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Sample records for quality laboratory microform

  1. Bibliographic Control of Microforms.

    ERIC Educational Resources Information Center

    Reichmann, Felix; Tharpe, Josephine M.

    There are two major parts to this book. The first is a study of bibliographic control of microforms, and the second is an extensive annotated bibliography of microforms. The study included a survey of 190 libraries and showed that local bibliographic control of microforms is often so inadequate that usefulness of the microform collection is…

  2. Microform and the Historian.

    ERIC Educational Resources Information Center

    Morrill, J. S.

    1987-01-01

    This discussion of the microform publication of primary source material focuses on the area of British history between 1450 and 1750. The efforts of University Microfilms International and Harvester Press Microforms Ltd. are reviewed, and a possible microform series of material from this period is suggested. Four references are listed. (MES)

  3. Microforms in Information Handling.

    ERIC Educational Resources Information Center

    Williams, B. J. S.

    In an attempt to identify some of the factors which influence the utility of microforms as a medium for information handling, this report first traces some of the landmarks in the evolution of microforms since their invention in 1893. It next provides a factual account of current microform media and formats. The last section of the report contains…

  4. Microform Developments Related to Acquisitions.

    ERIC Educational Resources Information Center

    Sullivan, Robert C.

    1985-01-01

    Focuses on significant developments of the recent past in acquisition and control of library microforms. Highlights include reference works essential to acquisition of microforms and microform equipment, microform utilization in libraries, bibliographic control, computer output microfilm (COM) and the Copyright Law, technological developments,…

  5. Microform Developments Related to Acquisitions.

    ERIC Educational Resources Information Center

    Sullivan, Robert C.

    1985-01-01

    Focuses on significant developments of the recent past in acquisition and control of library microforms. Highlights include reference works essential to acquisition of microforms and microform equipment, microform utilization in libraries, bibliographic control, computer output microfilm (COM) and the Copyright Law, technological developments,…

  6. Special Microform Collections.

    ERIC Educational Resources Information Center

    Stewart, R. C.; Byrnes, Margaret

    Focusing on the major collections in the microform reading room at the University of Michigan Library, this guide lists only those collections for which there are indexes or guides in the microform reference collection. Materials described include personal family and presidential papers, early American newspapers, bibliographies of books and…

  7. Microform Publications: Hardware and Suppliers

    ERIC Educational Resources Information Center

    Folcarelli, Ralph J.; Ferragamo, Ralph C.

    1976-01-01

    The importance of microforms as library media, the status of the micropublishing industry as it relates to libraries, developments in micropublishing and micrographics with impact on future library services, microform selection, and major sources. (Author/LS)

  8. Microforms Policy and Procedures Manual.

    ERIC Educational Resources Information Center

    Eichhorn, Sara, Comp.

    This manual formulates guidelines and serves as a policy document for microforms service at the Microforms Desk of the Government Publications and Microforms Department of the University of California, Irvine. Introductory materials include a description of the nature of the service and statements of its objectives and policies for dealing with…

  9. Microforms as Library Tools.

    ERIC Educational Resources Information Center

    Avedon, Don M.

    1981-01-01

    Describes various microforms (any form, either film or paper, which contains microimages), indicating the advantages and disadvantages of roll film, aperture cards, microfiche, jackets, and micro-opaques. Phases and benefits of micropublishing, seven types of microfilm, safety film, processed microfilm, and storage are noted. Ten references are…

  10. The ARL Microform Project.

    ERIC Educational Resources Information Center

    Association of Research Libraries, Washington, DC.

    In 1980, a study was conducted for the Association of Research Libraries (ARL) by Information Systems Consultants (ISCI) which led to the establishment of the ARL Microform Project. Based on a three-part survey, to which a total of 848 academic, government, public, and special libraries responded, the ISCI study covered: (1) general microform…

  11. Microform Reader Maintenance.

    ERIC Educational Resources Information Center

    Hall, Hal W.; Michaels, George H.

    1985-01-01

    Describes experiences in organizing a program of microform reader and reader/printer maintenance at Texas A & M's Sterling C. Evans Library and offers guidelines for regular machine maintenance and repair. Guidelines discussed relate to maintenance philosophy, general machine cleaning, troubleshooting, service contracts, supplies,…

  12. Microform Developments Related to Acquisitions

    ERIC Educational Resources Information Center

    Sullivan, Robert C.

    1973-01-01

    Libraries are spending an increasing amount of money on acquisitions and an expanding portion of these expenditures is for microforms. It behooves the acquisitions librarian to be aware of changes and developments in microforms and to interpret what effect they will have on acquisitions. (50 references) (Author/SJ)

  13. 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…

  14. 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…

  15. Microform Systems. A Handbook for Educators.

    ERIC Educational Resources Information Center

    Lee, Thomas Graham

    Microform systems are utilized by educational institutions for administrative, library, and instructional purposes. This booklet examines specific examples of all three types of microform usage. The basic components of a microform system-input devices, storage devices, retrieval methods, and output devices--are described and illustrated. Ten…

  16. Automation in Microforms: An Academic Microform Publisher's Response.

    ERIC Educational Resources Information Center

    Hamilton, Linda K.

    1984-01-01

    Summarizes current status of and concerns about automation in the academic microform publishing industry in two areas: automation of film production (computer-aided design, computer-assisted retrieval, computer-output microfilm) and automation of bibliographic control information (order-management systems, production of printed indexes,…

  17. Analytical laboratory quality audits

    SciTech Connect

    Kelley, William D.

    2001-06-11

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

  18. Microforms and the Library: A Review Article.

    ERIC Educational Resources Information Center

    Spreitzer, Francis F.

    1979-01-01

    This review of "Microform Librarianship" (a nontechnical guide) and "Computer-Output Microfilm: Its Library Applications" (a concise introduction to COM) points out that the vision of how the microform medium could be developed more imaginatively to better serve the user is missing from both books. (CWM)

  19. Microforms in a Medical Library Environment.

    ERIC Educational Resources Information Center

    Basile, Victor A.; Kapadia, Sushila

    A microform program is proposed based on the availability of the microforms and the literature requirements of a growing health science community. The program concentrates on miniaturized serials, government-sponsored research reports, and micrographic catalogues. It considers their acquisitions, format, and organization; itemizes the hardware…

  20. Microform Film Stock: A Hobson's Choice. Are Librarians Getting the Worst of Both Worlds? (and) Microfilm Types: There Really Is a Choice.

    ERIC Educational Resources Information Center

    Dupont, Jerry; Dodson, Suzanne Cates

    1986-01-01

    Two articles summarize qualities of medium being used in production of microforms: silver halide film, diazo film, and vesicular film. Highlights include policy of Law Library Microform Consortium, a nonprofit library cooperative and major supplier of legal materials on microfiche; archival storage and preservation; and recent recommendations.…

  1. Current Developments in Colour Microform Technology.

    ERIC Educational Resources Information Center

    Gunn, Michael J.

    1985-01-01

    Addresses some lingering problems with production and use of color microforms, e.g., reliable microfilm emulsion, color temperature, and image fading; and reports on recent advances in color stability and accuracy and international efforts to standardize production. (MBR)

  2. Factors Affecting the Acceptability of Microforms as a Reading Medium.

    ERIC Educational Resources Information Center

    Spencer, Herbert; Reynolds, Linda

    Based on visits to representative microform users and an extensive survey of relevant literature, a study was undertaken to assess the relative importance of factors affecting the acceptability of microforms as reading mediums. The following variables were considered: (1) microform characteristics; (2) equipment design; (3) work station design;…

  3. Factors Affecting the Acceptability of Microforms as a Reading Medium.

    ERIC Educational Resources Information Center

    Spencer, Herbert; Reynolds, Linda

    Based on visits to representative microform users and an extensive survey of relevant literature, a study was undertaken to assess the relative importance of factors affecting the acceptability of microforms as reading mediums. The following variables were considered: (1) microform characteristics; (2) equipment design; (3) work station design;…

  4. Quality in pathology laboratory practice.

    PubMed

    Weinstein, S

    1995-06-01

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

  5. 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.

  6. Cooperative Microform Publishing: The Law Library Experience.

    ERIC Educational Resources Information Center

    Dupont, Jerry

    1983-01-01

    Discussion of the Hawaii-based Law Library Microform Consortium (LLMC), a nonprofit interlibrary cooperative microfiche project involving several hundred American and foreign law libraries, outlines LLMC's history, organizational structure, operations, publishing record, marketing efforts, and prospects for the future. (EJS)

  7. Cooperative Microform Publishing: The Law Library Experience.

    ERIC Educational Resources Information Center

    Dupont, Jerry

    1983-01-01

    Discussion of the Hawaii-based Law Library Microform Consortium (LLMC), a nonprofit interlibrary cooperative microfiche project involving several hundred American and foreign law libraries, outlines LLMC's history, organizational structure, operations, publishing record, marketing efforts, and prospects for the future. (EJS)

  8. [Good Laboratory Practice (GPL) and quality control in Dutch laboratories].

    PubMed

    Goudswaard, J

    1991-03-15

    A review of the origin of GLP (Good Laboratory Practice) and ISO (International Standard Organisation) directives is followed by a number of definitions of concepts such as quality, guarantees of quality, quality systems, etc. by laboratories (NEN 2653). These requirements are discussed in the paper. Certification is one of the guarantees of quality assessment by laboratories. Certification of laboratories is carried out by STERLAB (Laboratory Accreditation Board of The Netherlands) or the CCKL (National Coordination Committee for Quality Assurance for Health Care Laboratories in The Netherlands). In addition to certification, laboratories in the Netherlands are extremely active as regards external quality control (QC). QC is carried out by the various occupational groups. The paper finally closes with a discussion of future developments regarding quality control and certification in medical and veterinary diagnostic laboratories.

  9. [Quality standards for medical laboratories].

    PubMed

    Pascal, P; Beyerle, F

    2006-07-01

    In France, medical laboratories must engage a quality approach according to the standard guide de bonne exécution des analyses (GBEA) and, for hospital laboratories, according to the Agence nationale d'évaluation en santé (Anaes). Except the GBEA and the Anaes handbook, which are obligatory standards by regulations, the biologists can choose, for a complementary and voluntary quality process, between the standards ISO 9001, ISO 17025 or ISO 15189. Our aim is to shed light on the advantages of these five standards by realizing a comparative study of their requirements. This work enabled us to highlight a great number of similarities and to raise the characteristics of these five standards. According to their objectives, the biologists will choose a recognition of their quality management system with an ISO 9001 certification or a recognition extended to the technical skills with an ISO 17025 or ISO 15189 accreditation. The contents of these last two documents are rather close and both integrate requirements of the standard ISO 9001. The standard ISO 17025 is, at first sight, rather distant from the biological analysis, requiring many efforts of adaptation, just like the ISO 9001 standard. The standard ISO 15189 seems to be well adapted but more constraining seeing the details requirements level needed. It necessitates a perfect control of the preanalytical phase, which is difficult to acquire in a clinical framework where the biological fluids are not taken by the laboratory staff.

  10. Analytical laboratory quality control charting

    SciTech Connect

    O'Bryan, Ervin F.

    2001-06-11

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

  11. Five Decades of Microforms at the Library of Congress.

    ERIC Educational Resources Information Center

    Sullivan, Robert C.

    1988-01-01

    Discusses the history of the microform collections at the Library of Congress (LC), highlighting the exchange of microfilmed newspapers between LC and the Biblioteca Nacional, Brazil. Recent developments in preservation microfilming, LC's acquisition of microforms, and the activities of the LC Preservation Microfilming Office are described. (3…

  12. Five Decades of Microforms at the Library of Congress.

    ERIC Educational Resources Information Center

    Sullivan, Robert C.

    1988-01-01

    Discusses the history of the microform collections at the Library of Congress (LC), highlighting the exchange of microfilmed newspapers between LC and the Biblioteca Nacional, Brazil. Recent developments in preservation microfilming, LC's acquisition of microforms, and the activities of the LC Preservation Microfilming Office are described. (3…

  13. Microform Catalogs: A Viable Alternative for Texas Libraries.

    ERIC Educational Resources Information Center

    Cox, Carolyn, M.; Juergens, Bonnie

    This project proposed to develop and test the use of microform catalogs produced from computer-generated magnetic tape records in both fiche and film formats. The Computer Output Microform (COM) catalog developed for this purpose is a union list of titles from the five participating libraries--Houston and Dallas Public Libraries, Texas State…

  14. Microform Catalogs: A Viable Alternative for Texas Libraries.

    ERIC Educational Resources Information Center

    Cox, Carolyn, M.; Juergens, Bonnie

    This project proposed to develop and test the use of microform catalogs produced from computer-generated magnetic tape records in both fiche and film formats. The Computer Output Microform (COM) catalog developed for this purpose is a union list of titles from the five participating libraries--Houston and Dallas Public Libraries, Texas State…

  15. Laboratory quality improvement in Thailand's northernmost provinces.

    PubMed

    Kanitvittaya, S; Suksai, U; Suksripanich, O; Pobkeeree, V

    2010-01-01

    In Thailand nearly 1000 public health laboratories serve 65 million people. A qualified indicator of a good quality laboratory is Thailand Medical Technology Council certification. Consequently, Chiang Rai Regional Medical Sciences Center established a development program for laboratory certification for 29 laboratories in the province. This paper seeks to examine this issue. The goal was to improve laboratory service quality by voluntary participation, peer review, training and compliance with standards. The program consisted of specific activities. Training and workshops to update laboratory staffs' quality management knowledge were organized. Staff in each laboratory performed a self-assessment using a standard check-list to evaluate ten laboratory management areas. Chiang Rai Regional Medical Sciences Center staff supported the distribution of quality materials and documents. They provided calibration services for laboratory equipment. Peer groups performed an internal audit and successful laboratories received Thailand Medical Technology Council certification. By December 2007, eight of the 29 laboratories had improved quality sufficiently to be certified. Factors that influenced laboratories' readiness for quality improvement included the number of staff, their knowledge, budget and staff commitment to the process. Moreover, the support of each hospital's laboratory working group or network was essential for success. There was no clear policy for supporting the program. Laboratories voluntarily conducted quality management using existing resources. A bottom-up approach to this kind of project can be difficult to accomplish. Laboratory professionals can work together to illustrate and highlight outcomes for top-level health officials. A top-down, practical approach would be much less difficult to implement. Quality certification is a critical step for laboratory staff, which also encourages them to aspire to international quality standards like ISO. The

  16. 36 CFR 1238.26 - What are the restrictions on use for permanent and unscheduled microform records?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... permanent and unscheduled microform records? (a) Agencies must not use the silver gelatin master microform or duplicate silver gelatin microform of permanent or unscheduled records created in accordance with...

  17. 36 CFR 1238.26 - What are the restrictions on use for permanent and unscheduled microform records?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... permanent and unscheduled microform records? (a) Agencies must not use the silver gelatin master microform or duplicate silver gelatin microform of permanent or unscheduled records created in accordance with...

  18. 36 CFR § 1238.26 - What are the restrictions on use for permanent and unscheduled microform records?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... permanent and unscheduled microform records? (a) Agencies must not use the silver gelatin master microform or duplicate silver gelatin microform of permanent or unscheduled records created in accordance with...

  19. 36 CFR 1238.26 - What are the restrictions on use for permanent and unscheduled microform records?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... permanent and unscheduled microform records? (a) Agencies must not use the silver gelatin master microform or duplicate silver gelatin microform of permanent or unscheduled records created in accordance with...

  20. 36 CFR 1238.26 - What are the restrictions on use for permanent and unscheduled microform records?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... permanent and unscheduled microform records? (a) Agencies must not use the silver gelatin master microform or duplicate silver gelatin microform of permanent or unscheduled records created in accordance with...

  1. 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…

  2. Helping You Identify Quality Laboratory Services

    MedlinePlus

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

  3. [Quality improvement of medical diagnostic laboratories].

    PubMed

    Horváth, Andrea Rita; Endröczi, Elemér; Mikó, Tivadar

    2003-07-13

    Service quality in medical laboratories is influenced by a number of variables. Medical laboratories have long recognized the need for total quality management that incorporates the continuous improvement of all stages, such as the pre-analytical, analytical and post-analytical phases, of the diagnostic process, in addition to the traditional internal and external quality control of analytical procedures. Based on national and international experience, continuous improvement of quality and its external assessment are of high priority in order to guarantee a reliable, effective and cost-effective diagnostic service. Certification of health care services, according to ISO 9001 standards in Hungarian hospitals, is not sufficient to prove professional competence of medical laboratories, which called for a system of laboratory accreditation. Accreditation is an external professional audit by which an independent accreditation body gives formal recognition that the medical laboratory is competent to provide high quality services that are compliant with rigorous professional standards of best practice. The primary aim of accreditation is the improvement of the quality of diagnostic services by voluntary participation, professional peer review, continuous training and education and compliance with professional standards. In vitro medical laboratories have pioneered quality control and quality assurance in health care. Based on these strengths and traditions, the introduction of the accreditation program of medical laboratories in Hungary is one of the key professional and ethical responsibilities of diagnostic professions, in order to improve the quality, efficiency and effectiveness of laboratory services during the course of Hungary's accession to the European Union.

  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. 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.

  6. Microform Market Place 1974/1975. An International Directory of Micropublishing.

    ERIC Educational Resources Information Center

    Veaner, Allen B., Ed.; Meckler, Alan M., Ed.

    The information for this international buyer's guide for the microform purchaser was gathered from questionnaires to the publishers themselves. The guide is divided into eight sections: directory of micropublishers, mergers and acquisitions, bibliography of first sources for the microform library, microform jobbers, organizations, a geographical…

  7. Microform Market Place 1974/1975. An International Directory of Micropublishing.

    ERIC Educational Resources Information Center

    Veaner, Allen B., Ed.; Meckler, Alan M., Ed.

    The information for this international buyer's guide for the microform purchaser was gathered from questionnaires to the publishers themselves. The guide is divided into eight sections: directory of micropublishers, mergers and acquisitions, bibliography of first sources for the microform library, microform jobbers, organizations, a geographical…

  8. 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.

  9. 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.

  10. Quality Control in Clinical Laboratory Samples

    DTIC Science & Technology

    2015-01-01

    Journal Article 3. DATES COVERED (From - To) Oct 2013 – Jan 2014 4. TITLE AND SUBTITLE Quality Control in Clinical Laboratory Samples 5a. CONTRACT...Bioeffects Branch, Bioeffects Division, Human Effectiveness Directorate, 711 HPW/RHDJ, Air Force Research Laboratory , Wright Patterson AFB, OH 45433, USA...Force Research Laboratory Wright-Patterson AFB OH 45433-5707 10. SPONSOR/MONITOR’S ACRONYM(S) 711 HPW/RHDJ 11. SPONSORING/MONITORING AGENCY REPORT

  11. Total quality management in clinical virology laboratories.

    PubMed

    Tibbets, M W; Gomez, R; Kannangai, R; Sridharan, G

    2006-10-01

    The diagnostic laboratories in India are progressively promoting higher standards and are moving towards accreditation and international acceptance. Hence, the concept of "Quality" will need to be understood and implemented. Total quality management (TQM) in a laboratory is an integrated program involving all laboratory staff and management. TQM is a framework to operate and it is aiming for integration, consistency, increase in efficiency and a continuous drive for improvement. A well structured clinical virology service will include serology setup, cell culture facility and capacity for molecular diagnosis. The quality of results from the laboratory is significantly influenced by many pre-analytical and post-analytical factors which needed attention. The end goal of the TQM should be to provide the best care possible for the patient.

  12. Measurement of material mechanical properties in microforming

    NASA Astrophysics Data System (ADS)

    Yun, Wang; Xu, Zhenying; Hui, Huang; Zhou, Jianzhong

    2006-02-01

    As the rapid market need of micro-electro-mechanical systems engineering gives it the wide development and application ranging from mobile phones to medical apparatus, the need of metal micro-parts is increasing gradually. Microforming technology challenges the plastic processing technology. The findings have shown that if the grain size of the specimen remains constant, the flow stress changes with the increasing miniaturization, and also the necking elongation and the uniform elongation etc. It is impossible to get the specimen material properties in conventional tensile test machine, especially in the high precision demand. Therefore, one new measurement method for getting the specimen material-mechanical property with high precision is initiated. With this method, coupled with the high speed of Charge Coupled Device (CCD) camera and high precision of Coordinate Measuring Machine (CMM), the elongation and tensile strain in the gauge length are obtained. The elongation, yield stress and other mechanical properties can be calculated from the relationship between the images and CCD camera movement. This measuring method can be extended into other experiments, such as the alignment of the tool and specimen, micro-drawing process.

  13. 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

  14. 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.

  15. Measurement quality assurance for radioassay laboratories

    SciTech Connect

    McCurdy, D.E.

    1993-12-31

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

  16. Automation and quality in analytical laboratories

    SciTech Connect

    Valcarcel, M.; Rios, A.

    1994-05-01

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

  17. 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.

  18. Landmarks of Science: Microforms Cataloging Project, September 1981-December 1983.

    ERIC Educational Resources Information Center

    Van Orden, Richard

    To improve bibliographic access to the individual works contained in "Landmarks of Science" and "Landmarks II," two comprehensive microform collections of materials related to the history of science, the staff of the University of Utah Libraries cataloged the individual titles. Staff members with backgrounds in Renaissance…

  19. The European Register of Microform Masters--Supporting International Cooperation.

    ERIC Educational Resources Information Center

    Schwartz, Werner

    With almost every country in the world doing costly microfilming to preserve the world's printed heritage, it is essential to find a way by which these vast stores of information are not knowingly duplicated. A significant contribution to this effort has been the establishment of the European Register of Microform Masters (EROMM), a shared…

  20. The GPO Reduced to Size: Microforms and Government Publications.

    ERIC Educational Resources Information Center

    Zink, Steven D.

    1983-01-01

    Identifies format-specific problems which depository and other government publications librarians frequently face as a result of the Government Printing Office's (GPO) micropublishing program. Program preparation and underpinnings, GPO microform storage in libraries, government publications librarians, and the independence of documents collections…

  1. The European Register of Microform Masters--Supporting International Cooperation.

    ERIC Educational Resources Information Center

    Schwartz, Werner

    With almost every country in the world doing costly microfilming to preserve the world's printed heritage, it is essential to find a way by which these vast stores of information are not knowingly duplicated. A significant contribution to this effort has been the establishment of the European Register of Microform Masters (EROMM), a shared…

  2. Sabbatical Report: Results of a Survey of Library Microforms Facilities.

    ERIC Educational Resources Information Center

    McIntosh, Melinda C.

    1987-01-01

    Highlights findings on the status of academic library microforms facilities in the United States and Canada based on visits to 11 libraries. Topics covered include administration, personnel, collection access and storage, classification, acquisition, circulation, indexes, hours, facilities, signage, equipment, photocopying, cleanliness, vandalism,…

  3. 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

  4. Quality and safety aspects in histopathology laboratory.

    PubMed

    Adyanthaya, Soniya; Jose, Maji

    2013-09-01

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

  5. 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.

  6. Laboratory Diagnostics and Quality of Blood Collection

    PubMed Central

    Lima-Oliveira, Gabriel; Lippi, Giuseppe; Salvagno, Gian Luca; Picheth, Geraldo; Guidi, Gian Cesare

    2015-01-01

    Summary Diagnostic blood samples collected by phlebotomy are the most common type of biological specimens drawn and sent to laboratory medicine facilities for being analyzed, thus supporting caring physicians in patient diagnosis, follow-up and/or therapeutic monitoring. Phlebotomy, a relatively invasive medical procedure, is indeed critical for the downstream procedures accomplished either in the analytical phase made in the laboratory or in the interpretive process done by the physicians. Diagnosis, management, treatment of patients and ultimately patient safety itself can be compromised by poor phlebotomy quality. We have read with interest a recent article where the authors addressed important aspects of venous blood collection for laboratory medicine analysis. The authors conducted a phlebotomy survey based on the Clinical and Laboratory Standard Institute (CLSI) H03-A6 document (presently replaced by the GP41-A6 document) in three government hospitals in Ethiopia to evaluate 120 professionals (101 non-laboratory professionals vs. 19 laboratory professionals) as regards the venous blood collection practice. The aim of this mini (non-systematic) review is to both take a cue from the above article and from current practices we had already observed in other laboratory settings, and discuss four questionable activities performed by health care professionals during venous blood collection. We refer to: i) diet restriction assessment; ii) puncture site cleansing; iii) timing of tourniquet removal and; iv) mixing specimen with additives. PMID:28356839

  7. [Total quality management in laboratory medicine].

    PubMed

    Vogt, W

    1998-12-01

    The German Public Health will be continuously challenged in the future. It has to be assumed that modified managed care will not only take place sporadically. Thus, quality aspects of services gain more and more significance. Only suppliers will be successful who can offer services of highest quality at lowest prices. Quality in a comprehensive sense has to be substantiated in the near future. It is recommended to apply industry proven models also in public health service. Medical laboratories can be pioneers in this field as they have been already in the past. All previously proposed procedures can not describe quality of results comprehensively. They are based to a high degree on external control. Total quality management, however, represents a comprehensive approach. Principles are zero-defect approach, customer orientation and system management. Quality is given in the sense of TQM if the customer is permanently satisfied with the service of the supplier. In such a way, the customer defines quality of service. A customer is everyone who receives products or services. TQM overcomes the drawbacks of quality management systems, which are strongly formal and oriented by external control, as accreditation (EN 45,000) or certification (ISO 9000). Competition between hospitals is a declared goal of German health politics because usually quality is increased and cost decreased as a consequence. Competition means also comparison of services. TQM emphasizes benchmarking especially among the best suppliers.

  8. Quality assurance and quality control in the laboratory andrology.

    PubMed

    Pacey, Allan A

    2010-01-01

    Quality assurance (QA) and quality control (QC) are fundamental aspects of any laboratory measurement. However, in comparison with other medical disciplines, the need for QA and QC in laboratory andrology has been recognized only recently. Furthermore, there is evidence that the effort required to undertake QA and QC has not been wholly welcomed by some clinicians. Nevertheless, accrediting bodies and regulatory authorities increasingly require evidence that laboratories have effective QA and QC measures in place because both are central to the quality management processes. Following the publication of the 5th edition of the World Health Organization Laboratory Manual, existing QA and QC systems will need to be updated to take into account some of the methodological changes recommended by the manual. Three of these are discussed in this commentary; they relate to: (i) the move to infer semen volume from its weight; (ii) the re-classification of sperm motility grades from four to three; and (iii) the publication of a lower reference limit for morphology of 4% (with a corresponding 95% confidence interval of 3%-4%). The importance of QA and QC in all laboratory tests, including up and coming new tests to assess sperm DNA integrity, is discussed. The need for adequate initial training and continuing professional development programmes to support laboratory scientists performing andrology is also described.

  9. Quality assurance and quality control in the laboratory andrology

    PubMed Central

    Pacey, Allan A.

    2010-01-01

    Quality assurance (QA) and quality control (QC) are fundamental aspects of any laboratory measurement. However, in comparison with other medical disciplines, the need for QA and QC in laboratory andrology has been recognized only recently. Furthermore, there is evidence that the effort required to undertake QA and QC has not been wholly welcomed by some clinicians. Nevertheless, accrediting bodies and regulatory authorities increasingly require evidence that laboratories have effective QA and QC measures in place because both are central to the quality management processes. Following the publication of the 5th edition of the World Health Organization Laboratory Manual, existing QA and QC systems will need to be updated to take into account some of the methodological changes recommended by the manual. Three of these are discussed in this commentary; they relate to: (i) the move to infer semen volume from its weight; (ii) the re-classification of sperm motility grades from four to three; and (iii) the publication of a lower reference limit for morphology of 4% (with a corresponding 95% confidence interval of 3%–4%). The importance of QA and QC in all laboratory tests, including up and coming new tests to assess sperm DNA integrity, is discussed. The need for adequate initial training and continuing professional development programmes to support laboratory scientists performing andrology is also described. PMID:20111077

  10. 222-S laboratory quality assurance plan

    SciTech Connect

    Meznarich, H.K.

    1995-04-01

    This document provides quality assurance guidelines and quality control requirements for analytical services. This document is designed on the basis of Hanford Analytical Services Quality Assurance Plan (HASQAP) technical guidelines and is used for governing 222-S and 222-SA analytical and quality control activities. The 222-S Laboratory provides analytical services to various clients including, but not limited to, waste characterization for the Tank Waste Remediation Systems (TWRS), waste characterization for regulatory waste treatment, storage, and disposal (TSD), regulatory compliance samples, radiation screening, process samples, and TPA samples. A graded approach is applied on the level of sample custody, QC, data verification, and data reporting to meet the specific needs of the client.

  11. Iowa Central Quality Fuel Testing Laboratory

    SciTech Connect

    Heach, Don; Bidieman, Julaine

    2013-09-30

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

  12. 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.

  13. Cardiac catheterization laboratory imaging quality assurance program.

    PubMed

    Wondrow, M A; Laskey, W K; Hildner, F J; Cusma, J; Holmes, D R

    2001-01-01

    With the recent approval of the National Electrical Manufacturers Association (NEMA) standard for "Characteristics of and Test Procedures for a Phantom to Benchmark Cardiac Fluoroscopic and Photographic Performance," comprehensive cardiac image assurance control programs are now possible. This standard was developed by a joint NEMA/Society for Cardiac Angiography and Interventions (SCA&I) working group of imaging manufacturers and cardiology society professionals over the past 4 years. This article details a cardiac catheterization laboratory image quality assurance and control program that includes the new standard along with current regulatory requirements for cardiac imaging. Because of the recent proliferation of digital imaging equipment, quality assurance for cardiac imaging fluoroscopy and digital imaging are critical. Included are the previous works recommended by the American College of Cardiology (ACC) and American Heart Association (AHA), Society for Cardiac Angiographers and Interventions (SCA&I), and authors of previous image quality subjects.

  14. 36 CFR 1238.30 - What must agencies do when transferring permanent microform records to the National Archives of...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... specified in § 1232.14(c) of this subchapter. (c) Transfer the silver gelatin original (or duplicate silver gelatin microform created in accordance with § 1238.14) plus one microform copy. (d) Ensure that the... separately from the silver gelatin original or silver duplicate microform copy and clearly label them as...

  15. 36 CFR 1238.30 - What must agencies do when transferring permanent microform records to the National Archives of...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... specified in § 1232.14(c) of this subchapter. (c) Transfer the silver gelatin original (or duplicate silver gelatin microform created in accordance with § 1238.14) plus one microform copy. (d) Ensure that the... separately from the silver gelatin original or silver duplicate microform copy and clearly label them as...

  16. 36 CFR 1238.30 - What must agencies do when transferring permanent microform records to the National Archives of...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... specified in § 1232.14(c) of this subchapter. (c) Transfer the silver gelatin original (or duplicate silver gelatin microform created in accordance with § 1238.14) plus one microform copy. (d) Ensure that the... separately from the silver gelatin original or silver duplicate microform copy and clearly label them as...

  17. 36 CFR 1238.30 - What must agencies do when transferring permanent microform records to the National Archives of...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... specified in § 1232.14(c) of this subchapter. (c) Transfer the silver gelatin original (or duplicate silver gelatin microform created in accordance with § 1238.14) plus one microform copy. (d) Ensure that the... separately from the silver gelatin original or silver duplicate microform copy and clearly label them as...

  18. 36 CFR 1238.30 - What must agencies do when transferring permanent microform records to the National Archives of...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... specified in § 1232.14(c) of this subchapter. (c) Transfer the silver gelatin original (or duplicate silver gelatin microform created in accordance with § 1238.14) plus one microform copy. (d) Ensure that the... separately from the silver gelatin original or silver duplicate microform copy and clearly label them as...

  19. Collaborative networks: helping rural laboratories achieve quality.

    PubMed

    Hassell, Lewis A; Fogler, Martha W; Russell, Sonia E

    2006-01-01

    Rural hospital laboratories can combine some of their significant advantages with the benefits of an egalitarian, collaborative network to create a setting in which the disadvantages of their size (such as limited skill sets and resources) may be more readily overcome. Participation in a knowledge-sharing network, a coordinated effort at reference-range establishment and validation, and development of quality and safety algorithms help them avoid many potentially costly problems. This article describes the experience of developing such a network over a 30-year period and illustrates the benefits of this practice.

