollip, Andre; Erni, Donatelle; Kao, Kekeletso

    2017-01-01

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

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

    PubMed

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

    2014-01-01

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

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

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

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

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

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

    PubMed

    Topić, E; Turek, S

    2000-01-01

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

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

    PubMed

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

    2011-05-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed

    Tembuyser, Lien; Dequeker, Elisabeth M C

    2016-01-01

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

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

    PubMed

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

    2018-02-17

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

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

    USGS Publications Warehouse

    Durum, W.H.

    1978-01-01

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

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

    PubMed

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

    2016-03-01

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

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

    PubMed

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

    2010-09-01

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

  3. 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.

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2014-01-01

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

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

    PubMed

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

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

    Men'shikov, V V

    2013-08-01

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

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

    PubMed

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

    2015-04-01

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

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

    PubMed

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

    1999-04-01

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

  11. An overview of Quality Management System implementation in a research laboratory

    NASA Astrophysics Data System (ADS)

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

    2018-02-01

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

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

    PubMed

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

    2017-03-01

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

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

    PubMed

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

    2017-10-01

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

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

    PubMed

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

    2008-01-01

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

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

    USGS Publications Warehouse

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

    1993-01-01

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

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

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

    2015-05-26

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

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

    PubMed

    Fulga, Netta

    2013-06-01

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

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

    PubMed

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

    2015-01-01

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

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

    ERIC Educational Resources Information Center

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

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

  2. 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...

  3. Cost Effectiveness of Adopted Quality Requirements in Hospital Laboratories

    PubMed Central

    HAMZA, Alneil; AHMED-ABAKUR, Eltayib; ABUGROUN, Elsir; BAKHIT, Siham; HOLI, Mohamed

    2013-01-01

    Background The present study was designed in quasi-experiment to assess adoption of the essential clauses of particular clinical laboratory quality management requirements based on international organization for standardization (ISO 15189) in hospital laboratories and to evaluate the cost effectiveness of compliance to ISO 15189. Methods: The quality management intervention based on ISO 15189 was conceded through three phases; pre – intervention phase, Intervention phase and Post-intervention phase. Results: In pre-intervention phase the compliance to ISO 15189 was 49% for study group vs. 47% for control group with P value 0.48, while the post intervention results displayed 54% vs. 79% for study group and control group respectively in compliance to ISO 15189 and statistically significant difference (P value 0.00) with effect size (Cohen’s d) of (0.00) in pre-intervention phase and (0.99) in post – intervention phase. The annual average cost per-test for the study group and control group was 1.80 ± 0.25 vs. 1.97 ± 0.39, respectively with P value 0.39 whereas the post-intervention results showed that the annual average total costs per-test for study group and control group was 1.57 ± 0.23 vs 2.08 ± 0.38, P value 0.019 respectively, with cost-effectiveness ratio of (0.88) in pre -intervention phase and (0.52) in post-intervention phase. Conclusion: The planned adoption of quality management requirements (QMS) in clinical laboratories had great effect to increase the compliance percent with quality management system requirement, raise the average total cost effectiveness, and improve the analytical process capability of the testing procedure. PMID:23967422

  4. Cost effectiveness of adopted quality requirements in hospital laboratories.

    PubMed

    Hamza, Alneil; Ahmed-Abakur, Eltayib; Abugroun, Elsir; Bakhit, Siham; Holi, Mohamed

    2013-01-01

    The present study was designed in quasi-experiment to assess adoption of the essential clauses of particular clinical laboratory quality management requirements based on international organization for standardization (ISO 15189) in hospital laboratories and to evaluate the cost effectiveness of compliance to ISO 15189. The quality management intervention based on ISO 15189 was conceded through three phases; pre - intervention phase, Intervention phase and Post-intervention phase. In pre-intervention phase the compliance to ISO 15189 was 49% for study group vs. 47% for control group with P value 0.48, while the post intervention results displayed 54% vs. 79% for study group and control group respectively in compliance to ISO 15189 and statistically significant difference (P value 0.00) with effect size (Cohen's d) of (0.00) in pre-intervention phase and (0.99) in post - intervention phase. The annual average cost per-test for the study group and control group was 1.80 ± 0.25 vs. 1.97 ± 0.39, respectively with P value 0.39 whereas the post-intervention results showed that the annual average total costs per-test for study group and control group was 1.57 ± 0.23 vs 2.08 ± 0.38, P value 0.019 respectively, with cost-effectiveness ratio of (0.88) in pre -intervention phase and (0.52) in post-intervention phase. The planned adoption of quality management requirements (QMS) in clinical laboratories had great effect to increase the compliance percent with quality management system requirement, raise the average total cost effectiveness, and improve the analytical process capability of the testing procedure.

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

    PubMed

    Richardson, H

    1999-12-01

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

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

    PubMed

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

    2018-06-15

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

  7. Quality-assurance results for routine water analysis in US Geological Survey laboratories, water year 1991

    USGS Publications Warehouse

    Maloney, T.J.; Ludtke, A.S.; Krizman, T.L.

    1994-01-01

    The US. Geological Survey operates a quality- assurance program based on the analyses of reference samples for the National Water Quality Laboratory in Arvada, Colorado, and the Quality of Water Service Unit in Ocala, Florida. Reference samples containing selected inorganic, nutrient, and low ionic-strength constituents are prepared and disguised as routine samples. The program goal is to determine precision and bias for as many analytical methods offered by the participating laboratories as possible. The samples typically are submitted at a rate of approximately 5 percent of the annual environmental sample load for each constituent. The samples are distributed to the laboratories throughout the year. Analytical data for these reference samples reflect the quality of environmental sample data produced by the laboratories because the samples are processed in the same manner for all steps from sample login through data release. The results are stored permanently in the National Water Data Storage and Retrieval System. During water year 1991, 86 analytical procedures were evaluated at the National Water Quality Laboratory and 37 analytical procedures were evaluated at the Quality of Water Service Unit. An overall evaluation of the inorganic (major ion and trace metal) constituent data for water year 1991 indicated analytical imprecision in the National Water Quality Laboratory for 5 of 67 analytical procedures: aluminum (whole-water recoverable, atomic emission spectrometric, direct-current plasma); calcium (atomic emission spectrometric, direct); fluoride (ion-exchange chromatographic); iron (whole-water recoverable, atomic absorption spectrometric, direct); and sulfate (ion-exchange chromatographic). The results for 11 of 67 analytical procedures had positive or negative bias during water year 1991. Analytical imprecision was indicated in the determination of two of the five National Water Quality Laboratory nutrient constituents: orthophosphate as phosphorus and

  8. Experience of quality management system in a clinical laboratory in Nigeria

    PubMed Central

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

    2012-01-01

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

  9. Sediment laboratory quality-assurance project: studies of methods and materials

    USGS Publications Warehouse

    Gordon, J.D.; Newland, C.A.; Gray, J.R.

    2001-01-01

    In August 1996 the U.S. Geological Survey initiated the Sediment Laboratory Quality-Assurance project. The Sediment Laboratory Quality Assurance project is part of the National Sediment Laboratory Quality-Assurance program. This paper addresses the fmdings of the sand/fme separation analysis completed for the single-blind reference sediment-sample project and differences in reported results between two different analytical procedures. From the results it is evident that an incomplete separation of fme- and sand-size material commonly occurs resulting in the classification of some of the fme-size material as sand-size material. Electron microscopy analysis supported the hypothesis that the negative bias for fme-size material and the positive bias for sand-size material is largely due to aggregation of some of the fine-size material into sand-size particles and adherence of fine-size material to the sand-size grains. Electron microscopy analysis showed that preserved river water, which was low in dissolved solids, specific conductance, and neutral pH, showed less aggregation and adhesion than preserved river water that was higher in dissolved solids and specific conductance with a basic pH. Bacteria were also found growing in the matrix, which may enhance fme-size material aggregation through their adhesive properties. Differences between sediment-analysis methods were also investigated as pan of this study. Suspended-sediment concentration results obtained from one participating laboratory that used a total-suspended solids (TSS) method had greater variability and larger negative biases than results obtained when this laboratory used a suspended-sediment concentration method. When TSS methods were used to analyze the reference samples, the median suspended sediment concentration percent difference was -18.04 percent. When the laboratory used a suspended-sediment concentration method, the median suspended-sediment concentration percent difference was -2

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

    PubMed

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

    2016-03-01

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

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

    PubMed

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

    2015-09-01

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

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

    PubMed

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

    2003-01-01

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

  13. Student laboratory reports: an approach to improving feedback and quality

    NASA Astrophysics Data System (ADS)

    Ellingsen, Pål Gunnar; Støvneng, Jon Andreas

    2018-05-01

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

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

    PubMed Central

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

    2018-01-01

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

  15. Quality management for the international transport of laboratory animals.

    PubMed

    Leary, Steven L

    2008-01-01

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

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

    PubMed

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

    2013-07-01

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

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

    PubMed

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

    2014-02-01

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

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

    PubMed

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

    2015-12-01

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

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

    USDA-ARS?s Scientific Manuscript database

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

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

    PubMed

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

    2017-03-01

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

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

    USGS Publications Warehouse

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

    1992-01-01

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

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

    PubMed

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

    2017-08-01

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

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

    PubMed

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

    1984-01-01

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

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

    USGS Publications Warehouse

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

    2000-01-01

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

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

    PubMed

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

    2004-01-01

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

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

    PubMed

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

    2012-09-01

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

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

    PubMed

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

    2017-01-01

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

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

    PubMed

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

    2014-12-01

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

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

    PubMed

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

    2016-12-01

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

  11. 21 CFR 111.110 - What quality control operations are required for laboratory operations associated with the...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

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

    2008-01-01

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

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

    PubMed

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

    2008-06-05

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

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

    Agarwal, Anuradha; Singh, Maithili R P

    2016-01-01

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

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

    USGS Publications Warehouse

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

    1987-01-01

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

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

    EPA Science Inventory

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

  20. 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.

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

    PubMed

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

    2011-06-01

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

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

    PubMed

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

    2017-01-01

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

  3. Implementation of Quality Management in Core Service Laboratories

    PubMed Central

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

    2010-01-01

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

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

    PubMed

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

    2017-12-22

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

  5. International External Quality Assurance for Laboratory Diagnosis of Diphtheria ▿

    PubMed Central

    Neal, S. E.; Efstratiou, A.

    2009-01-01

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

  6. 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

  7. 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.

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed

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

    2013-05-01

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

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

    USGS Publications Warehouse

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

    2018-04-02

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2010-10-01

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

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

    PubMed

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

    2002-07-01

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

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

    PubMed

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

    2010-09-01

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

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

    PubMed

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

    2013-02-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2017-09-01

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

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed

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

    2007-11-01

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

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

    PubMed

    Chuntarut, A; Tientadakul, P; Wongkrajang, P

    2016-06-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed

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

    2012-01-01

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

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

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

    Mann, L.J.

    1996-10-01

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

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

    PubMed

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

    2014-04-30

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

  8. Laboratory quality improvement in Tanzania.

    PubMed

    Andiric, Linda R; Massambu, Charles G

    2015-04-01

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

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

    PubMed

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

    2014-01-01

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

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

    PubMed

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

    2018-03-01

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

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

    PubMed

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

    2013-02-01

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

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

    PubMed

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

    2018-02-15

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

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

    PubMed

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

    2011-11-01

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

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

    PubMed

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

    2016-03-01

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

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

    PubMed

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

    2008-04-01

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

  16. 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…

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

    PubMed

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

    2016-11-01

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

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

    PubMed

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

    2010-01-01

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

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

    PubMed

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

    2016-01-01

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

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

    USGS Publications Warehouse

    Glodt, Stephen R.; Pirkey, Kimberly D.

    1998-01-01

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

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

    PubMed

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

    2018-03-02

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

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

    Elhoseeny, T A; Mohammad, E K

    2013-01-01

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

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

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

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

    2006-09-01

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

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

    PubMed

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

    2002-07-20

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

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

    PubMed

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

    2016-03-01

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

  8. Roles of laboratories and laboratory systems in effective tuberculosis programmes.

    PubMed

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

    2007-05-01

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

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

    PubMed Central

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

    2016-01-01

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

  10. 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

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

    PubMed

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2012-03-01

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

  14. External quality assessment of clinical laboratories in the United Kingdom

    PubMed Central

    Whitehead, TP; Woodford, FP

    1981-01-01

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

  15. Roles of laboratories and laboratory systems in effective tuberculosis programmes

    PubMed Central

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

    2007-01-01

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

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

    PubMed

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

    2009-07-01

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

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

    PubMed

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

    2018-05-01

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

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

    PubMed

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

    2016-04-15

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

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

    PubMed

    Teka, Abaynesh; Kibatu, Girma

    2012-03-01

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

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

    PubMed Central

    Undrill, P E; Frazer, S C

    1979-01-01

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

  1. Errors in clinical laboratories or errors in laboratory medicine?

    PubMed

    Plebani, Mario

    2006-01-01

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

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

    PubMed

    Moghadam, Marjan; Jahangiri, Leila

    2015-08-01

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

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

    PubMed

    Stavelin, Anne; Sandberg, Sverre

    2018-05-16

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

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

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

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

    2009-01-01

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

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

    USGS Publications Warehouse

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

    2008-01-01

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

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

    USGS Publications Warehouse

    Shreve, Elizabeth A.; Downs, Aimee C.

    2005-01-01

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

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

    PubMed

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

    2015-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2007-04-01

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

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

    PubMed

    Aidoo, Michael

    2013-09-01

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

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

    PubMed

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

    2013-08-01

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

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

    PubMed

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

    2018-02-01

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

  12. Expert Assessment of Conditions for Accredited Quality Management System Functioning in Testing Laboratories

    NASA Astrophysics Data System (ADS)

    Mytych, Joanna; Ligarski, Mariusz J.

    2018-03-01

    The quality management systems compliant with the ISO 9001:2009 have been thoroughly researched and described in detail in the world literature. The accredited management systems used in the testing laboratories and compliant with the ISO/IEC 17025:2005 have been mainly described in terms of the system design and implementation. They have also been investigated from the analytical point of view. Unfortunately, a low number of studies concerned the management system functioning in the accredited testing laboratories. The aim of following study was to assess the management system functioning in the accredited testing laboratories in Poland. On 8 October 2015, 1,213 accredited testing laboratories were present in Poland. They investigated various scientific areas and substances/objects. There are more and more such laboratories that have various problems and different long-term experience when it comes to the implementation, maintenance and improvement of the management systems. The article describes the results of the conducted expert assessment (survey) carried out to examine the conditions for the functioning of a management system in an accredited laboratory. It also focuses on the characteristics of the accredited research laboratories in Poland. The authors discuss the selection of the external and internal conditions that may affect the accredited management system. They show how the experts assessing the selected conditions were chosen. The survey results are also presented.

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

    PubMed

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

    2003-01-01

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

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

    PubMed

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

    2012-01-01

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

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

    PubMed

    Plebani, Mario

    2018-05-24

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

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

    PubMed

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

    2017-07-01

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

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

    PubMed

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

    2006-01-01

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

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

    PubMed

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

    2015-08-01

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

  19. Environmental Response Laboratory Network (ERLN) Laboratory Requirements

    EPA Pesticide Factsheets

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

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

    PubMed

    Forni, M

    2007-08-01

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

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

    USGS Publications Warehouse

    Lucey, K.J.

    1989-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  3. [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".

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

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

    2017-01-01

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

  6. 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.

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

    PubMed

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

    2016-03-01

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

  8. 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…

  9. Clinical laboratory accreditation in India.

    PubMed

    Handoo, Anil; Sood, Swaroop Krishan

    2012-06-01

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

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

    PubMed

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

    2016-04-15

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

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

    PubMed

    Tientadakul, Panutsaya; Opartkiattikul, Nisarat; Wongtiraporn, Wanida

    2009-01-01

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

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

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

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

    2005-01-01

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

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

    PubMed

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

    2009-10-01

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

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

    PubMed

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

    2014-10-01

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

  15. Establishment of National Laboratory Standards in Public and Private Hospital Laboratories

    PubMed Central

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

    2013-01-01

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

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

    PubMed

    Lee, Jungmin; Clarke, Kofi

    2017-11-01

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

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

    PubMed

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

    2014-02-01

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

  18. Diagnostic equipment outside the laboratory.

    PubMed Central

    Burrin, J M; Fyffe, J A

    1988-01-01

    A questionnaire was circulated to clinical biochemistry laboratories in the North West Thames region of the United Kingdom requesting information on extralaboratory equipment. Data on the types and numbers of instruments in use, their relationship with the laboratory, and quality assurance procedures were obtained. Laboratories were prepared to maintain equipment over which they had no responsibility for purchase, training of users, or use. The quality assurance of these instruments gave even greater cause for concern. Although internal quality control procedures were performed on many of the instruments, laboratories were involved in only a minority of these procedures. Quality control procedures and training of users were undertaken on site in less than 50% of blood gas analysers and bilirubin meters and in less than 25% of glucose meters. External quality assessment procedures were non-existent for all of the instruments in use with the exception of glucose stick meters in two laboratories. PMID:3192750

  19. Improvement of the quality of work in a biochemistry laboratory via measurement system analysis.

    PubMed

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

    2016-10-31

    An adequate and continuous monitoring of operational variations can effectively reduce the uncertainty and enhance the quality of laboratory reports. This study applied the evaluation rule of the measurement system analysis (MSA) method to estimate the quality of work conducted in a biochemistry laboratory. Using the gauge repeatability & reproducibility (GR&R) approach, variations in quality control (QC) data among medical technicians in conducting measurements of five biochemical items, namely, serum glucose (GLU), aspartate aminotransferase (AST), uric acid (UA), sodium (Na) and chloride (Cl), were evaluated. The measurements of the five biochemical items showed different levels of variance among the different technicians, with the variances in GLU measurements being higher than those for the other four items. The ratios of precision-to-tolerance (P/T) for Na, Cl and GLU were all above 0.5, implying inadequate gauge capability. The product variation contribution of Na was large (75.45% and 31.24% in normal and abnormal QC levels, respectively), which showed that the impact of insufficient usage of reagents could not be excluded. With regard to reproducibility, high contributions (of more than 30%) of variation for the selected items were found. These high operator variation levels implied that the possibility of inadequate gauge capacity could not be excluded. The analysis of variance (ANOVA) of GR&R showed that the operator variations in GLU measurements were significant (F=5.296, P=0.001 in the normal level and F=3.399, P=0.015 in the abnormal level, respectively). In addition to operator variations, product variations of Na were also significant for both QC levels. The heterogeneity of variance for the five technicians showed significant differences for the Na and Cl measurements in the normal QC level. The accuracy of QC for five technicians was identified for further operational improvement. This study revealed that MSA can be used to evaluate product and

  20. [Laboratory accreditation and proficiency testing].

    PubMed

    Kuwa, Katsuhiko

    2003-05-01

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

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

    PubMed

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

    2012-03-01

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

  2. Feasibility of establishing a biosafety level 3 tuberculosis culture laboratory of acceptable quality standards in a resource-limited setting: an experience from Uganda.

    PubMed

    Ssengooba, Willy; Gelderbloem, Sebastian J; Mboowa, Gerald; Wajja, Anne; Namaganda, Carolyn; Musoke, Philippa; Mayanja-Kizza, Harriet; Joloba, Moses Lutaakome

    2015-01-15

    Despite the recent innovations in tuberculosis (TB) and multi-drug resistant TB (MDR-TB) diagnosis, culture remains vital for difficult-to-diagnose patients, baseline and end-point determination for novel vaccines and drug trials. Herein, we share our experience of establishing a BSL-3 culture facility in Uganda as well as 3-years performance indicators and post-TB vaccine trials (pioneer) and funding experience of sustaining such a facility. Between September 2008 and April 2009, the laboratory was set-up with financial support from external partners. After an initial procedure validation phase in parallel with the National TB Reference Laboratory (NTRL) and legal approvals, the laboratory registered for external quality assessment (EQA) from the NTRL, WHO, National Health Laboratories Services (NHLS), and the College of American Pathologists (CAP). The laboratory also instituted a functional quality management system (QMS). Pioneer funding ended in 2012 and the laboratory remained in self-sustainability mode. The laboratory achieved internationally acceptable standards in both structural and biosafety requirements. Of the 14 patient samples analyzed in the procedural validation phase, agreement for all tests with NTRL was 90% (P <0.01). It started full operations in October 2009 performing smear microscopy, culture, identification, and drug susceptibility testing (DST). The annual culture workload was 7,636, 10,242, and 2,712 inoculations for the years 2010, 2011, and 2012, respectively. Other performance indicators of TB culture laboratories were also monitored. Scores from EQA panels included smear microscopy >80% in all years from NTRL, CAP, and NHLS, and culture was 100% for CAP panels and above regional average scores for all years with NHLS. Quarterly DST scores from WHO-EQA ranged from 78% to 100% in 2010, 80% to 100% in 2011, and 90 to 100% in 2012. From our experience, it is feasible to set-up a BSL-3 TB culture laboratory with acceptable quality

  3. 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. Copyright © 2011 American Association of Anatomists.

  4. [Quality use of commercial laboratory for clinical testing services - considering laboratory's role].

    PubMed

    Ogawa, Shinji

    2014-12-01

    The number of commercial laboratories for clinical testing in Japan run privately has decreased to about 30 companies, and their business is getting tougher. Branch Lab. and FMS businesses have not expanded recently due to the new reimbursement system which adds an additional sample management fee, becoming effective in 2010. This presentation gives an outline of each role for hospital and commercial laboratories, and their pros & cons considering the current medical situation. Commercial laboratories have investigated how to utilize ICT systems for sharing test information between hospitals and our facilities. It would be very helpful to clarify issues for each hospital. We will develop and create new values for clinical laboratory testing services and forge mutually beneficial relationships with medical institutions. (Review).

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

    PubMed

    Giannoli, Jean-Marc; Szymanowicz, Anton

    2011-01-01

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

  6. Implementation of the OECD principles of good laboratory practice in test facilities complying with a quality system accredited to the ISO/IEC 17025 standard.

    PubMed

    Feller, Etty

    2008-01-01

    Laboratories with a quality system accredited to the ISO/IEC 17025 standard have a definite advantage, compared to non-accredited laboratories, when preparing their facilities for the implementation of the principles of good laboratory practice (GLP) of the Organisation for Economic Co-operation and Development (OECD). Accredited laboratories have an established quality system covering the administrative and technical issues specified in the standard. The similarities and differences between the ISO/IEC 17025 standard and the OECD principles of GLP are compared and discussed.

  7. Los Alamos National Laboratory Meteorology Monitoring Program: 2016 Data Completeness/ Quality Report

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

    Bruggeman, David Alan

    This report summarizes data completeness by tower and by instrument for 2016 and compares that data with the Los Alamos National Laboratory (LANL) and American National Standards Institute (ANSI) 2015 standards. This report is designed to make data users aware of data completeness and any data quality issues. LANL meteorology monitoring goals include 95% completeness for all measurements. The ANSI 2015 standard requires 90% completeness for all measurements. This report documents instrument/tower issues as they impact data completeness.

  8. Causes of cine image quality deterioration in cardiac catheterization laboratories.

    PubMed

    Levin, D C; Dunham, L R; Stueve, R

    1983-10-01

    Deterioration of cineangiographic image quality can result from malfunctions or technical errors at a number of points along the cine imaging chain: generator and automatic brightness control, x-ray tube, x-ray beam geometry, image intensifier, optics, cine camera, cine film, film processing, and cine projector. Such malfunctions or errors can result in loss of image contrast, loss of spatial resolution, improper control of film optical density (brightness), or some combination thereof. While the electronic and photographic technology involved is complex, physicians who perform cardiac catheterization should be conversant with the problems and what can be done to solve them. Catheterization laboratory personnel have control over a number of factors that directly affect image quality, including radiation dose rate per cine frame, kilovoltage or pulse width (depending on type of automatic brightness control), cine run time, selection of small or large focal spot, proper object-intensifier distance and beam collimation, aperture of the cine camera lens, selection of cine film, processing temperature, processing immersion time, and selection of developer.

  9. A national clinical quality program for Veterans Affairs catheterization laboratories (from the Veterans Affairs clinical assessment, reporting, and tracking program).

    PubMed

    Maddox, Thomas M; Plomondon, Mary E; Petrich, Megan; Tsai, Thomas T; Gethoffer, Hans; Noonan, Gregory; Gillespie, Brian; Box, Tamara; Fihn, Stephen D; Jesse, Robert L; Rumsfeld, John S

    2014-12-01

    A "learning health care system", as outlined in a recent Institute of Medicine report, harnesses real-time clinical data to continuously measure and improve clinical care. However, most current efforts to understand and improve the quality of care rely on retrospective chart abstractions complied long after the provision of clinical care. To align more closely with the goals of a learning health care system, we present the novel design and initial results of the Veterans Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) program-a national clinical quality program for VA cardiac catheterization laboratories that harnesses real-time clinical data to support clinical care and quality-monitoring efforts. Integrated within the VA electronic health record, the CART program uses a specialized software platform to collect real-time patient and procedural data for all VA patients undergoing coronary procedures in VA catheterization laboratories. The program began in 2005 and currently contains data on 434,967 catheterization laboratory procedures, including 272,097 coronary angiograms and 86,481 percutaneous coronary interventions, performed by 801 clinicians on 246,967 patients. We present the initial data from the CART program and describe 3 quality-monitoring programs that use its unique characteristics-procedural and complications feedback to individual labs, coronary device surveillance, and major adverse event peer review. The VA CART program is a novel approach to electronic health record design that supports clinical care, quality, and safety in VA catheterization laboratories. Its approach holds promise in achieving the goals of a learning health care system. Published by Elsevier Inc.

