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Sample records for quality laboratory microform

  1. 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)

  2. 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…

  3. 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,…

  4. 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)

  5. 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,…

  6. 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…

  7. Microforms and Sport History.

    ERIC Educational Resources Information Center

    Levine, Peter

    1986-01-01

    Explores the importance of sport history as it reflects the social and cultural history of the United States. Discussion covers the various sport history materials that are available in microform, including the Spalding Collection, twentieth-century microfilm sources, and sports and social history (Sports Periodicals microfilm series). (EJS)

  8. Facsimile Transmission of Microforms.

    DTIC Science & Technology

    1983-12-30

    author and Whould not be construed as an official Department of the Army position, policy, or decision, unless so designated by other documentation...beconstrued as an official Department of the Army position, policy, or decision, unless so designated by other documentation. ,, -- UNCLASSIFIED SECURITY...researcher. Some form of tele- facsimile transmission of microform is needed. This study is designed to to describe the current state of the technology, and

  9. 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…

  10. 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…

  11. 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,…

  12. 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.

  13. 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)

  14. 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.…

  15. 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.

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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;…

  2. 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.

  3. [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.

  4. 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)

  5. [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.

  6. 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…

  7. 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…

  8. 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…

  9. 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

  10. 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.

  11. National Water Quality Laboratory - A Profile

    USGS Publications Warehouse

    Raese, Jon W.

    2001-01-01

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

  12. 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.

  13. 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…

  14. 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.

  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. 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.

  17. 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.

  18. 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.

  19. 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

  20. [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.

  1. 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.

  2. 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.

  3. 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…

  4. 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,…

  5. 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…

  6. 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.

  7. 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.

  8. 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.

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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)

  15. 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.

  16. 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

  17. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  18. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  19. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  20. 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...

  1. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  2. 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....

  3. 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....

  4. 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....

  5. 7 CFR 58.442 - Laboratory and quality control tests.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  6. 7 CFR 58.442 - Laboratory and quality control tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory and quality control tests. 58.442 Section... 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....

  7. 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.

  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. 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.

  10. 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...

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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).

  16. 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.

  17. [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.

  18. Helping You Identify Quality Laboratory Services

    MedlinePlus

    ... would like a printed copy, please call the Customer Service Center at (630) 792-5800. To report information or concerns about accredited organizations:  Call or e-mail our Office of Quality Monitoring (800) 994-6610 or complaint@ jointcommission. org.

  19. 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.

  20. Quality Control in Clinical Laboratory Samples

    DTIC Science & Technology

    2015-01-01

    misalignment are important aspects to observing shifting L-J charts and adjustments of accuracy over time. Continuous monitoring of quality control testing...calibration misalignment are important aspects to observing shifting L-J charts and 1 adjustments of accuracy over time. Continuous monitoring of...2673rd MDSS, SGSL, Elmendorf AFB, 99506-3702, AK 8. PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING/ MONITORING AGENCY NAME(S) AND ADDRESS(ES

  1. 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...

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Quality assurance programs at the PNL calibrations laboratory

    SciTech Connect

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

    1993-03-01

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

  7. 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.

  8. 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.

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  10. 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.

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

    PubMed

    Suzuki, Katsuhiro; Higuchi, Takeshi

    2007-03-01

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

  12. 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.

  13. 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.

  14. [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.

  15. 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…

  16. 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)...

  17. 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…

  18. 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…

  19. 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…

  20. 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.

  1. 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.

  2. [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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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...

  8. 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.

  9. [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.

  10. 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.

  11. 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.

  12. 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...

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. [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.

  19. 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.

  20. 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...

  1. 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…

  2. 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...

  3. 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...

  4. 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...

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. [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".

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

    PubMed Central

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

    2016-01-01

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

  14. 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

  15. 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.

  16. 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.

  17. 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.

  18. 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…

  19. 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.

  20. 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.

  1. 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

  2. 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.

  3. 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…

  4. 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.

  5. 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

  6. 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…

  7. 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

  8. 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.

  9. 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

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

    PubMed

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

    2013-05-01

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

  11. 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.

  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. 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.

  14. 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

  15. 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

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. 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

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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

  7. [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.

  8. 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.

  9. 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.

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

    PubMed

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

    2016-03-01

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

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. 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.

  19. 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.

  20. 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

  1. 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.

  2. 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.

  3. 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

  4. 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…

  5. 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.

  6. 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.

  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. 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

  9. 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.

  10. 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

  11. 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

  12. 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.

  13. 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...

  14. 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.

  15. 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

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. [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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.…

  8. 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.

  9. [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.

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. 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

  15. [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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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…

  7. [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.

  8. 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.

  9. 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".

  10. 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

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. 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

  17. 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.

  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. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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

    2017-03-15

    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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What quality control operations are required for laboratory operations associated with the production and process control system? 111.110 Section 111.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD...

  11. 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,…

  12. 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.

  13. 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.

  14. 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.

  15. 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

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

    USGS Publications Warehouse

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

    2014-01-01

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

  17. 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.

  18. 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.

  19. 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.

  20. [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.

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 78 FR 54643 - Proposed Information Collection Request; Comment Request; Laboratory Quality Assurance Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-05

    ... certification responsibilities for the chemistry and microbiology laboratories that they oversee in their... Chapter 7 of ``Supplement 2 to the Fifth Edition of the Manual for the Certification of Laboratories... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL...

  7. 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

  8. 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

  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. 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.

  13. [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.

  14. 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.

  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. 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...

  17. 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...

  18. 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)

  19. 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

  20. 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 ...

  1. 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.

  2. 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

  3. 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

  4. 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

  5. A high efficiency, high quality and low cost internal regulated bioanalytical laboratory to support drug development needs.

    PubMed

    Song, Yan; Dhodda, Raj; Zhang, Jun; Sydor, Jens

    2014-05-01

    In the recent past, we have seen an increase in the outsourcing of bioanalysis in pharmaceutical companies in support of their drug development pipeline. This trend is largely driven by the effort to reduce internal cost, especially in support of late-stage pipeline assets where established bioanalytical assays are used to analyze a large volume of samples. This article will highlight our perspective of how bioanalytical laboratories within pharmaceutical companies can be developed into the best partner in the advancement of drug development pipelines with high-quality support at competitive cost.

  6. 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

  7. 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.

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. [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.

  13. 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.

  14. 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.

  15. 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

  16. 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.

  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. 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).

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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…

  4. 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.

  5. [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.

  6. 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.

  7. 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.

  8. Medical Services: Department of Defense Veterinary/Medical Laboratory Food Safety and Quality Assurance Program

    DTIC Science & Technology

    1995-02-01

    ice (cream) milk and yogurt processing at the retail/user level (chap 5). o Revises and prescribes the use of DD Form 2385 (Microbiological Quality...production or packaging, as applicable and required by the contractual documents. (7) Provide source of manufacture information to the applicable origin and... yogurt , sandwiches and spreads, salad type convenience foods, and other processed/ p r e – p a c k a g e d a n d r e a d y – t o – e a t ( R T E ) f o o

  9. 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.

  10. 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.

  11. 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.

  12. Quality guidelines and standards for genetic laboratories/clinics in prenatal diagnosis on fetal samples obtained by invasive procedures. An attempt to establish a common European framework for quality assessment. EUCROMIC Quality Assessment Group.

    PubMed

    1997-01-01

    At a workshop in Leuven, November 8-10, 1996, 24 clinical and laboratory geneticists from 15 countries in Europe met and discussed minimum standards for prenatal diagnosis. These guidelines are intended for use as a reference manual by genetic centres all over Europe, especially in countries without national guidelines, in their efforts to achieve and maintain high standards. The workshop was restricted to discuss quality assessment on established invasive procedures for cytogenetic and molecular studies. The committee brought together from their own countries substantial experience of genetic counselling, cytogenetics, molecular biology and quality assessment. It is hoped that future discussions, embracing all aspects of clinical and laboratory genetic services will lead to the establishment of common guidelines for all European countries.

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

    PubMed

    Iqbal, Sahar; Mustansar, Tazeen

    2017-03-01

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

  14. The practical aspects of quality assurance in Good Laboratory Practice studies in an emergency situation.

    PubMed

    Nomura, A; Takahashi, T

    1995-12-01

    In this report, the damage and countermeasures taken in relation to the Great Hanshin Earthquake are described. We report on the measures taken to counter damage in affected Good Laboratory Practice (GLP) studies by citing concrete examples. Case A: the testing facility was not affected, but a regulatory inspection had been scheduled for this day. Fortunately, official inspectors had reached the facility on schedule. Case B: The building for toxicology experiments was destroyed. Fortunately, most of the GLP-compliant experiments had been completed except one, the preparation of histological samples that was the last stage of the experiment. We asked the regulatory authority for appropriate countermeasures. The answer was that an inspection of the study could be conducted if an inspection is judged to be necessary. Case C: A necropsy was scheduled on this day. The study director decided that the necropsy should be postponed at least 1 week until he could secure the number of researchers needed to conduct the necropsy. Case D: The facility in Itami was destroyed. The facility was closed and the animals were moved to Kobe. The animal facility in Kobe was not affected, but because water supply stopped for 3 days, stocked water was used. Case E: Damage to computer systems in Kinki area was reported. Numerous computers fell from desks or were damaged from the impact shock. With the exception of a few, most of the damaged computers were repaired.

  15. Final Report for the Quality of Service for Networks Laboratory Directed Research and Development Project

    SciTech Connect

    TSANG, ROSE; ELDRIDGE, JOHN M.; TARMAN, THOMAS D.; BRENKOSH, JOSEPH P.; DILLINGER, JOHN D.; MICHALSKI, JOHN T.

    2001-10-01

    The recent unprecedented growth of global network (Internet) usage has created an ever-increasing amount of congestion. Telecommunication companies (Telco) and Internet Service Providers (ISP's), which provide access and distribution through the network, are increasingly more aware of the need to manage this growth. Congestion, if left unmanaged, will result in a degradation of the over-all network. These access and distribution networks currently lack formal mechanisms to select Quality of Service (QoS) attributes for data transport. Network services with a requirement for expediency or consistent amounts of bandwidth cannot function properly in a communication environment without the implementation of a QoS structure. This report describes and implements such a structure that results in the ability to identify, prioritize, and police critical application flows.

  16. Status quo and future research challenges on organic food quality determination with focus on laboratory methods.

    PubMed

    Kahl, Johannes; Bodroza-Solarov, Marija; Busscher, Nicolaas; Hajslova, Jana; Kneifel, Wolfgang; Kokornaczyk, Maria Olga; van Ruth, Saskia; Schulzova, Vera; Stolz, Peter

    2014-10-01

    Organic food quality determination needs multi-dimensional evaluation tools. The main focus is on the authentication as an analytical verification of the certification process. New fingerprinting approaches such as ultra-performance liquid chromatography-mass spectrometry, gas chromatography-mass spectrometry, direct analysis in real time-high-resolution mass spectrometry as well as crystallization with and without the presence of additives seem to be promising methods in terms of time of analysis and detecting organic system-related parameters. For further methodological development, a system approach is recommended, which also takes into account food structure aspects. Furthermore, the authentication of processed organic samples needs more consciousness, hence most of organic food is complex and processed.

  17. Quality Assurance in the Polio Laboratory. Cell Sensitivity and Cell Authentication Assays.

    PubMed

    Dunn, Glynis

    2016-01-01

    The accuracy of poliovirus surveillance is largely dependent on the quality of the cell lines used for virus isolation, which is the foundation of poliovirus diagnostic work. Many cell lines are available for the isolation of enteroviruses, whilst genetically modified L20B cells can be used as a diagnostic tool for the identification of polioviruses. To be confident that cells can consistently isolate the virus of interest, it is necessary to have a quality assurance system in place, which will ensure that the cells in use are not contaminated with other cell lines or microorganisms and that they remain sensitive to the viruses being studied.The sensitivity of cell lines can be assessed by the regular testing of a virus standard of known titer in the cell lines used for virus isolation. The titers obtained are compared to previously obtained titers in the same assay, so that any loss of sensitivity can be detected.However, the detection of cell line cross contamination is more difficult. DNA bar coding is a technique that uses a short DNA sequence from a standardized position in the genome as a molecular diagnostic assay for species-level identification. For almost all groups of higher animals, the cytochrome c oxidase subunit 1 of mitochondrial DNA (CO1) is emerging as the standard barcode region. This region is 648 nucleotide base pairs long in most phylogenetic groups and is flanked by regions of conserved sequences, making it relatively easy to isolate and analyze. DNA barcodes vary among individuals of the same species to a very minor degree (generally less than 1-2 %), and a growing number of studies have shown that the COI sequences of even closely related species differ by several per cent, making it possible to identify different species with high confidence.

  18. Implementing Best Practices for Data Quality Assessment of the National Renewable Energy Laboratory's Solar Resource and Meteorological Assessment Project

    SciTech Connect

    Wilcox, S. M.; McCormack, P.

    2011-01-01

    Effective solar radiation measurements for research and economic analyses require a strict protocol for maintenance, calibration, and documentation to minimize station down-time and data corruption. The National Renewable Energy Laboratory's Concentrating Solar Power: Best Practices Handbook for the Collection and Use of Solar Resource Data (1) includes guidelines for operating a solar measure-ment station. This paper describes a suite of automated and semi-automated routines based on the best practices hand-book as developed for the National Renewable Energy La-boratory Solar Resource and Meteorological Assessment Project. These routines allow efficient inspection and data flagging to alert operators of conditions that require imme-diate attention. Although the handbook is targeted for con-centrating 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.

  19. Statistical methods for establishing quality control ranges for antibacterial agents in Clinical and Laboratory Standards Institute susceptibility testing.

    PubMed

    Turnidge, John; Bordash, Gerry

    2007-07-01

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

  20. Water quality evaluation of two interconnected dam lakes with field-captured and laboratory-acclimated fish, Cyprinus carpio.

    PubMed

    Güngördü, Abbas; Ozmen, Murat

    2012-01-01

    Karakaya and Sultansuyu Dam Lakes, located in the eastern part of Turkey, are important water sources, both for irrigation and fishery. The main goal of the study was to investigate water qualities of dam lakes using a set of biomarkers in the fish Cyprinus carpio. For this aim, field sample and laboratory-acclimated fish were compared to identify changes in selected biomarkers. The activities of ethoxyresorufin-O-deethylase, glutathione S-transferase, glutathione reductase, and carboxylesterase were determined in liver samples. Also, plasma and liver lactate dehydrogenase, aspartate aminotransferase, and alanine aminotransferase activities were assayed. Brain acetylcholinesterase and carboxylesterase activities were also determined. The hepatosomatic index and condition factors were calculated. Plasma vitellogenin assays were evaluated for the presence of xenoestrogen. Physicochemical values of water samples showed the existence of eutrophication risk, and also, some chemicals in both lakes were determined to be over tolerable limits. The comparisons of samples from both dam lake and laboratory-acclimated fish showed that the lakes may be at risk of pollution by some xenobiotics, namely xenoestrogens and acetylcholinesterase-inhibiting agents.

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

    PubMed

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

    2009-08-01

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

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

    USGS Publications Warehouse

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

    2000-01-01

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

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

    PubMed

    Guillot, Sophie; Guiso, Nicole

    2016-08-01

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

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

    PubMed Central

    Guiso, Nicole

    2016-01-01

    The French National Reference Centre (NRC) for Whooping Cough carried out an external quality control (QC) analysis in 2010 for the PCR diagnosis of whooping cough. The main objective of the study was to assess the impact of this QC in the participating laboratories through a repeat analysis in 2012. PMID:27194689

  5. Microbial response to the effect of quantity and quality soil organic matter alteration after laboratory heating

    NASA Astrophysics Data System (ADS)

    Bárcenas-Moreno, G.; Escalante, E.; Pérez-Bejarano, A.; Zavala, L. M.; Jordán, A.

    2012-04-01

    Fire-induced soil changes influence indirectly on soil microbial response, mainly due to pH increases and organic matter alterations. Partial carbon combustion can originate both, an increase in microbial activity due to dissolved organic carbon increases (Bárcenas-Moreno and Bååth, 2099, Bárcenas-Moreno et al., 2011), as well as limitation of microbial growth, either due to diminution of some fractions of organic matter (Fernández et al., 1997) or due to the formation of toxic compounds (Widden and Parkinson, 1975; Diaz-Raviña et al., 1996). The magnitude or direction of these changes is conditioned mainly by fire intensity and plant species, so forest with different vegetation could promote different quantity and quality alterations of soil organic matter after fire which leads to different soil microbial response. The objective of this work was to differentiate between the effect of reduction of carbon content and the presence of substances with inhibitory effect on soil microorganisms, inoculating microorganisms from an unaltered forest area on heated soil extract-based culture media. Soil collected from two different vegetation forest, pine (P) and oak (O) forests, with similar soil characteristics was sieved and heated at 450 °C in a muffle furnace. Heated and unheated soil was used to prepare culture media resulting in different treatments: pine unheated (PUH), pine heated at 450 °C (P450), Oak unheated (OUH) and oak heated at 450 °C (O450). To isolate inhibition of microbial proliferation and nutrient limitation, different nutritive supplements were added to the media, obtaining two levels of nutrient status for each media described above: no nutrients added (-) and nutrients added (+). Colony forming units (CFU) were enumerated as estimation of viable and cultivable microbial abundance and soil parameters characterization was also realized. Significant differences were found between CFU isolated using heated and unheated soil extract-based media

  6. Using the U.S. Geological Survey National Water Quality Laboratory LT-MDL to Evaluate and Analyze Data

    USGS Publications Warehouse

    Bonn, Bernadine A.

    2008-01-01

    A long-term method detection level (LT-MDL) and laboratory reporting level (LRL) are used by the U.S. Geological Survey?s National Water Quality Laboratory (NWQL) when reporting results from most chemical analyses of water samples. Changing to this method provided data users with additional information about their data and often resulted in more reported values in the low concentration range. Before this method was implemented, many of these values would have been censored. The use of the LT-MDL and LRL presents some challenges for the data user. Interpreting data in the low concentration range increases the need for adequate quality assurance because even small contamination or recovery problems can be relatively large compared to concentrations near the LT-MDL and LRL. In addition, the definition of the LT-MDL, as well as the inclusion of low values, can result in complex data sets with multiple censoring levels and reported values that are less than a censoring level. Improper interpretation or statistical manipulation of low-range results in these data sets can result in bias and incorrect conclusions. This document is designed to help data users use and interpret data reported with the LTMDL/ LRL method. The calculation and application of the LT-MDL and LRL are described. This document shows how to extract statistical information from the LT-MDL and LRL and how to use that information in USGS investigations, such as assessing the quality of field data, interpreting field data, and planning data collection for new projects. A set of 19 detailed examples are included in this document to help data users think about their data and properly interpret lowrange data without introducing bias. Although this document is not meant to be a comprehensive resource of statistical methods, several useful methods of analyzing censored data are demonstrated, including Regression on Order Statistics and Kaplan-Meier Estimation. These two statistical methods handle complex

  7. Role of secondary level laboratories in strengthening quality at primary level health facilities' laboratories: an innovative approach to ensure accurate HIV, tuberculosis, and malaria test results in resource-limited settings.

    PubMed

    Manyazewal, Tsegahun; Paterniti, Antonio D; Redfield, Robert R; Marinucci, Francesco

    2013-01-01

    Providing regular external quality assessment of primary level laboratories and timely feedback is crucial to ensure the reliability of testing capacity of the whole laboratory network. This study was aimed to assess the diagnostic performances of primary level laboratories in Southwest Showa Zone in Ethiopia. An external quality assessment protocol was devised whereby from among all the samples collected on-site at 4 health centers (HCs), each HC sent to a district hospital (DH) on a weekly basis 2 TB slides (1 Ziehl-Neelsen stained and another unstained), 2 malaria slides (1 Giemsa stained and another unstained), and 2 blood samples for HIV testing (1 whole blood and another plasma) for a comparative analysis. Similarly, the DH preserved the same amount and type of specimens to send to each HC for retesting. From October to November 2011, 192 single-blinded specimens were rechecked: 64 TB slides, 64 malaria slides, and 64 blood specimens for HIV testing. The analyses demonstrated an overall agreement of 95.3% (183/192) between the test and the retest, and 98.4% (63/64), 92.2% (59/64,) and 95.3% (61/64) for TB microscopy, malaria microscopy, and HIV rapid testing, respectively. Of the total TB slides tested positive, 20/23 (87%) were quantified similar in both laboratories. The agreement on HIV rapid testing was 100% (32/32) when plasma samples were tested either at HC (16/16) or at DH (16/16), while when whole blood specimens were tested, the agreement was 87.5% (14/16) and 93.8% (15/16) for samples prepared by HCs and DH, respectively. Results of this new approach proved that secondary laboratories could play a vital role in assuring laboratory qualities at primary level HCs, without depending on remotely located national and regional laboratories to provide this support.