  20. 36 CFR 1238.24 - What are NARA inspection requirements for temporary microform records?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false What are NARA inspection requirements for temporary microform records? 1238.24 Section 1238.24 Parks, Forests, and Public Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION RECORDS MANAGEMENT MICROFORMS RECORDS MANAGEMENT Storage, Use...

  1. Studying All Those "Tiny Little Tea Leaves": The Future of Microforms in a Complex Technological Environment.

    ERIC Educational Resources Information Center

    Yerburgh, Mark R.

    1987-01-01

    Considers the future of microforms by surveying the history of their use in libraries; reviewing the literature about them; and comparing them with electronic databases, full text delivery, and laser disks. It is concluded that microforms will continue to be the primary providers of significant but rarely used retrospective materials. (EM)

  2. Adaptive laser beam forming for laser shock micro-forming for 3D MEMS devices fabrication

    NASA Astrophysics Data System (ADS)

    Zou, Ran; Wang, Shuliang; Wang, Mohan; Li, Shuo; Huang, Sheng; Lin, Yankun; Chen, Kevin P.

    2016-07-01

    Laser shock micro-forming is a non-thermal laser forming method that use laser-induced shockwave to modify surface properties and to adjust shapes and geometry of work pieces. In this paper, we present an adaptive optical technique to engineer spatial profiles of the laser beam to exert precision control on the laser shock forming process for free-standing MEMS structures. Using a spatial light modulator, on-target laser energy profiles are engineered to control shape, size, and deformation magnitude, which has led to significant improvement of the laser shock processing outcome at micrometer scales. The results presented in this paper show that the adaptive-optics laser beam forming is an effective method to improve both quality and throughput of the laser forming process at micrometer scales.

  3. 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

  4. Quality of HIV laboratory testing in Tanzania: a situation analysis.

    PubMed

    Mfinanga, G S; Mutayoba, B; Mbogo, G; Kahwa, A; Kimaro, G; Mhame, P P; Mwangi, C; Malecela, M N; Kitua, A Y

    2007-01-01

    Tanzania is scaling up prevention, treatment, care and support of individuals affected with HIV. There is therefore a need for high quality and reliable HIV infection testing and AIDS staging. The objective of this study was to assess laboratories capacities of services in terms of HIV testing and quality control. A baseline survey was conducted from December 2004 to February 2005 in 12 laboratories which were conveniently selected to represent all the zones of Tanzania. The questionnaires comprised of questions on laboratory particulars, internal and external quality control for HIV testing and quality control of reagents. Source and level of customer satisfaction of HIV test kits supply was established. Of 12 laboratories, nine used rapid tests for screening and two used rapid tests for diagnosis. In the 12 laboratories, four used double ELISA and five used single ELISA and three did not use ELISA. Confirmatory tests observed were Western Blot in three laboratories, DNA PCR in two laboratories, CD4 counting in seven laboratories, and viral load in two laboratories. Although all laboratories conducted quality control (QC) of the HIV kits, only two laboratories had Standard Operating Procedures (SOPs). Internal and external quality control (EQC) was done at varied proportions with the highest frequency of 55.6% (5/9) for internal quality control (IQC) for rapid tests and EQC for ELISA, and the lowest frequency of 14.3% (1/ 7) for IQC for CD4 counting. None of the nine laboratories which conducted QC for reagents used for rapid tests and none of the five which performed IQC and EQC had SOPs. HIV kits were mainly procured by the Medical Store Department and most of laboratories were not satisfied with the delay in procurement procedures. Most of the laboratories used rapid tests only, while some used both rapid tests and ELISA method for HIV testing. In conclusion, the survey revealed inadequacy in Good Laboratory Practice and poor laboratory quality control process

  5. 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...

  6. 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.

  7. Thermoplastic Micro-Forming of Bulk Metallic Glasses: A Review

    NASA Astrophysics Data System (ADS)

    Li, Ning; Chen, Wen; Liu, Lin

    2016-04-01

    Bulk metallic glasses are a fascinating class of metallic alloys with an isotropic amorphous structure that is rapidly quenched from liquid melts. The absence of a crystalline micro-structure endows them with a portfolio of properties such as high strength, high elasticity, and excellent corrosion resistance. Whereas the limited plasticity and hence poor workability at ambient temperature impede the structural application of bulk metallic glasses, the unique superplasticity within the supercooled liquid region opens an alternative window of so-called thermoplastic forming, which allows precise and versatile net-shaping of complex geometries on length scales ranging from nanometers to centimeters that were previously unachievable with conventional crystalline metal processing. Thermoplastic forming not only breaks through the bottleneck of the manufacture of bulk metallic glasses at ambient temperature but also offers an alluring prospect in micro-engineering applications. This paper comprehensively reviews some pivotal aspects of bulk metallic glasses during thermoplastic micro-forming, including an in-depth understanding of the crystallization kinetics of bulk metallic glasses and the thermoplastic processing time window, the thermoplastic forming map that clarifies the relationship between the flow characteristics and the formability, the interfacial friction in micro-forming and novel forming methods to improve the formability, and the potential applications of the hot-embossed micro-patterns/components.

  8. Adaptive laser shock micro-forming for MEMS device applications.

    PubMed

    Zou, R; Wang, M; Wang, S L; Li, S; Zhang, C; Deng, L; Lu, Y F; Chen, K P

    2017-02-20

    Laser shock micro-forming is a non-thermal laser forming method that uses laser-induced shockwave to modify surface properties and to adjust shapes and geometry of work pieces. The magnitude and spatial distribution of the laser-induced shockwaves depend on the energy profiles of the laser beam focused on sample surfaces. In this paper, we present an adaptive optical technique to engineer spatial profiles of laser beams to control the shapes, sizes, and locations of the laser-induced shockwaves and the resulting forming features. Using a spatial light modulator, this adaptive laser beam forming tool was used to process free-standing MEMS structures in aluminum, which has led to highly uniform forming features. Shockwave simultaneously excited by multiple laser beams generated by the spatial light modulator and its effects on the micro-forming process were also studied. The results presented in this paper show that the adaptive optics laser beam forming is an effective and flexible method to generate shockwave with various shapes and sizes of wavefront and at multiple locations for laser processing at microscales.

  9. 36 CFR 1238.20 - How must microform records be stored?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... relative humidity of the storage area must be a constant 35 percent RH, plus or minus 5 percent. Non-silver copies of microforms must be maintained in a different storage area than are silver gelatin originals...

  10. 7 CFR 58.442 - Laboratory and quality control tests.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 3 2014-01-01 2014-01-01 false Laboratory and quality control tests. 58.442 Section... 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....

  11. 7 CFR 58.442 - 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. 58.442 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....

  12. 7 CFR 58.442 - Laboratory and quality control tests.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 3 2013-01-01 2013-01-01 false Laboratory and quality control tests. 58.442 Section... 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....

  13. 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...

  14. 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...

  15. 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

  16. Building the nation's first institute for laboratory quality.

    PubMed

    Stombler, Robin E

    2008-06-01

    Hopeful schemes to improve the quality of laboratory testing and services through a potential public-private partnership soon developed into the establishment of the Institute for Quality in Laboratory Medicine in 2005. This article chronicles the establishment of the Institute, its accomplishments, and the challenge that ultimately led to its voluntary closing in 2007. As the first institute of its kind, the Institute for Quality in Laboratory Medicine demonstrates how cooperation and collaboration among diverse, and sometimes disparate, parties can achieve quality of care objectives.

  17. Laser shock microforming of aluminum foil with fs laser

    NASA Astrophysics Data System (ADS)

    Ye, Yunxia; Feng, Yayun; Xuan, Ting; Hua, Xijun; Hua, Yinqun

    2014-12-01

    Laser shock microforming of Aluminum(Al) foil through fs laser has been researched in this paper. The influences of confining layer, clamping method and impact times on induced dent depths were investigated experimentally. Microstructure of fs laser shock forming Al foil was observed through Transmission electron microscopy (TEM). Under the condition of tightly clamping, the dent depths increase with impact times and finally tend to saturating. Another new confining layer, the main component of which is polypropylene, was applied and the confining effect of it is better because of its higher impedance. TEM results show that dislocation is one of the main deformation mechanisms of fs laser shock forming Al foil. Specially, most of dislocations exist in the form of short and discrete dislocation lines. Parallel straight dislocation slip line also were observed. We analyzed that these unique dislocation arrangements are due to fs laser-induced ultra high strain rate.

  18. State Public Health Laboratory System Quality Improvement Activities

    PubMed Central

    Vagnone, Paula Snippes

    2013-01-01

    The Association of Public Health Laboratories (APHL) and the APHL Laboratory Systems and Standards Committee manage the Laboratory System Improvement Program (L-SIP). One component of L-SIP is an assessment that allows the members and stakeholders of a laboratory system to have an open and honest discussion about the laboratory system's strengths and weaknesses. From these facilitated discussions, gaps and opportunities for improvement are identified. In some cases, ideas for how to best address these gaps emerge, and workgroups are formed. Depending on resources, both monetary and personnel, laboratory staff will then prioritize the next component of L-SIP: which quality improvement activities to undertake. This article describes a sample of quality improvement activities initiated by several public health laboratories after they conducted L-SIP assessments. These projects can result in more robust linkages between system entities, which can translate into improvements in the way the system addresses the needs of stakeholders. PMID:23997301

  19. IVD industry role for quality and accreditation in medical laboratories.

    PubMed

    Bremond, J; Plebani, M

    2001-07-20

    Manufacturers of in vitro diagnostic (IVD) medical devices and laboratory management have become integral partners in building and improving the quality of laboratory services. There is an increasing awareness that quality is inherent in the design of any reagent or analytical system. In vitro diagnostic medical devices should provide patients, users and third parties with a high level of health protection. Therefore, both manufacturers and users must work in partnership for continual improvement. For manufacturers, standards such as ISO 9000 already exist to guide applications of quality practices. In the field of laboratory medicine, the availability of a specific, universal standard (ISO/DIS 15189) for quality management in medical laboratories will represent a great opportunity for harmonising medical laboratories at an international level. In addition, accreditation of medical laboratories according to the proposed ISO 15189 standard can help develop the relationships between laboratories, and the biological follow-up of travelling patients. Manufacturers are able to help laboratory management to reach a high level of quality, not only by providing high value products, but also on the basis of their own experience of ISO 9000 certification.

  20. Quality documentation challenges for veterinary clinical pathology laboratories.

    PubMed

    Sacchini, Federico; Freeman, Kathleen P

    2008-05-01

    An increasing number of veterinary laboratories worldwide have obtained or are seeking certification based on international standards, such as the International Organization for Standardization/International Electrotechnical Commission 17025. Compliance with any certification standard or quality management system requires quality documentation, an activity that may present several unique challenges in the case of veterinary laboratories. Research specifically addressing quality documentation is conspicuously absent in the veterinary literature. This article provides an overview of the quality system documentation needed to comply with a quality management system with an emphasis on preparing written standard operating procedures specific for veterinary laboratories. In addition, the quality documentation challenges that are unique to veterinary clinical pathology laboratories are critically evaluated against the existing quality standards and discussed with respect to possible solutions and/or recommended courses of action. Documentation challenges include the establishment of quality requirements for veterinary tests, the use or modification of human analytic methods for animal samples, the limited availability of quality control materials satisfactory for veterinary clinical pathology laboratories, the limited availability of veterinary proficiency programs, and the complications in establishing species-specific reference intervals.

  1. 36 CFR 1238.32 - Do agencies need to request NARA approval for the disposition of all microform and source records?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., Forests, and Public Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION RECORDS MANAGEMENT MICROFORMS RECORDS MANAGEMENT Storage, Use, and Disposition of Microform Records § 1238.32 Do agencies need to... unscheduled records. Agencies must schedule both source documents (originals) and microforms. NARA must...

  2. Use of computers in quality assurance of laboratory testing.

    PubMed

    Tan, I K; Jacob, E; Lim, S H

    1990-09-01

    Implementation of comprehensive internal quality control programmes and participation in external quality assessment schemes to monitor analytical performance of laboratory tests have been widely accepted as an essential and integral part of good laboratory practice. As these programmes involve a great deal of repetitive statistical calculations and graphic presentation of data on quality control materials, many laboratories and practically all organisers of inter-laboratory quality assessment schemes increasingly rely on computers to handle the burdensome processing of data and to provide timely feedback in a manner that is easily understood and readily interpreted by analytical staff. However, in spite of the best effort to ensure reliable analytical performance, spurious and misleading results can still occur as a result of non-analytical errors which are not readily detected by methods designed to monitor the quality of analytical process. The use of sophisticated computer system has enabled our laboratory to check for the existence of some of these errors. This paper describes the application of computers in a variety of internal and external quality assessment programmes and demonstrates the usefulness of retrieving patients' cumulative test results and at the same time performing delta or percentage difference checks on such data in the detection of non-analytical errors and unexpected variations in results. The role of the computer in minimising transcription errors, reducing turn-around time of testing and reporting, as well as improving the quality of laboratory reports is also mentioned.

  3. 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.

  4. Most clinical laboratory testing in Kampala occurs in high-volume, high-quality laboratories or low-volume, low-quality laboratories. A tale of two cities.

    PubMed

    Amukele, Timothy K; Schroeder, Lee F; Jackson, J Brooks; Elbireer, Ali

    2015-01-01

    To describe key characteristics (laboratory quality, test volumes, and complexity) of clinical laboratories in Kampala, Uganda (population ~1.7 million). Cross-sectional survey using a standard questionnaire to document laboratory type and quality, as well as test menus and volumes. Quality was based on the World Health Organization-Africa Region checklist. Of the 954 laboratories identified (a density of one laboratory per 1,781 persons), 779 (82%) performed only simple kit tests or light microscope examinations. The 95% (907/954) of laboratories for whom volumes were obtained performed an average aggregate of 13,189 tests daily, for a test utilization rate of around 2 tests per individual per year. Laboratories could be segregated into eight groups based on quality, test volume, and complexity. However, 90% of the testing was performed by just two groups: (1) low-volume (≤100 tests daily), low-quality laboratories performing simple tests or (2) high-volume (>100 tests daily), high-quality laboratories. Each of these two groups did 45% of the daily testing volume (90% combined). Clinical laboratory density in Kampala (1/1,781 persons) is high, approaching that in the United States (1/1,347 persons). Low-volume/low-quality and high-volume/high-quality laboratories do 90% of the daily aggregate testing. Quality improvement (QI) schemes for Africa must be appropriate to low-volume laboratories as well as to the large laboratories that have been the focus of previous QI efforts. Copyright© by the American Society for Clinical Pathology.

  5. 222-S Laboratory Quality Assurance Plan. Revision 1

    SciTech Connect

    Meznarich, H.K.

    1995-07-31

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

  6. ISO and CEN documents on quality in medical laboratories.

    PubMed

    Kenny, D

    2001-07-20

    The forthcoming international standard ISO 15189 "Quality management in the medical laboratory" is a document of great importance for the development of quality systems and accreditation for medical/clinical laboratories. For the first time, there will be an internationally recognized standard designed specifically for the accreditation of medical laboratories. The document takes into account the special requirements imposed by the medical environment and by the essential contribution of the medical laboratory service to patient care. It recognizes that medical laboratories must provide not only testing of patient samples, but also advisory, interpretative and educational services. A further document, still in draft form (ISO/DIS 15190), deals with safety management for medical laboratories. ISO 15189 (and probably 15190 also) are expected be adopted by CEN as a European Standard (EN).

  7. [Quality management system in the medical laboratory--ISO15189 and laboratory accreditation].

    PubMed

    Kubono, Katsuo

    2004-03-01

    Medical laboratory services are essential to patient care and therefore should meet the needs of all patients and clinical personnel responsible for human health care. Recently, ISO15189, the first quality management ISO system for medical laboratories, has attracted the attention of all medical laboratories. ISO 15189:2003, Medical laboratories--Particular requirements for quality and competence, provides a framework for the design and improvement of process-based quality management systems by medical laboratories. It is based on ISO17025:1999, General requirements for the competence of testing and calibration laboratories, but provides specific requirements for implementation in medical laboratories. This will help medical laboratories to comply with regulatory requirements, to meet the expectations of their clients and, most importantly, to improve and maintain their service to patients. ISO15189 will be an important template for assessing and recognizing the competence of medical laboratories in their technical capacity and the effective quality management of a professional service and its staff--with or without the aim of accreditation.

  8. Internal quality assurance in cervical cytology one laboratory's experience.

    PubMed

    Cross, P A

    1996-02-01

    The results of an internal quality assurance exercise in one cervical cytology laboratory in England are presented, using different types of partial percentage re-screening of cervical smears. An overall false negative dyskaryotic rate of up to 4.3% was demonstrated, with the final cytology report diagnosis differing from the primary screening dignosis in 1.3% of cases. These finding are discussed, with the aim of helping to foster debate on the setting of national laboratory internal quality assurance standards.

  9. 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.

  10. QUALITY ASSURANCE IN RESEARCH LABORATORIES: RULES AND REASON

    EPA Science Inventory

    Quality Assurance in Research Laboratories: Rules and Reason

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

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

  11. 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...

  12. Quality assurance for the laboratory aspects of prosthodontic treatment.

    PubMed

    Maxson, B B; Nimmo, A

    1997-09-01

    Inconsistency in the product returned from the commercial dental laboratory led to the development of a formal quality assurance (QA) program at the University of Detroit Mercy School of Dentistry in 1994. The goal of the program was to improve the quality of prosthodontic laboratory submissions and the returned product, facilitate laboratory communications, and, ultimately, enhance the quality and timeliness of patient care. Each student submission is evaluated with a criterion-referenced evaluation form. Deficiencies are communicated to the student, and the corrected submission is then sent to the laboratory. Three-year remake data from the main clinic (QA site) and an extramural clinic (non-QA site) demonstrate the effectiveness of the program. The major benefits are more efficient, cost-effective patient care, as well as the provision of a model for the student to practice the skills needed for effective communication with the dental technician, upon graduation.

  13. A quality manual for the clinical laboratory including the elements of a quality system. Proposed guidelines.

    PubMed

    Dybkaer, R; Jordal, R; Jørgensen, P J; Hansson, P; Hjelm, M; Kaihola, H L; Kallner, A; Rustad, P; Uldall, A; de Verdier, C H

    1993-01-01

    Development of quality manuals is a means for the promotion of quality in clinical laboratories by describing the total quality system. It also provides opportunity of checking whether the quality system is implemented in reality and demonstrates to the hospital administration and the clinicians that the laboratory is committed to quality. The intention of these guidelines is to describe the elements of the quality system for a large clinical laboratory, and to present such a system in the form of a quality manual. The proposed guidelines comply, where relevant, with ISO/IEC guide 25 'General requirements for the technical competence of testing laboratories' and EN 45001 'General criteria for the operation of testing laboratories'. The document may be used as an aid for laboratories wishing to be accredited according to EN 45001, or intending to apply for formal certification of their quality systems, according to ISO 9001 'Quality systems--Model for quality assurance in design/development, production, installation, and servicing' utilizing ISO 9004 'Quality management and quality system elements--guidelines; Part 2 Guidelines for service'. However, information about the minimum requirements for official recognition should be obtained from the particular accreditation or certification body concerned.

  14. Noggin null allele mice exhibit a microform of holoprosencephaly.

    PubMed

    Lana-Elola, Eva; Tylzanowski, Przemko; Takatalo, Maarit; Alakurtti, Kirsi; Veistinen, Lotta; Mitsiadis, Thimios A; Graf, Daniel; Rice, Ritva; Luyten, Frank P; Rice, David P

    2011-10-15

    Holoprosencephaly (HPE) is a heterogeneous craniofacial and neural developmental anomaly characterized in its most severe form by the failure of the forebrain to divide. In humans, HPE is associated with disruption of Sonic hedgehog and Nodal signaling pathways, but the role of other signaling pathways has not yet been determined. In this study, we analyzed mice which, due to the lack of the Bmp antagonist Noggin, exhibit elevated Bmp signaling. Noggin(-/-) mice exhibited a solitary median maxillary incisor that developed from a single dental placode, early midfacial narrowing as well as abnormalities in the developing hyoid bone, pituitary gland and vomeronasal organ. In Noggin(-/-) mice, the expression domains of Shh, as well as the Shh target genes Ptch1 and Gli1, were reduced in the frontonasal region at key stages of early facial development. Using E10.5 facial cultures, we show that excessive BMP4 results in reduced Fgf8 and Ptch1 expression. These data suggest that increased Bmp signaling in Noggin(-/-) mice results in downregulation of the hedgehog pathway at a critical stage when the midline craniofacial structures are developing, which leads to a phenotype consistent with a microform of HPE.

  15. Strain gradient polycrystal plasticity for micro-forming

    NASA Astrophysics Data System (ADS)

    Yalçinkaya, Tuncay; Simonovski, Igor; Özdemir, Izzet

    2016-10-01

    The developments in the micro-device industry has produced a substantial demand for the miniaturized metallic components with ultra-thin sheet materials that have thickness dimensions on the order of 50-500 µm which are produced through micro-forming processes. It is essential to have predictive tools to simulate the constitutive behavior of the materials at this length scale taking into account the physical and statistical size effect. Recent studies have shown that on the scale of several micrometers and below, crystalline materials behave differently from their bulk equivalent due to micro-structural effects (e.g. grain size, lattice defects and impurities), gradient effects (e.g. lattice curvature due to a non-uniform deformation field) and surface constraints (e.g. hard coatings or free interfaces). These effects could lead to stronger or weaker material response depending on the size and unique micro-structural features of the material. In this paper a plastic slip based strain gradient crystal plasticity model is used to address the effect of microstructural features (e.g. grain size, orientation and the number of grains) on the macroscopic constitutive response and the local behavior of polycrystalline materials.

  16. 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)

  17. 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.

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

    PubMed Central

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

    2017-01-01

    Introduction 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. Materials and methods 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. Results 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. Conclusion 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. PMID:28392737

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

    PubMed

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

    2011-01-01

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

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

    PubMed

    Ivanov, G A; Émanuél', A V

    2011-05-01

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

  1. External quality assessment scheme and laboratory accreditation in Indonesia.

    PubMed

    Timan, Ina S; Aulia, Diana; Santoso, Witono

    2002-02-01

    The National Program on External Quality Assessment Scheme (NEQAS) in Indonesia was first started in 1979, organized by the Indonesian Ministry of Health collaborating with professional bodies. The first trial was for clinical chemistry test with 2 cycles per year, followed by the hematology NEQAS in 1986 in collaboration with WHO-Royal Post Graduate Medical School London. After that, the schemes for serology, microbiology and parasitology were also organized. Around 500-600 laboratories throughout Indonesia participated each year in these quality control schemes, 2-4 cycles per year. Samples would be sent to participants and results will be given back to each laboratory. Poor performers should participate in the workshop or training course conducted by the Central Health Laboratory to improve their results. Participation in this NEQAS is mandatory for obtaining the laboratory license, and the Ministry of Health uses these schemes as one of the means for monitoring and coordinating the performance of laboratories throughout Indonesia. There are also some other EQAS (External Quality Assessment Scheme) programs conducted by professional bodies, such as for hemostasis, clinical chemistry and serology. During the course of conducting these schemes, it could be observed that manual methods were gradually changed to the automatic methods, especially for the clinical chemistry and hematology laboratories, which counts also for improvements of their results. Since the last 6 years, the Ministry of Health also began to conduct the Accreditation System evaluation for hospitals, including the laboratory departments. There are 7 standards that were evaluated, such as the aspect of the organization, administration and management, staffing, facilities and equipment, standard operating procedures, research and developments and quality control. This accreditation program is still in progress for all public and private hospital laboratories.

  2. 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.

  3. 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.

  4. Quality assurance programs at the PNL calibrations laboratory

    SciTech Connect

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

    1993-03-01

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

  5. Microform-related community patterns of methane-cycling microbes in boreal Sphagnum bogs are site specific.

    PubMed

    Juottonen, Heli; Kotiaho, Mirkka; Robinson, Devin; Merilä, Päivi; Fritze, Hannu; Tuittila, Eeva-Stiina

    2015-09-01

    Vegetation and water table are important regulators of methane emission in peatlands. Microform variation encompasses these factors in small-scale topographic gradients of dry hummocks, intermediate lawns and wet hollows. We examined methane production and oxidization among microforms in four boreal bogs that showed more variation of vegetation within a bog with microform than between the bogs. Potential methane production was low and differed among bogs but not consistently with microform. Methane oxidation followed water table position with microform, showing higher rates closer to surface in lawns and hollows than in hummocks. Methanogen community, analysed by mcrA terminal restriction fragment length polymorphism and dominated by Methanoregulaceae or 'Methanoflorentaceae', varied strongly with bog. The extent of microform-related variation of methanogens depended on the bog. Methanotrophs identified as Methylocystis spp. in pmoA denaturing gradient gel electrophoresis similarly showed effect of bog, and microform patterns were stronger within individual bogs. Our results suggest that methane-cycling microbes in boreal Sphagnum bogs with seemingly uniform environmental conditions may show strong site-dependent variation. The bog-intrinsic factor may be related to carbon availability but contrary to expectations appears to be unrelated to current surface vegetation, calling attention to the origin of carbon substrates for microbes in bogs. © FEMS 2015. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  6. Towards harmonization of quality indicators in laboratory medicine.

    PubMed

    Plebani, Mario; Chiozza, Maria Laura; Sciacovelli, Laura

    2013-01-01

    The identification of reliable quality indicators (QIs) in the total testing process (TTP) represents a crucial step in enabling users to quantify the quality of laboratory services, but the current lack of attention to extra-laboratory factors is in stark contrast with the body of evidence showing the multitude of errors that continue to occur in the pre- and post-analytical phases. Although interesting programs on indicators of the extra-analytical phases have been developed in some countries, there is no consensus on the production of joint recommendations for the adoption of universal QIs and the use of common terminology in the total testing process. In view of the different QIs and terminologies currently used, there an urgent need to harmonize proposed QIs, which should comply with three main principles: they must be patient-centered, consistent with the requirements of the International Standard for medical laboratories accreditation, and address all stages of the TTP. A model of quality indicators (MQI), 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), includes 56 QIs related to key processes (34 pre-, 7 intra- and 15 post-analytical phase) and three to support processes. The scope of harmonization in laboratory medicine, more far-reaching than method harmonization, should cover a wider range of topics, namely all steps of the "brain-to-brain loop". The identification of valuable QIs is a key step in paving the way towards quality and patient safety in laboratory medicine.

  7. Harmonization of quality indicators in laboratory medicine. A preliminary consensus.

    PubMed

    Plebani, Mario; Astion, Michael L; Barth, Julian H; Chen, Wenxiang; de Oliveira Galoro, César A; Escuer, Mercedes Ibarz; Ivanov, Agnes; Miller, Warren G; Petinos, Penny; Sciacovelli, Laura; Shcolnik, Wilson; Simundic, Ana-Maria; Sumarac, Zorica

    2014-07-01

    Quality indicators (QIs) are fundamental tools for enabling users to quantify the quality of all operational processes by comparing it against a defined criterion. QIs data should be collected over time to identify, correct, and continuously monitor defects and improve performance and patient safety by identifying and implementing effective interventions. According to the international standard for medical laboratories accreditation, the laboratory shall establish and periodically review QIs to monitor and evaluate performance throughout critical aspects of pre-, intra-, and post-analytical processes. However, while some interesting programs on indicators in the total testing process have been developed in some countries, there is no consensus for the production of joint recommendations focusing on the adoption of universal QIs and common terminology in the total testing process. A preliminary agreement has been achieved in a Consensus Conference organized in Padua in 2013, after revising the model of quality indicators (MQI) developed by the Working Group on "Laboratory Errors and Patient Safety" of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The consensually accepted list of QIs, which takes into consideration both their importance and applicability, should be tested by all potentially interested clinical laboratories to identify further steps in the harmonization project.

  8. 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, ...

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

    SciTech Connect

    Dorsey, J.G.

    1993-11-01

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

  10. 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.

  11. New Support for the Research Process: Desktop Delivery of Microform Content

    ERIC Educational Resources Information Center

    Weare, William H., Jr.

    2011-01-01

    While trying to access microform content, patrons at the Christopher Center for Library and Information Resources at Valparaiso University were often hampered by unfamiliar equipment, temperamental software, and a puzzling file management system. In an effort to address these problems, the Access Services Department launched a pilot program for…

  12. Preparing a Union List of Microforms on the Classical, Medieval, and Renaissance Periods.

    ERIC Educational Resources Information Center

    Henneman, John B., Jr.

    1988-01-01

    Describes a project of the Association of College and Research Libraries to compile a union list of microforms dealing with the classical, medieval, and Renaissance periods. Goals of the project, questionnaire development, survey response, and questions raised by the project are discussed. The union list, including 101 titles and 45 libraries, is…

  13. Microform Collections in New Orleans Academic and Public Libraries: A Union List.

    ERIC Educational Resources Information Center

    Spano, Gregory P., Comp.

    This union list identifies 455 microform collections held by 8 public and academic libraries in New Orleans. It is noted that newspapers, periodicals, Government Printing Office (GPO) depository microfiche, and individual monograph titles were excluded from the list unless they are a part of a publisher's series, archival project, or manuscript…

  14. 36 CFR 1238.22 - What are the inspection requirements for permanent and unscheduled microform records?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 3 2011-07-01 2011-07-01 false What are the inspection... Public Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION RECORDS MANAGEMENT MICROFORMS RECORDS... reference, see § 1238.5); (2) A rereading of resolution targets; (3) A remeasurement of density; and (4)...

  15. 36 CFR 1238.22 - What are the inspection requirements for permanent and unscheduled microform records?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... following elements: (1) An inspection for aging blemishes following ANSI/AIIM MS45 (incorporated by...); (ii) The date of inspection; (iii) The elements of inspection (see paragraph (d) of this section); (iv... microform is deteriorating, the agency must make a silver duplicate in accordance with § 1238.14 to replace...

  16. University of New Mexico General Libraries Guide to the Microform Collections.

    ERIC Educational Resources Information Center

    Lewis, Linda K.

    The contents--sets of archives, books, documents, manuscripts, music, periodicals, plays and scores--and indexing of the university collection of microforms are described in this guide. When available, the following information has been included: call number, card catalog entry, description, format, indexes, publisher, and review. Arranged…

  17. The Mellon Microform Master Project at the New York Public Library.

    ERIC Educational Resources Information Center

    Persky, Gail

    1984-01-01

    Goals of micropreservation project at New York Public Library are twofold: to improve in-house processing and control of microforms (updating bibliograhic information, adding records to Research Libraries Information Network database, inspecting archival master negatives) and to participate in national preservation effort (supplementing…

  18. Primary Sources in History: A Guide to Microform Collections at Arizona State University. Second Edition.

    ERIC Educational Resources Information Center

    Palais, Elliot S., Comp.

    This guide describes history source materials available at Arizona State University (Tempe), as well as a selection of microforms located at other universities in Arizona and the Center for Research Libraries. Its purpose is to promote the use of sets and collections that, because of their publication in microformat, are relatively neglected. A…

  19. Determination of an Effective System of Bibliographic Control of Microform Publications. Interim Report.

    ERIC Educational Resources Information Center

    Reichmann, Felix; Tharpe, Josephine M.

    This interim report provides some guidelines for the bibliographic control of microforms which at the present time is either inadequate or non-existent on a local level within a given library. A literature search and direct inquiry of librarians revealed that adherence to cataloging rules is inconsistent, there is wide variation in microform…

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

    PubMed

    Suzuki, Katsuhiro; Higuchi, Takeshi

    2007-03-01

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

  1. New laboratory tools in the assessment of bone quality.

    PubMed

    Chappard, D; Baslé, M F; Legrand, E; Audran, M

    2011-08-01

    Bone quality is a complex set of intricated and interdependent factors that influence bone strength. A number of methods have emerged to measure bone quality, taking into account the organic or the mineral phase of the bone matrix, in the laboratory. Bone quality is a complex set of different factors that are interdependent. The bone matrix organization can be described at five different levels of anatomical organization: nature (organic and mineral), texture (woven or lamellar), structure (osteons in the cortices and arch-like packets in trabecular bone), microarchitecture, and macroarchitecture. Any change in one of these levels can alter bone quality. An altered bone remodeling can affect bone quality by influencing one or more of these factors. We have reviewed here the main methods that can be used in the laboratory to explore bone quality on bone samples. Bone remodeling can be evaluated by histomorphometry; microarchitecture is explored in 2D on histological sections and in 3D by microCT or synchrotron. Microradiography and scanning electron microscopy in the backscattered electron mode can measure the mineral distribution; Raman and Fourier-transformed infra-red spectroscopy and imaging can simultaneously explore the organic and mineral phase of the matrix on multispectral images; scanning acoustic microscopy and nanoindentation provide biomechanical information on individual trabeculae. Finally, some histological methods (polarization, surface staining, fluorescence, osteocyte staining) may also be of interest in the understanding of quality as a component of bone fragility. A growing number of laboratory techniques are now available. Some of them have been described many years ago and can find a new youth; others having benefited from improvements in physical and computer techniques are now available.