  10. TREAT Asia Quality Assessment Scheme (TAQAS) to standardize the outcome of HIV genotypic resistance testing in a group of Asian laboratories

    PubMed Central

    Land, Sally; Cunningham, Philip; Zhou, Jialun; Frost, Kevin; Katzenstein, David; Kantor, Rami; Chen, Yi-Ming Arthur; Oka, Shinichi; DeLong, Allison; Sayer, David; Smith, Jeffery; Dax, Elizabeth M.; Law, Matthew

    2010-01-01

    The TREAT Asia (Therapeutics, Research, Education, and AIDS Training in Asia) Network is building capacity for Human Immunodeficiency Virus Type-1 (HIV-1) drug resistance testing in the region. The objective of the TREAT Asia Quality Assessment Scheme – designated TAQAS – is to standardize HIV-1 genotypic resistance testing (HIV genotyping) among laboratories to permit rigorous comparison of results from different clinics and testing centres. TAQAS has evaluated three panels of HIV-1-positive plasma from clinical material or low-passage, culture supernatant for up to 10 Asian laboratories. Laboratory participants used their standard protocols to perform HIV genotyping. Assessment was in comparison to a target genotype derived from all participants and the reference laboratory’s result. Agreement between most participants at the edited nucleotide sequence level was high (>98%). Most participants performed to the reference laboratory standard in detection of drug resistance mutations (DRMs). However, there was variation in the detection of nucleotide mixtures (0–83%) and a significant correlation with the detection of DRMs (p < 0.01). Interpretation of antiretroviral resistance showed ~70% agreement among participants when different interpretation systems were used but >90% agreement with a common interpretation system, within the Stanford University Drug Resistance Database. Using the principles of external quality assessment and a reference laboratory, TAQAS has demonstrated high quality HIV genotyping results from Asian laboratories. PMID:19490972

  11. Electronic laboratory data quality and the value of a health information exchange to support public health reporting processes.

    PubMed

    Dixon, Brian E; McGowan, Julie J; Grannis, Shaun J

    2011-01-01

    There is increasing interest in leveraging electronic health data across disparate sources for a variety of uses. A fallacy often held by data consumers is that clinical data quality is homogeneous across sources. We examined one attribute of data quality, completeness, in the context of electronic laboratory reporting of notifiable disease information. We evaluated 7.5 million laboratory reports from clinical information systems for their completeness with respect to data needed for public health reporting processes. We also examined the impact of health information exchange (HIE) enhancement methods that attempt to improve completeness. The laboratory data were heterogeneous in their completeness. Fields identifying the patient and test results were usually complete. Fields containing patient demographics, patient contact information, and provider contact information were suboptimal. Data processed by the HIE were often more complete, suggesting that HIEs can support improvements to existing public health reporting processes.

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

    PubMed

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

    2017-03-01

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

  13. Evaluation of quality indicators in a laboratory supporting tertiary cancer care facilities in India.

    PubMed

    Kumar, Savitha Anil; Jayanna, Prashanth; Prabhudesai, Shilpa; Kumar, Ajai

    2014-01-01

    To collect and tabulate errors and nonconformities in the preanalytical, analytical, and postanalytical process phases in a diagnostic clinical laboratory that supports a super-specialty cancer center in India, and identify areas of potential improvement in patient services. We collected data from our laboratory during a period of 24 months. Departments in the study included clinical biochemistry, hematology, clinical pathology, microbiology and serology, surgical pathology, and molecular pathology. We had initiated quality assessment based on international standards in our laboratory in 2010, with the aim of obtaining accreditation by national and international governing bodies. We followed the guidelines specified by International Organization for Standardization (ISO) 15189:2007 to identify noncompliant elements of our processes. Among a total of 144,030 specimens that our referral laboratory received during the 2-year period of our study, we uncovered an overall error rate for all 3 process phases of 1.23%; all of our error rates closely approximated the results from our peer institutions. Errors were most common in the preanalytical phase in both years of study; preanalytical- and postanalytical-phase errors constituted more than 90% of all errors. Further improvements are warranted in laboratory services and are contingent on adequate training and interdepartmental communication and cooperation. Copyright© by the American Society for Clinical Pathology (ASCP).

  14. Validation of the Six Sigma Z-score for the quality assessment of clinical laboratory timeliness.

    PubMed

    Ialongo, Cristiano; Bernardini, Sergio

    2018-03-28

    The International Federation of Clinical Chemistry and Laboratory Medicine has introduced in recent times the turnaround time (TAT) as mandatory quality indicator for the postanalytical phase. Classic TAT indicators, namely, average, median, 90th percentile and proportion of acceptable test (PAT), are in use since almost 40 years and to date represent the mainstay for gauging the laboratory timeliness. In this study, we investigated the performance of the Six Sigma Z-score, which was previously introduced as a device for the quantitative assessment of timeliness. A numerical simulation was obtained modeling the actual TAT data set using the log-logistic probability density function. Five thousand replicates for each size of the artificial TAT random sample (n=20, 50, 250 and 1000) were generated, and different laboratory conditions were simulated manipulating the PDF in order to generate more or less variable data. The Z-score and the classic TAT indicators were assessed for precision (%CV), robustness toward right-tailing (precision at different sample variability), sensitivity and specificity. Z-score showed sensitivity and specificity comparable to PAT (≈80% with n≥250), but superior precision that ranged within 20% by moderately small sized samples (n≥50); furthermore, Z-score was less affected by the value of the cutoff used for setting the acceptable TAT, as well as by the sample variability that reflected into the magnitude of right-tailing. The Z-score was a valid indicator of laboratory timeliness and a suitable device to improve as well as to maintain the achieved quality level.

  15. [Application of laboratory information system in the management of the key indicators of quality inspection].

    PubMed

    Guo, Ye; Chen, Qian; Wu, Wei; Cui, Wei

    2015-03-31

    To establish a system of monitoring the key indicator of quality for inspection (KIQI) on a laboratory information system (LIS), and to have a better management of KIQI. Clinical sample made in PUMCH were collected during the whole of 2014. Next, interactive input program were designed to accomplish data collecting of the disqualification rate of samples, the mistake rate of samples and the occasions of losing samples, etc. Then, a series moment of sample collection, laboratory sample arrived, sample test, sample check, response to critical value, namely, trajectory information left on LIS were recorded and the qualification rate of TAT, the notification rate of endangering result were calculated. Finally, the information about quality control were collected to build an internal quality control database and the KIQI, such as the out-of-control rate of quality control and the total error of test items were monitored. The inspection of the sample management shows the disqualification rates in 2014 were all below the target, but the rates in January and February were a little high and the rates of four wards were above 2%. The mistake rates of samples was 0.47 cases/10 000 cases, attaining the target (< 2 cases/10 000 cases). Also, there was no occasion of losing samples in 2014, attaining the target too. The inspection of laboratory reports shows the qualification rates of TAT was within the acceptable range (> 95%), however the rates of blood routine in November (94.75%) was out of range. We have solved the problem by optimizing the processes. The notification rate of endangering result attained the target (≥ 98%), while the rate of timely notification is needed to improve. Quality inspection shows the CV of APTT in August (5.02%) was rising significantly, beyond the accepted CV (5.0%). We have solved the problem by changing the reagent. The CV of TT in 2014 were all below the allowable CV, thus the allowable CV of the next year lower to 10%. It is an objective

  16. Field methods and quality-assurance plan for water-quality activities and water-level measurements, U.S. Geological Survey, Idaho National Laboratory, Idaho

    USGS Publications Warehouse

    Bartholomay, Roy C.; Maimer, Neil V.; Wehnke, Amy J.

    2014-01-01

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

  17. 42 CFR 493.1407 - Standard; Laboratory director responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... developed and used for each of the tests performed in the laboratory provide quality laboratory services for... results are found to be unacceptable or unsatisfactory; (5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and...

  18. [Improving experimental teaching facilities and opening up of laboratories in order to raise experimental teaching quality of genetics].

    PubMed

    Xiao, Jian-Fu; Wu, Jian-Guo; Shi, Chun-Hai

    2011-12-01

    Advanced teaching facilities and the policy of opening laboratories to students play an important role in raising the quality in the experimental teaching of Genetics. This article introduces the superiority of some advanced instruments and equipment (such as digital microscope mutual laboratory system, flow cytometry, and NIRSystems) in the experimental teaching of genetics, and illustrates with examples the significance of exposing students to experiments in developing their creative consciousness and creative ability. This article also offers some new concepts on the further improvement upon teaching in the laboratory.

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

    PubMed

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

    2017-09-01

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

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

    PubMed

    Akyar, Işin

    2009-10-01

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

  1. Temperature management during semen processing: Impact on boar sperm quality under laboratory and field conditions.

    PubMed

    Schulze, M; Henning, H; Rüdiger, K; Wallner, U; Waberski, D

    2013-12-01

    Freshly collected boar spermatozoa are sensitive to a fast reduction in temperature because of lipid phase transition and phase separation processes. Temperature management during semen processing may determine the quality of stored samples. The aim of this study was to evaluate the influence of isothermic and hypothermic semen processing protocols on boar sperm quality under laboratory and field conditions. In the laboratory study, ejaculates (n = 12) were first diluted (1:1) with Beltsville Thawing Solution (BTS) at 32 °C, then processed either with isothermic (32 °C) or hypothermic (21 °C) BTS, stored at 17 °C, and assessed on days 1, 3, and 6. Temperature curves showed that 150 minutes after the first dilution, semen doses of both groups reached the same temperature. Two-step hypothermic processing resulted in lower sperm motility on days 1 and 6 (P < 0.05). Concomitantly, hypothermally processed samples contained less membrane intact sperm on days 3 and 6 (P < 0.05). Using AndroStar Plus extender instead of BTS reduced the negative effect of hypothermic processing. In the field study, 15 semen samples from each of 23 European artificial insemination studs were evaluated as part of an external quality control program. Semen quality based on motility, membrane integrity, mitochondrial activity, and a thermoresistance test was higher for stations using one-step isothermic dilutions (n = 7) compared with artificial insemination centers using two-step hypothermic protocols (n = 16). Both studies show that chilling injury associated with hypothermic dilution results in lower quality of stored boar semen compared with isothermic dilution and that the type of semen extender affects the outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

  2. AMT's Position on Physician's Office Laboratories.

    ERIC Educational Resources Information Center

    AMT Events, 1986

    1986-01-01

    The following standards are affirmed by the American Medical Technologists organization: (1) regardless of the size of the laboratory setting, the patient deserves the highest quality of laboratory service available; (2) certified personnel should be employed by physicians in office laboratories; (3) quality control should be mandatory and…

  3. Combining patient administration and laboratory computer systems - a proposal to measure and improve the quality of care.

    PubMed

    Wolff, Anthony H; Kellett, John

    2011-12-01

    Several approaches to measuring the quality of hospital care have been suggested. We propose the simple and objective approach of using the health related data of the patient administration systems and the laboratory results that have been collected and stored electronically in hospitals for years. Imaginative manipulation of this data can give new insights into the quality of patient care. Copyright © 2011 European Federation of Internal Medicine. All rights reserved.

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

    PubMed

    Iqbal, Sahar; Mustansar, Tazeen

    2017-03-01

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

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

    PubMed

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

    2013-12-01

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

  6. Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa

    PubMed Central

    Shott, Joseph P.; Saye, Renion; Diakité, Moussa L.; Sanogo, Sintry; Dembele, Moussa B.; Keita, Sekouba; Nagel, Mary C.; Ellis, Ruth D.; Aebig, Joan A.; Diallo, Dapa A.; Doumbo, Ogobara K.

    2012-01-01

    Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices. PMID:22492138

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

    PubMed

    Weykamp, Cas; Siebelder, Carla

    2017-11-01

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

  8. Certification standards transfer: from committee to laboratory.

    PubMed

    Lehmann, H P

    1998-12-01

    The ISO 9000 Standards series were developed to provide the international manufacturing industry with a framework to ensure purchased products meet quality criteria. Section 4 of ISO 9001, Quality System Model for Quality Assurance in Design, Development, Production, Installation and Servicing, contains 20 aspects of a quality system that must be addressed by an organization in order to receive ISO 9001 certification. This concept is extended to the clinical laboratory, where a quality system program establishes for the customer (patient/clinician) that the purchased product (requested information on a submitted specimen-test result) meets established quality norms. In order to satisfy the customer, the providing organization must have policies and procedures in place that ensure a quality product, and be certified. To become certified the organization must, through an inspection process, demonstrate to an independent accrediting agency that it meets defined standards. In the United States, the government through the Clinical Laboratory Improvement Amendment (CLIA) 1988 established quality standards for the clinical laboratory. The College of American Pathologists (CAP), through its Laboratory Accreditation Program (LAP), serves as an independent agency that certifies that laboratories meet standards. To demonstrate the applicability of an established clinical laboratory accreditation program to ISO 9001 certification, the standards and checklists of CLIA 1988 and the CAP LAP will be examined to determine their conformance to ISO 9001, Section 4.

  9. Pacific Northwest National Laboratory Apatite Investigation at the 100-NR-2 Quality Assurance Project Plan

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

    Fix, N. J.

    This Quality Assurance Project Plan provides the quality assurance requirements and processes that will be followed by staff working on the 100-NR-2 Apatite Project. The U.S. Department of Energy, Fluor Hanford, Inc., Pacific Northwest National Laboratory, and the Washington Department of Ecology agreed that the long-term strategy for groundwater remediation at 100-N would include apatite sequestration as the primary treatment, followed by a secondary treatment. The scope of this project covers the technical support needed before, during, and after treatment of the targeted subsurface environment using a new high-concentration formulation.

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

    PubMed Central

    Kumar, B. Vinodh; Mohan, Thuthi

    2018-01-01

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

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

    PubMed

    Kumar, B Vinodh; Mohan, Thuthi

    2018-01-01

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

  12. Replicating the microbial community and water quality performance of full-scale slow sand filters in laboratory-scale filters.

    PubMed

    Haig, Sarah-Jane; Quince, Christopher; Davies, Robert L; Dorea, Caetano C; Collins, Gavin

    2014-09-15

    Previous laboratory-scale studies to characterise the functional microbial ecology of slow sand filters have suffered from methodological limitations that could compromise their relevance to full-scale systems. Therefore, to ascertain if laboratory-scale slow sand filters (L-SSFs) can replicate the microbial community and water quality production of industrially operated full-scale slow sand filters (I-SSFs), eight cylindrical L-SSFs were constructed and were used to treat water from the same source as the I-SSFs. Half of the L-SSFs sand beds were composed of sterilized sand (sterile) from the industrial filters and the other half with sand taken directly from the same industrial filter (non-sterile). All filters were operated for 10 weeks, with the microbial community and water quality parameters sampled and analysed weekly. To characterize the microbial community phyla-specific qPCR assays and 454 pyrosequencing of the 16S rRNA gene were used in conjunction with an array of statistical techniques. The results demonstrate that it is possible to mimic both the water quality production and the structure of the microbial community of full-scale filters in the laboratory - at all levels of taxonomic classification except OTU - thus allowing comparison of LSSF experiments with full-scale units. Further, it was found that the sand type composing the filter bed (non-sterile or sterile), the water quality produced, the age of the filters and the depth of sand samples were all significant factors in explaining observed differences in the structure of the microbial consortia. This study is the first to the authors' knowledge that demonstrates that scaled-down slow sand filters can accurately reproduce the water quality and microbial consortia of full-scale slow sand filters. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. Does laboratory automation for the preanalytical phase improve data quality?

    PubMed

    Lima-Oliveira, Gabriel; Lippi, Giuseppe; Salvagno, Gian Luca; Danese, Elisa; Montagnana, Martina; Brocco, Giorgio; Voi, Monica; Picheth, Geraldo; Guidi, Gian Cesare

    2013-10-01

    Our aim was to evaluate whether automation for the preanalytical phase improves data quality. Blood from 100 volunteers was collected into two vacuum tubes. One sample from each volunteer was respectively assigned to (G1) traditional processing, starting with centrifugation at 1200 g for 10 min, and (G2) the MODULAR PRE-ANALYTICALS EVO-MPA system. The routine clinical chemistry tests were performed in duplicate on the same instrument Cobas 6000 module. G1 samples were uncapped manually and immediately placed into the instrument. G2 samples were directly fed from the MPA system to the instrument without further staff intervention. At the end, (1) the G1 samples were stored for 6 h at 4 °C as prescribed in our accredited laboratory and (2) the G2 samples were stored for 6 h in the MPA output buffer. Results from G1 and G2, before and after storage, were compared. Significant increases were observed in G1 compared with G2 samples as follows: (1) before storage for alkaline phosphatase (ALP), lactate dehydrogenase (LDH), phosphate (P), magnesium (MG), iron (FE), and hemolysis index and (2) after storage for total cholesterol (COL), triglycerides (TG), total protein (TP), albumin (ALB), blood urea nitrogen (BUN), creatinine (CRE), uric acid (UA), ALP, pancreatic amylase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), g-glutamyltransferase (GGT), LDH, creatine kinase (CK), calcium (CA), FE, sodium (NA), potassium (K), and hemolysis index. Moreover, significant increases were observed in (3) G1-after versus G1-before storage samples for COL, high-density lipoprotein cholesterol, TG, TP, ALB, BUN, CRE, UA, AST, ALT, GGT, LDH, P, CA, MG, FE, NA, K, and hemolysis index and (4) G2-after versus G2-before storage only for BUN, AST, LDH, P, and CA. In conclusion, our results show that the MPA system improves the quality of laboratory testing.

  14. Genotyping External Quality Assurance in the World Health Organization HIV Drug Resistance Laboratory Network During 2007–2010

    PubMed Central

    Bremer, James; Bertagnolio, Silvia

    2012-01-01

    The World Health Organization (WHO) has developed a global laboratory network to support human immunodeficiency virus drug resistance genotyping for public health surveillance in resource-limited countries. Blinded proficiency panels are an essential part of a genotyping quality-assurance program and are used to monitor the reliability of genotyping data in the WHO laboratory network. Laboratories in Europe, North America, Asia, Africa, and the Caribbean have tested panels annually since 2007; 103 of 131 submissions (79%) had >99% nucleotide sequence identity and resistance mutation concordance, compared with consensus. Most errors were associated with mixtures in the test specimen, leading to subjectivity in base-calling or amplification bias. Overall, genotyping assays used by the WHO laboratory network are reliable. PMID:22544186

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

    PubMed

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

    2014-11-01

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

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

    PubMed

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

    2018-05-01

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

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

    PubMed

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

    2016-04-01

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

  18. Safety in the Chemical Laboratory: Laboratory Air Quality: Part I. A Concentration Model.

    ERIC Educational Resources Information Center

    Butcher, Samuel S.; And Others

    1985-01-01

    Offers a simple model for estimating vapor concentrations in instructional laboratories. Three methods are described for measuring ventilation rates, and the results of measurements in six laboratories are presented. The model should provide a simple screening tool for evaluating worst-case personal exposures. (JN)

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

    PubMed

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

    2017-10-26

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

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

    PubMed

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

    2012-07-01

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

  1. Assessment Report Sandia National Laboratories Fuel Cycle Technologies Quality Assurance Evaluation of FY15 SNL FCT M2 Milestone Deliverables

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

    Appel, Gordon John

    Sandia National Laboratories (SNL) Fuel Cycle Technologies (FCT) program activities are conducted in accordance with FCT Quality Assurance Program Document (FCT-QAPD) requirements. The FCT-QAPD interfaces with SNL approved Quality Assurance Program Description (SNL-QAPD) as explained in the Sandia National Laboratories QA Program Interface Document for FCT Activities (Interface Document). This plan describes SNL's FY16 assessment of SNL's FY15 FCT M2 milestone deliverable's compliance with program QA requirements, including SNL R&A requirements. The assessment is intended to confirm that SNL's FY15 milestone deliverables contain the appropriate authenticated review documentation and that there is a copy marked with SNL R&A numbers.

  2. 42 CFR 493.1445 - Standard; Laboratory director responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  3. Parents of children referred to a sleep laboratory for disordered breathing reported anxiety, daytime sleepiness and poor sleep quality.

    PubMed

    Cadart, Marion; De Sanctis, Livio; Khirani, Sonia; Amaddeo, Alessandro; Ouss, Lisa; Fauroux, Brigitte

    2018-07-01

    We evaluated the impact that having a child with sleep-disordered breathing had on their parents, including their own sleep quality. Questionnaires were completed by 96 parents of 86 children referred for a sleep study or control of continuous positive airway pressure (CPAP) or noninvasive ventilation (NIV) at the sleep laboratory of the Necker Hospital, Paris, France, between October 2015 and January 2016. The questionnaires evaluated anxiety and depression, family functioning, the parents' quality of life, daytime sleepiness and sleep quality. The children had a mean age of seven ±five years and most of the responses (79%) came from their mothers. These showed that 26% of parents showed moderate-to-severe anxiety, 8% moderate-to-severe depression, 6% complex family cohesion, 59% moderate-to-severe daytime sleepiness and 54% poor sleep quality. Anxiety was higher in mothers than in fathers (p < 0.001). The questionnaire scores did not differ according to the child's age, the results of the sleep studies or the CPAP or NIV treatment. The symptoms seem to be more commonly related to the child's underlying disease than their sleep-disordered breathing. The parents of children referred to a sleep laboratory reported frequent anxiety, daytime sleepiness and poor sleep quality. ©2018 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

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

    PubMed

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

    2009-04-01

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

  5. Superfund Contract Laboratory Program

    EPA Pesticide Factsheets

    The Contract Laboratory Program (CLP) is a national network of EPA personnel, commercial laboratories, and support contractors whose primary mission is to provide data of known and documented quality to the Superfund program.

  6. The Italian external quality assessment for RAS testing in colorectal carcinoma identifies methods-related inter-laboratory differences.

    PubMed

    Normanno, Nicola; Pinto, Carmine; Castiglione, Francesca; Fenizia, Francesca; Barberis, Massimo; Marchetti, Antonio; Fontanini, Gabriella; De Rosa, Gaetano; Taddei, Gian Luigi

    2015-09-03

    In 2014 the European Medicines Agency included exon 2, 3 and 4 KRAS and NRAS testing for the selection of metastatic colorectal cancer (mCRC) patients eligible for the therapy with anti-EGFR monoclonal antibodies. The Italian Association of Medical Oncology (AIOM) and the Italian Society of Pathology and Cytology (SIAPEC) organized an external quality assessment (EQA) scheme for CRC to evaluate inter-laboratory consistency and to ensure standardization of the results in the transition from KRAS to all-RAS testing. Ten formalin fixed paraffin embedded specimens including KRAS/NRAS (exons 2, 3, 4) and BRAF (codon 600) mutations were validated by three referral laboratories and sent to 88 participant centers. Molecular pathology sample reports were also requested to each laboratory. A board of assessors from AIOM and SIAPEC evaluated the results according to a predefined scoring system. The scheme was composed of two rounds. In the first round 36% of the 88 participants failed, with 23 centers having at least one false positive or false negative while 9 centers did not meet the deadline. The genotyping error rate was higher when Sanger sequencing was employed for testing as compared with pyrosequencing (3 vs 1.3%; p = 0.01; Pearson Chi Square test). In the second round, the laboratories improved their performance, with 23/32 laboratories passing the round. Overall, 79/88 participants passed the RAS EQA scheme. Standardized Human Genome Variation Society nomenclature was incorrectly used to describe the mutations identified and relevant variations were noticed in the genotype specification. The results of the Italian RAS EQA scheme indicate that the mutational analyses are performed with good quality in many Italian centers, although significant differences in the methods used were highlighted. The relatively high number of centers failing the first round underlines the fundamental role in continued education covered by EQA schemes.

  7. The changing face of clinical laboratories.

    PubMed

    Plebani, M

    1999-07-01

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

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

    USGS Publications Warehouse

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

    2001-01-01

    A laboratory for analysis of low-ionic strength water has been developed at the U.S. Geological Survey (USGS) office in Troy, N.Y., to analyze samples collected by USGS projects in the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures developed to ensure proper sample collection, processing, and analysis. The quality-assurance/quality-control data are stored in the laboratory's SAS data-management system, which provides efficient review, compilation, and plotting of quality-assurance/quality-control data. This report presents and discusses samples analyzed from July 1993 through June 1995. Quality-control results for 18 analytical procedures were evaluated for bias and precision. Control charts show that data from seven of the analytical procedures were biased throughout the analysis period for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, dissolved inorganic carbon, dissolved organic carbon (soil expulsions), chloride, magnesium, nitrate (colorimetric method), and pH. Three of the analytical procedures were occasionally biased but were within control limits; they were: calcium (high for high-concentration samples for May 1995), dissolved organic carbon (high for highconcentration samples from January through September 1994), and fluoride (high in samples for April and June 1994). No quality-control sample has been developed for the organic monomeric aluminum procedure. Results from the filter-blank and analytical-blank analyses indicate that all analytical procedures in which blanks were run were within control limits, although values for a few blanks were outside the control limits. Blanks were not analyzed for acid-neutralizing capacity, dissolved inorganic carbon, fluoride, nitrate (colorimetric method), or pH. Sampling and analysis precision are evaluated herein in

  9. Does external evaluation of laboratories improve patient safety?

    PubMed

    Noble, Michael A

    2007-01-01

    Laboratory accreditation and External Quality Assessment (also called proficiency testing) are mainstays of laboratory quality assessment and performance. Both practices are associated with examples of improved laboratory performance. The relationship between laboratory performance and improved patient safety is more difficult to assess because of the many variables that are involved with patient outcome. Despite this difficulty, the argument to continue external evaluation of laboratories is too compelling to consider the alternative.

  10. Translating a National Laboratory Strategic Plan into action through SLMTA in a district hospital laboratory in Botswana.