  8. Evaluation of quality assurance/quality control data collected by the U.S. Geological Survey for water-quality activities at the Idaho National Engineering and Environmental Laboratory, Idaho, 1994 through 1995

    SciTech Connect

    Williams, L.M.

    1997-03-01

    More than 4,000 water samples were collected by the US Geological Survey (USGS) from 179 monitoring sites for the water-quality monitoring program at the Idaho National Engineering Laboratory from 1994 through 1995. Approximately 500 of the water samples were replicate or blank samples collected for the quality assurance/quality control program. Analyses were performed to determine the concentrations of major ions, nutrients, trace elements, gross radioactivity and radionuclides, total organic carbon, and volatile organic compounds in the samples. To evaluate the precision of field and laboratory methods, analytical results of the replicate pairs of samples were compared statistically for equivalence on the basis of the precision associated with each result. In all, the statistical comparison of the data indicated that 95% of the replicate pairs were equivalent. Within the major ion analyses, 97% were equivalent; nutrients, 88%; trace elements, 95%; gross radioactivity and radionuclides, 93%; and organic constituents, 98%. Ninety percent or more of the analytical results for each constituent were equivalent, except for nitrite, orthophosphate, phosphorus, aluminum, iron, strontium-90, and total organic carbon.

  9. [The system of quality management in medical laboratory: the problematic issues of implementation of GOST RKS 9001-2008, GOST R ISO 15189-2009 and GOST R ISO 53079-2008].

    PubMed

    Dolgikh, T I

    2013-04-01

    The article presents the approaches to development and implementation of system of quality management in laboratory as an integral part of the given system in whole medical institution. The costs of works execution concerning quality support are to be weighted with economic profitability and timeliness of medical care provision to ill people considering pre-analytic stage (out-laboratory and in-laboratory) laboratory analysis. Factually it is a matter of development of system of balanced indicators concerning quality management of institution and laboratory functioning. The problematic issues are presented concerning maintenance of particular requirements of GOSTR ISO 15189 about quality of production. The emphasis is made on the necessity of training of administrations of laboratories in the field of quality management and economics of laboratory business.

  10. Echocardiography laboratory accreditation.

    PubMed

    Katanick, S L

    1998-01-01

    In response to the need for standardization and improvement in the quality of echocardiographic laboratories an intersocietal commission has been created. The intent of the accreditation process is designed to recognize laboratories that provide quality services and to be used as an educational tool to improve the overall quality of the laboratory.

  11. Improvement of gamete quality and its short-term storage: an approach for biotechnology in laboratory fish.

    PubMed

    Yasui, G S; Senhorini, J A; Shimoda, E; Pereira-Santos, M; Nakaghi, L S O; Fujimoto, T; Arias-Rodriguez, L; Silva, L A

    2015-03-01

    In fish, in vitro fertilization is an important reproductive tool used as first step for application of others biotechniques as chromosome and embryo manipulation. In this study, we aimed to optimize gamete quality and their short-term storage from the yellowtail tetra Astyanax altiparanae, for future application in laboratory studies. Working with sperm, we evaluated the effects of spawning inducers (carp pituitary gland and Ovopel® [(D-Ala6, Pro9-NEt) - mGnRH+metoclopramide]) and the presence of female on sperm motility. Additionally, we developed new procedures for short-term storage of sperm and oocytes. Briefly, sperm motility was higher when male fish were treated with carp pituitary gland (73.1 ± 4.0%) or Ovopel® (79.5 ± 5.5%) when compared with the control group treated with 0.9% NaCl (55.6 ± 27.2%; P=0.1598). Maintenance of male fish with an ovulating female fish also improved sperm motility (74.4 ± 7.4%) when compared with untreated male fish (42.1 ± 26.1%; P=0.0018). Storage of sperm was optimized in modified Ringer solution, in which the sperm was kept motile for 18 days at 2.5°C. The addition of antibiotics or oxygen decreased sperm motility, but partial change of supernatant and the combination of those conditions improve storage ability of sperm. Fertilization ability of oocytes decreased significantly after storage for 30, 60 90 and 120 min at 5, 10, 15 and 20°C when compared with fresh oocytes (P=0.0471), but considering only the stored samples, the optimum temperature was 15°C. Those data describe new approaches to improve semen quality and gametes short-term storage in yellowtail tetra A. altiparanae and open new possibilities in vitro fertilization.

  12. Clinical and laboratory features, and quality of life assessment in wheat dependent exercise-induced anaphylaxis patients from central China.

    PubMed

    Chen, Hao; Huang, Nan; Li, Wen-Jing; Dong, Xiang; Qi, Shan-Shan; Wang, You-Na; Liu, Guang-Hui; Zhu, Rong-Fei

    2016-06-01

    Wheat dependent exercise-induced anaphylaxis (WDEIA) is a rare but potentially severe food allergy caused by the combination of wheat ingestion and physical exercise. The impact of WDEIA on quality of life (QOL) is unclear. This study characterized the clinical and laboratory features and investigated the QOL in WDEIA patients from Central China. Twenty-eight WDEIA patients were analyzed, and QOL was measured by validated Chinese version Food Allergy Quality of Life Questionnaire-Adult Form (FAQLQ-AF) and Food Allergy Independent Measure (FAIM) after obtaining the diagnosis. The results showed that half of the patients were females. The median onset age was 37 years old. The symptoms occurred within 1 h after wheat ingestion (26/28). Symptoms of anaphylaxis included cutaneous (26/28), respiratory (11/28), gastro-intestinal (5/28) and cardiovascular manifestations (27/28). Skin prick tests were positive to salt soluble (89.3%) and salt insoluble wheat allergen extracts (100%). Positive rate to wheat, gluten and omega-5 gliadin specific IgE was 64.3%, 92.9% and 92.9% respectively. Specific IgE to omega-5 gliadin with a cut-off value 0.83 KU/L offered highly efficient diagnostic criterion for WDEIA (sensitivity: 89.3%; and specificity: 88.9%). The mean scores of FAQLQ-AF and FAIM were 4.70 and 4.98 respectively and level of anti-omega-5 gliadin IgE had positive correlations with FAQLQ scores. Thereby, WDEIA is commonly found in mid-age adults. In most cases, multi-organs especially skin and cardiovascular systems are involved. Salt insoluble wheat allergen skin test and serum specific IgE to gluten and omega-5 gliadin help to diagnose WDEIA. QOL in WDEIA patients is severely impaired.

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

    SciTech Connect

    Williams, L.M.

    1996-06-01

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

  14. Optimization and qualification of capillary zone electrophoresis method for glycoprotein isoform distribution of erythropoietin for quality control laboratory.

    PubMed

    Zhang, Junge; Chakraborty, Utpal; Villalobos, Annabelle P; Brown, John M; Foley, Joe P

    2009-10-15

    The European Pharmacopoeia (Ph. Eur.) monograph for Erythropoietin Concentrated Solution describes a capillary zone electrophoresis method for identification of recombinant human erythropoietin. However, this method has shown poor reproducibility due to inadequate capillary conditioning. We have modified the Ph. Eur. method to make it more robust and suitable for the quality control laboratory for the analysis of epoetin alfa and epoetin alfa after formulation with polysorbate 80. This study qualified the modified method by showing improved robustness and reproducibility. The study also characterized and qualified a secondary standard of epoetin alfa as a substitute for the primary standard, Ph. Eur. erythropoietin Biological Reference Preparation, which is available in limited supply. Four sets of analyses were performed to assess repeatability, intermediate precision, and the secondary standard. The results showed that the modified method is suitable for its intended purpose to test epoetin alfa and formulated epoetin alfa samples. The epoetin alfa secondary standard is a suitable substitute for the primary standard. Further, we developed a procedure for the removal of polysorbate 80 from formulated epoetin alfa, allowing the material to be analyzed by the modified Ph. Eur. method.

  15. Pacific Northwest Laboratory annual report for 1988 to the Assistant Secretary for Environment, Safety, and Health: Part 5, Environment, safety, health, and quality assurance

    SciTech Connect

    Faust, L.G.; Pennell, W.T.; Selby, J.M.

    1989-02-01

    This document summarizes the research programs now underway at Battelle's Pacific Northwest Laboratory in the areas of environmental safety, health, and quality assurance. Topics include internal irradiation, emergency plans, dose equivalents, risk assessment, dose equivalents, surveys, neutron dosimetry, and radiation accidents. (TEM)

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  17. Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE).

    PubMed

    Lippi, Giuseppe; Banfi, Giuseppe; Church, Stephen; Cornes, Michael; De Carli, Gabriella; Grankvist, Kjell; Kristensen, Gunn B; Ibarz, Mercedes; Panteghini, Mauro; Plebani, Mario; Nybo, Mads; Smellie, Stuart; Zaninotto, Martina; Simundic, Ana-Maria

    2015-02-01

    Laboratory diagnostics develop through different phases that span from test ordering (pre-preanalytical phase), collection of diagnostic specimens (preanalytical phase), sample analysis (analytical phase), results reporting (postanalytical phase) and interpretation (post-postanalytical phase). Although laboratory medicine seems less vulnerable than other clinical and diagnostic areas, the chance of errors is not negligible and may adversely impact on quality of testing and patient safety. This article, which continues a biennial tradition of collective papers on preanalytical quality improvement, is aimed to provide further contributions for pursuing quality and harmony in the preanalytical phase, and is a synopsis of lectures of the third European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)-Becton Dickinson (BD) European Conference on Preanalytical Phase meeting entitled 'Preanalytical quality improvement. In pursuit of harmony' (Porto, 20-21 March 2015). The leading topics that will be discussed include unnecessary laboratory testing, management of test request, implementation of the European Union (EU) Directive on needlestick injury prevention, harmonization of fasting requirements for blood sampling, influence of physical activity and medical contrast media on in vitro diagnostic testing, recent evidence about the possible lack of necessity of the order of draw, the best practice for monitoring conditions of time and temperature during sample transportation, along with description of problems emerging from inappropriate sample centrifugation. In the final part, the article includes recent updates about preanalytical quality indicators, the feasibility of an External Quality Assessment Scheme (EQAS) for the preanalytical phase, the results of the 2nd EFLM WG-PRE survey, as well as specific notions about the evidence-based quality management of the preanalytical phase.

  18. Chemical Constituents in Ground Water from 39 Selected Sites with an Evaluation of Associated Quality Assurance Data, Idaho National Engineering and Environmental Laboratory and Vicinity, Idaho

    SciTech Connect

    L. L. Knobel; R. C. Bartholomay; B. J. Tucker; L. M. Williams; L. D. Cecil

    1999-08-01

    This report presents a compilation of water-quality data along with an evaluation of associated quality assurance data collected during 1990-94 from the Snake River Plain aquifer and two springs located in areas that provide recharge to the Snake River Plain aquifer. The data were collected as part of the continuing hydrogeologic investigation at the Idaho National Engineering and Environmental Laboratory (INEEL). This report is the third in a series of four reports and presents data collected to quantitatively assess the natural geochemical system at the INEEL. Ground-water quality data - collected during 1990-94 from 39 locations in the eastern Snake River Plain - are presented.

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

    PubMed

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

    2013-12-01

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

  20. Evolution of an International External Quality Assurance Model To Support Laboratory Investigation of Streptococcus pneumoniae, Developed for the SIREVA Project in Latin America, from 1993 to 2005▿

    PubMed Central

    Lovgren, Marguerite; Talbot, James A.; Brandileone, Maria Cristina; Casagrande, Silvana T.; Agudelo, Clara Inés; Castañeda, Elizabeth; Regueira, Mabel; Corso, Alejandra; Heitmann, Ingrid; Maldonado, Aurora; Echániz-Avilés, Gabriela; Soto-Noguerón, Araceli; Hortal, María; Camou, Teresa; Gabastou, Jean-Marc; Fabio, José Luis Di

    2007-01-01

    In 1993 the Pan American Health Organization initiated a laboratory-based surveillance system, called the SIREVA project, to learn about Streptococcus pneumoniae invasive disease in Latin American children. In 1994, National Laboratories in six countries were trained to perform serotyping and antibiotic susceptibility testing using broth microdilution to determine the MIC for specified antibiotics. An international External Quality Assurance (EQA) program was developed to monitor and support ongoing laboratory performance. The EQA program was coordinated by the National Centre for Streptococcus (NCS), Edmonton, Canada, and included external proficiency testing (EPT) and a validation process requiring regular submission of a sample of isolates from each laboratory to the NCS for verification of the serotype and MIC. In 1999, the EQA program was decentralized to use three of the original laboratories as regional quality control centers to address operational concerns and to accommodate the growth of the laboratory network to more than 20 countries including the Caribbean region. The overall EPT serotyping accuracies for phase I (1993 to 1998) and phase II (1999 to 2005) were 88.0 and 93.8%, respectively; the MIC correlations within ±1 log2 dilution of the expected result were 83.0 and 91.0% and the interpretive category agreements were 89.1 and 95.3%. Overall, the validation process serotyping accuracies for phases I and II were 81.9 and 88.1%, respectively, 80.4 and 90.5% for MIC agreement, and 85.8 and 94.3% for category agreement. These results indicate a high level of testing accuracy in participating National Laboratories and a sustained increase in EQA participation in Latin America and the Caribbean. PMID:17687007

  1. Water-quality characteristics and trends for selected sites at and near the Idaho National Laboratory, Idaho, 1949-2009

    USGS Publications Warehouse

    Bartholomay, Roy C.; Davis, Linda C.; Fisher, Jason C.; Tucker, Betty J.; Raben, Flint A.

    2012-01-01

    The U.S. Geological Survey, in cooperation with the U.S. Department of Energy, analyzed water-quality data collected from 67 aquifer wells and 7 surface-water sites at the Idaho National Laboratory (INL) from 1949 through 2009. The data analyzed included major cations, anions, nutrients, trace elements, and total organic carbon. The analyses were performed to examine water-quality trends that might inform future management decisions about the number of wells to sample at the INL and the type of constituents to monitor. Water-quality trends were determined using (1) the nonparametric Kendall's tau correlation coefficient, p-value, Theil-Sen slope estimator, and summary statistics for uncensored data; and (2) the Kaplan-Meier method for calculating summary statistics, Kendall's tau correlation coefficient, p-value, and Akritas-Theil-Sen slope estimator for robust linear regression for censored data. Statistical analyses for chloride concentrations indicate that groundwater influenced by Big Lost River seepage has decreasing chloride trends or, in some cases, has variable chloride concentration changes that correlate with above-average and below-average periods of recharge. Analyses of trends for chloride in water samples from four sites located along the Big Lost River indicate a decreasing trend or no trend for chloride, and chloride concentrations generally are much lower at these four sites than those in the aquifer. Above-average and below-average periods of recharge also affect concentration trends for sodium, sulfate, nitrate, and a few trace elements in several wells. Analyses of trends for constituents in water from several of the wells that is mostly regionally derived groundwater generally indicate increasing trends for chloride, sodium, sulfate, and nitrate concentrations. These increases are attributed to agricultural or other anthropogenic influences on the aquifer upgradient of the INL. Statistical trends of chemical constituents from several wells near

  2. Environmental Response Laboratory Network (ERLN) Laboratory Requirements

    EPA Pesticide Factsheets

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

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

    USGS Publications Warehouse

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

    1999-01-01

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

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

    USGS Publications Warehouse

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

    2006-01-01

    The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance/quality-control data for the time period addressed in this report were stored in the laboratory's SAS data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality- control samples analyzed from July 1997 through June 1999. Results for the quality-control samples for 18 analytical procedures were evaluated for bias and precision. Control charts indicate that data for eight of the analytical procedures were occasionally biased for either high-concentration and (or) low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, total aluminum, ammonium, calcium, chloride, specific conductance, and sulfate. The data from the potassium and sodium analytical procedures are insufficient for evaluation. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 11 of 13 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. Blank analysis results for chloride showed that 22 percent of blanks did not meet data-quality objectives and results for dissolved organic carbon showed that 31 percent of the blanks did not meet data-quality objectives. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 14 of the 18 analytes. At least 90 percent of the samples met data-quality

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

    USGS Publications Warehouse

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

    2009-01-01

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

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

    PubMed Central

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

    2007-01-01

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

  7. Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory; arsenic speciation in natural-water samples using laboratory and field methods

    USGS Publications Warehouse

    Garbarino, John R.; Bednar, Anthony J.; Burkhardt, Mark R.

    2002-01-01

    Analytical methods for the determination of arsenite [As(III)], arsenate [As(V)], dimethylarsinate (DMA), monomethylarsonate (MMA), and roxarsone in filtered natural-water samples are described. Various analytical methods can be used for the determination, depending on the arsenic species being determined. Arsenic concentration is determined by using inductively coupled plasma-mass spectrometry (ICP-MS) as an arsenic-specific detector for all methods. Laboratory-speciation methods are described that use an ion chromatographic column to separate the arsenic species; the column length, column packing, and mobile phase are dependent on the species of interest. Regardless of the separation technique, the arsenic species are introduced into plasma by eithe rpneumatic nebulization or arsine generation. Analysis times range from 2 to 8 minutes and method detection limits range from 0.1 to 0.6 microgram-arsenic per liter (ug-As/L), 10 to 60 picograms absolute (for a 100-microliter injection), depending on the arsenic species determined and the analytical method used. A field-generation specciation method also is described that uses a strong anion exchange cartridge to separate As(III) from As(V) in the field. As(III) in the eluate and the As(V) in the cartridge extract are determined by direct nebulization ICP-MS. Methylated arsenic species that also are retained on the cartridge will positively bias As(V) results without further laboratory separations. The method detection limit for field speciation is 0.3 ug-As/L. The distribution of arsenic species must be preserved in the field to eliminate changes caused by photochemical oxidation or metal oxyhydroxide precipitation. Preservation techniques, such as refrigeration, the addition of acides, or the additoin of ethylene-diaminetetraacetic acid (EDTA) and the effects of ambient light were tested. Of the preservatives evaluated, EDTA was found to work best with the laboratory- and field-speciation methods for all sample

  8. Impact of Horizontal Approach in Vertical Program: Continuous Quality Improvement of Malaria and Tuberculosis Diagnostic Services at Primary-Level Medical Laboratories in the Context of HIV Care and Treatment Program in Ethiopia

    PubMed Central

    Marinucci, Francesco; Manyazewal, Tsegahun; Paterniti, Antonio D.; Medina-Moreno, Sandra; Wattleworth, Matthew; Hagembe, Juliana; Redfield, Robert R.

    2013-01-01

    The use of standardized tools for continuous quality improvement of laboratory services is crucial to identify service gaps, plan targeted interventions, and prove successes. Laboratory quality improvement tools (LQITs) were developed and applied for 18 months at five health centers and one faith-based hospital laboratories in Southwest Showa Zone in Ethiopia to assess and monitor the quality of malaria and acid-fast bacilli (AFB) microscopy total testing processes. For the six laboratories, baseline malaria microscopy scores were 55%, 42%, 52%, 55%, 54%, and 61%. Similarly, baseline AFB microscopy scores were 49%, 41%, 46%, 58%, 44%, and 70%. On the sixth quarter for the first four laboratories and the fourth quarter for the last two laboratories, malaria microscopy scores were 89%, 88%, 88%, 90%, 88%, and 89%, whereas AFB microscopy scores were 90%, 88%, 89%, 95%, 88%, and 90%. All laboratories scored above 85% for both services at the end of interventions. PMID:23324221

  9. Impact of horizontal approach in vertical program: continuous quality improvement of malaria and tuberculosis diagnostic services at primary-level medical laboratories in the context of HIV care and treatment program in Ethiopia.

