Sample records for laboratory testing including

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

    PubMed

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

    2015-12-01

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

  2. The Naval Health Research Center Respiratory Disease Laboratory.

    PubMed

    Ryan, M; Gray, G; Hawksworth, A; Malasig, M; Hudspeth, M; Poddar, S

    2000-07-01

    Concern about emerging and reemerging respiratory pathogens prompted the development of a respiratory disease reference laboratory at the Naval Health Research Center. Professionals working in this laboratory have instituted population-based surveillance for pathogens that affect military trainees and responded to threats of increased respiratory disease among high-risk military groups. Capabilities of this laboratory that are unique within the Department of Defense include adenovirus testing by viral shell culture and microneutralization serotyping, influenza culture and hemagglutination inhibition serotyping, and other special testing for Streptococcus pneumoniae, Streptococcus pyogenes, Mycoplasma pneumonia, and Chlamydia pneumoniae. Projected capabilities of this laboratory include more advanced testing for these pathogens and testing for other emerging pathogens, including Bordetella pertussis, Legionella pneumoniae, and Haemophilus influenzae type B. Such capabilities make the laboratory a valuable resource for military public health.

  3. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test... establishment of master records containing appropriate specifications and a description of the test procedures... necessary laboratory test procedures to check such specifications. (c) Assays which shall be made of...

  4. Analysis of on-line clinical laboratory manuals and practical recommendations.

    PubMed

    Beckwith, Bruce; Schwartz, Robert; Pantanowitz, Liron

    2004-04-01

    On-line clinical laboratory manuals are a valuable resource for medical professionals. To our knowledge, no recommendations currently exist for their content or design. To analyze publicly accessible on-line clinical laboratory manuals and to propose guidelines for their content. We conducted an Internet search for clinical laboratory manuals written in English with individual test listings. Four individual test listings in each manual were evaluated for 16 data elements, including sample requirements, test methodology, units of measure, reference range, and critical values. Web sites were also evaluated for supplementary information and search functions. We identified 48 on-line laboratory manuals, including 24 academic or community hospital laboratories and 24 commercial or reference laboratories. All manuals had search engines and/or test indices. No single manual contained all 16 data elements evaluated. An average of 8.9 (56%) elements were present (range, 4-14). Basic sample requirements (specimen and volume needed) were the elements most commonly present (98% of manuals). The frequency of the remaining data elements varied from 10% to 90%. On-line clinical laboratory manuals originate from both hospital and commercial laboratories. While most manuals were user-friendly and contained adequate specimen-collection information, other important elements, such as reference ranges, were frequently absent. To ensure that clinical laboratory manuals are of maximal utility, we propose the following 13 data elements be included in individual test listings: test name, synonyms, test description, test methodology, sample requirements, volume requirements, collection guidelines, transport guidelines, units of measure, reference range, critical values, test availability, and date of latest revision.

  5. Syphilis testing in antenatal care: Policies and practices among laboratories in the Americas.

    PubMed

    Luu, Minh; Ham, Cal; Kamb, Mary L; Caffe, Sonja; Hoover, Karen W; Perez, Freddy

    2015-06-01

    To asses laboratory syphilis testing policies and practices among laboratories in the Americas. Laboratory directors or designees from PAHO member countries were invited to participate in a structured, electronically-delivered survey between March and August, 2014. Data on syphilis tests, algorithms, and quality control (QC) practices were analyzed, focusing on laboratories receiving specimens from antenatal clinics (ANCs). Surveys were completed by 69 laboratories representing 30 (86%) countries. Participating laboratories included 36 (52%) national or regional reference labs and 33 (48%) lower-level laboratories. Most (94%) were public sector facilities and 71% reported existence of a national algorithm for syphilis testing in pregnancy, usually involving both treponemal and non-treponemal testing (72%). Less than half (41%) used rapid syphilis tests (RSTs); and only seven laboratories representing five countries reported RSTs were included in the national algorithm for pregnant women. Most (83%) laboratories serving ANCs reported using some type of QC system; 68% of laboratories reported participation in external QC. Only 36% of laboratories reported data to national/local surveillance. Half of all laboratories serving ANC settings reported a stockout of one or more essential supplies during the previous year (median duration, 30days). Updating laboratory algorithms, improving testing standards, integrating data into existing surveillance, and improved procurement and distribution of commodities may be needed to ensure elimination of MTCT of syphilis in the Americas. Copyright © 2015. Published by Elsevier Ireland Ltd.

  6. An effective utilization management strategy by dual approach of influencing physician ordering and gate keeping.

    PubMed

    Elnenaei, Manal O; Campbell, Samuel G; Thoni, Andrea J; Lou, Amy; Crocker, Bryan D; Nassar, Bassam A

    2016-02-01

    There is increasing recognition of the importance of appropriate laboratory test utilization. We investigate the effect of a multifaceted educational approach that includes physician feedback on individual test ordering, in conjunction with targeted restriction, on the utilization of selected laboratory tests. Scientific evidence was compiled on the usefulness and limitations of tests suspected of being over utilized in our laboratories. A variety of approaches were used to deliver education on each of the targeted tests, with greater focus on primary care physicians (PCPs). Feedback on requesting behavior of these tests was also communicated to the latter group which included an educational component. Laboratory based restriction of testing was also exercised, including the unbundling of our electrolyte panel. PCP requesting patterns for the selected tests were found to be markedly skewed. The interventions implemented over the study period resulted in a substantial 51% reduction in overall ordering of five of the targeted tests equating to an annual marginal cost saving of $60,124. Unbundling of the electrolyte panel resulted in marginal cost savings that equated annually to $42,500 on chloride and $48,000 on total CO2. A multifaceted educational approach combined with feedback on utilization and laboratory driven gate-keeping significantly reduced the number of laboratory tests suspected of being redundant or unjustifiably requested. Laboratory professionals are well positioned to manage demand on laboratory tests by utilizing evidence base in developing specific test ordering directives and gate-keeping rules. Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.

  7. Competitive bidding for Medicare Part B clinical laboratory services.

    PubMed

    Kautter, John; Pope, Gregory C

    2014-06-01

    The traditional Medicare fee-for-service program may be able to purchase clinical laboratory test services at a lower cost through competitive bidding. Demonstrations of competitive bidding for clinical laboratory tests have been twice mandated or authorized by Congress but never implemented. This article provides a summary and review of the final design of the laboratory competitive bidding demonstration mandated by the Medicare Modernization Act of 2003. The design was analogous to a sealed bid (first price), clearing price auction. Design elements presented include covered laboratory tests and beneficiaries, laboratory bidding and payment status under the demonstration, composite bids, determining bidding winners and the demonstration fee schedule, and quality under the demonstration. Expanded use of competitive bidding in Medicare, including specifically for clinical laboratory tests, has been recommended in some proposals for Medicare reform. The presented design may be a useful point of departure if Medicare clinical laboratory competitive bidding is revived in the future.

  8. Diagnostic Testing and Interpretation of Tests for Autoimmunity

    PubMed Central

    Castro, Christine; Gourley, Mark

    2010-01-01

    Laboratory testing is of great value when evaluating a patient with a suspected autoimmune disease. The results can confirm a diagnosis, estimate disease severity, aid in assessing prognosis and are useful to follow disease activity. Components of the laboratory exam include complete blood count with differential, comprehensive metabolic panel, inflammatory markers, autoantibodies, and flow cytometry. This chapter discusses these components and includes a discussion about organ-specific immunologic diseases where immunological laboratory testing is employed. Comprehensive laboratory evaluation of a suspected autoimmune illness in conjunction with a thorough clinical evaluation provides a better understanding of a patient's immunologic disease. PMID:20061009

  9. Development of criteria for the use of asphalt-rubber as a Stress-Absorbing Membrane Interlayer (SAMI)

    NASA Astrophysics Data System (ADS)

    Newcomb, D. E.; McKeen, R. G.

    1983-12-01

    This report documents over 2 years of research efforts to characterize asphalt-rubber mixtures to be used in Stress-Absorbing Membrane Interlayers (SAMI). The purpose of these SAMIs is to retard or prevent reflection cracking in asphalt-concrete overlays. Several laboratory experiments and one field trial were conducted to define significant test methods and parameters for incorporation into construction design and specification documents. Test methods used in this study included a modified softening point test, force-ductility, and Schweyer viscosity. Variables investigated included (1) Laboratory-mixing temperature; (2) Rubber type; (3) Laboratory storage time; (4) Laboratory storage condition; (5) Laboratory batch replication; (6) Laboratory mixing time; (7) Field mixing time; (8) Laboratory test temperature; (9) Force-Ductility elongation rates; and (10) Asphalt grade. It was found that mixing temperature, mixing time, rubber type, and asphalt grade all have significant effects upon the behavior of asphalt-rubber mixtures. Significant variability was also noticed in different laboratory batch replications. Varying laboratory test temperature and force-ductility elongation rate revealed further differences in asphalt-rubber mixtures.

  10. Structural Test Laboratory | Water Power | NREL

    Science.gov Websites

    Structural Test Laboratory Structural Test Laboratory NREL engineers design and configure structural components can validate models, demonstrate system reliability, inform design margins, and assess , including mass and center of gravity, to ensure compliance with design goals Dynamic Characterization Use

  11. Chronic myelogenous leukemia: laboratory diagnosis and monitoring.

    PubMed

    Wang, Y L; Bagg, A; Pear, W; Nowell, P C; Hess, J L

    2001-10-01

    Rapid developments have occurred both in laboratory medicine and in therapeutic interventions for the management of patients with chronic myelogenous leukemia (CML). With a wide array of laboratory tests available, selecting the appropriate test for a specific diagnostic or therapeutic setting has become increasingly difficult. In this review, we first discuss, from the point of view of laboratory medicine, the advantages and disadvantages of several commonly used laboratory assays, including cytogenetics, fluorescence in situ hybridization (FISH), and qualitative and quantitative reverse transcriptase-polymerase chain reaction (RT-PCR). We then discuss, from the point of view of clinical care, the test(s) of choice for the most common clinical scenarios, including diagnosis and monitoring of the therapeutic response and minimal residual disease in patients treated with different therapies. The purpose of this review is to help clinicians and laboratory physicians select appropriate tests for the diagnosis and monitoring of CML, with the ultimate goal of improving the cost-effective usage of clinical laboratories and improving patient care. Copyright 2001 Wiley-Liss, Inc.

  12. Some new tests at the Gottingen laboratory

    NASA Technical Reports Server (NTRS)

    1921-01-01

    The tests at the Gottingen laboratory included: friction tests on a surface treated with omelette, verification tests on the M.V.A. 356 wing, and comparative tests of wing no. 36 at the Eiffel laboratory. The examination of all these experiments leads to the belief that, at large incidences, the speeds registered by the suction manometer of the testing chamber of the Eiffel laboratory wind tunnel are, owing to pressure drop, greater than the actual speeds. Therefore, the values of k(sub x) and k(sub y) measured at the Eiffel laboratory at large incidences are too low.

  13. Use of proficiency test performance to determine clinical laboratory director qualifications.

    PubMed

    Howanitz, P J

    1988-04-01

    Many activities and policies influence laboratory test quality. Proficiency test results are one measure of laboratory quality, and during the past 25 years, five studies have examined the relationship of laboratory director educational requirements to proficiency test results. Data from three studies support the association between director qualifications and quality as measured by proficiency test performance, whereas no relationship was found in the other two studies. Possible reasons for conflicting results include differences in database size and demographics; in addition, proficiency test results may be inappropriate, although widely used, as the sole measure of laboratory director performance.