  2. [Development of laboratory information system--quality standards].

    PubMed

    Srenger, Vesna; Stavljenić-Rukavina, Ana; Cvorisćec, Dubravka; Brkljacić, Vera; Rogić, Dunja; Juricić, Ljiljana

    2005-01-01

    The aim of the study was to determine structural modules of laboratory information system (LIS) for the application of new biomedical and information technologies by utilizing current organizational trends. The method used included definition of structural modules according to significant LIS properties, e.g., a large number of data, automation of analyses and rapid exchange of information, and according to the process of information establishment the collection, organization, selection, synthesis and distribution. Thus, outdated distributed software at the Clinical Institute of Laboratory Diagnosis has now been replaced by modular organization. Modules have been developed for the following: data input, online operation of laboratory instruments, preparation of results, compilation of medical documentation on quality assurance based on the application of quality standards, management of finances, and for point of care testing. The method of re-engineering as well as adherence to EN and ISO quality standards were utilized in planning the development of LIS based on the application of new information technologies and in shaping business processes. The application of re-engineering in LIS development results in quality improvement, reduces the cost and time necessary for performance of procedures, and improves relations in organizational structure.

  3. 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.

  4. 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

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

    PubMed

    Luksamijarulkul, Pipat; Kiennukul, Nuchanard; Vatthanasomboon, Pisit

    2014-05-01

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

  6. 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.

  7. Modification of red blood cells for laboratory quality control use.

    PubMed

    Henry, Stephen M

    2009-11-01

    This review describes the current state-of-the-art with respect to the modification of red blood cells for creating quality controls for use in immunohaematology. The author has identified five technologies able to create modified red blood cells potentially suitable for use in quality control. Two of the technologies use enzymes, glycosidases or glycosyltransferases, to modify red blood cells and create ABO quality control cells. A third technology uses polyethylene glycol to reduce antigen expression by masking epitopes, whereas a fourth technology is speculative and involves the in-vitro generation of genetically modified erythroid cells. None of these four technologies are in routine use to make commercially available quality controls. A fifth commercially available technology creates quality controls by adding synthetic blood group A and B antigens (FSLs) to group O red blood cells, creating what are referred to as 'kodecytes'. This technology is also being used to add blood group peptides onto red cells for use in the future in a range of diagnostic applications. Transducing cell-derived erythroid populations with blood group encoding or silencing vectors, and the use of FSLs to create kodecytes, are two technologies with the potential to provide quality controls for laboratory use.

  8. 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.

  9. [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.

  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. 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

  12. 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.

  13. Sandia National Laboratories ASCI Applications Software Quality Engineering Practices

    SciTech Connect

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

    2003-04-01

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

  14. Sandia National Laboratories ASCI Applications Software Quality Engineering Practices

    SciTech Connect

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

    2002-01-01

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

  15. Microforms in gravel bed rivers: Formation, disintegration, and effects on bedload transport

    USGS Publications Warehouse

    Strom, K.; Papanicolaou, A.N.; Evangelopoulos, N.; Odeh, M.

    2004-01-01

    This research aims to advance current knowledge on cluster formation and evolution by tackling some of the aspects associated with cluster microtopography and the effects of clusters on bedload transport. The specific objectives of the study are (1) to identify the bed shear stress range in which clusters form and disintegrate, (2) to quantitatively describe the spacing characteristics and orientation of clusters with respect to flow characteristics, (3) to quantify the effects clusters have on the mean bedload rate, and (4) to assess the effects of clusters on the pulsating nature of bedload. In order to meet the objectives of this study, two main experimental scenarios, namely, Test Series A and B (20 experiments overall) are considered in a laboratory flume under well-controlled conditions. Series A tests are performed to address objectives (1) and (2) while Series B is designed to meet objectives (3) and (4). Results show that cluster microforms develop in uniform sediment at 1.25 to 2 times the Shields parameter of an individual particle and start disintegrating at about 2.25 times the Shields parameter. It is found that during an unsteady flow event, effects of clusters on bedload transport rate can be classified in three different phases: a sink phase where clusters absorb incoming sediment, a neutral phase where clusters do not affect bedload, and a source phase where clusters release particles. Clusters also increase the magnitude of the fluctuations in bedload transport rate, showing that clusters amplify the unsteady nature of bedload transport. A fourth-order autoregressive, autoregressive integrated moving average model is employed to describe the time series of bedload and provide a predictive formula for predicting bedload at different periods. Finally, a change-point analysis enhanced with a binary segmentation procedure is performed to identify the abrupt changes in the bedload statistic characteristics due to the effects of clusters and detect the

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... quality assessment. (a) The laboratory must establish and follow written policies and procedures for an... quality assessment must include a review of the effectiveness of corrective actions taken to resolve... of general laboratory systems quality assessment reviews with appropriate staff. (c) The laboratory...

  17. Maintaining data quality in an environmental testing laboratory

    SciTech Connect

    Cohen, Roy J.

    2001-03-05

    In today's competitive and highly litigious world, it is critical that any laboratory generating data for the environmental and allied industries have a world-class Quality Assurance Program. This Plan must conform to the requirements of every agency and client with whom the lab does business. The goal of such a program is data defensibility; i.e., data validity. Data (usually qualitative analyte [compound or element] identifications and quantitative numerical results) are the end results of nearly all analytical laboratory processes, and the source of revenue. Clients pay for results. The clients expect the results to be accurate, precise, and repeatable. If their data has to go to court, the laboratory will be called upon to defend the accuracy and precision of their work. Without a strong QA program, this will be impossible. The potential implications and repercussions of non-defensible lab data are far-reaching and very costly in terms of loss of future revenues and in legal judgments.

  18. 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

  19. Using analytical services at the National Water Quality Laboratory

    USGS Publications Warehouse

    Pratt, L.K.

    1994-01-01

    The National Water Quality Laboratory (NWQL) offers a variety of analytical services for the determination of constituents in samples of water, sediment, and biological material. As technology has advanced, many new methods have been introduced but not always incorporated into plans and schedules developed in the districts. The strengths and weaknesses of many different techniques are discussed and evaluated to promote a broad understanding of the services available at the NWQL. Method detection limits, precision, and costs are discussed, as well as possible applications for the methods. To aid in project planning, several tables have been developed that list the approved method for certain determination, particularly those being requested to satisfy cooperator or U.S. Environ- mental Protection Agency regulatory requirements.

  20. Quality indicators from laboratory and radiology information systems.

    PubMed

    Schuers, Matthieu; Joulakian, Mehr B; Griffon, Nicolas; Pachéco, Joanne; Périgard, Carine; Lepage, Eric; Watbled, Ludivine; Massari, Philippe; Darmoni, Stéfan J

    2015-01-01

    Consequences of the computerization of laboratory and radiology information system (LIS and RIS) are not well documented. The aim of this study was to evaluate the impact of computerization of LIS and RIS of four hospitals on performance and quality of care. The study was divided into three phases. First, the subprocesses and information flows of LIS and RIS were described. Then, a literature review was performed in order to identify the indicators used to assess the impact of computerization. Finally, comparisons were made between 2 hospitals. Using the initial framework, each partner described its process mapping concerning LIS and RIS. The review identified a wide panel of indicators. Only 41 were useful to assess the impact of information systems. For each two by two comparison, lists of relevant indicators have been selected from the identified indicators and according to the process mapping comparison. Two by two comparisons have to be completed. Eventually, these indicators may be integrated in the quality process of hospital information systems.

  1. Effect of Viscosity on the Microformability of Bulk Amorphous Alloy in Supercooled Liquid Region

    SciTech Connect

    Cheng Ming; Zhang Shihong; Wang Ruixue

    2010-06-15

    Previously published results have shown that viscosity greatly influences on the deformation behavior of the bulk amorphous alloy in supercooled liquid region during microforming process. And viscosity is proved to be a component of the evaluation index which indicating microformability. Based on the fluid flow theory and assumptions, bulk amorphous alloy can be regarded as the viscous materials with a certain viscosity. It is helpful to understand how the viscosity plays an important role in viscous materials with various viscosities by numerical simulation on the process. Analysis is carried out by linear state equation in FEM with other three materials, water, lubricant oil and polymer melt, whose viscosities are different obviously. The depths of the materials flow into the U-shaped groove during the microimprinting process are compared in this paper. The result shows that the deformation is quite different when surface tension effect is not considered in the case. With the lowest viscosity, water can reach the bottom of micro groove in a very short time. Lubricant oil and polymer melt slower than it. Moreover bulk amorphous alloys in supercooled liquid state just flow into the groove slightly. Among the alloys of different systems including Pd-, Mg- and Zr-based alloy, Pd-based alloy ranks largest in the depth. Mg-based alloy is the second. And Zr-based alloy is the third. Further more the rank order of the viscosities of the alloys is Pd-, Mg- and Zr-based. It agrees well with the results of calculation. Therefore viscosity plays an important role in the microforming of the bulk amorphous alloy in the supercooled liquid state.

  2. [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.

  3. 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.

  4. A laboratory study on groundwater quality and mass movement occurrence

    NASA Astrophysics Data System (ADS)

    Fan, Jen-Chen; Liu, Che-Hsin; Yang, Chih-Hsiang; Huang, Hsiao-Yu

    2009-06-01

    In this study, soil samples collected from the sides of two streams with high debris flow potential at Shenmu and Fengchiou village in Nantou County, Taiwan, were used for seepage tank tests in the laboratory. While the tests were being conducted, observations were made to investigate the relationships among displacement of the slope, quality of the seepage water and occurrence of mass movement. The results showed that according to the change rate, displacement could be divided into two stages, namely, the initial failure displacement stage and primary failure displacement stage. While the displacement of the slope was in primary failure displacement stages, the probability of slope failure became much higher. Before general slope failure, electrical conductivity (EC) and sulfate ion (SO4 2-) concentration of the seepage water increased significantly. The time when EC of the seepage water started to increase rapidly was much earlier than that when displacement of the slope started to increase significantly. Therefore, from the hazard mitigation view, there will be a longer time for response if EC of the seepage water was monitored.

  5. Total quality concepts in the laboratory: The Automated Intelligent Assistant

    SciTech Connect

    Filby, E.E.; Rankin, R.A.

    1991-01-01

    Minimizing instrument downtime is a significant factor for the Mass Spectrometry Laboratory (MSL) at the Idaho Chemical Processing Plant, where spent fuel is repocessed to recover uranium. MSL measures the amount and isotopic content of the uranium in the dissolver solution and in the final uranium oxide product. High quality, timely data are needed for accountability, and the Automated Intelligent Assistant is designed for that purpose. Its design revolves around a multi-tasking computer system, and the core system would integrate data collection, interrupt handling, data handling, expert system, and user interface. The ultrahigh vacuum components were chosen as a starting point for the initial implementation. The multi-tasking part of the concept was not yet tackled; the current system employs sequential program code. Information from the analog input board goes through an analog-to-digital converter into the data interface part of the Vacuum System Assistant, which collects a tremendous amount of real-time data. The data were used to develop a rule base for the expert system, which also utilized a commercial expert system shell. The current system identifies 12 normal'' events or situations: 8 responses are triggered by data changes, while 4 of the recognizable events require a user request. The stored data will be useful for training new operators. Plans include the addition of more ability to handle off-normal events and (long-term) implementation of the fully integrated design for the Automated Intelligent Assistant. 14 figs. (DLC)

  6. Total quality concepts in the laboratory: The Automated Intelligent Assistant

    SciTech Connect

    Filby, E.E.; Rankin, R.A.

    1991-12-31

    Minimizing instrument downtime is a significant factor for the Mass Spectrometry Laboratory (MSL) at the Idaho Chemical Processing Plant, where spent fuel is repocessed to recover uranium. MSL measures the amount and isotopic content of the uranium in the dissolver solution and in the final uranium oxide product. High quality, timely data are needed for accountability, and the Automated Intelligent Assistant is designed for that purpose. Its design revolves around a multi-tasking computer system, and the core system would integrate data collection, interrupt handling, data handling, expert system, and user interface. The ultrahigh vacuum components were chosen as a starting point for the initial implementation. The multi-tasking part of the concept was not yet tackled; the current system employs sequential program code. Information from the analog input board goes through an analog-to-digital converter into the data interface part of the Vacuum System Assistant, which collects a tremendous amount of real-time data. The data were used to develop a rule base for the expert system, which also utilized a commercial expert system shell. The current system identifies 12 ``normal`` events or situations: 8 responses are triggered by data changes, while 4 of the recognizable events require a user request. The stored data will be useful for training new operators. Plans include the addition of more ability to handle off-normal events and (long-term) implementation of the fully integrated design for the Automated Intelligent Assistant. 14 figs. (DLC)

  7. 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.

  8. 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...

  9. 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...

  10. Determination of the Environmental Conditions Required in a Library for the Effective Utilization of Microforms. Interim Report.

    ERIC Educational Resources Information Center

    Holmes, Donald C.

    This report contains recommended guidelines for selected aspects of the environment affecting the use of microforms. Environmental factors discussed include those related to the convenience and comfort of the readers and the custodianship of the material. The recommendations focus on daily routine problems faced by librarians and readers when…

  11. 36 CFR 1238.28 - What must agencies do when sending permanent microform records to a records storage facility?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 1232 of this chapter and the additional requirements in this section. (b) Package non-silver copies separately from the silver gelatin original or silver duplicate microform copy and clearly label them as non-silver copies. (c) Include the following information on the transmittal (SF 135 for NARA Federal...

  12. 36 CFR 1238.28 - What must agencies do when sending permanent microform records to a records storage facility?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 1232 of this chapter and the additional requirements in this section. (b) Package non-silver copies separately from the silver gelatin original or silver duplicate microform copy and clearly label them as non-silver copies. (c) Include the following information on the transmittal (SF 135 for NARA Federal...

  13. 36 CFR 1238.28 - What must agencies do when sending permanent microform records to a records storage facility?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 1232 of this chapter and the additional requirements in this section. (b) Package non-silver copies separately from the silver gelatin original or silver duplicate microform copy and clearly label them as non-silver copies. (c) Include the following information on the transmittal (SF 135 for NARA Federal...

  14. 36 CFR 1238.28 - What must agencies do when sending permanent microform records to a records storage facility?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 1232 of this chapter and the additional requirements in this section. (b) Package non-silver copies separately from the silver gelatin original or silver duplicate microform copy and clearly label them as non-silver copies. (c) Include the following information on the transmittal (SF 135 for NARA Federal Records...

  15. 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.

  16. High Intellectual Function in Individuals with Mutation-Positive Microform Holoprosencephaly.

    PubMed

    Solomon, B D; Pineda-Alvarez, D E; Gropman, A L; Willis, M J; Hadley, D W; Muenke, M

    2012-09-01

    Holoprosencephaly is the most common malformation of the forebrain and typically results in severe neurocognitive impairment with accompanying midline facial anomalies. Holoprosencephaly is heterogeneous and may be caused by chromosome aberrations or environmental factors, occur in the context of a syndrome or be due to heterozygous mutations in over 10 identified genes. The presence of these mutations may result in an extremely wide spectrum of severity, ranging from brain malformations incompatible with life to individuals with normal brain findings and subtle midline facial differences. Typically, clinicians regard intellectual disability as a sign that a parent or relative of a severely affected patient may be a mildly affected mutation 'carrier' with what is termed microform holoprosencephaly. Here we present 5 patients with clear phenotypic signs of microform holoprosencephaly, all of whom have evidence of above-average intellectual function. In 4 of these 5 individuals, the molecular cause of holoprosencephaly has been identified and includes mutations affecting SHH, SIX3, GLI2, and FGF8. This report expands the phenotypic spectrum of holoprosencephaly and is important in the counseling of patient and affected families.

  17. Macroform and microform-induced change in redox-sensitive chemistries of river channel surface sediments

    NASA Astrophysics Data System (ADS)

    Byrne, P.; Zhang, H.; Heathwaite, A. L.; Binley, A.; Ullah, S.; Kaeser, D.; Heppell, C. M.; Lansdown, K.; Trimmer, M.

    2012-04-01

    In-stream geomorphological features such as riffle-pool sequences (macroforms) can produce steep hydraulic gradients which induce flow in and out of the riverbed - hyporheic exchange flow (HEF). The acceleration of flow over channel obstacles such as large cobbles and boulders (microforms) can create variation in surface-subsurface pressure gradients and generation of HEF. HEF in shallow surface sediments affect the transformation of redox-sensitive chemical forms and, therefore, the attenuation or release of nutrients in river systems. Here, we examine the relationship between stream geomorphological environment (microform and macroform) and concentration profiles of redox-sensitive species (nitrate, sulphate, iron, manganese) in shallow (15cm) subsurface sediments. In-situ passive samplers (diffusive equilibrium in thin films - DET) are used to obtain biogeochemical data from armoured environments at fine scale (cm) depth resolution where there is strong upwelling. The probes were deployed in a 50m reach of the River Eden, Cumbria, UK, during baseflow conditions. The experimental setup allowed for the assessment of differences in redox-sensitive chemistries between a riffle and pool environment and between smooth and rough bed surfaces in the pool. The passive sensing basis of the DET methodology provided a means for investigating how HEF systems generated at two different geomorphological scales influence the concentration and spatial patterns of redox-sensitive species. DET's capability of measuring at high spatial resolution allowed the extent of hyporheic mixing to be targeted, even though it is often limited to the top few centimetres of sediment.

  18. Experimental Study of Local Micro-forming for Bi-HTS

    SciTech Connect

    Zeng Pan; Lu Yongjin; Lei Liping; Qu Timing; Fang Gang

    2010-06-15

    The Bi-HTS (BSCCO high temperature superconductor) tape now has become the product in an industrial way, which has been available to apply in electric and electron fields. The main way to manufacture Bi-HTS tape is to use the technique of oxide powder in silver tube (OPIT), which involves the multi-step drawing and rolling with plastic deformation, which obviously belongs to a type of the micro-forming in macro-scale processing. There are two main characteristics founded: (a) contact and friction between silver and BSCCO surfaces, (b) interface between two materials. A series of micro-tensile experiments of silver foil with thicknesses of 0.03, 0.06 and 0.1 mm are designed to investigate the behaviors of silver with various scale of sizes. And the surface topography measurements have been carried out to analyze the changes in surface topography. Based upon experiments, some topics are researched which are referred to inhomogeneous, local effect, size effect, grain and micro-structure affecting, surface roughness, long-distance sausage phenomenon. Further the local breakdown of silver by Bi-HTS powder during process is analyzed through failure criterion. The results of this work will bring out an important exploration value to the theory and computation of micro-forming.

  19. 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

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

    PubMed

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

    2012-11-01

    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.

  2. The Good, the Bad, and the Unknown: Quality of Clinical Laboratories in Kampala, Uganda

    PubMed Central

    Elbireer, Ali M.; Jackson, J. Brooks; Sendagire, Hakim; Opio, Alex; Bagenda, Danstan; Amukele, Timothy K.

    2013-01-01

    Background Clinical laboratories are crucial in addressing the high rates of communicable and non-communicable diseases seen in sub-Saharan Africa (SSA). However, the most basic information, such as the number and quality of clinical laboratories in SSA, is not available. The objective of this study was to create a practical method for obtaining this information in SSA towns and cities using an initial survey in Kampala, Uganda. Methods Kampala city was divided into 5 partially-overlapping regions. Each region was assigned to 2–3 surveyors who identified and surveyed laboratories in their respective regions; in person and on foot. A modified version of the World Health Organization - African Region (WHO/AFRO) Laboratory Strengthening Checklist was used to obtain baseline measures of quality for all clinical laboratories within Kampala city. The surveyors also measured other attributes of each laboratory, such as their affiliation (government, private etc), designation (national hospital, district hospital, standalone etc), staff numbers, and type of staff. Results The survey team identified and surveyed 954 laboratories in Kampala city. 96% of laboratories were private. Only 45 (5%) of the laboratories met or surpassed the lowest quality standards defined by the WHO/AFRO-derived laboratory strengthening tool (1-star). These 45 higher-quality laboratories were, on average, larger and had a higher number of laboratory-specific staff (technologists, phlebotomists etc) than the other 909 laboratories. 688 (72%) of the 954 laboratories were not registered with the Ministry of Health (MoH). Conclusions This comprehensive evaluation of the number, scope, and quality of clinical laboratories in Kampala is the first published survey of its kind in sub-Saharan Africa. The survey findings demonstrated that laboratories in Kampala that had qualified personnel and those that had higher testing volumes, tended to be of higher-quality. PMID:23737993

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

    SciTech Connect

    Not Available

    1993-08-01

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

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

    SciTech Connect

    Grady, T.M.

    1993-12-31

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

  5. Philip Morris involvement in the development of an air quality laboratory in El Salvador

    PubMed Central

    Kummerfeldt, C E; Barnoya, J; Bero, L

    2009-01-01

    Background: The tobacco industry has organised research institutions to generate misleading data on indoor air quality, including second-hand smoke exposure and health effects. Objectives: To describe tobacco industry involvement in the organisation and financial support of an air quality research laboratory in El Salvador. Methods: Tobacco industry documents on the internet were systematically searched from August 2007 to February 2008 for air quality studies undertaken in El Salvador, and laboratory personnel were interviewed. Results: Philip Morris sought to establish a network of air quality laboratories throughout Latin America. In El Salvador, in 1997, through Tabacalera de El Salvador (a subsidiary of Philip Morris) and the Salvadoran Foundation for Economic Development (FUSADES), the industry organised an air quality research laboratory. FUSADES was part of the industry’s Latin American Scientific Network, which consisted of doctors hired as consultants who would send air samples from their research to FUSADES. Philip Morris Scientific Affairs personnel hired LabStat, a Canadian-based laboratory, to provide technical assistance to FUSADES (train and assist the laboratory in air quality measurements). In addition, the Washington-based HMS Group successfully implemented a plan to upgrade the laboratory and obtain international certifications. HMS Group also assisted in searching for sustainable funding for FUSADES, including seeking funds from international aid for Hurricane Mitch. Conclusion: Air quality studies that have used the FUSADES laboratory should be carefully interpreted, given the support that this laboratory received from Philip Morris. PMID:19211614

  6. Total quality management for clinical laboratories: a need or a new fashion?

    PubMed

    Libeer, J C

    1997-01-01

    In most European countries, concepts of quality management in medical laboratories have been proposed. These concepts are based on general standards for test laboratories (EN 45001, ISO 25) or specific adapted standards. Improvement of quality lays on the foundation of the implementation of quality systems in medical laboratories. This new approach will have consequences on management style and on working conditions. Efficacy on the implementation can only be tested by external audits. During this audit, not only the quality system and analytical competence must be examined, but also if there is a real contact between pathologists and clinicians and if laboratory results are clinically validated (clinical audit). This new vision on quality in medical laboratories will ask a reconsideration of the tasks, duties and knowledge of clinical pathologists.

  7. 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.

  8. [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.

  9. Argonne National Laboratory Internal Appraisal Program environment, safety, health/quality assurance oversight

    SciTech Connect

    Winner, G.L.; Siegfried, Y.S.; Forst, S.P.; Meshenberg, M.J.

    1995-06-01

    Argonne National Laboratory`s Internal Appraisal Program has developed a quality assurance team member training program. This program has been developed to provide training to non-quality assurance professionals. Upon successful completion of this training and approval of the Internal Appraisal Program Manager, these personnel are considered qualified to assist in the conduct of quality assurance assessments. The training program has been incorporated into a self-paced, computerized, training session.

  10. 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.

  11. 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.

  12. [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

  13. 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.

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

    SciTech Connect

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

    1993-12-31

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

  15. The Individualized Quality Control Plan – Coming Soon to Clinical Microbiology Laboratories Everywhere!

    PubMed Central

    Anderson, Nancy

    2016-01-01

    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. PMID:26997689

  16. 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

  17. 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.

  18. [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".

  19. A practical statistical quality control scheme for the industrial hygiene chemistry laboratory.

    PubMed

    Burkart, J A; Eggenberger, L M; Nelson, J H; Nicholson, P R

    1984-06-01

    A computerized statistical quality control system has been developed for use in the industrial hygiene chemistry laboratory. The system is practical and sufficiently flexible to allow for multiple analytes, concentrations, replicate sizes and sample types. The computerized system provides an immediate evaluation of the quality of analytical results and produces automatically simple but informative accuracy and precision quality control charts.

  20. The World Health Organization African region laboratory accreditation process: improving the quality of laboratory systems in the African region.

    PubMed

    Gershy-Damet, Guy-Michel; Rotz, Philip; Cross, David; Belabbes, El Hadj; Cham, Fatim; Ndihokubwayo, Jean-Bosco; Fine, Glen; Zeh, Clement; Njukeng, Patrick A; Mboup, Souleymane; Sesse, Daniel E; Messele, Tsehaynesh; Birx, Deborah L; Nkengasong, John N

    2010-09-01

    Few developing countries have established laboratory quality standards that are affordable and easy to implement and monitor. To address this challenge, the World Health Organization Regional Office for Africa (WHO AFRO) established a stepwise approach, using a 0- to 5-star scale, to the recognition of evolving fulfillment of the ISO 15189 standard rather than pass-fail grading. Laboratories that fail to achieve an assessment score of at least 55% will not be awarded a star ranking. Laboratories that achieve 95% or more will receive a 5-star rating. This stepwise approach acknowledges to laboratories where they stand, supports them with a series of evaluations to use to demonstrate improvement, and recognizes and rewards their progress. WHO AFRO's accreditation process is not intended to replace established ISO 15189 accreditation schemes, but rather to provide an interim pathway to the realization of international laboratory standards. Laboratories that demonstrate outstanding performance in the WHO-AFRO process will be strongly encouraged to enroll in an established ISO 15189 accreditation scheme. We believe that the WHO-AFRO approach for laboratory accreditation is affordable, sustainable, effective, and scalable.

  1. Microform holoprosencephaly with bilateral congenital elbow dislocation; increasing the phenotypic spectrum of Steinfeld syndrome.

    PubMed

    Jones, Gabriela E; Robertson, Lisa; Maniyar, Amit; Shammas, Christos; Phelan, Marie M; Vasudevan, Pradeep C; Tanteles, George A

    2016-03-01

    Steinfeld syndrome (MIM #184705) was first reported in 1982. It is characterised by holoprosencephaly and limb defects, however other anomalies may also be present. Following the initial description, three further cases have been reported in the literature. We report on a 23-year-old girl, with features of microform holoprosencephaly and bilateral congenital elbow dislocation in association with hypoplastic radial heads. She was identified to have a variant in the CDON gene inherited from her father who had ocular hypotelorism, but no other clinical features. We discuss the clinical features of Steinfeld syndrome, and broaden the phenotypic spectrum of this condition. Structural analysis suggests that this variant could lead to destabilisation of binding of CDON with hedgehog proteins. Further work needs to be done to confirm whether mutations in the CDON gene are the cause of Steinfeld syndrome.

  2. 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.

  3. 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.

  4. 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…

  5. 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…

  6. Quality assurance consideration for cement-based grout technology programs at Oak Ridge National Laboratory

    SciTech Connect

    McDaniel, E.W.; Tallent, O.K.; Sams, T.L.; Delzer, D.B.

    1987-01-01

    Oak Ridge National Laboratory has developed and is continuing to refine a method of immobilizing low-level radioactive liquid wastes by mixing them with cementitious dry-solid blends. A quality assurance program is vital to the project because Nuclear Regulatory Commission (NRC), Environmental Protection Agency (EPA) and state environmental regulations must be demonstrably met (the work must be defensible in a court of law). The end result of quality assurance (QA) is, by definition, a product of demonstrable quality. In the laboratory, this entails traceability, repeatability, and credibility. This paper describes the application of QA in grout technology development at Oak Ridge National Laboratory.

  7. Quality assurance growing pains: a state perspective on implementing an organizational-wide quality system in environmental laboratories.

    PubMed

    Siders, S D

    1999-01-01

    To implement an effective and efficient quality system in a network of established environmental testing laboratories requires a committed long-term effort that is potentially fraught with multiple obstacles. This presentation discusses one state's ongoing efforts at implementing such a system. First is the need to convince management of the rationale for a quality systems-based approach versus the traditional QA/QC program. Once development of a quality system has been sanctioned, a team-based approach utilizing project planning tools is a good way to approach the effort. Resources are assigned to the development of key quality system components, and generally a phased-deployment or roll-out works best. Once implementation is underway, assuring operational utilization and compliance with the quality system are vital steps in the process. Important to successful implementation is ongoing assessment and refinement of the quality system. Fundamental and key elements of the laboratory quality system are numerous and need to work in concert with each other. Quality system elements to be discussed in the presentation range from management and QA roles and functions to the typical documentation of laboratory policies and procedures. Numerous QA assessment tools and other vital quality system practices that play an important role in making a complete quality system are addressed. In addition, efforts must be undertaken to integrate the laboratory quality system with other management systems within the organization. The bottom line is that all environmental laboratories need a quality system more now than ever. Data users need it. Customers' expectations for data quality are high. USEPA policy and/or programs call for it. Additionally, good quality systems can benefit the organization in multiple ways and help avoid the "pay-me-now or pay-me-later" syndrome. In conclusion, all environmental testing laboratories (i.e., academic, private, commercial and especially

  8. Users' and health service providers' perception on quality of laboratory malaria diagnosis in Tanzania.

    PubMed

    Derua, Yahya A; Ishengoma, Deus Rs; Rwegoshora, Rwehumbiza T; Tenu, Filemoni; Massaga, Julius J; Mboera, Leonard Eg; Magesa, Stephen M

    2011-04-06

    Correct diagnosis of malaria is crucial for proper treatment of patients and surveillance of the disease. However, laboratory diagnosis of malaria in Tanzania is constrained by inadequate infrastructure, consumables and insufficient skilled personnel. Furthermore, the perceptions and attitude of health service providers (laboratory personnel and clinicians) and users (patients/care-takers) on the quality of laboratory services also present a significant challenge in the utilization of the available services. This study was conducted to assess perceptions of users and health-care providers on the quality and utilization of laboratory malaria diagnostic services in six districts from three regions in Tanzania. Questionnaires were used to collect information from laboratory personnel, clinicians and patients or care-takers. A total of 63 laboratory personnel, 61 clinicians and 753 patients/care-takers were interviewed. Forty-six (73%) laboratory personnel claimed to be overworked, poorly motivated and that their laboratories were under-equipped. About 19% (N = 12) of the laboratory personnel were lacking professional qualification. Thirty-seven clinicians (60.7%) always requested for blood smear examination to confirm malaria. Only twenty five (41.0%) clinicians considered malaria microscopy results from their respective laboratories to be reliable. Forty-five (73.8%) clinicians reported to have been satisfied with malaria diagnostic services provided by their respective laboratories. Majority (90.2%, N = 679) of the patients or care-takers were satisfied with the laboratory services. The findings show that laboratory personnel were not satisfied with the prevailing working conditions, which were reported to undermine laboratory performance. It was evident that there was no standard criteria for ordering malaria laboratory tests and test results were under-utilized. Majority of the clinicians and patients or care-takers were comfortable with the overall performance of

  9. Sandia National Laboratories, California Air Quality Program annual report.

    SciTech Connect

    Gardizi, Leslee P.; Smith, Richard

    2009-06-01

    The annual program report provides detailed information about all aspects of the SNL/CA Air Quality Program. It functions as supporting documentation to the SNL/CA Environmental Management System Program Manual. The program report describes the activities undertaken during the past year, and activities planned in future years to implement the Air Quality Program, one of six programs that supports environmental management at SNL/CA.

  10. Sandia National Laboratories, California Air Quality Program : annual report.

    SciTech Connect

    Shih, Richard; Gardizi, Leslee P.