    PubMed

    Marinucci, Francesco; Manyazewal, Tsegahun; Paterniti, Antonio D; Medina-Moreno, Sandra; Wattleworth, Matthew; Hagembe, Juliana; Redfield, Robert R

    2013-03-01

    The use of standardized tools for continuous quality improvement of laboratory services is crucial to identify service gaps, plan targeted interventions, and prove successes. Laboratory quality improvement tools (LQITs) were developed and applied for 18 months at five health centers and one faith-based hospital laboratories in Southwest Showa Zone in Ethiopia to assess and monitor the quality of malaria and acid-fast bacilli (AFB) microscopy total testing processes. For the six laboratories, baseline malaria microscopy scores were 55%, 42%, 52%, 55%, 54%, and 61%. Similarly, baseline AFB microscopy scores were 49%, 41%, 46%, 58%, 44%, and 70%. On the sixth quarter for the first four laboratories and the fourth quarter for the last two laboratories, malaria microscopy scores were 89%, 88%, 88%, 90%, 88%, and 89%, whereas AFB microscopy scores were 90%, 88%, 89%, 95%, 88%, and 90%. All laboratories scored above 85% for both services at the end of interventions.

  10. Laboratory testing for von Willebrand's disease: an assessment of current diagnostic practice and efficacy by means of a multi-laboratory survey. RCPA Quality Assurance Program (QAP) in Haematology Haemostasis Scientific Advisory Panel.

    PubMed

    Favaloro, E J; Smith, J; Petinos, P; Hertzberg, M; Koutts, J

    1999-10-01

    We report an evaluation of current laboratory practice for the diagnosis of von Willebrand's disease (VWD) by means of a multilaboratory survey. This assessment was undertaken with the RCPA Quality Assurance Program (QAP) in Haematology, which covers a wide geographic area encompassing Australia, New Zealand and Asia. A total of 25 laboratories actively involved in testing for VWD were selected to participate in a sample testing assessment exercise. Samples comprised 10 plasmas: (i) a normal plasma pool (in duplicate), (ii) this pool diluted to 50% (in duplicate), (iii) a normal individual (X1), (iv) severe Type 1 VWD (X1), (v) Type 2B VWD (x2 unrelated donors), (vi) Type 3 VWD (x1), (vii) Type 2A VWD (x1). Laboratories were asked to perform all tests available to them in order to establish a laboratory diagnosis of VWD, and then to comment on the possibility or otherwise of VWD. Overall findings indicated a wide variation in test practice, in the effectiveness of various test procedures in detecting VWD, and in the ability of various composite test panels to identify type 2 VWD subtypes. Firstly, while all laboratories (n = 25) performed tests for FVIII:C activity, von Willebrand factor 'antigen' (VWF:Ag) and a functional VWF assay [using the ristocetin cofactor assay (VWF:RCo; n = 23) and/or the collagen binding assay (VWF:CBA; n = 12)], only three laboratories carried out VWF:Multimer analysis. Secondly, for the three quantitative VWF assays, 10/25 (40%) laboratories performed all three, whereas 15/25 (60%) performed only two [VWF:Ag and VWF:RCo (n = 13); VWF:Ag and VWF:CBA (n = 2)]. Thirdly, a variety of assay methodologies were evident for VWF:Ag [ELISA, electro-immuno diffusion (EID), latex immuno-assay (LIA), and VIDAS assay] and VWF:RCo (platelet agglutination/'aggregometry' and a 'functional VWF:RCo-alternative' ELISA assay). Between method analysis for the quantitative VWF assays showed that the VWF:RCo yielded the greatest degree of inter-laboratory

  11. Quality assurance plan for the data acquisition and management system for monitoring the fuel oil spill at the Sandia National Laboratories installation in Livermore, California

    SciTech Connect

    Peerenboom, J.P.; Leser, C.C.; Ramsey, G.M.; Widing, M.A.

    1995-04-01

    In February 1975, the accidental puncture of an underground transfer line buried about 4 ft below the ground surface at the SNL installation in Livermore, California, resulted in the release of approximately 225.5 m{sup 3} of No. 2 diesel fuel. This report describes the formal quality assurance plan that will be used for the data acquisition and management system developed to monitor a bioremediation pilot study by Argonne National Laboratory in association with Sandia National Laboratories. The data acquisition and management system will record the site data during the bioremediation effort and assist users in site analysis. The designs of the three major subsystems of this system are described in this report. Quality assurance criteria are defined for the management, performance, and assessment of the system. Finally, the roles and responsibilities for configuration management of this system are defined for the entire life cycle of the project.

  12. Field demonstration of CO2 leakage detection and potential impacts on groundwater quality at Brackenridge Field Laboratory

    NASA Astrophysics Data System (ADS)

    Zou, Y.; Yang, C.; Guzman, N.; Delgado, J.; Mickler, P. J.; Horvoka, S.; Trevino, R.

    2015-12-01

    One concern related to GCS is possible risk of unintended CO2 leakage from the storage formations into overlying potable aquifers on underground sources of drinking water (USDW). Here we present a series of field tests conducted in an alluvial aquifer which is on a river terrace at The University of Texas Brackenridge Field Laboratory. Several shallow groundwater wells were completed to the limestone bedrock at a depth of 6 m and screened in the lower 3 m. Core sediments recovered from the shallow aquifer show that the sediments vary in grain size from clay-rich layers to coarse sandy gravels. Two main types of field tests were conducted at the BFL: single- (or double-) well push-pull test and pulse-like CO2 release test. A single- (or double-) well push-pull test includes three phases: the injection phase, the resting phase and pulling phase. During the injection phase, groundwater pumped from the shallow aquifer was stored in a tank, equilibrated with CO2 gasand then injected into the shallow aquifer to mimic CO2 leakage. During the resting phase, the groundwater charged with CO2 reacted with minerals in the aquifer sediments. During the pulling phase, groundwater was pumped from the injection well and groundwater samples were collected continuously for groundwater chemistry analysis. In such tests, large volume of groundwater which was charged with CO2 can be injected into the shallow aquifer and thus maximize contact of groundwater charged with CO2. Different than a single- (or double-) well push-pull test, a pulse-like CO2 release test for validating chemical sensors for CO2 leakage detection involves a CO2 release phase that CO2 gas was directly bubbled into the testing well and a post monitoring phase that groundwater chemistry was continuously monitored through sensors and/or grounder sampling. Results of the single- (or double-) well push-pull tests conducted in the shallow aquifer shows that the unintended CO2 leakage could lead to dissolution of

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

    USGS Publications Warehouse

    Wegner, S.J.

    1989-01-01

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

  14. Project quality assurance plan for research and development services provided by Oak Ridge National Laboratory in support of the Hanford Grout Disposal Program

    SciTech Connect

    Spence, R.D.; Gilliam, T.M.

    1991-11-01

    This Project Quality Assurance Plan (PQAP) is being published to provide the sponsor with referenceable documentation for work conducted in support of the Hanford WHC Grout Disposal Program. This plan, which meets NQA-1 requirements, is being applied to work performed at Oak Ridge National Laboratory (ORNL) during FY 1991 in support of this program. It should also be noted that with minor revisions, this plan should be applicable to other projects involving research and development that must comply with NQA-1 requirements.

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

    SciTech Connect

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

    1998-10-01

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

  16. Quality-Assurance Data for Routine Water Analyses by the U.S. Geological Survey Laboratory in Troy, New York - July 2003 through June 2005

    USGS Publications Warehouse

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

    2009-01-01

    The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory qualityassurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's Lab Master data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality control samples analyzed from July 2003 through June 2005. Results for the quality-control samples for 20 analytical procedures were evaluated for bias and precision. Control charts indicate that data for five of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, pH, silicon, and sodium. Seven of the analytical procedures were biased throughout the analysis period for the high-concentration sample, but were within control limits; these procedures were: dissolved organic carbon, chloride, nitrate (ion chromatograph), nitrite, silicon, sodium, and sulfate. The calcium and magnesium procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The total aluminum and specific conductance procedures were biased for the highconcentration and low-concentration samples, but were within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 17 of 18 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for dissolved organic

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

    USGS Publications Warehouse

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

    2009-01-01

    The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's Lab Master data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality control samples analyzed from July 2001 through June 2003. Results for the quality-control samples for 19 analytical procedures were evaluated for bias and precision. Control charts indicate that data for six of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, chloride, magnesium, nitrate (ion chromatography), potassium, and sodium. The calcium procedure was biased throughout the analysis period for the high-concentration sample, but was within control limits. The total monomeric aluminum and fluoride procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The total aluminum, pH, specific conductance, and sulfate procedures were biased for the high-concentration and low-concentration samples, but were within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 16 of 18 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for the dissolved organic carbon or specific conductance procedures. Sampling and analysis precision are evaluated

  18. Testing a new version of the DigiBog model to explore the differential response of peatland microforms to shifts in surface wetness

    NASA Astrophysics Data System (ADS)

    Garneau, Michelle; Baird, Andrew J.; Morris, Paul J.; van Bellen, Simon

    2016-04-01

    Over the last decades, many hypotheses have been put forward to explain pool formation in northern peatlands including topographic, biotic or climatic factors. Several studies suggest that pool formation is primarily controlled by autogenic, edaphic and topographic factors rather than external climatic influences (allogenic factors). However, there is still no consensus to explain pool formation and to confirm whether their initiation is primarily associated with autogenic or allogenic processes. Subarctic fens in northeastern Canada are characterized by a patterned surface of pools, flarks and narrow strings. Due to their geographic location at the northern ombrotrophic peatland distribution, these poor fens have been highly sensitive to hydroclimatic variations that influenced pool development and expansion. Our data indicate that wet hollows or shallow pools developed at minimal ages between ca 4200 cal BP and ca 2500 cal BP. We hypothesize that pool developed as secondary features under wetter and cooler conditions that (i) caused shorter growing seasons which negatively impacted on peat accumulation and (ii) led to lower rates of evaporation, and that (i) and (ii) in combination led to increased surface wetness. The differential response of microforms to shifts in surface wetness show the complexity of processes involved in pool initiation. A recent version of the DigiBog model (Morris et al, 2015), that allows for sub-seasonal variations in precipitation and evaporation, is used to explore the interactions between climate, growing season, peat productivity, peat hydraulic properties and water-table behaviour. Model results suggest that decreases in growing season length, combined with decreases in evapotranspiration, can explain long-lived shifts to wetter conditions in peatlands. If evapotranspiration is reduced but growing season does not vary, long-lived shifts in peatland wetness are less likely and the peatland instead tends to show a homeostatic

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

    USGS Publications Warehouse

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

    2006-01-01

    The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's LabMaster data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality-control samples analyzed from July 1999 through June 2001. Results for the quality-control samples for 18 analytical procedures were evaluated for bias and precision. Control charts indicate that data for eight of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, total aluminum, calcium, chloride and nitrate (ion chromatography and colormetric method) and sulfate. The total aluminum and dissolved organic carbon procedures were biased throughout the analysis period for the high-concentration sample, but were within control limits. The calcium and specific conductance procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The magnesium procedure was biased for the high-concentration and low concentration samples, but was within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 14 of 15 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for dissolved organic carbon. Sampling and analysis precision are

  20. Superfund Contract Laboratory Program

    EPA Pesticide Factsheets

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

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

    PubMed

    Zenina, L P; Godkov, M A

    2013-08-01

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

  2. Evaluation of well-purging effects on water-quality results for samples collected from the eastern Snake River Plain aquifer underlying the Idaho National Laboratory, Idaho

    USGS Publications Warehouse

    Knobel, LeRoy L.

    2006-01-01

    This report presents qualitative and quantitative comparisons of water-quality data from the Idaho National Laboratory, Idaho, to determine if the change from purging three wellbore volumes to one wellbore volume has a discernible effect on the comparability of the data. Historical water-quality data for 30 wells were visually compared to water-quality data collected after purging only 1 wellbore volume from the same wells. Of the 322 qualitatively examined constituent plots, 97.5 percent met 1 or more of the criteria established for determining data comparability. A simple statistical equation to determine if water-quality data collected from 28 wells at the INL with long purge times (after pumping 1 and 3 wellbore volumes of water) were statistically the same at the 95-percent confidence level indicated that 97.9 percent of 379 constituent pairs were equivalent. Comparability of water-quality data determined from both the qualitative (97.5 percent comparable) and quantitative (97.9 percent comparable) evaluations after purging 1 and 3 wellbore volumes of water indicates that the change from purging 3 to 1 wellbore volumes had no discernible effect on comparability of water-quality data at the INL. However, the qualitative evaluation was limited because only October-November 2003 data were available for comparison to historical data. This report was prepared by the U.S. Geological Survey in cooperation with the U.S. Department of Energy.

  3. Bringing measurement and management science to the cath laboratory: the National Cardiovascular Data Registry (ACC-NCDR) and the Cardiac Catheterization Laboratory Continuous Quality Improvement Toolkit (ACC-CathKIT).

    PubMed

    Dehmer, Gregory J; Elma, MaryAnne; Hewitt, Kathleen; Brindis, Ralph G

    2004-01-01

    Diagnostic cardiac catheterization and percutaneous coronary interventions are widely performed for the evaluation and treatment of patients with cardiac disease. Because of high utilization, cost, and complication rates, invasive cardiac procedures are closely monitored and frequently measured using national benchmark databases and public reports. Before decision makers can accept these data and reports as accurate, it is necessary that the measurement process be performed correctly. However, collecting and measuring data is only the first step and does not automatically lead to improvements in quality. For an improvement to occur, a continuous quality improvement effort must exist to transform data into improved outcomes for patients. Recognizing the need to supply healthcare providers with methods and standards for measurement reporting and tools to assist facilities in the development of effective continuous quality improvement efforts, the American College of Cardiology developed the National Cardiovascular Data Registry (ACC-NCDR). Subsequently, the American College of Cardiology Foundation, in cooperation with the Society for Cardiovascular Angiography and Interventions, the American College of Cardiovascular Administrators, and several other professional organizations, developed the ACC-Cardiac Catheterization Laboratory Continuous Quality Improvement Toolkit (ACC-CathKIT). The development and usefulness of these products is described in this paper.

  4. Comparison of laboratory and field bioassays of lab-reared Cydia pomonella (Lepidoptera: Tortricidae) quality and field performance.

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Maximum production and fitness of insect species that are mass-reared for biological control programs such as the sterile insect technique (SIT) have benefitted from the employment of quality control and quality management. With a growing interest in the use of SIT as a tactic for the suppression/e...

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  6. Optimizing the culture environment in the IVF laboratory: impact of pH and buffer capacity on gamete and embryo quality.

    PubMed

    Swain, Jason E

    2010-07-01

    Supplying and maintaining appropriate culture conditions is critical to minimize stress imposed upon gametes and embryos and to optimize the in-vitro environment. One parameter that requires close scrutiny in this endeavour is pH. Though embryos have a limited ability to regulate their internal pH (pH(i)), oocytes lack robust mechanisms. Thus, careful attention to external pH (pH(e)) of culture media is imperative in IVF. Ability to withstand deviations in hydrogen ion concentration varies depending on culture conditions, as well as laboratory procedures. Cryopreserved--thaw--thawed embryos, as well as denuded oocytes, are especially susceptible to perturbations in pH(e). Therefore, proper setting, monitoring and stabilizing of pH(e) during IVF laboratory procedures is a crucial component of a rigorous quality control programme. Here, importance of both pH(i) and pH(e) in respect to gamete and embryo quality are discussed. Furthermore, factors influencing selection of pH(e), as well as emerging methods to stabilize pH(e) in the IVF laboratory are detailed.

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

    PubMed

    Tsiamyrtzis, Panagiotis; Sobas, Frédéric; Négrier, Claude

    2015-07-01

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

  8. Evaluation of a quality assurance program for quantitation of human immunodeficiency virus type 1 RNA in plasma by the AIDS Clinical Trials Group virology laboratories.

    PubMed

    Yen-Lieberman, B; Brambilla, D; Jackson, B; Bremer, J; Coombs, R; Cronin, M; Herman, S; Katzenstein, D; Leung, S; Lin, H J; Palumbo, P; Rasheed, S; Todd, J; Vahey, M; Reichelderfer, P

    1996-11-01

    A number of quantitative assays have been developed by using amplification techniques to measure human immunodeficiency virus type 1 RNA in the plasma of infected individuals. The Virology Committee of the AIDS Clinical Trials Group in the Division of AIDS, National Institute of Allergy and Infectious Diseases, has established a quality assurance program (QAP) for quantitative assays of HIV-1 RNA levels in plasma. The primary objective of the QAP was to ascertain that a laboratory could maintain the precision required to have a 90% power to detect a fivefold difference in RNA copy number between two samples in the same batch. To achieve this goal, the QAP required an intra-assay standard deviation of no greater than 0.15 log10 RNA copies per ml. Panels for proficiency testing consisted of coded replicate samples and a common set of standards. To date, 41 laboratories have participated in the program and have used both commercial and in-house assays. We demonstrated that 65% of the laboratories were capable of attaining the necessary level of intra-assay precision. The fitted regressions indicated that the differences among laboratories that used the same kit were generally greater than the differences among population-average regressions for the kits themselves. The use of an external QAP and a common set of standards reduced differences both among laboratories that used the same kit and among laboratories that used different kits. Thus, use of a common set of standards across clinical trial protocols would allow for cross-protocol comparisons.

  9. Environmental laboratory design

    SciTech Connect

    Newill, R.F.

    1996-11-01

    An effective, efficient laboratory building, operating at a reasonable cost within performance parameters set by the owner, determines quality control, employee morale and retention, operating costs, maintenance costs and renovation costs for the next thirty years. For better or worse, a new laboratory is managerial policy cast in stone. This paper, based on the author`s environmental laboratory design experience, offers an understanding of the relationship between costs, flexibility, function and quality in environmental laboratory design and construction. The comments are generally structured around publicly owned laboratories, with notes regarding private laboratories where appropriate.

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  11. A rapid amphipod reproduction test for sediment quality assessment: In situ bioassays do not replicate laboratory bioassays.

    PubMed

    Mann, Reinier M; Hyne, Ross V; Simandjuntak, Desiree L; Simpson, Stuart L

    2010-11-01

    An underlying assumption of laboratory-based toxicity tests is that the sensitivity and exposure of organisms in the laboratory is comparable to that in the field. We sought to make a comparison between field-based and laboratory-based sediment toxicity tests using a recently developed rapid amphipod reproduction test that encompasses gametogenesis, fertilization, and embryo development before hatching. The test species, Melita plumulosa, is an epibenthic, detritivorous amphipod native to Eastern Australia. Test sediments were sourced from Lake Macquarie, a large saltwater lagoon located 100 km north of Sydney (New South Wales, Australia) that has received heavy-metal pollution over many decades, primarily from a Pb/Zn smelter but also from collieries, coal-fired power stations, and urban areas. This has led to a north-south trace-metal concentration gradient, including Pb, Zn, Cd and Cu, in the sediments of Lake Macquarie. Sediments from these northern bays were demonstrated to reduce amphipod fecundity in laboratory-based tests. For the current study, the amphipod reproduction test has been modified for use in situ. In situ test chambers were deployed at the mouth of Cockle Creek, Lake Macquarie. Sediments that were demonstrated to reduce fecundity of M. plumulosa in the laboratory reproduction test were not similarly toxic when amphipods were exposed to the same sediments in situ. Factors related to the regular tidal renewal of overlying water likely altered exposure profiles in situ, including the provision of additional or alternative nutrition that obviated the need for amphipods to interact with the contaminated sediments, and a washout effect that prevented the accretion of dissolved zinc in the overlying water.

  12. Innovation expedition. As the CMS gears up its new laboratory for payment and quality control, excitement is mixed with anxiety.