  14. Laboratory-acquired infections of Salmonella enterica serotype Typhi in South Africa: phenotypic and genotypic analysis of isolates.

    PubMed

    Smith, Anthony Marius; Smouse, Shannon Lucrecia; Tau, Nomsa Pauline; Bamford, Colleen; Moodley, Vineshree Mischka; Jacobs, Charlene; McCarthy, Kerrigan Mary; Lourens, Adré; Keddy, Karen Helena

    2017-09-29

    Workers in clinical microbiology laboratories are exposed to a variety of pathogenic microorganisms. Salmonella species is among the most commonly reported bacterial causes of laboratory-acquired infections. We report on three cases of laboratory-acquired Salmonella enterica serotype Typhi (Salmonella Typhi) infection which occurred over the period 2012 to 2016 in South Africa. Laboratory investigation included phenotypic and genotypic characterization of isolates. Phenotypic analysis included standard microbiological identification techniques, serotyping and antimicrobial susceptibility testing. Genotypic analysis included the molecular subtyping methodologies of pulsed-field gel electrophoresis analysis, multilocus sequence typing and whole-genome sequencing (WGS); with WGS data analysis including phylogenetic analysis based upon comparison of single nucleotide polymorphism profiles of isolates. All cases of laboratory-acquired infection were most likely the result of lapses in good laboratory practice and laboratory safety. The following critical issues were highlighted. There was misdiagnosis and misreporting of Salmonella Typhi as nontyphoidal Salmonella by a diagnostic laboratory, with associated public health implications. We highlight issues concerning the importance of accurate fluoroquinolone susceptibility testing and interpretation of results according to updated guidelines. We describe potential shortcomings of a single disk susceptibility screening test for fluoroquinolone susceptibility and suggest that confirmatory minimum inhibitory concentration testing should always be performed in cases of invasive Salmonella infections. These antimicrobial susceptibility testing issues resulted in inappropriate ciprofloxacin therapy which may have been responsible for failure in clearance of pathogen from patients. Salmonella Typhi capsular polysaccharide vaccine was not protective in one case, possibly secondarily to a faulty vaccine. Molecular subtyping of isolates proved effective to investigate the genetic relatedness of isolates. Molecular subtyping data interpreted together with epidemiological data allowed us to pinpoint the most likely sources for our cases of laboratory-acquired infection.

  15. Antianaerobic Antimicrobials: Spectrum and Susceptibility Testing

    PubMed Central

    Wexler, Hannah M.; Goldstein, Ellie J. C.

    2013-01-01

    SUMMARY Susceptibility testing of anaerobic bacteria recovered from selected cases can influence the choice of antimicrobial therapy. The Clinical and Laboratory Standards Institute (CLSI) has standardized many laboratory procedures, including anaerobic susceptibility testing (AST), and has published documents for AST. The standardization of testing methods by the CLSI allows comparisons of resistance trends among various laboratories. Susceptibility testing should be performed on organisms recovered from sterile body sites, those that are isolated in pure culture, or those that are clinically important and have variable or unique susceptibility patterns. Organisms that should be considered for individual isolate testing include highly virulent pathogens for which susceptibility cannot be predicted, such as Bacteroides, Prevotella, Fusobacterium, and Clostridium spp.; Bilophila wadsworthia; and Sutterella wadsworthensis. This review describes the current methods for AST in research and reference laboratories. These methods include the use of agar dilution, broth microdilution, Etest, and the spiral gradient endpoint system. The antimicrobials potentially effective against anaerobic bacteria include beta-lactams, combinations of beta-lactams and beta-lactamase inhibitors, metronidazole, chloramphenicol, clindamycin, macrolides, tetracyclines, and fluoroquinolones. The spectrum of efficacy, antimicrobial resistance mechanisms, and resistance patterns against these agents are described. PMID:23824372

  16. Good laboratory practices for biochemical genetic testing and newborn screening for inherited metabolic disorders.

    PubMed

    2012-04-06

    Biochemical genetic testing and newborn screening are essential laboratory services for the screening, detection, diagnosis, and monitoring of inborn errors of metabolism or inherited metabolic disorders. Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, laboratory testing is categorized on the basis of the level of testing complexity as either waived (i.e., from routine regulatory oversight) or nonwaived testing (which includes tests of moderate and high complexity). Laboratories that perform biochemical genetic testing are required by CLIA regulations to meet the general quality systems requirements for nonwaived testing and the personnel requirements for high-complexity testing. Laboratories that perform public health newborn screening are subject to the same CLIA regulations and applicable state requirements. As the number of inherited metabolic diseases that are included in state-based newborn screening programs continues to increase, ensuring the quality of performance and delivery of testing services remains a continuous challenge not only for public health laboratories and other newborn screening facilities but also for biochemical genetic testing laboratories. To help ensure the quality of laboratory testing, CDC collaborated with the Centers for Medicare & Medicaid Services, the Food and Drug Administration, the Health Resources and Services Administration, and the National Institutes of Health to develop guidelines for laboratories to meet CLIA requirements and apply additional quality assurance measures for these areas of genetic testing. This report provides recommendations for good laboratory practices that were developed based on recommendations from the Clinical Laboratory Improvement Advisory Committee, with additional input from the Secretary's Advisory Committee on Genetics, Health, and Society; the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; and representatives of newborn screening laboratories. The recommended practices address the benefits of using a quality management system approach, factors to consider before introducing new tests, establishment and verification of test performance specifications, the total laboratory testing process (which consists of the preanalytic, analytic, and postanalytic phases), confidentiality of patient information and test results, and personnel qualifications and responsibilities for laboratory testing for inherited metabolic diseases. These recommendations are intended for laboratories that perform biochemical genetic testing to improve the quality of laboratory services and for newborn screening laboratories to ensure the quality of laboratory practices for inherited metabolic disorders. These recommendations also are intended as a resource for medical and public health professionals who evaluate laboratory practices, for users of laboratory services to facilitate their collaboration with newborn screening systems and use of biochemical genetic tests, and for standard-setting organizations and professional societies in developing future laboratory quality standards and practice recommendations. This report complements Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions (CDC. Good laboratory practices for molecular genetic testing for heritable diseases and conditions. MMWR 2009;58 [No. RR-6]) to provide guidance for ensuring and improving the quality of genetic laboratory services and public health outcomes. Future recommendations for additional areas of genetic testing will be considered on the basis of continued monitoring and evaluation of laboratory practices, technology advancements, and the development of laboratory standards and guidelines.

  17. Promoting clinical and laboratory interaction by harmonization.

    PubMed

    Plebani, Mario; Panteghini, Mauro

    2014-05-15

    The lack of interchangeable results in current practice among clinical laboratories has underpinned greater attention to standardization and harmonization projects. Although the focus was mainly on the standardization and harmonization of measurement procedures and their results, the scope of harmonization goes beyond method and analytical results: it includes all other aspects of laboratory testing, including terminology and units, report formats, reference limits and decision thresholds, as well as test profiles and criteria for the interpretation of results. In particular, as evidence collected in last decades demonstrates that pre-pre- and post-post-analytical steps are more vulnerable to errors, harmonization initiatives should be performed to improve procedures and processes at the laboratory-clinical interface. Managing upstream demand, down-stream interpretation of laboratory results, and subsequent appropriate action through close relationships between laboratorians and clinicians remains a crucial issue of the laboratory testing process. Therefore, initiatives to improve test demand management from one hand and to harmonize procedures to improve physicians' acknowledgment of laboratory data and their interpretation from the other hand are needed in order to assure quality and safety in the total testing process. © 2013.

  18. Creep Laboratory manual

    NASA Astrophysics Data System (ADS)

    Osgerby, S.; Loveday, M. S.

    1992-06-01

    A manual for the NPL Creep Laboratory, a collective name given to two testing laboratories, the Uniaxial Creep Laboratory and the Advanced High Temperature Mechanical Testing Laboratory, is presented. The first laboratory is devoted to uniaxial creep testing and houses approximately 50 high sensitivity creep machines including 10 constant stress cam lever machines. The second laboratory houses a low cycle fatigue testing machine of 100 kN capacity driven by a servo-electric actuator, five machines for uniaxial tensile creep testing of engineering ceramics at temperatures up to 1600C, and an electronic creep machine. Details of the operational procedures for carrying out uniaxial creep testing are given. Calibration procedures to be followed in order to comply with the specifications laid down by British standards, and to provide traceability back to the primary standards are described.

  19. A multivariate assessment of the effect of the laboratory homework component of a microcomputer-based laboratory for a college freshman physics course

    NASA Astrophysics Data System (ADS)

    Ramlo, Susan E.

    Microcomputer-based laboratories (MBLs) have been defined as software that uses an electronic probe to collect information about a physical system and then converts that information into graphical systems in real-time. Realtime Physics Laboratories (RTP) are an example of laboratories that combine the use of MBLs with collaboration and guided-inquiry. RTP Mechanics Laboratories include both laboratory activities and laboratory homework for the first semester of college freshman physics courses. Prior research has investigated the effectiveness of the RTP laboratories as a package (laboratory activities with laboratory homework). In this study, an experimental-treatment had students complete both the RTP laboratory activity and the associated laboratory homework during the same laboratory period. Observations of this treatment indicated that students primarily consulted the laboratory instructor and referred to their completed laboratory activity while completing the homework in their collaborative groups. In the control-treatment, students completed the laboratory homework outside the laboratory period. Measures of force and motion conceptual understanding included the Force and Motion Conceptual Understanding (FMCE), a 47 multiple-choice question test. Analyses of the FMCE indicated that it is both a reliable and a valid measure of force and motion conceptual understanding. A distinct, five-factor structure for the FMCE post-test answers reflected specific concepts related to force and motion. However, the three FMCE pretest factors were less distinct. Analysis of the experimental-treatment, compared to a control-treatment, included multiple regression analysis with covariates of age, prior physics-classroom experience, and the three FMCE pretest factors. Criterion variables included each of the five post-test factors, the total laboratory homework score, and a group of seven exam questions. The results were all positive, in favor of the experimental-treatment. However, the results were significant only with the criterions of the FMCE post-test factor "Concepts Regarding Newton's First and Second Laws" and the laboratory homework score. The interaction between the treatments and prior physics-classroom experience was not significant. Implications of the qualitative and quantitative findings are discussed.

  20. Announcement: Guidance for U.S. Laboratory Testing for Zika Virus Infection: Implications for Health Care Providers.

    PubMed

    2016-11-25

    CDC has released updated guidance online for U.S. laboratory testing for Zika virus infection. The guidance is available at https://www.cdc.gov/zika/laboratories/lab-guidance.html. Frequently asked questions are addressed at https://www.cdc.gov/zika/laboratories/lab-guidance-faq.html. This guidance updates recommendations for testing of specimens by U.S. laboratories for possible Zika virus infection. Major updates to the guidance with clinical implications for health care providers include the following.

  1. Cruise Stage Testing for Mars Science Laboratory

    NASA Image and Video Library

    2010-09-02

    Testing of the cruise stage for NASA Mars Science Laboratory in August 2010 included a session in a facility that simulates the environment found in interplanetary space. Spacecraft technicians at JPL prepare a space-simulation test.