    PubMed

    Ntshambiwa, Keoratile; Ntabe-Jagwer, Winnie; Kefilwe, Chandapiwa; Samuel, Fredrick; Moyo, Sikhulile

    2014-01-01

    The Ministry of Health (MOH) of Botswana adopted Strengthening Laboratory Management Toward Accreditation (SLMTA), a structured quality improvement programme, as a key tool for the implementation of quality management systems in its public health laboratories. Coupled with focused mentorship, this programme aimed to help MOH achieve the goals of the National Laboratory Strategic Plan to provide quality and timely clinical diagnoses. This article describes the impact of implementing SLMTA in Sekgoma Memorial Hospital Laboratory (SMHL) in Serowe, Botswana. SLMTA implementation in SMHL included trainings, improvement projects, site visits and focused mentorship. To measure progress, audits using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist were conducted at baseline and exit of the programme, with scores corresponding to a zero- to five-star scale. Turnaround times, customer satisfaction, and several other health service indicators were tracked. The laboratory scored 53% (zero stars) at the baseline audit and 80% (three stars) at exit. Nearly three years later, the laboratory scored 85% (four stars) in an official audit conducted by the African Society for Laboratory Medicine. Turnaround times became shorter after SLMTA implementation, with reductions ranging 19% to 52%; overall patient satisfaction increased from 56% to 73%; and clinician satisfaction increased from 41% to 72%. Improvements in inventory management led to decreases in discarded reagents, reducing losses from US $18 000 in 2011 to $40 in 2013. The SLMTA programme contributed to enhanced performance of the laboratory, which in turn yielded potential positive impacts for patient care at the hospital.

  11. Quality knowledge of science through virtual laboratory as an element of visualization

    NASA Astrophysics Data System (ADS)

    Rizman Herga, Natasa

    experiment, carried out over a period of two school years (2012/2013 and 2013/2014) in ten primary schools, the effectiveness of teaching carried out with the support of a virtual laboratory was analyzed. The obtained empirical findings reveal that the use of virtual laboratory has great impact on the pupils' knowledge and interest. At the end of the experiment, pupils in the experimental group had an advantage according to knowledge of chemical contents in science. Also, the use of virtual laboratory had an impact on the sustainability of the acquired knowledge of science contents and pupils' interest at the end of the experiment, because the pupils in the experimental group had a higher interest for learning science contents. The didactic experiment determined, that the use of virtual laboratory enables quality learning and teaching chemical contents of science, because it allows: (1) experimental work as an active learning method, (2) the visualization of abstract concepts and phenomena, (3) dynamic sub micro presentations (4) integration of all three levels of the chemical concept as a whole and (5) positively impacts pupils' interest, knowledge and sustainability of the acquired knowledge.

  12. The RCP Information Laboratory (iLab): breaking the cycle of poor data quality.

    PubMed

    Croft, Giles P; Williams, John G

    2005-01-01

    A review of data quality in the NHS by the Audit Commission cited a lack of clinician involvement in the validation and use of centrally held activity data as one of the key issues to resolve. The perception that hospital episode statistics cannot support the needs of the individual clinician results in mistrust and disinterest. This in turn leads to under-development of such data from a clinical perspective, and the cycle continues. The RCP Information Laboratory (iLab) aims to address this problem by accessing, analysing and presenting information from these central repositories concerning the activity of visiting individual consultant physicians. With support from iLab staff--an information analyst and a clinician--local data quality issues are highlighted and local solutions sought. The information obtained can be used as an objective measure of activity to support the processes of appraisal and revalidation.

  13. The Case for Laboratory Developed Procedures

    PubMed Central

    Sabatini, Linda M.; Tsongalis, Gregory J.; Caliendo, Angela M.; Olsen, Randall J.; Ashwood, Edward R.; Bale, Sherri; Benirschke, Robert; Carlow, Dean; Funke, Birgit H.; Grody, Wayne W.; Hayden, Randall T.; Hegde, Madhuri; Lyon, Elaine; Pessin, Melissa; Press, Richard D.; Thomson, Richard B.

    2017-01-01

    An explosion of knowledge and technology is revolutionizing medicine and patient care. Novel testing must be brought to the clinic with safety and accuracy, but also in a timely and cost-effective manner, so that patients can benefit and laboratories can offer testing consistent with current guidelines. Under the oversight provided by the Clinical Laboratory Improvement Amendments, laboratories have been able to develop and optimize laboratory procedures for use in-house. Quality improvement programs, interlaboratory comparisons, and the ability of laboratories to adjust assays as needed to improve results, utilize new sample types, or incorporate new mutations, information, or technologies are positive aspects of Clinical Laboratory Improvement Amendments oversight of laboratory-developed procedures. Laboratories have a long history of successful service to patients operating under Clinical Laboratory Improvement Amendments. A series of detailed clinical examples illustrating the quality and positive impact of laboratory-developed procedures on patient care is provided. These examples also demonstrate how Clinical Laboratory Improvement Amendments oversight ensures accurate, reliable, and reproducible testing in clinical laboratories. PMID:28815200

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

    PubMed

    Zenina, L P; Godkov, M A

    2013-08-01

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

  15. Measurement of IgE antibodies using liquid allergens--an inter-method and inter-laboratory quality assessment.

    PubMed

    Aberer, Werner; Kränke, Birger

    2002-11-30

    The determination of IgE antibodies is important for the in vitro diagnosis of allergic diseases. However, not all systems currently available in the market fulfill essential quality criteria, e.g. regarding characteristics such as sensitivity and specificity, and the data do not always reflect true clinical relevance in the required fashion. Recent innovations may reduce the workload for the technician, and thus help save time and money. More importantly, they might reduce potential sources of error. Two allergy systems, the well established Pharmacia CAP system that uses the allergens conventionally in a solid phase and the ALLERgen system that employs liquid allergens, were compared with regard to quality criteria and practicability. Defined serum pools were checked for within-run and between-days imprecision of IgE antibody detection in two independent laboratories. Serum specimens from allergic patients and controls were tested in parallel using both methods for total and antigen-specific IgE antibody detection under standardized conditions. In addition, one laboratory working exclusively with the ALLERgen system participated in the Austrian inter-laboratory quality assessment program. The two systems were comparable in terms of sensitivity and specificity, and also showed good correlation. Within-run evaluations were excellent for total IgE and antigen-specific IgE, and the between-days imprecision was satisfactory. Coefficients of variation were within an acceptable range for the different groups of allergens. In the external quality control program the data obtained with the ALLERgen system showed good concordance with other systems in use; up to 94% of the results were identical when considering clinically relevant sensitizations. Regarding practicability, both systems were most satisfactory for the operator. The ALLERgen system offered a certain advantage in terms of automated operation, which resulted in shorter fixed and variable phases of personnel

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

    PubMed Central

    Osaro, Erhabor; Chima, Njemanze

    2014-01-01

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

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

    PubMed

    Osaro, Erhabor; Chima, Njemanze

    2014-06-01

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

  18. Improving quality management systems of laboratories in developing countries: an innovative training approach to accelerate laboratory accreditation.

    PubMed

    Yao, Katy; McKinney, Barbara; Murphy, Anna; Rotz, Phil; Wafula, Winnie; Sendagire, Hakim; Okui, Scolastica; Nkengasong, John N

    2010-09-01

    The Strengthening Laboratory Management Toward Accreditation (SLMTA) program was developed to promote immediate, measurable improvement in laboratories of developing countries. The laboratory management framework, a tool that prescribes managerial job tasks, forms the basis of the hands-on, activity-based curriculum. SLMTA is implemented through multiple workshops with intervening site visits to support improvement projects. To evaluate the effectiveness of SLMTA, the laboratory accreditation checklist was developed and subsequently adopted by the World Health Organization Regional Office for Africa (WHO AFRO). The SLMTA program and the implementation model were validated through a pilot in Uganda. SLMTA yielded observable, measurable results in the laboratories and improved patient flow and turnaround time in a laboratory simulation. The laboratory staff members were empowered to improve their own laboratories by using existing resources, communicate with clinicians and hospital administrators, and advocate for system strengthening. The SLMTA program supports laboratories by improving management and building preparedness for accreditation.

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

    PubMed

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

    2017-08-28

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

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

    PubMed

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

    2015-01-01

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

  1. Safety in the Chemical Laboratory: Laboratory Air Quality: Part II. Measurements of Ventilation Rates.

    ERIC Educational Resources Information Center

    Butcher, Samuel S.; And Others

    1985-01-01

    Part I of this paper (SE 538 295) described a simple model for estimating laboratory concentrations of gas phase pollutants. In this part, the measurement of ventilation rates and applications of the model are discussed. The model can provide a useful starting point in planning for safer instructional laboratories. (JN)

  2. Education and Research Laboratories as a Means of Enhancing the Quality of Professional Engineering Education in Design and Production of Composite Parts

    ERIC Educational Resources Information Center

    Khaliulin, Valentin I.; Gershtein, Elena M.

    2016-01-01

    Relevance of this research is determined by quality improvement of professional engineering education. The purpose of this paper is to offer practical recommendations for those interested in establishment of education and research laboratories as a means of enhancing the quality of professional engineering education in design and production of…

  3. Strengthening laboratory systems in resource-limited settings.

    PubMed

    Olmsted, Stuart S; Moore, Melinda; Meili, Robin C; Duber, Herbert C; Wasserman, Jeffrey; Sama, Preethi; Mundell, Ben; Hilborne, Lee H

    2010-09-01

    Considerable resources have been invested in recent years to improve laboratory systems in resource-limited settings. We reviewed published reports, interviewed major donor organizations, and conducted case studies of laboratory systems in 3 countries to assess how countries and donors have worked together to improve laboratory services. While infrastructure and the provision of services have seen improvement, important opportunities remain for further advancement. Implementation of national laboratory plans is inconsistent, human resources are limited, and quality laboratory services rarely extend to lower tier laboratories (eg, health clinics, district hospitals). Coordination within, between, and among governments and donor organizations is also frequently problematic. Laboratory standardization and quality control are improving but remain challenging, making accreditation a difficult goal. Host country governments and their external funding partners should coordinate their efforts effectively around a host country's own national laboratory plan to advance sustainable capacity development throughout a country's laboratory system.

  4. Development of the Global Measles Laboratory Network.

    PubMed

    Featherstone, David; Brown, David; Sanders, Ray

    2003-05-15

    The routine reporting of suspected measles cases and laboratory testing of samples from these cases is the backbone of measles surveillance. The Global Measles Laboratory Network (GMLN) has developed standards for laboratory confirmation of measles and provides training resources for staff of network laboratories, reference materials and expertise for the development and quality control of testing procedures, and accurate information for the Measles Mortality Reduction and Regional Elimination Initiative. The GMLN was developed along the lines of the successful Global Polio Laboratory Network, and much of the polio laboratory infrastructure was utilized for measles. The GMLN has developed as countries focus on measles control activities following successful eradication of polio. Currently more than 100 laboratories are part of the global network and follow standardized testing and reporting procedures. A comprehensive laboratory accreditation process will be introduced in 2002 with six quality assurance and performance indicators.

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

    PubMed

    Ueno, Tamio; Matuda, Junichi; Yamane, Nobuhisa

    2013-03-01

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

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

    PubMed

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

    2003-01-01

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

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

    PubMed

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

    2015-03-01

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

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

    PubMed

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

    2017-06-01

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

  9. The Status of Secondary School Science Laboratory Activities for Quality Education in Case of Wolaita Zone, Southern Ethiopia

    ERIC Educational Resources Information Center

    Zengele, Ashebir Gogile; Alemayehu, Bereket

    2016-01-01

    A high quality science education in primary and secondary schools contributes to developing scientific literacy and would be expected to predispose students to study the enabling sciences at university. The major purpose of this study was to assess the practice and problems in science laboratory activities in the secondary school of Wolaita Zone,…

  10. An inter-laboratory comparison study of image quality of PET scanners using the NEMA NU 2-2001 procedure for assessment of image quality

    NASA Astrophysics Data System (ADS)

    Bergmann, Helmar; Dobrozemsky, Georg; Minear, Gregory; Nicoletti, Rudolf; Samal, Martin

    2005-05-01

    An inter-laboratory comparison study was conducted to assess the image quality of PET scanners in Austria. The survey included both dedicated PET scanners (D-PET, n = 8) and coincidence cameras (GC-PET, n = 7). Measurement of image quality was based on the NEMA (National Electrical Manufacturers Association) NU 2-2001 protocol and the IEC (International Electrotechnical Commission) body phantom. The latter contains six fillable spheres ranging in diameter from 37 mm down to 10 mm and a 'lung' insert. The two largest lesions L1-2 simulate cold lesions, the four smaller ones (L3-6) are filled with 18F and activity concentration ratios relative to background of 8:1 and 4:1, respectively. Acquisition and reconstruction in the study employed the participating institutes' standard oncological processing protocol. Calculation of contrast of the spheres was performed with a fully automated procedure. Contrast quality indices (CQIs) reflecting global performance were obtained by summing individual contrast values. Other image quality parameters calculated according to the NEMA protocol were background variability and relative error for correction of attenuation and scatter. Contrast values obtained were 61 ± 16 and 37 ± 14 for L1 (per cent contrast ± SD for D-PET and GC-PET, respectively), 57 ± 16 and 29 ± 16 for L2, 46 ± 10 and 26 ± 6.3 for L3, 37 ± 10 and 15 ± 4.3 for L4, 26 ± 11.5 and 6.1 ± 2.5 for L5, 14 ± 7.1 and 2.6 ± 2.6 for L6, with D-PET systems consistently being superior to GC-PET systems. CQIs permitted ranking of the scanners, also demonstrating a clear distinction between D-PET and GC-PET systems. Background variability was largest for GC-PET systems; the relative error of attenuation and scatter correction was significantly correlated with image quality for D-PET systems only. The study demonstrated considerable differences in image quality not only between GC-PET and D-PET systems but also between individual D-PET systems with possible

  11. Quality-Assurance/Quality-Control Manual for Collection and Analysis of Water-Quality Data in the Ohio District, US Geological Survey

    USGS Publications Warehouse

    Francy, D.S.; Jones, A.L.; Myers, Donna N.; Rowe, G.L.; Eberle, Michael; Sarver, K.M.

    1998-01-01

    The U.S. Geological Survey (USGS), Water Resources Division (WRD), requires that quality-assurance/quality-control (QA/QC) activities be included in any sampling and analysis program. Operational QA/QC procedures address local needs while incorporating national policies. Therefore, specific technical policies were established for all activities associated with water-quality project being done by the Ohio District. The policies described in this report provide Ohio District personnel, cooperating agencies, and others with a reference manual on QA/QC procedures that are followed in collecitng and analyzing water-quality samples and reporting water-quality information in the Ohio District. The project chief, project support staff, District Water-Quality Specialist, and District Laboratory Coordinator are all involved in planning and implementing QA/QC activities at the district level. The District Chief and other district-level managers provide oversight, and the Regional Water-Quality Specialist, Office of Water Quality (USGS headquarters), and the Branch of Quality Systems within the Office of Water Quality create national QA/QC polices and provide assistance to District personnel. In the literature, the quality of all measurement data is expressed in terms of precision, variability, bias, accuracy, completeness, representativeness, and comparability. In the Ohio District, bias and variability will be used to describe quality-control data generated from samples in the field and laboratory. Each project chief must plan for implementation and financing of QA/QC activities necessary to achieve data-quality objectives. At least 15 percent of the total project effort must be directed toward QA/QC activities. Of this total, 5-10 percent will be used for collection and analysis of quality-control samples. This is an absolute minimum, and more may be required based on project objectives. Proper techniques must be followed in the collection and processing of surface

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

    PubMed

    Guillot, Sophie; Guiso, Nicole

    2016-08-01

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

  13. 42 CFR 493.1230 - Condition: General laboratory systems.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: General laboratory systems. 493.1230... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1230 Condition: General laboratory systems. Each laboratory that...

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

    PubMed

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

    2007-10-28

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

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

    PubMed Central

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

    2007-01-01

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

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

    PubMed

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

    2017-08-01

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

  17. Harmonization of good laboratory practice requirements and laboratory accreditation programs.

    PubMed

    Royal, P D

    1994-09-01

    Efforts to harmonize Good Laboratory Practice (GLP) requirements have been underway through the Organization for Economic Cooperation and Development (OECD) since 1981. In 1985, a GLP panel was established to facilitate the practical implementation of the OECD/GLP program. Through the OECD/GLP program, Memoranda of Understanding (MOU) agreements which foster requirements for reciprocal data and study acceptance and unified GLP standards have been developed among member countries. Three OECD Consensus Workshops and three inspectors training workshops have been held. In concert with these efforts, several OECD countries have developed GLP accreditation programs, managed by local health and environmental ministries. In addition, Canada and the United States are investigating Laboratory Accreditation programs for environmental monitoring assessment and GLP-regulated studies. In the European Community (EC), the need for quality standards specifying requirements for production and international trade has promoted International Standards Organization (ISO) certification for certain products. ISO-9000 standards identify requirements for certification of quality systems. These certification programs may affect the trade and market of laboratories conducting GLP studies. Two goals identified by these efforts are common to both programs: first, harmonization and recognition of requirements, and second, confidence in the rigor of program components used to assess the integrity of data produced and study activities. This confidence can be promoted, in part, through laboratory inspection and screening processes. However, the question remains, will data produced by sanctioned laboratories be mutually accepted on an international basis?(ABSTRACT TRUNCATED AT 250 WORDS)

  18. Improving patient safety through quality assurance.

    PubMed

    Raab, Stephen S

    2006-05-01

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

  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 test...

  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 test...

  1. 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 test...

  2. Data Quality Objectives Supporting Radiological Air Emissions Monitoring for the Marine Sciences Laboratory, Sequim Site

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

    Barnett, J. Matthew; Meier, Kirsten M.; Snyder, Sandra F.

    2012-12-27

    This document of Data Quality Objectives (DQOs) was prepared based on the U.S. Environmental Protection Agency (EPA) Guidance on Systematic Planning Using the Data Quality Objectives Process, EPA, QA/G4, 2/2006 (EPA 2006), as well as several other published DQOs. The intent of this report is to determine the necessary steps required to ensure that radioactive emissions to the air from the Marine Sciences Laboratory (MSL) headquartered at the Pacific Northwest National Laboratory’s Sequim Marine Research Operations (Sequim Site) on Washington State’s Olympic Peninsula are managed in accordance with regulatory requirements and best practices. The Sequim Site was transitioned in Octobermore » 2012 from private operation under Battelle Memorial Institute to an exclusive use contract with the U.S. Department of Energy, Office of Science, Pacific Northwest Site Office.« less

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

    NASA Technical Reports Server (NTRS)

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

    2000-01-01

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

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

    PubMed

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

    2013-10-01

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

  5. Inter-laboratory comparison measurements of radiochemical laboratories in Slovakia.

    PubMed

    Meresová, J; Belanová, A; Vrsková, M

    2010-01-01

    The first inter-laboratory comparison organized by the radiochemistry laboratory of Water Research Institute (WRI) in Bratislava was carried out in 1993 and since then is it realized on an annual basis and about 10 radiochemical laboratories from all over Slovakia are participating. The gross alpha and gross beta activities, and the activity concentrations of (222)Rn, tritium, and (226)Ra, and U(nat) concentration in synthetic water samples are compared. The distributed samples are covering the concentration range prevailing in potable and surface waters and are prepared by dilution of certified reference materials. Over the course of the years 1993-2008, we observed the improvement in the quality of results for most of the laboratories. However, the success rate of the gross alpha determination activity is not improving as much as the other parameters. Copyright 2009 Elsevier Ltd. All rights reserved.

  6. LEGO plot for simultaneous application of multiple quality requirements during trueness verification of quantitative laboratory tests.

    PubMed

    Park, Hae-il; Chae, Hyojin; Kim, Myungshin; Lee, Jehoon; Kim, Yonggoo

    2014-03-01

    We developed a two-dimensional plot for viewing trueness that takes into account potential shift and variable quality requirements to verify trueness using certified reference material (CRM). Glucose, total cholesterol (TC), and creatinine levels were determined by two kinds of assay in two levels of a CRM. Available quality requirements were collected, codified, and sorted in an ascending order in the plot's header row. Centering on the mean of measured values from CRM, the "mean ± US CLIA '88 allowable total error" was located in the header of the leftmost and rightmost columns. Twenty points were created in intervening columns as potential shifts. Uncertainties were calculated according to regression between certified values and uncertainties of CRM, and positioned in the corresponding columns. Cells were assigned different colors where column and row intersected based on comparison of the 95% confidence interval of the percentage bias with each quality requirement. A glucose assay failed to meet the highest quality criteria, for which shift of +0.13-0.14 mmol/l was required. A TC assay met the quality requirement and a shift of ±0.03 mmol/l was tolerable. A creatinine assay also met the quality requirement but any shift was not tolerable. The plot provides a systematic view of the trueness of quantitative laboratory tests. © 2014 Wiley Periodicals, Inc.

  7. [Accreditation of medical laboratories].

    PubMed

    Horváth, Andrea Rita; Ring, Rózsa; Fehér, Miklós; Mikó, Tivadar

    2003-07-27

    official acceptance of ISO 15189 the clauses of this harmonized guideline fulfill the requirements of the new international standard as well. Accreditation of medical laboratories in Hungary may not only facilitate quality improvement of laboratory services, but also the development of a quality-based purchasing and reimbursement policy of the health insurance fund.

  8. Data Quality Objectives Supporting the Environmental Soil Monitoring Program for the Idaho National Laboratory Site

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

    Haney, Thomas Jay

    This document describes the process used to develop data quality objectives for the Idaho National Laboratory (INL) Environmental Soil Monitoring Program in accordance with U.S. Environmental Protection Agency guidance. This document also develops and presents the logic that was used to determine the specific number of soil monitoring locations at the INL Site, at locations bordering the INL Site, and at locations in the surrounding regional area. The monitoring location logic follows the guidance from the U.S. Department of Energy for environmental surveillance of its facilities.

  9. Mozambique's journey toward accreditation of the National Tuberculosis Reference Laboratory.

    PubMed

    Viegas, Sofia O; Azam, Khalide; Madeira, Carla; Aguiar, Carmen; Dolores, Carolina; Mandlaze, Ana P; Chongo, Patrina; Masamha, Jessina; Cirillo, Daniela M; Jani, Ilesh V; Gudo, Eduardo S

    2017-01-01

    Internationally-accredited laboratories are recognised for their superior test reliability, operational performance, quality management and competence. In a bid to meet international quality standards, the Mozambique National Institute of Health enrolled the National Tuberculosis Reference Laboratory (NTRL) in a continuous quality improvement process towards ISO 15189 accreditation. Here, we describe the road map taken by the NTRL to achieve international accreditation. The NTRL adopted the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme as a strategy to implement a quality management system. After SLMTA, the Mozambique National Institute of Health committed to accelerate the NTRL's process toward accreditation. An action plan was designed to streamline the process. Quality indicators were defined to benchmark progress. Staff were trained to improve performance. Mentorship from an experienced assessor was provided. Fulfilment of accreditation standards was assessed by the Portuguese Accreditation Board. Of the eight laboratories participating in SLMTA, the NTRL was the best-performing laboratory, achieving a 53.6% improvement over the SLMTA baseline conducted in February 2011 to the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) assessment in June 2013. During the accreditation assessment in September 2014, 25 minor nonconformities were identified and addressed. In March 2015, the NTRL received Portuguese Accreditation Board recognition of technical competency for fluorescence smear microscopy, and solid and liquid culture. The NTRL is the first laboratory in Mozambique to achieve ISO 15189 accreditation. From our experience, accreditation was made possible by institutional commitment, strong laboratory leadership, staff motivation, adequate infrastructure and a comprehensive action plan.

  10. 'By the work, one knows the workman': the practice and profession of the embryologist and its translation to quality in the embryology laboratory.

    PubMed

    Go, Kathryn J

    2015-10-01

    The embryologist presides over the fulfillment of a patient's treatment in the laboratory for IVF through use of assisted reproduction techniques, and is in a unique position to impart quality to the process. Although the technical skill of the embryologist is critical, the embryologist's contribution to quality is equally conveyed through a knowledge of reproductive biology, keen observation and judgment, astute decision-making, the 'grit' to work under pressure and time constraints, and a sense of mission in the provision and continual development of a safe and effective laboratory. The embryologist also ensures that the laboratory complies with the regulations of federal, state, local and institutional authorities and the recommendations and guidelines of professional associations. In these roles, the embryologist assumes unique responsibilities counterbalanced by the unique rewards of assisting patients in having a family. This article aspires to illuminate this singular profession for those who may be contemplating a career in embryology and act as a resource for those who seek insight into this amalgam of basic science, technical proficiency, and managerial skill and acumen that characterize the practice of clinical embryology and the myriad of ways that practitioners contribute to the quality of assisted reproduction techniques and patient care. Copyright © 2015 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

  11. Routine internal- and external-quality control data in clinical laboratories for estimating measurement and diagnostic uncertainty using GUM principles.

    PubMed

    Magnusson, Bertil; Ossowicki, Haakan; Rienitz, Olaf; Theodorsson, Elvar

    2012-05-01

    Healthcare laboratories are increasingly joining into larger laboratory organizations encompassing several physical laboratories. This caters for important new opportunities for re-defining the concept of a 'laboratory' to encompass all laboratories and measurement methods measuring the same measurand for a population of patients. In order to make measurement results, comparable bias should be minimized or eliminated and measurement uncertainty properly evaluated for all methods used for a particular patient population. The measurement as well as diagnostic uncertainty can be evaluated from internal and external quality control results using GUM principles. In this paper the uncertainty evaluations are described in detail using only two main components, within-laboratory reproducibility and uncertainty of the bias component according to a Nordtest guideline. The evaluation is exemplified for the determination of creatinine in serum for a conglomerate of laboratories both expressed in absolute units (μmol/L) and relative (%). An expanded measurement uncertainty of 12 μmol/L associated with concentrations of creatinine below 120 μmol/L and of 10% associated with concentrations above 120 μmol/L was estimated. The diagnostic uncertainty encompasses both measurement uncertainty and biological variation, and can be estimated for a single value and for a difference. This diagnostic uncertainty for the difference for two samples from the same patient was determined to be 14 μmol/L associated with concentrations of creatinine below 100 μmol/L and 14 % associated with concentrations above 100 μmol/L.