    2007-05-01

    The annual program report provides detailed information about all aspects of the SNL/CA Air Quality Program. It functions as supporting documentation to the SNL/CA Environmental Management System Program Manual. The program report describes the activities undertaken during the past year, and activities planned in future years to implement the Air Quality Program, one of six programs that supports environmental management at SNL/CA.

  11. 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.

  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. Development of an internal dynamic web site to promote quality assurance in a clinical laboratory.

    PubMed

    Pernet, Pascal; Mario, Nathalie; Vaubourdolle, Michel

    2004-01-01

    In clinical laboratories, one challenging quality assurance objective is to maintain standardized practices. Meeting this objective entails ensuring information flow, which is necessary to smooth running of the laboratory. To facilitate information flow, we developed an internal quality Web site on our local network. The dynamic generated pages of the site were constructed with EasyPHP v.1.6, a complete freeware package providing PHP dynamic language and databases. The site comprises various sections: general news, specific laboratory units news, documents (quality manual, guidelines, emergency processes), schedules, National Quality Control results, forum, etc. Five to 10 pages are updated each week. This work was facilitated by the use of PHP-written pages and data tables, which enable us to record in real time the operation of our assurance quality project and to improve traceability. This approach could be extended to other aspects of quality management and could help meet the future IS015189 standard requirements.

  14. Laboratory accreditation: quality in management and analysis and the input-output control.

    PubMed

    Bunyaratvej, A

    1999-01-01

    An attempt to overcome the uncertainties and errors of all processes in clinical laboratory has been done in systematic ways. To reach the stage of laboratory accreditation, quality and standard criteria in the laboratory must be developed. Two aspects of quality are considered as management and analysis. Input-output control is proposed to handle the process from the beginning of laboratory design until post analytical phase or the control at the outcome. The model of ten Ms including model, material, machine, man, mind, money, method, mechanism, measurement and menace and one O or outcome, is elaborated to cover pre-analytical, analytical and post-analytical phases. Laboratory accreditation is then an integral part of hospital accreditation with total quality management.

  15. Truncating loss-of-function mutations of DISP1 contribute to holoprosencephaly-like microform features in humans

    PubMed Central

    Roessler, Erich; Ma, Yong; Ouspenskaia, Maia V.; Lacbawan, Felicitas; Bendavid, Claude; Dubourg, Christèle; Beachy, Philip A.; Muenke, Maximilian

    2009-01-01

    Defective function of the Sonic Hedgehog (SHH) signaling pathway is the most frequent alteration underlying holoprosencephaly (HPE) or its various clinical microforms. We performed an extensive mutational analysis of the entire human DISP1 gene, required for secretion of all hedgehog ligand(s) and which maps to the HPE 10 locus of human chromosome 1q41, as a HPE candidate gene. Here, we describe two independent families with truncating mutations in human DISP1 that resemble the cardinal craniofacial and neuro-developmental features of a recently described microdeletion syndrome that includes this gene; therefore, we suggest that DISP1 function contributes substantially to both of these signs in humans. While these clinical features are consistent with common HPE microforms, especially those linked to defective signaling by Sonic Hedgehog, we have insufficient evidence so far that functionally abnormal DISP1 alleles will commonly contribute to the more severe features of typical HPE. PMID:19184110

  16. 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.

  17. [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.

  18. Science Laboratories and Indoor Air Quality in Schools. Technical Bulletin.

    ERIC Educational Resources Information Center

    Jacobs, Bruce W.

    Some of the issues surrounding the indoor air quality (IAQ) problems presented by science labs are discussed. Described are possible contaminants in labs, such as chemicals and biological organisms, and ways to lessen accidents arising from these sources are suggested. Some of the factors contributing to comfort, such as temperature levels, are…

  19. Science Laboratories and Indoor Air Quality in Schools. Technical Bulletin.

    ERIC Educational Resources Information Center

    Jacobs, Bruce W.

    Some of the issues surrounding the indoor air quality (IAQ) problems presented by science labs are discussed. Described are possible contaminants in labs, such as chemicals and biological organisms, and ways to lessen accidents arising from these sources are suggested. Some of the factors contributing to comfort, such as temperature levels, are…

  20. 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…

  1. Quality control of the isolation rate of pathogens in medical microbiology laboratories.

    PubMed Central

    Tillett, H. E.; Crone, P. B.

    1976-01-01

    Two statistical analyses are suggested to compare the success rates in isolating and identifying pathogenic organisms from specimens achieved by different laboratories participating in a quality control scheme. An example is given in which the analyses are applied to 25 laboratories that received 30 simulated specimens. PMID:1069816

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

    PubMed

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

    2002-01-01

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

  3. Quality Management Systems in the Clinical Laboratories in Latin America.

    PubMed

    Garzon, Alba C

    2015-11-01

    The implementation of management systems in accordance with standards like ISO 9001:2008 (1,2) in the clinical laboratories has conferred and added value of reliability and therefore a very significant input to patient safety. As we know the ISO 9001:2008 (1) a certification standard, and ISO 15189:2012 (2) an accreditation standard, both, at the time have generated institutional memory where they have been implemented, the transformation of culture focused on correct execution, control and following, evidence needed and the importance of register.

  4. Quality Management Systems in the Clinical Laboratories in Latin America

    PubMed Central

    2015-01-01

    The implementation of management systems in accordance with standards like ISO 9001:2008 (1,2) in the clinical laboratories has conferred and added value of reliability and therefore a very significant input to patient safety. As we know the ISO 9001:2008 (1) a certification standard, and ISO 15189:2012 (2) an accreditation standard, both, at the time have generated institutional memory where they have been implemented, the transformation of culture focused on correct execution, control and following, evidence needed and the importance of register. PMID:27683495

  5. A quality control program for the radioimmunoassay laboratory.

    PubMed

    Woo, J; Cannon, D C

    1976-11-01

    The major problems in applying quality control to radioimmunoassay measurements are (a) nonlinearity of the dose-response curve, and (b) nonuniformity of the residual variance. A logit-log transformation of the dose-response variables combined with an iterative weighted regression analysis appears to overcome most of the difficulties. This technic is particularly helpful when applied to substandard runs where extraneous standard points tend to distort assay results. The authors describe a quality control program that involves recording control values on calendar and histogram formats, monitoring assay variables by charting, and comparing the computer-calculated slope with the graphic plot to reveal "outliers." This program is useful in guiding technologists to locate possible causes for "out-of-limits" runs.

  6. 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

  7. 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.

  8. 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.

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

    PubMed Central

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

    2016-01-01

    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

  10. Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China.

    PubMed

    Fei, Yang; Kang, Fengfeng; Wang, Wei; Zhao, Haijian; He, Falin; Zhong, Kun; Wang, Zhiguo; Chen, Wenxiang

    2016-08-01

    The aim of the study was to promote the establishment and implementation of quality indicators (QIs) in clinical laboratories, catch up with the state of art, and provide preliminary quality specifications for established QIs. Clinical laboratories from different provinces in China were included in this QIs survey in 2015. All participants were asked to collect data related to QIs and complete QIs questionnaires. Defect percentages and sigma values were calculated for each QI. The 25th percentile, median, and the 75th percentile of defect percentages and TATs were calculated as optimum, desirable and minimum quality specifications. While 25th, median, and 75th of sigma values were calculated as minimum, desirable and optimum quality specifications, respectively. Five thousand seven hundred and fifty-three clinical laboratories from 28 provinces in China participated in this survey. Median defect percentages of pre-examination QIs varied largely from 0.01% (incorrect sample container) to 0.57% (blood culture contamination) with sigma values varied from 4.0σ to 5.1σ. Median defect percentages of examination phase QIs were all really high. The most common problem in examination phase was test uncovered by inter-laboratory comparison (86.67%). Defect percentages of critical values notification and timely critical values notification were all 0.00% (6.0σ). While the median of defect percentages of incorrect laboratory reports was only 0.01% (5.4σ). Improvements are needed in all phases of total testing process (TTP) in laboratories in China, especially in examination phase. More attention should be paid when microbiology specimens are collected and results are reported. Quality specifications can provide directions for laboratories to make effort for.

  11. 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

  12. 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.

  13. The implementation of a system for managing analytical quality in networked laboratories.

    PubMed

    Jassam, Nuthar; Lindsay, Chris; Harrison, Kevin; Thompson, Douglas; Bosomworth, Mike P; Barth, Julian H

    2011-03-01

    In a network of laboratories analytical variability between instruments, even of the same type, may exist for reasons beyond the control of laboratory staff. Controlling variability is a prerequisite for the application of shared reference ranges and for ensuring the transferability of patient test results. Controlling variability requires a robust, non-conventional quality system to detect poor performance of analysers that are geographically distant. Essential to this quality system is a set of well-defined quality specifications. The approach used in our study started with (1) selection of a model for quality specifications based on biological variation; the 'three-level model' (TLM) was selected on the basis of its flexibility to accommodate various levels of analytical performance; (2) determination of the performance characteristics of the 71 analytes measured in core biochemistry in terms of imprecision and bias; (3) defining quality requirements in the form of imprecision, bias and total error for 71 analytes measured routinely in core biochemistry; and (4) developing software to assist a consistent wide application of the quality specifications and to monitor analytical indices to the common quality specifications. In this paper we describe how we have implemented this model across our network. Forty-six of the 71 analytes in our core laboratory repertoire were allocated to the TLM. We were able to demonstrate equivalence of results on all analysers, for 42 out of 46 analytes allocated to this model. We propose that other networked laboratories should investigate the suitability of this quality system for use in their network.

  14. 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.

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

    PubMed Central

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

    2016-01-01

    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. PMID:26194882

  16. External Quality Assessment in the Evaluation of Laboratory Performance of Faecal Culture.

    PubMed

    Kiiskinen, Salla J; Ojanen, Tarja; Björkman, Yvonne; Laitinen, Harri; Siitonen, Anja

    2017-01-01

    In Finland, all laboratories carrying out diagnostics of infectious diseases in humans are approved by the Regional State Administrative Agencies and are obligated to participate in External Quality Assurance rounds. Performance in these rounds is thought to reflect the quality of laboratory work. In the 6-year study period, 17 Finnish laboratories received 48 simulated faecal specimens for the culturing of diarrhoeal pathogens, yielding altogether 586 faecal culture External Quality Control specimens and 581 reports. The results were correct in 92% of all reports and in 67% of all specimens. False-negative Salmonella results were given for 2 of the 18 specimens, one with biochemically atypical Salmonella strain and the other with a low count of Salmonella cells. False-negative Shigella report was given for 6 of the 7 specimens in some participating laboratory. Detection of all common faecal pathogens is especially relevant to patient safety, public health, and epidemiological surveillance.

  17. Drug quality screening in developing countries: establishment of an appropriate laboratory in Swaziland.

    PubMed Central

    Kenyon, T. A.; Kenyon, A. S.; Sibiya, T.

    1994-01-01

    A simple, low-cost, accurate thin-layer chromatography (TLC) method has been used to establish the first drug quality screening laboratory in Swaziland. For this purpose, office space at the central medical stores was first converted into a simple laboratory. Basic equipment, supplies, and materials were purchased, existing manpower was trained to perform accurately the TLC procedure, and a system was established for the qualitative/quantitative screening of selected drugs purchased by the Ministry of Health prior to their distribution to user facilities. The TLC method described can be used to set up similar low-cost, drug quality screening laboratories in other developing countries where analytical chemistry expertise is lacking, resources are scarce, and sophisticated analytical laboratories to assess drug quality are not available. PMID:7923541

  18. 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.

  19. Recommended procedures for performance testing of radiobioassay laboratories: Volume 1, Quality assurance. [Contains Glossary

    SciTech Connect

    Fenrick, H.W.; MacLellan, J.A.

    1988-11-01

    Draft American National Standards Institute (ANSI) Standard N13.30 (Performance Criteria for Radiobioassay) was developed in response to a concern expressed by the US Department of Energy and US Nuclear Regulatory Commission to help ensure that bioassay laboratories provide accurate and consistent results. The draft standard specifies the criteria for defining the procedures necessary to establish a bioassay performance-testing laboratory and program. The testing laboratory will conduct tests to evaluate the performance of service laboratories. Pacific Northwest Laboratory helped define responsibilities and develop procedures as part of an effort to evaluate the draft ANSI N13.30 performance criteria for quality assurance at bioassay laboratories. This report recommends elements of quality assurance and quality control responsibilities for the bioassay performance-testing laboratory program, including the qualification and performance of personnel and the calibration, certification, and performance of equipment. The data base and recommended records system for documenting radiobioassay performance at the service laboratories are also presented. 15 refs.

  20. Collective opinion paper on findings of the 2010 convocation of experts on laboratory quality.

    PubMed

    Cooper, Greg; DeJonge, Niels; Ehrmeyer, Sharon; Yundt-Pacheco, John; Jansen, Rob; Ricós, Carmen; Plebani, Mario

    2011-05-01

    As a part of a series of yearly meeting, in May 2010 over 40 medical laboratory opinion leaders, pathologists, clinical biochemists and physicians from Europe, Israel and South Africa gathered together in Bardolino, Italy to discuss issues and current challenges for laboratory medicine, including a) the use of biological variation 10 years after the Stockholm Conference; b) achieving quality in point-of-care testing; c) assessing risk and controlling sources of error in the laboratory; d) determining the appropriate frequency of quality control; and f) putting laboratory medicine at the core of patient care. The intended goal of the convocation was to give laboratory professionals from different countries and backgrounds the opportunity to share ideas, concerns and experiences in previously mentioned areas of interest. This paper provide a synopsis of the reports from each working group.

  1. 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.

  2. 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

  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. Sampling Plan Development in Support of DLA’s Quality Assurance Laboratory Testing Program

    DTIC Science & Technology

    1991-09-01

    Objective 2 states "Develop and implement initiatives for continuously improving the quality of products and services delivered to our customers." Task 6 of... of products provided to the military services, Defense Logistics Agency (DLA) embarked on a comprehensive plan *° for enhancing its Quality Assurance...technically sound and appropriate for supporting the DoDIG’s Audit recommendation for laboratory testing. xi I. INTRODUCTION In its quest to improve the quality

  5. Quality indicators in the preanalytical phase of testing in a stat laboratory.

    PubMed

    Grecu, Daniela Stefania; Vlad, Daliborca Cristina; Dumitrascu, Victor

    2014-01-01

    To quantify performance in the preanalytical phase in a stat laboratory using quality indicators, and compare our results with those in the literature to improve laboratory services. We counted the test request forms, samples, and the types of preanalytical errors that occured in a stat laboratory between January 1 and December 31, 2011. We then compared the quality-indicator scores with the quality specifications mentioned in the literature. During the 1-year period, a total of 168,728 samples and 88655 requests forms were received in stat laboratory. The total number of preanalytical errors was 1457, accounting for 0.8% of the total number of samples received in a year. Of the total preanalytical errors, 46.4% were hemolysed samples (biochemistry), 43.2% were clotted samples (hematology), 6.4% were samples lost-not received in the laboratory, 2.9% samples showed an inadequate sample-anticoagulant ratio, 0.7% were requests with errors in patient identification, 0.3% were samples collected in blood collection tubes with inappropriate anticoagulant and 0.1% were requests with errors--missing test requests. The preanalytical performance of a stat laboratory in our setting is favorable and complies with international quality specifications.

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

    PubMed

    Albert, Heidi; de Dieu Iragena, Jean; Kao, Kekeletso; Erni, Donatelle; Mekonen, Teferi; Onyebujoh, Philip C

    2017-01-01

    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. 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. 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. 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. 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-benefit.

  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. 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.

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

    PubMed Central

    Esteves, Sandro C; Bento, Fabiola C

    2016-01-01

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

  10. Piloting Laboratory Quality System Management in Six Health Facilities in Nigeria

    PubMed Central

    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

    Background 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. Method 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. Results 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. Conclusion 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. PMID:25542022

  11. [Computerization of a clinical chemical laboratory. A contribution for quality assurance].

    PubMed

    Miguel, M J; Matias, J S; Barros, F B

    1997-11-01

    The application of computer science to the practice of laboratory medicine, one of the medical informatics fields, brings a complete revolution in laboratory work and the clinical pathologists profile. The authors explain the methodology for the implementation of such a system, in a perspective of quality assurance, defining the goals, objectives, customer requirements and analysis of the benefits they achieve. Finally the authors explain the future perspectives.

  12. 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.

  13. 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.

  14. Error budgets for quality management--practical tools for planning and assuring the analytical quality of laboratory testing processes.

    PubMed

    Westgard, J O

    1996-01-01

    Analytical quality is often assumed, rather than being assured or guaranteed. Given that it is still essential that laboratories produce reliable test results, managers must continue to improve their skills in analytical quality management. This paper shows managers how to use error budgets and charts of operating specifications (¿OPSpecs¿ charts) to select appropriate control rules and numbers of control measurements, taking into account the analytical or clinical quality required for a test and the imprecision and inaccuracy observed for a method. With currently available tools and a little practice, quality control (QC) procedures can be selected quickly and easily, in just 1 minute or less. Future technology is expected to automate the QC selection process and provide dynamic quality control.

  15. Identification of bacterial strains by laboratories participating in the Deutsches Krebsforschungszentrum quality assurance programme.

    PubMed

    Boot, R; Reubsaet, F A G

    2007-10-01

    The quality assurance programme (QAP) of the Deutsches Krebsforschungszentrum (DKFZ) is a proficiency testing system developed to service the laboratory animal discipline. QAP comprises the quarterly distribution of two bacterial strains originating from various species of animals for identification to the species level and antibiotic susceptibility testing. We compared identification results reported by QAP participants over the years 1996-2004 with those obtained by the Dutch Bacterial Diagnostics reference laboratory on 68 samples comprising 71 bacterial strains and a fungus. Significant differences were found in the frequency of reported and correct identifications when bacteria were assigned to different groups based on morphology by Gram stain and on origin (animal versus environmental, rodent and rabbit versus other animal species, pathogen versus non-pathogens). Rodent and rabbit pathogens yielded 73% correct identifications, and with all bacterial strains only 60% of the identifications were correct. We assume that most QAP participants were from laboratory animal diagnostic laboratories. If this is true, the capabilities of laboratories in the laboratory animal discipline to correctly identify bacterial species are well below what are considered acceptable limits for human diagnostic laboratories. The distribution of cultured bacteria circumvents the most difficult step in the microbiological monitoring of animals, namely primary culture from clinical samples. We propose to set up a QAP that comprises the distribution of specimens mimicking clinical samples normally submitted to laboratory animal diagnostic laboratories.

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

    SciTech Connect

    Sailer, S.J.

    1996-08-01

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

  17. Risk management in laboratory medicine: quality assurance programs and professional competence.

    PubMed

    Sciacovelli, Laura; Secchiero, Sandra; Zardo, Lorena; D'Osualdo, Alessandra; Plebani, Mario

    2007-01-01

    To guarantee excellent performance and service, the process of identifying and treating error risks must be integrated into the total testing process. Quality Assurance Programs (QAPs) represent an important tool that allows us to identify errors and pinpoint any need for further systematic investigations, and to rectify procedures to improve the inputs and processes by which the service is delivered. The models used by the laboratory to assure quality and manage the risk of errors have been modified in line with an approach in which the identification of quality goals and the redefinition of professionals duties and responsibilities are indispensable. Error risk is currently high in some areas of laboratory activity, and QAP is needed now more than ever. The present paper provides some descriptive examples of an approach that can be followed to manage an External Quality Assessment Scheme (EQAS) and quality indicators (QIs), the main tools used by laboratories to assure the quality of their service, for the prevention of error risk. In particular, we describe the correct approach to choose EQAS, to use information from the EQAS report, to design a QI model, and to analyze any QI data. The examples highlight that any well-designed quality system can be ineffective if it is not managed by highly competent professionals with a deep sense of responsibility.

  18. 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.

  19. Measurement control is one component of laboratory quality assurance: What are the others

    SciTech Connect

    Delvin, W.L.

    1986-05-30

    The value of a quality assurance program is that the overlooking, ignoring, or downgrading of useful functions and practices will be minimized. The principles of quality assurance make a great tool for minimizing problems and for helping to find and correct deficiencies and problems when they occur. Finding and correcting deficiencies and problems while they are still small - before they become monsters - will certainly make life easier in the operation of a laboratory. This takes diligence in being aware of what is going on in the laboratory and firm resolve by management to take effective corrective actions when necessary. It takes more than applying band aids to problems. 4 refs.

  20. The making of a successful seminar: Pacific Northwest Laboratory`s {open_quotes}Quest for Quality{close_quotes}

    SciTech Connect

    Lumetta, C.C.; Downs, S.L.; Parnell, K.A.; Allen, R.E.

    1994-10-01

    Five contractors located on or near the Hanford Site in southeastern Washington State support technical communications staffs, all trying to meet the needs of one primary customer the U.S. Department of Energy. Historically, these staffs have maintained different processes and standards with regard to document production, and little interaction or information-sharing has occurred. To begin remedying that situation, the communications staff of Pacific Northwest Laboratory, a multiprogram national laboratory located in Richland, Wash., planned and hosted a one-day {open_quotes}Quest for Quality{close_quotes} seminar. The seminar was the first of its kind to comprise technical communications professionals from all the local DOE prime contractors, including technical editors and writers, publications assistants, text processors, and document production staff. The goals of the seminar were to identify ways to improve the quality of Hanford`s communication products and processes, to strengthen ties among technical communications staffs, and to open the lines of communication for future collaborative efforts. An eight-person committee selected topics, arranged facilities, recruited speakers, coordinated activities, hosted the seminar, and prepared proceedings.

  1. Quality management at Argonne National Laboratory: Status, accomplishments, and lessons learned

    SciTech Connect

    1995-06-01

    In April 1992, Argonne National Laboratory (ANL) launched the implementation of quality management (QM) as an initiative of the Laboratory Director. The goal of the program is to seek ways of improving Laboratory performance and effectiveness by drawing from the realm of experiences in the global total quality management movement. The Argonne QM initiative began with fact finding and formulating a strategy for implementation; the emphasis is that the underlying principles of QM should be an integral part of how the Laboratory is managed and operated. A primary theme that has guided the Argonne QM initiative is to consider only those practices that offer the potential for real improvement, make sense, fit the culture, and would be credible to the broad population. In October 1993, the Laboratory began to pilot a targeted set of QM activities selected to produce outcomes important to the Laboratory--strengthening the customer focus, improving work processes, enhancing employee involvement and satisfaction, and institutionalizing QM. This report describes the results of the just-concluded QM development and demonstration phase in terms of detailed strategies, accomplishments, and lessons learned. These results are offered as evidence to support the conclusion that the Argonne QM initiative has achieved value-added results and credibility and is well positioned to support future deployment across the entire Laboratory as an integrated management initiative. Recommendations for follow-on actions to implement future deployment are provided separately.

  2. Evidence from 617 laboratories in 47 countries for SLMTA-driven improvement in quality management systems

    PubMed Central

    Yao, Katy; Luman, Elizabeth T.

    2015-01-01

    Background The Strengthening Laboratory Management Toward Accreditation (SLMTA) programme is a large-scale effort to improve the quality of laboratories in resource-limited countries. Objectives This study sought to evaluate the first four years (2010–2013) of SLMTA implementation. Methods Country-level data were submitted by SLMTA programme leads and compiled globally. Performance was measured before (baseline) and after (exit) SLMTA implementation using an audit checklist which results in a percentage score and a rating of zero to five stars. Some laboratories continued to monitor performance in post-exit surveillance audits. We evaluated score improvements using two-tailed t-tests for equal variances and estimated the number of tests performed by SLMTA laboratories based on star level. Results SLMTA was implemented in 617 laboratories in 47 countries in Africa, the Caribbean, Latin America and Southeast Asia. At the baseline audit, the laboratories scored an average of 39% on the checklist and 84% of them were rated below one star. As of December 2013, 302 laboratories had completed the SLMTA programme; mean checklist scores increased from 39% at baseline to 64% at exit (p < 0.001) over an average 16-month programme duration. Ninety-two laboratories conducted a surveillance audit at a median of 11 months after their exit audit; 62% further increased their performance. Six SLMTA laboratories have achieved accreditation status. In total, the 617 SLMTA laboratories conduct an estimated 111 million tests annually. Only 16% of these tests were conducted by laboratories with at least one star at baseline, which increased to 68% of tests after SLMTA training. Thus, approximately 23 million tests are conducted annually by laboratories previously at zero stars that now have one to five stars; this number is projected to increase to 58 million when currently-enrolled laboratories complete the programme. Conclusion SLMTA has transformed the laboratory landscape in

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

    SciTech Connect

    Turgeon, Jennifer L.; Minana, Molly A.; Hackney, Patricia; Pilch, Martin M.

    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 the 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.

  4. The performance of health laboratories and the quality of malaria diagnosis in six districts of Tanzania.

    PubMed

    Ishengoma, D R S; Derua, Y A; Rwegoshora, R T; Tenu, F; Massaga, J J; Mboera, L E G; Magesa, S M

    2010-03-01

    Early laboratory diagnosis is critical for the optimal management of human malaria, particularly following the introduction of relatively expensive, artemisinin-combination therapies (ACT). The performance of the laboratories and the quality of malaria diagnosis have recently been assessed in 36 healthcare facilities in six districts of Tanzania. Questionnaires, checklists and observations were used to collect information on the availability and functional status of equipment as well as on laboratory personnel and their performance in malaria diagnosis. Together, the surveyed facilities had 112 laboratory staff [almost half (41.1%) of whom were laboratory assistants] and 57 microscopes. Twenty-seven (75.0%) of the healthcare facilities included in the survey had only one functional microscope each. Only seven (12.3%) of the assessed microscopes had been serviced in the previous 2 years. Of the 38 microscopists who were assessed, 24 (63.2%) were re-using microscope slides, 29 (73.5%) were producing bloodsmears of low quality, and 30 (79.0%) were using Field's stain. Although the facility microscopists gave similar results to experienced research microscopists when reading bloodsmears prepared by the survey team, using high-quality reagents (kappa=0.769), they appeared far less competent when reading smears stained using the reagents from the study laboratories (kappa=0.265-0.489). The quality of malaria diagnosis at healthcare facilities in Tanzania, which is generally poor (largely because of inadequate supplies of consumables and the limited skills of laboratory staff in the preparation of bloodsmears), urgently needs to be improved if the utilization of ACT is to be sustainable.

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

    SciTech Connect

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

    1985-10-01

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

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

    SciTech Connect

    Bolivar, S.L.

    1996-03-01

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

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

    PubMed Central

    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

    Introduction 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. Materials and Methods 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. Results 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. Conclusion 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

  8. 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.

  9. 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.

  10. Comparison of Laboratory and Field Remote Sensing Methods to Measure Forage Quality

    PubMed Central

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

    2010-01-01

    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. PMID:20948940

  11. Inter-laboratory study to improve the quality of the analysis of nutrients in rainwater chemistry

    NASA Astrophysics Data System (ADS)

    Karthikeyan, Sathrugnan; Balasubramanian, Rajasekhar; He, Jun

    This paper describes the results of an inter-laboratory study conducted for the analysis of nutrients (nitrate, ammonium, phosphate, total nitrogen (TN), and total phosphorus (TP)) in natural rainwater. For this purpose, rainwater samples were collected and aggregated in Singapore and homogenized. These samples were immediately filtered through 0.45 μm membrane filters and autoclaved for 15 min at 80 °C in order to stabilize the nutrients. The homogeneity and the stability of nutrients were rigorously tested for a period of three months initially. Upon ensuring the homogeneity and stability, the samples were distributed to 15 different laboratories from various countries around the world (Australia, Brazil, India, Mauritius, Singapore, Slovenia, Spain, Taiwan, and USA). Almost all laboratories have reported the analytical results for nitrate whereas only 8 of the 15 laboratories reported results for other nutrients such as ammonium, phosphate, TN, and TP. The discrepancy was mainly due to the presence of these nutrients in low concentration levels (particularly ammonium ion and phosphate). Not all the laboratories were equipped with analytical capabilities to conduct the analysis of nutrients in low concentration levels. Further, the uncertainty associated with the analysis of TN and TP restricted the number of laboratories that could report their analytical data on nutrients. All 14 laboratories reported nitrate-nitrogen results which were in good agreement with each other (0.68 ± 0.07 mg l -1). Similarly, the results of TN and TP were also comparable among at least 8 laboratories. This inter-laboratory study on the analysis of nutrients in natural rainwater, conducted for the first time, provided an opportunity to the participating laboratories to assess and improve their laboratory performance, thereby, improving the quality of their analytical data.

  12. 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.

  13. 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.

  14. External failures as descriptor of quality in clinical microbiology laboratory services.

    PubMed

    Saarela, Ulla; Kivinen, Tuula; Sarkkinen, Hannu

    2005-01-01

    This study employed customer feedback surveys to assess the quality of the laboratory services provided by an accredited clinical microbiology laboratory. The purpose of the study was to classify external failures and determine the quantity of such errors, and to establish how much time was spent processing and correcting these errors, together with the costs arising. The study indicates that the quality of laboratory test results can be regarded as good based on the accuracy of the result. Customer needs were also well taken into account in practice because of the good quality of the service. However, improvements are required in providing customers with test results without delay. The cost of processing and correcting such errors was negligible. The use of a customer feedback system allows systematic monitoring of external failures. In the accredited laboratory under study, it is unnecessary to monitor continually the costs and working time involved in processing and correcting external failures. The most essential point is to monitor the effects of the quality measures taken to reduce the number of failures.

  15. Los Alamos National Laboratory Yucca Mountain Site Characterization Project 1995 quality program status report

    SciTech Connect

    Bolivar, S.L.

    1996-07-01

    This status report summarizes the activities and accomplishments of the Los Alamos National Laboratory Yucca Mountain Site Characterization Project`s (YMP`s) quality assurance program for January 1 to September 30, 1995. The report includes major sections on program activities and trend analysis.

  16. 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.

  17. 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.

  18. 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…

  19. 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

  20. 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…

  1. Diagnostic laboratories in Asia Pacific region: Investigation on quality characteristics and time of reporting.

    PubMed

    Badrick, Tony C; Gutscher, Anton; Sakamoto, Nakako; Chin, Daniel

    2017-07-01

    This is the result of a Survey of various aspects of quality, cost and speed in a large sample of diagnostic laboratories in the Asia Pacific region. It is the first of its type to be published and represents a snapshot of the current performance in a large number of diagnostic laboratories in a broad range of countries in the Asia Pacific region. This demonstrates that there are common issues facing all the laboratories surveyed but also common solutions using a Quality Systems approach which involves Accreditation, Customer responsiveness, greater use of IT, automation and Lean principles. The Survey provides data on some quality characteristics such as Turnaround Time (TAT) and quality improvement activities. It has been the case that some of the KPIs have improved over the course of the Surveys for example a reduction in the average TAT, and it might be that this occurred as a result of participation. Most laboratories have a target of 46-60min for STAT (Short Turnaround Time) on Clinical Chemistry and Immunoassay samples. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  2. A platelet quality assessment scheme for comparing the performance of quality monitoring laboratories in the UK National Blood Service.

    PubMed

    Seghatchian, Jerard; Krailadsiri, Pranee; Rigsby, Peter; Bukasa, Antoaneta; Bashir, Saber

    2002-02-01

    This exercise focused on performance of NBS quality monitoring establishments with respect to enumeration of low leucocyte and other quality indexes of platelet concentration. Paired identical leucodepleted platelet samples, spiked with WBC (20 cells/microl) in 'vacuette' or 'pouch' were assessed by participants (n = 20) on days 1, 2 and 5. For low WBC counting, all laboratories gave estimates within acceptable range (+/-25%) and good agreement between storage and assay methods was observed on days 1 and 2. Day 5 results showed greater variability. Under improved performance criteria (+/-15%), only one laboratory under-estimated at days 1 and 2. Similarly, other parameters demonstrated good agreement between storage methods on days 1 and 2. At day 5, mean results were often significantly different to previous days. Improved performance target (+/-15%) will allow identification of non-conformers.