  2. A laboratory medicine residency training program that includes clinical consultation and research.

    PubMed

    Spitzer, E D; Pierce, G F; McDonald, J M

    1990-04-01

    We describe a laboratory medicine residency training program that includes ongoing interaction with both clinical laboratories and clinical services as well as significant research experience. Laboratory medicine residents serve as on-call consultants in the interpretation of test results, design of testing strategies, and assurance of test quality. The consultative on-call beeper system was evaluated and is presented as an effective method of clinical pathology training that is well accepted by the clinical staff. The research component of the residency program is also described. Together, these components provide training in real-time clinical problem solving and prepare residents for the changing technological environment of the clinical laboratory. At the completion of the residency, the majority of the residents are qualified laboratory subspecialists and are also capable of running an independent research program.

  3. Testing painted wood : past practices at the Forest Products Laboratory and recommendations for future research

    Treesearch

    R. Sam Williams

    2009-01-01

    A brief history of paint research at the Forest Products Laboratory (FPL) in Madison, Wisconsin, sets the stage for a discussion of testing paint on wood and wood products. Tests include laboratory and outdoor tests, and I discuss them in terms of several degradation mechanisms (loss of gloss and fading, mildew growth, extractives bleed, and cracking, flaking, and...

  4. Workgroup for Hydraulic laboratory Testing and Verification of Hydroacoustic Instrumentation

    USGS Publications Warehouse

    Fulford, Janice M.; Armstrong, Brandy N.; Thibodeaux, Kirk G.

    2015-01-01

    An international workgroup was recently formed for hydraulic laboratory testing and verification of hydroacoustic instrumentation used for water velocity measurements. The activities of the workgroup have included one face to face meeting, conference calls and an inter-laboratory exchange of two acoustic meters among participating laboratories. Good agreement was found among four laboratories at higher tow speeds and poorer agreement at the lowest tow speed.

  5. Advanced Materials Laboratory User Test Planning Guide

    NASA Technical Reports Server (NTRS)

    Orndoff, Evelyne

    2012-01-01

    Test process, milestones and inputs are unknowns to first-time users of the Advanced Materials Laboratory. The User Test Planning Guide aids in establishing expectations for both NASA and non-NASA facility customers. The potential audience for this guide includes both internal and commercial spaceflight hardware/software developers. It is intended to assist their test engineering personnel in test planning and execution. Material covered includes a roadmap of the test process, roles and responsibilities of facility and user, major milestones, facility capabilities, and inputs required by the facility. Samples of deliverables, test article interfaces, and inputs necessary to define test scope, cost, and schedule are included as an appendix to the guide.

  6. Assuring the Quality of Test Results in the Field of Nuclear Techniques and Ionizing Radiation. The Practical Implementation of Section 5.9 of the EN ISO/IEC 17025 Standard

    NASA Astrophysics Data System (ADS)

    Cucu, Daniela; Woods, Mike

    2008-08-01

    The paper aims to present a practical approach for testing laboratories to ensure the quality of their test results. It is based on the experience gained in assessing a large number of testing laboratories, discussing with management and staff, reviewing results obtained in national and international PTs and ILCs and exchanging information in the EA laboratory committee. According to EN ISO/IEC 17025, an accredited laboratory has to implement a programme to ensure the quality of its test results for each measurand. Pre-analytical, analytical and post-analytical measures shall be applied in a systematic manner. They shall include both quality control and quality assurance measures. When designing the quality assurance programme a laboratory should consider pre-analytical activities (like personnel training, selection and validation of test methods, qualifying equipment), analytical activities ranging from sampling, sample preparation, instrumental analysis and post-analytical activities (like decoding, calculation, use of statistical tests or packages, management of results). Designed on different levels (analyst, quality manager and technical manager), including a variety of measures, the programme shall ensure the validity and accuracy of test results, the adequacy of the management system, prove the laboratory's competence in performing tests under accreditation and last but not least show the comparability of test results. Laboratory management should establish performance targets and review periodically QC/QA results against them, implementing appropriate measures in case of non-compliance.

  7. Reporting Results of Molecular Tests: A Retrospective Examination of BRAF Mutation Reporting.

    PubMed

    Treece, Amanda L; Gulley, Margaret L; Vasalos, Patricia; Paquette, Cherie; Lindeman, Neal I; Jennings, Lawrence J; Bartley, Angela N

    2017-05-01

    - With enormous growth in the field of molecular pathology, the reporting of results gleaned from this testing is essential to guide patient care. - To examine molecular reports from laboratories participating in proficiency testing for required elements to convey molecular laboratory test results to clinicians and patients. - Molecular laboratories participating in the College of American Pathologists (CAP) proficiency testing program for BRAF mutation analysis were solicited to submit examples of final reports from 2 separate proficiency testing reporting cycles. Reports were reviewed for the presence or absence of relevant components. - A total of 107 evaluable reports were received (57 demonstrating a positive result for the BRAF V600E mutation and 50 negative). Methods for BRAF testing varied, with 95% (102 of 107) of reports adequately describing their assay methods and 87% (93 of 107) of reports adequately describing the target(s) of their assays. Information on the analytic sensitivity of the assay was present in 74% (79 of 107) of reports and 83% (89 of 107) reported at least 1 assay limitation, though only 34% (36 of 107) reported on variants not detected by their assays. Analytic and clinical interpretive comments were included in 99% (106 of 107) and 90% (96 of 107) of reports, respectively. Of participants that perform a laboratory-developed test, 88% (88 of 100) included language addressing the development of the assay. - Laboratories participating in BRAF proficiency testing through the CAP are including most of the required reporting elements to unambiguously convey molecular results. Laboratories should continue to strive to report these results in a concise and comprehensive manner.

  8. The Point-of-Care Laboratory in Clinical Microbiology

    PubMed Central

    Michel-Lepage, Audrey; Boyer, Sylvie; Raoult, Didier

    2016-01-01

    SUMMARY Point-of-care (POC) laboratories that deliver rapid diagnoses of infectious diseases were invented to balance the centralization of core laboratories. POC laboratories operate 24 h a day and 7 days a week to provide diagnoses within 2 h, largely based on immunochromatography and real-time PCR tests. In our experience, these tests are conveniently combined into syndrome-based kits that facilitate sampling, including self-sampling and test operations, as POC laboratories can be operated by trained operators who are not necessarily biologists. POC laboratories are a way of easily providing clinical microbiology testing for populations distant from laboratories in developing and developed countries and on ships. Modern Internet connections enable support from core laboratories. The cost-effectiveness of POC laboratories has been established for the rapid diagnosis of tuberculosis and sexually transmitted infections in both developed and developing countries. PMID:27029593

  9. Use of coal fly ash and other waste products in soil stabilization and road construction including non-destructive testing of roadways.

    DOT National Transportation Integrated Search

    2012-06-01

    An extensive laboratory testing program was performed on subgrade soils stabilized using fly ash and : lime kiln dust. The laboratory program included measurements of: compaction curves, small strain elastic moduli, : resilient modulus (Mr), Briaud C...

  10. Use of coal fly ash and other waste products in soil stabilization and road construction-including non-destructive testing of roadways.

    DOT National Transportation Integrated Search

    2012-02-01

    An extensive laboratory testing program was performed on subgrade soils stabilized using fly ash and lime kiln dust. The laboratory : program included measurements of: compaction curves, small strain elastic moduli, resilient modulus (Mr), Briaud Com...

  11. Good Laboratory Practices of Materials Testing at NASA White Sands Test Facility

    NASA Technical Reports Server (NTRS)

    Hirsch, David; Williams, James H.

    2005-01-01

    An approach to good laboratory practices of materials testing at NASA White Sands Test Facility is presented. The contents include: 1) Current approach; 2) Data analysis; and 3) Improvements sought by WSTF to enhance the diagnostic capability of existing methods.

  12. Thermal-Mechanical Testing of Hypersonic Vehicle Structures

    NASA Technical Reports Server (NTRS)

    Hudson, Larry; Stephens, Craig

    2007-01-01

    A viewgraph presentation describing thermal-mechanical tests on the structures of hypersonic vehicles is shown. The topics include: 1) U.S. Laboratories for Hot Structures Testing; 2) NASA Dryden Flight Loads Laboratory; 3) Hot Structures Test Programs; 4) Typical Sequence for Hot Structures Testing; 5) Current Hot Structures Testing; and 6) Concluding Remarks.

  13. Benchmarking in pathology: development of an activity-based costing model.

    PubMed

    Burnett, Leslie; Wilson, Roger; Pfeffer, Sally; Lowry, John

    2012-12-01

    Benchmarking in Pathology (BiP) allows pathology laboratories to determine the unit cost of all laboratory tests and procedures, and also provides organisational productivity indices allowing comparisons of performance with other BiP participants. We describe 14 years of progressive enhancement to a BiP program, including the implementation of 'avoidable costs' as the accounting basis for allocation of costs rather than previous approaches using 'total costs'. A hierarchical tree-structured activity-based costing model distributes 'avoidable costs' attributable to the pathology activities component of a pathology laboratory operation. The hierarchical tree model permits costs to be allocated across multiple laboratory sites and organisational structures. This has enabled benchmarking on a number of levels, including test profiles and non-testing related workload activities. The development of methods for dealing with variable cost inputs, allocation of indirect costs using imputation techniques, panels of tests, and blood-bank record keeping, have been successfully integrated into the costing model. A variety of laboratory management reports are produced, including the 'cost per test' of each pathology 'test' output. Benchmarking comparisons may be undertaken at any and all of the 'cost per test' and 'cost per Benchmarking Complexity Unit' level, 'discipline/department' (sub-specialty) level, or overall laboratory/site and organisational levels. We have completed development of a national BiP program. An activity-based costing methodology based on avoidable costs overcomes many problems of previous benchmarking studies based on total costs. The use of benchmarking complexity adjustment permits correction for varying test-mix and diagnostic complexity between laboratories. Use of iterative communication strategies with program participants can overcome many obstacles and lead to innovations.

  14. Reducing Overutilization of Testing for Clostridium difficile Infection in a Pediatric Hospital System: A Quality Improvement Initiative.

    PubMed

    Klatte, J Michael; Selvarangan, Rangaraj; Jackson, Mary Anne; Myers, Angela L

    2016-01-01

    Study objectives included addressing overuse of Clostridium difficile laboratory testing by decreasing submission rates of nondiarrheal stool specimens and specimens from children ≤12 months of age and determining resultant patient and laboratory cost savings associated with decreased testing. A multifaceted initiative was developed, and components included multiple provider education methods, computerized order entry modifications, and automatic declination from laboratory on testing stool specimens of nondiarrheal consistency and from children ≤12 months old. A run chart, demonstrating numbers of nondiarrheal plus infant stool specimens submitted over time, was developed to analyze the initiative's impact on clinicians' test-ordering practices. A p-chart was generated to evaluate the percentage of these submitted specimens tested biweekly over a 12-month period. Cost savings for patients and the laboratory were assessed at the study period's conclusion. Run chart analysis revealed an initial shift after the interventions, suggesting a temporary decrease in testing submission; however, no sustained differences in numbers of specimens submitted biweekly were observed over time. On the p-chart, the mean percentage of specimens tested before the intervention was 100%. After the intervention, the average percentage of specimens tested dropped to 53.8%. Resultant laboratory cost savings totaled nearly $3600, and patient savings on testing charges were ∼$32 000. Automatic laboratory declination of nondiarrheal stools submitted for CDI testing resulted in a sustained decrease in the number of specimens tested, resulting in significant laboratory and patient cost savings. Despite multiple educational efforts, no sustained changes in physician ordering practices were observed. Copyright © 2016 by the American Academy of Pediatrics.