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

    USGS Publications Warehouse

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

    2009-01-01

    The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's Lab Master data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality control samples analyzed from July 2005 through June 2007. Results for the quality-control samples for 19 analytical procedures were evaluated for bias and precision. Control charts indicate that data for eight of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: total aluminum, calcium, magnesium, nitrate (colorimetric method), potassium, silicon, sodium, and sulfate. Eight of the analytical procedures were biased throughout the analysis period for the high-concentration sample, but were within control limits; these procedures were: total aluminum, calcium, dissolved organic carbon, chloride, nitrate (ion chromatograph), potassium, silicon, and sulfate. The magnesium and pH procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The acid-neutralizing capacity, total monomeric aluminum, nitrite, and specific conductance procedures were biased for the high-concentration and low-concentration samples, but were within control limits. Results from the filter-blank and analytical-blank analyses indicated that the procedures for 16 of 17 analytes were within control limits, although the concentrations for blanks were

  13. Building laboratory capacity to support HIV care in Nigeria: Harvard/APIN PEPFAR, 2004-2012.

    PubMed

    Hamel, Donald J; Sankalé, Jean-Louis; Samuels, Jay Osi; Sarr, Abdoulaye D; Chaplin, Beth; Ofuche, Eke; Meloni, Seema T; Okonkwo, Prosper; Kanki, Phyllis J

    From 2004-2012, the Harvard/AIDS Prevention Initiative in Nigeria, funded through the US President's Emergency Plan for AIDS Relief programme, scaled up HIV care and treatment services in Nigeria. We describe the methodologies and collaborative processes developed to improve laboratory capacity significantly in a resource-limited setting. These methods were implemented at 35 clinic and laboratory locations. Systems were established and modified to optimise numerous laboratory processes. These included strategies for clinic selection and management, equipment and reagent procurement, supply chains, laboratory renovations, equipment maintenance, electronic data management, quality development programmes and trainings. Over the eight-year programme, laboratories supported 160 000 patients receiving HIV care in Nigeria, delivering over 2.5 million test results, including regular viral load quantitation. External quality assurance systems were established for CD4+ cell count enumeration, blood chemistries and viral load monitoring. Laboratory equipment platforms were improved and standardised and use of point-of-care analysers was expanded. Laboratory training workshops supported laboratories toward increasing staff skills and improving overall quality. Participation in a World Health Organisation-led African laboratory quality improvement system resulted in significant gains in quality measures at five laboratories. Targeted implementation of laboratory development processes, during simultaneous scale-up of HIV treatment programmes in a resource-limited setting, can elicit meaningful gains in laboratory quality and capacity. Systems to improve the physical laboratory environment, develop laboratory staff, create improvements to reduce costs and increase quality are available for future health and laboratory strengthening programmes. We hope that the strategies employed may inform and encourage the development of other laboratories in resource-limited settings.

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

    PubMed

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

    2015-12-01

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

  15. Savannah River Laboratory quality assurance manual. Revision 2

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

    Not Available

    1985-02-01

    The SRL quality assurance program is a management activity that verifies that the results of our research and development are adequate for their intended use and that our facilities function properly. The program is based on Savannah River Quality Assurance Plan (DPW-82-111-2, Rev 0) as applied through Quality Assurance Procedures and Divisional Plans (following section). The AED policy states that ''all activities shall be conducted to achieve a high quality of product and performance...'' The policy contains 18 considerations to be applied ''proportional to needs, based on the technical and professional judgment of responsible Du Pont employees.'' Quality is themore » responsibility of each individual and his line organization, as is safety. To ensure that quality is being considered for all SRL activities, all research programs are reviewed, and all facilities are assessed. These assessments and reviews are the nucleus of the Quality Assurance program.« less

  16. The Tanzania experience: clinical laboratory testing harmonization and equipment standardization at different levels of a tiered health laboratory system.

    PubMed

    Massambu, Charles; Mwangi, Christina

    2009-06-01

    The rapid scale-up of the care and treatment programs in Tanzania during the preceding 4 years has greatly increased the demand for quality laboratory services for diagnosis of HIV and monitoring patients during antiretroviral therapy. Laboratory services were not in a position to cope with this demand owing to poor infrastructure, lack of human resources, erratic and/or lack of reagent supply and commodities, and slow manual technologies. With the limited human resources in the laboratory and the need for scaling up the care and treatment program, it became necessary to install automated equipment and train personnel for the increased volume of testing and new tests across all laboratory levels. With the numerous partners procuring equipment, the possibility of a multitude of equipment platforms with attendant challenges for procurement of reagents, maintenance of equipment, and quality assurance arose. Tanzania, therefore, had to harmonize laboratory tests and standardize laboratory equipment at different levels of the laboratory network. The process of harmonization of tests and standardization of equipment included assessment of laboratories, review of guidelines, development of a national laboratory operational plan, and stakeholder advocacy. This document outlines this process.

  17. Hydrogeologic and water-quality data for the main site, Naval Surface Warfare Center, Dahlgren Laboratory, Dahlgren, Virginia

    USGS Publications Warehouse

    Bell, Clifton F.; Bolles, Thomas P.; Harlow, George E.

    1994-01-01

    Hydrogeologic and water-quality data were collected at the Naval Surface Warfare Center, Dahlgren Laboratory at Dahlgren, Virginia, as part of a hydrogeologic assessment of the shallow aquifer system begun in 1992. The U.S. Geological Survey conducted this study to provide the Navy with hydrogeologic data to meet the requirements of a Spill Contingency Plan. This report describes the ground-water observation-well network, hydro- geologic, and water-quality data collected between August 1992 and September 1993. The report includes a description of the locations and con- struction of 35 observation wells on the Main Site. Hydrologic data include lithologic core samples, geophysical logs, and vertical hydraulic conductivity measurements of selected core intervals. Hydrologic data include synoptic and hourly measurements of ground-water levels, observation-well slug tests to determine horizontal hydraulic conductivity, and tide data. Water-quality data include analyses of major dissolved constituents in ground water and surface water.

  18. Development of a laboratory prototype water quality monitoring system suitable for use in zero gravity

    NASA Technical Reports Server (NTRS)

    Misselhorn, J. E.; Witz, S.; Hartung, W. H.

    1973-01-01

    The development of a laboratory prototype water quality monitoring system for use in the evaluation of candidate water recovery systems and for study of techniques for measuring potability parameters is reported. Sensing techniques for monitoring of the most desirable parameters are reviewed in terms of their sensitivities and complexities, and their recommendations for sensing techniques are presented. Rationale for selection of those parameters to be monitored (pH, specific conductivity, Cr(+6), I2, total carbon, and bacteria) in a next generation water monitor is presented along with an estimate of flight system specifications. A master water monitor development schedule is included.

  19. Data Validation & Laboratory Quality Assurance for Region 9

    EPA Pesticide Factsheets

    In all hazardous site investigations it is essential to know the quality of the data used for decision-making purposes. Validation of data requires that appropriate quality assurance and quality control (QA/QC) procedures be followed.

  20. Valid methods: the quality assurance of test method development, validation, approval, and transfer for veterinary testing laboratories.

    PubMed

    Wiegers, Ann L

    2003-07-01

    Third-party accreditation is a valuable tool to demonstrate a laboratory's competence to conduct testing. Accreditation, internationally and in the United States, has been discussed previously. However, accreditation is only I part of establishing data credibility. A validated test method is the first component of a valid measurement system. Validation is defined as confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. The international and national standard ISO/IEC 17025 recognizes the importance of validated methods and requires that laboratory-developed methods or methods adopted by the laboratory be appropriate for the intended use. Validated methods are therefore required and their use agreed to by the client (i.e., end users of the test results such as veterinarians, animal health programs, and owners). ISO/IEC 17025 also requires that the introduction of methods developed by the laboratory for its own use be a planned activity conducted by qualified personnel with adequate resources. This article discusses considerations and recommendations for the conduct of veterinary diagnostic test method development, validation, evaluation, approval, and transfer to the user laboratory in the ISO/IEC 17025 environment. These recommendations are based on those of nationally and internationally accepted standards and guidelines, as well as those of reputable and experienced technical bodies. They are also based on the author's experience in the evaluation of method development and transfer projects, validation data, and the implementation of quality management systems in the area of method development.

  1. Benchmarking and the laboratory

    PubMed Central

    Galloway, M; Nadin, L

    2001-01-01

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

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

    PubMed

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

    2018-04-25

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

  3. Application of sigma metrics for the assessment of quality control in clinical chemistry laboratory in Ghana: A pilot study.

    PubMed

    Afrifa, Justice; Gyekye, Seth A; Owiredu, William K B A; Ephraim, Richard K D; Essien-Baidoo, Samuel; Amoah, Samuel; Simpong, David L; Arthur, Aaron R

    2015-01-01

    Sigma metrics provide a uniquely defined scale with which we can assess the performance of a laboratory. The objective of this study was to assess the internal quality control (QC) in the clinical chemistry laboratory of the University of Cape Cost Hospital (UCC) using the six sigma metrics application. We used commercial control serum [normal (L1) and pathological (L2)] for validation of quality control. Metabolites (glucose, urea, and creatinine), lipids [triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C)], enzymes [alkaline phosphatase (ALP), alanine aminotransferase (AST)], electrolytes (sodium, potassium, chloride) and total protein were assessed. Between-day imprecision (CVs), inaccuracy (Bias) and sigma values were calculated for each control level. Apart from sodium (2.40%, 3.83%), chloride (2.52% and 2.51%) for both L1 and L2 respectively, and glucose (4.82%), cholesterol (4.86%) for L2, CVs for all other parameters (both L1 and L2) were >5%. Four parameters (HDL-C, urea, creatinine and potassium) achieved sigma levels >1 for both controls. Chloride and sodium achieved sigma levels >1 for L1 but <1 for L2. In contrast, cholesterol, total protein and AST achieved sigma levels <1 for L1 but >1 for L2. Glucose and ALP achieved a sigma level >1 for both control levels whereas TG achieved a sigma level >2 for both control levels. Unsatisfactory sigma levels (<3) where achieved for all parameters using both control levels, this shows instability and low consistency of results. There is the need for detailed assessment of the analytical procedures and the strengthening of the laboratory control systems in order to achieve effective six sigma levels for the laboratory.

  4. Application of sigma metrics for the assessment of quality control in clinical chemistry laboratory in Ghana: A pilot study

    PubMed Central

    Afrifa, Justice; Gyekye, Seth A.; Owiredu, William K. B. A.; Ephraim, Richard K. D.; Essien-Baidoo, Samuel; Amoah, Samuel; Simpong, David L.; Arthur, Aaron R.

    2015-01-01

    Background: Sigma metrics provide a uniquely defined scale with which we can assess the performance of a laboratory. The objective of this study was to assess the internal quality control (QC) in the clinical chemistry laboratory of the University of Cape Cost Hospital (UCC) using the six sigma metrics application. Materials and Methods: We used commercial control serum [normal (L1) and pathological (L2)] for validation of quality control. Metabolites (glucose, urea, and creatinine), lipids [triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C)], enzymes [alkaline phosphatase (ALP), alanine aminotransferase (AST)], electrolytes (sodium, potassium, chloride) and total protein were assessed. Between-day imprecision (CVs), inaccuracy (Bias) and sigma values were calculated for each control level. Results: Apart from sodium (2.40%, 3.83%), chloride (2.52% and 2.51%) for both L1 and L2 respectively, and glucose (4.82%), cholesterol (4.86%) for L2, CVs for all other parameters (both L1 and L2) were >5%. Four parameters (HDL-C, urea, creatinine and potassium) achieved sigma levels >1 for both controls. Chloride and sodium achieved sigma levels >1 for L1 but <1 for L2. In contrast, cholesterol, total protein and AST achieved sigma levels <1 for L1 but >1 for L2. Glucose and ALP achieved a sigma level >1 for both control levels whereas TG achieved a sigma level >2 for both control levels. Conclusion: Unsatisfactory sigma levels (<3) where achieved for all parameters using both control levels, this shows instability and low consistency of results. There is the need for detailed assessment of the analytical procedures and the strengthening of the laboratory control systems in order to achieve effective six sigma levels for the laboratory. PMID:25657495

  5. Mozambique’s journey toward accreditation of the National Tuberculosis Reference Laboratory

    PubMed Central

    Madeira, Carla; Aguiar, Carmen; Dolores, Carolina; Mandlaze, Ana P.; Chongo, Patrina; Masamha, Jessina

    2017-01-01

    Background Internationally-accredited laboratories are recognised for their superior test reliability, operational performance, quality management and competence. In a bid to meet international quality standards, the Mozambique National Institute of Health enrolled the National Tuberculosis Reference Laboratory (NTRL) in a continuous quality improvement process towards ISO 15189 accreditation. Here, we describe the road map taken by the NTRL to achieve international accreditation. Methods The NTRL adopted the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme as a strategy to implement a quality management system. After SLMTA, the Mozambique National Institute of Health committed to accelerate the NTRL’s process toward accreditation. An action plan was designed to streamline the process. Quality indicators were defined to benchmark progress. Staff were trained to improve performance. Mentorship from an experienced assessor was provided. Fulfilment of accreditation standards was assessed by the Portuguese Accreditation Board. Results Of the eight laboratories participating in SLMTA, the NTRL was the best-performing laboratory, achieving a 53.6% improvement over the SLMTA baseline conducted in February 2011 to the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) assessment in June 2013. During the accreditation assessment in September 2014, 25 minor nonconformities were identified and addressed. In March 2015, the NTRL received Portuguese Accreditation Board recognition of technical competency for fluorescence smear microscopy, and solid and liquid culture. The NTRL is the first laboratory in Mozambique to achieve ISO 15189 accreditation. Conclusions From our experience, accreditation was made possible by institutional commitment, strong laboratory leadership, staff motivation, adequate infrastructure and a comprehensive action plan. PMID:28879162

  6. Horizontal and vertical integration in hospital laboratories and the laboratory information system.

    PubMed

    Friedman, B A; Mitchell, W

    1990-09-01

    An understanding of horizontal and vertical integration and their quasi-integration variants is important for pathologists to formulate a competitive strategy for hospital clinical laboratories. These basic organizational concepts, in turn, are based on the need to establish control over critical laboratory inputs and outputs. The pathologist seeks greater control of mission-critical system inputs and outputs to increase the quality and efficiency of the laboratory operations. The LIS produces horizontal integration of the various hospital laboratories by integrating them vertically. Forward vertical quasi-integration of the laboratories is mediated primarily by the LIS through front-end valued-added features such as reporting of results and creating a long-term on-line test result archive. These features increase the value of the information product of pathology for clinicians and increase the cost of switching to another system. The LIS can also serve as a means for customizing the information product of the laboratories to appeal to new market segments such as hospital administrators.

  7. Use of proficiency test performance to determine clinical laboratory director qualifications.

    PubMed

    Howanitz, P J

    1988-04-01

    Many activities and policies influence laboratory test quality. Proficiency test results are one measure of laboratory quality, and during the past 25 years, five studies have examined the relationship of laboratory director educational requirements to proficiency test results. Data from three studies support the association between director qualifications and quality as measured by proficiency test performance, whereas no relationship was found in the other two studies. Possible reasons for conflicting results include differences in database size and demographics; in addition, proficiency test results may be inappropriate, although widely used, as the sole measure of laboratory director performance.

  8. Building laboratory capacity to support HIV care in Nigeria: Harvard/APIN PEPFAR, 2004–2012

    PubMed Central

    Hamel, Donald J.; Sankalé, Jean-Louis; Samuels, Jay Osi; Sarr, Abdoulaye D.; Chaplin, Beth; Ofuche, Eke; Meloni, Seema T.; Okonkwo, Prosper; Kanki, Phyllis J.

    2015-01-01

    Introduction From 2004–2012, the Harvard/AIDS Prevention Initiative in Nigeria, funded through the US President’s Emergency Plan for AIDS Relief programme, scaled up HIV care and treatment services in Nigeria. We describe the methodologies and collaborative processes developed to improve laboratory capacity significantly in a resource-limited setting. These methods were implemented at 35 clinic and laboratory locations. Methods Systems were established and modified to optimise numerous laboratory processes. These included strategies for clinic selection and management, equipment and reagent procurement, supply chains, laboratory renovations, equipment maintenance, electronic data management, quality development programmes and trainings. Results Over the eight-year programme, laboratories supported 160 000 patients receiving HIV care in Nigeria, delivering over 2.5 million test results, including regular viral load quantitation. External quality assurance systems were established for CD4+ cell count enumeration, blood chemistries and viral load monitoring. Laboratory equipment platforms were improved and standardised and use of point-of-care analysers was expanded. Laboratory training workshops supported laboratories toward increasing staff skills and improving overall quality. Participation in a World Health Organisation-led African laboratory quality improvement system resulted in significant gains in quality measures at five laboratories. Conclusions Targeted implementation of laboratory development processes, during simultaneous scale-up of HIV treatment programmes in a resource-limited setting, can elicit meaningful gains in laboratory quality and capacity. Systems to improve the physical laboratory environment, develop laboratory staff, create improvements to reduce costs and increase quality are available for future health and laboratory strengthening programmes. We hope that the strategies employed may inform and encourage the development of other

  9. To QC or not to QC: the key to a consistent laboratory?

    PubMed

    Lane, Michelle; Mitchell, Megan; Cashman, Kara S; Feil, Deanne; Wakefield, Sarah; Zander-Fox, Deirdre L

    2008-01-01

    A limiting factor in every embryology laboratory is its capacity to grow 'normal' embryos. In human in vitro fertilisation (IVF), there is considerable awareness that the environment of the laboratory itself can alter the quality of the embryos produced and the industry as a whole has moved towards the implementation of auditable quality management systems. Furthermore, in some countries, such as Australia, an established quality management system is mandatory for clinical IVF practice, but such systems are less frequently found in other embryology laboratories. Although the same challenges of supporting consistent and repeatable embryo development are paramount to success in all embryology laboratories, it could be argued that they are more important in a research setting where often the measured outcomes are at an intracellular or molecular level. In the present review, we have outlined the role and importance of quality control and quality assurance systems in any embryo laboratory and have highlighted examples of how simple monitoring can provide consistency and avoid the induction of artefacts, irrespective of the laboratory's purpose, function or species involved.

  10. 7 CFR 75.43 - Laboratory testing.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Laboratory testing. 75.43 Section 75.43 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards... AND CERTIFICATION OF QUALITY OF AGRICULTURAL AND VEGETABLE SEEDS Fees and Charges § 75.43 Laboratory...

  11. 7 CFR 75.43 - Laboratory testing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory testing. 75.43 Section 75.43 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards... AND CERTIFICATION OF QUALITY OF AGRICULTURAL AND VEGETABLE SEEDS Fees and Charges § 75.43 Laboratory...

  12. Laboratory Automation and Middleware.

    PubMed

    Riben, Michael

    2015-06-01

    The practice of surgical pathology is under constant pressure to deliver the highest quality of service, reduce errors, increase throughput, and decrease turnaround time while at the same time dealing with an aging workforce, increasing financial constraints, and economic uncertainty. Although not able to implement total laboratory automation, great progress continues to be made in workstation automation in all areas of the pathology laboratory. This report highlights the benefits and challenges of pathology automation, reviews middleware and its use to facilitate automation, and reviews the progress so far in the anatomic pathology laboratory. Copyright © 2015 Elsevier Inc. All rights reserved.

  13. Cost containment: strategies and responsibilities of the laboratory manager.

    PubMed

    Martin, B G

    1985-12-01

    In these difficult times we must not lose the sense of purpose and the personal drive that makes it possible to achieve excellence. We can be exasperated with reduced funding, burdened with excuses, debilitated with confusion about budgetary cuts, and even be stubborn about alternatives, but we must be serious about excellence and quality. It is natural that during these times we will face those with conflicting views, negative ideas, and erratic long-term goals, but that in itself should rouse us, as professionals, toward the pursuit of quality health care services. With better scheduling of tests and procedure, improved discharge planning, more careful review of the need for patient hospitalization, and a more careful examination of the number, mix, and quality of services furnished during a patient's hospital stay, we, as a health care team, can and will reduce unnecessary utilization of all services. Well-managed laboratories must operate around a return on investment threshold, from which all products, services, and expenditures are ranked. On this basis, management decisions will be made to add to service, reduce service, improve or sustain quality, change technology, or discontinue the business altogether. Given the mandate embodied in the DRG regulations, laboratories have become cost centers. New ideas, new technology, and creative efforts must now be used to improve laboratory productivity while sustaining quality health care services. It is argued philosophically that the DRGs or other major measures to reduce funding adversely affect quality of service. This may be true under the traditional definition of services, but there must be "a new order of things." Today's complex problems indicate that orthodox solutions no longer apply, and in our quest to answer who should pay versus who should receive, and how much is enough, we must ensure quality of all services offered. This new order of doing things could result in far greater savings than has

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

    PubMed

    Ialongo, Cristiano; Bernardini, Sergio

    2018-06-18

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

  15. NASA Glenn's Acoustical Testing Laboratory Awarded Accreditation by the National Voluntary Laboratory Accreditation Program

    NASA Technical Reports Server (NTRS)

    Akers, James C.; Cooper, Beth A.

    2004-01-01

    NASA Glenn Research Center's Acoustical Testing Laboratory (ATL) provides a comprehensive array of acoustical testing services, including sound pressure level, sound intensity level, and sound-power-level testing per International Standards Organization (ISO)1 3744. Since its establishment in September 2000, the ATL has provided acoustic emission testing and noise control services for a variety of customers, particularly microgravity space flight hardware that must meet International Space Station acoustic emission requirements. The ATL consists of a 23- by 27- by 20-ft (height) convertible hemi/anechoic test chamber and a separate sound-attenuating test support enclosure. The ATL employs a personal-computer-based data acquisition system that provides up to 26 channels of simultaneous data acquisition with real-time analysis (ref. 4). Specialized diagnostic tools, including a scanning sound-intensity system, allow the ATL's technical staff to support its clients' aggressive low-noise design efforts to meet the space station's acoustic emission requirement. From its inception, the ATL has pursued the goal of developing a comprehensive ISO 17025-compliant quality program that would incorporate Glenn's existing ISO 9000 quality system policies as well as ATL-specific technical policies and procedures. In March 2003, the ATL quality program was awarded accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP) for sound-power-level testing in accordance with ISO 3744. The NVLAP program is administered by the National Institutes of Standards and Technology (NIST) of the U.S. Department of Commerce and provides third-party accreditation for testing and calibration laboratories. There are currently 24 NVLAP-accredited acoustical testing laboratories in the United States. NVLAP accreditation covering one or more specific testing procedures conducted in accordance with established test standards is awarded upon successful completion of an intensive

  16. Contracting with the Frederick National Laboratory | Frederick National Laboratory for Cancer Research

    Cancer.gov

    Our Acquisitions Directorate supports the national laboratory with high quality products and services to achieve its national mission. In addition to engaging large subcontractors, we are also committed to working with small businesses, minority- and

  17. The total laboratory solution: a new laboratory E-business model based on a vertical laboratory meta-network.

    PubMed

    Friedman, B A

    2001-08-01

    Major forces are now reshaping all businesses on a global basis, including the healthcare and clinical laboratory industries. One of the major forces at work is information technology (IT), which now provides the opportunity to create a new economic and business model for the clinical laboratory industry based on the creation of an integrated vertical meta-network, referred to here as the "total laboratory solution" (TLS). Participants at the most basic level of such a network would include a hospital-based laboratory, a reference laboratory, a laboratory information system/application service provider/laboratory portal vendor, an in vitro diagnostic manufacturer, and a pharmaceutical/biotechnology manufacturer. It is suggested that each of these participants would add value to the network primarily in its area of core competency. Subvariants of such a network have evolved over recent years, but a TLS comprising all or most of these participants does not exist at this time. Although the TLS, enabled by IT and closely akin to the various e-businesses that are now taking shape, offers many advantages from a theoretical perspective over the current laboratory business model, its success will depend largely on (a) market forces, (b) how the collaborative networks are organized and managed, and (c) whether the network can offer healthcare organizations higher quality testing services at lower cost. If the concept is successful, new demands will be placed on hospital-based laboratory professionals to shift the range of professional services that they offer toward clinical consulting, integration of laboratory information from multiple sources, and laboratory information management. These information management and integration tasks can only increase in complexity in the future as new genomic and proteomics testing modalities are developed and come on-line in clinical laboratories.

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

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

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

    1998-10-01

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

  19. Managing laboratory automation

    PubMed Central

    Saboe, Thomas J.

    1995-01-01

    This paper discusses the process of managing automated systems through their life cycles within the quality-control (QC) laboratory environment. The focus is on the process of directing and managing the evolving automation of a laboratory; system examples are given. The author shows how both task and data systems have evolved, and how they interrelate. A BIG picture, or continuum view, is presented and some of the reasons for success or failure of the various examples cited are explored. Finally, some comments on future automation need are discussed. PMID:18925018

  20. Managing laboratory automation.

    PubMed

    Saboe, T J

    1995-01-01

    This paper discusses the process of managing automated systems through their life cycles within the quality-control (QC) laboratory environment. The focus is on the process of directing and managing the evolving automation of a laboratory; system examples are given. The author shows how both task and data systems have evolved, and how they interrelate. A BIG picture, or continuum view, is presented and some of the reasons for success or failure of the various examples cited are explored. Finally, some comments on future automation need are discussed.

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

    USGS Publications Warehouse

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

    2000-01-01

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

  2. Methodology in diagnostic laboratory test research in clinical chemistry and clinical chemistry and laboratory medicine.