    PubMed

    McKinney, Maureen

    2010-06-14

    As the CMS prepares to launch its center for innovation, there's both excitement and apprehension. The center holds the promise of crafting bold improvements for payment systems and quality of care. "As long as there is the promise of long-term cost savings and quality improvement, they have the authority to say, 'We found something that works and we want to do it more broadly,' "says Stuart Guterman, left, of the Commonwealth Fund.

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

    USGS Publications Warehouse

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

    1996-01-01

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

  14. [EXTERNAL QUALITY ASSESSMENT FOR THE LABORATORY IDENTIFICATION OF THE PATHOGENS OF PARASITIC DISEASES AS AN ELEMENT FOR IMPROVING THE POSTGRADUATE TRAINING OF SPECIALISTS].

    PubMed

    Dovgalev, A S; Astanina, S Yu; Malakhov, V N; Serdyuk, A P; Imamkuliev, K D; Gorbunova, Yu P; Pautova, E A; Prodeus, T V; Semenova, T A; Fedyanina, L V

    2016-01-01

    Within the framework of the Federal External Quality Assessment (EQA) System and in the context of postgraduate training improvement for health workers in 2010-2014, specialists from the laboratories of the therapeutic-prophylactic organizations and institutions of the Russian Federal Service for Supervision of Consumer Rights Protection and Human Welfare were examined for their professional competence in microscopically identifying the pathogens of parasitic diseases in feces. The virtual remote educational computer technology tools that included different combinations of 16 helminthic species, 5 intestinal protozoan species, and a number of artefacts, were used. The specialists from 984 laboratories of multidisciplinary therapeutic-prophylactic organizations and hygiene and epidemiology centers in all Federal Districts of the Russian Federation were covered. A total of 8245 replies were analyzed. The detection rate for helminths was 64.0%, including those by a taxonomic group (nematodes, 65.0%; cestodes, 72.0%; trematodes, 55.1%). There was a dynamic decrease in the above indicators. There were low detection rates for trematodes parasitizing the small intestine (Metagonimus, 10.2%; Nanophyetus, 26.2%) and hepatobiliary organs (Fasciola, 59.6%; Clonorchis, 34.9%). The similar trend was seen in the detection rates for the pathogens of geohelminthisms (ascariasis, trichocephaliasis, etc.) and contagious helminthisms (enterobiasis, hymenolepiasis). The level of competence in detecting and identifying intestinal protozoa was much lower than the similar rates for helminthism pathogens. EQA for the laboratory diagnosis of the pathogens of parasitic diseases, by using the virtual tools is a leading element of the postgraduate training system for laboratory specialists. The results of EQA for the laboratory diagnosis of the pathogens of parasitic diseases are a basic material for the development, and improvement of training modernization programs, by applying a modular

  15. Groundwater quality sampling and analysis plan for environmental monitoring in Waste Area Grouping 6 at Oak Ridge National Laboratory, Oak Ridge, Tennessee

    SciTech Connect

    Not Available

    1994-03-01

    This Sampling and Analysis Plan addresses groundwater quality sampling and analysis activities that will be conducted in support of the Environmental Monitoring Plan for Waste Area Grouping (WAG) 6. WAG 6 is a shallow-burial land disposal facility for low-level radioactive waste at the Oak Ridge National Laboratory, a research facility owned by the US Department of energy and managed by martin Marietta Energy Systems, Inc. (Energy Systems). Groundwater sampling will be conducted by Energy Systems at 45 wells within WAG 6. The samples will be analyzed for various organic, inorganic, and radiological parameters. The information derived from the groundwater quality monitoring, sampling, and analysis will aid in evaluating relative risk associated with contaminants migrating off-WAG, and also will fulfill Resource Conservation and Recovery Act (RCRA) interim permit monitoring requirements. The sampling steps described in this plan are consistent with the steps that have previously been followed by Energy Systems when conducting RCRA sampling.

  16. Sandia National Laboratories Advanced Simulation and Computing (ASC) : appraisal method for the implementation of the ASC software quality engineering practices: Version 1.0.

    SciTech Connect

    Turgeon, Jennifer; Minana, Molly A.

    2008-02-01

    This document provides a guide to the process of conducting software appraisals under the Sandia National Laboratories (SNL) ASC Program. The goal of this document is to describe a common methodology for planning, conducting, and reporting results of software appraisals thereby enabling: development of an objective baseline on implementation of the software quality engineering (SQE) practices identified in the ASC Software Quality Plan across the ASC Program; feedback from project teams on SQE opportunities for improvement; identification of strengths and opportunities for improvement for individual project teams; guidance to the ASC Program on the focus of future SQE activities Document contents include process descriptions, templates to promote consistent conduct of appraisals, and an explanation of the relationship of this procedure to the SNL ASC software program.

  17. Groundwater Quality Sampling and Analysis Plan for Environmental Monitoring Waste Area Grouping 6 at Oak Ridge National Laboratory. Environmental Restoration Program

    SciTech Connect

    1995-09-01

    This Sampling and Analysis Plan addresses groundwater quality sampling and analysis activities that will be conducted in support of the Environmental Monitoring Plan for Waste Area Grouping (WAG) 6. WAG 6 is a shallow-burial land disposal facility for low-level radioactive waste at the Oak Ridge National Laboratory, a research facility owned by the US Department of Energy and managed by Martin Marietta Energy Systems, Inc. (Energy Systems). Groundwater sampling will be conducted by Energy Systems at 45 wells within WAG 6. The samples will be analyzed for various organic, inorganic, and radiological parameters. The information derived from the groundwater quality monitoring, sampling, and analysis will aid in evaluating relative risk associated with contaminants migrating off-WAG, and also will fulfill Resource Conservation and Recovery Act (RCRA) interim permit monitoring requirements. The sampling steps described in this plan are consistent with the steps that have previously been followed by Energy Systems when conducting RCRA sampling.

  18. Usefulness of EC4 essential criteria for quality systems of medical laboratories as guideline to the ISO 15189 and ISO 17025 documents. European Community Confederation of Clinical Chemistry (EC4) Working Group on Harmonisation of Quality Systems and Accreditation.

    PubMed

    Jansen, R T; Kenny, D; Blaton, V; Burnett, D; Huisman, W; Plebani, M; Queraltó, J M; Zérah, S; van Lieshout, J

    2000-10-01

    Many medical laboratories have made a start with the introduction of quality management systems. However, it is still not clear against which standards such systems should be measured. The existing ISO and CEN standards do not cover essential aspects of medical laboratories. The publication of the EC4 Essential Criteria has stimulated the development of the ISO/Draft International Standard 15189. This standard seems adequate for our type of laboratories. However, it is not easy to read. The EC4 Essential Criteria could well serve as a guide, covering additional aspects, e.g. on total quality management and budget management as required in the EFQM model, that are not (yet) included in the ISO standard. In the present article the EC4 Essential Criteria are cross-referenced with two new international ISO standards, ISO/FDIS 15189 and ISO/FDIS 17025, the latter being the successor of ISO guide 25 and EN 45000. Both new ISO documents are in compliance with the new ISO 9000:2000 standard.

  19. MPEG-2 Over Asynchronous Transfer Mode (ATM) Over Satellite Quality of Service (QoS) Experiments: Laboratory Tests

    NASA Technical Reports Server (NTRS)

    Ivancic, William D.; Frantz, Brian D.; Spells, Marcus J.

    1998-01-01

    Asynchronous transfer mode (ATM) quality of service (QoS) experiments were performed using MPEG-2 (ATM application layer 5, AAL5) over ATM over an emulated satellite link. The purpose of these experiments was to determine the free-space link quality necessary to transmit high-quality multimedia information by using the ATM protocol. The detailed test plan and test configuration are described herein as are the test results. MPEG-2 transport streams were baselined in an errored environment, followed by a series of tests using, MPEG-2 over ATM. Errors were created both digitally as well as in an IF link by using a satellite modem and commercial gaussian noise test set for two different MPEG-2 decoder implementations. The results show that ITU-T Recommendation 1.356 Class 1, stringent ATM applications will require better link quality than currently specified; in particular, cell loss ratios of better than 1.0 x 10(exp -8) and cell error ratios of better than 1.0 x 10(exp -7) are needed. These tests were conducted at the NASA Lewis Research Center in support of satellite-ATM interoperability research.

  20. A safe inexpensive method to isolate high quality plant and fungal DNA in an open laboratory environment

    Technology Transfer Automated Retrieval System (TEKTRAN)

    A simple, economical and rapid phenol/chloroform free protocol to obtain high quality DNA from plant and fungal samples is described in this report. Potassium ions are used to precipitate protein and other cellar molecules in SDS extraction buffer. Purified DNA is achieved using a low salt CTAB trea...

  1. Quality Assurance Project Plan for the treatability study of in situ vitrification of Seepage Pit 1 in Waste Area Grouping 7 at Oak Ridge National Laboratory

    SciTech Connect

    1995-07-01

    This Quality Assurance Project Plan (QAPjP) establishes the quality assurance procedures and requirements to be implemented for the control of quality-related activities for Phase 3 of the Treatability Study (TS) of In Situ Vitrification (ISV) of Seepage Pit 1, ORNL Waste Area Grouping 7. This QAPjP supplements the Quality Assurance Plan for Oak Ridge National Laboratory Environmental Restoration Program by providing information specific to the ISV-TS. Phase 3 of the TS involves the actual ISV melt operations and posttest monitoring of Pit 1 and vicinity. Previously, Phase 1 activities were completed, which involved determining the boundaries of Pit 1, using driven rods and pipes and mapping the distribution of radioactivity using logging tools within the pipes. Phase 2 involved sampling the contents, both liquid and solids, in and around seepage Pit 1 to determine their chemical and radionuclide composition and the spatial distribution of these attributes. A separate QAPjP was developed for each phase of the project. A readiness review of the Phase 3 activities presented QAPjP will be conducted prior to initiating field activities, and an Operational Acceptance, Test (OAT) will also be conducted with no contamination involved. After, the OAT is complete, the ISV process will be restarted, and the melt will be allowed to increase with depth and incorporate the radionuclide contamination at the bottom of Pit 1. Upon completion of melt 1, the equipment will be shut down and mobilized to an adjacent location at which melt 2 will commence.

  2. Examination of specimens for mycobacteria in clinical laboratories in 21 countries: a 10-year review of the UK National Quality Assessment Scheme for Mycobacteria Culture.

    PubMed

    Walton, C; Hawkey, P M; James, V L A

    2005-12-01

    Results from clinical diagnostic microbiology laboratories taking part in the UK National Quality Assessment Service (UK NEQAS) scheme for Mycobacteria Culture between 1993 and 2003 were evaluated and assessed to determine whether the perceived increase in the use of rapid methods is improving time-to-positive reporting of results. Four simulated sputum specimens containing mycobacteria in mixed cultures with normal commensal organisms were distributed three times a year. Participating laboratories were required to report on the presence of 'mycobacteria' and on the time required to obtain a positive result. The overall level of performance with the mycobacteria culture external quality assessment specimens remained consistently high, with an average success rate of 94% over 10 years. The mean time-to-positive decreased from 24 to 17 days during the previous 8 years. A survey questionnaire, circulated in 2002, addressed the use of continuous automated mycobacterial liquid culture (CAMLiC) and molecular methods. The increase in the use of rapid culture methods for the detection of Mycobacterium tuberculosis has resulted in an overall reduction in time-to-positive data reported by participants, and has provided an indication of participants' ability to meet the 21-day target recommended by the CDC for the detection and identification of M. tuberculosis.

  3. Quality of laboratory studies assessing effects of Bt-proteins on non-target organisms: minimal criteria for acceptability.

    PubMed

    De Schrijver, Adinda; Devos, Yann; De Clercq, Patrick; Gathmann, Achim; Romeis, Jörg

    2016-08-01

    The potential risks that genetically modified plants may pose to non-target organisms and the ecosystem services they contribute to are assessed as part of pre-market risk assessments. This paper reviews the early tier studies testing the hypothesis whether exposure to plant-produced Cry34/35Ab1 proteins as a result of cultivation of maize 59122 is harmful to valued non-target organisms, in particular Arthropoda and Annelida. The available studies were assessed for their scientific quality by considering a set of criteria determining their relevance and reliability. As a case-study, this exercise revealed that when not all quality criteria are met, weighing the robustness of the study and its relevance for risk assessment is not obvious. Applying a worst-case expected environmental concentration of bioactive toxins equivalent to that present in the transgenic crop, confirming exposure of the test species to the test substance, and the use of a negative control were identified as minimum criteria to be met to guarantee sufficiently reliable data. This exercise stresses the importance of conducting studies meeting certain quality standards as this minimises the probability of erroneous or inconclusive results and increases confidence in the results and adds certainty to the conclusions drawn.

  4. Quality Assurance Plan for the remedial investigation of Waste Area Grouping 2 at Oak Ridge National Laboratory, Oak Ridge, Tennessee

    SciTech Connect

    Atwood, G.P.; Miller, D.E. )

    1992-12-01

    The Oak Ridge National Laboratory (ORNL) Waste Area Grouping (WAG) 2 Site Investigation (SI)includes the lower portion of the White Oak Creek (WOC) drainage and enbayment, and associated floodplain and subsurface environment. The ORNL main plant and the major waste storage and disposal facilities at ORNL are located in the WOC watershed and are drained by the WOC system to the Clinch River, located off-site. Environmental media are contaminated and continue to receive contaminants from hydrologically upgradient WAGS. WAG 2 is important as a conduit from upgradient areas to the Clinch River. The general objectives of the WAG 2 SI Project are to conduct a multimedia monitoring and characterization program to define and monitor the input of contaminants from adjacent WAGS, monitor and gather sufficient information for processes controlling or driving contaminant fluxes to construct an appropriate conceptual model for WAG 2, and prepare for the eventual remediation of WAG 2.

  5. The quality of impressions for crowns and bridges: an assessment of the work received at three commercial dental laboratories. assessing qualities of impressions that may lead to occlusal discrepancies with indirect restorations.

    PubMed

    Storey, D; Coward, T J

    2014-03-01

    There are few published studies that directly assess the quality of impressions for crowns and bridges in the UK. This paper considers aspects of impression quality with particular attention to factors causing potential occlusal discrepancies in the final restoration. To this end three dental laboratories were visited over a 3-month period. All impressions for conventional crown and bridgework that arrived on the days of the visits were examined and assessed against criteria defined on a custom-designed assessment form. A total of 206 impression cases were considered in this study. Flexible impression trays were used for 65% of working impressions. Their use was more common for NHS work than for private work. 31.9% of all alginate impressions examined were not adequately fixed to the tray. Visible contamination of impressions was not uncommon.

  6. Laboratory accreditation

    SciTech Connect

    Pettit, R.B.

    1998-08-01

    Accreditation can offer many benefits to a testing or calibration laboratory, including increased marketability of services, reduced number of outside assessments, and improved quality of services. Compared to ISO 9000 registration, the accreditation process includes a review of the entire quality system, but in addition a review of testing or calibration procedures by a technical expert and participation in proficiency testing in the areas of accreditation. Within the DOE, several facilities have recently become accredited in the area of calibration, including Sandia National Laboratories, Oak Ridge, AlliedSignal FM and T; Lockheed Martin Idaho Technologies Co., and Pacific Northwest National Lab. At the national level, a new non-profit organization was recently formed called the National Cooperation for Laboratory Accreditation (NACLA). The goal of NACLA is to develop procedures, following national and international requirements, for the recognition of competent accreditation bodies in the US. NACLA is a voluntary partnership between the public and private sectors with the goal of a test or calibration performed once and accepted world wide. The NACLA accreditation body recognition process is based on the requirements of ISO Guide 25 and Guide 58. A membership drive will begin some time this fall to solicit organizational members and an election of a permanent NACLA Board of Directors will follow later this year or early 1999.

  7. Quality of mass-reared codling moth (Lepidoptera: Tortricidae) after long-distance transportation: 1. Logistics of shipping procedures and quality parameters as measured in the laboratory.

    PubMed

    Blomefield, T; Carpenter, J E; Vreysen, M J B

    2011-06-01

    The sterile insect technique (SIT) is a proven effective control tactic against lepidopteran pests when applied in an areawide integrated pest management program. The construction of insect mass-rearing facilities requires considerable investment and moth control strategies that include the use of sterile insects could be made more cost-effective through the importation of sterile moths produced in other production centers. For codling moth, Cydia pomonella (L.) (Lepidoptera: Tortricidae), this is an attractive option because mating studies have confirmed the absence of mating barriers between codling moth populations from geographically different areas. To assess the feasibility of long-distance transportation of codling moths, pupae and adult moths were transported in 2004 from Canada to South Africa in four shipments by using normal commercial transport routes. The total transport time remained below 67 h in three of the consignments, but it was 89 h in the fourth consignment. Temperature in the shipping boxes was fairly constant and remained between -0.61 and 0.16 degrees C for 76.8-85.7% of the time. The data presented indicate that transporting codling moths as adults and pupae from Canada to South Africa had little effect on moth emergence, longevity, and ability to mate, as assessed in the laboratory. These results provide support to the suggestion that the STT for codling moth in pome fruit production areas might be evaluated and implemented by the importation of irradiated moths from rearing facilities in a different country or hemisphere.

  8. Automated damage test facilities for materials development and production optic quality assurance at Lawrence Livermore National Laboratory

    SciTech Connect

    Battersby, C; Dickson, R; Jennings, R; Kimmons, J; Kozlowski, M R; Maricle, S; Mouser, R; Runkel, M; Schwartz, S; Sheehan, L M; Weinzapfel, C

    1998-12-22

    The Laser Program at LLNL has developed automated facilities for damage testing optics up to 1 meter in diameter. The systems were developed to characterize the statistical distribution of localized damage performance across large-aperture National Ignition Facility optics. Full aperture testing is a key component of the quality assurance program for several of the optical components. The primary damage testing methods used are R:1 mapping and raster scanning. Automation of these test methods was required to meet the optics manufacturing schedule. The automated activities include control and diagnosis of the damage-test laser beam as well as detection and characterization of damage events.

  9. Groundwater quality monitoring well installation for Waste Area Grouping at Oak Ridge National Laboratory, Oak Ridge, Tennessee. Environmental Restoration Program

    SciTech Connect

    Mortimore, J.A.; Lee, T.A.

    1994-09-01

    This report documents the drilling and installation of 18 groundwater quality monitoring (GQM) wells on the perimeter of Waste Area Grouping (WAG) 11. WAG 11 (White Wing Scrap Yard) is located on the west end of East Fork Ridge between White Wing Road and the Oak Ridge Turnpike. The scrap yard is approximately 25 acres in size. The wells at WAG 11 were drilled and developed between January 1990 and October 1990. These wells were installed to characterize and assess the WAG in accordance with applicable Department of Energy, state, and Environmental Protection Agency regulatory requirements. The wells at WAG 11 were drilled with auger or air rotary rigs. Depending on the hydrogeologic conditions present at each proposed well location, one of four basic installation methods was utilized. Detailed procedures for well construction were specified by the Engineering Division to ensure that the wells would provide water samples representative of the aquifer. To ensure conformance with the specifications, Energy Systems Construction Engineering and ERCE provided continuous oversight of field activities. The purpose of the well installation program was to install GQM wells for groundwater characterization at WAG 11. Data packages produced during installation activities by the ERCE hydrogeologists are an important product of the program. These packages document the well drilling, installation, and development activities and provide valuable data for well sampling and WAG characterization. The forms contained in the packages include predrilling and postdrilling checklists, drilling and construction logs, development and hydraulic conductivity records, and quality control-related documents.

  10. Groundwater quality monitoring well installation for Upper Waste Areas Grouping 2 at Oak Ridge National Laboratory, Oak Ridge, Tennessee

    SciTech Connect

    Mortimore, J.A.; Lee, T.A.