  15. Initial Public Health Laboratory Response After Hurricane Maria - Puerto Rico, 2017.

    PubMed

    Concepción-Acevedo, Jeniffer; Patel, Anita; Luna-Pinto, Carolina; Peña, Rafael González; Cuevas Ruiz, Rosa Ivette; Arbolay, Héctor Rivera; Toro, Mayra; Deseda, Carmen; De Jesus, Victor R; Ribot, Efrain; Gonzalez, Jennifer-Quiñones; Rao, Gouthami; De Leon Salazar, Alfonsina; Ansbro, Marisela; White, Brunilís B; Hardy, Margaret C; Georgi, Joaudimir Castro; Stinnett, Rita; Mercante, Alexandra M; Lowe, David; Martin, Haley; Starks, Angela; Metchock, Beverly; Johnston, Stephanie; Dalton, Tracy; Joglar, Olga; Stafford, Cortney; Youngblood, Monica; Klein, Katherine; Lindstrom, Stephen; Berman, LaShondra; Galloway, Renee; Schafer, Ilana J; Walke, Henry; Stoddard, Robyn; Connelly, Robin; McCaffery, Elaine; Rowlinson, Marie-Claire; Soroka, Stephen; Tranquillo, Darin T; Gaynor, Anne; Mangal, Chris; Wroblewski, Kelly; Muehlenbachs, Atis; Salerno, Reynolds M; Lozier, Matthew; Sunshine, Brittany; Shapiro, Craig; Rose, Dale; Funk, Renee; Pillai, Satish K; O'Neill, Eduardo

    2018-03-23

    Hurricane Maria made landfall in Puerto Rico on September 20, 2017, causing major damage to infrastructure and severely limiting access to potable water, electric power, transportation, and communications. Public services that were affected included operations of the Puerto Rico Department of Health (PRDOH), which provides critical laboratory testing and surveillance for diseases and other health hazards. PRDOH requested assistance from CDC for the restoration of laboratory infrastructure, surveillance capacity, and diagnostic testing for selected priority diseases, including influenza, rabies, leptospirosis, salmonellosis, and tuberculosis. PRDOH, CDC, and the Association of Public Health Laboratories (APHL) collaborated to conduct rapid needs assessments and, with assistance from the CDC Foundation, implement a temporary transport system for shipping samples from Puerto Rico to the continental United States for surveillance and diagnostic and confirmatory testing. This report describes the initial laboratory emergency response and engagement efforts among federal, state, and nongovernmental partners to reestablish public health laboratory services severely affected by Hurricane Maria. The implementation of a sample transport system allowed Puerto Rico to reinitiate priority infectious disease surveillance and laboratory testing for patient and public health interventions, while awaiting the rebuilding and reinstatement of PRDOH laboratory services.

  16. Mistakes in a stat laboratory: types and frequency.

    PubMed

    Plebani, M; Carraro, P

    1997-08-01

    Application of Total Quality Management concepts to laboratory testing requires that the total process, including preanalytical and postanalytical phases, be managed so as to reduce or, ideally, eliminate all defects within the process itself. Indeed a "mistake" can be defined as any defect during the entire testing process, from ordering tests to reporting results. We evaluated the frequency and types of mistakes found in the "stat" section of the Department of Laboratory Medicine of the University-Hospital of Padova by monitoring four different departments (internal medicine, nephrology, surgery, and intensive care unit) for 3 months. Among a total of 40490 analyses, we identified 189 laboratory mistakes, a relative frequency of 0.47%. The distribution of mistakes was: preanalytical 68.2%, analytical 13.3%, and postanalytical 18.5%. Most of the laboratory mistakes (74%) did not affect patients' outcome. However, in 37 patients (19%), laboratory mistakes were associated with further inappropriate investigations, thus resulting in an unjustifiable increase in costs. Moreover, in 12 patients (6.4%) laboratory mistakes were associated with inappropriate care or inappropriate modification of therapy. The promotion of quality control and continuous improvement of the total testing process, including pre- and postanalytical phases, seems to be a prerequisite for an effective laboratory service.

  17. LabRS: A Rosetta stone for retrospective standardization of clinical laboratory test results.

    PubMed

    Hauser, Ronald George; Quine, Douglas B; Ryder, Alex

    2018-02-01

    Clinical laboratories in the United States do not have an explicit result standard to report the 7 billion laboratory tests results they produce each year. The absence of standardized test results creates inefficiencies and ambiguities for secondary data users. We developed and tested a tool to standardize the results of laboratory tests in a large, multicenter clinical data warehouse. Laboratory records, each of which consisted of a laboratory result and a test identifier, from 27 diverse facilities were captured from 2000 through 2015. Each record underwent a standardization process to convert the original result into a format amenable to secondary data analysis. The standardization process included the correction of typos, normalization of categorical results, separation of inequalities from numbers, and conversion of numbers represented by words (eg, "million") to numerals. Quality control included expert review. We obtained 1.266 × 109 laboratory records and standardized 1.252 × 109 records (98.9%). Of the unique unstandardized records (78.887 × 103), most appeared <5 times (96%, eg, typos), did not have a test identifier (47%), or belonged to an esoteric test with <100 results (2%). Overall, these 3 reasons accounted for nearly all unstandardized results (98%). Current results suggest that the tool is both scalable and generalizable among diverse clinical laboratories. Based on observed trends, the tool will require ongoing maintenance to stay current with new tests and result formats. Future work to develop and implement an explicit standard for test results would reduce the need to retrospectively standardize test results. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  18. Updating the immunology curriculum in clinical laboratory science.

    PubMed

    Stevens, C D

    2000-01-01

    To determine essential content areas of immunology/serology courses at the clinical laboratory technician (CLT) and clinical laboratory scientist (CLS) levels. A questionnaire was designed which listed all major topics in immunology and serology. Participants were asked to place a check beside each topic covered. For an additional list of serological and immunological laboratory testing, participants were asked to indicate if each test was performed in either the didactic or clinical setting, or not performed at all. A national survey of 593 NAACLS approved CLT and CLS programs was conducted by mail under the auspices of ASCLS. Responses were obtained from 158 programs. Respondents from all across the United States included 60 CLT programs, 48 hospital-based CLS programs, 45 university-based CLS programs, and 5 university-based combined CLT and CLS programs. The survey was designed to enumerate major topics included in immunology and serology courses by a majority of participants at two distinct educational levels, CLT and CLS. Laboratory testing routinely performed in student laboratories as well as in the clinical setting was also determined for these two levels of practitioners. Certain key topics were common to most immunology and serology courses. There were some notable differences in the depth of courses at the CLT and CLS levels. Laboratory testing associated with these courses also differed at the two levels. Testing requiring more detailed interpretation, such as antinuclear antibody patterns (ANAs), was mainly performed by CLS students only. There are certain key topics as well as specific laboratory tests that should be included in immunology/serology courses at each of the two different educational levels to best prepare students for the workplace. Educators can use this information as a guide to plan a curriculum for such courses.

  19. A program for the investigation of the Multibody Modeling, Verification, and Control Laboratory

    NASA Technical Reports Server (NTRS)

    Tobbe, Patrick A.; Christian, Paul M.; Rakoczy, John M.; Bulter, Marlon L.

    1993-01-01

    The Multibody Modeling, Verification, and Control (MMVC) Laboratory is under development at NASA MSFC in Huntsville, Alabama. The laboratory will provide a facility in which dynamic tests and analyses of multibody flexible structures representative of future space systems can be conducted. The purpose of the tests are to acquire dynamic measurements of the flexible structures undergoing large angle motions and use the data to validate the multibody modeling code, TREETOPS, developed under sponsorship of NASA. Advanced control systems design and system identification methodologies will also be implemented in the MMVC laboratory. This paper describes the ground test facility, the real-time control system, and the experiments. A top-level description of the TREETOPS code is also included along with the validation plan for the MMVC program. Dynamic test results from component testing are also presented and discussed. A detailed discussion of the test articles, which manifest the properties of large flexible space structures, is included along with a discussion of the various candidate control methodologies to be applied in the laboratory.

  20. Calculating cost savings in utilization management.

    PubMed

    MacMillan, Donna

    2014-01-01

    A major motivation for managing the utilization of laboratory testing is to reduce the cost of medical care. For this reason it is important to understand the basic principles of cost accounting in the clinical laboratory. The process of laboratory testing includes three distinct components termed the pre-analytic, analytic and post-analytic phases. Utilization management efforts may impact the cost structure of these three phases in different ways depending on the specific details of the initiative. Estimates of cost savings resulting from utilization management programs reported in the literature have often been fundamentally flawed due to a failure to understand basic concepts such as the difference between laboratory costs versus charges and the impact of reducing laboratory test volumes on the average versus marginal cost structure in the laboratory. This article will provide an overview of basic cost accounting principles in the clinical laboratory including both job order and process cost accounting. Specific examples will be presented to illustrate these concepts in various different scenarios. © 2013.

  1. Transferability and within- and between-laboratory reproducibilities of EpiSensA for predicting skin sensitization potential in vitro: A ring study in three laboratories.

    PubMed

    Mizumachi, Hideyuki; Sakuma, Megumi; Ikezumi, Mayu; Saito, Kazutoshi; Takeyoshi, Midori; Imai, Noriyasu; Okutomi, Hiroko; Umetsu, Asami; Motohashi, Hiroko; Watanabe, Mika; Miyazawa, Masaaki

    2018-05-03

    The epidermal sensitization assay (EpiSensA) is an in vitro skin sensitization test method based on gene expression of four markers related to the induction of skin sensitization; the assay uses commercially available reconstructed human epidermis. EpiSensA has exhibited an accuracy of 90% for 72 chemicals, including lipophilic chemicals and pre-/pro-haptens, when compared with the results of the murine local lymph node assay. In this work, a ring study was performed by one lead and two naive laboratories to evaluate the transferability, as well as within- and between-laboratory reproducibilities, of EpiSensA. Three non-coded chemicals (two lipophilic sensitizers and one non-sensitizer) were tested for the assessment of transferability and 10 coded chemicals (seven sensitizers and three non-sensitizers, including four lipophilic chemicals) were tested for the assessment of reproducibility. In the transferability phase, the non-coded chemicals (two sensitizers and one non-sensitizer) were correctly classified at the two naive laboratories, indicating that the EpiSensA protocol was transferred successfully. For the within-laboratory reproducibility, the data generated with three coded chemicals tested in three independent experiments in each laboratory gave consistent predictions within laboratories. For the between-laboratory reproducibility, 9 of the 10 coded chemicals tested once in each laboratory provided consistent predictions among the three laboratories. These results suggested that EpiSensA has good transferability, as well as within- and between-laboratory reproducibility. Copyright © 2018 John Wiley & Sons, Ltd.

  2. How well do general practitioners manage laboratory test results for patients with diabetes mellitus and cardiovascular disease?: A systematic review.