  3. AUDILAB: a knowledge-based quality audit simulator for testing laboratories.

    PubMed

    Brai, A; Garnerin, P

    1997-05-01

    In order to obtain an accreditation, a laboratory must be prepared to provide a point-by-point check of various activities against the chosen reference standard, both from a general point of view and in relation to details of application. This paper describes AUDILAB, a computerized simulator accessible by network, able to provide testing laboratories with realistic quality audits performed in a customized way. AUDILAB establishes a detailed list of strengths (compliance with corresponding requirements of established standards) and weaknesses (improvements needed for laboratory's accreditation). The standard used by AUDILAB is the EN 45001 "General criteria for the operation of testing laboratories". A preliminary validation has already been completed. AUDILAB became operational in September 1993.

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. Los Alamos National Laboratory transuranic waste quality assurance project plan. Revision 1

    SciTech Connect

    1997-04-14

    This Transuranic (TRU) Waste Quality Assurance Project Plan (QAPjP) serves as the quality management plan for the characterization of transuranic waste in preparation for certification and transportation. The Transuranic Waste Characterization/Certification Program (TWCP) consists of personnel who sample and analyze waste, validate and report data; and provide project management, quality assurance, audit and assessment, and records management support, all in accordance with established requirements for disposal of TRU waste at the Waste Isolation Pilot Plant (WIPP) facility. This QAPjP addresses how the TWCP meets the quality requirements of the Carlsbad Area Office (CAO) Quality Assurance Program Description (QAPD) and the technical requirements of the Transuranic Waste Characterization Quality Assurance Program Plan (QAPP). The TWCP characterizes and certifies retrievably stored and newly generated TRU waste using the waste selection, testing, sampling, and analytical techniques and data quality objectives (DQOs) described in the QAPP, the Los Alamos National Laboratory Transuranic Waste Certification Plan (Certification Plan), and the CST Waste Management Facilities Waste Acceptance Criteria and Certification [Los Alamos National Laboratory (LANL) Waste Acceptance Criteria (WAC)]. At the present, the TWCP does not address remote-handled (RH) waste.

  9. Integrated patient data for optimal patient management: the value of laboratory data in quality improvement.

    PubMed

    Emons, M F

    2001-08-01

    Managed care organizations are shifting from traditional utilization management programs to focus on initiatives that improve the health of an insured population. This strategy requires sophisticated data integration to identify at-risk individuals and track outcomes. Laboratory data are becoming increasingly valuable tools for managed care organizations and healthcare providers. The HEDIS Effectiveness of Care measures have incorporated laboratory data into several key performance indicators. By building a comprehensive repository of laboratory data that includes both procedure codes and laboratory values, managed care organizations can realize substantial savings by avoiding the costly medical record reviews required when administrative data are incomplete. In addition to tracking clinical outcomes, laboratory data provide the ability to risk-stratify a population to target high-risk individuals for case management and disease management interventions. Healthcare organizations face several challenges in the integration of laboratory data into medical databases and practice management software. Confidentiality is a key consideration in view of recent healthcare regulations. Providers of laboratory services should work collaboratively with organizations setting standards for healthcare informatics to facilitate the pooling of data for quality improvement and outcomes research. Health Level Seven, Inc. (HL7), Logical Observation Identifier Names and Codes (LOINC), and Systematized Nomenclature of Medicine (SNOMED) will likely play a key role in this process.

  10. 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.

  11. 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.

  12. Counting Microfiche: The Utilization of the Microform Section of the ANSI Standard Z39.7-1983 "Library Statistics"; Microfiche Curl; and "Poly" or "Cell"?

    ERIC Educational Resources Information Center

    Caldwell-Wood, Naomi; And Others

    1987-01-01

    The first of three articles describes procedures for using ANSI statistical methods for estimating the number of pieces in large homogeneous collections of microfiche. The second discusses causes of curl, its control, and measurement, and the third compares the advantages and disadvantages of cellulose acetate and polyester base for microforms.…

  13. Counting Microfiche: The Utilization of the Microform Section of the ANSI Standard Z39.7-1983 "Library Statistics"; Microfiche Curl; and "Poly" or "Cell"?

    ERIC Educational Resources Information Center

    Caldwell-Wood, Naomi; And Others

    1987-01-01

    The first of three articles describes procedures for using ANSI statistical methods for estimating the number of pieces in large homogeneous collections of microfiche. The second discusses causes of curl, its control, and measurement, and the third compares the advantages and disadvantages of cellulose acetate and polyester base for microforms.…

  14. Quality Control Performance in a Provincial Veterinary Diagnostic Microbiology Laboratory System

    PubMed Central

    Lynch, John A.; Kierstead, Marsha E.

    1986-01-01

    A quality control exercise was carried out in a provincial laboratory system to assess the performance of nine bacteriology technologists working in six laboratories. A group of ten mock specimens were distributed to each participant. Identification of all organisms and antibiotic susceptibility testing of pathogens was requested. Of the 117 organisms distributed, 104 were correctly identified, five were incorrectly identified and eight were not reported. Overall less than 1% very major errors, less than 5% major errors and less than 10% minor errors were observed in the antibiotic susceptibility testing. Most frequent errors were associated with penicillins, aminoglycosides, polymyxin, tetracycline and fastidious organisms. PMID:17422640

  15. 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.

  16. Water quality laboratories in Colombia: a GIS-based study of urban and rural accessibility.

    PubMed

    Wright, Jim; Liu, Jing; Bain, Robert; Perez, Andrea; Crocker, Jonny; Bartram, Jamie; Gundry, Stephen

    2014-07-01

    The objective of this study was to quantify sample transportation times associated with mandated microbiological monitoring of drinking-water in Colombia. World Health Organization Guidelines for Drinking-Water Quality recommend that samples spend no more than 6h between collection and analysis in a laboratory. Census data were used to estimate the minimum number of operational and surveillance samples required from piped water supplies under national regulations. Drive-times were then computed from each supply system to the nearest accredited laboratory and translated into sample holding times based on likely daily monitoring patterns. Of 62,502 surveillance samples required annually, 5694 (9.1%) were found to be more than 6 h from the nearest of 278 accredited laboratories. 612 samples (1.0%) were more than 24 hours' drive from the nearest accredited laboratory, the maximum sample holding time recommended by the World Health Organization. An estimated 30% of required rural samples would have to be stored for more than 6 h before reaching a laboratory. The analysis demonstrates the difficulty of undertaking microbiological monitoring in rural areas and small towns from a fixed laboratory network. Our GIS-based approach could be adapted to optimise monitoring strategies and support planning of testing and transportation infra-structure development. It could also be used to estimate sample transport and holding times in other countries.

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 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...

  18. 21 CFR 111.110 - What quality control operations are required for laboratory operations associated with the...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 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...

  19. 21 CFR 111.110 - What quality control operations are required for laboratory operations associated with the...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  20. 21 CFR 111.110 - What quality control operations are required for laboratory operations associated with the...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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...

  1. 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...

  2. [The practical experience of quality control organization in the laboratory of Municipal consultative diagnostic center 1 of St. Petersburg].

    PubMed

    Ostroumova, M N; Mnuskina, M M

    2011-10-01

    The article specifies the functioning of quality control system in the laboratory of Municipal consultative diagnostic center i 1 of St. Petersburg. Initially, on the basis of interpretations of biological variations of every analyte, the requirements to analytical quality are developed. Subsequently, the actually attainable reproducibility of measurements and their bias is examined. The real analytical characteristics of 27 biochemical analytes are presented. The aggregate laboratory ratings are quoted based on the results of involvement in three EQAS programs since 2005, concerning biochemistry, immunochemistry and hematology. The important quality of laboratory research on its analytical stage is maintained by the interaction between inter-laboratory and regular external control.

  3. 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

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

    SciTech Connect

    Not Available

    1994-01-01

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

  5. Quality Management System, U.S. Geological Survey National Water Quality Laboratory

    DTIC Science & Technology

    2005-01-01

    Laboratory—Processing, taxonomy, and quality control of benthic macroinvertebrate samples: U.S. Geological Survey Open-File Report 00-212, 49 p...Qualitative visual sort method for processing benthic macroinvertebrate sam- ples, accessible at URL http://www nwql.cr.usgs.gov/pub/.SOP/Word/Bio...biob0332.1.doc • BS0333.1, Quantitative fixed-count method for processing benthic macroinvertebrate samples, accessible at URL http://www

  6. [Importance of quality control of baciloscopy in laboratories that perform diagnosis of tuberculosis].

    PubMed

    Sardiñas, Misleidis; García, Grechen; Rosarys Martínez, María; Díaz, Raúl; Mederos, Lilian M

    2016-06-01

    Baciloscopy is the primary tool for pulmonary tuberculosis diagnosis, being this technique the most used internationally in the search for infectious cases. Quality control is the process of the rechecking smears by a highly qualified observer. To evaluate and highlight the importance of quality control of smear microscopy in the Provincial Laboratories diagnosticians of Tuberculosis in Cuba. This study was conducted at the National Reference Laboratory and Research in Tuberculosis, Leprosy and Mycobacteria in the Institute of Tropical Medicine "Pedro Kouri", Havana, Cuba, Were evaluated 2676 smears received from January 2013 to December 2014, from Provincial Centers of Hygiene, Epidemiology and Microbiology of Cuba, including the special municipality Isla de la Juventud. 2,664 (99.5%) were concordant smears, the correlation obtained for the positive smears were 96.5% and 99.8% for negative. Were identified12 reading errors: 7 (3.5%) false positive and 5 (0.2%) false negatives. Slides were classified with adequate quality of smears in 2039 (76.2%), showed difficulties in realizing the extension in 1464 (54.7%) and staining were adequate in 2343 (87.6%). The kappa index was 0.9674. Although there was good agreement between observations it is recommended to improve the quality of extended, maintain staff training program that performs this activity, like regular supervision by specialists, to further improve the quality of diagnosis.

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

    SciTech Connect

    Fix, N. J.

    2008-03-28

    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.

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

    SciTech Connect

    Morton, J.S.

    1993-12-31

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

  9. Quality Assurance Baseline Assessment Report to Los Alamos National Laboratory Analytical Chemistry Operations

    SciTech Connect

    Jordan, R. A.

    1998-09-01

    This report summarizes observations that were made during a Quality Assurance (QA) Baseline Assessment of the Nuclear Materials Technology Analytical Chemistry Group (NMT-1). The Quality and Planning personnel, for NMT-1, are spending a significant amount of time transitioning out of their roles of environmental oversight into production oversight. A team from the Idaho National Engineering and Environmental Laboratory Defense Program Environmental Surety Program performed an assessment of the current status of the QA Program. Several Los Alamos National Laboratory Analytical Chemistry procedures were reviewed, as well as Transuranic Waste Characterization Program (TWCP) QA documents. Checklists were developed and the assessment was performed according to an Implementation Work Plan, INEEL/EXT-98-00740.

  10. 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.

  11. Method for quality control of laboratory tests using histograms of daily patient data.

    PubMed

    Okada, M

    1990-01-01

    A method for controlling the quality of laboratory tests is proposed. Histograms of patients' daily results which fall within reference ranges of healthy individuals are used for estimating accuracy and precision of measurements. For the determination of accuracy, three methods are evaluated; computing an average of patients' results; determining the location of the peak of the histogram; approximating the histogram by an Erland distribution and determining the peak of the distribution. For precision control, standard deviations are calculated from patient data. We applied these methods to serum aspartate aminotransferase (AST or SGOT) and total cholesterol of patients in a general hospital. Averages, peaks of approximated Erland distribution, and standard deviations were found to be useful to daily quality control in laboratories of large hospitals.

  12. [RESAOLAB: West African network of laboratories to enhance the quality of clinical biology].

    PubMed

    Delorme, L; Machuron, J L; Sow, I; Diagne, R; Sakandé, J; Nikiéma, A; Bougoudogo, F; Keita, A; Longuet, C

    2015-02-01

    The Fondation Mérieux, in partnership with the Ministries of Health of Burkina Faso, Mali and Senegal, implemented for four years a project to reinforce the laboratory sector in the three participating countries: the RESAOLAB project (West African Network of Biomedical Analysis Laboratories).The objective of RESAOLAB project, in partnership with the WHO Office for West Africa and the West African Health Organization, was to strengthen the systems of biomedical laboratories to improve diagnostic services, access, monitoring and management of infectious diseases. Following the successful results achieved under the RESAOLAB project and due to the demand of the neighbour countries ministries, the RESAOLAB project is now extended to four other countries of the West African region: Benin, Guinea-Conakry, Niger and Togo. The RESAOLAB project has become the RESAOLAB programme, its purpose is to strengthen the quality of the medical biology services thanks to a regional and transversal approach.

  13. 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

  14. External quality assessment of national public health laboratories in Africa, 2002-2009.

    PubMed

    Frean, John; 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

    2012-03-01

    To describe findings from an external quality assessment programme involving laboratories in Africa that routinely investigate epidemic-prone diseases. 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. 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. The external quality assessment programme consistently identified certain functional deficiencies requiring strengthening that were present in African public health microbiology laboratories.

  15. 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.

  16. Total Quality Management: An Application in a Research and Development Laboratory

    DTIC Science & Technology

    1989-12-01

    auto"i. t 10 AlrqtoAi -,rea mn Safcini. Oirocoto ov for IC aao. Oueratsof and AepoMn 12 1 S j 1 lef3. mr ,wv. Sate .20. afiertoe, 4fA 22202-4302. &Mo to...Texas 78235-5601 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADORESS(ES) 10 . SPONSORING/ MONITORING AGENCY REPORT NUMBER 11. SUPPLEMENTARY NOTES 12a... 10 APPENDIX A: AIR FORCE HUMAN RESOURCES LABORATORY TOTAL QUALITY MANAGEMENT TRAINING PLAN

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

    SciTech Connect

    Shanahan, K.L.

    1990-09-01

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

  18. Isotopic power supplies for space and terrestrial systems: quality assurance by Sandia National Laboratories

    SciTech Connect

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

    1981-09-01

    The Sandia National Laboratories participation in Quality Assurance (QA) programs for Radioisotopic Thermoelectric Generators which have been used in space and terrestrial systems over the past 15 years is summarized. Basic elements of the 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 also presented. In addition, the outlook for Sandia participation in RTG programs for the next several years is noted.

  19. Information Roundup: A Continuing Education Session on Microforms and Data Processing in the Library and Information Center: Costs/Benefits/History/Trends. Proceedings of the ASIS Mid-Year Meeting (4th, Portland, Oregon, May 15-17, 1975).

    ERIC Educational Resources Information Center

    Spigai, Frances G., Ed.; And Others

    Sixteen papers are presented which focus on microforms and data processing in library and information centers. Articles include discussions of cost analysis, decision making and program planning, library automation, information retrieval, indexing, cataloging, and computer services for libraries. (CH)

  20. Development of an internal quality assessment scheme in a clinical bacteriology laboratory.

    PubMed

    Constantine, C E; Amphlett, M; Farrington, M; Brown, D F; Messer, S; Rampling, A; Warren, R E

    1993-11-01

    To develop an internal quality assessment (IQA) scheme in a clinical bacteriology laboratory. Over 24 months, 1230 diagnostic specimens, representing 0.42% of laboratory workload, were anonymised and resubmitted for analysis. Six hundred and twenty one (48.7%) of these gave positive culture results; 44 fecal and upper respiratory specimens were "spiked" (artificially inoculated) to increase the proportion of positive samples. Discrepancies between IQA and clinical sample results occurred in 188 cases (14.8%): 76.6% of these were in culture results, 13.3% in microscopy performance, and 10.1% in clerical recording. The culture discrepancy rate for each positive sample was lowest for wound (17.5%) and urine (18.1%) specimens, and highest for faeces (34.9%) and upper respiratory (37.7%) samples. Discrepancies in several areas responded to staff training and improvement in technical methods. An IQA programme of this type assesses the reproducibility of tests within a diagnostic laboratory when analysing common specimen types and organisms. It permits blind assessment of many areas of diagnostic work that are not readily amenable to other quality assurance methods, and it raises the awareness of all staff to the importance of quality in every aspect of specimen and data processing.

  1. [Implementation of nine quality indicators in a hospital emergency clinical laboratory].

    PubMed

    Guzmán D, Ana María; Sánchez P, Tomás; DE LA Barra D, Ricardo; Madrid Q, Angélica; Quiroga G, Teresa

    2011-02-01

    Quality indicators are tools used to monitor specific activities within a process and improve it. In the area of clinical laboratories, the National Accreditation Standards for Providers of Health and the ISO 15189 standard recommend the implementation of indicators that monitor the test cycle with emphasis on those that contribute to a safer health care. To describe the implementation of nine indicators in a hospital clinical laboratory and their measurement during one year. The indicators implemented and measured were four of the pre-analytical phase (number of rejected samples, times of transport, blood culture contamination and blood cultures inoculated with adequate blood volumes), two of the analytical phase (coherence of Gram stains of blood culture with microorganism cultured and correct results in external quality control surveys) and three of the post-analytical phase (compliance with order to report lapse goals, corrected reports and alert values report). Two indicators of pre-analytical phase did not meet the per determined targets: number of rejected samples and blood cultures inoculated with adequate blood volume. All indicators of the analytical and post analytical phases were within the pre-determined targets. Coordinated work should be initiated especially with the nursing service to correct the two indicators that did not meet the target. The incorporation of quality indicators to monitor critical processes within the laboratory was undoubtedly an opportunity to identify areas for improvement.

  2. Exploring wildfire impact on post-fire runoff water quality: field and laboratory investigation

    NASA Astrophysics Data System (ADS)

    Chen, L.; Acharya, K.; Miller, J.; Berli, M.

    2014-12-01

    Wildfire can have complex effects on physical and chemical properties of soil and post-fire runoff. Water quality issues in the post-fire runoff may have caused catastrophic events in aquatic ecosystem in the Virgin River in Southwestern U.S. To examined the mechanisms of the impact of wildfire on post-fire runoff water quality, field sampling and experiments were conducted on surfaces of various fuel types at a burned site in the Virgin River Watershed. Rainfall simulation tests were performed to generate runoff for water quality test including in-situ DO and pH measurement and laboratory tests on a number of water quality constituents. Soil/ash samples collected from burned surfaces were applied in a laboratory test to produce solutions of different concentrations and DO changes over a 24-hour period were measured. Results confirmed that, for runoff carrying large amounts of sediment or debris, DO values can be substantially reduced to a level close to or lower than 5 mg/L. Fire effects may enhance this trend, but is not necessarily a critical reason for the reduction of DO levels. Laboratory runoff and soil sample analysis show that the post-fire runoff in this watershed may contain a large amount of ammonia (NH3 and NH4+). The concentration of ammonia can be higher than the lethal level to many (if not all) fish species. Fire effects appear to have a significant impact on the ammonia level, which lead to an increase of several times to one order of magnitude in the ammonia concentration in the runoff or soil solution under burned conditions. These results provide information to better understand post-fire water quality in this and similar watersheds.

  3. 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

  4. 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.

  5. Groundwater quality assessment plan for the Metallurgical Laboratory Hazardous Waste Management Facility

    SciTech Connect

    Jerome, K.M.

    1990-10-01

    The Metallurgical Laboratory Hazardous Waste Management Facility (MLHWMF) will be closed under interim status regulation and permitted as a hazardous waste management facility by a Post Closure Part B Permit under 40 CFR 264. This report discusses the ground water quality assessment plan for the MLHWMF. The Metallurgical Laboratory Hazardous Waste Management Facility consists of the process sewer line leading to the Metallurgical Laboratory basin from the fence, the Metallurgical Laboratory basin, the drainage outfall to the Carolina bay, and the Carolina bay itself. The Metallurgical Laboratory HWMF received F001, F003, F007, and D011 waste. F001 waste includes spent halogenated solvents used in degreasing (trichloroethylene, 1,1,1-trichloroethane, and carbon tetrachloride). F003 waste includes spent nonhalogenated solvents (acetone), and F007 waste is spent cyanide plating bath solution. At present forty-three constituents are analyzed per sample. Trichloroethylene, tetrachloroethylene, and total radium are the only constituents that were reported above Primary Drinking Water Standards (PDWS) during the second quarter of 1990. Listed in this report are the constituents that are being analyzed at present. Appendix A presents the trends for the analyzed constituents from the fourth quarter of 1988 to the second quarter of 1990. 5 figs., 5 tabs.

  6. Repeated HIV-1 resistance genotyping external quality assessments improve virology laboratory performance.

    PubMed

    Descamps, Diane; Delaugerre, Constance; Masquelier, Bernard; Ruffault, Annick; Marcelin, Anne-Geneviève; Izopet, Jacques; Chaix, Marie-Laure; Calvez, Vincent; Brun-Vézinet, Françoise; Costagliola, Dominique

    2006-02-01

    The performance of French virology laboratories belonging to the ANRS network has been assessed annually for 3 years. The performance of these laboratories was compared between the years 2002 and 2003. Ten and 7 coded samples were sent to 38 virology laboratories in 2002 and 45 virology laboratories in 2003, respectively. Each panel of coded samples included at least one HIV-negative control, a pair of duplicate specimens, samples with a wide range of viral loads, and samples with a large number of resistance mutations. The laboratories used their standard sequencing procedures and were asked to report the amino acids at codons associated with resistance mutations, based on the IAS-USA expert panel list. The reference amino acid sequences were defined as those most frequently reported by the participants. The specificity of detection of RT mutations was significantly better in 2003 (99.9%) than in 2002 (99.7%) (P = 0.05). There was no difference between 2002 and 2003 in the specificity of detection of protease mutations (99.6% and 99.8%) or the sensitivity of detection of RT mutations (98.8% and 98.2%). The sensitivity of detection of protease mutations improved significantly between 2002 and 2003 (97.6% and 99.0%, respectively; P = 0.037). The proportion of laboratories reporting fully accurate results, in terms of amplification, specificity, sensitivity, and reproducibility, tended to increase between 2002 and 2003 (P = 0.077). No errors were made by 19% of laboratories in 2002, compared to 42% in 2003. These results show the value of repeated external quality assessments.

  7. [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.

  8. [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

  9. Evaluating dissection in the gross anatomy course: Correlation between quality of laboratory dissection and students outcomes.

    PubMed

    Nwachukwu, Chika; Lachman, Nirusha; Pawlina, Wojciech

    2015-01-01

    Anatomy learned by active exploration through dissection has many proven benefits including improvement of anatomic knowledge. Decreased laboratory time may affect the quality of dissection and ultimately lower student performance in anatomy translating to lower knowledge acquisition. The aim of this study was to determine whether the quality of students' dissection in teams correlates with their performance in the gross anatomy course. Quality of dissections for each team enrolled in a gross anatomy course at Mayo Medical School was evaluated biweekly using a five-point rubric based on course learning objectives. Assessment of anatomic knowledge was based on sequential laboratory practice practical examination scores, achievements on daily audience response system (ARS) quizzes, and final practical, written, and National Board of Medical Examiners(®) (NBME(®) ) Gross Anatomy and Embryology Subject Examinations. Twelve teams comprising 48 students were included in the study. There was a positive correlation between dissection quality and practice practical examination score (R = 0.83) and a negative correlation between dissection quality and ARS quizzes (R = -0.985). Dissection teams with a passing score on their dissection evaluations (>70%) performed better on their final examinations. Based on an end of course survey, students agreed that dissection evaluations should continue to be a part of the course. This study showed that better quality of dissection was associated with higher scores on practice practical examinations, final practical, written, and NBME examinations. The study demonstrated a positive correlation between dissection evaluations, accompanied by formative feedback during the course, and higher scores on final course assessments.

  10. 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.

  11. Aquatic macroinvertebrates and water quality of Sandia Canyon, Los Alamos National Laboratory, November 1993--October 1994

    SciTech Connect

    Cross, S.

    1995-08-01

    The Ecological Studies Team (EST) of ESH-20 at Los Alamos National Laboratory (LANL) has collected samples from the stream within Sandia Canyon since the summer of 1990. These field studies gather water quality measurements and collect aquatic macroinvertebrates from permanent sampling sites. Reports by Bennett (1994) and Cross (1994) discuss previous EST aquatic studies in Sandia Canyon. This report updates and expands those findings. EST collected water quality data and aquatic macroinvertebrates at five permanent stations within the canyon from November 1993 through October 1994. The two upstream stations are located below outfalls that discharge industrial and sanitary waste effluent into the stream, thereby maintaining year-round flow. Some water quality parameters are different at the first three stations from those expected of natural streams in the area, indicating degraded water quality due to effluent discharges. The aquatic habitat at the upper stations has also been degraded by sedimentation and channelization. The macroinvertebrate communities at these stations are characterized by low diversities and unstable communities. In contrast, 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. The two lower stations have increased macroinvertebrate diversity and stable communities, further indications of downstream water quality improvement.

  12. 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

  13. 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.

  14. 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

  15. 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

  16. XPAD X-ray hybrid pixel detector for charge density quality diffracted intensities on laboratory equipment.

    PubMed

    Wenger, Emmanuel; Dahaoui, Slimane; Alle, Paul; Parois, Pascal; Palin, Cyril; Lecomte, Claude; Schaniel, Dominik

    2014-10-01

    The new generation of X-ray detectors, the hybrid pixel area detectors or `pixel detectors', is based on direct detection and single-photon counting processes. A large linearity range, high dynamic and extremely low noise leading to an unprecedented high signal-to-noise ratio, fast readout time (high frame rates) and an electronic shutter are among their intrinsic characteristics which render them very attractive. First used on synchrotron beamlines, these detectors are also promising in the laboratory, in particular for pump-probe or quasi-static experiments and accurate electron density measurements, as explained in this paper. An original laboratory diffractometer made from a Nonius Mach3 goniometer equipped with an Incoatec Mo microsource and an XPAD pixel area detector has been developed at the CRM2 laboratory. Mo Kα accurate charge density quality data up to 1.21 Å(-1) resolution have been collected on a sodium nitroprusside crystal using this home-made diffractometer. Data quality for charge density analysis based on multipolar modelling are discussed in this paper. Deformation electron densities are compared to those already published (based on data collected with CCD APEXII and CAD4 diffractometers).

  17. Quality assurance for radon exposure chambers at the National Air and Radiation Environmental Laboratory, Montgomery, Alabama

    SciTech Connect

    Semler, M.O.; Sensintaffar, E.L.

    1993-12-31

    The Office of Radiation and Indoor Air, U.S. Environmental Protection Agency (EPA), operates six radon exposure chambers in its two laboratories, the National Air and Radiation Environmental Laboratory (NAREL) in Montgomery, Alabama, and the Las Vegas Facility, Las Vegas, Nevada. These radon exposure chambers are used to calibrate and test portable radon measuring instruments, test commercial suppliers of radon measurement services through the Radon Measurement Proficiency Program, and expose passive measurement devices to known radon concentrations as part of a quality assurance plan for federal and state studies measuring indoor radon concentrations. Both laboratories participate in national and international intercomparisons for the measurement of radon and are presently working with the National Institute of Standards and Technology (NIST) to receive a certificate of traceability for radon measurements. NAREL has developed an estimate of the total error in its calibration of each chamber`s continuous monitors as part of an internal quality assurance program. This paper discusses the continuous monitors and their calibration for the three chambers located in Montgomery, Alabama, as well as the results of the authors intercomparisons and total error analysis.

  18. [Proficiency testing schemes as a quality rating in industrial hygiene laboratories].

    PubMed

    Dobecki, Marek; Wziątek, Agata

    This publication presents the principles of organization, implementation, assessment and exploitation of proficiency testing results in the work environmental laboratory based on basic requirements included in standard PN-EN ISO/IEC 17043 and ISO 13528. The basis for the proper functioning of the laboratory is to use and observe the basic requirements for the competence to carry out the tests and the guidelines on ensuring reliable and accurate results, specified e.g., according to the guidelines described in the standard PN-EN ISO/IEC 17043. The confirmation of the laboratory competence is the obtained accreditation. To obtain this certificate several conditions, including proficiency testing (PT) should be met. The main aspects of this paper is to show the role of proficiency testing in the process of assuring a properly functioning quality system in the laboratory. The accreditation requirements, the types of proficiency testing schemes, methods of statistical analysis and interpretation of results are also discussed by the authors. Med Pr 2016;67(2):267-283. This work is available in Open Access model and licensed under a CC BY-NC 3.0 PL license.

  19. 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.

  20. The use of total quality principles to achieve regulatory compliance in research laboratories.

    PubMed

    Hynes, M D

    1995-03-01

    Since the late 1980s, the U.S. Food and Drug Administration (FDA) has increased its focus on regulatory compliance. This is evidenced by an increase in warning letters, product seizures, injunctions, prosecutions, and recalls. This increased level of FDA enforcement activity is evidenced across all of the compliance regulations. Thus, the ability to comply with the Good Laboratory Practices (GLPs). Good Clinical Practices (GCPs) and Good Manufacturing Practices regulations could result in FDA enforcement activities and delays in the approval process for new products. Therefore, the ability to achieve compliance with the GLPs, GCPs, and GMPs in research laboratories is a key to business success in the 1990s. Applying the principles of total quality is one way to address these important business issues. The principles of total quality (customer focus, improvement, involvement, leadership, and measurement) provide a methodology for ensuring success in a rapidly changing regulatory environment. The FDA needs to be treated as a customer by research organizations. Valid regulatory requirements need to be negotiated with the agency. Once these customer requirements have been identified, the quality unit needs to play a leadership role in translating these requirements into action plans. Quality units, no matter how skillful or good, cannot achieve success without involvement of the scientific staff and management group of their organizations. Without their involvement there will be no organizational commitment to compliance programs undertaken to meet the valid requirements of the FDA. Meeting these valid customer requirements will require improvement efforts. The many tools of quality improvement in achieving the desired improvements.(ABSTRACT TRUNCATED AT 250 WORDS)

  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.

  2. 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.

  3. 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.

  4. 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

  5. Implementation of Oak Ridge National Laboratory Software Quality Assurance Requirements for COMSOL 3.4

    SciTech Connect

    Freels, James D

    2008-01-01

    It is desirable for nuclear safety-related calculations to be performed at the Oak Ridge National Laboratory (ORNL) using COMSOL. The Department of Energy (DOE) has mandated that ORNL will incorporate software quality assurance (SQA) with special attention to nuclear safety-related software applications. The author has developed a procedure for implementing these DOE-mandated SQA requirements on nuclear safety-related software applicable to the High Flux Isotope Reactor (HFIR). This paper will describe how this procedure will be implemented for COMSOL so that nuclear safety-related calculations may be performed.

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

    SciTech Connect

    Haney, Thomas Jay

    2016-02-01

    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.

  7. 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.

  8. 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.

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

    SciTech Connect

    Barnett, J. Matthew; Meier, Kirsten M.; Snyder, Sandra F.; Antonio, Ernest J.; Fritz, Brad G.; Poston, Theodore M.

    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 October 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.

  10. Sandia National Laboratories Advanced Simulation and Computing (ASC) software quality plan part 2 mappings for the ASC software quality engineering practices, version 2.0.

    SciTech Connect

    Heaphy, Robert; Sturtevant, Judith E.; Hodges, Ann Louise; Boucheron, Edward A.; Drake, Richard Roy; Minana, Molly A.; Hackney, Patricia; Forsythe, Christi A.; Schofield, Joseph Richard, Jr.; Pavlakos, Constantine James; Williamson, Charles Michael; Edwards, Harold Carter

    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 CPR001.3.2 and CPR001.3.6 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.

  11. Sandia National Laboratories Advanced Simulation and Computing (ASC) Software Quality Plan. Part 2, Mappings for the ASC software quality engineering practices. Version 1.0.

    SciTech Connect

    Ellis, Molly A.; Heaphy, Robert; Sturtevant, Judith E.; Hodges, Ann Louise; Boucheron, Edward A.; Drake, Richard Roy; Forsythe, Christi A.; Schofield, Joseph Richard, Jr.; Pavlakos, Constantine James; Williamson, Charles Michael; Edwards, Harold Carter

    2005-01-01

    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.

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

    SciTech Connect

    Sturtevant, Judith E.; Heaphy, Robert; Hodges, Ann Louise; Boucheron, Edward A.; Drake, Richard Roy; Minana, Molly A.; Hackney, Patricia; Forsythe, Christi A.; Schofield, Joseph Richard, Jr.; Pavlakos, Constantine James; Williamson, Charles Michael; Edwards, Harold Carter

    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.

  13. [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

  14. 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…

  15. 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…

  16. 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.

  17. 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.