    1994-09-01

    This report documents the drilling and installation of seven groundwater quality monitoring (GQM) wells on the perimeter of Upper Waste Area Grouping (WAG) 2. Upper WAG 2 is composed of portions of White Oak Creek (WOC), Melton Branch, two of Melton Branch`s tributaries, and the floodplains surrounding these water bodies. The WOC section of the subject site begins at the confluence of WOC and Melton Branch and extends 0.62 mile upstream to the 7,500 bridge. The Melton Branch portion of the site also begins at the confluence of WOC and Melton Branch and extends eastward 0.88 mile upstream. The wells at Upper WAG 2 were drilled and developed between December 1989 and October 1990. These wells were installed to characterize and assess the WAG in accordance with applicable Department of Energy, state, and Environmental Protection Agency regulatory requirements. The purpose of the well installation program was to install GQM wells for groundwater characterization at Upper WAG-2. Data packages produced during installation activities by the ERCE hydrogeologists are an important product of the program. These packages document the well drilling, installation, and development activities and provide valuable data for well sampling and WAG characterization. The forms contained in the packages include predrilling and postdrilling checklists, drilling and construction logs, development and hydraulic conductivity records, and quality control-related documents.

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

    USGS Publications Warehouse

    Rattray, Gordon W.

    2014-01-01

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

  12. Sleep laboratory studies in restless legs syndrome patients as compared with normals and acute effects of ropinirole. 1. Findings on objective and subjective sleep and awakening quality.

    PubMed

    Saletu, B; Gruber, G; Saletu, M; Brandstätter, N; Hauer, C; Prause, W; Ritter, K; Saletu-Zyhlarz, G

    2000-01-01

    Although the restless legs syndrome (RLS) is a disorder with a relatively high prevalence rate (8% in Austria) and leads to insomnia and excessive daytime tiredness, there is a paucity of sleep laboratory data concerning objective and subjective sleep and awakening quality. Thus, the aim of this study was to investigate 12 untreated RLS patients as compared with 12 normal controls and subsequently measure the acute effects of 0.5 mg ropinirole (Requip((R))) - a nonergoline dopamine agonist - as compared with placebo. In 3 nights (adaptation, placebo, ropinirole night) sleep induction, maintenance and architecture were measured objectively by polysomnography, subjective sleep and awakening quality were assessed by self-rating scales and visual-analog scales, and objective awakening quality was evaluated by a psychometric test battery. In polysomnography, RLS patients demonstrated, as compared with normal controls, a decreased total sleep time (TST) and sleep efficacy, increased wakefulness during the total sleep period and frequency of nocturnal awakenings, increased sleep stage S1, decreased S2 and increased stage shifts. Subjective sleep quality tended to decrease, and morning well-being, mood, affectivity and wakefulness were deteriorated. In the noopsyche, fine motor activity and reaction time performance were deteriorated. Ropinirole 0.5 mg induced, as compared with placebo, an increase in TST, sleep efficacy, S2 sleep and stage shifts. In the morning, somatic complaints increased slightly, while fine motor activity and reaction time performance improved. Our findings suggest a key-lock principle in the diagnosis/treatment of RLS and a dopaminergic mechanism in its pathogenesis, which is supported by the data on periodic leg movements during sleep and arousals of the subsequent paper.

  13. Specific application for Oak Ridge National Laboratory dismantlement of Building 3004. Appendix A -- Quality assurance plan; Appendix B -- Records management plan

    SciTech Connect

    1997-03-01

    This quality assurance (QA) plan defines the QA requirements for the dismantlement and removal of Building 3004 at Oak Ridge National Laboratory (ORNL). The building is a four-story wooden trained structure with wooden siding, which resides approximately 150 ft west of the Bulk Shielding Reactor, and only several feet away from the visitors entrance to the Graphite Reactor museum. Complete descriptions and sketches are in the Performance Specification document for this project. This project is being conducted as a non-CERCLA maintenance action. This plan is an appendix to the QA plan for the ORNL Environmental Restoration (ER) Program. ORNL/ER-225, which is the source of the project QA requirements, tailors those QA requirements to the specific needs of this project as defined in ORNL/ER-225. Project-specific description and organization are also provided in this plan. Appendix B, Records Management Plan, is included.

  14. Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory : determination of nonpurgeable suspended organic carbon by wet-chemical oxidation and infrared spectrometry

    USGS Publications Warehouse

    Burkhardt, Mark R.; Kammer, James A.; Jha, Virendra K.; O'Mara-Lopez, Peggy G.; Woodworth, Mark T.

    1997-01-01

    Precision and accuracy results are described for the determination of nonpurgeable suspended organic carbon (SOC) by silver-filter filtration, wet-chemical oxidation, and infrared determination of hte resulting carbon dioxide (CO2) used at the U.S. Geological Survey's nationalWater Quality Laboratory. An aliquot of raw water isfiltered through a 0.45-micrometer silver filter. The trapped organic material is oxidized using phosphoric acid and potassium persulfate in a scaled glass ampule,and the rseulting CO2 is measured by an infrared CO2 detector. The amount of CO3 is proportional to the concentration of chemically oxidizable nonpurgeable organic carbon in the sample. The SOC method detection limit for routine analysis is 0.2 milligram per liter. The average percent recovery is 97.1 percent and the average standard deviation is 11 percent.

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

    PubMed

    Kuhn, Stefan; Schlörer, Nils E

    2015-08-01

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

  16. Reliability of nucleic acid amplification methods for detection of Chlamydia trachomatis in urine: results of the first international collaborative quality control study among 96 laboratories.

    PubMed

    Verkooyen, Roel P; Noordhoek, Gerda T; Klapper, Paul E; Reid, Jim; Schirm, Jurjen; Cleator, Graham M; Ieven, Margareta; Hoddevik, Gunnar

    2003-07-01

    The first European Quality Control Concerted Action study was organized to assess the ability of laboratories to detect Chlamydia trachomatis in a panel of urine samples by nucleic acid amplification tests (NATs). The panel consisted of lyophilized urine samples, including three negative, two strongly positive, and five weakly positive samples. Ninety-six laboratories in 22 countries participated with a total of 102 data sets. Of 204 strongly positive samples 199 (97.5%) were correctly reported, and of 506 weakly positive samples 466 (92.1%) were correctly reported. In 74 (72.5%) data sets correct results were reported on all samples, and 17 data sets (16.7%) showed either one false-negative or one false-positive result. In another 11 data sets, two or more incorrect results were reported, and two data sets reported a false-positive result on one negative sample. The Roche COBAS Amplicor test was performed in 44 (43%) data sets, the Abbott LCx assay was performed in 31 (30%) data sets, the Roche Amplicor manual assay was performed in 9 (9%) data sets, an in-house PCR was performed in 9 (9%) data sets, the Becton Dickinson ProbeTec ET assay was performed in 5 (4.9%) data sets, and the GenProbe TMA assay was performed in 4 (3.9%) data sets. The results of the Roche Amplicor manual (95.6% correct), COBAS Amplicor (97.0%), and Abbott LCx (94.8%) tests were comparable (P = 0.48). The results with the in-house PCR, BD ProbeTec ET, and GenProbe TMA tests were reported correctly in 88.6, 98, and 92.5% of the tests, respectively. Freeze-drying of clinical urine specimens proved to be a successful method for generating standardized, stable, and easy-to-transport samples for the detection of C. trachomatis by using NATs. Although the results, especially the specificity, for this proficiency panel were better than most quality control studies, sensitivity problems occurred frequently, underlining the need for good laboratory practice and reference reagents to monitor the

  17. Laboratory Turnaround Time

    PubMed Central

    Hawkins, Robert C

    2007-01-01

    Turnaround time (TAT) is one of the most noticeable signs of laboratory service and is often used as a key performance indicator of laboratory performance. This review summarises the literature regarding laboratory TAT, focusing on the different definitions, measures, expectations, published data, associations with clinical outcomes and approaches to improve TAT. It aims to provide a consolidated source of benchmarking data useful to the laboratory in setting TAT goals and to encourage introduction of TAT monitoring for continuous quality improvement. A 90% completion time (sample registration to result reporting) of <60 minutes for common laboratory tests is suggested as an initial goal for acceptable TAT. PMID:18392122

  18. The Alternative Press in Microform.

    ERIC Educational Resources Information Center

    Tsang, Daniel C.

    Presented is an analysis of what has been done regarding the preservation of alternative publications in microfilm. The alternative press was defined, for the purposes of this study, as "nonstandard, nonestablishment publications." Two projects undertaken to microfilm such publications, one by the Microphoto Division of Bell and Howell…

  19. Quality Manual

    NASA Astrophysics Data System (ADS)

    Koch, Michael

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

  20. Environmental Response Laboratory Network

    EPA Pesticide Factsheets

    The ERLN as a national network of laboratories that can be ramped up as needed to support large scale environmental responses. It integrates capabilities of existing public and private sector labs, providing consistent capacity and quality data.

  1. Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory; determination of low-level silver by graphite furnace atomic absorption spectrophotometry

    USGS Publications Warehouse

    Damrau, D.L.

    1993-01-01

    Increased awareness of the quality of water in the United States has led to the development of a method for determining low levels (0.2-5.0 microg/L) of silver in water samples. Use of graphite furnace atomic absorption spectrophotometry provides a sensitive, precise, and accurate method for determining low-level silver in samples of low ionic-strength water, precipitation water, and natural water. The minimum detection limit determined for low-level silver is 0.2 microg/L. Precision data were collected on natural-water samples and SRWS (Standard Reference Water Samples). The overall percent relative standard deviation for natural-water samples with silver concentrations more than 0.2 microg/L was less than 40 percent throughout the analytical range. For the SRWS with concentrations more than 0.2 microg/L, the overall percent relative standard deviation was less than 25 percent throughout the analytical range. The accuracy of the results was determined by spiking 6 natural-water samples with different known concentrations of the silver standard. The recoveries ranged from 61 to 119 percent at the 0.5-microg/L spike level. At the 1.25-microg/L spike level, the recoveries ranged from 92 to 106 percent. For the high spike level at 3.0 microg/L, the recoveries ranged from 65 to 113 percent. The measured concentrations of silver obtained from known samples were within the Branch of Quality Assurance accepted limits of 1 1/2 standard deviations on the basis of the SRWS program for Inter-Laboratory studies.

  2. Effect of activities at the Idaho National Engineering and Environmental Laboratory on the water quality of the Snake River Plain aquifer in the Magic Valley study

    USGS Publications Warehouse

    Bartholomay, Roy C.

    1998-01-01

    Radiochemical and chemical constituents in wastewater generated at facilities of the Idaho National Engineering and Environmental Laboratory (INEEL) (figure 1) have been discharged to waste-disposal ponds and wells since the early 1950 s. Public concern has been expressed that some of these constituents could migrate through the Snake River Plain aquifer to the Snake River in the Twin Falls-Hagerman area Because of these concerns the U.S. Department of Energy (DOE) requested that the U.S. Geological Survey (USGS) conduct three studies to gain a greater understanding of the chemical quality of water in the aquifer. One study described a one-time sampling effort for radionuclides, trace elements, and organic compounds in the eastern part of the A&B Irrigation District in Minidoka County (Mann and Knobel, 1990). Another ongoing study involves sampling for tritium from 19 springs on the north side of the Snake River in the Twin Falls-Hagerman area (Mann, 1989; Mann and Low, 1994). A third study an ongoing annual sampling effort in the area between the southern boundary of the INEEL and Hagerman (figure 1) (hereafter referred to as the Magic Valley study area), is being conducted with the Idaho Department of Water Resources in cooperation with the DOE. Data for a variety of radiochemical and chemical constituents from this study have been published by Wegner and Campbell (1991); Bartholomay, Edwards, and Campbell (1992, 1993, 1994a, 1994b); and Bartholomay, Williams, and Campbell (1995, 1996, 1997b). Data discussed in this fact sheet were taken from these reports. An evaluation of data collected during the first four years of this study (Bartholomay Williams, and Campbell, 1997a) showed no pattern of water-quality change for radionuclide data as concentrations randomly increased or decreased. The inorganic constituent data showed no statistical change between sample rounds.

  3. Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory; preparation procedure for aquatic biological material determined for trace metals

    USGS Publications Warehouse

    Hoffman, Gerald L.

    1996-01-01

    A method for the chemical preparation of tissue samples that are subsequently analyzed for 22 trace metals is described. The tissue-preparation procedure was tested with three National Institute of Standards and Technology biological standard reference materials and two National Water Quality Laboratory homogenized biological materials. A low-temperature (85 degrees Celsius) nitric acid digestion followed by the careful addition of hydrogen peroxide (30-percent solution) is used to decompose the biological material. The solutions are evaporated to incipient dryness, reconstituted with 5 percent nitric acid, and filtered. After filtration the solutions were diluted to a known volume and analyzed by inductively coupled plasma-mass spectrometry (ICP-MS), inductively coupled plasma-atomic emission spectrometry (ICP-AES), and cold vapor-atomic absorption spectrophotometry (CV-AAS). Many of the metals were determined by both ICP-MS and ICP-AES. This report does not provide a detailed description of the instrumental procedures and conditions used with the three types of instrumentation for the quantitation of trace metals determined in this study. Statistical data regarding recovery, accuracy, and precision for individual trace metals determined in the biological material tested are summarized.

  4. Monitoring of tricyclic antidepressants in human serum and plasma by HPLC: characterization of a simple, laboratory developed method via external quality assessment.

    PubMed

    Theurillat, R; Thormann, W

    1998-12-01

    A reversed-phase high performance liquid chromatography (HPLC) method for the determination of plasma and serum levels of amitriptyline (AMI), nortriptyline (NORT), imipramine (IMI), desipramine (DESI), clomipramine (CLOMI), and norclomipramine (NCLOMI) is described. The assay is based upon single step liquid/liquid extraction of these compounds using hexane at pH 11 (recovery between 92 and 105%), a Nova-Pack C-18 HPLC cartridge column, a mobile phase composed of a phosphate buffer with 50% (v/v) acetonitrile and about 0.2% (v/v) diethylamine (final pH: 8) and solute detection at 242 nm. Using 1 ml of plasma or serum and econazole as internal standard, drug levels between 20 and 400 ng ml(-1) (about 60-1450 nM) were found to provide linear calibration graphs. For drug concentrations in the range of 70-120 ng ml(-1) (about 240-430 nM), intraday and interday imprecisions (n = 5) were determined to be < 6.0, and < 15%, respectively. Data reported include those gathered over a 3-year period during which this assay was employed for therapeutic drug monitoring and clinical toxicology. The performance of the laboratory developed assay was assessed via analysis of monthly samples provided by an external quality control scheme.

  5. Distribution of U and REE on colloids in granitic groundwater and quality-controlled sampling at the Mizunami underground research laboratory

    NASA Astrophysics Data System (ADS)

    Munemoto, Takashi; Ohmori, Kazuaki; Iwatsuki, Teruki

    2014-12-01

    Colloids and their association with analogue elements, uranium, and rare earth elements (REEs), in deep granitic groundwater were investigated at the Mizunami Underground Research Laboratory (MIU). Groundwater was sampled from underground boreholes and gallery walls, and the colloids were separated by size-fractionated ultrafiltration (pore sizes, 0.2 μm, 10 kDa, and 1 kDa). For the groundwater sampled from fractures in excavation walls, the size-fractionated concentrations of the colloid-forming elements were approximately constant relative to different size fractions (0.2 μm, 200 kDa, 50 kDa, and 10 kDa). The contamination of Fe- and Al-bearing materials was insignificant in the filtered groundwater from fracture seepages. Changes in the concentrations of U in the groundwater sampled from boreholes and excavation walls were associated with the Al-bearing colloids, Fe-bearing colloids, and organic matter. The REE-bearing material(s) that were >0.2 μm in size were mobile in the deep granitic groundwater, rather than occurring in association with Al-bearing, Fe-bearing colloids, and organic matter. It is suggested that sampling from water-conducting fractures in host rock and colloid elimination in borehole are important components of water quality control in geochemical investigations.

  6. Preparation of a sewage sludge laboratory quality control material for butyltin compounds and their determination by isotope-dilution mass spectrometry.

    PubMed

    Zuliani, Tea; Milačič, Radmila; Ščančar, Janez

    2012-05-01

    The characterisation of a laboratory quality control material (QCM) for dibutyltin (DBT) and tributyltin (TBT) in sewage sludge is described. The reference values were determined by the use of two different types of isotope-dilution mass spectrometry: gas chromatography-mass spectrometry and gas chromatography-inductively coupled plasma mass spectrometry. To avoid possible analytical errors such as non-quantitative extraction and species degradation during sample preparation, different extraction methods were tested (microwave- and ultrasound-assisted extraction and mechanical stirring). The reference values were based on the unweighted means of results from the homogenisation and characterisation studies. The reference values obtained were 1,553 ± 87 and 534 ± 38 ng Sn g(-1) for DBT and TBT, respectively. In the uncertainty budget estimation, the sample inhomogeneity and between-method imprecision were taken into account. The concentrations of DBT and TBT in QCM are similar to those in the harbour sediment certified reference material PACS-2. Likewise, the levels of DBT and TBT are in the range of these compounds normally present in sewage sludge worldwide. In the future, the QCM will be used for an intercomparison study on DBT and TBT in sewage sludge, and as a day-to-day QCM during studies concerning the application of sewage sludge as an additive to artificial soil or as a raw material in civil engineering construction.

  7. High heterogeneity in methods used for the laboratory confirmation of pertussis diagnosis among European countries, 2010: integration of epidemiological and laboratory surveillance must include standardisation of methodologies and quality assurance.

    PubMed

    He, Q; Barkoff, A M; Mertsola, J; Glismann, S; Bacci, S

    2012-08-09

    Despite extensive childhood immunisation, pertussis remains one of the world’s leading causes of vaccine preventable deaths. The current methods used for laboratory diagnosis of pertussis include bacterial culture, polymerase chain reaction (PCR) and enzyme linked immunosorbent assay (ELISA) serology. We conducted a questionnaire survey to identify variations in the laboratory methods and protocols used among participating countries included in the European surveillance network for vaccine-preventable diseases(EUVAC.NET). In February 2010, we performed the survey using a web-based questionnaire and sent it to the country experts of 25 European Union countries,and two European Economic Area (EEA) countries,Norway and Iceland. The questionnaire consisted of 37 questions which covered both general information on surveillance methods and detailed laboratory methods used. A descriptive analysis was performed.Questionnaires were answered by all 27 contacted countries. Nineteen countries had pertussis reference laboratories at the national level; their functions varied from performing diagnosis to providing technical advice for routine microbiology laboratories. Culture,PCR and serology were used in 17, 18 and 20 countries,respectively. For PCR, nine laboratories used insertion sequence IS481 as the target gene, which is present in multiple copies in the Bordetella pertussis genome and thus has a greater sensitivity over single copy targets, but has been proved not to be specific for B.pertussis. Antibodies directed against pertussis toxin(PT) are specific for B. pertussis infections. For ELISA serology, only 13 countries’ laboratories used purified PT as coating antigen and 10 included World Health Organization (WHO) or Food and Drug Administration (FDA) reference sera in their tests. This present survey shows that methods used for laboratory confirmation of pertussis differ widely among European countries and that there is a great heterogeneity of the reference

  8. Quality and safety issues highlighted by patients in the handling of laboratory test results by general practices–a qualitative study

    PubMed Central

    2014-01-01

    Background In general practice internationally, many care teams handle large numbers of laboratory test results relating to patients in their care. Related research about safety issues is limited with most of the focus on this workload from secondary care and in North American settings. Little has been published in relation to primary health care in the UK and wider Europe. This study aimed to explore experiences and perceptions of patients with regards to the handling of test results by general practices. Methods A qualitative research approach was used with patients. The setting was west of Scotland general practices from one National Health Service territorial board area. Patients were purposively sampled from practice held lists of patients who received a number of laboratory tests because of chronic medical problems or surveillance of high risk medicines. Focus groups were held and were audio-recorded. Tapes were transcribed and subjected to qualitative analysis. Transcripts were coded and codes merged into themes by two of the researchers. Results 19 participants from four medical practices took part in four focus groups. The main themes identified were: 1. Patients lacked awareness of the results handling process in their practice. 2. Patients usually did not contact their practice for test results, unless they considered themselves to be ill. 3. Patients were concerned about the appropriateness of administrators being involved in results handling. 4. Patients were concerned about breaches of confidentiality when administrators were involved in results handling. 5. Patients valued the use of dedicated results handling staff. 6. Patients welcomed the use of technology to alert them to results being available, and valued the ability to choose how this happened. Conclusions The study confirms the quality and safety of care problems associated with results handling systems and adds to our knowledge of the issues that impact in these areas. Practices need to be

  9. Standardization of sensitive human immunodeficiency virus coculture procedures and establishment of a multicenter quality assurance program for the AIDS Clinical Trials Group. The NIH/NIAID/DAIDS/ACTG Virology Laboratories.