    PubMed

    McCaughey, Euan J; Li, Julie; Badrick, Tony C; Westbrook, Johanna I; Georgiou, Andrew

    2017-10-01

    To evaluate how well general practitioners (GPs) manage and respond to laboratory results for patients with diabetes mellitus (DM) and cardiovascular disease (CVD). MEDLINE, CINAHL, Embase, EBM reviews, ProQuest and Scopus. Peer-reviewed journal articles published between 2000 and 2015 that assessed GPs' management of laboratory results for patients with DM or CVD. Study design and demographics, laboratory tests and key findings relating to GP management of laboratory results were extracted from studies. Thirteen articles were included, comprising seven studies which utilized surveys, four observational studies, one cohort study and one randomized controlled trial. Findings indicate that GPs often overestimate the risk of complications associated with DM and CVD based on laboratory results and have unrealistically high expectations regarding the precision of laboratory tests. Considerable variation existed in the use of repeat testing for diagnostic confirmation and in GPs' identification of the difference between two consecutive results required to indicate a change in patient condition. GPs also often failed to initiate appropriate treatment for patients with DM and CVD based on laboratory results. Feedback to GPs about their test ordering patterns and educational messages on laboratory results improved clinical outcomes. Evidence about how well GPs manage results and its impact on patient outcomes remains weak and inconclusive. This review identified a number of areas where interventions could support GPs to improve the interpretation and management of laboratory test results, including feedback to GPs and educational messages on test result reports. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  3. Interlaboratory ring trial to evaluate CFT proficiency of European laboratories for diagnosis of glanders in equids.

    PubMed

    Laroucau, K; Colaneri, C; Jaÿ, M; Corde, Y; Drapeau, A; Durand, B; Zientara, S; Beck, C

    2016-06-18

    To evaluate the routine complement fixation test (CFT) used to detect Burkholderia mallei antibodies in equine sera, an interlaboratory proficiency test was held with 24 European laboratories, including 22 National Reference Laboratories for glanders. The panels sent to participants were composed of sera with or without B mallei antibodies. This study confirmed the reliability of CFT and highlighted its intralaboratory reproducibility. However, the sensitivity of glanders serodiagnosis and laboratory proficiency may be improved by standardising critical reagents, including antigens, and by developing a standard B mallei serum. British Veterinary Association.

  4. 42 CFR 493.1283 - Standard: Test records.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic Systems § 493.1283 Standard: Test records. (a) The laboratory must maintain an information or record system that includes the following: (1) The positive identification of the specimen. (2) The date and...

  5. The centrality of laboratory services in the HIV treatment and prevention cascade: The need for effective linkages and referrals in resource-limited settings.

    PubMed

    Alemnji, George; Fonjungo, Peter; Van Der Pol, Barbara; Peter, Trevor; Kantor, Rami; Nkengasong, John

    2014-05-01

    Strong laboratory services and systems are critical for delivering timely and quality health services that are vital to reduce patient attrition in the HIV treatment and prevention cascade. However, challenges exist in ensuring effective laboratory health systems strengthening and linkages. In particular, linkages and referrals between laboratory testing and other services need to be considered in the context of an integrated health system that includes prevention, treatment, and strategic information. Key components of laboratory health systems that are essential for effective linkages include an adequate workforce, appropriate point-of-care (POC) technology, available financing, supply chain management systems, and quality systems improvement, including accreditation. In this review, we highlight weaknesses of and gaps between laboratory testing and other program services. We propose a model for strengthening these systems to ensure effective linkages of laboratory services for improved access and retention in care of HIV/AIDS patients, particularly in low- and middle-income countries.

  6. 40 CFR 161.32 - Format of data submission.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., including identification of the substance(s) tested and the test name or data requirement addressed; (2) The author(s) of the study; (3) The date the study was completed; (4) If the study was performed in a laboratory, the name and address of the laboratory and any laboratory project numbers or other identifying...

  7. Comparative evaluation of subgrade resilient modulus from non-destructive, in-situ, and laboratory methods.

    DOT National Transportation Integrated Search

    2007-08-01

    Field and laboratory testing programs were conducted to develop models that predict the resilient modulus of subgrade soils from : the test results of DCP, CIMCPT, FWD, Dynaflect, and soil properties. The field testing program included DCP, CIMCPT, F...

  8. Proficiency Testing for Determination of Water Content in Toluene of Chemical Reagents by iteration robust statistic technique

    NASA Astrophysics Data System (ADS)

    Wang, Hao; Wang, Qunwei; He, Ming

    2018-05-01

    In order to investigate and improve the level of detection technology of water content in liquid chemical reagents of domestic laboratories, proficiency testing provider PT0031 (CNAS) has organized proficiency testing program of water content in toluene, 48 laboratories from 18 provinces/cities/municipals took part in the PT. This paper introduces the implementation process of proficiency testing for determination of water content in toluene, including sample preparation, homogeneity and stability test, the results of statistics of iteration robust statistic technique and analysis, summarized and analyzed those of the different test standards which are widely used in the laboratories, put forward the technological suggestions for the improvement of the test quality of water content. Satisfactory results were obtained by 43 laboratories, amounting to 89.6% of the total participating laboratories.

  9. College of American Pathologists' laboratory standards for next-generation sequencing clinical tests.

    PubMed

    Aziz, Nazneen; Zhao, Qin; Bry, Lynn; Driscoll, Denise K; Funke, Birgit; Gibson, Jane S; Grody, Wayne W; Hegde, Madhuri R; Hoeltge, Gerald A; Leonard, Debra G B; Merker, Jason D; Nagarajan, Rakesh; Palicki, Linda A; Robetorye, Ryan S; Schrijver, Iris; Weck, Karen E; Voelkerding, Karl V

    2015-04-01

    The higher throughput and lower per-base cost of next-generation sequencing (NGS) as compared to Sanger sequencing has led to its rapid adoption in clinical testing. The number of laboratories offering NGS-based tests has also grown considerably in the past few years, despite the fact that specific Clinical Laboratory Improvement Amendments of 1988/College of American Pathologists (CAP) laboratory standards had not yet been developed to regulate this technology. To develop a checklist for clinical testing using NGS technology that sets standards for the analytic wet bench process and for bioinformatics or "dry bench" analyses. As NGS-based clinical tests are new to diagnostic testing and are of much greater complexity than traditional Sanger sequencing-based tests, there is an urgent need to develop new regulatory standards for laboratories offering these tests. To develop the necessary regulatory framework for NGS and to facilitate appropriate adoption of this technology for clinical testing, CAP formed a committee in 2011, the NGS Work Group, to deliberate upon the contents to be included in the checklist. Results . -A total of 18 laboratory accreditation checklist requirements for the analytic wet bench process and bioinformatics analysis processes have been included within CAP's molecular pathology checklist (MOL). This report describes the important issues considered by the CAP committee during the development of the new checklist requirements, which address documentation, validation, quality assurance, confirmatory testing, exception logs, monitoring of upgrades, variant interpretation and reporting, incidental findings, data storage, version traceability, and data transfer confidentiality.

  10. Mars Science Laboratory Spacecraft Assembled for Testing

    NASA Technical Reports Server (NTRS)

    2008-01-01

    The major components of NASA's Mars Science Laboratory spacecraft cruise stage atop the aeroshell, which has the descent stage and rover inside were connected together in October 2008 for several weeks of system testing, including simulation of launch vibrations and deep-space environmental conditions.

    These components will be taken apart again, for further work on each of them, after the environmental testing. The Mars Science Laboratory spacecraft is being assembled and tested for launch in 2011.

    This image was taken inside the Spacecraft Assembly Facility at NASA's Jet Propulsion Laboratory, Pasadena, Calif., which manages the Mars Science Laboratory Project for the NASA Science Mission Directorate, Washington. JPL is a division of the California Institute of Technology.

  11. Culturing Stool Specimens for Campylobacter spp., Pennsylvania, USA

    PubMed Central

    M’ikanatha, Nkuchia M.; Dettinger, Lisa A.; Perry, Amanda; Rogers, Paul; Reynolds, Stanley M.

    2012-01-01

    In 2010, we surveyed 176 clinical laboratories in Pennsylvania regarding stool specimen testing practices for enteropathogens, including Campylobacter spp. Most (96.3%) routinely test for Campylobacter spp. In 17 (15.7%), a stool antigen test is the sole method for diagnosis. We recommend that laboratory practice guidelines for Campylobacter spp. testing be developed. PMID:22377086

  12. Validating Laboratory Results in Electronic Health Records

    PubMed Central

    Perrotta, Peter L.; Karcher, Donald S.

    2017-01-01

    Context Laboratories must ensure that the test results and pathology reports they transmit to a patient’s electronic health record (EHR) are accurate, complete, and presented in a useable format. Objective To determine the accuracy, completeness, and formatting of laboratory test results and pathology reports transmitted from the laboratory to the EHR. Design Participants from 45 institutions retrospectively reviewed results from 16 different laboratory tests, including clinical and anatomic pathology results, within the EHR used by their providers to view laboratory results. Results were evaluated for accuracy, presence of required elements, and usability. Both normal and abnormal results were reviewed for tests, some of which were performed in-house and others at a reference laboratory. Results Overall accuracy for test results transmitted to the EHR was greater than 99.3% (1052 of 1059). There was lower compliance for completeness of test results, with 69.6% (732 of 1051) of the test results containing all essential reporting elements. Institutions that had fewer than half of their orders entered electronically had lower test result completeness rates. The rate of appropriate formatting of results was 90.9% (98 of 1010). Conclusions The great majority of test results are accurately transmitted from the laboratory to the EHR; however, lower percentages are transmitted completely and in a useable format. Laboratories should verify the accuracy, completeness, and format of test results at the time of test implementation, after test changes, and periodically. PMID:27575266

  13. TESTING PRACTICES AND VOLUME OF NON-LYME TICKBORNE DISEASES IN THE UNITED STATES

    PubMed Central

    Connally, Neeta P.; Hinckley, Alison F.; Feldman, Katherine A.; Kemperman, Melissa; Neitzel, David; Wee, Siok-Bi; White, Jennifer L.; Mead, Paul S.; Meek, James I.

    2015-01-01

    Large commercial laboratories in the United States were surveyed regarding the number of specimens tested for eight tickborne diseases in 2008. Seven large commercial laboratories reported testing a total of 2,927,881 specimens nationally (including Lyme disease). Of these, 495,585 specimens (17 percent) were tested for tickborne diseases other than Lyme disease. In addition to large commercial laboratories, another 1,051 smaller commercial, hospital, and government laboratories in four states (CT, MD, MN, and NY) were surveyed regarding tickborne disease testing frequency, practices, and results. Ninety-two of these reported testing a total of 10,091 specimens for four tickborne diseases other than Lyme disease. We estimate the cost of laboratory diagnostic testing for non-Lyme disease tickborne diseases in 2008 to be $9.6 million. These data provide a baseline to evaluate trends in tickborne disease test utilization and insight into the burden of these diseases. PMID:26565931

  14. The cost of implementation of the Clinical Laboratory Improvement Amendments of 1988--the example of pediatric office-based cholesterol screening.

    PubMed

    Tershakovec, A M; Brannon, S D; Bennett, M J; Shannon, B M

    1995-08-01

    To measure the additional costs of office-based laboratory testing due to the implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), using cholesterol screening for children as an example. Four- to ten-year-old children who received their well child care at one of seven participating pediatric practices were screened for hypercholesterolemia. The average number of analyses per day and days per month were derived from the volume of testing completed by the practices. Nurses and technicians time in the screening process were measured and personnel costs were calculated based on salary and fringe benefit rates. Costs of supplies, analyzing control samples, instrument calibration, and instrument depreciation were included. Costs estimates of screening were then completed. CLIA '88 implementation costs were derived from appropriate proficiency testing and laboratory inspection programs. In six practices completing a low volume of testing, 2807 children (5 to 6 children per week) were screened during the observation period, while 414 (about 25 children per week) were screened in one high-volume practice implementing universal screening over a 4-month period. For the six low-volume practices, the cost of screening was $10.60 per child. This decreased to $5.47 for the high-volume practice. Estimated costs of CLIA '88 implementation, including additional proficiency testing and laboratory inspection, added $3.20 per test for the low-volume practices, and $0.71 per test for the high-volume testing. Implementation of CLIA adds significantly to the cost of office-based chemistry laboratory screening. Despite these additional expenses, the cost of testing is still within a reasonable charge for laboratory testing, and is highly sensitive to the volume of tests completed.