    PubMed

    Lumbreras-Lacarra, Blanca; Ramos-Rincón, José Manuel; Hernández-Aguado, Ildefonso

    2004-03-01

    The application of epidemiologic principles to clinical diagnosis has been less developed than in other clinical areas. Knowledge of the main flaws affecting diagnostic laboratory test research is the first step for improving its quality. We assessed the methodologic aspects of articles on laboratory tests. We included articles that estimated indexes of diagnostic accuracy (sensitivity and specificity) and were published in Clinical Chemistry or Clinical Chemistry and Laboratory Medicine in 1996, 2001, and 2002. Clinical Chemistry has paid special attention to this field of research since 1996 by publishing recommendations, checklists, and reviews. Articles were identified through electronic searches in Medline. The strategy combined the Mesh term "sensitivity and specificity" (exploded) with the text words "specificity", "false negative", and "accuracy". We examined adherence to seven methodologic criteria used in the study by Reid et al. (JAMA1995;274:645-51) of papers published in general medical journals. Three observers evaluated each article independently. Seventy-nine articles fulfilled the inclusion criteria. The percentage of studies that satisfied each criterion improved from 1996 to 2002. Substantial improvement was observed in reporting of the statistical uncertainty of indices of diagnostic accuracy, in criteria based on clinical information from the study population (spectrum composition), and in avoidance of workup bias. Analytical reproducibility was reported frequently (68%), whereas information about indeterminate results was rarely provided. The mean number of methodologic criteria satisfied showed a statistically significant increase over the 3 years in Clinical Chemistry but not in Clinical Chemistry and Laboratory Medicine. The methodologic quality of the articles on diagnostic test research published in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine is comparable to the quality observed in the best general medical journals

  3. The Quest for Quality 1964. A Report on School Planning Laboratory Efforts to Encourage Better Planning for Better Schools in 1964.

    ERIC Educational Resources Information Center

    MacConnell, James D.

    The Fourth Annual Report from the School Planning Laboratory discusses the quest for quality and explains how better schools have been planned at the Center through--(1) systems construction, (2) an airborne institute, (3) school planning education, (4) service to visitors, (5) community college planning, (6) direct assistance, and (7) continued…

  4. Seven Q-Tracks monitors of laboratory quality drive general performance improvement: experience from the College of American Pathologists Q-Tracks program 1999-2011.

    PubMed

    Meier, Frederick A; Souers, Rhona J; Howanitz, Peter J; Tworek, Joseph A; Perrotta, Peter L; Nakhleh, Raouf E; Karcher, Donald S; Bashleben, Christine; Darcy, Teresa P; Schifman, Ron B; Jones, Bruce A

    2015-06-01

    Many production systems employ standardized statistical monitors that measure defect rates and cycle times, as indices of performance quality. Clinical laboratory testing, a system that produces test results, is amenable to such monitoring. To demonstrate patterns in clinical laboratory testing defect rates and cycle time using 7 College of American Pathologists Q-Tracks program monitors. Subscribers measured monthly rates of outpatient order-entry errors, identification band defects, and specimen rejections; median troponin order-to-report cycle times and rates of STAT test receipt-to-report turnaround time outliers; and critical values reporting event defects, and corrected reports. From these submissions Q-Tracks program staff produced quarterly and annual reports. These charted each subscriber's performance relative to other participating laboratories and aggregate and subgroup performance over time, dividing participants into best and median performers and performers with the most room to improve. Each monitor's patterns of change present percentile distributions of subscribers' performance in relation to monitoring durations and numbers of participating subscribers. Changes over time in defect frequencies and the cycle duration quantify effects on performance of monitor participation. All monitors showed significant decreases in defect rates as the 7 monitors ran variously for 6, 6, 7, 11, 12, 13, and 13 years. The most striking decreases occurred among performers who initially had the most room to improve and among subscribers who participated the longest. All 7 monitors registered significant improvement. Participation effects improved between 0.85% and 5.1% per quarter of participation. Using statistical quality measures, collecting data monthly, and receiving reports quarterly and yearly, subscribers to a comparative monitoring program documented significant decreases in defect rates and shortening of a cycle time for 6 to 13 years in all 7 ongoing

  5. Status, quality and specific needs of Zika virus (ZIKV) diagnostic capacity and capability in National Reference Laboratories for arboviruses in 30 EU/EEA countries, May 2016

    PubMed Central

    Mögling, Ramona; Zeller, Hervé; Revez, Joana; Koopmans, Marion; Reusken, Chantal

    2017-01-01

    With international travel, Zika virus (ZIKV) is introduced to Europe regularly. A country's ability to robustly detect ZIKV introduction and local transmission is important to minimise the risk for a ZIKV outbreak. Therefore, sufficient expertise and diagnostic capacity and capability are required in European laboratories. To assess the capacity, quality, operational specifics (guidelines and algorithms), technical and interpretation issues and other possible difficulties that were related to ZIKV diagnostics in European countries, a questionnaire was conducted among national reference laboratories in 30 countries in the European Union/European Economic Area (EU/EEA) in May 2016. While the coverage and capacity of ZIKV diagnostics in the EU/EEA national reference laboratories were found to be adequate, the assessment of the quality and needs indicated several crucial points of improvement that will need support at national and EU/EEA level to improve ZIKV preparedness, response and EU/EEA ZIKV surveillance activities. PMID:28920574

  6. 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 of...

  7. 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 of...

  8. 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 of...

  9. Contributions of CCLM to advances in quality control.

    PubMed

    Kazmierczak, Steven C

    2013-01-01

    Abstract The discipline of laboratory medicine is relatively young when considered in the context of the history of medicine itself. The history of quality control, within the context of laboratory medicine, also enjoys a relatively brief, but rich history. Laboratory quality control continues to evolve along with advances in automation, measurement techniques and information technology. Clinical Chemistry and Laboratory Medicine (CCLM) has played a key role in helping disseminate information about the proper use and utility of quality control. Publication of important advances in quality control techniques and dissemination of guidelines concerned with laboratory quality control has undoubtedly helped readers of this journal keep up to date on the most recent developments in this field.

  10. Image quality, meteorological optical range, and fog particulate number evaluation using the Sandia National Laboratories fog chamber

    DOE PAGES

    Birch, Gabriel C.; Woo, Bryana L.; Sanchez, Andres L.; ...

    2017-08-24

    The evaluation of optical system performance in fog conditions typically requires field testing. This can be challenging due to the unpredictable nature of fog generation and the temporal and spatial nonuniformity of the phenomenon itself. We describe the Sandia National Laboratories fog chamber, a new test facility that enables the repeatable generation of fog within a 55 m×3 m×3 m (L×W×H) environment, and demonstrate the fog chamber through a series of optical tests. These tests are performed to evaluate system image quality, determine meteorological optical range (MOR), and measure the number of particles in the atmosphere. Relationships between typical opticalmore » quality metrics, MOR values, and total number of fog particles are described using the data obtained from the fog chamber and repeated over a series of three tests.« less

  11. Image quality, meteorological optical range, and fog particulate number evaluation using the Sandia National Laboratories fog chamber

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

    Birch, Gabriel C.; Woo, Bryana L.; Sanchez, Andres L.

    The evaluation of optical system performance in fog conditions typically requires field testing. This can be challenging due to the unpredictable nature of fog generation and the temporal and spatial nonuniformity of the phenomenon itself. We describe the Sandia National Laboratories fog chamber, a new test facility that enables the repeatable generation of fog within a 55 m×3 m×3 m (L×W×H) environment, and demonstrate the fog chamber through a series of optical tests. These tests are performed to evaluate system image quality, determine meteorological optical range (MOR), and measure the number of particles in the atmosphere. Relationships between typical opticalmore » quality metrics, MOR values, and total number of fog particles are described using the data obtained from the fog chamber and repeated over a series of three tests.« less

  12. [Application study of human sperm motility bioassay in IVF laboratory quality control].

    PubMed

    Cai, Xia; Pomeroy, Kimball O; Mattox, John H

    2006-07-01

    To investigate the sensitivity of human sperm survival bioassay to using known concentrations of potential toxin of formalin and to elevate the application value of human sperm motility assay as a quality control method in detecting the components used in IVF program. Fresh semen was obtained from healthy males at andrology laboratory by masturbation. Sperm was processed on a gradient column of isolate medium and PBS medium. In experiment 1, the medium with 0.25%, 0.75% concentration of formalin and control medium were added to the Falcon culture tubes containing HTF medium with or without 0.3% bovine albumin serum and with or without light mineral oil. In experiment 2, in 3 types of culture tubes containing HTF medium with or without 0.3% bovine albumin serum and with or without light mineral oil, the sperm was exposed to each culture tube and cultured for 24 and 48 hrs at room temperature, and the motile sperms were counted under the microscope. The average sperm motility index in the HTF medium with 0.25% formalin at 24 hrs was 0.594 +/- 0.331, significantly higher than in the HTF medium with 0.75% formalin (0.450 +/- 0.284) (P < 0.01). In the medium containing 0.25% and 0.75% formalin with 0.3% bovine albumin serum and light mineral oil, the average sperm survival indexes were 0.683 +/- 0.334 and 0.527 +/- 0.345, respectively, higher than without bovine albumin serum and light mineral oil (0.394 +/- 0.311 and 0.424 +/- 0.311). The average sperm index of 7 ml tissue culture tube made in Denmark was 0.677 +/- 0.335, higher than the other two types of culture tubes made in the USA (0.551 +/- 0.317 and 0.596 +/- 0.327) (P < 0.001). When the sperm cultured in the medium with 0.3% bovine albumin serum and light mineral oil, the average sperm survival indexes were 0.821 +/- 0.259 and 0.645 +/- 0.335, respectively, higher than without bovine albumin serum or light mineral oil (0.571 +/- 0.321 and 0.395 +/- 0.245) (P < 0.01). The sperm survival bioassay is a sensitivity

  13. Selecting automation for the clinical chemistry laboratory.

    PubMed

    Melanson, Stacy E F; Lindeman, Neal I; Jarolim, Petr

    2007-07-01

    Laboratory automation proposes to improve the quality and efficiency of laboratory operations, and may provide a solution to the quality demands and staff shortages faced by today's clinical laboratories. Several vendors offer automation systems in the United States, with both subtle and obvious differences. Arriving at a decision to automate, and the ensuing evaluation of available products, can be time-consuming and challenging. Although considerable discussion concerning the decision to automate has been published, relatively little attention has been paid to the process of evaluating and selecting automation systems. To outline a process for evaluating and selecting automation systems as a reference for laboratories contemplating laboratory automation. Our Clinical Chemistry Laboratory staff recently evaluated all major laboratory automation systems in the United States, with their respective chemistry and immunochemistry analyzers. Our experience is described and organized according to the selection process, the important considerations in clinical chemistry automation, decisions and implementation, and we give conclusions pertaining to this experience. Including the formation of a committee, workflow analysis, submitting a request for proposal, site visits, and making a final decision, the process of selecting chemistry automation took approximately 14 months. We outline important considerations in automation design, preanalytical processing, analyzer selection, postanalytical storage, and data management. Selecting clinical chemistry laboratory automation is a complex, time-consuming process. Laboratories considering laboratory automation may benefit from the concise overview and narrative and tabular suggestions provided.

  14. 7 CFR 90.102 - Quality assurance review.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

  15. 7 CFR 90.102 - Quality assurance review.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

  16. 7 CFR 90.102 - Quality assurance review.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

  17. 7 CFR 90.102 - Quality assurance review.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

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

    USGS Publications Warehouse

    Wegner, S.J.

    1989-01-01

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

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  20. The Formation of Indicators on Engineering Laboratory Management

    ERIC Educational Resources Information Center

    Yasin, Ruhizan M.; Mohamad, Zunuwanas; Rahman, Mohd Nizam Ab.; Hashim, Mohamad Hisyam Mohd

    2012-01-01

    This research is a developmental study of Engineering Laboratory Management indicators. It is formed to assess the level of quality management of the polytechnic level laboratory. The purpose of indicators is to help provide input into the management process of an engineering laboratory. Effectiveness of teaching and learning at technical…

  1. Safety in laboratories: Indian scenario.

    PubMed

    Mustafa, Ajaz; Farooq, A Jan; Qadri, Gj; S A, Tabish

    2008-07-01

    Health and safety in clinical laboratories is becoming an increasingly important subject as a result of emergence of highly infectious diseases such as Hepatitis and HIV. A cross sectional study was carried out to study the safety measures being adopted in clinical laboratories of India. Heads of laboratories of teaching hospitals of India were subjected to a standardized, pretested questionnaire. Response rate was 44.8%. only 60% of laboratories had person in-charge of safety in laboratory. Seventy three percent of laboratories had safety education program regarding hazards. In 91% of laboratories staff is using protective clothing while working in laboratories. Hazardous material regulations are followed in 78% of laboratories. Regular health check ups are carried among laboratory staff in 43.4% of laboratories.Safety manual is available in 56.5% of laboratories. 73.9% of laboratories are equipped with fire extinguishers. Fume cupboards are provided in 34.7% of laboratories and they are regularly checked in 87.5% of these laboratories. In 78.26% of laboratories suitable measures are taken to minimize formation of aerosols.In 95.6% of laboratories waste is disposed off as per bio-medical waste management handling rules. Laboratory of one private medical college was accredited with NABL and safety parameters were better in that laboratory. Installing safety engineered devices apparently contributes to significant decrease in injuries in laboratories; laboratory safety has to be a part of overall quality assurance programme in hospitals. Accreditation has to be made necessary for all laboratories.

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

    PubMed

    2012-04-06

    Biochemical genetic testing and newborn screening are essential laboratory services for the screening, detection, diagnosis, and monitoring of inborn errors of metabolism or inherited metabolic disorders. Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, laboratory testing is categorized on the basis of the level of testing complexity as either waived (i.e., from routine regulatory oversight) or nonwaived testing (which includes tests of moderate and high complexity). Laboratories that perform biochemical genetic testing are required by CLIA regulations to meet the general quality systems requirements for nonwaived testing and the personnel requirements for high-complexity testing. Laboratories that perform public health newborn screening are subject to the same CLIA regulations and applicable state requirements. As the number of inherited metabolic diseases that are included in state-based newborn screening programs continues to increase, ensuring the quality of performance and delivery of testing services remains a continuous challenge not only for public health laboratories and other newborn screening facilities but also for biochemical genetic testing laboratories. To help ensure the quality of laboratory testing, CDC collaborated with the Centers for Medicare & Medicaid Services, the Food and Drug Administration, the Health Resources and Services Administration, and the National Institutes of Health to develop guidelines for laboratories to meet CLIA requirements and apply additional quality assurance measures for these areas of genetic testing. This report provides recommendations for good laboratory practices that were developed based on recommendations from the Clinical Laboratory Improvement Advisory Committee, with additional input from the Secretary's Advisory Committee on Genetics, Health, and Society; the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; and representatives of newborn

  3. [Approval of ISO/IEC 17025 and quality control of laboratory testing].

    PubMed

    Yamamoto, Shigeki; Asakura, Hiroshi; Machii, Kenji; Igimi, Shizunobu

    2010-01-01

    First section of Division of Biomedical Food Research, National Institute of Health Sciences (NIHS) was approved by ISO/IEC 17025 as a laboratory having an appropriate laboratory testing technique. NIHS is the first national laboratory approved by ISO/IEC 17025. NIHS has also been accepted the appropriate technique and facility for the BSL3 level pathogens by ISO/IEC 17025. NIHS is necessary to take an external audit almost every year. This approval is renewed every 4 years.

  4. The State Public Health Laboratory System.

    PubMed

    Inhorn, Stanley L; Astles, J Rex; Gradus, Stephen; Malmberg, Veronica; Snippes, Paula M; Wilcke, Burton W; White, Vanessa A

    2010-01-01

    This article describes the development since 2000 of the State Public Health Laboratory System in the United States. These state systems collectively are related to several other recent public health laboratory (PHL) initiatives. The first is the Core Functions and Capabilities of State Public Health Laboratories, a white paper that defined the basic responsibilities of the state PHL. Another is the Centers for Disease Control and Prevention National Laboratory System (NLS) initiative, the goal of which is to promote public-private collaboration to assure quality laboratory services and public health surveillance. To enhance the realization of the NLS, the Association of Public Health Laboratories (APHL) launched in 2004 a State Public Health Laboratory System Improvement Program. In the same year, APHL developed a Comprehensive Laboratory Services Survey, a tool to measure improvement through the decade to assure that essential PHL services are provided.

  5. A high efficiency, high quality and low cost internal regulated bioanalytical laboratory to support drug development needs.

    PubMed

    Song, Yan; Dhodda, Raj; Zhang, Jun; Sydor, Jens

    2014-05-01

    In the recent past, we have seen an increase in the outsourcing of bioanalysis in pharmaceutical companies in support of their drug development pipeline. This trend is largely driven by the effort to reduce internal cost, especially in support of late-stage pipeline assets where established bioanalytical assays are used to analyze a large volume of samples. This article will highlight our perspective of how bioanalytical laboratories within pharmaceutical companies can be developed into the best partner in the advancement of drug development pipelines with high-quality support at competitive cost.

  6. Clinical laboratory: bigger is not always better.

    PubMed

    Plebani, Mario

    2018-06-27

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

  7. Environmental Response Laboratory Network

    EPA Pesticide Factsheets

    The ERLN as a national network of laboratories that can be ramped up as needed to support large scale environmental responses. It integrates capabilities of existing public and private sector labs, providing consistent capacity and quality data.

  8. Inter-laboratory quality control for hormone-dependent gene expression in human breast tumors using real-time reverse transcription-polymerase chain reaction.

    PubMed

    de Cremoux, P; Bieche, I; Tran-Perennou, C; Vignaud, S; Boudou, E; Asselain, B; Lidereau, R; Magdelénat, H; Becette, V; Sigal-Zafrani, B; Spyratos, F

    2004-09-01

    Quantitative reverse transcription-polymerase chain reaction (RT-PCR) used to detect minor changes in specific mRNA concentrations may be associated with poor reproducibility. Stringent quality control is therefore essential at each step of the protocol, including the PCR procedure. We performed inter-laboratory quality control of quantitative PCR between two independent laboratories, using in-house RT-PCR assays on a series of hormone-related target genes in a retrospective consecutive series of 79 breast tumors. Total RNA was reverse transcribed in a single center. Calibration curves were performed for five target genes (estrogen receptor (ER)alpha, ERbeta, progesterone receptor (PR), CYP19 (aromatase) and Ki 67) and for two reference genes (human acidic ribosomal phosphoprotein PO (RPLPO) and TATA box-binding protein (TBP)). Amplification efficiencies of the calibrator were determined for each run and used to calculate mRNA expression. Correlation coefficients were evaluated for each target and each reference gene. A good correlation was observed for all target and reference genes in both centers using their own protocols and kits (P < 0.0001). The correlation coefficients ranged from 0.90 to 0.98 for the various target genes in the two centers. A good correlation was observed between the level of expression of the ERalpha and the PR transcripts (P < 0.001). A weak inverse correlation was observed in both centers between ERalpha and ERbeta levels, but only when TBP was the reference gene. No other correlation was observed with other parameters. Real-time PCR assays allow convenient quantification of target mRNA transcripts and quantification of target-derived nucleic acids in clinical specimens. This study addresses the importance of inter-laboratory quality controls for the use of a panel of real-time PCR assays devoted to clinical samples and protocols and to ensure their appropriate accuracy. This can also facilitate exchanges and multicenter comparison of

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

    USGS Publications Warehouse

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

    2006-01-01

    The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance/quality-control data for the time period addressed in this report were stored in the laboratory's SAS data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality- control samples analyzed from July 1997 through June 1999. Results for the quality-control samples for 18 analytical procedures were evaluated for bias and precision. Control charts indicate that data for eight of the analytical procedures were occasionally biased for either high-concentration and (or) low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, total aluminum, ammonium, calcium, chloride, specific conductance, and sulfate. The data from the potassium and sodium analytical procedures are insufficient for evaluation. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 11 of 13 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. Blank analysis results for chloride showed that 22 percent of blanks did not meet data-quality objectives and results for dissolved organic carbon showed that 31 percent of the blanks did not meet data-quality objectives. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 14 of the 18 analytes. At least 90 percent of the samples met data-quality

  10. Quality beyond compliance.

    PubMed

    Centanni, N; Monroe, M; White, L; Larson, R

    1999-01-01

    The service sector within the biopharmaceutical industry has experienced phenomenal growth over the past decade. In the highly regulated Good Laboratory Practices environment, the need for timely, high-quality service, accurate results, and on-time deliverables becomes paramount for the success and profitability of biopharmaceutical companies. The quality assurance process is a vital component of this drug product-development cycle and ensures compliance to the highest domestic and international regulatory standards. Quality-assurance professionals historically have held the role of independent auditors of the processes, who certify that results meet current standards of practice. Covance, a contract research organization that includes Good Laboratory Practices laboratories, reorganized and expanded the functional responsibilities of its quality assurance team in 1997. Auditors and quality assurance professionals have assumed roles beyond traditional compliance auditing and are forging new leadership and mentoring roles as process-improvement specialists. The results have been tangible, measurable benefits for clients and the Covance organization. This article provides an overview of this cultural change and the processes put in place to improve efficiency, productivity, and customer and employee satisfaction.

  11. The laboratory diagnosis of syphilis.

    PubMed

    Ratnam, Sam

    2005-01-01

    Syphilis has several clinical manifestations, making laboratory testing a very important aspect of diagnosis. In North America, many unsuspected cases are discovered by laboratory testing. The etiological agent, Treponema pallidum, cannot be cultured, and there is no single optimal alternative test. Serological testing is the most frequently used approach in the laboratory diagnosis of syphilis. The present paper discusses the various serological and alternative tests currently available along with their limitations, and relates their results to the likely corresponding clinical stage of the disease. The need to use multiple tests is discussed, and the importance of quality control is noted. The complexity of syphilis serology means that the services of reference laboratories and clinical experts are often needed.

  12. Laboratory issues: use of nutritional biomarkers.

    PubMed

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

    2003-03-01

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

  13. Challenges to laboratory hematology practice: Egypt perspective.

    PubMed

    Rizk, S H

    2018-05-01

    Laboratory hematology is an integral part of all clinical laboratories along the extensive healthcare facilities in Egypt. The aim of this review is to portrait the laboratory hematology practice in Egypt including its unique socioeconomic background, blood disease pattern, education and training, regulatory oversight, and the related challenges. Current practice varies widely between different parts of the healthcare system in terms of the range of tests, applied techniques, workforce experience, and quality of service. The national transfusion service (NBTS) in Egypt has been recently upgraded and standardized according to the World Health Organization (WHO) guidelines. Formal postgraduate education roughly follows the British system. Laboratory hematology specialization is achieved through 2-3 years masters' degree followed by 2-4 years doctorate degree in clinical pathology with training and research in hematology. Improvement of laboratory hematology education is recently undergoing a reform as a part of the modernization of higher education policy and following the standards developed by the National Quality Assurance and Accreditation Agency (NQAAA). Accreditation of medical laboratories is recently progressing with the development of the "Egyptian Accreditation Council" (EGAC) as the sole accreditation body system and training of assessors. Current laboratory system has many challenges, some are related to the inadequate system performance, and others are unique to laboratory hematology issues. The rapid technological advances and therapeutic innovations in hematology practice call for an adapting laboratory system with continuous upgrading. © 2018 John Wiley & Sons Ltd.

  14. Microbial ecology laboratory procedures manual NASA/MSFC

    NASA Technical Reports Server (NTRS)

    Huff, Timothy L.

    1990-01-01

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

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

    PubMed

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

    2002-06-01

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

  16. Preservice laboratory education strengthening enhances sustainable laboratory workforce in Ethiopia

    PubMed Central

    2013-01-01

    Background There is a severe healthcare workforce shortage in sub Saharan Africa, which threatens achieving the Millennium Development Goals and attaining an AIDS-free generation. The strength of a healthcare system depends on the skills, competencies, values and availability of its workforce. A well-trained and competent laboratory technologist ensures accurate and reliable results for use in prevention, diagnosis, care and treatment of diseases. Methods An assessment of existing preservice education of five medical laboratory schools, followed by remedial intervention and monitoring was conducted. The remedial interventions included 1) standardizing curriculum and implementation; 2) training faculty staff on pedagogical methods and quality management systems; 3) providing teaching materials; and 4) procuring equipment for teaching laboratories to provide practical skills to complement didactic education. Results A total of 2,230 undergraduate students from the five universities benefitted from the standardized curriculum. University of Gondar accounted for 252 of 2,230 (11.3%) of the students, Addis Ababa University for 663 (29.7%), Jimma University for 649 (29.1%), Haramaya University for 429 (19.2%) and Hawassa University for 237 (10.6%) of the students. Together the universities graduated 388 and 312 laboratory technologists in 2010/2011 and 2011/2012 academic year, respectively. Practical hands-on training and experience with well-equipped laboratories enhanced and ensured skilled, confident and competent laboratory technologists upon graduation. Conclusions Strengthening preservice laboratory education is feasible in resource-limited settings, and emphasizing its merits (ample local capacity, country ownership and sustainability) provides a valuable source of competent laboratory technologists to relieve an overstretched healthcare system. PMID:24164781

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

    PubMed

    Zaninotto, Martina; Plebani, Mario

    2010-07-01

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

  18. Electromedical devices test laboratories accreditation

    NASA Astrophysics Data System (ADS)

    Murad, C.; Rubio, D.; Ponce, S.; Álvarez Abri, A.; Terrón, A.; Vicencio, D.; Fascioli, E.

    2007-11-01

    In the last years, the technology and equipment at hospitals have been increase in a great way as the risks of their implementation. Safety in medical equipment must be considered an important issue to protect patients and their users. For this reason, test and calibrations laboratories must verify the correct performance of this kind of devices under national and international standards. Is an essential mission for laboratories to develop their measurement activities taking into account a quality management system. In this article, we intend to transmit our experience working to achieve an accredited Test Laboratories for medical devices in National technological University.