    PubMed Central

    Hollinger, F B; Bremer, J W; Myers, L E; Gold, J W; McQuay, L

    1992-01-01

    An independent quality assurance program has been established by the Division of AIDS, National Institute of Allergy and Infectious Diseases, for monitoring virologic assays performed by nearly 40 laboratories participating in multicenter clinical trials in the United States. Since virologic endpoints are important in evaluating the timing and efficacy of therapeutic interventions, it is imperative that virologic measurements be accurate and uniform. When the quality assurance program was initially created, fewer than 40% of the laboratories could consistently recover human immunodeficiency virus (HIV) from peripheral blood mononuclear cells (PBMCs) of HIV-infected patients. By comparing coculture procedures in the more competent laboratories with those in laboratories who were struggling to isolate virus, optimal conditions were established and nonessential reagents and practices were eliminated. Changes were rapidly introduced into a laboratory when experience dictated that such modifications would result in a favorable outcome. Isolation of HIV was enhanced by optimizing the numbers and ratios of patient and donor cells used in cultures, by standardizing PBMC separation procedures, by using fresh rather than frozen donor PBMCs, by processing whole blood within 24 h, and by using natural delectinated interleukin 2 instead of recombinant interleukin 2 products in existence at that time. Delays of more than 8 h in the addition of phytohemagglutinin-stimulated donor cells to freshly separated patient PBMCs reduced recovery. Phytohemagglutinin in cocultures and the addition of Polybrene and anti-human alpha interferon to media were not important in HIV isolation. The introduction of a consensus protocol based on this information brought most laboratories quickly into compliance. In addition, monthly monitoring has successfully maintained proficiency among the laboratories, a process that is critical for the scientific integrity of collaborative multicenter trials

  10. Laboratory accreditation and inspection.

    PubMed

    Rauch, Carol A; Nichols, James H

    2007-12-01

    Clinical laboratories perform diagnostic testing in a highly regulated environment in which federal, state, and private accreditation agencies monitor the quality of testing processes. These agencies vary in the focus and stringency of their requirements, and differences exist among states. Continued accreditation requires regular inspection to assure quality of test results for physicians, insurers, and, ultimately, the patients being tested. Preparation for inspection requires understanding of the unique accreditation requirements for each institution, establishment of quality assurance and quality improvement oversight, and communication of each staff member's role in delivering quality test results for patient care.

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

    PubMed

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

    2007-05-01

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

  12. Overestimation of on-road air quality surveying data measured with a mobile laboratory caused by exhaust plumes of a vehicle ahead in dense traffic areas.

    PubMed

    Woo, Sang-Hee; Kwak, Kyung-Hwan; Bae, Gwi-Nam; Kim, Kyung Hwan; Kim, Chang Hyeok; Yook, Se-Jin; Jeon, Sangzin; Kwon, Sangil; Kim, Jeongsoo; Lee, Seung-Bok

    2016-11-01

    The unintended influence of exhaust plumes emitted from a vehicle ahead to on-road air quality surveying data measured with a mobile laboratory (ML) at 20-40 km h(-1) in dense traffic areas was investigated by experiment and life-sized computational fluidic dynamics (CFD) simulation. The ML equipped with variable sampling inlets of five columns by four rows was used to measure the spatial distribution of CO2 and NOx concentrations when following 5-20 m behind a sport utility vehicle (SUV) as an emitter vehicle equipped with a portable emission monitoring system (PEMS). The PEMS measured exhaust gases at the tailpipe for input data of the CFD simulations. After the CFD method was verified with experimental results of the SUV, dispersion of exhaust plumes emitted from a bus and a sedan was numerically analyzed. More dilution of the exhaust plume was observed at higher vehicle speeds, probably because of eddy diffusion that was proportional to turbulent kinetic energy and vehicle speed. The CO2 and NOx concentrations behind the emitter vehicle showed less overestimation as both the distance between the two vehicles and their background concentrations increased. If the height of the ML inlet is lower than 2 m and the ML travels within 20 m behind a SUV and a sedan ahead at 20 km h(-1), the overestimation should be considered by as much as 200 ppb in NOx and 80 ppm in CO2. Following a bus should be avoided if possible, because effect of exhaust plumes from a bus ahead could not be negligible even when the distance between the bus and the ML with the inlet height of 2 m, was more than 40 m. Recommendations are provided to avoid the unintended influence of exhaust plumes from vehicles ahead of the ML during on-road measurement in urban dense traffic conditions.

  13. The Confederate medical laboratories.

    PubMed

    Hasegawa, Guy R; Hambrecht, F Terry

    2003-12-01

    During the Civil War, the scarcity and expense of imported drugs forced the Confederate Army to establish several medical laboratories to manufacture drugs for military use. The laboratories produced medicines from indigenous plants and also made non-plant-based drugs. The Confederate Surgeon General and the Chief Purveyor in Richmond, VA, coordinated activities of most of the laboratories. The laboratories employed talented and resourceful personnel and manufactured a large volume and wide variety of drugs, the most useful of which included ether, chloroform, and opiates. The pharmaceutical quality of the laboratories' output was evidently uneven. Empirical testing in military hospitals helped determine the clinical value of indigenous remedies. The Confederate medical laboratories participated in a coordinated effort to supply the Army with substitutes for drugs whose availability was curtailed or uncertain.

  14. Requirements for Reference (Calibration) Laboratories in Laboratory Medicine

    PubMed Central

    Siekmann, Lothar

    2007-01-01

    In addition to reference measurement procedures and reference materials, reference or calibration laboratories play an integral role in the implementation of measurement traceability in routine laboratories. They provide results of measurements using higher-order methods, e.g. isotope dilution mass spectrometry and may assign values to materials to be used for external quality assessment programs and to secondary reference materials. The requirements for listing of laboratories that provide reference measurement services include a statement of the metrological level or principle of measurement, accreditation as a calibration laboratory according to ISO 15195 and the participation in a proficiency testing system (regular inter-laboratory comparisons) for reference laboratories. Ring trials are currently conducted for thirty well-defined measurands and the results are made available to all laboratories. Through the use of reference laboratory services that are listed by the Joint Committee for Traceability in Laboratory Medicine there is the opportunity to further promote traceability and standardisation of laboratory measurements. PMID:18392129

  15. Laboratory Tests

    MedlinePlus

    Laboratory tests check a sample of your blood, urine, or body tissues. A technician or your doctor ... compare your results to results from previous tests. Laboratory tests are often part of a routine checkup ...

  16. Immunohistochemical demonstration of oestrogen and progesterone receptors: correlation of standards achieved on in house tumours with that achieved on external quality assessment material in over 150 laboratories from 26 countries

    PubMed Central

    Rhodes, A; Jasani, B; Balaton, A; Miller, K

    2000-01-01

    Aims—To investigate the sensitivity of immunohistochemical (IHC) assays for oestrogen receptors (ER) and progesterone receptors (PR) achieved by laboratories on breast tumours fixed and processed in their own department, and to compare this with the degree of sensitivity they achieve on tumours circulated as part of an external quality assessment (EQA) programme. Methods—On 10 occasions between April 1994 and June 1998, histological sections from breast cancers showing various degrees of expression of ER and PR were circulated for IHC staining to laboratories participating in the UK national external quality assessment scheme for immunocytochemistry (UK NEQAS-ICC). The staining of these tumours, in addition to that of tumours fixed and processed in the participants own laboratories (in house tumours), was assessed by a panel of four assessors, using the established UK NEQAS-ICC scoring system. For a selected assessment run, the degree of expression of participants in house tumours was evaluated by means of the semiquantitative quick score method. Results—Although the scores awarded for the staining of in house tumours were generally higher than those awarded for the staining of UK NEQAS tumours, there was also a significant positive correlation between the two sets of scores. Using the quick score method of evaluation for one of the assessment runs, 47% of in house tumours were classified as having a high degree of ER expression. Of the remaining cases, a significant proportion initially classified as having only low or medium expression of ER were found to have higher expression when stained by the organising laboratory. The UK NEQAS-ICC centre's routine assay for hormonal receptors was found to be 90–100% efficient in achieving optimal demonstration of breast tumours from over 150 different laboratories. Conclusions—The significant positive correlation between the results obtained on the UK NEQAS tumours and the in house tumours provides evidence for

  17. The External Quality Assurance Oversight Laboratory (EQAPOL) proficiency program for IFN-gamma enzyme-linked immunospot (IFN-γ ELISpot) assay.

    PubMed

    Sanchez, Ana M; Rountree, Wes; Berrong, Mark; Garcia, Ambrosia; Schuetz, Alexandra; Cox, Josephine; Frahm, Nicole; Manak, Mark; Sarzotti-Kelsoe, Marcella; D'Souza, M Patricia; Denny, Thomas; Ferrari, Guido

    2014-07-01

    The interferon-gamma enzyme-linked immunospot (IFN-γ ELISpot) assay has been developed and used as an end-point assay in clinical trials for infectious diseases and cancer to detect the magnitude of antigen-specific immune responses. The ability to compare data generated by different laboratories across organizations is pivotal to understand the relative potency of different therapeutic and vaccine strategies. We developed an external proficiency program for the IFN-γ ELISpot assay that evaluates laboratory performance based on five parameters: timeliness for data reporting; ability to handle cellular samples; detection of background (non-specific) responses; accuracy to consensus of the results; and precision of the measurements. Points are awarded for each criterion, and the sum of the points is used to determine a numeric and adjectival performance rating. Importantly, the evaluation of the accuracy to the consensus mean for the detection of antigen-specific responses using laboratory-specific procedures informs each laboratory and its sponsor on the degree of concordance of its results with those obtained by other laboratories. This study will ultimately provide the scientific community with information on how to organize and implement an external proficiency program to evaluate longitudinally the performance of the participating laboratories and, therefore, fulfill the requirements of the GCLP guidelines for laboratories performing end-point IFN-γ ELISpot assay for clinical trials.

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

    USGS Publications Warehouse

    Rattray, Gordon W.

    2012-01-01

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

  19. Laboratory Automation and Middleware.

    PubMed

    Riben, Michael

    2015-06-01

    The practice of surgical pathology is under constant pressure to deliver the highest quality of service, reduce errors, increase throughput, and decrease turnaround time while at the same time dealing with an aging workforce, increasing financial constraints, and economic uncertainty. Although not able to implement total laboratory automation, great progress continues to be made in workstation automation in all areas of the pathology laboratory. This report highlights the benefits and challenges of pathology automation, reviews middleware and its use to facilitate automation, and reviews the progress so far in the anatomic pathology laboratory.

  20. Do English NHS Microbiology laboratories offer adequate services for the diagnosis of UTI in children? Healthcare Quality Improvement Partnership (HQIP) Audit of Standard Operational Procedures.

    PubMed

    McNulty, Cliodna A M; Verlander, Neville Q; Moore, Philippa C L; Larcombe, James; Dudley, Jan; Banerjee, Jaydip; Jadresic, Lyda

    2015-09-01

    The National Institute of Care Excellence (NICE) 2007 guidance CG54, on urinary tract infection (UTI) in children, states that clinicians should use urgent microscopy and culture as the preferred method for diagnosing UTI in the hospital setting for severe illness in children under 3 years old and from the GP setting in children under 3 years old with intermediate risk of severe illness. NICE also recommends that all 'infants and children with atypical UTI (including non-Escherichia coli infections) should have renal imaging after a first infection'. We surveyed all microbiology laboratories in England with Clinical Pathology Accreditation to determine standard operating procedures (SOPs) for urgent microscopy, culture and reporting of children's urine and to ascertain whether the SOPs facilitate compliance with NICE guidance. We undertook a computer search in six microbiology laboratories in south-west England to determine urine submissions and urine reports in children under 3 years. Seventy-three per cent of laboratories (110/150) participated. Enterobacteriaceae that were not E. coli were reported only as coliforms (rather than non-E. coli coliforms) by 61% (67/110) of laboratories. Eighty-eight per cent of laboratories (97/110) provided urgent microscopy for hospital and 54% for general practice (GP) paediatric urines; 61% of laboratories (confidence interval 52-70%) cultured 1 μl volume of urine, which equates to one colony if the bacterial load is 106 c.f.u. l(-1). Only 22% (24/110) of laboratories reported non-E. coli coliforms and provided urgent microscopy for both hospital and GP childhood urines; only three laboratories also cultured a 5 μl volume of urine. Only one of six laboratories in our submission audit had a significant increase in urine submissions and urines reported from children less than 3 years old between the predicted pre-2007 level in the absence of guidance and the 2008 level following publication of the NICE guidance. Less than a

  1. A laboratory perspective on environmental laboratory certification

    SciTech Connect

    Herdlick, M.J.

    1996-11-01

    With the approach of the end of the millennium, one issue stands at the forefront in the minds of politicians, scholars, and the world in general: The constant need and desire to protect, to beautify, and to heal the environment and the earth`s resources. A crucial and integral part of this plan is the environmental testing laboratory which, for the most part, bursted into existence with the formation of the United States Environmental Protection Agency in the 1970`s. The need for good quality labs is an on-going concern since the federal and state regulations are constantly in a state of flux. Just like any other business sector, the laboratory is monitored by its peer groups including its respective clients, state authorities, and regional EPA personnel through the process of accreditation and certification. Unfortunately, the laboratory certification program for environmental laboratories is a complicated process since no true national program exists that blankets the entire regulatory dilemma. It is the purpose of my poster session to discuss the current state of the formal laboratory certification process for a typical testing laboratory that operates in many states for a wide variety of clients.

  2. Laboratory accreditation in Thailand: a systemic approach.

    PubMed

    Wattanasri, Naiyana; Manoroma, Wannika; Viriyayudhagorn, Somchai

    2010-10-01

    Improvement of quality standards for health care service delivery has been a commitment of the Ministry of Public Health in Thailand for more than 2 decades; however, laboratory quality systems in Thailand did not become a focus until 10 years ago. International accreditation can increase recognition of laboratory quality, but it is difficult to reach for many laboratories, especially those in remote areas. This article describes Thailand's experience in developing a national laboratory standard and establishing a national laboratory accreditation program to guarantee the quality of laboratory services. The Thai laboratory standard derived from multiple international standards, retaining the most important elements yet making the standard applicable to Thailand. The national accreditation program was established as a local alternative for improvement of laboratory quality. The program is affordable, feasible, scalable, sustainable, and effective.

  3. Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory; in-bottle acid digestion of whole-water samples

    USGS Publications Warehouse

    Hoffman, G.L.; Fishman, M. J.; Garbarino, J.R.

    1996-01-01

    Water samples for trace-metal determinations routinely have been prepared in open laboratories. For example, the U.S. Geological Survey method I-3485-85 (Extraction Procedure, for Water- Suspended Sediment) is performed in a laboratory hood on a laboratory bench without any special precautions to control airborne contamination. This method tends to be contamination prone for several trace metals primarily because the samples are transferred, acidified, digested, and filtered in an open laboratory environment. To reduce trace-metal contamination of digested water samples, procedures were established that rely on minimizing sample-transfer steps and using a class-100 clean bench during sample filtration. This new procedure involves the following steps: 1. The sample is acidified with HCl directly in the original water-sample bottle. 2. The water-sample bottle with the cap secured is heated in a laboratory oven. 3. The digestate is filtered in a class-100 laminar-flow clean bench. The exact conditions used (that is, oven temperature, time of heating, and filtration methods) for this digestion procedure are described. Comparisons between the previous U.S Geological Survey open-beaker method I-3485-85 and the new in-bottle procedure for synthetic and field-collected water samples are given. When the new procedure is used, blank concentrations for most trace metals determined are reduced significantly.

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

    ERIC Educational Resources Information Center

    AMT Events, 1986

    1986-01-01

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

  5. Laboratory Building

    SciTech Connect

    Herrera, Joshua M.

    2015-03-01

    This report is an analysis of the means of egress and life safety requirements for the laboratory building. The building is located at Sandia National Laboratories (SNL) in Albuquerque, NM. The report includes a prescriptive-based analysis as well as a performance-based analysis. Following the analysis are appendices which contain maps of the laboratory building used throughout the analysis. The top of all the maps is assumed to be north.

  6. Pacific Northwest Laboratory annual report for 1987 to the Assistant Secretary for Environment, Safety, and Health: Part 5: Environment, safety, health, and quality assurance

    SciTech Connect

    Faust, L.G.; Steelman, B.L.; Selby, J.M.

    1988-02-01

    Part 5 of the 1987 Annual Report to the US Department of Energy's Assistant Secretary for Environment, Safety, and Health presents Pacific Northwest Laboratory's progress on work performed for the Office of Nuclear Safety, the Office of Environmental Guidance and Compliance, the Office of Environmental Audit, and the Office of National Environmental Policy Act Project Assistance. For each project, as identified by the Field Work Proposal, articles describe progress made during fiscal year 1987. Authors of these articles represent a broad spectrum of capabilities derived from five of the seven technical centers of the Laboratory, reflecting the interdisciplinary nature of the work.

  7. [Accreditation of medical laboratories].

    PubMed

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

    2003-07-27

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

  8. Analysis of the Quality of Research and Development at the OERI Research and Development Centers and at the OERI Regional Educational Laboratories.

    ERIC Educational Resources Information Center

    Vinovskis, Maris A.

    An evaluation of the Research and Development Centers and the Regional Educational Laboratories of the Office of Educational Research and Improvement (OERI) was conducted by an outside analyst brought in in September 1991 by then Assistant Secretary Diane Ravitch. The Research and Development Centers have been one of the primary sources of…

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

    PubMed Central

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

    2014-01-01

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

  10. Quality-assurance data for routine water analyses by the U.S. Geological Survey Laboratory in Troy, New York—July 1995 through June 1997

    USGS Publications Warehouse

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

    2005-01-01

    Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 90 percent of the calcium, pH, potassium, and sodium samples. Data-quality objectives were met by 77 percent of the chloride samples, 83 percent of the magnesium samples, and 80 percent of the sulfate samples. There is insufficient data to evaluate the specific conductance samples.

  11. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  12. Pacific Northwest Laboratory annual report for 1989 to the Assistant Secretary for Environment, Safety, and Health - Part 5: Environment, Safety, Health, and Quality Assurance

    SciTech Connect

    Faust, L.G.; Doctor, P.G.; Selby, J.M.

    1990-04-01

    Part 5 of the 1989 Annual Report to the US Department of Energy's Assistant Secretary for Environment, Safety, and Health presents Pacific Northwest Laboratory's progress on work performed for the Office of Environmental Guidance and Compliance, the Office of Environmental Audit, the Office of National Environmental Policy Act Project Assistance, the Office of Nuclear Safety, the Office of Safety Compliance, and the Office of Policy and Standards. For each project, as identified by the Field Work Proposal, there is an article describing progress made during fiscal year 1989. Authors of these articles represent a broad spectrum of capabilities derived from five of the seven technical centers of the Laboratory, reflecting the interdisciplinary nature of the work. 35 refs., 1 fig.

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

    USGS Publications Warehouse

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

    2003-01-01

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

  14. [Bringing criteria for external assessment of the quality of biochemical studies within the framework of the Federal System for External Evaluation of the Quality of Clinical Laboratory Studies, in conformity with requirements of the Order No. 45 of the Ministry of Health of Russia, 2/7/2000].

    PubMed

    Zaikin, E V; Malakhov, V N

    2000-07-01

    Criteria for external assessment of the quality of evaluation of 23 biochemical parameters of the blood, meeting the standards of accuracy determined by the Order No. 45 of Ministry of Health of Russia of February 7, 2000 for intralaboratory quality control have been estimated. According to the data of the Federal System for External Evaluation of the Quality of Clinical Laboratory Studies, the percentage of results of analyses of test sera meeting these criteria has been estimated. Introduction of new criteria for external assessment of the quality of biochemical tests into the practice of the Federal System will not notably modify the currently used criteria with regard to the majority of biochemical parameters, except introduction of more stringent criteria for albumin and magnesium and less stringent for creatine kinase.