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

    PubMed

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

    2017-02-15

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

  16. Laboratory development and testing of spacecraft diagnostics

    NASA Astrophysics Data System (ADS)

    Amatucci, William; Tejero, Erik; Blackwell, Dave; Walker, Dave; Gatling, George; Enloe, Lon; Gillman, Eric

    2017-10-01

    The Naval Research Laboratory's Space Chamber experiment is a large-scale laboratory device dedicated to the creation of large-volume plasmas with parameters scaled to realistic space plasmas. Such devices make valuable contributions to the investigation of space plasma phenomena under controlled, reproducible conditions, allowing for the validation of theoretical models being applied to space data. However, in addition to investigations such as plasma wave and instability studies, such devices can also make valuable contributions to the development and testing of space plasma diagnostics. One example is the plasma impedance probe developed at NRL. Originally developed as a laboratory diagnostic, the sensor has now been flown on a sounding rocket, is included on a CubeSat experiment, and will be included on the DoD Space Test Program's STP-H6 experiment on the International Space Station. In this talk, we will describe how the laboratory simulation of space plasmas made this development path possible. Work sponsored by the US Naval Research Laboratory Base Program.

  17. Microbiological methods for the water recovery systems test, revision 1.1

    NASA Technical Reports Server (NTRS)

    Rhoads, Tim; Kilgore, M. V., Jr.; Mikell, A. T., Jr.

    1990-01-01

    Current microbiological parameters specified to verify microbiological quality of Space Station Freedom water quality include the enumeration of total bacteria, anaerobes, aerobes, yeasts and molds, enteric bacteria, gram positives, gram negatives, and E. coli. In addition, other parameters have been identified as necessary to support the Water Recovery Test activities to be conducted at the NASA/MSFC later this year. These other parameters include aerotolerant eutrophic mesophiles, legionellae, and an additional method for heterotrophic bacteria. If inter-laboratory data are to be compared to evaluate quality, analytical methods must be eliminated as a variable. Therefore, each participating laboratory must utilize the same analytical methods and procedures. Without this standardization, data can be neither compared nor validated between laboratories. Multiple laboratory participation represents a conservative approach to insure quality and completeness of data. Invariably, sample loss will occur in transport and analyses. Natural variance is a reality on any test of this magnitude and is further enhanced because biological entities, capable of growth and death, are specific parameters of interest. The large variation due to the participation of human test subjects has been noted with previous testing. The resultant data might be dismissed as 'out of control' unless intra-laboratory control is included as part of the method or if participating laboratories are not available for verification. The purpose of this document is to provide standardized laboratory procedures for the enumeration of certain microorganisms in water and wastewater specific to the water recovery systems test. The document consists of ten separate cultural methods and one direct count procedure. It is not intended nor is it implied to be a complete microbiological methods manual.

  18. Information Technology Support for Clinical Genetic Testing within an Academic Medical Center.

    PubMed

    Aronson, Samuel; Mahanta, Lisa; Ros, Lei Lei; Clark, Eugene; Babb, Lawrence; Oates, Michael; Rehm, Heidi; Lebo, Matthew

    2016-01-20

    Academic medical centers require many interconnected systems to fully support genetic testing processes. We provide an overview of the end-to-end support that has been established surrounding a genetic testing laboratory within our environment, including both laboratory and clinician facing infrastructure. We explain key functions that we have found useful in the supporting systems. We also consider ways that this infrastructure could be enhanced to enable deeper assessment of genetic test results in both the laboratory and clinic.

  19. Evaluation of Iranian microbiology laboratories for identification of etiologic agents of bacterial meningitidis. Survey results of an external quality assessment scheme (EQAS) programme.

    PubMed

    Marandi, Farinaz Rashed; Rahbar, Mohammad; Sabourian, Roghieh; Saremi, Mahnaz

    2010-01-01

    To determine the ability of Iranian microbiology laboratories for identification and susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae as causative agents of bacterial meningitides. Two strains of bacteria including Haemophilus influenzae and Streptococcus pneumoniae as a common causative agents of meningitides were chosen and coded as strain number 1 and number 2. The strains were distributed among 679 microbiology laboratories. All laboratories were requested for identification of each unknown microorganism and susceptibility testing of S. pneumoniae against five commonly used antibiotics. Of 679 microbiology laboratories 310 (46%) laboratories participated in the survey and among these, 258 laboratories completely identified S. pneumoniae. About 85% laboratories produced correct susceptibility testing against oxacillin, erythromycin, tetracycline, and vancomycin. Of 310 received responses only 50 laboratories identified H. influenza correctly. The majority of the laboratories did not have the capacity to identification H. influenza. Microbiology laboratories in our country are qualified for identification and susceptibility testing of S. pneumoniae. However, majority of laboratories are not qualified for identification of H. influenzae.

  20. A Window Into Clinical Next-Generation Sequencing-Based Oncology Testing Practices.

    PubMed

    Nagarajan, Rakesh; Bartley, Angela N; Bridge, Julia A; Jennings, Lawrence J; Kamel-Reid, Suzanne; Kim, Annette; Lazar, Alexander J; Lindeman, Neal I; Moncur, Joel; Rai, Alex J; Routbort, Mark J; Vasalos, Patricia; Merker, Jason D

    2017-12-01

    - Detection of acquired variants in cancer is a paradigm of precision medicine, yet little has been reported about clinical laboratory practices across a broad range of laboratories. - To use College of American Pathologists proficiency testing survey results to report on the results from surveys on next-generation sequencing-based oncology testing practices. - College of American Pathologists proficiency testing survey results from more than 250 laboratories currently performing molecular oncology testing were used to determine laboratory trends in next-generation sequencing-based oncology testing. - These presented data provide key information about the number of laboratories that currently offer or are planning to offer next-generation sequencing-based oncology testing. Furthermore, we present data from 60 laboratories performing next-generation sequencing-based oncology testing regarding specimen requirements and assay characteristics. The findings indicate that most laboratories are performing tumor-only targeted sequencing to detect single-nucleotide variants and small insertions and deletions, using desktop sequencers and predesigned commercial kits. Despite these trends, a diversity of approaches to testing exists. - This information should be useful to further inform a variety of topics, including national discussions involving clinical laboratory quality systems, regulation and oversight of next-generation sequencing-based oncology testing, and precision oncology efforts in a data-driven manner.

  1. Automatic Vacuum Flushing Technology for Combined Sewer Solids: Laboratory Testing and Proposed Improvements (WERF Report INFR7SG09)

    EPA Science Inventory

    This research study included an extensive literature review on existing sewer sediment flushing technologies. An innovative vacuum flush system previously developed by the U.S. EPA was tested under laboratory conditions. The tests revealed a strong correlation between the strengt...

  2. Isotherm Sensor Calibration Program for Mars Science Laboratory Heat Shield Flight Data Analysis

    NASA Technical Reports Server (NTRS)

    Santos, Jose A.; Oishi, Tomo; Martinez, Ed R.

    2011-01-01

    Seven instrumented sensor plugs were installed on the Mars Science Laboratory heat shield in December 2008 as part of the Mars Science Laboratory Entry, Descent, and Landing Instrumentation (MEDLI) project. These sensor plugs contain four in-depth thermocouples and one Hollow aErothermal Ablation and Temperature (HEAT) sensor. The HEAT sensor follows the time progression of a 700 C isotherm through the thickness of a thermal protection system (TPS) material. The data can be used to infer char depth and, when analyzed in conjunction with the thermocouple data, the thermal gradient through the TPS material can also be determined. However, the uncertainty on the isotherm value is not well defined. To address this uncertainty, a team at NASA Ames Research Center is carrying out a HEAT sensor calibration test program. The scope of this test program is described, and initial results from experiments conducted in the laboratory to study the isotherm temperature of the HEAT sensor are presented. Data from the laboratory tests indicate an isotherm temperature of 720 C 60 C. An overview of near term arc jet testing is also given, including preliminary data from 30.48cm 30.48cm PICA panels instrumented with two MEDLI sensor plugs and tested in the NASA Ames Panel Test Facility. Forward work includes analysis of the arc jet test data, including an evaluation of the isotherm value based on the instant in time when it reaches a thermocouple depth.

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

    PubMed

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

    2015-01-01

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

  4. Statistical Analysis Tools for Learning in Engineering Laboratories.

    ERIC Educational Resources Information Center

    Maher, Carolyn A.

    1990-01-01

    Described are engineering programs that have used automated data acquisition systems to implement data collection and analyze experiments. Applications include a biochemical engineering laboratory, heat transfer performance, engineering materials testing, mechanical system reliability, statistical control laboratory, thermo-fluid laboratory, and a…

  5. Creating Best Practices for the Submission of Actionable Food and Feed Testing Data Generated in State and Local Laboratories.

    PubMed

    Wangsness, Kathryn; Salfinger, Yvonne; Randolph, Robyn; Shea, Shari; Larson, Kirsten

    2017-07-01

    Laboratory accreditation provides a level of standardization in laboratories and confidence in generated food and feed testing results. For some laboratories, ISO/IEC 17025:2005 accreditation may not be fiscally viable, or a requested test method may be out of the scope of the laboratory's accreditation. To assist laboratories for whom accreditation is not feasible, the Association of Public Health Laboratories Data Acceptance Work Group developed a white paper entitled "Best Practices for Submission of Actionable Food and Feed Testing Data Generated in State and Local Laboratories." The basic elements of a quality management system, along with other best practices that state and local food and feed testing laboratories should follow, are included in the white paper. It also covers program-specific requirements that may need to be addressed. Communication with programs and end data users is regarded as essential for establishing the reliability and accuracy of laboratory data. Following these suggested best practices can facilitate the acceptance of laboratory data, which can result in swift regulatory action and the quick removal of contaminated product from the food supply, improving public health nationally.

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

    PubMed

    Massambu, Charles; Mwangi, Christina

    2009-06-01

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

  7. Fire tests for airplane interior materials

    NASA Technical Reports Server (NTRS)

    Tustin, E. A.

    1980-01-01

    Large scale, simulated fire tests of aircraft interior materials were carried out in salvaged airliner fuselage. Two "design" fire sources were selected: Jet A fuel ignited in fuselage midsection and trash bag fire. Comparison with six established laboratory fire tests show that some laboratory tests can rank materials according to heat and smoke production, but existing tests do not characterize toxic gas emissions accurately. Report includes test parameters and test details.

  8. Point-of-Care Test Equipment for Flexible Laboratory Automation.

    PubMed

    You, Won Suk; Park, Jae Jun; Jin, Sung Moon; Ryew, Sung Moo; Choi, Hyouk Ryeol

    2014-08-01

    Blood tests are some of the core clinical laboratory tests for diagnosing patients. In hospitals, an automated process called total laboratory automation, which relies on a set of sophisticated equipment, is normally adopted for blood tests. Noting that the total laboratory automation system typically requires a large footprint and significant amount of power, slim and easy-to-move blood test equipment is necessary for specific demands such as emergency departments or small-size local clinics. In this article, we present a point-of-care test system that can provide flexibility and portability with low cost. First, the system components, including a reagent tray, dispensing module, microfluidic disk rotor, and photometry scanner, and their functions are explained. Then, a scheduler algorithm to provide a point-of-care test platform with an efficient test schedule to reduce test time is introduced. Finally, the results of diagnostic tests are presented to evaluate the system. © 2014 Society for Laboratory Automation and Screening.