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

    USGS Publications Warehouse

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

    2009-01-01

    The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's Lab Master data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality control samples analyzed from July 2003 through June 2005. Results for the quality-control samples for 20 analytical procedures were evaluated for bias and precision. Control charts indicate that data for five of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, pH, silicon, and sodium. Seven of the analytical procedures were biased throughout the analysis period for the high-concentration sample, but were within control limits; these procedures were: dissolved organic carbon, chloride, nitrate (ion chromatograph), nitrite, silicon, sodium, and sulfate. The calcium and magnesium procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The total aluminum and specific conductance procedures were biased for the high-concentration and low-concentration samples, but were within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 17 of 18 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for dissolved organic

  20. Continuing professional development training needs of medical laboratory personnel in Botswana

    PubMed Central

    2014-01-01

    Background Laboratory professionals are expected to maintain their knowledge on the most recent advances in laboratory testing and continuing professional development (CPD) programs can address this expectation. In developing countries, accessing CPD programs is a major challenge for laboratory personnel, partly due to their limited availability. An assessment was conducted among clinical laboratory workforce in Botswana to identify and prioritize CPD training needs as well as preferred modes of CPD delivery. Methods A self-administered questionnaire was disseminated to medical laboratory scientists and technicians registered with the Botswana Health Professions Council. Questions were organized into domains of competency related to (i) quality management systems, (ii) technical competence, (iii) laboratory management, leadership, and coaching, and (iv) pathophysiology, data interpretation, and research. Participants were asked to rank their self-perceived training needs using a 3-point scale in order of importance (most, moderate, and least). Furthermore, participants were asked to select any three preferences for delivery formats for the CPD. Results Out of 350 questionnaires that were distributed, 275 were completed and returned giving an overall response rate of 79%. The most frequently selected topics for training in rank order according to key themes were (mean, range) (i) quality management systems, most important (79%, 74–84%); (ii) pathophysiology, data interpretation, and research (68%, 52–78%); (iii) technical competence (65%, 44–73%); and (iv) laboratory management, leadership, and coaching (60%, 37–77%). The top three topics selected by the participants were (i) quality systems essentials for medical laboratory, (ii) implementing a quality management system, and (iii) techniques to identify and control sources of error in laboratory procedures. The top three preferred CPD delivery modes, in rank order, were training workshops, hands

  1. The ideal laboratory information system.

    PubMed

    Sepulveda, Jorge L; Young, Donald S

    2013-08-01

    Laboratory information systems (LIS) are critical components of the operation of clinical laboratories. However, the functionalities of LIS have lagged significantly behind the capacities of current hardware and software technologies, while the complexity of the information produced by clinical laboratories has been increasing over time and will soon undergo rapid expansion with the use of new, high-throughput and high-dimensionality laboratory tests. In the broadest sense, LIS are essential to manage the flow of information between health care providers, patients, and laboratories and should be designed to optimize not only laboratory operations but also personalized clinical care. To list suggestions for designing LIS with the goal of optimizing the operation of clinical laboratories while improving clinical care by intelligent management of laboratory information. Literature review, interviews with laboratory users, and personal experience and opinion. Laboratory information systems can improve laboratory operations and improve patient care. Specific suggestions for improving the function of LIS are listed under the following sections: (1) Information Security, (2) Test Ordering, (3) Specimen Collection, Accessioning, and Processing, (4) Analytic Phase, (5) Result Entry and Validation, (6) Result Reporting, (7) Notification Management, (8) Data Mining and Cross-sectional Reports, (9) Method Validation, (10) Quality Management, (11) Administrative and Financial Issues, and (12) Other Operational Issues.

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

    USGS Publications Warehouse

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

    1999-01-01

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

  3. Quality Manual

    NASA Astrophysics Data System (ADS)

    Koch, Michael

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

  4. 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

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

    PubMed

    Westgard, James O; Westgard, Sten A

    2017-03-01

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

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

    USGS Publications Warehouse

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

    2009-01-01

    The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's Lab Master data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality control samples analyzed from July 2001 through June 2003. Results for the quality-control samples for 19 analytical procedures were evaluated for bias and precision. Control charts indicate that data for six of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, chloride, magnesium, nitrate (ion chromatography), potassium, and sodium. The calcium procedure was biased throughout the analysis period for the high-concentration sample, but was within control limits. The total monomeric aluminum and fluoride procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The total aluminum, pH, specific conductance, and sulfate procedures were biased for the high-concentration and low-concentration samples, but were within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 16 of 18 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for the dissolved organic carbon or specific conductance procedures. Sampling and analysis precision are evaluated

  7. The SLMTA programme: Transforming the laboratory landscape in developing countries

    PubMed Central

    Maruta, Talkmore; Luman, Elizabeth T.; Nkengasong, John N.

    2014-01-01

    Background Efficient and reliable laboratory services are essential to effective and well-functioning health systems. Laboratory managers play a critical role in ensuring the quality and timeliness of these services. However, few laboratory management programmes focus on the competencies required for the daily operations of a laboratory in resource-limited settings. This report provides a detailed description of an innovative laboratory management training tool called Strengthening Laboratory Management Toward Accreditation (SLMTA) and highlights some challenges, achievements and lessons learned during the first five years of implementation (2009–2013) in developing countries. Programme SLMTA is a competency-based programme that uses a series of short courses and work-based learning projects to effect immediate and measurable laboratory improvement, while empowering laboratory managers to implement practical quality management systems to ensure better patient care. A SLMTA training programme spans from 12 to 18 months; after each workshop, participants implement improvement projects supported by regular supervisory visits or on-site mentoring. In order to assess strengths, weaknesses and progress made by the laboratory, audits are conducted using the World Health Organization’s Regional Office for Africa (WHO AFRO) Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist, which is based on International Organization for Standardization (ISO) 15189 requirements. These internal audits are conducted at the beginning and end of the SLMTA training programme. Conclusion Within five years, SLMTA had been implemented in 617 laboratories in 47 countries, transforming the laboratory landscape in developing countries. To our knowledge, SLMTA is the first programme that makes an explicit connection between the performance of specific management behaviours and routines and ISO 15189 requirements. Because of this close relationship, SLMTA is

  8. Providing Quality Laboratories to Long-Distance Educational Programs.

    ERIC Educational Resources Information Center

    Gammon, Tammy; Sutton, John

    2003-01-01

    North Carolina State University (UNC) has been on the forefront of long-distance education by offering a Bachelor of Science in Engineering with a Mechatronics Concentration at its remote campus located at UNC Asheville. The program demonstrates that long-distance laboratories are feasible and should not be a stumbling block to offering…

  9. From grass to grace: How SLMTA revolutionised the Bamenda Regional Hospital Laboratory in Cameroon

    PubMed Central

    Batumani, Nakeli N.; Maruta, Talkmore; Awasom, Charles N.

    2014-01-01

    Background Public health laboratories form the foundation on which today’s clinical laboratory practice in Cameroon is built. The advent of the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme in 2009 empowered the Bamenda Regional Hospital Laboratory (BRHL) to improve its working culture, practices and management. Objectives To evaluate the results of SLMTA implementation at BRHL and discuss lessons learned. Method In 2010, the SLMTA programme was rolled out in Cameroon to improve laboratory quality management systems in five laboratories, including BRHL. Three workshops were conducted (the first centralised, the remaining two on-site at each laboratory) and improvement projects were implemented after each workshop with the assistance of mentors. Audits were used in order to evaluate performance and to identify areas for further improvement. Results BRHL had the lowest score (18%) amongst the cohort at the baseline audit and the highest (81%) at the official Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) audit conducted in August 2013 by the African Society for Laboratory Medicine. Improvements were observed in each of the 12 Quality System Essentials; improvement was especially noteworthy in the areas of facilities and safety, and purchasing and inventory. Staff investment and pride in the quality of laboratory services increased. Conclusion BRHL’s remarkable improvement was achieved with a combination of SLMTA training activities, intensive on-site mentorship and the collective focus of all laboratory staff. The experience at Bamenda Hospital illustrates what can be achieved when a laboratory successfully harnesses the energy of its staff and implements changes to improve the quality of services in a transformation taking them from grass to grace. PMID:29043186

  10. Using the U.S. Geological Survey National Water Quality Laboratory LT-MDL to Evaluate and Analyze Data

    USGS Publications Warehouse

    Bonn, Bernadine A.

    2008-01-01

    A long-term method detection level (LT-MDL) and laboratory reporting level (LRL) are used by the U.S. Geological Survey?s National Water Quality Laboratory (NWQL) when reporting results from most chemical analyses of water samples. Changing to this method provided data users with additional information about their data and often resulted in more reported values in the low concentration range. Before this method was implemented, many of these values would have been censored. The use of the LT-MDL and LRL presents some challenges for the data user. Interpreting data in the low concentration range increases the need for adequate quality assurance because even small contamination or recovery problems can be relatively large compared to concentrations near the LT-MDL and LRL. In addition, the definition of the LT-MDL, as well as the inclusion of low values, can result in complex data sets with multiple censoring levels and reported values that are less than a censoring level. Improper interpretation or statistical manipulation of low-range results in these data sets can result in bias and incorrect conclusions. This document is designed to help data users use and interpret data reported with the LTMDL/ LRL method. The calculation and application of the LT-MDL and LRL are described. This document shows how to extract statistical information from the LT-MDL and LRL and how to use that information in USGS investigations, such as assessing the quality of field data, interpreting field data, and planning data collection for new projects. A set of 19 detailed examples are included in this document to help data users think about their data and properly interpret lowrange data without introducing bias. Although this document is not meant to be a comprehensive resource of statistical methods, several useful methods of analyzing censored data are demonstrated, including Regression on Order Statistics and Kaplan-Meier Estimation. These two statistical methods handle complex

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

    PubMed

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

    2016-03-01

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

  12. Modular laboratories--cost-effective and sustainable infrastructure for resource-limited settings.

    PubMed

    Bridges, Daniel J; Colborn, James; Chan, Adeline S T; Winters, Anna M; Dengala, Dereje; Fornadel, Christen M; Kosloff, Barry

    2014-12-01

    High-quality laboratory space to support basic science, clinical research projects, or health services is often severely lacking in the developing world. Moreover, the construction of suitable facilities using traditional methods is time-consuming, expensive, and challenging to implement. Three real world examples showing how shipping containers can be converted into modern laboratories are highlighted. These include use as an insectary, a molecular laboratory, and a BSL-3 containment laboratory. These modular conversions have a number of advantages over brick and mortar construction and provide a cost-effective and timely solution to offer high-quality, user-friendly laboratory space applicable within the developing world. © The American Society of Tropical Medicine and Hygiene.

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

    USGS Publications Warehouse

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

    2006-01-01

    The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's LabMaster data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality-control samples analyzed from July 1999 through June 2001. Results for the quality-control samples for 18 analytical procedures were evaluated for bias and precision. Control charts indicate that data for eight of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, total aluminum, calcium, chloride and nitrate (ion chromatography and colormetric method) and sulfate. The total aluminum and dissolved organic carbon procedures were biased throughout the analysis period for the high-concentration sample, but were within control limits. The calcium and specific conductance procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The magnesium procedure was biased for the high-concentration and low concentration samples, but was within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 14 of 15 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for dissolved organic carbon. Sampling and analysis precision are

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

    PubMed

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

    2018-05-11

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

  15. Global and national laboratory networks support high quality surveillance for measles and rubella.

    PubMed

    Xu, Wenbo; Zhang, Yan; Wang, Huiling; Zhu, Zhen; Mao, Naiying; Mulders, Mick N; Rota, Paul A

    2017-05-01

    Laboratory networks are an essential component of disease surveillance systems because they provide accurate and timely confirmation of infection. WHO coordinates global laboratory surveillance of vaccine preventable diseases, including measles and rubella. The more than 700 laboratories within the WHO Global Measles and Rubella Laboratory Network (GMRLN) supports surveillance for measles, rubella and congenial rubella syndrome in 191 counties. This paper describes the overall structure and function of the GMRLN and highlights the largest of the national laboratory networks, the China Measles and Rubella Laboratory Network. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  16. Mistakes in a stat laboratory: types and frequency.

    PubMed

    Plebani, M; Carraro, P

    1997-08-01

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

  17. 78 FR 44954 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical... and Human Services; the Assistant Secretary for Health; the Director, Centers for Disease Control and... laboratory quality and laboratory [[Page 44955

  18. Image Quality Assessment of JPEG Compressed Mars Science Laboratory Mastcam Images using Convolutional Neural Networks

    NASA Astrophysics Data System (ADS)

    Kerner, H. R.; Bell, J. F., III; Ben Amor, H.

    2017-12-01

    The Mastcam color imaging system on the Mars Science Laboratory Curiosity rover acquires images within Gale crater for a variety of geologic and atmospheric studies. Images are often JPEG compressed before being downlinked to Earth. While critical for transmitting images on a low-bandwidth connection, this compression can result in image artifacts most noticeable as anomalous brightness or color changes within or near JPEG compression block boundaries. In images with significant high-frequency detail (e.g., in regions showing fine layering or lamination in sedimentary rocks), the image might need to be re-transmitted losslessly to enable accurate scientific interpretation of the data. The process of identifying which images have been adversely affected by compression artifacts is performed manually by the Mastcam science team, costing significant expert human time. To streamline the tedious process of identifying which images might need to be re-transmitted, we present an input-efficient neural network solution for predicting the perceived quality of a compressed Mastcam image. Most neural network solutions require large amounts of hand-labeled training data for the model to learn the target mapping between input (e.g. distorted images) and output (e.g. quality assessment). We propose an automatic labeling method using joint entropy between a compressed and uncompressed image to avoid the need for domain experts to label thousands of training examples by hand. We use automatically labeled data to train a convolutional neural network to estimate the probability that a Mastcam user would find the quality of a given compressed image acceptable for science analysis. We tested our model on a variety of Mastcam images and found that the proposed method correlates well with image quality perception by science team members. When assisted by our proposed method, we estimate that a Mastcam investigator could reduce the time spent reviewing images by a minimum of 70%.

  19. Decoding Student Satisfaction: How to Manage and Improve the Laboratory Experience

    ERIC Educational Resources Information Center

    Nikolic, Sasha; Ritz, Christian; Vial, Peter James; Ros, Montserrat; Stirling, David

    2015-01-01

    The laboratory plays an important role in teaching engineering skills. An Electrical Engineering department at an Australian University implemented a reform to monitor and improve student satisfaction with the teaching laboratories. A Laboratory Manager was employed to oversee the quality of 27 courses containing instructional laboratories.…

  20. [ISO 15189 medical laboratory accreditation].

    PubMed

    Aoyagi, Tsutomu

    2004-10-01

    This International Standard, based upon ISO/IEC 17025 and ISO 9001, provides requirements for competence and quality that are particular to medical laboratories. While this International Standard is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines will also find it useful and appropriate. In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this International Standard as the basis for their activities. The Japan Accreditation Board for Conformity Assessment (AB) and the Japanese Committee for Clinical Laboratory Standards (CCLS) are jointly developing the program of accreditation of medical laboratories. ISO 15189 requirements consist of two parts, one is management requirements and the other is technical requirements. The former includes the requirements of all parts of ISO 9001, moreover it includes the requirement of conformity assessment body, for example, impartiality and independence from any other party. The latter includes the requirements of laboratory competence (e.g. personnel, facility, instrument, and examination methods), moreover it requires that laboratories shall participate proficiency testing(s) and laboratories' examination results shall have traceability of measurements and implement uncertainty of measurement. Implementation of ISO 15189 will result in a significant improvement in medical laboratories management system and their technical competence. The accreditation of medical laboratory will improve medical laboratory service and be useful for patients.

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

    PubMed

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

    2016-01-01

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

  2. Laboratory Animal Technician | Center for Cancer Research

    Cancer.gov

    PROGRAM DESCRIPTION The Laboratory Animal Sciences Program (LASP) provides exceptional quality animal care and technical support services for animal research performed at the National Cancer Institute at the Frederick National Laboratory for Cancer Research. LASP executes this mission by providing a broad spectrum of state-of-the-art technologies and services that are focused

  3. Strengthening national health laboratories in sub-Saharan Africa: a decade of remarkable progress

    PubMed Central

    Alemnji, G. A.; Zeh, C.; Yao, K.; Fonjungo, P. N.

    2016-01-01

    OBJECTIVES Efforts to combat the HIV/AIDS pandemic have underscored the fragile and neglected nature of some national health laboratories in Africa. In response, national and international partners and various governments have worked collaboratively over the last several years to build sustainable laboratory capacities within the continent. Key accomplishments reflecting this successful partnership include the establishment of the African-based World Health Organization Regional Office for Africa (WHO-AFRO) Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA); development of the Strengthening Laboratory Management Toward Accreditation (SLMTA) training programme; and launching of a Pan African-based institution, the African Society for Laboratory Medicine (ASLM). These platforms continue to serve as the foundations for national health laboratory infrastructure enhancement, capacity development and overall quality system improvement. Further targeted interventions should encourage countries to aim at integrated tiered referral networks, promote quality system improvement and accreditation, develop laboratory policies and strategic plans, enhance training and laboratory workforce development and a retention strategy, create career paths for laboratory professionals and establish public–private partnerships. Maintaining the gains and ensuring sustainability will require concerted action by all stakeholders with strong leadership and funding from African governments and from the African Union. PMID:24506521

  4. Performance evaluation for screening laboratories of the Asia-Pacific region.

    PubMed

    Hannon, W Harry

    2003-01-01

    The Centers for Disease Control and Prevention (CDC) has a long history of involvement in quality assurance (QA) activities for support of newborn screening laboratories. Since 1978, CDC's Newborn Screening Quality Assurance Program (NSQAP), has distributed dried-blood spot (DBS) materials for external QA and has maintained related projects to serve newborn screening laboratories. The first DBS materials were distributed for congenital hypothyroidism screening in 1978 and by 2001, NSQAP had expanded to over 30 disorders and performance monitoring for all filter paper production lots from approved commercial sources. In 2001, there were 250 active NSQAP participants, 167 laboratories from 45 countries and 83 laboratories in the United States. Of these laboratories, 31 are from the Asia Pacific Region representing nine countries primarily for two disorders. In 1999, US laboratories had more errors for Performance Evaluation (PE) specimens than other laboratories; but in 2000, US laboratories had fewer errors. International laboratories reported 0.3% false-negative PE clinical assessments for congenital hypothyroidism and 0.5% for phenylketonuria (0.5%) in 2000. Paperless PE data-reporting operation using an Internet website has recently been implemented.

  5. The impact of automating laboratory request forms on the quality of healthcare services.

    PubMed

    Dogether, Majed Al; Muallem, Yahya Al; Househ, Mowafa; Saddik, Basema; Khalifa, Mohamed

    In recent decades, healthcare organizations have undergone a significant transformation with the integration of Information and Communication Technologies within healthcare operations to improve healthcare services. Various technologies such as Hospital Information Systems (HIS), Electronic Health Records (EHR) and Laboratory Information Systems (LIS) have been incorporated into healthcare services. The aim of this study is to evaluate the completeness of outpatients' laboratory paper based request forms in comparison with a electronic laboratory request system. This study was carried out in the laboratory department at King Abdulaziz Medical City (KAMC), National Guard Health Affairs, Riyadh, Saudi Arabia. We used a sample size calculator for comparing two proportions. We estimated the sample size to be 228 for each group. Any laboratory requests including paper and electronic forms were included. We categorized the clarity of the forms into understandable, readable, and unclear. A total of 57 incomplete paper forms or 25% were identified as being incomplete. For electronic forms, there were no incomplete fields, as all fields were mandatory, therefore, rendering them complete. The total of understandable paper-based laboratory forms was 11.4%. Additionally, it was found that the total of readable was 33.8% and the total for unclear was 54.8%, while for electronic-based forms, there were no unclear forms. Electronic based laboratory forms provide a more complete, accurate, clear, and understandable format than paper-based laboratory records. Based on these findings, KAMC should move toward the implementation of electronic-based laboratory request forms for the outpatient laboratory department. Copyright © 2016 King Saud Bin Abdulaziz University for Health Sciences. Published by Elsevier Ltd. All rights reserved.

  6. Evaluation of a laboratory quality assurance pilot programme for malaria diagnostics in low-transmission areas of Kenya, 2013.

    PubMed

    Wanja, Elizabeth; Achilla, Rachel; Obare, Peter; Adeny, Rose; Moseti, Caroline; Otieno, Victor; Morang'a, Collins; Murigi, Ephantus; Nyamuni, John; Monthei, Derek R; Ogutu, Bernhards; Buff, Ann M

    2017-05-25

    One objective of the Kenya National Malaria Strategy 2009-2017 is scaling access to prompt diagnosis and effective treatment. In 2013, a quality assurance (QA) pilot was implemented to improve accuracy of malaria diagnostics at selected health facilities in low-transmission counties of Kenya. Trends in malaria diagnostic and QA indicator performance during the pilot are described. From June to December 2013, 28 QA officers provided on-the-job training and mentoring for malaria microscopy, malaria rapid diagnostic tests and laboratory QA/quality control (QC) practices over four 1-day visits at 83 health facilities. QA officers observed and recorded laboratory conditions and practices and cross-checked blood slides for malaria parasite presence, and a portion of cross-checked slides were confirmed by reference laboratories. Eighty (96%) facilities completed the pilot. Among 315 personnel at pilot initiation, 13% (n = 40) reported malaria diagnostics training within the previous 12 months. Slide positivity ranged from 3 to 7%. Compared to the reference laboratory, microscopy sensitivity ranged from 53 to 96% and positive predictive value from 39 to 53% for facility staff and from 60 to 96% and 52 to 80%, respectively, for QA officers. Compared to reference, specificity ranged from 88 to 98% and negative predictive value from 98 to 99% for health-facility personnel and from 93 to 99% and 99%, respectively, for QA officers. The kappa value ranged from 0.48-0.66 for facility staff and 0.57-0.84 for QA officers compared to reference. The only significant test performance improvement observed for facility staff was for specificity from 88% (95% CI 85-90%) to 98% (95% CI 97-99%). QA/QC practices, including use of positive-control slides, internal and external slide cross-checking and recording of QA/QC activities, all increased significantly across the pilot (p < 0.001). Reference material availability also increased significantly; availability of six microscopy job

  7. Quality Assurance Specifications for Planetary Protection Assays

    NASA Astrophysics Data System (ADS)

    Baker, Amy

    As the European Space Agency planetary protection (PP) activities move forward to support the ExoMars and other planetary missions, it will become necessary to increase staffing of labo-ratories that provide analyses for these programs. Standardization of procedures, a comprehen-sive quality assurance program, and unilateral training of personnel will be necessary to ensure that the planetary protection goals and schedules are met. The PP Quality Assurance/Quality Control (QAQC) program is designed to regulate and monitor procedures performed by labora-tory personnel to ensure that all work meets data quality objectives through the assembly and launch process. Because personnel time is at a premium and sampling schedules are often de-pendent on engineering schedules, it is necessary to have flexible staffing to support all sampling requirements. The most productive approach to having a competent and flexible work force is to establish well defined laboratory procedures and training programs that clearly address the needs of the program and the work force. The quality assurance specification for planetary protection assays has to ensure that labora-tories and associated personnel can demonstrate the competence to perform assays according to the applicable standard AD4. Detailed subjects included in the presentation are as follows: • field and laboratory control criteria • data reporting • personnel training requirements and certification • laboratory audit criteria. Based upon RD2 for primary and secondary validation and RD3 for data quality objectives, the QAQC will provide traceable quality assurance safeguards by providing structured laboratory requirements for guidelines and oversight including training and technical updates, standardized documentation, standardized QA/QC checks, data review and data archiving.

  8. 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.

  9. Quality Control in Clinical Laboratory Samples

    DTIC Science & Technology

    2015-01-01

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

  10. 40 CFR 136.7 - Quality assurance and quality control.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... quality control elements, where applicable, into the laboratory's documented standard operating procedure... quality control elements must be clearly documented in the written standard operating procedure for each... Methods contains QA/QC procedures in the Part 1000 section of the Standard Methods Compendium. The...

  11. 40 CFR 136.7 - Quality assurance and quality control.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... quality control elements, where applicable, into the laboratory's documented standard operating procedure... quality control elements must be clearly documented in the written standard operating procedure for each... Methods contains QA/QC procedures in the Part 1000 section of the Standard Methods Compendium. The...

  12. 40 CFR 136.7 - Quality assurance and quality control.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... quality control elements, where applicable, into the laboratory's documented standard operating procedure... quality control elements must be clearly documented in the written standard operating procedure for each... Methods contains QA/QC procedures in the Part 1000 section of the Standard Methods Compendium. The...

  13. Field and laboratory analyses of water from the Columbia aquifer in Eastern Maryland

    USGS Publications Warehouse

    Bachman, L.J.

    1984-01-01

    Field and laboratory analyses of pH, alkalinity, and specific conductance from water samples collected from the Columbia aquifer on the Delmarva Peninsula in eastern Maryland were compared to determine if laboratory analyses could be used for making regional water-quality interpretations. Kruskal-Wallis tests of field and laboratory data indicate that the difference between field and laboratory values is usually not enough to affect the outcome of the statistical tests. Thus, laboratory measurements of these constituents may be adequate for making certain regional water-quality interpretations, although they may result in errors if used for geochemical interpretations.

  14. A senior manufacturing laboratory for determining injection molding process capability

    NASA Technical Reports Server (NTRS)

    Wickman, Jerry L.; Plocinski, David

    1992-01-01

    The following is a laboratory experiment designed to further understanding of materials science. This subject material is directed at an upper level undergraduate/graduate student in an Engineering or Engineering Technology program. It is assumed that the student has a thorough understanding of the process and quality control. The format of this laboratory does not follow that which is normally recommended because of the nature of process capability and that of the injection molding equipment and tooling. This laboratory is instead developed to be used as a point of departure for determining process capability for any process in either a quality control laboratory or a manufacturing environment where control charts, process capability, and experimental or product design are considered important topics.

  15. A winning formula for new laboratories.

    PubMed

    Robinson, Tim

    2012-11-01

    High quality architecture and extensive stakeholder consultations have transformed the delivery of Laboratory Medicine within Sheffield Teaching Hospitals NHS Foundation Trust (NHSFT), explains Tim Robinson, senior architect at Race Cottam Associates, the architects on a scheme that has seen laboratory services from across the city consolidated within one modern, spacious, well-lit, and well-equipped building that should provide an extremely positive, 'future-proofed' working environment for staff.