  18. [The practice of development and implementation of quality management systems in medical laboratories. The GOST R ISO 15189-2009 "medical laboratories. The detailed requirements to quality and competence". Particular difficulties of global nature].

    PubMed

    Emanuel', A V; Ivanov, G A; Fleganova, I N; Emanuel', V L

    2012-12-01

    The article discusses the methodological issues related to the implementation of international principles of standardization in the format of GOST R ISO 9001-2008 "Quality management systems. Requirements", GOST R ISO 15189-2009 "Medical laboratories. The detailed requirements to quality and competence" and GOST R ISO 18113.1-5 "Medical items for diagnostics in vitro. Information provided by manufacturer (marking)". This approach legibly assigns the responsibility concerning the support of metrological correctness of laboratory measurements. The lacking of both full-value public and sectorial normative documentation and coordinated positions of Rosstandard and Minzdrav of Russia on functioning of medical laboratories is noted.

  19. 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.

  20. 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.

  1. Guidelines for good practice in PGD: programme requirements and laboratory quality assurance.

    PubMed

    2008-01-01

    The Preimplantation Genetic Diagnosis International Society (PGDIS) was organized in October 2002, with the purpose of encouraging and co-ordinating research, education and training in this multidisciplinary field, requiring a close collaboration of obstetricians, fertility specialists, embryologists and human geneticists. One of the major tasks of PGDIS is to advance the safety and accuracy of PGD and to encourage its adoption into clinical practice for improvement of genetic practices and reproductive medicine. In this context, PGDIS published voluntary guidelines applicable for any centre offering PGD in 2004, and these guidelines are now being updated and extended based on the present extensive PGD experience. The application of these guidelines is intended to further benefit patients and provide guidance to the laboratory staff. As in previous guidelines, PGDIS presents this document being aware that differences in national regulations exist that can affect local PGD practice. The document contains recent consensus points of general application that promote quality biopsy procedures and laboratory practice, enabling PGD centres to offer an improved clinical outcome to their patients. A variety of aspects related to a safe working system have been taken into consideration, based on the assumption that a quality programme depends on the cooperation of the whole PGD team.

  2. Quality indicators for critical international normalized ratio measurements in a hemostatic laboratory.

    PubMed

    Hussain, Shabneez; Moiz, Bushra; Afaq, Bushra

    2015-05-01

    This study aimed at reviewing the quality indicators for reporting critical international normalized ratio (INR) in a coagulation laboratory. This is a retrospective study conducted at Aga Khan University Hospital, hemostatic laboratory from February 2010 till January 2011. Critical INR was defined as ≥5.0. All critical INRs were rechecked and results were communicated to the doctor or patient. Two quality indicators monitored were % of results communicated to the patient/doctor and % of results that remained critical after re-testing. During the study period, a total of 59,980 INRs were reported. Of these 376 or 0.6% were critical. Successful communication of critical results to the doctor or patient was achieved in 275/376 (73.1%). Overall 353 or 94% (343 initial and 10 re-draw) samples had critical INR on repetition. Twenty five patients of the 240 warfarinized patients with critical INR had mild bleeding. No life threatening bleeding was observed in any patient. We observed poor communication for notifying critical INR results during the study period. Routine repeat analysis of critical INR did not alter results in majority of samples. The study assisted in improving communication in subsequent years. Further work is needed to establish evidence based upper and lower cutoff of critical INR. Effect of replicate analysis on turnaround time and accuracy of results needs evaluation. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  3. 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".

  4. 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

  5. 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.

  6. Quality control of laboratory methods for semen evaluation in a multicenter research study.

    PubMed

    Brazil, Charlene; Swan, Shanna H; Tollner, Charlene R; Treece, Cathy; Drobnis, Erma Z; Wang, Christina; Redmon, J Bruce; Overstreet, James W

    2004-01-01

    Rigorously standardized laboratory protocols and strict quality control (QC) are essential for meaningful comparisons between semen quality data from multiple sites. We describe our experience with the Study for Future Families (SFF), a multicenter study of semen quality in the United States. Detailed protocols were developed, and technicians from each study site attended a training session at the central laboratory. Technicians received blinded replicates from diluted semen specimens for counting by MicroCell and hemacytometer. Sperm motility was assessed using videotaped recordings for simple percent motility and categorical assessment of individual sperm progression as recommended by the World Health Organization (WHO). The mean intertechnician coefficient of variation for individual specimens was 12.6% for MicroCell counts, 15.2% for hemacytometer counts, and 10.5% for percent motility. Intratechnician coefficients of variation averaged 10.3% for MicroCell counts, 12.5% for hemacytometer counts, and 5.2% for percent motility. The average percent differences between the technicians' values and the central standard for individual specimens were 13.5%, 16.6%, and 11.9% for MicroCell counts, hemacytometer counts, and simple percent motility, respectively. We achieved our goal of maintaining mean intratechnician coefficients of variation and mean percent differences from the standard values of 15% or less for measurements of simple percent motility and sperm concentration by MicroCell. Standardization using the Improved Neubauer hemacytometer chamber proved more difficult. We were not successful in standardizing a method for categorical assessment of individual sperm progression.

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

    PubMed Central

    Borgert, Christopher J.; Mihaich, Ellen M.

    2012-01-01

    Background: 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. Objective: We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. Method: We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Discussion: 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. Conclusions: 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. PMID:22343028

  8. Using performance tasks employing IOM patient safety competencies to introduce quality improvement processes in medical laboratory science education.

    PubMed

    Golemboski, Karen; Otto, Catherine N; Morris, Susan

    2013-01-01

    In order to contribute to improved healthcare quality through patient-centered care, laboratory professionals at all levels of practice must be able to recognize the connection between non-analytical factors and laboratory analysis, in the context of patient outcomes and quality improvement. These practices require qualities such as critical thinking (CT), teamwork skills, and familiarity with the quality improvement process, which will be essential for the development of evidence-based laboratory science practice. Performance tasks (PT) are an educational strategy which can be used to teach and assess CT and teamwork, while introducing Medical Laboratory Science (MLS) students at both baccalaureate and advanced-practice levels to the concepts of quality improvement processes and patient outcomes research. PT presents students with complex, realistic scenarios which require the incorporation of subject-specific knowledge with competencies such as effective team communication, patient-centered care, and successful use of information technology. A PT with assessment rubric was designed for use in a baccalaureate-level MLS program to teach and assess CT and teamwork competency. The results indicated that, even when students were able to integrate subject-specific knowledge in creative ways, their understanding of teamwork and quality improvement was limited. This indicates the need to intentionally teach skills such as collaboration and quality system design. PT represent one of many strategies that may be used in MLS education to develop essential professional competencies, encourage expert practice, and facilitate quality improvement.

  9. 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.

  10. [The microbiological quality of food sent to a public health laboratory in 2009].

    PubMed

    Blanco-Ríos, Freddy A; Casadiego-Ardila, Gloria; Pacheco, Paola A

    2011-12-01

    Testing the microbiological quality of food samples from municipalities in the Santander department which were processed by the Public Health Laboratory(PHL) in 2009. The microbiological quality of food samples sent to the Santander PHL in 2009 was analysed by collecting reports issued by the institution and conducting a statistical analysis of 763 food samples from 76 municipalities in the department. Minitab statistical software (version 15) and Statistica (version 8.0) were used for analysing the information by municipality; this information was organised by food category and adverse incident frequency was analysed in each municipality from January to December 2009. It was seen that 45.2% (n=345) of 763 food records had bacterial contamination; there was a greater frequency of these events in the municipalities of Barichara, Barrancabermeja, Floridablanca, Girón, Socorro and Valle de San Jose accounting for 33.6% (n=116) of all affected samples. The main foods that had non-standard parameters were prepared foods (160 samples submitted), of which 80 had alterations in quality (50%), followed by drinks like fruit juice and soft drinks (48.3%), dairy products (47.9%) and meat (40.7%). A high rate of food contamination was found in the samples sent to PHL during 2009; this information is useful for planning preventative action within the ongoing PHL surveillance programme.

  11. Air quality investigations of the Sandia National Laboratories Sol se Mete Aerial Cable Facility

    SciTech Connect

    Gutman, W.M.; Silver, R.J.

    1994-12-01

    The air quality implications of the test and evaluation activities at the Sandia National Laboratories Sol se Mete Aerial Cable Facility are examined. All facets of the activity that affect air quality are considered. Air contaminants produced directly include exhaust products of rocket motors used to accelerate test articles, dust and gas from chemical explosives, and exhaust gases from electricity generators in the test arenas. Air contaminants produced indirectly include fugitive dust and exhaust contaminants from vehicles used to transport personnel and material to the test area, and effluents produced by equipment used to heat the project buildings. Both the ongoing program and the proposed changes in the program are considered. Using a reliable estimate of th maximum annual testing level, the quantities of contaminants released by project activities ar computed either from known characteristics of test items or from EPA-approved emission factors Atmospheric concentrations of air contaminants are predicted using EPA dispersion models. The predicted quantities and concentrations are evaluated in relation to Federal, New Mexico, an Bernalillo County air quality regulations and the human health and safety standards of the American Conference of Governmental Industrial Hygienists.

  12. 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.

  13. 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

  14. The Biological Stain Commission's Quality Control Laboratory operations and improved traceability of certified stains.

    PubMed

    Fagan, C L

    2012-01-01

    The Biological Stain Commission (BSC) is a quality control laboratory that certifies biological dyes for staining cells and tissues. Originally, a single lot of a certified dye was sold to histologists. Today, companies frequently change their lot numbers as part of regulatory efforts. When a certified dye undergoes a lot number change, the BSC must re-certify this dye to verify that it is identical to the one certified earlier. The BSC has improved how these lot changes are monitored using a redesigned BSC certification label. Certification labels always have been issued by the BSC and are attached to every bottle of "BSC certified dye" that is sold. The new BSC certification label has added security features and currently bears both the BSC certification number and the manufacturer batch lot number. The result is improved security and traceability of certified dyes.

  15. 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.

  16. 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.

  17. Implementing a regulation-complaint quality improvement program on a commercial laboratory information system.

    PubMed

    Cowan, D F

    1992-10-01

    Implementing a quality improvement (QI) program on an automated laboratory information system (LIS) in the current regulatory climate requires first that the QI program be defined and second that the selected LIS be able to capture important events and use flexible vendor-provided or user-defined routines to prepare reports. Reports key on specific monitors and thresholds defined in the QI program. The product of a pathology laboratory is communicated information. The QI program focuses on the accuracy, clarity and timeliness with which the whole information-generating process functions. To support peer review the LIS must be able to select reports for evaluation based on user-defined parameters, such as diagnosis keyed through Systematized Nomenclature of Medicine codes, or by random or pattern selection by accession number. Counting and review of revised reports will focus attention on accuracy and skill in communication since these indicators often reflect client satisfaction with the report. To link services--e.g., cytology with surgical pathology--the LIS must be able to gather cases from the accession lists of both services and to flag diagnostic inconsistencies. LIS transaction logging at every step in the information process allows tracking of work load, productivity and resource utilization by functional areas and by individual, thus meeting regulatory requirements. Transaction logging also provides management information, such as segmented turnaround time audits, pinpointing sources of delay by kind and location of work or individual involved. Critical data must be held on-line for at least five years.

  18. Measurement of lupus anticoagulants: an update on quality in laboratory testing.

    PubMed

    Adams, Murray

    2013-04-01

    Lupus anticoagulants (LAs) are antiphospholipid antibodies that interfere with in vitro phospholipid-dependent clotting tests, but are associated in vivo with significant clinical manifestations such as recurrent pregnancy loss and venous and arterial thrombosis. Although their detection is important for the diagnosis of thrombotic disorders such as the antiphospholipid syndrome, laboratory identification has historically been fraught with many issues. These have included variability in the sensitivity of assays and reagents; high false-negative and false-positive detection rates; a lack of consensus for the use of mixing tests; and, to some extent, lack of compliance with guidelines published by the Lupus Anticoagulant/Antiphospholipid Antibody Scientific Standardization Committee of the International Society on Thrombosis and Haemostasis (ISTH). Since the most recently updated guidelines in 2009, external quality assurance (EQA) programs have conducted surveys to provide a "snapshot" of laboratory practices related to the investigation of LA and to identify problems and monitor improvements in testing for LA. This article will review the impact of the most recently updated ISTH guidelines for LA testing and discuss the findings of recent EQA surveys.

  19. 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.

  20. [Influence of permafrost microorganisms on the quality and duration of life of laboratory animals].

    PubMed

    Kalenova, L F; Sukhoveĭ, Iu G; Brushkov, A V; Mel'nikov, V P; Fisher, T A; Besedin, I M; Novikova, M A; Efimova, Iu A

    2010-01-01

    Microorganisms of genus Bacillus strain 3M (permafrost microorganisms--PM), allocated from the samples of permafrost soils from Mamontova Mountain (Yakutia) are influenced by the quality and duration of life of elderly mice. PMs were injected intraperitoneally to CBA mice at the age of 17 months. Motion activity, muscular force (lifting of cargo test), food instinct activity (dosed starvation test) and cellular immunity activity (reaction of delayed-type hypersensitivity in vivo) of animals have increased, and psychoemotional condition of animals has improved under influence of PM. Average duration of life has increased by 9.19%, minimal duration of life--by 41.93%, maximal duration of life--by 7.68%. Duration of survival (the remaining life after injection of microorganisms) has increased more significantly: minimal--by 141.9%, on the average--by 28.0%, maximal--by 20.4%. Mechanisms of PM influence on increase of laboratory mice duration of life up to the top specific limit through the positive influence on quality of their life are discussed.

  1. [Quality control of defrosted cord blood units: results from an inter-laboratory study].

    PubMed

    Panterne, B; Richard, M-J; Sabatini, C; Pouthier, F; Mouillot, L; Bardey, D; Boulanger, F; Créa, S; Dal Cortivo, L; Decot, V; Fleury-Cappellesso, S; Giraud, C; Lapierre, V; Léauté, A-G; Le Berre, C; Lemarié, C; Piard, N; Rapatel, C; Rosenzwajg, M

    2010-04-01

    Today, haematopoietic stem cell graft from placental blood concerns more than 15 % of allogeneic grafts. An inter-laboratory study of the quality control of defrosted cord blood units has been coordinated by the French society for cell and tissue bioengineering (SFBCT), with the cord blood bank of Bourgogne Franche-Comté and controlled by the French health products safety agency (Afssaps). The aim of this study is to ensure the inter-laboratory reproducibility of the quality controls practised by the banks during defrosting. The cellular outputs were analyzed according to the defrosting techniques, according to the method used in flow cytometry: single-platform (SP) versus double-platform (DP), or the product nature, i.e. in total blood or miniaturized. Forty-two units of placental blood (USP), which were out of range were provided for defrosting to 14 participating sites. USP were defrosted and controlled according to the procedures of each bank. Once the USP is defrosted, a part of the product was controlled by the site and the other part by Afssaps. Following controls were carried out: numeration of the total nucleated cells (TNC) and of CD34+ cells (made by a SP method in Afssaps) and functional assay. Concerning TNC, the defrosting sites obtained a cellular output of 94 %+/-28 in day 0 compared with an output of 72 %+/-24 in Afssaps showing a rather good stability of the USP transmitted with an average deviation of 23 %+/-22. The freezing process with or without reduction of volume does not affect this variation. Concerning the numeration of CD34+ cells, the average deviation between the participating sites and Afssaps was 29 %+/-23 compared with 21 %+/-16 for the sites using a SP method against 47 %+/-25 for those using a DP method. The CD34+ outputs are equal to 82 % +/- 60 in day 0 for the participating sites against 52 %+/-20 for Afssaps. For the sites using a DP method, it is stressed that this output is particularly high with a rate of 126 %+/-90 (n=15

  2. Aquatic macroinvertebrates and water quality of Sandia Canyon, Los Alamos National Laboratory, 1995

    SciTech Connect

    Cross, S.; Nottelman, H.

    1997-01-01

    The Biology Team of ESH-20 (the Ecology Group) at Los Alamos National Laboratory (LANL) has collected samples from the stream within Sandia Canyon since the summer of 1990. These field studies measure water quality parameters and collect aquatic macroinvertebrates from sampling sites within the upper canyon stream. Reports by Bennett and Cross discuss previous aquatic studies in Sandia Canyon. This report updates and expands the previous findings. The Biology Team collected water quality data and aquatic macroinvertebrates monthly at three sampling stations within Sandia Canyon in 1995. The two upstream stations occur near a cattail (Typha latifolia) dominated marsh downstream from outfalls that discharge industrial and sanitary waste effluent into the stream, thereby maintaining year-round flow. The third station is approximately 1.5 miles downstream from the outfalls within a mixed conifer forest. All water chemistry parameters measured in Sandia Canyon during 1995 fell within acceptable State limits and scored in the {open_quotes}good{close_quotes} or {open_quotes}excellent{close_quotes} ranges when compared to an Environmental Quality Index. However, aquatic macroinvertebrates habitats have been degraded by widespread erosion, channelization, loss of wetlands due to deposition and stream lowering, scour, limited acceptable substrates, LANL releases and spills, and other stressors. Macroinvertebrate communities at all the stations had low diversities, low densities, and erratic numbers of individuals. These results indicate that although the stream possesses acceptable water chemistry, it has reduced biotic potential. The best developed aquatic community occurs at the sampling station with the best habitat and whose downstream location partially mitigates the effects of upstream impairments.

  3. Improving patient safety and healthcare quality in the 21st century--competencies required of future medical laboratory science practitioners.

    PubMed

    Morris, Susan; Otto, Catherine N; Golemboski, Karen

    2013-01-01

    Healthcare quality has yet to meet the aims of the Institute of Medicine (IOM) with respect to safety, effectiveness, patient-centeredness, efficiency, timeliness and equity. No professional curricula adequately prepare future healthcare practitioners-including medical laboratory science professionals-with all competencies necessary to deliver quality healthcare. Practicing evidence-based medicine, focusing on quality improvement, using information technology, delivering patient-centered care and working as part of interdisciplinary teams are identified by the IOM as the five core competencies that every healthcare practitioner needs to effectively provide healthcare. Medical laboratory science educators need to incorporate patient safety concepts into the curricula and include assignments to develop the IOM competencies in order to adequately prepare future practitioners to effectively practice medical laboratory science in the healthcare system of the 21st century.

  4. [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.

  5. 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.

  6. External quality assessment for molecular typing of Salmonella 2013-2015: performance of the European national public health reference laboratories.

    PubMed

    Jensen, M B F; Schjørring, S; Björkman, J T; Torpdahl, M; Litrup, E; Nielsen, E M; Niskanen, T

    2017-06-01

    We report the results of three consecutive External Quality Assessments (EQAs) for molecular subtyping of Salmonella to assess the performance of the European national public health reference laboratories (NPHRLs). The EQA included the molecular typing methods used for European enhanced surveillance of human Salmonella infections: pulsed field gel electrophoresis (PFGE), including gel analysis by the use of the software BioNumerics, and 5-locus multiple locus variable number of tandem repeat analysis (MLVA) for serovar Typhimurium. The participation in the PFGE laboratory part was higher (27/35) than in the gel analysis (19/35) and MLVA (15/35), suggestive of the need for capacity building in methods requiring specialized equipment (MLVA) or software (gel analysis). The majority (25/27) of the participating NPHRLs produced inter-laboratory comparable PFGE gel(s). Two laboratories continued to produce low-quality gels and should have additional technical assistance in the future. In particular, two gel quality evaluation parameters, measuring "image acquisition and running conditions" and "bands", were identified to cause gel quality problems throughout the EQAs. Despite the high number of laboratories participating in the PFGE laboratory part, the participation in gel analysis was low, although increasing. In the MLVA part, the NPHRLs correctly assigned 96% (405/420) allelic profiles according to the nomenclature. In conclusion, the EQAs identified critical parameters for unsuccessful performance and helped to offer assistance to those laboratories that needed it most. The assessments supported the development of quality in molecular typing and promoted the harmonization of subtyping methods used for EU/EEA-wide surveillance of human Salmonella infections.

  7. Using E-WorkBook Suite to implement quality control in real time: expanding the role of electronic laboratory notebooks within a bioanalysis laboratory.

    PubMed

    Rajarao, Joe; Weiss, Scott

    2011-07-01

    In order to support the increasing number of software tools within the bioanalytical (BA) laboratory, electronic laboratory notebooks (ELNs) have to provide more than just paper replacement capabilities. ELN solutions must provide additional functionality to justify deployment in BA laboratories that currently depend on sophisticated instrument software and laboratory information management systems for the capture, analysis and reporting of data. This article reviews how E-WorkBook Suite is positioned to provide functionality not found in other ELN solutions, namely managing workflow execution and tracking quality control compliance in real time. These capabilities are demonstrated by descriptions of a routine BA laboratory process; the registration of a test article, its use in preparing a stock solution and the verification of a balance instrument for weighing the test article. The software solution, in this configuration, guides the analyst through the process and enforces business rules that ensure compliance with specified SOP guidelines. This case study reviews the implementation in a bioanalytical CRO and highlights the use of E-WorkBook Suite in areas that remain unsupported by other software solutions.

  8. Ultrahigh-resolution mapping of peatland microform using ground-based structure from motion with multiview stereo

    NASA Astrophysics Data System (ADS)

    Mercer, Jason J.; Westbrook, Cherie J.

    2016-11-01

    Microform is important in understanding wetland functions and processes. But collecting imagery of and mapping the physical structure of peatlands is often expensive and requires specialized equipment. We assessed the utility of coupling computer vision-based structure from motion with multiview stereo photogrammetry (SfM-MVS) and ground-based photos to map peatland topography. The SfM-MVS technique was tested on an alpine peatland in Banff National Park, Canada, and guidance was provided on minimizing errors. We found that coupling SfM-MVS with ground-based photos taken with a point and shoot camera is a viable and competitive technique for generating ultrahigh-resolution elevations (i.e., <0.01 m, mean absolute error of 0.083 m). In evaluating 100+ viable SfM-MVS data collection and processing scenarios, vegetation was found to considerably influence accuracy. Vegetation class, when accounted for, reduced absolute error by as much as 50%. The logistic flexibility of ground-based SfM-MVS paired with its high resolution, low error, and low cost makes it a research area worth developing as well as a useful addition to the wetland scientists' toolkit.

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

    SciTech Connect

    Appel, Gordon John

    2016-05-01

    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.

  10. [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.

  11. 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.

  12. Quality assessment of vitamin D metabolite assays used by clinical and research laboratories.

    PubMed

    Carter, G D; Berry, J; Durazo-Arvizu, R; Gunter, E; Jones, G; Jones, J; Makin, H L J; Pattni, P; Phinney, K W; Sempos, C T; Williams, E L

    2017-10-01

    The Vitamin D External Quality Assessment Scheme (DEQAS) was launched in 1989 and monitors the performance of 25-hydroxyvitamin D (25-OHD) and 1,25- dihydroxyvitamin D (1,25(OH)2D) assays. In April 2015 a pilot scheme for 24,25-dihydroxyvitamin D (24,25(OH)2D) was introduced. The 25-OHD scheme is accuracy - based with target values assigned by the NIST Reference Measurement Procedure (RMP) for 25-OHD2 and 25-OHD3. A similar method is used to assign values for 3-epi-25-OHD. Five samples of human serum are distributed quarterly to over 1000 participants in 58 countries (April 2016) and clinical laboratories are expected to submit results within approximately 5 weeks. Research laboratories with assays run less frequently are not given a deadline. Archived samples with NIST- assigned values are also available. Performance is assessed on the first four samples with the fifth reserved for investigations e.g. recovery experiments or to assess the influence of other serum constituents such as lipids. DEQAS provides rapid feedback, with an on-line preliminary report available immediately after a participant submits results and a comprehensive report soon after the results deadline. In 2015, DEQAS investigations revealed that several 25-OHD immunoassays under-recovered 25-OHD2 and 25-OHD results were falsely low on a sample with a modestly raised triglyceride concentration. An RMP for 1,25 (OH)2D is not yet available and results are judged against the Method Mean. Free advice is available from the DEQAS Advisory Panel which includes experts on methodology and biostatistics. DEQAS collaborates closely with the Vitamin D Standardization Program (VDSP) and both organizations have successfully worked with participants and manufacturers to improve the accuracy of vitamin D assays. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. [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

  14. 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

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

    SciTech Connect

    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 will 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.

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

    SciTech Connect

    Minana, Molly A.; Sturtevant, Judith E.; Heaphy, Robert; Hodges, Ann Louise; Boucheron, Edward A.; Drake, Richard Roy; Forsythe, Christi A.; Schofield, Joseph Richard, Jr.; Pavlakos, Constantine James; Williamson, Charles Michael; Edwards, Harold Carter

    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 and 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.

  17. [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.

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

    PubMed

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

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

  19. 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.

  20. Construction quality assurance for Pit 6 landfill closure, Lawrence Livermore National Laboratory, Site 300

    SciTech Connect

    1997-10-30

    Golder Construction Services, Inc. (GCS), under contract to the Regents of the University of California, Lawrence Livermore National Laboratory (LLNL), provided the construction quality assurance (CQA) observation and testing during the construction of the Site 300, Pit 6 landfill closure cover. The cap construction was performed as a CERCLA non-time-critical removal action from June 2 to August 29, 1997. the project site is located 18 miles east of Livermore on Tesla Road and approximately 10 miles southwest of Tracy on Corral Hollow Road in San Joaquin County, California. This report certifies that the LLNL, Site 300, Pit 6, Landfill Closure was constructed in accordance with the construction specifications and design drawings. This report documents construction activities and CQA monitoring and testing for construction of the Pit 6 Landfill Closure. Golder Associates, Inc. of Oakland, California was the design engineering firm responsible for preparation of the drawings and specifications. CQA services were provided by GCS, of Roseville, California, under supervision of a California registered civil Engineer.

  1. The External Quality Assessment Scheme (EQAS): Experiences of a medium sized accredited laboratory.

    PubMed

    Bhat, Vivek; Chavan, Preeti; Naresh, Chital; Poladia, Pratik

    2015-06-15

    We put forth our experiences of EQAS, analyzed the result discrepancies, reviewed the corrective actions and also put forth strategies for risk identification and prevention of potential errors in a medical laboratory. For hematology, EQAS samples - blood, peripheral and reticulocyte smears - were received quarterly every year. All the blood samples were processed on HMX hematology analyzer by Beckman-Coulter. For clinical chemistry, lyophilized samples were received and were processed on Siemens Dimension Xpand and RXL analyzers. For microbiology, EQAS samples were received quarterly every year as lyophilized strains along with smears and serological samples. In hematology no outliers were noted for reticulocyte and peripheral smear examination. Only one outlier was noted for CBC. In clinical chemistry outliers (SDI ≥ 2) were noted in 7 samples (23 parameters) out of total 36 samples (756 parameters) processed. Thirteen of these parameters were analyzed as random errors, 3 as transcriptional errors and seven instances of systemic error were noted. In microbiology, one discrepancy was noted in isolate identification and in the grading of smears for AFB by Ziehl Neelsen stain. EQAS along with IQC is a very important tool for maintaining optimal quality of services. Copyright © 2015 Elsevier B.V. All rights reserved.

  2. Quality assurance of CFU-GM assays: inter-laboratory variation despite standard reagents.

    PubMed

    Lumley, M A; Burton, A; Billingham, L J; McDonald, D F; Czarnecka, H M; Milligan, D W

    1999-01-01

    To investigate the hypothesis that commercial kits for CFU-GM (colony forming unit granulocyte-macrophage) assay will reduce the interlaboratory variation noted by many workers, we carried out a quality assurance exercise in 2 parts. There were 8 participants in the first study and each performed CFU-GM assays using their in-house method and a commercial kit (Stem Cell CFU Kit, Gibco) in parallel. In the second exercise there were 10 participants and each performed CFU-GM with in-house methods and with a different commercial medium (Methocult GF H4534, Stem Cell Technologies). Twelve samples of cryopreserved peripheral blood progenitor cells (PBPC) were analysed by each participant in each part of the study. A very wide range of results was found for the different in-house methods, but standardizing the clonogenic assay with the commercial kits did not reduce the variation seen. To improve the reproducibility of CFU-GM assays between laboratories, scrupulous attention should be paid to all the steps involved in the assays, as little progress will be made by using commercial medium in isolation from efforts to reduce other sources of variation.

  3. Quality control procedures for flow cytometric applications in the hematology laboratory.

    PubMed

    D'hautcourt, J L

    1996-12-01

    Clinical diagnosis is one of the areas in which flow cytometry (FCM) has gained wide popularity and FCM now plays a crucial role in several aspects of medical hematology. It has progressively replaced many traditional laboratory tests due to its greater accuracy, sensitivity and rapidity. Unfortunately, among the very large number of its potential applications, only a minority of flow cytometric protocols have been standardized. Numerous factors are responsible for variation in analytical conditions and may affect results obtained by FCM. All these variables can be schematically divided into three major groups: factors related to the biological samples, immunological and accessory reagent factors and factors associated with the use of instruments. The quality control program must monitor and evaluate all aspects of the procedure. This includes the following main aspects: 1) performance of the flow cytometer, 2) specimen collection, transportation and maintenance of its integrity, 3) reagents, particularly monoclonal antibodies and 4) sample measurements, data acquisition and their interpretation. Procedures described here are designed to assess all the settings which affect the reliability, reproducibility and sensitivity of the cytometer in order to ensure identical conditions on a daily basis.

  4. 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,…

  5. Implementing Best Practices for Data Quality Assessment of the National Renewable Energy Laboratory?s Solar Resource and Meteorological Assessment Project: Preprint

    SciTech Connect

    Wilcox, S. M.; McCormack, P.

    2011-04-01

    Effective solar radiation measurements for research and economic analyses require a strict protocol for maintenance, calibration, and documentation to minimize station downtime and data corruption. The National Renewable Energy Laboratory's Concentrating Solar Power: Best Practices Handbook for the Collection and Use of Solar Resource Data includes guidelines for operating a solar measurement station. This paper describes a suite of automated and semi-automated routines based on the best practices handbook as developed for the National Renewable Energy Laboratory Solar Resource and Meteorological Assessment Project. These routines allow efficient inspection and data flagging to alert operators of conditions that require immediate attention. Although the handbook is targeted for concentrating solar power applications, the quality-assessment procedures described are generic and should benefit many solar measurement applications. The routines use data in one-minute measurement resolution, as suggested by the handbook, but they could be modified for other time scales.

  6. Toward a quality guide to facilitate the transference of analytical methods from research to testing laboratories: a case study.

    PubMed

    Bisetty, Krisnha; Gumede, Njabulo Joyfull; Escuder-Gilabert, Laura; Sagrado, Salvador

    2009-01-01

    At present, there is no single viewpoint that defines QA strategies in analytical chemistry. On the other hand, there are no unique protocols defining a set of analytical tasks and decision criteria to be performed during the method development phase (e.g., by a single research laboratory) in order to facilitate the transference to the testing laboratories intending to adapt, validate, and routinely use this method. This study proposes general criteria, a priori valid for any developed method, recommended as a provisional quality guide containing the minimum internal tasks necessary to publish new analytical method results. As an application, the selection of some basic internal quality tasks and the corresponding accepted criteria are adapted to a concrete case study: indirect differential pulse polarographic determination of nitrate in water samples according to European Commission requisites. Extra tasks to be performed by testing laboratories are also outlined.

  7. Application of sigma metrics for the assessment of quality assurance in clinical biochemistry laboratory in India: a pilot study.

    PubMed

    Singh, Bhawna; Goswami, Binita; Gupta, Vinod Kumar; Chawla, Ranjna; Mallika, Venkatesan

    2011-04-01

    Ensuring quality of laboratory services is the need of the hour in the field of health care. Keeping in mind the revolution ushered by six sigma concept in corporate world, health care sector may reap the benefits of the same. Six sigma provides a general methodology to describe performance on sigma scale. We aimed to gauge our laboratory performance by sigma metrics. Internal quality control (QC) data was analyzed retrospectively over a period of 6 months from July 2009 to December 2009. Laboratory mean, standard deviation and coefficient of variation were calculated for all the parameters. Sigma was calculated for both the levels of internal QC. Satisfactory sigma values (>6) were elicited for creatinine, triglycerides, SGOT, CPK-Total and Amylase. Blood urea performed poorly on the sigma scale with sigma <3. The findings of our exercise emphasize the need for detailed evaluation and adoption of ameliorative measures in order to effectuate six sigma standards for all the analytical processes.