  15. Communication Laboratories: Genesis, Assessment, Challenges.

    ERIC Educational Resources Information Center

    Ellis, Kathleen; Shockley-Zalabak, Pamela; Hackman, Michael Z.

    2000-01-01

    Claims the quality of educational preparation in basic communication skills is insufficient for students to compete in the new millennium. Discusses the communication laboratory as one educational strategy for addressing the issue of communication competency. Describes the rationale for creating a communication laboratory, curricula and…

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

    USGS Publications Warehouse

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

    2005-01-01

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

  17. Laboratory accreditation.

    PubMed

    Bradway, D E; Siegelman, F L

    1994-09-01

    An investigation of alleged data fraud at a pesticide analytical laboratory led EPA to take a closer look at the Good Laboratory Practice (GLP) inspection program. There was special focus on changes which might be made in the program to enhance the chances of detecting fraud in regulated studies. To this end, the Assistant Administrator of the Office of Prevention, Pesticides and Toxic Substances (OPPTS) requested EPA's Office of Inspector General (OIG) to examine the GLP program. Several reports were issued by the OIG, including the recommendation that a laboratory accreditation program be adopted. EPA has been examining ways to implement the OIG's recommendations, including (1) laboratory accreditation consisting of three components: document submission and assessment, site visit and assessment, and proficiency assessment; and (2) mandatory registration of all facilities participating in GLP-regulated studies, based on document submission and assessment. These two alternatives are compared, and the advantages and disadvantages of each are discussed.

  18. [Laboratory accreditation and proficiency testing].

    PubMed

    Kuwa, Katsuhiko

    2003-05-01

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

  19. Total Quality Management in Higher Education: Latest Fad or Lasting Legacy? Policy Briefs of the Education Policy Studies Laboratory. No. 93-01.

    ERIC Educational Resources Information Center

    Wolverton, Mimi

    This policy brief examines the fundamental principles that undergird the current Total Quality Management (TQM) movement, describes application examples and discusses application problems particular to higher education. An opening section reviews the basic premises of TQM and differentiates between two perspectives on the approach: the first see…

  20. Laboratory Evaluations of the Enterococcus qPCR Method for Recreational Water Quality Testing: Method Performance and Sources of Uncertainty in Quantitative Measurements

    EPA Science Inventory

    The BEACH Act of 2000 directed the U.S. EPA to establish more expeditious methods for the detection of pathogen indicators in coastal waters, as well as new water quality criteria based on these methods. Progress has been made in developing a quantitative PCR (qPCR) method for en...

  1. Managing laboratory automation

    PubMed Central

    Saboe, Thomas J.

    1995-01-01

    This paper discusses the process of managing automated systems through their life cycles within the quality-control (QC) laboratory environment. The focus is on the process of directing and managing the evolving automation of a laboratory; system examples are given. The author shows how both task and data systems have evolved, and how they interrelate. A BIG picture, or continuum view, is presented and some of the reasons for success or failure of the various examples cited are explored. Finally, some comments on future automation need are discussed. PMID:18925018

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

    PubMed

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

    2017-03-01

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

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

    PubMed

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

    2016-02-01

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

  4. Clinical laboratory accreditation in India.

    PubMed

    Handoo, Anil; Sood, Swaroop Krishan

    2012-06-01

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

  5. Progressing towards laboratory accreditation in developing countries.

    PubMed

    Young, D S

    2010-12-01

    Laboratory testing is of great value in the diagnosis and management of diseases. Good quality of results is essential if test results are to be meaningful. Uniformly high standards of laboratory practice are required to ensure that physicians may consistently rely on test results. Accreditation provides a way whereby a laboratory may meet international standards and provide assurance to a hospital's administration, medical and laboratory staff and patients that the laboratory is providing high quality results. In the absence of a national accreditation program, laboratories should undertake the low-cost or no cost actions that are elements of all accreditation programs. National societies concerned with the field of laboratory medicine or clinical pathology should work together with the appropriate government agencies to establish aNational Accrediting Body. Institution of an accrediting program will raise the visibility of clinical laboratory testing and ensure enhanced quality of testing for the entire population,

  6. Quality Assurance Plan for the remedial investigation of Waste Area Grouping 2 at Oak Ridge National Laboratory, Oak Ridge, Tennessee. Environmental Restoration Program

    SciTech Connect

    Atwood, G.P.; Miller, D.E.

    1992-12-01

    The Oak Ridge National Laboratory (ORNL) Waste Area Grouping (WAG) 2 Site Investigation (SI)includes the lower portion of the White Oak Creek (WOC) drainage and enbayment, and associated floodplain and subsurface environment. The ORNL main plant and the major waste storage and disposal facilities at ORNL are located in the WOC watershed and are drained by the WOC system to the Clinch River, located off-site. Environmental media are contaminated and continue to receive contaminants from hydrologically upgradient WAGS. WAG 2 is important as a conduit from upgradient areas to the Clinch River. The general objectives of the WAG 2 SI Project are to conduct a multimedia monitoring and characterization program to define and monitor the input of contaminants from adjacent WAGS, monitor and gather sufficient information for processes controlling or driving contaminant fluxes to construct an appropriate conceptual model for WAG 2, and prepare for the eventual remediation of WAG 2.

  7. Cerro Grande Fire Impact to Water Quality and Stream Flow near Los Alamos National Laboratory: Results of Four Years of Monitoring

    SciTech Connect

    B.M. Gallaher; R.J. Koch

    2004-09-15

    In May 2000, the Cerro Grande fire burned about 7400 acres of mixed conifer forest on the Los Alamos National Laboratory (LANL), and much of the 10,000 acres of mountainside draining onto LANL was severely burned. The resulting burned landscapes raised concerns of increased storm runoff and transport of contaminants by runoff in the canyons traversing LANL. The first storms after the fire produced runoff peaks that were more than 200 times greater than prefire levels. Total runoff volume for the year 2000 increased 50% over prefire years, despite a decline in total precipitation of 13% below normal and a general decrease in the number of monsoonal thunderstorms. The majority of runoff in 2000 occurred in the canyons at LANL south of Pueblo Canyon (70%), where the highest runoff volume occurred in Water Canyon and the peak discharge occurred in Pajarito Canyon. This report describes the observed effects of the Cerro Grande fire and related environmental impacts to watersheds at and near Los Alamos National Laboratory (LANL) for the first four runoff seasons after the fire, from 2000 through 2003. Spatial and temporal trends in radiological and chemical constituents that were identified as being associated with the Cerro Grande fire and those that were identified as being associated with historic LANL discharges are evaluated with regard to impacts to the Rio Grande and area reservoirs downstream of LANL. The results of environmental sampling performed by LANL, the New Mexico Environment Department (NMED), and U.S. Geological Survey (USGS) after the Cerro Grande fire are included in the evaluation. Effects are described for storm runoff, baseflow, stream sediments, and area regional reservoir sediment.

  8. Princeton Plasma Physics Laboratory:

    SciTech Connect

    Phillips, C.A.

    1986-01-01

    This paper discusses progress on experiments at the Princeton Plasma Physics Laboratory. The projects and areas discussed are: Principal Parameters Achieved in Experimental Devices, Tokamak Fusion Test Reactor, Princeton Large Torus, Princeton Beta Experiment, S-1 Spheromak, Current-Drive Experiment, X-ray Laser Studies, Theoretical Division, Tokamak Modeling, Spacecraft Glow Experiment, Compact Ignition Tokamak, Engineering Department, Project Planning and Safety Office, Quality Assurance and Reliability, and Administrative Operations.

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

    USGS Publications Warehouse

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

    2004-01-01

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

  10. Laboratory diagnosis

    Technology Transfer Automated Retrieval System (TEKTRAN)

    One of the first major goals of the microbiology laboratory is to isolate or detect clinically significant microorganisms from an affected site and, if more than one type of microorganism is present, to isolate them in approximately the same ratio as occurs in vivo. Whether an isolate is “clinically...

  11. Groundwater quality monitoring well installation for Lower Waste Area Grouping 2 at Oak Ridge National Laboratory, Oak Ridge, Tennessee. Environmental Restoration Program

    SciTech Connect

    Mortimore, J.A.; Lee, T.A.

    1994-09-01

    This report documents the drilling and installation of 11 groundwater quality monitoring (GQM) wells on the perimeter of Lower Waste Area Grouping (WAG) 2. Lower WAG 2 consists of White Oak Lake and the embayment below White Oak Dam above the Clinch River. The wells in Lower WAG 2 were drilled and developed between December 1989 and September 1990. These wells were installed to characterize and assess the WAG in accordance with applicable Department of Energy, state, and Environmental Protection Agency regulatory requirements. The wells at Lower WAG 2 were drilled with auger or air rotary rigs. Depending on the hydrogeologic conditions present at each proposed well location, one of three basic installation methods was utilized. Detailed procedures for well construction were specified by the Engineering Division to ensure that the wells would provide water samples representative of the aquifer. To ensure conformance with the specifications, Energy Systems Construction Engineering and ERCE provided continuous oversight of field activities. The purpose of the well installation program was to install GQM wells for groundwater characterization at Lower WAG 2. Data packages produced during installation activities by the ERCE hydrogeologists are an important product of the program. These packages document the well drilling, installation, and development activities and provide valuable data for well sampling and WAG characterization. The forms contained in the packages include predrilling and postdrilling checklists, drilling and construction logs, development and hydraulic conductivity records, and quality control-related documents.

  12. Changes in the persistence of two phenylurea herbicides in two Mediterranean soils under irrigation with low- and high-quality water: A laboratory approach.

    PubMed

    ElGouzi, Siham; Draoui, Khalid; Chtoun, E H; Dolores Mingorance, M; Peña, Aránzazu

    2015-12-15

    The disappearance of two phenylurea herbicides, chlorotoluron (CHL) and isoproturon (IPU), in two Mediterranean soils, an agricultural calcareous soil (S5) and an organic forest soil (S2), was assessed under irrigation with high- and low-quality water. Irrigation with wastewater, as opposed to irrigation with high-quality water, increased the degradation rate of both herbicides in both soils. For each soil, the decay rate of IPU was always higher than that of CHL, and both pesticides disappeared more rapidly from S5 with lower clay and organic carbon content than from S2. The degradation rate was inversely related with pesticide sorption on soil, because increased sorption would reduce pesticide bioavailability for decomposition. In most cases the residual concentration in soil of both phenylurea herbicides was better fitted to a bi-exponential decay model than to first-order or first-order with plateau models. Dehydrogenase activity, used as an indication of microbial activity, was very high in S2 in comparison with S5, but was not related to pesticide disappearance.

  13. 42 CFR 493.1407 - Standard; Laboratory director responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... assessment programs are established and maintained to assure the quality of laboratory services provided and... developed and used for each of the tests performed in the laboratory provide quality laboratory services for... capability of providing the quality of results required for patient care; (ii) Verification procedures...

  14. [ISO 15189 medical laboratory accreditation].

    PubMed

    Aoyagi, Tsutomu

    2004-10-01

    This International Standard, based upon ISO/IEC 17025 and ISO 9001, provides requirements for competence and quality that are particular to medical laboratories. While this International Standard is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines will also find it useful and appropriate. In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this International Standard as the basis for their activities. The Japan Accreditation Board for Conformity Assessment (AB) and the Japanese Committee for Clinical Laboratory Standards (CCLS) are jointly developing the program of accreditation of medical laboratories. ISO 15189 requirements consist of two parts, one is management requirements and the other is technical requirements. The former includes the requirements of all parts of ISO 9001, moreover it includes the requirement of conformity assessment body, for example, impartiality and independence from any other party. The latter includes the requirements of laboratory competence (e.g. personnel, facility, instrument, and examination methods), moreover it requires that laboratories shall participate proficiency testing(s) and laboratories' examination results shall have traceability of measurements and implement uncertainty of measurement. Implementation of ISO 15189 will result in a significant improvement in medical laboratories management system and their technical competence. The accreditation of medical laboratory will improve medical laboratory service and be useful for patients.

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 23 2014-07-01 2014-07-01 false Quality assurance and quality control... assurance and quality control. The permittee/laboratory shall use suitable QA/QC procedures when conducting... quality control elements, where applicable, into the laboratory's documented standard operating...

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

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 24 2012-07-01 2012-07-01 false Quality assurance and quality control... assurance and quality control. The permittee/laboratory shall use suitable QA/QC procedures when conducting... quality control elements, where applicable, into the laboratory's documented standard operating...

  17. 40 CFR 136.7 - Quality assurance and quality control.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 24 2013-07-01 2013-07-01 false Quality assurance and quality control... assurance and quality control. The permittee/laboratory shall use suitable QA/QC procedures when conducting... quality control elements, where applicable, into the laboratory's documented standard operating...

  18. A quality by design (QbD) case study on liposomes containing hydrophilic API: II. Screening of critical variables, and establishment of design space at laboratory scale.

    PubMed

    Xu, Xiaoming; Khan, Mansoor A; Burgess, Diane J

    2012-02-28

    Two statistical designs were used in this case study as part of an investigation into the feasibility and the advantages of applying QbD concepts to liposome-based complex parenteral controlled release systems containing a hydrophilic active pharmaceutical ingredient (API). The anti-viral drug tenofovir was used as a model compound. First design (Plackett-Burman) was used to screen eight high-risk variables obtained from risk analysis and assess their impact on liposome characteristics (drug encapsulation efficiency, particle size, and physical stability). It was discovered that out of eight high-risk variables only lipid and drug concentration had significant effects on the drug encapsulation efficiency. This allowed the use of a central composite design (CCD) (with more predictive capability) to fully elucidate the relationship between lipid concentration, drug concentration and encapsulation efficiency. On comparing the CCD model generated response surface with additional data points, the accuracy and robustness of the model was confirmed. Using this developed model, the design space for tenofovir liposomes preparation has been established in a laboratory setting, within which the preparation variability is minimized. With regard to sample storage stability, it was shown that at 4°C the prepared tenofovir liposomes, dispersed in aqueous phase, achieved stability for at least 2 years. These principles can be applied to liposomes containing other hydrophilic APIs, and can provide time and cost saving to industrial formulation scientists, and result in a more robust liposome preparation process.

  19. Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine. Part 3: Technical Validation of Immunohistochemistry (IHC) Assays in Clinical IHC Laboratories.

    PubMed

    Torlakovic, Emina E; Cheung, Carol C; D'Arrigo, Corrado; Dietel, Manfred; Francis, Glenn D; Gilks, C Blake; Hall, Jacqueline A; Hornick, Jason L; Ibrahim, Merdol; Marchetti, Antonio; Miller, Keith; van Krieken, J Han; Nielsen, Soren; Swanson, Paul E; Vyberg, Mogens; Zhou, Xiaoge; Taylor, Clive R

    2017-03-01

    Validation of immunohistochemistry (IHC) assays is a subject that is of great importance to clinical practice as well as basic research and clinical trials. When applied to clinical practice and focused on patient safety, validation of IHC assays creates objective evidence that IHC assays used for patient care are "fit-for-purpose." Validation of IHC assays needs to be properly informed by and modeled to assess the purpose of the IHC assay, which will further determine what sphere of validation is required, as well as the scope, type, and tier of technical validation. These concepts will be defined in this review, part 3 of the 4-part series "Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine."

  20. Groundwater quality and simulation of sources of water to wells in the Marsh Creek valley at the U.S. Geological Survey Northern Appalachian Research Laboratory, Tioga County, Pennsylvania

    USGS Publications Warehouse

    Risser, Dennis W.; Breen, Kevin J.

    2012-01-01

    This report provides a November 2010 snapshot of groundwater quality and an analysis of the sources of water to wells at the U.S. Geological Survey (USGS) Northern Appalachian Research Laboratory (NARL) near Wellsboro, Pennsylvania. The laboratory, which conducts fisheries research, currently (2011) withdraws 1,000 gallons per minute of high-quality groundwater from three wells completed in the glacial sand and gravel aquifer beneath the Marsh Creek valley; a fourth well that taps the same aquifer provides the potable supply for the facility. The study was conducted to document the source areas and quality of the water supply for this Department of Interior facility, which is surrounded by the ongoing development of natural gas from the Marcellus Shale. Groundwater samples were collected from the four wells used by the NARL and from two nearby domestic-supply wells. The domestic-supply wells withdraw groundwater from bedrock of the Catskill Formation. Samples were analyzed for major ions, nutrients, trace metals, radiochemicals, dissolved gases, and stable isotopes of oxygen and hydrogen in water and carbon in dissolved carbonate to document groundwater quality. Organic constituents (other than hydrocarbon gases) associated with hydraulic fracturing and other human activities were not analyzed as part of this assessment. Results show low concentrations of all constituents. Only radon, which ranged from 980 to 1,310 picocuries per liter, was somewhat elevated. These findings are consistent with the pristine nature of the aquifer in the Marsh Creek valley, which is the reason the laboratory was sited at this location. The sources of water and areas contributing recharge to wells were identified by the use of a previously documented MODFLOW groundwater-flow model for the following conditions: (1) withdrawals of 1,000 to 3,000 gallons per minute from the NARL wells, (2) average or dry hydrologic conditions, and (3) withdrawals of 1,000 gallons per minute from a new

  1. Lunar laboratory

    SciTech Connect

    Keaton, P.W.; Duke, M.B.

    1986-01-01

    An international research laboratory can be established on the Moon in the early years of the 21st Century. It can be built using the transportation system now envisioned by NASA, which includes a space station for Earth orbital logistics and orbital transfer vehicles for Earth-Moon transportation. A scientific laboratory on the Moon would permit extended surface and subsurface geological exploration; long-duration experiments defining the lunar environment and its modification by surface activity; new classes of observations in astronomy; space plasma and fundamental physics experiments; and lunar resource development. The discovery of a lunar source for propellants may reduce the cost of constructing large permanent facilities in space and enhance other space programs such as Mars exploration. 29 refs.

  2. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  3. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  4. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  5. ON THE ACCURACY OF THE PROPAGATION THEORY AND THE QUALITY OF BACKGROUND OBSERVATIONS IN A SCHUMANN RESONANCE INVERSION PROCEDURE Vadim MUSHTAK, Earle WILLIAMS PARSONS LABORATORY, MIT

    NASA Astrophysics Data System (ADS)

    Mushtak, V. C.

    2009-12-01

    Observations of electromagnetic fields in the Schumann resonance (SR) frequency range (5 to 40 Hz) contain information about both the major source of the electromagnetic radiation (repeatedly confirmed to be global lightning activity) and the source-to-observer propagation medium (the Earth-ionosphere waveguide). While the electromagnetic signatures from individual lightning discharges provide preferable experimental material for exploring the medium, the properties of the world-wide lightning process are best reflected in background spectral SR observations. In the latter, electromagnetic contributions from thousands of lightning discharges are accumulated in intervals of about 10-15 minutes - long enough to present a statistically significant (and so theoretically treatable) ensemble of individual flashes, and short enough to reflect the spatial-temporal dynamics of global lightning activity. Thanks to the small (well below 1 dB/Mm) attenuation in the SR range and the accumulated nature of background SR observations, the latter present globally integrated information about lightning activity not available via other (satellite, meteorological) techniques. The most interesting characteristics to be extracted in an inversion procedure are the rates of vertical charge moment change (and their temporal variations) in the major global lightning “chimneys”. The success of such a procedure depends critically on the accuracy of the propagation theory (used to carry out “direct” calculations for the inversion) and the quality of experimental material. Due to the nature of the problem, both factors - the accuracy and the quality - can only be estimated indirectly, which requires specific approaches to assure that the estimates are realistic and more importantly, that the factors could be improved. For the first factor, simulations show that the widely exploited theory of propagation in a uniform (spherically symmetrical) waveguide provides unacceptable (up to

  6. Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory; a method supplement for the determination of Fipronil and degradates in water by gas chromatography/mass spectrometry

    USGS Publications Warehouse

    Madsen, James F.; Sandstrom, Mark W.; Zaugg, Steven D.