  9. Laboratory testing in primary care: A systematic review of health IT impacts.

    PubMed

    Maillet, Éric; Paré, Guy; Currie, Leanne M; Raymond, Louis; Ortiz de Guinea, Ana; Trudel, Marie-Claude; Marsan, Josianne

    2018-08-01

    Laboratory testing in primary care is a fundamental process that supports patient management and care. Any breakdown in the process may alter clinical information gathering and decision-making activities and can lead to medical errors and potential adverse outcomes for patients. Various information technologies are being used in primary care with the goal to support the process, maximize patient benefits and reduce medical errors. However, the overall impact of health information technologies on laboratory testing processes has not been evaluated. To synthesize the positive and negative impacts resulting from the use of health information technology in each phase of the laboratory 'total testing process' in primary care. We conducted a systematic review. Databases including Medline, PubMed, CINAHL, Web of Science and Google Scholar were searched. Studies eligible for inclusion reported empirical data on: 1) the use of a specific IT system, 2) the impacts of the systems to support the laboratory testing process, and were conducted in 3) primary care settings (including ambulatory care and primary care offices). Our final sample consisted of 22 empirical studies which were mapped to a framework that outlines the phases of the laboratory total testing process, focusing on phases where medical errors may occur. Health information technology systems support several phases of the laboratory testing process, from ordering the test to following-up with patients. This is a growing field of research with most studies focusing on the use of information technology during the final phases of the laboratory total testing process. The findings were largely positive. Positive impacts included easier access to test results by primary care providers, reduced turnaround times, and increased prescribed tests based on best practice guidelines. Negative impacts were reported in several studies: paper-based processes employed in parallel to the electronic process increased the potential for medical errors due to clinicians' cognitive overload; systems deemed not reliable or user-friendly hampered clinicians' performance; and organizational issues arose when results tracking relied on the prescribers' memory. The potential of health information technology lies not only in the exchange of health information, but also in knowledge sharing among clinicians. This review has underscored the important role played by cognitive factors, which are critical in the clinician's decision-making, the selection of the most appropriate tests, correct interpretation of the results and efficient interventions. By providing the right information, at the right time to the right clinician, many IT solutions adequately support the laboratory testing process and help primary care clinicians make better decisions. However, several technological and organizational barriers require more attention to fully support the highly fragmented and error-prone process of laboratory testing. Copyright © 2018 Elsevier B.V. All rights reserved.

  10. Assessing student understanding of measurement and uncertainty

    NASA Astrophysics Data System (ADS)

    Jirungnimitsakul, S.; Wattanakasiwich, P.

    2017-09-01

    The objectives of this study were to develop and assess student understanding of measurement and uncertainty. A test has been adapted and translated from the Laboratory Data Analysis Instrument (LDAI) test, consists of 25 questions focused on three topics including measures of central tendency, experimental errors and uncertainties, and fitting regression lines. The test was evaluated its content validity by three physics experts in teaching physics laboratory. In the pilot study, Thai LDAI was administered to 93 freshmen enrolled in a fundamental physics laboratory course. The final draft of the test was administered to three groups—45 freshmen taking fundamental physics laboratory, 16 sophomores taking intermediated physics laboratory and 21 juniors taking advanced physics laboratory at Chiang Mai University. As results, we found that the freshmen had difficulties in experimental errors and uncertainties. Most students had problems with fitting regression lines. These results will be used to improve teaching and learning physics laboratory for physics students in the department.

  11. 2000-hour cyclic endurance test of a laboratory model multipropellant resistojet

    NASA Technical Reports Server (NTRS)

    Morren, W. Earl; Sovey, James S.

    1987-01-01

    The technological readiness of a long-life multipropellant resistojet for space station auxiliary propulsion is demonstrated. A laboratory model resistojet made from grain-stabilized platinum served as a test bed to evaluate the design characteristics, fabrication methods, and operating strategies for an engineering model multipropellant resistojet developed under contract by the Rocketdyne Division of Rockwell International and Technion Incorporated. The laboratory model thruster was subjected to a 2000-hr, 2400-thermal-cycle endurance test using carbon dioxide propellant. Maximum thruster temperatures were approximately 1400 C. The post-test analyses of the laboratory model thruster included an investigation of component microstructures. Significant observations from the laboratory model thruster are discussed as they relate to the design of the engineering model thruster.

  12. A 2000-hour cyclic endurance test of a laboratory model multipropellant resistojet

    NASA Technical Reports Server (NTRS)

    Morren, W. Earl; Sovey, James S.

    1987-01-01

    The technological readiness of a long-life multipropellant resistojet for space station auxiliary propulsion is demonstrated. A laboratory model resistojet made from grain-stabilized platinum served as a test bed to evaluate the design characteristics, fabrication methods, and operating strategies for an engineering model multipropellant resistojet developed under contract by the Rocketdyne Division of Rockwell International and Technion Incorporated. The laboratory model thruster was subjected to a 2000-hr, 2400-thermal-cycle endurance test using carbon dioxide propellant. Maximum thruster temperatures were approximately 1400 C. The post-test analyses of the laboratory model thruster included an investigation of component microstructures. Significant observations from the laboratory model thruster are discussed as they relate to the design of the engineering model thruster.

  13. Laboratory testing in management of patients with suspected Ebolavirus disease: infection control and safety.

    PubMed

    Gilbert, G L

    2015-08-01

    If routine laboratory safety precautions are followed, the risk of laboratory-acquired infection from handling specimens from patients with Ebolavirus disease (EVD) is very low, especially in the early 'dry' stage of disease. In Australia, border screening to identify travellers returning from EVD-affected west African countries during the 2014-2015 outbreak has made it unlikely that specimens from patients with unrecognised EVD would be sent to a routine diagnostic laboratory. Australian public health and diagnostic laboratories associated with hospitals designated for the care of patients with EVD have developed stringent safety precautions for EVD diagnostic and other tests likely to be required for supportive care of the sickest (and most infectious) patients with EVD, including as wide a range of point-of-care tests as possible. However, it is important that the stringent requirements for packaging, transport and testing of specimens that might contain Ebolavirus--which is a tier 1 security sensitive biology agent--do not delay the diagnosis and appropriate management of other potentially serious but treatable infectious diseases, which are far more likely causes of a febrile illness in people returning from west Africa. If necessary, urgent haematology, biochemistry and microbiological tests can be performed safely, whilst awaiting the results of EVD tests, in a PC-2 laboratory with appropriate precautions including: use of recommended personal protective equipment (PPE) for laboratory staff; handling any unsealed specimens in a class 1 or II biosafety cabinet; using only centrifuges with sealed rotors; and safe disposal or decontamination of all used equipment and laboratory waste.

  14. Changing resident test ordering behavior: a multilevel intervention to decrease laboratory utilization at an academic medical center.

    PubMed

    Vidyarthi, Arpana R; Hamill, Timothy; Green, Adrienne L; Rosenbluth, Glenn; Baron, Robert B

    2015-01-01

    Hospital laboratory test volume is increasing, and overutilization contributes to errors and costs. Efforts to reduce laboratory utilization have targeted aspects of ordering behavior, but few have utilized a multilevel collaborative approach. The study team partnered with residents to reduce unnecessary laboratory tests and associated costs through multilevel interventions across the academic medical center. The study team selected laboratory tests for intervention based on cost, volume, and ordering frequency (complete blood count [CBC] and CBC with differential, common electrolytes, blood enzymes, and liver function tests). Interventions were designed collaboratively with residents and targeted components of ordering behavior, including system changes, teaching, social marketing, academic detailing, financial incentives, and audit/feedback. Laboratory ordering was reduced by 8% cumulatively over 3 years, saving $2 019 000. By involving residents at every stage of the intervention and targeting multiple levels simultaneously, laboratory utilization was reduced and cost savings were sustained over 3 years. © 2014 by the American College of Medical Quality.

  15. Closing the brain-to-brain loop in laboratory testing.

    PubMed

    Plebani, Mario; Lippi, Giuseppe

    2011-07-01

    Abstract The delivery of laboratory services has been described 40 years ago and defined with the foremost concept of "brain-to-brain turnaround time loop". This concept consists of several processes, including the final step which is the action undertaken on the patient based on laboratory information. Unfortunately, the need for systematic feedback to improve the value of laboratory services has been poorly understood and, even more risky, poorly applied in daily laboratory practice. Currently, major problems arise from the unavailability of consensually accepted quality specifications for the extra-analytical phase of laboratory testing. This, in turn, does not allow clinical laboratories to calculate a budget for the "patient-related total error". The definition and use of the term "total error" refers only to the analytical phase, and should be better defined as "total analytical error" to avoid any confusion and misinterpretation. According to the hierarchical approach to classify strategies to set analytical quality specifications, the "assessment of the effect of analytical performance on specific clinical decision-making" is comprehensively at the top and therefore should be applied as much as possible to address analytical efforts towards effective goals. In addition, an increasing number of laboratories worldwide are adopting risk management strategies such as FMEA, FRACAS, LEAN and Six Sigma since these techniques allow the identification of the most critical steps in the total testing process, and to reduce the patient-related risk of error. As a matter of fact, an increasing number of laboratory professionals recognize the importance of understanding and monitoring any step in the total testing process, including the appropriateness of the test request as well as the appropriate interpretation and utilization of test results.

  16. Comparative analytical costs of central laboratory glucose and bedside glucose testing: a College of American Pathologists Q-Probes study.

    PubMed

    Howanitz, Peter J; Jones, Bruce A

    2004-07-01

    One of the major attributes of laboratory testing is cost. Although fully automated central laboratory glucose testing and semiautomated bedside glucose testing (BGT) are performed at most institutions, rigorous determinations of interinstitutional comparative costs have not been performed. To compare interinstitutional analytical costs of central laboratory glucose testing and BGT and to provide suggestions for improvement. Participants completed a demographic form about their institutional glucose monitoring practices. They also collected information about the costs of central laboratory glucose testing, BGT at a high-volume testing site, and BGT at a low-volume testing site, including specified cost variables for labor, reagents, and instruments. A total of 445 institutions enrolled in the College of American Pathologists Q-Probes program. Median cost per glucose test at 3 testing sites. The median (10th-90th percentile range) costs per glucose test were 1.18 dollars (5.59 dollars-0.36 dollars), 1.96 dollars (9.51 dollars-0.77 dollars), and 4.66 dollars (27.54 dollars-1.02 dollars) for central laboratory, high-volume BGT sites, and low-volume BGT sites, respectively. The largest percentages of the cost per test were for labor (59.3%, 72.7%, and 85.8%), followed by supplies (27.2%, 27.3%, and 13.4%) and equipment (2.1%, 0.0%, and 0.0%) for the 3 sites, respectively. The median number of patient specimens per month at the high-volume BGT sites was 625 compared to 30 at the low-volume BGT sites. Most participants did not include labor, instrument maintenance, competency assessment, or oversight in their BGT estimated costs until required to do so for the study. Analytical costs per glucose test were lower for central laboratory glucose testing than for BGT, which, in turn, was highly variable and dependent on volume. Data that would be used for financial justification for BGT were widely aberrant and in need of improvement.

  17. Validation of the OECD reproduction test guideline with the New Zealand mudsnail Potamopyrgus antipodarum using trenbolone and prochloraz.