  8. Indicators and quality specifications for strategic and support processes related to the clinical laboratory: four years' experience.

    PubMed

    Ruiz, Rosa; Llopis, Ma Antònia; Biosca, Carme; Trujillo, Gloria; Llovet, Ma Isabel; Tarrés, Ester; Ibarz, Mercè; Alsina, Ma Jesus; Alvarez, Virtudes; Busquets, Glòria; Doménech, Ma Vicenta; Figueres, Carme; Minchinela, Joana; Pastor, Rosa Ma; Perich, Carmen; Ricós, Carmen; Sansalvador, Mireia; Simón, Margarita

    2010-07-01

    Quality specifications for indicators of the key analytic processes have been defined by international consensus. However, only preliminary specifications for laboratory-related strategic and support processes have been developed. The present study attempts to increase the robustness of the preliminary proposed specifications. Recovering records and incidences occurred over a 4-year follow-up period, for 12 indicators, used in all laboratories from this group regarding strategic and support processes. The results obtained indicate that it is better to establish an interval rather than a fixed value for the majority of indicators. Longer studies are needed to properly assess some quality specifications, and data recording system must be standardized in others. Additional, multicenter studies are needed to establish more robust specifications and determine the state of the art of laboratories in other settings.

  9. 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.

  10. The Status of Quality Control Investigation and Analysis for Maternal Serum Marker of Prenatal Screening Laboratories in China.

    PubMed

    He, Falin; Wang, Wei; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

    2017-01-01

    This national survey was initiated to investigate the current status of quality control practice of prenatal screening by statistical analysis of the previous half year data of prenatal screening in 2015. Data were sent to all Chinese prenatal screening centers via the National Quality Assessment Scheme. This covered the software used, the risk cutoffs, monthly sample throughput, monthly median MoM of AFP, HCG, β-HCG, free β-HCG and uE3, monthly screening positive rates for trisomy 21, trisomy 18, and Open Neural Tube Defect (ONTD). Screening protocols were versatile, 73.5% (133/181) used the two-marker model, 24.3% (44/181) used the three-marker model, and 2.2% used the four-marker model. Regarding the software used, 350 laboratories never updated the screening parameters, 89 laboratories had updated their median or parameter by manufacturers, and 24 laboratories had updated the parameters by themselves. Cutoffs differ between laboratories. 59.9% (275/459) use 1/270 as their cutoffs for trisomy 21. 66.2% (296/447) use 1/350 as their cutoff for trisomy 18. 96.5% (361/374) use cutoffs between 2.0 - 2.5 MoM for ONTD. Regarding the results of the monthly median MoM, the percentage of laboratories for which all six monthly median MoMs were within the target of 0.90 - 1.10 was 46.7% (155/332) for AFP, 20.0% (4/20) for hCG, 29.2% (28/96) for β-HCG, 15.7% (31/198) for free β-HCG, and 4.8% (11/228) for uE3. The percentage of laboratories for which all six monthly median MoMs were within the target of 0.95 - 1.05 was 14.2% (47/332) for AFP, 0% (0/20) for HCG, 4.3% (4/96) for β-HCG, 12.6% (31/198) for free β-HCG, and 4.8% (11/228) for uE3. Regarding the screening positive rate, there was a difference in the trisomy 21 positive rate in the same laboratory within the six month. There were variations in the types of screening protocols, different kinds of soft platforms, randomness of choice or update of medians or other important parameters, and great difference in the

  11. 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

  12. 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.

  13. 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.

  14. Quantifying the Impact of Additional Laboratory Tests on the Quality of a Geomechanical Model

    NASA Astrophysics Data System (ADS)

    Fillion, Marie-Hélène; Hadjigeorgiou, John

    2017-05-01

    In an open-pit mine operation, the design of safe and economically viable slopes can be significantly influenced by the quality and quantity of collected geomechanical data. In several mining jurisdictions, codes and standards are available for reporting exploration data, but similar codes or guidelines are not formally available or enforced for geotechnical design. Current recommendations suggest a target level of confidence in the rock mass properties used for slope design. As these guidelines are qualitative and somewhat subjective, questions arise regarding the minimum number of tests to perform in order to reach the proposed level of confidence. This paper investigates the impact of defining a priori the required number of laboratory tests to conduct on rock core samples based on the geomechanical database of an operating open-pit mine in South Africa. In this review, to illustrate the process, the focus is on uniaxial compressive strength properties. Available strength data for 2 project stages were analysed using the small-sampling theory and the confidence interval approach. The results showed that the number of specimens was too low to obtain a reliable strength value for some geotechnical domains even if more specimens than the minimum proposed by the ISRM suggested methods were tested. Furthermore, the testing sequence used has an impact on the minimum number of specimens required. Current best practice cannot capture all possibilities regarding the geomechanical property distributions, and there is a demonstrated need for a method to determine the minimum number of specimens required while minimising the influence of the testing sequence.

  15. An Internet-based external quality assessment in cytogenetics that audits a laboratory's analytical and interpretative performance.

    PubMed

    Hastings, Rosalind J; Maher, Eddy J; Quellhorst-Pawley, Bettina; Howell, Rodney T

    2008-10-01

    A novel approach to external quality assessment (EQA) using the Internet mimics the diagnostic situation so that multiple tests can be requested and EQA cases can be 'tailor made' to address a specific chromosome syndrome, disease, or clinical dilemma. The web-based EQA system was trialled on a large UK EQA scheme, UK NEQAS for Clinical Cytogenetics. It has also been used to implement a new Cytogenetics European Quality Assessment scheme, CEQA, set up with the intention of providing laboratories in countries without access to a local EQA scheme the opportunity of participation in EQA. Overall, Internet-based EQA allows for a varied EQA programme. Poor performance was detected in both CEQA and UK NEQAS constitutional EQA schemes and also in the UK NEQAS oncology EQA scheme. The Internet-based EQA overcomes submission delays due to international surface mail. There is also a reduction in administration and assessors' time compared to a retrospective EQA involving the submission of unique cases for EQA assessment, as participants analyse the same three Internet-based EQA cases simultaneously. Many EU27 (EU member states) laboratories still do not participate in their national EQA schemes, so until EQA participation becomes mandatory as a component of compulsory laboratory accreditation, the quality of laboratory diagnostic service is unpredictable.

  16. External Quality Assessment for Detection of Fetal Trisomy 21, 18, and 13 by Massively Parallel Sequencing in Clinical Laboratories.

    PubMed

    Zhang, Rui; Zhang, Hongyun; Li, Yulong; Han, Yanxi; Xie, Jiehong; Li, Jinming

    2016-03-01

    An external quality assessment for detection of trisomy 21, 18, and 13 by massively parallel sequencing was implemented by the National Center for Clinical Laboratories of People's Republic of China in 2014. Simulated samples were prepared by mixing fragmented abnormal DNA with plasma from non-pregnant women. The external quality assessment panel, comprising 5 samples from pregnant healthy women, 2 samples with sex chromosome aneuploidies, and 13 samples with different concentrations of fetal fractions positive for trisomy 21, 18, and 13, was then distributed to participating laboratories. In total, 55.6% (47 of 84) of respondents correctly identified each of the samples in the panel. Seventeen false-negative and 87 gray zone results were reported, most [102 of 104 (98.1%)] of which were derived from for trisomy samples with effective fetal fractions <4%. No laboratories generated false-positive results. In addition, we observed varied diagnostic capabilities of different assays, with the assay on the basis of NextSeq CN500 performing better than others, whereas Z values generated by BGISEQ-100 fluctuated greatly. There were no significant correlations between the numbers of unique sequence reads and Z values from any trisomy sample generated by BGISEQ-100. Overall, most clinical laboratories detected samples containing effective fetal fractions >4%. Our study shows need for further laboratory training in the management of samples with low fetal fractions. For some assays, precision of Z values needs to be improved.

  17. Principles of analytic validation of immunohistochemical assays: Guideline from the College of American Pathologists Pathology and Laboratory Quality Center.

    PubMed

    Fitzgibbons, Patrick L; Bradley, Linda A; Fatheree, Lisa A; Alsabeh, Randa; Fulton, Regan S; Goldsmith, Jeffrey D; Haas, Thomas S; Karabakhtsian, Rouzan G; Loykasek, Patti A; Marolt, Monna J; Shen, Steven S; Smith, Anthony T; Swanson, Paul E

    2014-11-01

    Laboratories must validate all assays before they can be used to test patient specimens, but currently there are no evidence-based guidelines regarding validation of immunohistochemical assays. To develop recommendations for initial analytic validation and revalidation of immunohistochemical assays. The College of American Pathologists Pathology and Laboratory Quality Center convened a panel of pathologists and histotechnologists with expertise in immunohistochemistry to develop validation recommendations. A systematic evidence review was conducted to address key questions. Electronic searches identified 1463 publications, of which 126 met inclusion criteria and were extracted. Individual publications were graded for quality, and the key question findings for strength of evidence. Recommendations were derived from strength of evidence, open comment feedback, and expert panel consensus. Fourteen guideline statements were established to help pathology laboratories comply with validation and revalidation requirements for immunohistochemical assays. Laboratories must document successful analytic validation of all immunohistochemical tests before applying to patient specimens. The parameters for cases included in validation sets, including number, expression levels, fixative and processing methods, should take into account intended use and should be sufficient to ensure that the test accurately measures the analyte of interest in specimens tested in that laboratory. Recommendations are also provided for confirming assay performance when there are changes in test methods, reagents, or equipment.

  18. [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.

  19. Analysis of Compounded Pharmaceutical Products to Teach the Importance of Quality in an Applied Pharmaceutics Laboratory Course

    PubMed Central

    Pignato, Alyssa

    2014-01-01

    Objective. To assess the effectiveness of a product-analysis laboratory exercise in teaching students the importance of quality in pharmaceutical compounding. Design. Second-year pharmacy students (N=77) participated in a pharmaceutical compounding laboratory exercise and subsequently analyzed their final product using ultraviolet (UV) spectrometry. Assessment. Reflection, survey instruments, and quiz questions were used to measure how well students understood the importance of quality in their compounded products. Product analysis showed that preparations compounded by students had an error range of 0.6% to 140%, with an average error of 23.7%. Students’ reflections cited common sources of error, including inaccurate weighing, contamination, and product loss during both the compounding procedure and preparation of the sample for analysis. Ninety percent of students agreed that the exercise improved their understanding of the importance of quality in compounded pharmaceutical products. Most students (85.7%) reported that this exercise inspired them to be more diligent in their preparation of compounded products in their future careers. Conclusion. Integrating an analytical assessment during a pharmaceutical compounding laboratory can enhance students’ understanding of quality of compounded pharmaceutical products. It can also provide students a chance to reflect on sources of error to improve their compounding technique in the future. PMID:24761022

  20. Analysis of compounded pharmaceutical products to teach the importance of quality in an applied pharmaceutics laboratory course.

    PubMed

    Pignato, Alyssa; Birnie, Christine R

    2014-04-17

    To assess the effectiveness of a product-analysis laboratory exercise in teaching students the importance of quality in pharmaceutical compounding. Second-year pharmacy students (N=77) participated in a pharmaceutical compounding laboratory exercise and subsequently analyzed their final product using ultraviolet (UV) spectrometry. Reflection, survey instruments, and quiz questions were used to measure how well students understood the importance of quality in their compounded products. Product analysis showed that preparations compounded by students had an error range of 0.6% to 140%, with an average error of 23.7%. Students' reflections cited common sources of error, including inaccurate weighing, contamination, and product loss during both the compounding procedure and preparation of the sample for analysis. Ninety percent of students agreed that the exercise improved their understanding of the importance of quality in compounded pharmaceutical products. Most students (85.7%) reported that this exercise inspired them to be more diligent in their preparation of compounded products in their future careers. Integrating an analytical assessment during a pharmaceutical compounding laboratory can enhance students' understanding of quality of compounded pharmaceutical products. It can also provide students a chance to reflect on sources of error to improve their compounding technique in the future.

  1. 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.

  2. A review on laboratory tests’ utilization: A trigger for cutting costs and quality improvement in health care settings

    PubMed Central

    Meidani, Zahra; Farzandipour, Mehrdad; Farrokhian, Alireza; Haghighat, Masomeh

    2016-01-01

    Background: Considering the role of laboratory tests as a central part of controlling health expenditure, this study intends to investigate laboratory tests overutilization in Iran to pave the way for future interventions. Methods: Inappropriate laboratory utilization was reviewed in a cross-sectional survey through the retrospective analysis of 384 medical records at a tertiary center. To pave the way for future intervention, overutilization tests were classified into two categories, inappropriate and inefficient, and then they were analyzed. Frequency analysis was used to analysis patient’s age, gender, hospital wards, length of stay, and diagnosis as well as inappropriate test and inefficient tests. Results: A total of 143 (1.50 %) of the tests were inefficient and was ordered due to laboratory errors including hemolysis, inefficient sampling, or absurd results. 2522 (26.40%) of the tests were inappropriate and stem from failure to meet medical/clinical appropriateness criteria. Conclusion: Whereas, inappropriate test ordering was more frequent than inefficient tests, the initial improvement strategy should focus on physicians’ test ordering behavior through conducting proper teaching strategies, ongoing audit and educational feedback, implementing health information technology tools and employing laboratory practice guidelines (LPGs) and testing algorithms. Conducting continuous quality improvement cycle for laboratory services and training of personnel involved in blood sampling is recommended for inefficient tests. PMID:27493909

  3. The Role of Laboratory Supervision in Improving the Quality of Malaria Diagnosis: A Pilot Study in Huambo, Angola.

    PubMed

    Luckett, Rebecca; Mugizi, Rukaaka; Lopes, Sergio; Etossi, R Cacilda; Allan, Richard

    2016-03-01

    In 2006, the Angolan National Malaria Control Program introduced clinical guidelines for malaria case management, which included diagnostic confirmation of malaria before administration of treatment; however, diagnostic practices were inconsistent and of unknown quality. In 2009, a laboratory supervision program was implemented in Huambo Province, with the goal of assessing and improving diagnosis of malaria within the confines of available in-country resources. Supervisions were carried out from 2009 to 2014 using a standardized supervision tool by national laboratory trainers. Data from the first supervision were compared with that from the final supervision. Over the study period, the number and level of training of laboratory technicians increased, and there was a nonstatistically significant trend toward improved laboratory conditions. There was a significant reduction in false-positive microscopy slide reading (P = 0.0133). Laboratory infrastructural capacity to diagnose other communicable diseases, including syphilis, human immunodeficiency virus and hepatitis B virus infections (P = 0.0012, 0.0233 and 0.0026, respectively), also improved significantly. Laboratory supervision for malaria diagnosis found significant areas for improvement, and in combination with concurrent capacity-building activities, it improved the diagnostic capacity for malaria and other diseases. Importantly, this study demonstrates that locally available resources can be used to improve the accuracy of malaria diagnosis.

  4. APPLICATION OF NON-PARAMETRIC STATISTICS TO EVALUATE THE COMPARABILITY OF ANALYTICAL DATA FROM TWO U. S. GEOLOGICAL SURVEY WATER-QUALITY LABORATORIES.

    USGS Publications Warehouse

    Peart, Dale B.; Friedman, Linda C.

    1984-01-01

    The U. S. Geological Survey operates two water-quality laboratories. The quality of data produced by each laboratory is judged primarily from an evaluation of the data obtained from the analysis of reference samples. Quality-assurance reports that contain an analysis of the results obtained from chemical analysis of these reference materials by the two laboratories are prepared quarterly, and annual summaries of the data are published. The procedures that are used to determine whether a laboratory shows an overall lack of precision or bias involve the application of binomial distributions to the data.

  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. Quality assurance plan for the molten salt reactor experiment Remediation Project at Oak Ridge National Laboratory, Oak Ridge, Tennessee

    SciTech Connect

    1998-02-01

    This Quality Assurance Plan (QAP) identifies and describes the systems utilized by Molten Salt Reactor Experiment (MSRE) Remediation Project personnel to implement the requirements and associated applicable guidance contained in the Quality Program Description, Y/QD-15 Rev. 2 (Martin Marietta Energy Systems, Inc., 1995) and Environmental Management and Enrichment Facilities Work Smart Standards. This QAP defines the quality assurance (QA) requirements applicable to all activities and operations in and directly pertinent to the MSRE Remediation Project. This QAP will be periodically reviewed, revised, and approved as necessary. This QAP identifies and describes the QA activities and procedures implemented by the various Oak Ridge National Laboratory support organizations and personnel to provide confidence that these activities meet the requirements of this project. Specific support organization (Division) quality requirements, including the degree of implementation of each, are contained in the appendixes of this plan.

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

    PubMed

    Coplen, Tyler B; Qi, Haiping

    2009-06-01

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

  8. 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

  9. 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

  10. Quality of materials supplied to dental laboratories for the fabrication of cobalt chromium removable partial dentures in Ireland.

    PubMed

    Lynch, Christopher D; Allen, P Finbarr

    2003-12-01

    The adequacy of prescription for fabrication of cobalt chromium removable partial dentures is often regarded as being less than ideal. This study examines the nature and quality of written instructions and master impression sent to dental laboratories in Ireland for fabrication of cobalt chromium removable partial denture frameworks. Questionnaires were issued to dental laboratories seeking specific information relating to the materials (impression materials and trays) and written instructions supplied, as well as the technicians' opinion regarding the suitability of these materials. One hundred completed questionnaires were returned. One-third of master impressions were made using a plastic stock tray and alginate; technicians felt that one-fifth of master impressions were unsuitable; almost three-fifths of written instructions were inadequate. The quality of clinical information examined was found to be less than adequate.

  11. Quality of Undergraduate Physics Students' Written Scientific Arguments: How to Promote Students' Appropriation of Scientific Discourse in Physics Laboratory Reports?

    NASA Astrophysics Data System (ADS)

    Aydeniz, Mehmet; Yeter-Aydeniz, Kubra

    2015-03-01

    In this study we challenged 18 undergraduate physics students to develop four written scientific arguments across four physics labs: 1) gravity-driven acceleration, 2) conservation of mechanical energy, 3) conservation of linear momentum and 4) boyle's law, in a mechanics and thermodynamics laboratory course. We evaluated quality of the written scientific arguments developed by the participants using the Claim, Evidence, Reasoning and Rebuttal (CERR) rubric. The results indicate that while students developed adequate scientific explanations that summarized the findings of their experiments, they experienced unique difficulties in using a persuasive and critical discourse in their written arguments. Students experienced the most difficulty in considering alternative explanations in formulating their written scientific arguments. We elaborate on the implications of these findings for teaching physics laboratories and assessing students' learning in physics laboratories. We especially focus on the importance of framing in helping students to appropriate the epistemic norms of science in writing scientific arguments.

  12. [Providing studies quality for pesticides risk evaluation in their use according to proper laboratory practice rules].

    PubMed

    Rakitskiy, V N; Bereznyak, I V

    2016-01-01

    The article covers experience of proper laboratory practice in hygienic studies examining air and workers' skin for assessment of exposure levels of pesticides in natural conditions of agricultural production.

  13. 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.

  14. The use of fractals to quantify the morphology of cluster microforms

    NASA Astrophysics Data System (ADS)

    Papanicolaou, A. N. (Thanos); Tsakiris, Achilleas G.; Strom, Kyle B.

    2012-02-01

    The emphasis of this paper is on the fractal-analysis of irregular objects like particle clusters that fill the two-dimensional Euclidean space R2. A common fractal descriptor of such objects is DL (1 < DL < 2), which defines the fractal dimension of the object outline and is determined by the divider method. In this case, an object may possibly exhibit only two statistically self-similar scales, namely 'structural' and 'textural'. The structural fractal dimension describes the form structure (or the degree of convolution) of the object perimeter and the textural describes the crenellations (or edge effects) found on the object perimeter. Recent studies have shown that the DL does not uniquely define the morphology of complex objects like clusters as it does not include the morphologic attributes, associated with the objects enclosed projected area. A key contribution of this work is the recognition that the 'total areal' fractal dimension of the object, DAT (1 < DAT < 2) offers a unique description of cluster morphology as it accounts for the collective contributions from the crenellations found on the object perimeter and its form structure, as well as contributions from the object core structure or equivalently object projected area. The DAT, which is theoretically interrelated to DL, satisfies the key self-similarity principle of fractals and is employed here to differentiate among four cluster morphologic groups observed in field and laboratory studies, namely, in-line clusters with elongation ratio, ER < 5 and ER > 5, pseudo-triangle, and -rhomboid. The analysis for this study is performed by applying the box-counting method for analyzing cluster planview images from four groups of cluster morphologies derived from synthetic, laboratory, and field data sets. The DAT is determined via Richardson plots by estimating the slope of the best-fit line over the entire range of box sizes. Doing so, provides a single aggregate dimension that includes the embedded

  15. 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.

  16. Service quality: understanding and implementing the concept in the clinical laboratory. Match service quality to consumer expectations.

    PubMed

    O'Connor, S J

    1989-01-01

    The increasingly competitive health-care marketplace has mandated that health-care managers pay careful attention to the issue of quality from the perspective of the consumer. The importance of this issue is underscored by the fact that numerous health-care institutions and associations have recently begun to recognize the urgent need to obtain a greater understanding of service quality in a health-care situation. This article suggests means to understand, identify, improve, and implement effective approaches to this vital aspect of the marketing mix.

  17. Laboratory quality assurance in the Department of Restorative Dentistry at the University of Illinois at Chicago, College of Dentistry.

    PubMed

    Chan, Christopher T; Sukotjo, Cortino; Gehrke, Kenneth W; Yuan, Judy Chia-Chun; Campbell, Stephen D; Clark, David M; Fayz, Farhad

    2013-01-01

    The purpose of this study was to evaluate data collected in University of Illinois at Chicago College of Dentistry (UIC COD) laboratory quality assurance (QA) forms, analyze the collected data, and create a report of the findings. The goals of the study were to (1) identify the most common mistakes occurring during laboratory and clinical procedures when performing prosthodontic treatment, (2) note the incidence and trends of mistakes made by D3, D4, and IDDP2 students, and (3) observe any differences in the types of mistakes made by D3, D4, and IDDP2. QA data from June 1, 2007 to May 31, 2009 were evaluated based on forms gathered from the QA dental laboratory from all D3, D4, and IDDP2 students' submissions. All students had graduated from the UIC COD at the time of collection. Data were recorded for type of errors made in submission of laboratory work (Indirect Restorations [IR], Removable Partial Dentures [RPD], Complete Dentures [CD]), year of student in dental school (D3, D4, IDDP2), and frequency of rejection for each respective student. The frequency of common mistakes were pooled, evaluated, and reported by respective class year. The five most common laboratory submission errors for D3, D4, and IDDP2 students were nearly the same among student years for IR, RPD, and CD. D4 students had disproportionately higher numbers of work rejections compared to D3 and IDDP2 students. D4 students had a higher percentage of laboratory submission errors compared to D3 students for all laboratory procedures. There were similar types of errors noted between foreign-trained students (IDDP2) and domestically trained students (D3, D4). © 2012 by the American College of Prosthodontists.

  18. Variable sensitivity in molecular detection of Zika virus in European expert laboratories; external quality assessment, November 2016.

    PubMed

    Charrel, Remi; Mögling, Ramona; Pas, Suzan; Papa, Anna; Baronti, Cecile; Koopmans, Marion; Zeller, Hervé; LeParc-Goffart, Isabelle; Reusken, Chantal B

    2017-08-23

    Background: Zika virus (ZIKV) infections are a significant public health concern. A high capability for ZIKV detection is an absolute requirement for adequate preparedness and response strategies and individual patient care.Objectives: To assess and improve the capability of European expert laboratories for ZIKV molecular testing through an External Quality Assessment scheme.Study design: Laboratories were provided with a panel of 12 samples which included negative samples, samples containing African or Asian lineage ZIKV at variable concentrations (10(3) to 10(9) copies/ml) and samples containing dengue virus, yellow fever virus or chikungunya virus. Results were analysed based on sample outcomes and used extraction/detection. Samples with a ZIKV RNA status scored correctly by >50% of the laboratories were designated as core sample.Results: A total of 85 panel outcomes were submitted by 50 laboratories in 31 countries. Results designated all samples as core. 33% of panel outcomes identified all samples correctly (28/85), while 15% (13/85) had a score lower than 20 out of 24 points. Analysis at laboratory level showed that only 40% of the laboratories (20/50) representing 45% of the countries scored sufficiently, i.e. had at least one test operational that scored all core samples correctly.Conclusions: There is need for improvement of molecular detection of ZIKV in 60% of the participating laboratories. While the specificity of the tests was more robust, the results of the EQA showed large variation in test sensitivity. Improvement should focus on both nucleic acid extraction and ZIKV detection methods. Copyright © 2017 American Society for Microbiology.

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general... quality assessment must include a review of the effectiveness of corrective actions taken to...

  20. 42 CFR 493.1239 - Standard: General laboratory systems quality assessment.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general... quality assessment must include a review of the effectiveness of corrective actions taken to...

  1. Experimental investigation on: Laser shock micro-forming process using the mask and flexible pad

    NASA Astrophysics Data System (ADS)

    Wang, Xiao; Li, Liyin; Shen, Zongbao; Sha, Chaofei; Gao, Shuai; Li, Cong; Sun, Xianqing; Ma, Youjuan; Liu, Huixia

    2017-01-01

    A forming process called the mask and flexible pad laser shock forming was proposed to fabricate the micro-features on the copper foil. In this process, the mask and laser beam were used as rigid punches. Shock waves induced by plasma were used as the source of loading and plasticine was used as a flexible pad. This was a micro scale and high strain rate forming process and the traditional forming method with micro-mold was changed. In the experiment, surface morphology of formed parts was represented and it was found that the mask played a significant role in the forming process. In order to understand the forming process in the experiment, process parameters, including laser pulse energy, numbers of laser pulse and grain size, were analyzed. The experimental results showed that different parameters had different effects on formed parts. The surface quality and the thickness distribution of formed parts were investigated. It was found that formed parts could keep good surface quality after laser shocking and the reasons were explored. The thickness distribution was measured and the thickness thinning rate was calculated. There was no local tightening or rupture in the forming area. In this paper, the micro-features could be obtained on metallic foils and the method of mold-free was proved to be feasible.

  2. 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)

  3. Quality of factor XI activity testing in North American Specialized Coagulation Laboratories.

    PubMed

    Zantek, N D; Hsu, P; Meijer, P; Smock, K J; Plumhoff, E A; Refaai, M A; Van Cott, E M

    2015-05-01

    The performance of factor XI activity (FXI) by laboratories in the North American Specialized Coagulation Laboratory Association proficiency testing program was analyzed. Over 10 years (2003-2013), 80 samples were distributed; 33-55 laboratories participated per exercise providing 3833 total responses. Analysis was performed on numeric results and qualitative classification of results. The sample FXI levels ranged from 3.8 to 154.0 IU/dL. The overall interlaboratory average coefficient of variation (CV%) was 17.5%; the CV was higher for a sample with low (3.8 IU/dL) FXI. Results were correctly classified as abnormal (100%) for a sample with 3.8 IU/dL FXI and normal/borderline normal (97.7%) for 45 samples with 80 to < 140 IU/dL FXI. The classification was heterogeneous for samples with FXI of 50 to < 80 IU/dL. Six specimens were repeat-tested from 2007 to 2013. The mean FXI was not significantly different in laboratories using the same method on both exercises, suggesting good intralaboratory precision over time. Univariate analysis of data from 2011 to 2012 did not find a consistent significant difference among the activators, analyzers, calibrators, and FXI-deficient plasmas. Laboratories generally performed well in assessment of FXI based on interlaboratory precision when FXI >30 IU/dL and on classification of samples with very low or normal FXI. © 2015 John Wiley & Sons Ltd.

  4. PS2-45: Conducting Multi-site Quality Assurance on Laboratory Results Data Incorporated into the Virtual Data Warehouse

    PubMed Central

    Saylor, Gwyn; Bredfeldt, Christine; Butler, Melissa; Folck, Bruce; Hitz, Paul; Krajenta, Richard; Ogarek, Jessica; Ovans, Lucas; Pardee, Roy; Riedlinger, Karen; Schmidt, Mark; Sterrett, Andrew; Raebel, Marsha

    2012-01-01

    Background/Aims Assuring that complete and correct laboratory test results are brought into the VDW and associated with the correct Test_Type is an ongoing task. Many problems can occur. For example, a particular version of a test can incorrectly be left out when the data are extracted. Results can be duplicated, or results can be associated incorrectly with a Test_Type. Creating quality assurance checks to locate problems or validate data requires evaluating the same data record from several different angles. Methods We conducted quality assurance on numerous laboratory test results that had been incorporated into VDW format across as many as 11 HMORN sites. Quality assurance programs were written to provide counts of test results across sites and over time. These programs also detailed result values, result units, patient location, result location, and other specific metrics. Descriptive statistics and graphical displays were used to facilitate assessment of across-site data variability and identify potential data quality issues. Sites were provided their site-specific results and results for all participating sites. Results Masking site information, we will show examples of quality assurance checks and depict what type of problem each is designed to point out. Examples may include incorrectly mapped tests (e.g., “hemoglobin” test results where the result unit was in percent and was determined to actually be glycosylated hemoglobin results) and tests that require investigation by the site because the result unit is possible, but unusual (e.g., total cholesterol units of g/dl require verification of g/dl unit and conversion to mg/dl before use or verification that g/dl was entered or read incorrectly). Other examples can include the volume of test results now contained within the VDW (e.g., total cholesterol total n is over 26.6 million results). Conclusions Laboratory result quality assurance requires assessment of problems as well as verifying expectations

  5. 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.

  6. NATIONAL EXPOSURE RESEARCH LABORATORY (NERL) INTEGRATED INFORMATOIN AND QUALITY MANAGEMENT PLAN TRAINING

    EPA Science Inventory

    The success of the NERL quality system relies on participation by all managers and staff. This training was developed for the purpose of communicating the basic features of the quality system in a convenient and efficient manner. The total time to complete a review of all five ...

  7. NATIONAL EXPOSURE RESEARCH LABORATORY (NERL) INTEGRATED INFORMATOIN AND QUALITY MANAGEMENT PLAN TRAINING

    EPA Science Inventory

    The success of the NERL quality system relies on participation by all managers and staff. This training was developed for the purpose of communicating the basic features of the quality system in a convenient and efficient manner. The total time to complete a review of all five ...

  8. 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.

  9. Developing Quality in Professional Laboratory Experiences. School Practicum; Description and Seminar Outline.

    ERIC Educational Resources Information Center

    Georgia Univ., Athens. Coll. of Education.

    The University of Georgia Office of Professional Laboratory Experiences has developed several different programs to provide practical experience for future teachers. The School Practicum is a program in which students spend several weeks in the beginning of the school year observing and participating in a local public school prior to the opening…

  10. View of Voss at photo quality window in Destiny Laboratory module

    NASA Image and Video Library

    2001-03-31

    ISS002-E-5493 (31 March 2001) --- Astronaut James S. Voss, Expedition Two flight engineer, studies the Earth from the very advantageous perspective of 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.

  11. View of Usachev at photo quality window in Destiny Laboratory module

    NASA Image and Video Library

    2001-03-31

    ISS02-E-5492 (31 March 2001) --- Cosmonaut Yury V. Usachev, Expedition Two mission commander, looks through the window on the Destiny laboratory onboard the International Space Station (ISS). Representing Rosaviakosmos, Usachev is joined by two astronauts on the orbiting outpost for several months' research and work. The photo was taken with a digital still camera.

  12. A comparison of two laboratory methods to test dental unit waterline water quality

    PubMed Central

    Porteous, Nuala; Sun, Yuyu; Dang, Shichien; Schoolfield, John

    2013-01-01

    The performance of two APHA standard laboratory methods, the R2A spread plate and the SimPlate™ for heterotrophic plate count (HPC), for quantifying heterotrophic microorganisms in dental waterline samples was evaluated. Microbial counts were underestimated on SimPlate™ compared with R2A and the results indicated a poor correlation between the two methods. PMID:24054735

  13. A comparison of 2 laboratory methods to test dental unit waterline water quality.

    PubMed

    Porteous, Nuala; Sun, Yuyu; Dang, Shichien; Schoolfield, John

    2013-11-01

    The performance of 2 American Public Health Association standard laboratory methods, the R2A spread plate and the SimPlate(TM) for heterotrophic plate count, for quantifying heterotrophic microorganisms in dental waterline samples was evaluated. Microbial counts were underestimated on SimPlate(TM) compared with R2A, and the results indicated a poor correlation between the 2 methods.