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

    PubMed

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  18. Audit to assess the quality of communication between operators and technicians in a fixed prosthodontic laboratory: educational and training implications.

    PubMed

    Dickie, J; Shearer, A C; Ricketts, D N J

    2014-02-01

    This audit aimed to assess the quality of communication between dental students/qualified dentists and dental technicians, increase the percentage of satisfactorily completed laboratory prescriptions and reduce the number of errors that can result from poor communication. A subsidiary aim was to educate students and staff in this respect. An audit of laboratory prescription completion was conducted within Dundee Dental Hospital. Four hundred and eighteen prescriptions for indirect fixed restorations completed by dental undergraduates and qualified staff were audited over a three month period (first audit cycle). Educational reminders on laboratory prescriptions were then provided to undergraduates and qualified staff, a further three hundred and twenty-two prescriptions were audited (second audit cycle) and compared with the first cycle. Satisfactorily completed prescriptions increased from 28% to 43% following basic educational intervention. However, this percentage still signifies a poor level of completion and the need for improvement. Some aspects of the prescription were completed better than others, but overall the standard remained poor with a significant number failing to comply with guidelines set by the UK General Dental Council, the European Union's Medical Devices Directive and the British Society for Restorative Dentistry (BSRD). Further undergraduate and staff training on laboratory prescription writing will be necessary through staff training events and developments in the undergraduate curriculum. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  19. A professional development model for medical laboratory scientists working in the immunohematology laboratory.

    PubMed

    Garza, Melinda N; Pulido, Lila A; Amerson, Megan; Ali, Faheem A; Greenhill, Brandy A; Griffin, Gary; Alvarez, Enrique; Whatley, Marsha; Hu, Peter C

    2012-01-01

    Transfusion medicine, a section of the Department of Laboratory Medicine at The University of Texas MD Anderson Cancer Center is committed to the education and advancement of its health care professionals. It is our belief that giving medical laboratory professionals a path for advancement leads to excellence and increases overall professionalism in the Immunohematology Laboratory. As a result of this strong commitment to excellence and professionalism, the Immunohematology laboratory has instituted a Professional Development Model (PDM) that aims to create Medical Laboratory Scientists (MLS) that are not only more knowledgeable, but are continually striving for excellence. In addition, these MLS are poised for advancement in their careers. The professional development model consists of four levels: Discovery, Application, Maturation, and Expert. The model was formulated to serve as a detailed path to the mastery of all process and methods in the Immunohematology Laboratory. Each level in the professional development model consists of tasks that optimize the laboratory workflow and allow for concurrent training. Completion of a level in the PDM is rewarded with financial incentive and further advancement in the field. The PDM for Medical Laboratory Scientists in the Immunohematology Laboratory fosters personal development, rewards growth and competency, and sets high standards for all services and skills provided. This model is a vital component of the Immunohematology Laboratory and aims to ensure the highest quality of care and standards in their testing. It is because of the success of this model and the robustness of its content that we hope other medical laboratories aim to reach the same level of excellence and professionalism, and adapt this model into their own environment.

  20. 42 CFR 493.1230 - Condition: General laboratory systems.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: General laboratory systems. 493.1230 Section 493.1230 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... overall quality of the general laboratory systems and correct identified problems as specified in § 493...

  1. Aquatic macroinvertebrates and water quality of Sandia Canyon, Los Alamos National Laboratory, December 1992--October 1993. Status report

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

    Cross, S.

    1994-09-01

    In the summer of 1990, an accidental spill from the TA-3 Power Plant Environment Tank released more than 3,785 liters of sulfuric acid into upper Sandia Canyon. The Biological Resource Evaluation Team (BRET) of EM-8 at Los Alamos National Laboratory (LANL) has collected aquatic samples from the stream within Sandia Canyon since then. These field studies gather water quality measurements and collect macroinvertebrates from permanent sampling sites. An earlier report by Bennett (1994) discusses previous BRET aquatic studies in Sandia Canyon. This report updates and expands Bennett`s initial findings. During 1993, BRET collected water quality data and aquatic macroinvertebrates atmore » five permanent stations within the canyon. The substrates of the upper three stations are largely sands and silts while the substrates of the two lower stations are largely rock and cobbles. The two upstream stations are located near outfalls that discharge industrial and sanitary waste effluent. The third station is within a natural cattail marsh, approximately 0.4 km (0.25 mi) downstream from Stations SC1 and SC2. Water quality parameters are slightly different at these first three stations from those expected of natural streams, suggesting slightly degraded water quality. Correspondingly, the macroinvertebrate communities at these stations are characterized by low diversities and poorly-developed community structures. The two downstream stations appear to be in a zone of recovery, where water quality parameters more closely resemble those found in natural streams of the area. Macroinvertebrate diversity increases and community structure becomes more complex at the two lower stations, which are further indications of improved water quality downstream.« less

  2. Lipid and lipoprotein testing in resource-limited laboratories.

    PubMed

    Myers, Gary L

    2003-01-01

    The role of total cholesterol (TC) and lipoproteins in the assessment of coronary heart disease (CHD) is firmly established from population and intervention studies. Total and low-density lipoprotein cholesterol (LDLC) levels are positively associated with CHD, and high-density lipoprotein cholesterol (HDLC) levels are negatively associated with CHD. Efforts to identify and treat people at increased risk based on cholesterol and lipoprotein levels have led to more lipid testing and the need for very reliable test results. Thus, quality laboratory services are an essential component of healthcare delivery and play a vital role in any strategy to reduce morbidity and mortality from CHD. In laboratories with limited resources, establishing laboratory capability to measure CHD risk markers may be a considerable challenge. Laboratories face problems in selecting proper techniques, difficulties in equipment availability and maintenance, and shortage of supplies, staffing, and supervision. The Centers for Disease Control and Prevention (CDC) has been providing technical assistance for more than 30 years to laboratories that measure lipids and lipoproteins and is willing to provide technical assistance as needed for other laboratories to develop this capability. CDC can provide technical assistance to establish lipid and lipoprotein testing capability to support a CHD public health program in areas with limited laboratory resources. This assistance includes: selecting a suitable testing instrument; providing training for laboratory technicians; establishing a simple quality control plan; and instructing staff on how to prepare frozen serum control materials suitable for assessing accuracy of lipid and lipoprotein testing.

  3. Error identification in a high-volume clinical chemistry laboratory: Five-year experience.

    PubMed

    Jafri, Lena; Khan, Aysha Habib; Ghani, Farooq; Shakeel, Shahid; Raheem, Ahmed; Siddiqui, Imran

    2015-07-01

    Quality indicators for assessing the performance of a laboratory require a systematic and continuous approach in collecting and analyzing data. The aim of this study was to determine the frequency of errors utilizing the quality indicators in a clinical chemistry laboratory and to convert errors to the Sigma scale. Five-year quality indicator data of a clinical chemistry laboratory was evaluated to describe the frequency of errors. An 'error' was defined as a defect during the entire testing process from the time requisition was raised and phlebotomy was done until the result dispatch. An indicator with a Sigma value of 4 was considered good but a process for which the Sigma value was 5 (i.e. 99.977% error-free) was considered well controlled. In the five-year period, a total of 6,792,020 specimens were received in the laboratory. Among a total of 17,631,834 analyses, 15.5% were from within hospital. Total error rate was 0.45% and of all the quality indicators used in this study the average Sigma level was 5.2. Three indicators - visible hemolysis, failure of proficiency testing and delay in stat tests - were below 5 on the Sigma scale and highlight the need to rigorously monitor these processes. Using Six Sigma metrics quality in a clinical laboratory can be monitored more effectively and it can set benchmarks for improving efficiency.

  4. Monitoring laboratory data across manufacturers and laboratories--A prerequisite to make "Big Data" work.

    PubMed

    Goossens, Kenneth; Van Uytfanghe, Katleen; Twomey, Patrick J; Thienpont, Linda M

    2015-05-20

    "The Percentiler" project provides quasi real-time access to patient medians across laboratories and manufacturers. This data can serve as "clearinghouse" for electronic health record applications, e.g., use of laboratory data for global health-care research. Participants send their daily outpatient medians to the Percentiler application. After 6 to 8weeks, the laboratory receives its login information, which gives access to the user interface. Data is assessed by peer group, i.e., 10 or more laboratories using the same test system. Participation is free of charge. Participation is global with, to date, >120 laboratories and >250 instruments. Up to now, several reports have been produced that address i) the general features of the project, ii) peer group observations; iii) synergisms between "The Percentiler" and dedicated external quality assessment surveys. Reasons for long-term instability and bias (calibration- or lot-effects) have been observed for the individual laboratory and manufacturers. "The Percentiler" project has the potential to build a continuous, global evidence base on in vitro diagnostic test comparability and stability. As such, it may be beneficial for all stakeholders and, in particular, the patient. The medical laboratory is empowered for contributing to the development, implementation, and management of global health-care policies. Copyright © 2015 Elsevier B.V. All rights reserved.

  5. Evolution of an International External Quality Assurance Model To Support Laboratory Investigation of Streptococcus pneumoniae, Developed for the SIREVA Project in Latin America, from 1993 to 2005▿

    PubMed Central

    Lovgren, Marguerite; Talbot, James A.; Brandileone, Maria Cristina; Casagrande, Silvana T.; Agudelo, Clara Inés; Castañeda, Elizabeth; Regueira, Mabel; Corso, Alejandra; Heitmann, Ingrid; Maldonado, Aurora; Echániz-Avilés, Gabriela; Soto-Noguerón, Araceli; Hortal, María; Camou, Teresa; Gabastou, Jean-Marc; Fabio, José Luis Di

    2007-01-01

    In 1993 the Pan American Health Organization initiated a laboratory-based surveillance system, called the SIREVA project, to learn about Streptococcus pneumoniae invasive disease in Latin American children. In 1994, National Laboratories in six countries were trained to perform serotyping and antibiotic susceptibility testing using broth microdilution to determine the MIC for specified antibiotics. An international External Quality Assurance (EQA) program was developed to monitor and support ongoing laboratory performance. The EQA program was coordinated by the National Centre for Streptococcus (NCS), Edmonton, Canada, and included external proficiency testing (EPT) and a validation process requiring regular submission of a sample of isolates from each laboratory to the NCS for verification of the serotype and MIC. In 1999, the EQA program was decentralized to use three of the original laboratories as regional quality control centers to address operational concerns and to accommodate the growth of the laboratory network to more than 20 countries including the Caribbean region. The overall EPT serotyping accuracies for phase I (1993 to 1998) and phase II (1999 to 2005) were 88.0 and 93.8%, respectively; the MIC correlations within ±1 log2 dilution of the expected result were 83.0 and 91.0% and the interpretive category agreements were 89.1 and 95.3%. Overall, the validation process serotyping accuracies for phases I and II were 81.9 and 88.1%, respectively, 80.4 and 90.5% for MIC agreement, and 85.8 and 94.3% for category agreement. These results indicate a high level of testing accuracy in participating National Laboratories and a sustained increase in EQA participation in Latin America and the Caribbean. PMID:17687007

  6. MICROBIAL LABORATORY GUIDANCE MANUAL FOR THE ...

    EPA Pesticide Factsheets

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

  7. Innovation in healthcare. The challenge for laboratory medicine.

    PubMed

    Price, Christopher P; St John, Andrew

    2014-01-01

    The delivery of healthcare is the product of a complex organization and it is not entirely surprising that innovation is not always considered to deliver on the expectations generated by invention. As policymakers and payers seek to improve the quality and value-for-money of healthcare, more attention is being directed at the barriers to innovation, and the challenges of translating inventions into outcomes. Laboratory medicine is one facet of healthcare that has generated considerable levels of invention but, while showing increasing volumes of activity over the past decades, it has not been recognized for generating the benefit in outcomes that might have been expected. One of the major reasons for this position has been the poor quality of evidence available to demonstrate the impact of laboratory investigations on health outcomes. Consequently an absence of evidence stifles the opportunity to develop the business case that demonstrates the link between test result and improved outcome. This has a major influence on the success of innovation in laboratory medicine. This review explores the process of innovation applied to laboratory medicine and offers an insight into how the impact of laboratory medicine on health outcomes can be improved. © 2013.

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

    PubMed

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

    2014-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  10. Environmental Response Laboratory Network (ERLN) Overview

    EPA Pesticide Factsheets

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

  11. On the Viability of Supporting Institutional Sharing of Remote Laboratory Facilities

    ERIC Educational Resources Information Center

    Lowe, David; Dang, Bridgette; Daniel, Keith; Murray, Stephen; Lindsay, Euan

    2015-01-01

    Laboratories are generally regarded as critical to engineering education, and yet educational institutions face significant challenges in developing and maintaining high-quality laboratory facilities. Remote laboratories are increasingly being explored as a partial solution to this challenge, with research showing that--for the right learning…

  12. Innovative ventilation system for animal anatomy laboratory

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

    Lacey, D.R.; Smith, D.C.

    1997-04-01

    A unique ventilation system was designed and built to reduce formaldehyde fumes in the large animal anatomy lab at the Vet Medical Center at Cornell University. The laboratory includes four rooms totaling 5,500 ft{sup 2}. The main room has 2,300 ft{sup 2} and houses the laboratory where up to 60 students dissect as many as 12 horses at a time. Other rooms are a cold storage locker, an animal preparation room and a smaller lab for specialized instruction. The large animal anatomy laboratory has a history of air quality complaints despite a fairly high ventilation rate of over 10 airmore » changes/hour. The horses are embalmed, creating a voluminous source of formaldehyde and phenol vapors. Budget constraints and increasingly stringent exposure limits for formaldehyde presented a great challenge to design a ventilation system that yields acceptable air quality. The design solution included two innovative elements: air-to-air heat recovery, and focused ventilation.« less

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

    PubMed

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

    2009-02-01

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

  14. 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...

  15. Training in laboratory management and the MBA/MD in laboratory medicine.

    PubMed

    Weiss, Ronald L

    2007-06-01

    The business of medicine requires more than just the knowledge and skills necessary to provide quality patient care. A growing number of opportunities are available for physicians to learn how to better manage the business side of their practices. Today's clinical laboratories, particularly those in health care organizations under pressure to efficiently use limited resources, benefit from having management and leadership specifically trained for these roles.

  16. Helms at photo quality window in Destiny Laboratory module

    NASA Image and Video Library

    2001-03-31

    ISS002-E-5489 (31 March 2001) --- Astronaut Susan J. Helms, Expedition Two flight engineer, views the topography of a point on Earth from the nadir window in the U.S. Laboratory / Destiny module of the International Space Station (ISS). The image was recorded with a digital still camera.

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

    PubMed

    Heintze, Siegward D

    2007-01-01

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

  18. [Accreditation of clinical laboratories based on ISO standards].

    PubMed

    Kawai, Tadashi

    2004-11-01

    International Organization for Standardization (ISO) have published two international standards (IS) to be used for accreditation of clinical laboratories; ISO/IEC 17025:1999 and ISO 15189:2003. Any laboratory accreditation body must satisfy the requirements stated in ISO/IEC Guide 58. In order to maintain the quality of the laboratory accreditation bodies worldwide, the International Laboratory Accreditation Cooperation (ILAC) has established the mutual recognition arrangement (MRA). In Japan, the International Accreditation Japan (IAJapan) and the Japan Accreditation Board for Conformity Assessment (JAB) are the members of the ILAC/MRA group. In 2003, the Japanese Committee for Clinical Laboratory Standards (JCCLS) and the JAB have established the Development Committee of Clinical Laboratory Accreditation Program (CLAP), in order to establish the CLAP, probably starting in 2005.

  19. Senior Laboratory Animal Technician | Center for Cancer Research

    Cancer.gov

    PROGRAM DESCRIPTION The Laboratory Animal Sciences Program (LASP) provides exceptional quality animal care and technical support services for animal research performed at the National Cancer Institute at the Frederick National Laboratory for Cancer Research. LASP executes this mission by providing a broad spectrum of state-of-the-art technologies and services that are focused

  20. National Laboratory Planning: Developing Sustainable Biocontainment Laboratories in Limited Resource Areas.

    PubMed

    Yeh, Kenneth B; Adams, Martin; Stamper, Paul D; Dasgupta, Debanjana; Hewson, Roger; Buck, Charles D; Richards, Allen L; Hay, John

    2016-01-01

    Strategic laboratory planning in limited resource areas is essential for addressing global health security issues. Establishing a national reference laboratory, especially one with BSL-3 or -4 biocontainment facilities, requires a heavy investment of resources, a multisectoral approach, and commitments from multiple stakeholders. We make the case for donor organizations and recipient partners to develop a comprehensive laboratory operations roadmap that addresses factors such as mission and roles, engaging national and political support, securing financial support, defining stakeholder involvement, fostering partnerships, and building trust. Successful development occurred with projects in African countries and in Azerbaijan, where strong leadership and a clear management framework have been key to success. A clearly identified and agreed management framework facilitate identifying the responsibility for developing laboratory capabilities and support services, including biosafety and biosecurity, quality assurance, equipment maintenance, supply chain establishment, staff certification and training, retention of human resources, and sustainable operating revenue. These capabilities and support services pose rate-limiting yet necessary challenges. Laboratory capabilities depend on mission and role, as determined by all stakeholders, and demonstrate the need for relevant metrics to monitor the success of the laboratory, including support for internal and external audits. Our analysis concludes that alternative frameworks for success exist for developing and implementing capabilities at regional and national levels in limited resource areas. Thus, achieving a balance for standardizing practices between local procedures and accepted international standards is a prerequisite for integrating new facilities into a country's existing public health infrastructure and into the overall international scientific community.

  1. National Laboratory Planning: Developing Sustainable Biocontainment Laboratories in Limited Resource Areas

    PubMed Central

    Adams, Martin; Stamper, Paul D.; Dasgupta, Debanjana; Hewson, Roger; Buck, Charles D.; Richards, Allen L.; Hay, John

    2016-01-01

    Strategic laboratory planning in limited resource areas is essential for addressing global health security issues. Establishing a national reference laboratory, especially one with BSL-3 or -4 biocontainment facilities, requires a heavy investment of resources, a multisectoral approach, and commitments from multiple stakeholders. We make the case for donor organizations and recipient partners to develop a comprehensive laboratory operations roadmap that addresses factors such as mission and roles, engaging national and political support, securing financial support, defining stakeholder involvement, fostering partnerships, and building trust. Successful development occurred with projects in African countries and in Azerbaijan, where strong leadership and a clear management framework have been key to success. A clearly identified and agreed management framework facilitate identifying the responsibility for developing laboratory capabilities and support services, including biosafety and biosecurity, quality assurance, equipment maintenance, supply chain establishment, staff certification and training, retention of human resources, and sustainable operating revenue. These capabilities and support services pose rate-limiting yet necessary challenges. Laboratory capabilities depend on mission and role, as determined by all stakeholders, and demonstrate the need for relevant metrics to monitor the success of the laboratory, including support for internal and external audits. Our analysis concludes that alternative frameworks for success exist for developing and implementing capabilities at regional and national levels in limited resource areas. Thus, achieving a balance for standardizing practices between local procedures and accepted international standards is a prerequisite for integrating new facilities into a country's existing public health infrastructure and into the overall international scientific community. PMID:27559843

  2. [Strategy Development for International Cooperation in the Clinical Laboratory Field].

    PubMed

    Kudo, Yoshiko; Osawa, Susumu

    2015-10-01

    The strategy of international cooperation in the clinical laboratory field was analyzed to improve the quality of intervention by reviewing documents from international organizations and the Japanese government. Based on the world development agenda, the target of action for health has shifted from communicable diseases to non-communicable diseases (NCD). This emphasizes the importance of comprehensive clinical laboratories instead of disease-specific examinations in developing countries. To achieve this goal, the World Health Organization (WHO) has disseminated to the African and Asian regions the Laboratory Quality Management System (LQMS), which is based on the same principles of the International Organization of Standardization (ISO) 15189. To execute this strategy, international experts must have competence in project management, analyze information regarding the target country, and develop a strategy for management of the LQMS with an understanding of the technical aspects of laboratory work. However, there is no appropriate pre- and post-educational system of international health for Japanese international workers. Universities and academic organizations should cooperate with the government to establish a system of education for international workers. Objectives of this education system must include: (1) training for the organization and understanding of global health issues, (2) education of the principles regarding comprehensive management of clinical laboratories, and (3) understanding the LQMS which was employed based on WHO's initiative. Achievement of these objectives will help improve the quality of international cooperation in the clinical laboratory field.

  3. Strengthening national health laboratories in sub-Saharan Africa: a decade of remarkable progress.

    PubMed

    Alemnji, G A; Zeh, C; Yao, K; Fonjungo, P N

    2014-04-01

    Efforts to combat the HIV/AIDS pandemic have underscored the fragile and neglected nature of some national health laboratories in Africa. In response, national and international partners and various governments have worked collaboratively over the last several years to build sustainable laboratory capacities within the continent. Key accomplishments reflecting this successful partnership include the establishment of the African-based World Health Organization Regional Office for Africa (WHO-AFRO) Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA); development of the Strengthening Laboratory Management Toward Accreditation (SLMTA) training programme; and launching of a Pan African-based institution, the African Society for Laboratory Medicine (ASLM). These platforms continue to serve as the foundations for national health laboratory infrastructure enhancement, capacity development and overall quality system improvement. Further targeted interventions should encourage countries to aim at integrated tiered referral networks, promote quality system improvement and accreditation, develop laboratory policies and strategic plans, enhance training and laboratory workforce development and a retention strategy, create career paths for laboratory professionals and establish public-private partnerships. Maintaining the gains and ensuring sustainability will require concerted action by all stakeholders with strong leadership and funding from African governments and from the African Union. Published 2014. This article is a U.S. Government work and is in the public domain in the U.S.A.

  4. [Responses to customer complaints at commercial laboratories].

    PubMed

    Honma, M

    1997-10-01

    For commercial laboratories, one of the routine duties involves responding to various kinds of inquiries and complaints received from customers. As causes of complaints, lack of communication between the laboratory and customer, and test errors were considered. In this paper, complaints received by our laboratory were collected and classified by content, and measures to prevent test error are reported. We think the complaints contain important information that can be used to improve the quality of our laboratory. We hope that reinforcement of communication with customers and promoting test knowledge among the customers can produce more clearly worded complaints which will provide more valuable information. We try to receive and deal with these complaints seriously.

  5. Quality management system and accreditation of the in vivo monitoring laboratory at Karslruhe Institute of Technology.

    PubMed

    Breustedt, B; Mohr, U; Biegard, N; Cordes, G

    2011-03-01

    The in vivo monitoring laboratory (IVM) at Karlsruhe Institute of Technology (KIT), with one whole body counter and three partial-body counters, is an approved lab for individual monitoring according to German regulation. These approved labs are required to prove their competencies by accreditation to ISO/IEC 17025:2005. In 2007 a quality management system (QMS), which was successfully audited and granted accreditation, was set up at the IVM. The system is based on the ISO 9001 certified QMS of the central safety department of the Research Centre Karlsruhe the IVM belonged to at that time. The system itself was set up to be flexible and could be adapted to the recent organisational changes (e.g. founding of KIT and an institute for radiation research) with only minor effort.

  6. The Pathology Laboratory Act 2007 explained.

    PubMed

    Looi, Lai-Meng

    2008-06-01

    The past century has seen tremendous changes in the scope and practice of pathology laboratories in tandem with the development of the medical services in Malaysia. Major progress was made in the areas of training and specialization of pathologists and laboratory technical staff. Today the pathology laboratory services have entered the International arena, and are propelled along the wave of globalization. Many new challenges have emerged as have new players in the field. Landmark developments over the past decade include the establishment of national quality assurance programmes, the mushrooming of private pathology laboratories, the establishment of a National Accreditation Standard for medical testing laboratories based on ISO 15189, and the passing of the Pathology Laboratory Act in Parliament in mid-2007. The Pathology Laboratory Act 2007 seeks to ensure that the pathology laboratory is accountable to the public, meets required standards of practice, participates in Quality Assurance programmes, is run by qualified staff, complies with safety requirements and is subject to continuous audit. The Act is applicable to all private laboratories (stand alone or hospital) and laboratories in statutory bodies (Universities, foundations). It is not applicable to public laboratories (established and operated by the government) and side-room laboratories established in clinics of registered medical or dental practitioners for their own patients (tests as in the First and Second Schedules respectively). Tests of the Third Schedule (home test blood glucose, urine glucose, urine pregnancy test) are also exempted. The Act has 13 Parts and provides for control of the pathology laboratory through approval (to establish and maintain) and licensing (to operate or provide). The approval or license may only be issued to a sole proprietor, partnership or body corporate, and then only if the entity includes a registered medical practitioner. Details of personnel qualifications and

  7. Challenges in small screening laboratories: implementing an on-demand laboratory information management system.

    PubMed

    Lemmon, Vance P; Jia, Yuanyuan; Shi, Yan; Holbrook, S Douglas; Bixby, John L; Buchser, William

    2011-11-01

    The Miami Project to Cure Paralysis, part of the University of Miami Miller School of Medicine, includes a laboratory devoted to High Content Analysis (HCA) of neurons. The goal of the laboratory is to uncover signaling pathways, genes, compounds, or drugs that can be used to promote nerve growth. HCA permits the quantification of neuronal morphology, including the lengths and numbers of axons. HCA of various libraries on primary neurons requires a team-based approach, a variety of process steps and complex manipulations of cells and libraries to obtain meaningful results. HCA itself produces vast amounts of information including images, well-based data and cell-based phenotypic measures. Documenting and integrating the experimental workflows, library data and extensive experimental results is challenging. For academic laboratories generating large data sets from experiments involving thousands of perturbagens, a Laboratory Information Management System (LIMS) is the data tracking solution of choice. With both productivity and efficiency as driving rationales, the Miami Project has equipped its HCA laboratory with an On Demand or Software As A Service (SaaS) LIMS to ensure the quality of its experiments and workflows. The article discusses how the system was selected and integrated into the laboratory. The advantages of a SaaS based LIMS over a client-server based system are described. © 2011 Bentham Science Publishers

  8. Development opportunities for hospital clinical laboratory joint ventures.

    PubMed

    Van Riper, J A

    1995-01-01

    Regional health-care providers are being given the opportunity to collaborate in specialty health-care services. Collaboration to achieve superior economies of scale is very effective in the clinical laboratory industry. National laboratory chains are consolidating and enhancing their control of the industry to ensure their historic profitability. National companies have closed many laboratory facilities and have laid off substantial numbers of laboratory personnel. Health-care providers can regain control of their locally generated laboratory health-care dollars by joining forces with clinical laboratory joint ventures. Laboratorians can assist the healthcare providers in bringing laboratory services and employment back to the local community. New capital for operational development and laboratory information systems will help bring the laboratory to the point of care. The independent regional laboratory is focused on supporting the medical needs of the community. The profit generated from a laboratory joint venture is shared among local health-care providers, supporting their economic viability. The laboratories' ability to contribute to the development of profit-making ventures will provide capital for new laboratory development. All of the above will ensure the clinical laboratories' role in providing quality health care to our communities and employment opportunities for laboratory personnel.