    2002-01-01

    A method for the isolation and detemrination of fipronil and four of its degradates has been developed. This method adapts an analytical method created by the U.S. Geological Survey National Water Quality Laboratory in 1995 for the determination of a broad range of high-use pesticides typically found in filtered natural-water samples. In 2000, fipronil and four of its degradates were extracted, analyzed, and validated using this method. The recoveries for these five compounds in reagent-water samples fortified at 1 microgram per liter (ug/L) avereraged 98 percent. Initial method detection limits averaged 0.0029 ug/L. The performance of these five new compounds is consistent with the performance of the compounds in the initial method, making it possible to include them in addition to the other 41 pesticides and pesticide degradates in the original method.

  7. 42 CFR 493.1230 - Condition: General laboratory systems.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Condition: General laboratory systems. 493.1230... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1230 Condition: General laboratory systems. Each laboratory...

  8. 42 CFR 493.1230 - Condition: General laboratory systems.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Condition: General laboratory systems. 493.1230... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1230 Condition: General laboratory systems. Each laboratory...

  9. 42 CFR 493.1230 - Condition: General laboratory systems.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: General laboratory systems. 493.1230... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1230 Condition: General laboratory systems. Each laboratory...

  10. 42 CFR 493.1230 - Condition: General laboratory systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Condition: General laboratory systems. 493.1230... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1230 Condition: General laboratory systems. Each laboratory...

  11. 42 CFR 493.1230 - Condition: General laboratory systems.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  12. Evaluation of data quality in a laboratory-based surveillance of M. tuberculosis drug resistance and impact on the prevalence of resistance: France, 2004

    PubMed Central

    KHUÊ, P. M.; MALLET, A.; VEZIRIS, N.; JARLIER, V.; ROBERT, J.

    2008-01-01

    SUMMARY In France, surveillance of anti-tuberculosis drug resistance is performed by the Azay-Mycobacteria network, representing 30% of all culture-positive cases. We sought to validate administrative and clinical data gathered by the network in 2004 and to produce corrected resistance rates accounting for the observed misclassification. We reviewed a 10% sample of patients' records diagnosed in 2004 and measured the agreement between controlled data and data collected by the network by using the kappa (κ) statistic. A re-sampling bootstrap-based method was used to investigate the impact of bias found on resistance rates. Most of data collected by the network, such as demographic data, and country of birth had an excellent agreement (κ>0·8) with controlled data. The concordance was good (κ>0·6) for HIV status and tuberculosis site. The only variable slightly discordant with controlled data was prior history of treatment (κ=0·52). However, after correcting crude resistance rates for the observed misclassification, all estimated rates were within confidence intervals based on reported rates. This validation study is in favour of a good quality of data produced by the network, even though corrected rates are slightly different from observed rates. Therefore, data collected through the network may be used for policy making and tuberculosis programme evaluation. However, improvement in data collection regarding prior history of treatment should be considered. PMID:18028573

  13. Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory : determination of polycyclic aromatic hydrocarbon compounds in sediment by gas chromatography/mass spectrometry

    USGS Publications Warehouse

    Olson, Mary C.; Iverson, Jana L.; Furlong, Edward T.; Schroeder, Michael P.

    2004-01-01

    A method for the determination of 28 polycyclic aromatic hydrocarbons (PAHs) and 25 alkylated PAH homolog groups in sediment samples is described. The compounds are extracted from sediment by solvent extraction, followed by partial isolation using high-performance gel permeation chromatography. The compounds are identified and uantitated using capillary-column gas chromatography/mass spectrometry. The report presents performance data for full-scan ion monitoring. Method detection limits in laboratory reagent matrix samples range from 1.3 to 5.1 micrograms per kilogram for the 28 PAHs. The 25 groups of alkylated PAHs are homologs of five groups of isomeric parent PAHs. Because of the lack of authentic standards, these homologs are reported semiquantitatively using a response factor from a parent PAH or a specific alkylated PAH. Precision data for the alkylated PAH homologs are presented using two different standard reference manuals produced by the National Institute of Standards and Technology: SRM 1941b and SRM 1944. The percent relative standard deviations for identified alkylated PAH homolog groups ranged from 1.55 to 6.98 for SRM 1941b and from 6.11 to 12.0 for SRM 1944. Homolog group concentrations reported under this method include the concentrations of individually identified compounds that are members of the group. Organochlorine (OC) pesticides--including toxaphene, polychlorinated biphenyls (PCBs), and organophosphate (OP) pesticides--can be isolated simultaneously using this method. In brief, sediment samples are centrifuged to remove excess water and extracted overnight with dichloromethan (95 percent) and methanol (5 percent). The extract is concentrated and then filtered through a 0.2-micrometer polytetrafluoroethylene syringe filter. The PAH fraction is isolated by quantitatively injecting an aliquot of sample onto two polystyrene-divinylbenzene gel-permeation chromatographic columns connected in series. The compounds are eluted with dichloromethane

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

    USGS Publications Warehouse

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

    1994-01-01

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

  15. Components of laboratory accreditation.

    PubMed

    Royal, P D

    1995-12-01

    Accreditation or certification is a recognition given to an operation or product that has been evaluated against a standard; be it regulatory or voluntary. The purpose of accreditation is to provide the consumer with a level of confidence in the quality of operation (process) and the product of an organization. Environmental Protection Agency/OCM has proposed the development of an accreditation program under National Environmental Laboratory Accreditation Program for Good Laboratory Practice (GLP) laboratories as a supplement to the current program. This proposal was the result of the Inspector General Office reports that identified weaknesses in the current operation. Several accreditation programs can be evaluated and common components identified when proposing a structure for accrediting a GLP system. An understanding of these components is useful in building that structure. Internationally accepted accreditation programs provide a template for building a U.S. GLP accreditation program. This presentation will discuss the traditional structure of accreditation as presented in the Organization of Economic Cooperative Development/GLP program, ISO-9000 Accreditation and ISO/IEC Guide 25 Standard, and the Canadian Association for Environmental Analytical Laboratories, which has a biological component. Most accreditation programs are managed by a recognized third party, either privately or with government oversight. Common components often include a formal review of required credentials to evaluate organizational structure, a site visit to evaluate the facility, and a performance evaluation to assess technical competence. Laboratory performance is measured against written standards and scored. A formal report is then sent to the laboratory indicating accreditation status. Usually, there is a scheduled reevaluation built into the program. Fee structures vary considerably and will need to be examined closely when building a GLP program.

  16. Consolidated clinical microbiology laboratories.

    PubMed

    Sautter, Robert L; Thomson, Richard B

    2015-05-01

    The manner in which medical care is reimbursed in the United States has resulted in significant consolidation in the U.S. health care system. One of the consequences of this has been the development of centralized clinical microbiology laboratories that provide services to patients receiving care in multiple off-site, often remote, locations. Microbiology specimens are unique among clinical specimens in that optimal analysis may require the maintenance of viable organisms. Centralized laboratories may be located hours from patient care settings, and transport conditions need to be such that organism viability can be maintained under a variety of transport conditions. Further, since the provision of rapid results has been shown to enhance patient care, effective and timely means for generating and then reporting the results of clinical microbiology analyses must be in place. In addition, today, increasing numbers of patients are found to have infection caused by pathogens that were either very uncommon in the past or even completely unrecognized. As a result, infectious disease specialists, in particular, are more dependent than ever on access to high-quality diagnostic information from clinical microbiology laboratories. In this point-counterpoint discussion, Robert Sautter, who directs a Charlotte, NC, clinical microbiology laboratory that provides services for a 40-hospital system spread over 3 states in the southeastern United States explains how an integrated clinical microbiology laboratory service has been established in a multihospital system. Richard (Tom) Thomson of the NorthShore University HealthSystem in Evanston, IL, discusses some of the problems and pitfalls associated with large-scale laboratory consolidation.

  17. Virtual Laboratories

    NASA Astrophysics Data System (ADS)

    Hut, P.

    At the frontier of most areas in science, computer simulations playa central role. The traditional division of natural science into experimental and theoretical investigations is now completely outdated. Instead, theory, simulation, and experimentation form three equally essential aspects, each with its own unique flavor and challenges. Yet, education in computational science is still lagging far behind, and the number of text books in this area is minuscule compared to the many text books on theoretical and experimental science. As a result, many researchers still carry out simulations in a haphazard way, without properly setting up the computational equivalent of a well equipped laboratory. The art of creating such a virtual laboratory, while providing proper extensibility and documentation, is still in its infancy. A new approach is described here, Open Knowledge, as an extension of the notion of Open Source software. Besides open source code, manuals, and primers, an open knowledge project provides simulated dialogues between code developers, thus sharing not only the code, but also the motivations behind the code.

  18. Aerosol Dynamics Laboratory

    SciTech Connect

    Rader, D.J.; Mondy, L.A.

    1990-04-01

    In past five years, Department 1510 has developed a state-of-the-art Aerosol Dynamics Laboratory (ADL). This report documents the current instrumentation and capabilities that exist in this laboratory. The ADL was developed from a variety of sources, with a primary contribution from Department 1510's Independent Research and Development program in aerosol dynamics. Current capabilities of the ADL include: (1) generation of calibration-quality monodisperse particles with diameters between 0.005 to 100 {mu}m, (2) real-time measurement of particle size distributions for particle diameters between 0.01 and 100 {mu}m, (3) in situ, real-time measurement of particle size distributions for particle diameters between 0.3 and 100 {mu}m, and (4) real-time measurement of particle charge distributions for particle diameters between 0.01 and 1.0 {mu}m. 14 refs., 5 figs.

  19. Laboratory investigations

    NASA Technical Reports Server (NTRS)

    Russell, Ray W.

    1988-01-01

    Laboratory studies related to cometary grains and the nuclei of comets can be broken down into three areas which relate to understanding the spectral properties, the formation mechanisms, and the evolution of grains and nuclei: (1) Spectral studies to be used in the interpretation of cometary spectra; (2) Sample preparation experiments which may shed light on the physical nature and history of cometary grains and nuclei by exploring the effects on grain emissivities resulting from the ways in which the samples are created; and (3) Grain processing experiments which should provide insight on the interaction of cometary grains with the environment in the immediate vicinity of the cometary nucleus as the comet travels from the Oort cloud through perihelion, and perhaps even suggestions regarding the relationship between interstellar grains and cometary matter. A summary is presented with a different view of lab experiments than is found in the literature, concentrating on measurement techniques and sample preparations especially relevant to cometary dust.

  20. Princeton Plasma Physics Laboratory

    SciTech Connect

    Not Available

    1990-01-01

    This report discusses the following topics: principal parameters achieved in experimental devices fiscal year 1990; tokamak fusion test reactor; compact ignition tokamak; Princeton beta experiment- modification; current drive experiment-upgrade; international collaboration; x-ray laser studies; spacecraft glow experiment; plasma processing: deposition and etching of thin films; theoretical studies; tokamak modeling; international thermonuclear experimental reactor; engineering department; project planning and safety office; quality assurance and reliability; technology transfer; administrative operations; PPPL patent invention disclosures for fiscal year 1990; graduate education; plasma physics; graduate education: plasma science and technology; science education program; and Princeton Plasma Physics Laboratory reports fiscal year 1990.

  1. The Role of Microforms in Journal Publication

    ERIC Educational Resources Information Center

    Kuney, J. H.

    1972-01-01

    The need for increased use of microfilm in primary publications is discussed. The microfilm editions of the American Chemical Society journals are now being used for supplementary material of restricted interest. Details of this arrangement and experience to date are presented. (4 references) (Author)

  2. Microforms; Catalog of Publications 1972-1973.

    ERIC Educational Resources Information Center

    1972

    Among the wide variety of materials available in mocroform edition from the National Cash Register (NCR)/Microcard Editions are papal documents, transcription of the Nuremberg trials, the complete works of Swinburne, and the complete files of many magazines, including many nineteenth century magazines. This catalog indexes offerings alphabetically…

  3. Recent Canadian Government Publications in Microform.

    ERIC Educational Resources Information Center

    Luebbe, Mary

    1983-01-01

    This biennial survey of microformatted Canadian government publications highlights the diverse publications of Micromedia Ltd., the National Library of Canada, Public Archives of Canada, and Statistics Canada. Technical reports of a federal government department--Fisheries and Oceans--patent literature, and archival materials are noted. Eight…

  4. Monitoring the performance of occupational health laboratories.

    PubMed

    Abell, M T; Doemeny, L J

    1991-08-01

    To monitor the performance of occupational health laboratories analyzing workplace air, the American Industrial Hygiene Association (AIHA), with assistance from the National Institute for Occupational Safety and Health, has established four national quality assurance programs. They are the Proficiency Analytical Testing (PAT) Program, the AIHA Laboratory Accreditation Program, the Asbestos Analysts Registry, and the Bulk Quality Assurance Program. This paper focuses on the PAT program, a quality audit program that provides samples of asbestos, silica, metals, and solvents to laboratories quarterly. PAT data for asbestos, silica, and lead were examined for trends in precision. Simple graphs of coefficient of variation during the 18-yr history of the program provide evidence of improved agreement among laboratories performing these analyses. The improvement took place in spite of growth in the number of laboratories and decreases in the levels being analyzed. The improvement is attributed to several factors, including improved analytical methods and the very existence of the PAT and AIHA Laboratory Accreditation Programs.

  5. Certification standards transfer: from committee to laboratory.

    PubMed

    Lehmann, H P

    1998-12-01

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

  6. QUALITY CONTROLS FOR PCR

    EPA Science Inventory

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

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

    PubMed

    Meresová, J; Belanová, A; Vrsková, M

    2010-01-01

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

  8. Making Laboratories Count -- Better Integration of Laboratories in Physics Courses

    NASA Astrophysics Data System (ADS)

    Sizemore, Jim

    2011-10-01

    The quality of K-12 education leaves something to be desired and presents higher education faculty with the challenge of instructing under-prepared students. However, by their own admission, students from many institutions inform us that laboratory sections in science classes, including physics, consist mostly of showing up, going through the motions, and getting grades that boost their overall grade. This work presents laboratories that challenge students to take their laboratory work more seriously including specific rubrics enforcing SOLVE and Bloom's Taxonomy, pre-lab preparation work, and quizzes on pre-lab preparation. Early results are encouraging revealing greater student progress with better integration of laboratory with the rest of a complete physics course.

  9. Guidelines for Water Quality Laboratory Operations.

    DTIC Science & Technology

    1985-07-01

    Analysis. 1977 D 045 .47’ flmlnM.@ Wr o ~ Porn a" CWNW ld am 811 ufch 17114 050 tut rafw organism15 to be ouktva.1 and tree 0f extactabbm e04-1000440...Opem.Fft RApe 76478o. or ciMtds for 09.mram of bmrW190 Suhbemces a WSW awd RAINe Se I w" PtW Sko..gsad. W at. US. Golokou Seeeay. Tedu~iss of

  10. Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory; use of a modified ultrasonic nebulizer for the analysis of low ionic-strength water by inductively coupled optical emission spectrometry

    USGS Publications Warehouse

    Harris, Carl M.; Litteral, Charles J.; Damrau, Donna L.

    1997-01-01

    The U.S. Geological Survey National Water Quality Laboratory has developed a method for the determination of dissolved calcium, iron, magnesium, manganese, silica, and sodium using a modified ultrasonic nebulizer sample-introduction system to an inductively coupled plasma-optical emission spectrometer. The nebulizer's spray chamber has been modified to avoid carryover and memory effects common in some conventional ultrasonic designs. The modified ultrasonic nebulizer is equipped with a high-speed rinse cycle to remove previously analyzed samples from the spray chamber without excessive flush times. This new rinse cycle decreases sample washout times by reducing carryover and memory effects from salt or analytes in previously analyzed samples by as much as 45 percent. Plasma instability has been reduced by repositioning the argon carrier gas inlet on the spray chamber and by directly pumping waste from the chamber, instead of from open drain traps, thereby maintaining constant pressure to the plasma. The ultrasonic nebulizer improves signal intensities, which are 8 to 16 times greater than for a conventional cross-flow pneumatic nebulizer, without being sensitive to clogging from salt buildup as in cross-flow nebulizers. Detection limits for the ultrasonic nebulizer are 4 to 18 times less than detection limits achievable using a cross-flow pneumatic nebulizer, with equivalent sample analysis time.

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

    USGS Publications Warehouse

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

    1996-01-01

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

  12. Good laboratory practice and laboratory accreditation.

    PubMed

    Lawrence, J; McQuaker, N

    1993-12-01

    Principles of good laboratory practice (GLP) and laboratory accreditation programs, particularly as they pertain to the environmental sector, are reviewed. The multitude of programs is proving costly for many laboratories and there is mounting pressure to develop reciprocity agreements between programs and to consolidate nationally and internationally. Inclusion of GLP and laboratory accreditation requirements in government regulations is resulting in a significantly increased number of laboratories participating in these programs.

  13. CRCPD`S laboratory accrediation program

    SciTech Connect

    Dukes, P.M.

    1993-12-31

    The Conference of Radiation Control Program Directors, or CRCPD, first became involved in a calibration laboratory accreditation program about 17 years ago. Since that time, the CRCPD has formed a Committee on Ionizing Measurements which writes criteria for the accreditation of laboratories, and performs the accreditation review process. To become accredited, a laboratory must agree to an administrative review, and an onsite review, and participate in measurement quality assurance (MQA) testing with the National Institute of Standards and Technology (NIST). The CRCPD currently has four accredited laboratories. All the laboratories are working with the Conference in promoting the improvement of MQA in radiation control programs.

  14. 42 CFR 493.1445 - Standard; Laboratory director responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... assessment programs are established and maintained to assure the quality of laboratory services provided and... quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic... methodologies selected have the capability of providing the quality of results required for patient care;...

  15. Environmental Response Laboratory Network (ERLN) Overview

    EPA Pesticide Factsheets

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

  16. Environmental Response Laboratory Network Membership and Benefits

    EPA Pesticide Factsheets

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

  17. [Future roles of clinical laboratories and clinical laboratory technologists in university hospitals].

    PubMed

    Yokota, Hiromitsu; Yatomi, Yutaka

    2013-08-01

    Clinical laboratories in university hospitals should be operated with a good balance of medical practice, education, research, and management. The role of a clinical laboratory is to promptly provide highly reliable laboratory data to satisfy the needs of clinicians involved in medical practice and health maintenance of patients. Improvement and maintenance of the quality of the laboratory staff and environment are essential to achieve this goal. In order to implement these requirements efficiently, an appropriate quality management system should be introduced and established, and evaluated objectively by a third party (e.g. by obtaining ISO 15189 certification). ISO 15189 is an international standard regarding the quality and competence of clinical laboratories, and specifies a review of the efficient operational system and technical requirements such as competence in implementing practical tests and calibration. This means the results of laboratory tests reported by accredited laboratories withstand any international evaluation, which is very important to assure the future importance of the existence and management of clinical laboratories as well as internationalization of medical practice. "Education" and "research" have important implications in addition to "medical practice" and "management", as the roles that clinical laboratories should play in university hospitals. University hospital laboratories should be operated by keeping these four factors in good balance. Why are "education" and "research" required in addition to "medical practice" services? If individual clinical laboratory technologists can provide an appropriate response to this question, the importance of the existence of clinical laboratories would be reinforced, without being compromised.

  18. Secondary calibration laboratory for ionizing radiation laboratory accreitation program National Institute of Standards and Technology National Voluntary Laboratory Accreditation Program

    SciTech Connect

    Martin, P.R.

    1993-12-31

    This paper presents an overview of the procedures and requirements for accreditation under the Secondary Calibration Laboratory for Ionizing Radiation Program (SCLIR LAP). The requirements for a quality system, proficiency testing and the onsite assessment are discussed. The purpose of the accreditation program is to establish a network of secondary calibration laboratories that can provide calibrations traceable to the primary national standards.

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

    PubMed

    Royal, P D

    1994-09-01

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

  20. 21 CFR 225.58 - Laboratory controls.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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