  14. 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.

  15. 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

    2017-07-07

    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.

  16. 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.

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

    PubMed Central

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

    2016-01-01

    Background. 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. Methods. 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. Results. 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. Conclusions. 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. PMID:27025698

  18. Quality control validation, application of sigma metrics, and performance comparison between two biochemistry analyzers in a commercial veterinary laboratory.

    PubMed

    Farr, Alison J; Freeman, Kathleen P

    2008-09-01

    A review of the literature pertinent to interpretation of biochemistry data and quality control (QC) and proficiency testing data from 2 biochemistry analyzers was used to determine clinical quality requirements for biochemistry assays, characterize the performance of and calculate sigma metrics for the analytes run on the 2 analyzers, and perform QC validation in order to determine the needs for statistical QC for each analyzer. Quality requirements suitable for the analytes based on the needs of the authors' laboratory are presented. These requirements may or may not be appropriate for other laboratories, depending on the needs of the clients, species, and equipment performance capability. The majority of the analytes were easily controlled using the 1(3s) control rule, with a sigma metric approaching or exceeding 6 and with a high probability of error detection and a low probability of false rejection. Some analytes could not be controlled using the 1(3s) rule, and additional control rules with a greater number of control data points were required. There were differences between performances of the 2 analyzers. The findings in the present study emphasize the need for QC specific for the analyte and the clinical decision level and the need for separate QC validation on every instrument.

  19. 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.

  20. 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.

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

    PubMed Central

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

    2010-01-01

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

  2. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for Use of Tumor Markers in Clinical Practice: Quality Requirements*

    PubMed Central

    Sturgeon, Catharine M.; Hoffman, Barry R.; Chan, Daniel W.; Ch’ng, Soo-Ling; Hammond, Elizabeth; Hayes, Daniel F.; Liotta, Lance A.; Petricoin, Emmanuel F.; Schmitt, Manfred; Semmes, O. John; Söletormos, Györg; van der Merwe, Elena; Diamandis, Eleftherios P.

    2017-01-01

    BACKGROUND This report presents updated National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines summarizing quality requirements for the use of tumor markers. METHODS One subcommittee developed guidelines for analytical quality relevant to serum and tissue-based tumor markers in current clinical practice. Two other subcommittees formulated recommendations particularly relevant to the developing technologies of microarrays and mass spectrometry. RESULTS Prerequisites for optimal use of tumor markers in routine practice include formulation of the correct clinical questions to ensure selection of the appropriate test, adherence to good clinical and laboratory practices (e.g., minimization of the risk of incorrect patient and/or specimen identification, tube type, or timing), use of internationally standardized and well-characterized methods, careful adherence to manufacturer instructions, and proactive and timely reactions to information derived from both internal QC and proficiency-testing specimens. Highly desirable procedures include those designed to minimize the risk of the reporting of erroneous results attributable to interferences such as heterophilic antibodies or hook effects, to facilitate the provision of informative clinical reports (e.g., cumulative and/or graphical reports, appropriately derived reference intervals, and interpretative comments), and when possible to integrate these reports with other patient information through electronic health records. Also mandatory is extensive validation encompassing all stages of analysis before introduction of new technologies such as microarrays and mass spectrometry. Provision of high-quality tumor marker services is facilitated by dialogue involving researchers, diagnostic companies, clinical and laboratory users, and regulatory agencies. CONCLUSIONS Implementation of these recommendations, adapted to local practice, should encourage optimization of the clinical use of tumor markers

  3. Department of Defense Quality Systems Manual for Environmental Laboratories. Version 1

    DTIC Science & Technology

    2000-10-01

    of the standard dilution water used for testing or culturing must be sufficient to allow satisfactory survival, growth and reproduction of the test...for toxic metals and organics whenever the minimum acceptability criteria for control survival, growth or reproduction are not met and no other cause...and reproduction of the test species as demonstrated by routine reference toxicant tests and negative control performance. The laboratory shall have

  4. Speeding up laboratory test reporting in Medical Emergency and Cardiac Arrest calls: a quality improvement project

    PubMed Central

    Al-Talib, Mohammed; Leslie, Isla

    2017-01-01

    Many hospitals deploy Medical Emergency (MET) and Cardiac Arrest teams to improve the management and treatment of patients who become critically ill. In many cases, blood results are key in allowing the clinicians involved in these teams to make definitive management decisions for these patients. Following anecdotal reports that these results were often delayed, we assessed the process of blood tests being reported in emergency calls, identified the key factors causing delays and sought to make improvements. The initial intervention involved implementing a new blood form that specified the nature of the call, the tests required and a contact number for laboratory staff to contact the clinical team with results. We also developed a streamlined process within the laboratory for these samples to be fast-tracked. Successive improvement cycles sought to increase awareness of the project, improve accessibility to the new forms and embed spontaneous practices that contributed to improvement. Results demonstrated an overall reduction in the time taken for blood samples in emergencies to be reported from 130 minutes to 97 minutes. This project demonstrates that using a specific blood request form for emergency calls, and tying this to a specified laboratory process, improves the time taken for these tests to be reported. In addition, the project provides some insight into challenges faced when implementing change in new departments. PMID:28243442

  5. Novel findings of left ventricular non-compaction cardiomyopathy, microform cleft lip and poor vision in patient with SMC1A-associated Cornelia de Lange syndrome.

    PubMed

    Wenger, Tara L; Chow, Penny; Randle, Stephanie C; Rosen, Anna; Birgfeld, Craig; Wrede, Joanna; Javid, Patrick; King, Darcy; Manh, Vivian; Hing, Anne V; Albers, Erin

    2017-02-01

    Relatively few patients with Cornelia de Lange syndrome (CdLS) due to SMC1A mutation have been reported, limiting understanding of the full extent of the phenotype. Compared to children with classic NIPBL-associated CdLS, patients with SMC1A-associated CdLS have a milder physical phenotype with prominent intellectual disability, high rate of cleft palate and absence of limb reductions. We present a patient with SMC1A-associated CdLS who had typical features including developmental delay, seizure disorder, feeding difficulties, hirsutism, and cleft palate. She also was found to have three novel features: (i) left ventricular non-compaction (LVNC) cardiomyopathy; (ii) microform cleft lip; and (iii) severe hyperopia and astigmatism. These features have implications regarding potential insight into the pathogenesis of the disorder, screening, and medical management. Hypertrophic cardiomyopathy has previously been reported in SMC1A-associated CdLS, but to our knowledge this is the first reported child with LVNC. Previous reports have included children with isolated clefts of the palate without involvement of the lip. When cleft palate alone is associated with a disorder, the underlying pathophysiology for clefting is sometimes secondary due to mechanical blocking of the fusion of the palatal shelves with the developing tongue. The presence of microform cleft lip in this patient suggests that the pathophysiology of clefting in SMC1A is primary rather than secondary. Few studies report ophthalmologic findings specific to SMC1A. Based on these findings, LVNC cardiomyopathy and cleft lip should be considered features of SMC1A-associated CdLS. All patients should receive echocardiogram and undergo thorough ophthalmologic evaluation as part of routine CdLS care. © 2016 Wiley Periodicals, Inc.

  6. 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.

  7. [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.

  8. Experience with Formal Methods techniques at the Jet Propulsion Laboratory from a quality assurance perspective

    NASA Technical Reports Server (NTRS)

    Kelly, John C.; Covington, Rick

    1993-01-01

    Recent experience with Formal Methods (FM) in the Software Quality Assurance Section at the Jet Propulsion Lab is presented. An integrated Formal Method process is presented to show how related existing requirements analysis and FM techniques complement one another. Example application of FM techniques such as formal specifications and specification animators are presented. The authors suggest that the quality assurance organization is a natural home for the Formal Methods specialist, whose expertise can then be used to best advantage across a range of projects.

  9. Experience with Formal Methods techniques at the Jet Propulsion Laboratory from a quality assurance perspective

    NASA Technical Reports Server (NTRS)

    Kelly, John C.; Covington, Rick

    1993-01-01

    Recent experience with Formal Methods (FM) in the Software Quality Assurance Section at the Jet Propulsion Lab is presented. An integrated Formal Method process is presented to show how related existing requirements analysis and FM techniques complement one another. Example application of FM techniques such as formal specifications and specification animators are presented. The authors suggest that the quality assurance organization is a natural home for the Formal Methods specialist, whose expertise can then be used to best advantage across a range of projects.

  10. Image quality, meteorological optical range, and fog particulate number evaluation using the Sandia National Laboratories fog chamber

    NASA Astrophysics Data System (ADS)

    Birch, Gabriel C.; Woo, Bryana L.; Sanchez, Andres L.; Knapp, Haley

    2017-08-01

    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 optical 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.

  11. Credibility and Confidence in Your Dental Laboratory Work-How Quality Assurance Systems Can Be Used in the Manufacturing of Individual Custom-Made Dental Devices.

    PubMed

    Griffin, Anthony

    2015-08-01

    Manufacturing of custom-made dental devices such as removable dentures, fixed prosthodontics and orthodontics are subject to the requirements of the Medical Devices Directive (MDD). Many dental laboratories often enhance these requirements by implementing quality assurance procedures that then provide enhanced consistency. This paper provided a personal view of some of the systems currently being used in dental laboratories to provide a quality assured product and associated issues.

  12. Los Alamos National Laboratory Yucca Mountain Site Characterization Project 1992 quality program status report

    SciTech Connect

    Bolivar, S.L.; Burningham, A.; Chavez, P.

    1994-03-01

    This status report summarizes the activities and accomplishments of the Los Alamos Yucca Mountain Site Characterization Project`s quality assurance program for calendar year 1992. The report includes major sections on Program Activities and Trend Analysis. Program Activities are discussed periodically at quality meetings. The most significant issue addressed in 1992 has been the timely revision of quality administrative procedures. The procedure revision process was streamlined from 55 steps to 7. The number of forms in procedures was reduced by 38%, and the text reduced by 29%. This allowed revision in 1992 of almost half of all implementing procedures. The time necessary to complete the revision process (for a procedure) was reduced from 11 months to 3 months. Other accomplishments include the relaxation of unnecessarily strict training requirements, requiring quality assurance reviews only from affected organizations, and in general simplifying work processes. All members of the YMP received training to the new Orientation class Eleven other training classed were held. Investigators submitted 971 records to the Project and only 37 were rejected. The software program has 115 programs approved for quality-affecting work. The Project Office conducted 3 audits and 1 survey of Los Alamos activities. We conducted 14 audits and 4 surveys. Eight corrective action reports were closed, leaving only one open. Internally, 22 deficiencies were recognized. This is a decrease from 65 in 1991. Since each deficiency requires about 2 man weeks to resolve, the savings are significant. Problems with writing acceptable deficiency reports have essentially disappeared. Trend reports for 1992 were examined and are summarized herein. Three adverse trends have been closed; one remaining adverse trend will be closed when the affected procedures are revised. The number of deficiencies issued to Los Alamos compared to other participants is minimal.

  13. Improvement in the quality of enzyme determinations by Scandinavian laboratories upon introduction of Scandinavian recommended methods.

    PubMed

    Strömme, J H; Björnstad, P; Eldjarn, L

    1976-10-01

    The last annual Scandinavian proficiency survey (January 1975) offered an opportunity to evaluate the effect of the introduction of recommended methods for ASAT, ALAT, LD, and ALP on routinely performed enzyme determinations in clinical chemical laboratories. The results obtained by the recommended methods showed a marked improvement in precision, bringing the interlaboratory variations down to levels that have previously been achieved only for the determination of non-enzymic constituents. Enzymes for which no recommended method have been proposed were still determined with low interlaboratory precision.

  14. [Definition of priority medicines for monitoring laboratory quality in Brazil: the interface between health surveillance and the National Drug Policy].

    PubMed

    Pontes Junior, Durval Martins; Pepe, Vera Lúcia Edais; Osorio-de-Castro, Claudia Garcia Serpa; Massena, Elisa Prestes; Portela, Margareth Crisóstomo; Miranda, Maria do Carmo; Silva, Raulino Sabino da

    2008-09-01

    A key objective of the Brazilian National Drug Policy is the quality of medicines supplied to the population. This study aimed to set priorities for the analysis of the National Program for Quality Control of Medicines. The main criterion was the drug's presence in at least three Pharmaceutical Care Programs under the Ministry of Health. Additional criteria were presence on the National List of Essential Drugs (RENAME) in 2002 and its indication for the 20 main causes of disability-adjusted life years (DALY). The sources were data from the Ministry of Health and related legislation. The drugs were classified according to the Anatomical Therapeutic Chemical Classification System (ATC) of the WHO. The 13 pharmaceutical care programs included 893 products classified in 449 different ATC codes. Twenty-eight drugs were considered priorities, 26 of which were listed on the RENAME and 12 indicated as causes of DALY. It is recommended that the National Health Surveillance Agency and Secretariat of Science, Technology, and Strategic Inputs establish an integrated strategy to guarantee comprehensive quality of these drugs, including laboratory quality, registration, good manufacturing practices, and information for health professionals and the general population.

  15. 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

  16. Aquatic macroinvertebrates and water quality of Sandia Canyon, Los Alamos National Laboratory, December 1992--October 1993. Status report

    SciTech Connect

    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 at 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.

  17. Quality-control analytical methods: endtoxins: essential testing for pyrogens in the compounding laboratory, part 1.

    PubMed

    Dubczak, John; Latta, Kennth S; Hedman, Hilary; Smith, Donald R

    2010-01-01

    Inadvertent exposure to endotoxins administered intravenously, intramuscularly, or intrathecally can cause a constellation of adverse effects that range from fever to multiple organ failure and death. Pharmacists who compound sterile formulations must remain exceptionally vigilant to guard against the contamination of such preparations with those pyrogens. Fortunately, endotoxin screening analyses are available for onsite use or from contract testing laboratories, and both options offer accurate, repeatable, and timely results. The volume of sterile compounding performed, the need for immediate results, and cost often dictate the compounder's choice of endotoxin testing. In this first of a 3-part series, we summarize the evolution of pyrogen screening and explain the mechanisms of two endotoxin test kits that provide valid results on site. A Table comparing those kits is presented for easy reference. In part 2 of the series, additional endotoxin test kits will be compared, and contract laboratory pyrogen testing will be profiled. In part 3, a simplified endotoxin test method for compounded sterile products will be presented.

  18. Evaluation of heterotrophic plate and chromogenic agar colony counting in water quality laboratories

    PubMed Central

    Hallas, Gary; Monis, Paul

    2015-01-01

    The enumeration of bacteria using plate-based counts is a core technique used by food and water microbiology testing laboratories. However, manual counting of bacterial colonies is both time and labour intensive, can vary between operators and also requires manual entry of results into laboratory information management systems, which can be a source of data entry error. An alternative is to use automated digital colony counters, but there is a lack of peer-reviewed validation data to allow incorporation into standards. We compared the performance of digital counting technology (ProtoCOL3) against manual counting using criteria defined in internationally recognized standard methods. Digital colony counting provided a robust, standardized system suitable for adoption in a commercial testing environment. The digital technology has several advantages:•Improved measurement of uncertainty by using a standard and consistent counting methodology with less operator error.•Efficiency for labour and time (reduced cost).•Elimination of manual entry of data onto LIMS.•Faster result reporting to customers. PMID:26649275

  19. Evaluation of heterotrophic plate and chromogenic agar colony counting in water quality laboratories.

    PubMed

    Hallas, Gary; Monis, Paul

    2015-01-01

    The enumeration of bacteria using plate-based counts is a core technique used by food and water microbiology testing laboratories. However, manual counting of bacterial colonies is both time and labour intensive, can vary between operators and also requires manual entry of results into laboratory information management systems, which can be a source of data entry error. An alternative is to use automated digital colony counters, but there is a lack of peer-reviewed validation data to allow incorporation into standards. We compared the performance of digital counting technology (ProtoCOL3) against manual counting using criteria defined in internationally recognized standard methods. Digital colony counting provided a robust, standardized system suitable for adoption in a commercial testing environment. The digital technology has several advantages:•Improved measurement of uncertainty by using a standard and consistent counting methodology with less operator error.•Efficiency for labour and time (reduced cost).•Elimination of manual entry of data onto LIMS.•Faster result reporting to customers.

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

    SciTech Connect

    Bogner, J.; Spokas, K.

    1995-05-01

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

  1. A Validated High-Throughput Fluorometric Method for Determination of Omeprazole in Quality Control Laboratory via Charge Transfer Sensitized Fluorescence.

    PubMed

    Mahmoud, Ashraf M; Ahmed, Sameh A

    2016-03-01

    A high-throughput 96-microwell plate fluorometric method was developed and validated to determine omeprazole (OMZ) in its dosage forms. The method was based on the charge-transfer (CT) sensitized fluorescence reaction of OMZ with 2, 3-dichloro-5, 6-dicyano-1, 4-benzoquinone (DDQ). This fluorescence reaction provided a new approach for simple, sensitive and selective determinations of OMZ in pharmaceutical preparations. In the present method, the fluorescence reaction was carried out in 96-microwell plates as reaction vessels in order to increase the automation of the methodology and the efficiency of its use in quality control laboratories. All factors affecting the fluorescence reaction were carefully studied and the conditions were optimized. The stoichiometry of the fluorescence reaction between OMZ and DDQ was determined and the reaction mechanism was suggested. Under the optimum conditions, the linear range was 100-6000 ng/ml with the lowest LOD of 33 ng/ml. Analytical performance of the proposed assay, in terms of accuracy and precision, was statistically validated and the results were satisfactory; RSD was <2.6 % and the accuracy was 98.6-101.6 %. The method was successfully applied to the analysis of OMZ in its dosage forms; the recovery values were 98.26-99.60 ± 0.95-2.22 %. The developed methodology may provide a safer, automated and economic tool for the analysis of OMZ in quality control laboratories.

  2. Reducing radiation to patients and improving image quality in a real-world nuclear cardiology laboratory.

    PubMed

    Bloom, Stephen A; Meyers, Karen

    2017-03-22

    In part because of aging equipment and reduced reimbursement for imaging services in the last several years, nuclear cardiologists who remain in private practice face challenges in maintaining high quality and in reducing radiation exposure to patients. We review patient-centered approaches and affordable software solutions employed in our practice combined with supine-prone myocardial perfusion imaging to achieve increased interpretive confidence with reduced radiation exposure to patients.

  3. Monitoring space shuttle air quality using the Jet Propulsion Laboratory electronic nose

    NASA Technical Reports Server (NTRS)

    Ryan, Margaret Amy; Zhou, Hanying; Buehler, Martin G.; Manatt, Kenneth S.; Mowrey, Victoria S.; Jackson, Shannon P.; Kisor, Adam K.; Shevade, Abhijit V.; Homer, Margie L.

    2004-01-01

    A miniature electronic nose (ENose) has been designed and built at the Jet Propulsion Laboratory (JPL), Pasadena, CA, and was designed to detect, identify, and quantify ten common contaminants and relative humidity changes. The sensing array includes 32 sensing films made from polymer carbon-black composites. Event identification and quantification were done using the Levenberg-Marquart nonlinear least squares method. After successful ground training, this ENose was used in a demonstration experiment aboard STS-95 (October-November, 1998), in which the ENose was operated continuously for six days and recorded the sensors' response to the air in the mid-deck. Air samples were collected daily and analyzed independently after the flight. Changes in shuttle-cabin humidity were detected and quantified by the JPL ENose; neither the ENose nor the air samples detected any of the contaminants on the target list. The device is microgravity insensitive.

  4. Monitoring space shuttle air quality using the Jet Propulsion Laboratory electronic nose.

    PubMed

    Ryan, Margaret Amy; Zhou, Hanying; Buehler, Martin G; Manatt, Kenneth S; Mowrey, Victoria S; Jackson, Shannon P; Kisor, Adam K; Shevade, Abhijit V; Homer, Margie L

    2004-06-01

    A miniature electronic nose (ENose) has been designed and built at the Jet Propulsion Laboratory (JPL), Pasadena, CA, and was designed to detect, identify, and quantify ten common contaminants and relative humidity changes. The sensing array includes 32 sensing films made from polymer carbon-black composites. Event identification and quantification were done using the Levenberg-Marquart nonlinear least squares method. After successful ground training, this ENose was used in a demonstration experiment aboard STS-95 (October-November, 1998), in which the ENose was operated continuously for six days and recorded the sensors' response to the air in the mid-deck. Air samples were collected daily and analyzed independently after the flight. Changes in shuttle-cabin humidity were detected and quantified by the JPL ENose; neither the ENose nor the air samples detected any of the contaminants on the target list. The device is microgravity insensitive.

  5. Review of concepts useful for maintaining quality of male reproductive field samples for laboratory study

    USGS Publications Warehouse

    Jenkins, Jill A.

    2011-01-01

    Investigations into cellular and molecular characteristics of male gametes obtained from fish in natural ecosystems require careful sample handling and shipping in order to minimize artifacts. Maintaining sample integrity engenders confident assessments of ecosystem health, whereby animal condition is often reflected by gamete biomarkers - indicators that respond in measurable ways to changes. A number of our investigations have addressed the hypothesis that biomarkers from fish along a pollution gradient are reflective of site location. Species biology and the selected biological endpoints direct choice of parameters such as: temperature, buffer osmolality, time in transit, fixation, cryoprotectants, protease inhibition, and antibiotic inclusion in extender. This paper will highlight case studies, and outline parameters and thoughts on approaches for use by field and laboratory researchers.

  6. Monitoring space shuttle air quality using the Jet Propulsion Laboratory electronic nose

    NASA Technical Reports Server (NTRS)

    Ryan, Margaret Amy; Zhou, Hanying; Buehler, Martin G.; Manatt, Kenneth S.; Mowrey, Victoria S.; Jackson, Shannon P.; Kisor, Adam K.; Shevade, Abhijit V.; Homer, Margie L.

    2004-01-01

    A miniature electronic nose (ENose) has been designed and built at the Jet Propulsion Laboratory (JPL), Pasadena, CA, and was designed to detect, identify, and quantify ten common contaminants and relative humidity changes. The sensing array includes 32 sensing films made from polymer carbon-black composites. Event identification and quantification were done using the Levenberg-Marquart nonlinear least squares method. After successful ground training, this ENose was used in a demonstration experiment aboard STS-95 (October-November, 1998), in which the ENose was operated continuously for six days and recorded the sensors' response to the air in the mid-deck. Air samples were collected daily and analyzed independently after the flight. Changes in shuttle-cabin humidity were detected and quantified by the JPL ENose; neither the ENose nor the air samples detected any of the contaminants on the target list. The device is microgravity insensitive.

  7. Facsimile Transmission of Microforms.

    DTIC Science & Technology

    1983-12-30

    acoustico-optic laser and precision lenses to scan microimages. Boticelli et al. (1975, 1976) of Epsco Labs summarize a parametric study which presents... Epsco Labs. Botticelli, R.A. at al. (1976). Accessing and Displaying Stored Microimage Information. Society for Information Display International

  8. 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.

  9. Improving image quality in laboratory x-ray phase-contrast imaging

    NASA Astrophysics Data System (ADS)

    De Marco, F.; Marschner, M.; Birnbacher, L.; Viermetz, M.; Noël, P.; Herzen, J.; Pfeiffer, F.

    2017-03-01

    Grating-based X-ray phase-contrast (gbPC) is known to provide significant benefits for biomedical imaging. To investigate these benefits, a high-sensitivity gbPC micro-CT setup for small (≍ 5 cm) biological samples has been constructed. Unfortunately, high differential-phase sensitivity leads to an increased magnitude of data processing artifacts, limiting the quality of tomographic reconstructions. Most importantly, processing of phase-stepping data with incorrect stepping positions can introduce artifacts resembling Moiré fringes to the projections. Additionally, the focal spot size of the X-ray source limits resolution of tomograms. Here we present a set of algorithms to minimize artifacts, increase resolution and improve visual impression of projections and tomograms from the examined setup. We assessed two algorithms for artifact reduction: Firstly, a correction algorithm exploiting correlations of the artifacts and differential-phase data was developed and tested. Artifacts were reliably removed without compromising image data. Secondly, we implemented a new algorithm for flatfield selection, which was shown to exclude flat-fields with strong artifacts. Both procedures successfully improved image quality of projections and tomograms. Deconvolution of all projections of a CT scan can minimize blurring introduced by the finite size of the X-ray source focal spot. Application of the Richardson-Lucy deconvolution algorithm to gbPC-CT projections resulted in an improved resolution of phase-contrast tomograms. Additionally, we found that nearest-neighbor interpolation of projections can improve the visual impression of very small features in phase-contrast tomograms. In conclusion, we achieved an increase in image resolution and quality for the investigated setup, which may lead to an improved detection of very small sample features, thereby maximizing the setup's utility.

  10. 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…

  11. ATM Quality of Service Parameters at 45 Mbps Using a Satellite Emulator: Laboratory Measurements

    NASA Technical Reports Server (NTRS)

    Ivancic, William D.; Bobinsky, Eric A.

    1997-01-01

    Results of 45-Mbps DS3 intermediate-frequency loopback measurements of asynchronous transfer mode (ATM) quality of service parameters (cell error ratio and cell loss ratio) are presented. These tests, which were conducted at the NASA Lewis Research Center in support of satellite-ATM interoperability research, represent initial efforts to quantify the minimum parameters for stringent ATM applications, such as MPEG-1 and MPEG-2 video transmission. Portions of these results were originally presented to the International Telecommunications Union's ITU-R Working Party 4B in February 1996 in support of their Draft Preliminary Recommendation on the Transmission of ATM Traffic via Satellite.

  12. ATM Quality of Service Tests for Digitized Video Using ATM Over Satellite: Laboratory Tests

    NASA Technical Reports Server (NTRS)

    Ivancic, William D.; Brooks, David E.; Frantz, Brian D.

    1997-01-01

    A digitized video application was used to help determine minimum quality of service parameters for asynchronous transfer mode (ATM) over satellite. For these tests, binomially distributed and other errors were digitally inserted in an intermediate frequency link via a satellite modem and a commercial gaussian noise generator. In this paper, the relation- ship between the ATM cell error and cell loss parameter specifications is discussed with regard to this application. In addition, the video-encoding algorithms, test configurations, and results are presented in detail.

  13. [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.

  14. 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.

  15. 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.

  16. Lawrence Livermore National Laboratory Quality Assurance Project Plan for National Emission Standards for Hazardous Air Pollutants (NESHAPs), Subpart H

    SciTech Connect

    Hall, L.; Biermann, A

    2000-06-27

    As a Department of Energy (DOE) Facility whose operations involve the use of radionuclides, Lawrence Livermore National Laboratory (LLNL) is subject to the requirements of 40 CFR 61, the National Emission Standards for Hazardous Air Pollutants (NESHAPs). Subpart H of this Regulation establishes standards for exposure of the public to radionuclides (other than radon) released from DOE Facilities (Federal Register, 1989). These regulations limit the emission of radionuclides to ambient air from DOE facilities (see Section 2.0). Under the NESHAPs Subpart H Regulation (hereafter referred to as NESHAPs), DOE facilities are also required to establish a quality assurance program for radionuclide emission measurements; specific requirements for preparation of a Quality Assurance Program Plan (QAPP) are given in Appendix B, Method 114 of 40 CFR 61. Throughout this QAPP, the specific Quality Assurance Method elements of 40 CFR 61 Subpart H addressed by a given section are identified. In addition, the US Environmental Protection Agency (US EPA) (US EPA, 1994a) published draft requirements for QAPP's prepared in support of programs that develop environmental data. We have incorporated many of the technical elements specified in that document into this QAPP, specifically those identified as relating to measurement and data acquisition; assessment and oversight; and data validation and usability. This QAPP will be evaluated on an annual basis, and updated as appropriate.

  17. The quality of the extra-analytical phase of laboratory practice in some developing European countries and Mexico - a multicentric study.

    PubMed

    Simundic, Ana-Maria; Bilic-Zulle, Lidija; Nikolac, Nora; Supak-Smolcic, Vesna; Honovic, Lorena; Avram, Sanja; Beregovaja, Elena; Dobreanu, Minodora; Guimaraes, Joao-Tiago; Kovacs, Gabor L; Singh, Nada Majkic; Sierra-Amor, Rosa Isabel; Sypniewska, Grazyna; Zima, Tomas

    2011-02-01

    This cross-sectional multicentric survey study aimed to assess the quality of the extra-analytical phase of laboratory activities in some developing European countries and Mexico. We assessed the quality of the extra-analytical practices in participating laboratories regarding the: a) sample acceptance criteria; b) phlebotomy procedures; c) test results reporting and d) recording non-conformities. A survey was performed during the April-May 2009. A total of 15 clinical laboratories from the following countries were included: Bosnia, Croatia, Czech Republic, Hungary, Mexico, Poland, Portugal, Romania, Serbia and Ukraine. Questions were scored (scores from 1-4) and average scores was calculated for each category. The overall score for all respondents (n = 443) was 3.10 ± 0.33. The average score was 3.11 ± 0.56 for sample acceptance criteria, 2.76 ± 0.58 for phlebotomy and 3.34 ± 0.53, for test results reporting (F = 116.49; p < 0.001). Laboratory accreditation was associated with better practices and higher overall quality of the extra-analytical procedures (F = 16.62; p < 0.001). Moreover, the highest scores for sample acceptance criteria (F = 8.32; p < 0.001), phlebotomy procedures (F = 13.28; p < 0.001) and for reporting non-conformities (F = 33.62; p < 0.001) were observed for accredited laboratories or laboratories under preparation for accreditation. The overall quality of the extra-analytical practices in countries in this survey is not satisfactory. Phlebotomy practices are the most critical extra-analytical activity. Since laboratory accreditation was associated with better practices and higher overall quality of the extra-analytical procedures, we believe that the most significant improvement could be made by implementing the total quality management system and standardizing laboratory procedures.

  18. 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.

  19. Quality of teaching in chemical pathology: ability of interns to order and interpret laboratory tests.

    PubMed

    Stanfliet, J C; Macauley, J; Pillay, T S

    2009-07-01

    There has been a steady decline in the overt teaching of many basic and pathology sciences in the medical curriculum worldwide. As interns are the doctors most likely to request and act on tests, an assessment of their confidence in dealing with laboratory investigations was undertaken. Interns at two hospitals in Cape Town, South Africa, were asked to complete a structured questionnaire designed to assess their confidence in ordering and interpreting a number of tests. The questionnaire also probed their desire for further teaching and the preferred delivery vehicle for such teaching. 61 out of 117 questionnaires were returned. Interns were confident in the use of common tests, but 23% were not confident in interpreting a test that they were confident in ordering. All respondents felt they would benefit from teaching in at least one area and lectures were the preferred method, although the majority felt it very likely that they would complete an online tutorial if available. The results suggest that institutions need to devise strategies to fulfil the learning needs of new graduates in the area of chemical pathology and clinical biochemistry.

  20. Groundwater quality assessment/corrective action feasibility plan. Savannah River Laboratory Seepage Basins

    SciTech Connect

    Stejskal, G.F.

    1989-11-15

    The Savannah River Laboratory (SRL) Seepage Basins are located in the northeastern section of the 700 Area at the Savannah River Site. Currently the four basins are out of service and are awaiting closure in accordance with the Consent Decree settled under Civil Act No. 1:85-2583. Groundwater monitoring data from the detection monitoring network around the SRL Basins was recently analyzed using South Carolina Hazardous Waste Management Regulations R.61-79.264.92 methods to determine if groundwater in the immediate vicinity of the SRL Basins had been impacted. Results from the data analysis indicate that the groundwater has been impacted by both volatile organic constituents (VOCs) and inorganic constituents. The VOCs, specifically trichloroethylene and tetrachloroethylene, are currently being addressed under the auspices of the SRS Hazardous Waste Permit Application (Volume III, Section J.6.3). The impacts resulting from elevated levels of inorganic constituent, such as barium, calcium, and zinc in the water table, do not pose a threat to human health and the environment. In order to determine if vertical migration of the inorganic constituents has occurred three detection monitoring wells are proposed for installation in the upper portion of the Congaree Aquifer.