  9. Final report on the waste area grouping perimeter groundwater quality monitoring well installation program at Oak Ridge National Laboratory, Oak Ridge, Tennessee

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

    Greene, J.A.

    1991-06-01

    A groundwater quality monitoring well installation program was conducted at Oak Ridge National Laboratory (ORNL) to meet the requirements of environmental regulations, including the Resource Conservation and Recovery Act (RCRA) and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). A total of 173 wells were installed and developed at 11 different waste area groupings (WAGs) between June 1986 and November 1990. A location map of the wells is included.

  10. [The running status of Chinese Measles Laboratory Network in 2008].

    PubMed

    Zhang, Yan; Xu, Song-Tao; Jiang, Xiao-Hong

    2009-04-01

    To evaluate the running status of Measles laboratory network of China (Hong Kong, Macao and Taiwan were excluded) in 2008. To analyze the database of Measles laboratory network surveillance of the year 2008, and the database of serologic and virologic surveillance of National laboratory for Measles in Chinese Centers for Disease Control and Prevention(CCDC), then the indicators of the running of Measles laboratory network of China were analyzed. 1, serologic surveillance: 107,160 Measles sera samples were collected between Feburary and September of 2008, and the collection rate was 77.93%; 53 778 samples were qualified and positive for IgM, the positive percentage was 50.2%. 2, Virologic surveillance: 287 Measles viral isolates were isolated by 18 provincial Measles laboratories in 2008, all were certified as H1a genotype, H1a genotype was still the predominant genotype circulating in China; 29 Rubella viral isolates were isolated by 4 provincial Measles laboratories in 2008, all belonged to 1E genotype. 3, Laboratory quality control: National laboratory for Measles passed the proficiency test and on-site review in 2008; all provincial Measles laboratories passed the sera samples recheck and proficiency test hold by National laboratory for Measles in 2008; Tianjin, Shanxi, Shandong, Zhejiang, Jilin, Hubei, provincial Measles laboratory passed the on-site review by WHO. The running status of Chinese Measles laboratory network was good in 2008, and good laboratory quality control system was also set up, methods such as specimens collection, serologic detection, cell culture and viral isolation, etc, were standardized, and applied to Chinese Measles laboratory network, and it provided important scientific basis for eradication Measles in the year of 2012.

  11. International standards for tuberculosis care: relevance and implications for laboratory professionals.

    PubMed

    Pai, M; Daley, P; Hopewell, P C

    2007-04-01

    On World Tuberculosis (TB) Day 2006, the International Standards for Tuberculosis Care (ISTC) was officially released and widely endorsed by several agencies and organizations. The ISTC release was the culmination of a year long global effort to develop and set internationally acceptable, evidence-based standards for tuberculosis care. The ISTC describes a widely endorsed level of care that all practitioners, public and private, should seek to achieve in managing individuals who have or are suspected of having, TB and is intended to facilitate the effective engagement of all healthcare providers in delivering high quality care for patients of all ages, including those with smear-positive, smear-negative and extra-pulmonary TB, TB caused by drug-resistant Mycobacterium tuberculosis and TB/HIV coinfection. In this article, we present the ISTC, with a special focus on the diagnostic standards and describe their implications and relevance for laboratory professionals in India and worldwide. Laboratory professionals play a critical role in ensuring that all the standards are actually met by providing high quality laboratory services for smear microscopy, culture and drug susceptibility testing and other services such as testing for HIV infection. In fact, if the ISTC is widely followed, it can be expected that there will be a greater need and demand for quality assured laboratory services and this will have obvious implications for all laboratories in terms of work load, requirement for resources and trained personnel and organization of quality assurance systems.

  12. Accreditation experience of radioisotope metrology laboratory of Argentina.

    PubMed

    Iglicki, A; Milá, M I; Furnari, J C; Arenillas, P; Cerutti, G; Carballido, M; Guillén, V; Araya, X; Bianchini, R

    2006-01-01

    This work presents the experience developed by the Radioisotope Metrology Laboratory (LMR), of the Argentine National Atomic Energy Commission (CNEA), as result of the accreditation process of the Quality System by ISO 17025 Standard. Considering the LMR as a calibration laboratory, services of secondary activity determinations and calibration of activimeters used in Nuclear Medicine were accredited. A peer review of the (alpha/beta)-gamma coincidence system was also carried out. This work shows in detail the structure of the quality system, the results of the accrediting audit and gives the number of non-conformities detected and of observations made which have all been resolved.

  13. Science Laboratory Environment and Academic Performance

    NASA Astrophysics Data System (ADS)

    Aladejana, Francisca; Aderibigbe, Oluyemisi

    2007-12-01

    The study determined how students assess the various components of their science laboratory environment. It also identified how the laboratory environment affects students' learning outcomes. The modified ex-post facto design was used. A sample of 328 randomly selected students was taken from a population of all Senior Secondary School chemistry students in a state in Nigeria. The research instrument, Science Laboratory Environment Inventory (SLEI) designed and validated by Fraser et al. (Sci Educ 77:1-24, 1993) was administered on the selected students. Data analysis was done using descriptive statistics and Product Moment Correlation. Findings revealed that students could assess the five components (Student cohesiveness, Open-endedness, Integration, Rule clarity, and Material Environment) of the laboratory environment. Student cohesiveness has the highest assessment while material environment has the least. The results also showed that the five components of the science laboratory environment are positively correlated with students' academic performance. The findings are discussed with a view to improving the quality of the laboratory environment, subsequent academic performance in science and ultimately the enrolment and retaining of learners in science.

  14. [Costs and prices of laboratory services].

    PubMed

    Magid, E; Bartels, P D; Brandslund, I; Christensen, M S; Fahrenkrug, J; Hørder, M; Olsen, H; Pedersen, K O; Riber, E

    1991-09-23

    Cost accounting is performed in private and public laboratories. Guidelines for these activities are required and with this objective in mind, the Board of the Danish Society of Clinical Chemistry commissioned a working group to produce a position paper which is presented now in this report. The report discusses the objectives, the principles and the general requirements for cost accounting. The significance of information on costs for the clinicians' rational use of the laboratory is also illustrated. The working group points out that prerequisites for lucid and appropriate costing guidelines are clarification of which purposes information on costs are meant to serve, identification of the relevant cost centers and quality assurance of laboratory services to a defined extent. It is common practice to express laboratory costs as costs per test. The report advocates calculation of the cost per patient contact, i.e. the overall costs for laboratory service in a given investigative situation.

  15. U.S. Geological Survey Standard Reference Sample Project: Performance Evaluation of Analytical Laboratories

    USGS Publications Warehouse

    Long, H. Keith; Daddow, Richard L.; Farrar, Jerry W.

    1998-01-01

    Since 1962, the U.S. Geological Survey (USGS) has operated the Standard Reference Sample Project to evaluate the performance of USGS, cooperator, and contractor analytical laboratories that analyze chemical constituents of environmental samples. The laboratories are evaluated by using performance evaluation samples, called Standard Reference Samples (SRSs). SRSs are submitted to laboratories semi-annually for round-robin laboratory performance comparison purposes. Currently, approximately 100 laboratories are evaluated for their analytical performance on six SRSs for inorganic and nutrient constituents. As part of the SRS Project, a surplus of homogeneous, stable SRSs is maintained for purchase by USGS offices and participating laboratories for use in continuing quality-assurance and quality-control activities. Statistical evaluation of the laboratories results provides information to compare the analytical performance of the laboratories and to determine possible analytical deficiences and problems. SRS results also provide information on the bias and variability of different analytical methods used in the SRS analyses.

  16. Environmental Response Laboratory Network Membership and Benefits

    EPA Pesticide Factsheets

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

  17. Category 1 external quality assessment program for serum creatinine.

    PubMed

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

    2017-03-01

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

  18. Perceptions of a medical microbiology service: a survey of laboratory users.

    PubMed Central

    Morgan, M S

    1995-01-01

    AIM--To ascertain the perception of laboratory users regarding the quality of the medical microbiology services in a district general hospital. METHODS--Detailed questionnaires were circulated to all clinicians in the locality, with headings covering the quality of medical advice provided, the availability of information on specimen collection, format of request forms, specimen transport arrangements, turnaround times, the quality and need for interpretative advice, and the overall impression of the quality of the services provided. RESULTS--Two hundred and thirty five replies were received, giving a response rate of 69%. Transportation of specimens and communication of reports were identified as priority areas for improvement. The overall quality of the service was perceived as satisfactory, although areas were identified where substantial improvements could be made, some at little or no cost to the laboratory. CONCLUSIONS--The survey focused clinicians' attention on the service, raised the profile of the laboratory, and resulted in improved communications and a better understanding of customer needs. Overall, the exercise was felt to be extremely useful, and worthwhile repeating to gauge the effect of the changes instituted as a result. PMID:8537489

  19. A modified laboratory canning protocol for quality evaluation of dry bean (Phaseolus vulgaris L).

    PubMed

    Balasubramanian, Parthiba; Slinkard, Alfred; Tyler, Robert; Vandenberg, Albert

    2000-05-01

    The effects of calcium (Ca 2+ ) level in the soak water, blanch water and brine, blanching temperature, and total seed solids on dry bean canning quality were investigated to optimise a laboratory canning protocol. A linear increase in the Ca 2+ level of soak water, blanch water and brine resulted in a linear decrease in hydration coefficient and percent washed drained weight but a linear increase in texture. Low Ca 2+ level (10 mg kg -1 ) reduced the hydration time for dry bean seed from 14 to 1 h. Blanching temperatures of 50, 70 and 88 °C had non-significant effects on canning quality traits. Blanching for 30 min at 70 °C for black bean or at 88 °C for navy bean and pinto bean resulted in percent washed drained weight ≥ 60, as required by the Canada Agricultural Products Standards Act. Seed solids levels of 95-97 g per 300 × 407 (14 fl oz) can were sufficient to attain a percent washed drained weight of 60. It was confirmed that the thermal processing conditions (115.6 °C retort temperature, 45 min) used in this study were sufficient to achieve commercial sterility. The optimised lab protocol for evaluation of the canning quality of dry bean breeding lines is as follows. Seed containing 95 g of solids for pinto bean, 96 g for navy bean and 97 g for black bean is soaked in water for 30 min at 20 °C and blanched for 30 min at 70 °C for black bean and 88 °C for navy bean and pinto bean in water containing 10 mg kg -1 of Ca 2+ . The seed is then transferred to a 300 × 407 can, filled with brine containing 10 mg kg -1 of Ca 2+ , 1.3% (w/v) of NaCl and 1.6% (w/v) of sugar. The can is then sealed, processed in steam at 115.6 °C for 45 min and cooled at 20 °C for 20 min. Cans are stored for at least 2 weeks prior to quality evaluation of the canned product. Canning of dry bean seed according to this protocol results in precise estimation of canning quality traits, particularly percent

  20. Accreditation of medical laboratories in Croatia--experiences of the Institute of Clinical Chemistry, University Hospital "Merkur", Zagreb.

    PubMed

    Flegar-Mestrić, Zlata; Nazor, Aida; Perkov, Sonja; Surina, Branka; Kardum-Paro, Mirjana Mariana; Siftar, Zoran; Sikirica, Mirjana; Sokolić, Ivica; Ozvald, Ivan; Vidas, Zeljko

    2010-03-01

    Since 2003 when the international norm for implementation of quality management in medical laboratories (EN ISO 15189, Medical laboratories--Particular requirements for quality and competence) was established and accepted, accreditation has become practical, generally accepted method of quality management and confirmation of technical competence of medical laboratories in the whole world. This norm has been translated into Croatian and accepted by the Croatian Institute for Norms as Croatian norm. Accreditation is carried out on voluntary basis by the Croatian Accreditation Agency that has up to now accredited two clinical medical biochemical laboratories in the Republic of Croatia. Advantages of accredited laboratory lie in its documented management system, constant improvement and training, reliability of test results, establishing users' trust in laboratory services, test results comparability and interlaboratory (international) test results acceptance by adopting the concept of metrological traceability in laboratory medicine.

  1. Bone Marrow Synoptic Reporting for Hematologic Neoplasms: Guideline From the College of American Pathologists Pathology and Laboratory Quality Center.

    PubMed

    Sever, Cordelia; Abbott, Charles L; de Baca, Monica E; Khoury, Joseph D; Perkins, Sherrie L; Reichard, Kaaren Kemp; Taylor, Ann; Terebelo, Howard R; Colasacco, Carol; Rumble, R Bryan; Thomas, Nicole E

    2016-09-01

    -There is ample evidence from the solid tumor literature that synoptic reporting improves accuracy and completeness of relevant data. No evidence-based guidelines currently exist for synoptic reporting for bone marrow samples. -To develop evidence-based recommendations to standardize the basic components of a synoptic report template for bone marrow samples. -The College of American Pathologists Pathology and Laboratory Quality Center convened a panel of experts in hematopathology to develop recommendations. A systematic evidence review was conducted to address 5 key questions. Recommendations were derived from strength of evidence, open comment feedback, and expert panel consensus. -Nine guideline statements were established to provide pathology laboratories with a framework by which to develop synoptic reporting templates for bone marrow samples. The guideline calls for specific data groups in the synoptic section of the pathology report; provides a list of evidence-based parameters for key, pertinent elements; and addresses ancillary testing. -A framework for bone marrow synoptic reporting will improve completeness of the final report in a manner that is clear, succinct, and consistent among institutions.

  2. [Point-of-care-testing--the intensive care laboratory].

    PubMed

    Müller, M M; Hackl, W; Griesmacher, A

    1999-01-01

    After successful centralization of laboratory analyses since more than 30 years, advances in biosensors, microprocessors, measurement of undiluted whole blood and miniaturization of laboratory analyzers are leading nowadays more and more to a re-decentralization in the laboratory medicine. Point-of-care-testing (POCT), which is defined as any laboratory test performed outside central or decentralized laboratories, is becoming more and more popular. The theoretical advantages of POCT are faster turn-around-times (TAT), more rapid medical decisions, avoidance of sample identification and sample transport problems and the need of only small specimen volumes. These advantages are frequently mentioned, but are not associated with a clear clinical benefit. The disadvantages of POCT such as incorrect handling and/or maintenance of the analyzers by nontrained clinical staff, inadequate or even absent calibrations and/or quality controls, lack of cost-effectiveness because of an increased number of analyzers and more expensive reagents, insufficient documentation and difficult comparability of the obtained POCT-results with routine laboratory results, are strongly evident. According to the authors' opinion the decision for the establishing of POCT has only to be made in a close co-operation between physicians and laboratorians in order to vouch for necessity and high quality of the analyses. Taking the local situation into consideration (24-h-central laboratory, etc.) the spectrum of parameters measured by means of POCT should be rigorously restricted to the vital functions. Such analytes should be: hemoglobin or hematocrit, activated whole blood clotting time, blood gases, sodium, potassium, ionized calcium, glucose, creatinine, ammonia and lactate.

  3. Highly Integrated Quality Assurance – An Empirical Case

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

    Drake Kirkham; Amy Powell; Lucas Rich

    2011-02-01

    Highly Integrated Quality Assurance – An Empirical Case Drake Kirkham1, Amy Powell2, Lucas Rich3 1Quality Manager, Radioisotope Power Systems (RPS) Program, Idaho National Laboratory, P.O. Box 1625 M/S 6122, Idaho Falls, ID 83415-6122 2Quality Engineer, RPS Program, Idaho National Laboratory 3Quality Engineer, RPS Program, Idaho National Laboratory Contact: Voice: (208) 533-7550 Email: Drake.Kirkham@inl.gov Abstract. The Radioisotope Power Systems Program of the Idaho National Laboratory makes an empirical case for a highly integrated Quality Assurance function pertaining to the preparation, assembly, testing, storage and transportation of 238Pu fueled radioisotope thermoelectric generators. Case data represents multiple campaigns including the Pluto/New Horizons mission,more » the Mars Science Laboratory mission in progress, and other related projects. Traditional Quality Assurance models would attempt to reduce cost by minimizing the role of dedicated Quality Assurance personnel in favor of either functional tasking or peer-based implementations. Highly integrated Quality Assurance adds value by placing trained quality inspectors on the production floor side-by-side with nuclear facility operators to enhance team dynamics, reduce inspection wait time, and provide for immediate, independent feedback. Value is also added by maintaining dedicated Quality Engineers to provide for rapid identification and resolution of corrective action, enhanced and expedited supply chain interfaces, improved bonded storage capabilities, and technical resources for requirements management including data package development and Certificates of Inspection. A broad examination of cost-benefit indicates highly integrated Quality Assurance can reduce cost through the mitigation of risk and reducing administrative burden thereby allowing engineers to be engineers, nuclear operators to be nuclear operators, and the cross-functional team to operate more efficiently. Applicability of this

  4. [What's the point of cost management in clinical laboratories?].

    PubMed

    Setoyama, Tomokazu; Yamauchi, Kazuyoshi; Katsuyama, Tsutomu

    2006-11-01

    Clinical laboratories need to know and manage the costs of laboratory tests, because they need financial data (1) to estimate costs per patient, (2) to request a budget to buy equipment, and (3) to improve their work; however, less than 40% laboratories practice cost management. In 2002, Shinshu University Hospital began to assess the costs of laboratory tests, but it was difficult to evaluate the quality of our cost management because there are few data and papers about the costs of laboratory tests in Japan. In this article, we practiced cost analysis using Shinshu University Hospital's data for 3 years (2002-2004), and studied the features of laboratory test costs and the problems of laboratory cost management. As a result, we listed 7 points to check cost management in clinical laboratories. This check list was established using only one data from our hospital. So, we suggest the benchmarking laboratory test costs between laboratories of the same type of hospitals or various laboratories.

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

    USGS Publications Warehouse

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

    1996-01-01

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

  6. Competency Assessment of Microbiology Medical Laboratory Technologists in Ontario, Canada

    PubMed Central

    Fleming, Christine Ann

    2014-01-01

    Accreditation in Ontario, Canada, requires that licensed clinical laboratories participate in external quality assessment (also known as proficiency testing) and perform competency evaluation of their staff. To assess the extent of ongoing competency assessment practices, the Quality Management Program—Laboratory Services (QMP-LS) Microbiology Committee surveyed all 112 licensed Ontario microbiology laboratories. The questionnaire consisted of a total of 21 questions that included yes/no, multiple-choice, and short-answer formats. Participants were asked to provide information about existing programs, the frequency of testing, what areas are evaluated, and how results are communicated to the staff. Of the 111 responding laboratories, 6 indicated they did not have a formal evaluation program since they perform only limited bacteriology testing. Of the remaining 105 respondents, 87% perform evaluations at least annually or every 2 years, and 61% include any test or task performed, whereas 16% and 10% focus only on problem areas and high-volume complex tasks, respectively. The most common methods of evaluation were review of external quality assessment (EQA) challenges, direct observation, and worksheet review. With the exception of one participant, all communicate results to staff, and most take remedial action to correct the deficiencies. Although most accredited laboratories have a program to assess the ongoing competency of their staff, the methods used are not standardized or consistently applied, indicating that there is room for improvement. The survey successfully highlighted potential areas for improvement and allowed the QMP-LS Microbiology Committee to provide guidance to Ontario laboratories for establishing or improving existing microbiology-specific competency assessment programs. PMID:24899030

  7. Promoting, building and sustaining a regional laboratory network in a changing environment.

    PubMed

    More, J D; Sengupta, S K; Manley, P N

    2000-01-01

    The Queen's University Department of Pathology and its affiliated hospital laboratories (Kingston, Canada) have operated a successful laboratory outreach program for more than a decade in Southeastern Ontario. The outreach program provides high quality reference testing and technical and professional expertise in laboratory medicine to largely rural and small urban community hospitals. As a consequence of dramatic cuts to the publicly funded health-care system in the Province of Ontario, the environment in which laboratory medicine is practiced has altered irrevocably. This article discusses some of the difficult internal and external challenges faced by the outreach program within the region and how they were effectively managed, not only to maintain but to enhance the program's services. The result has been a continued improvement in the quality of laboratory services in the region with significantly increased cost-effectiveness, largely through reengineering and consolidation.

  8. Laboratory ginning and blending impacts on cotton fiber micronaire measurements

    USDA-ARS?s Scientific Manuscript database

    Micronaire, a critical cotton quality parameter, is normally measured in a conditioned laboratory, but increasing interest has been shown in new technologies that can measure micronaire both in and outside of the laboratory. Near Infrared (NIR) technology has demonstrated its ability to measure cot...

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

    PubMed Central

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

    2013-01-01

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

  10. 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

  11. Tritium laboratory with multiple purposes at NIPNE Magurele Romania

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

    Matei, L.; Postolache, C.

    2008-07-15

    The Tritium Laboratory from NIPNE (Romania)) is part of Radioisotope Research and Production Center. The Tritium Laboratory has been in operation since 1960, and carries out R and D activities involving tritium sources in gaseous, liquids and solid state, provides specialized service to CANDU NPP Cernavoda (Romania)), and provides tritium assay services to internal and external customers. The paper presents the activities and perspectives of Tritium Laboratory and its performances in accordance with Quality System Management. (authors)

  12. Uses and biases of volunteer water quality data

    USGS Publications Warehouse

    Loperfido, J.V.; Beyer, P.; Just, C.L.; Schnoor, J.L.

    2010-01-01

    State water quality monitoring has been augmented by volunteer monitoring programs throughout the United States. Although a significant effort has been put forth by volunteers, questions remain as to whether volunteer data are accurate and can be used by regulators. In this study, typical volunteer water quality measurements from laboratory and environmental samples in Iowa were analyzed for error and bias. Volunteer measurements of nitrate+nitrite were significantly lower (about 2-fold) than concentrations determined via standard methods in both laboratory-prepared and environmental samples. Total reactive phosphorus concentrations analyzed by volunteers were similar to measurements determined via standard methods in laboratory-prepared samples and environmental samples, but were statistically lower than the actual concentration in four of the five laboratory-prepared samples. Volunteer water quality measurements were successful in identifying and classifying most of the waters which violate United States Environmental Protection Agency recommended water quality criteria for total nitrogen (66%) and for total phosphorus (52%) with the accuracy improving when accounting for error and biases in the volunteer data. An understanding of the error and bias in volunteer water quality measurements can allow regulators to incorporate volunteer water quality data into total maximum daily load planning or state water quality reporting. ?? 2010 American Chemical Society.

  13. Integration of laboratory and process testing data

    PubMed Central

    Tyszkiewicz, Michael

    1995-01-01

    The author describes ACS Inc.'s Pro-LIMS system which integrates laboratory and process procedures. The system has been shown to be an important toolfor quality assurance in the process manufacturing industry. PMID:18924782

  14. Environmental Response Laboratory Network (ERLN) Data Submission Requirements

    EPA Pesticide Factsheets

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

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

    PubMed

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

    2015-01-01

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

  16. Individualized Quality Control Plan (IQCP): Is It Value-Added for Clinical Microbiology?

    PubMed Central

    Miller, Melissa B.; Hindler, Janet

    2015-01-01

    The Center for Medicaid and Medicare Services (CMS) recently published their Individualized Quality Control Plan (IQCP [https://www.cms.gov/regulations-and-guidance/legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html]), which will be the only option for quality control (QC) starting in January 2016 if laboratories choose not to perform Clinical Laboratory Improvement Act (CLIA) [U.S. Statutes at Large 81(1967):533] default QC. Laboratories will no longer be able to use “equivalent QC” (EQC) or the Clinical and Laboratory Standards Institute (CLSI) standards alone for quality control of their microbiology systems. The implementation of IQCP in clinical microbiology laboratories will most certainly be an added burden, the benefits of which are currently unknown. PMID:26447112

  17. Laboratory challenges conducting international clinical research in resource-limited settings.

    PubMed

    Fitzgibbon, Joseph E; Wallis, Carole L

    2014-01-01

    There are many challenges to performing clinical research in resource-limited settings. Here, we discuss several of the most common laboratory issues that must be addressed. These include issues relating to organization and personnel, laboratory facilities and equipment, standard operating procedures, external quality assurance, shipping, laboratory capacity, and data management. Although much progress has been made, innovative ways of addressing some of these issues are still very much needed.

  18. 24th geotechnical laboratory testing short course

    DOT National Transportation Integrated Search

    2008-02-01

    This is a 3-day workshop/short course to teach practicing professionals techniques and procedures for conducting high quality geotechnical laboratory tests. Transportation facility design and construction begins with an investigation of the type, ext...

  19. Quality assurance for health and environmental chemistry: 1990

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

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

    1991-10-01

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

  20. Managing laboratory automation in a changing pharmaceutical industry

    PubMed Central

    Rutherford, Michael L.

    1995-01-01

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