    PubMed

    Geiß, Cornelia; Ruppert, Katharina; Askem, Clare; Barroso, Carlos; Faber, Daniel; Ducrot, Virginie; Holbech, Henrik; Hutchinson, Thomas H; Kajankari, Paula; Kinnberg, Karin Lund; Lagadic, Laurent; Matthiessen, Peter; Morris, Steve; Neiman, Maurine; Penttinen, Olli-Pekka; Sanchez-Marin, Paula; Teigeler, Matthias; Weltje, Lennart; Oehlmann, Jörg

    2017-04-01

    The Organisation for Economic Cooperation and Development (OECD) provides several standard test methods for the environmental hazard assessment of chemicals, mainly based on primary producers, arthropods, and fish. In April 2016, two new test guidelines with two mollusc species representing different reproductive strategies were approved by OECD member countries. One test guideline describes a 28-day reproduction test with the parthenogenetic New Zealand mudsnail Potamopyrgus antipodarum. The main endpoint of the test is reproduction, reflected by the embryo number in the brood pouch per female. The development of a new OECD test guideline involves several phases including inter-laboratory validation studies to demonstrate the robustness of the proposed test design and the reproducibility of the test results. Therefore, a ring test of the reproduction test with P. antipodarum was conducted including eight laboratories with the test substances trenbolone and prochloraz and results are presented here. Most laboratories could meet test validity criteria, thus demonstrating the robustness of the proposed test protocol. Trenbolone did not have an effect on the reproduction of the snails at the tested concentration range (nominal: 10-1000 ng/L). For prochloraz, laboratories produced similar EC 10 and NOEC values, showing the inter-laboratory reproducibility of results. The average EC 10 and NOEC values for reproduction (with coefficient of variation) were 26.2 µg/L (61.7%) and 29.7 µg/L (32.9%), respectively. This ring test shows that the mudsnail reproduction test is a well-suited tool for use in the chronic aquatic hazard and risk assessment of chemicals.

  18. [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.

  19. Impact of Laboratory Test Use Strategies in a Turkish Hospital

    PubMed Central

    Yılmaz, Fatma Meriç; Kahveci, Rabia; Aksoy, Altan; Özer Kucuk, Emine; Akın, Tezcan; Mathew, Joseph Lazar; Meads, Catherine; Zengin, Nurullah

    2016-01-01

    Objectives Eliminating unnecessary laboratory tests is a good way to reduce costs while maintain patient safety. The aim of this study was to define and process strategies to rationalize laboratory use in Ankara Numune Training and Research Hospital (ANH) and calculate potential savings in costs. Methods A collaborative plan was defined by hospital managers; joint meetings with ANHTA and laboratory professors were set; the joint committee invited relevant staff for input, and a laboratory efficiency committee was created. Literature was reviewed systematically to identify strategies used to improve laboratory efficiency. Strategies that would be applicable in local settings were identified for implementation, processed, and the impact on clinical use and costs assessed for 12 months. Results Laboratory use in ANH differed enormously among clinics. Major use was identified in internal medicine. The mean number of tests per patient was 15.8. Unnecessary testing for chloride, folic acid, free prostate specific antigen, hepatitis and HIV testing were observed. Test panel use was pinpointed as the main cause of overuse of the laboratory and the Hospital Information System test ordering page was reorganized. A significant decrease (between 12.6–85.0%) was observed for the tests that were taken to an alternative page on the computer screen. The one year study saving was equivalent to 371,183 US dollars. Conclusion Hospital-based committees including laboratory professionals and clinicians can define hospital based problems and led to a standardized approach to test use that can help clinicians reduce laboratory costs through appropriate use of laboratory tests. PMID:27077653

  20. Building and Rebuilding: The National Public Health Laboratory Systems and Services Before and After the Earthquake and Cholera Epidemic, Haiti, 2009-2015.

    PubMed

    Jean Louis, Frantz; Buteau, Josiane; Boncy, Jacques; Anselme, Renette; Stanislas, Magalie; Nagel, Mary C; Juin, Stanley; Charles, Macarthur; Burris, Robert; Antoine, Eva; Yang, Chunfu; Kalou, Mireille; Vertefeuille, John; Marston, Barbara J; Lowrance, David W; Deyde, Varough

    2017-10-01

    Before the 2010 devastating earthquake and cholera outbreak, Haiti's public health laboratory systems were weak and services were limited. There was no national laboratory strategic plan and only minimal coordination across the laboratory network. Laboratory capacity was further weakened by the destruction of over 25 laboratories and testing sites at the departmental and peripheral levels and the loss of life among the laboratory health-care workers. However, since 2010, tremendous progress has been made in building stronger laboratory infrastructure and training a qualified public health laboratory workforce across the country, allowing for decentralization of access to quality-assured services. Major achievements include development and implementation of a national laboratory strategic plan with a formalized and strengthened laboratory network; introduction of automation of testing to ensure better quality of results and diversify the menu of tests to effectively respond to outbreaks; expansion of molecular testing for tuberculosis, human immunodeficiency virus, malaria, diarrheal and respiratory diseases; establishment of laboratory-based surveillance of epidemic-prone diseases; and improvement of the overall quality of testing. Nonetheless, the progress and gains made remain fragile and require the full ownership and continuous investment from the Haitian government to sustain these successes and achievements.

  1. Building and Rebuilding: The National Public Health Laboratory Systems and Services Before and After the Earthquake and Cholera Epidemic, Haiti, 2009–2015

    PubMed Central

    Jean Louis, Frantz; Buteau, Josiane; Boncy, Jacques; Anselme, Renette; Stanislas, Magalie; Nagel, Mary C.; Juin, Stanley; Charles, Macarthur; Burris, Robert; Antoine, Eva; Yang, Chunfu; Kalou, Mireille; Vertefeuille, John; Marston, Barbara J.; Lowrance, David W.; Deyde, Varough

    2017-01-01

    Abstract. Before the 2010 devastating earthquake and cholera outbreak, Haiti’s public health laboratory systems were weak and services were limited. There was no national laboratory strategic plan and only minimal coordination across the laboratory network. Laboratory capacity was further weakened by the destruction of over 25 laboratories and testing sites at the departmental and peripheral levels and the loss of life among the laboratory health-care workers. However, since 2010, tremendous progress has been made in building stronger laboratory infrastructure and training a qualified public health laboratory workforce across the country, allowing for decentralization of access to quality-assured services. Major achievements include development and implementation of a national laboratory strategic plan with a formalized and strengthened laboratory network; introduction of automation of testing to ensure better quality of results and diversify the menu of tests to effectively respond to outbreaks; expansion of molecular testing for tuberculosis, human immunodeficiency virus, malaria, diarrheal and respiratory diseases; establishment of laboratory-based surveillance of epidemic-prone diseases; and improvement of the overall quality of testing. Nonetheless, the progress and gains made remain fragile and require the full ownership and continuous investment from the Haitian government to sustain these successes and achievements. PMID:29064354

  2. Research and test facilities for development of technologies and experiments with commercial applications

    NASA Technical Reports Server (NTRS)

    1989-01-01

    One of NASA'S agency-wide goals is the commercial development of space. To further this goal NASA is implementing a policy whereby U.S. firms are encouraged to utilize NASA facilities to develop and test concepts having commercial potential. Goddard, in keeping with this policy, will make the facilities and capabilities described in this document available to private entities at a reduced cost and on a noninterference basis with internal NASA programs. Some of these facilities include: (1) the Vibration Test Facility; (2) the Battery Test Facility; (3) the Large Area Pulsed Solar Simulator Facility; (4) the High Voltage Testing Facility; (5) the Magnetic Field Component Test Facility; (6) the Spacecraft Magnetic Test Facility; (7) the High Capacity Centrifuge Facility; (8) the Acoustic Test Facility; (9) the Electromagnetic Interference Test Facility; (10) the Space Simulation Test Facility; (11) the Static/Dynamic Balance Facility; (12) the High Speed Centrifuge Facility; (13) the Optical Thin Film Deposition Facility; (14) the Gold Plating Facility; (15) the Paint Formulation and Application Laboratory; (16) the Propulsion Research Laboratory; (17) the Wallops Range Facility; (18) the Optical Instrument Assembly and Test Facility; (19) the Massively Parallel Processor Facility; (20) the X-Ray Diffraction and Scanning Auger Microscopy/Spectroscopy Laboratory; (21) the Parts Analysis Laboratory; (22) the Radiation Test Facility; (23) the Ainsworth Vacuum Balance Facility; (24) the Metallography Laboratory; (25) the Scanning Electron Microscope Laboratory; (26) the Organic Analysis Laboratory; (27) the Outgassing Test Facility; and (28) the Fatigue, Fracture Mechanics and Mechanical Testing Laboratory.

  3. [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.

  4. Revitalizing pathology laboratories in a gastrointestinal pathophysiology course using multimedia and team-based learning techniques.

    PubMed

    Carbo, Alexander R; Blanco, Paola G; Graeme-Cooke, Fiona; Misdraji, Joseph; Kappler, Steven; Shaffer, Kitt; Goldsmith, Jeffrey D; Berzin, Tyler; Leffler, Daniel; Najarian, Robert; Sepe, Paul; Kaplan, Jennifer; Pitman, Martha; Goldman, Harvey; Pelletier, Stephen; Hayward, Jane N; Shields, Helen M

    2012-05-15

    In 2008, we changed the gastrointestinal pathology laboratories in a gastrointestinal pathophysiology course to a more interactive format using modified team-based learning techniques and multimedia presentations. The results were remarkably positive and can be used as a model for pathology laboratory improvement in any organ system. Over a two-year period, engaging and interactive pathology laboratories were designed. The initial restructuring of the laboratories included new case material, Digital Atlas of Video Education Project videos, animations and overlays. Subsequent changes included USMLE board-style quizzes at the beginning of each laboratory, with individual readiness assessment testing and group readiness assessment testing, incorporation of a clinician as a co-teacher and role playing for the student groups. Student responses for pathology laboratory contribution to learning improved significantly compared to baseline. Increased voluntary attendance at pathology laboratories was observed. Spontaneous student comments noted the positive impact of the laboratories on their learning. Pathology laboratory innovations, including modified team-based learning techniques with individual and group self-assessment quizzes, multimedia presentations, and paired teaching by a pathologist and clinical gastroenterologist led to improvement in student perceptions of pathology laboratory contributions to their learning and better pathology faculty evaluations. These changes can be universally applied to other pathology laboratories to improve student satisfaction. Copyright © 2012 Elsevier GmbH. All rights reserved.

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

    Buchholz, Stuart A.

    This memorandum documents laboratory thermomechanical triaxial strength testing of Waste Isolation Pilot Plant (WIPP) clean salt. The limited study completed independent, adjunct laboratory tests in the United States to assist in validating similar testing results being provided by the German facilities. The testing protocol consisted of completing confined triaxial, constant strain rate strength tests of intact WIPP clean salt at temperatures of 25°C and 100°C and at multiple confining pressures. The stratigraphy at WIPP also includes salt that has been labeled “argillaceous.” The much larger test matrix conducted in Germany included both the so-called clean and argillaceous salts. When combined,more » the total database of laboratory results will be used to develop input parameters for models, assess adequacy of existing models, and predict material behavior. These laboratory studies are also consistent with the goals of the international salt repository research program. The goal of this study was to complete a subset of a test matrix on clean salt from the WIPP undertaken by German research groups. The work was performed at RESPEC in Rapid City, South Dakota. A rigorous Quality Assurance protocol was applied, such that corroboration provides the potential of qualifying all of the test data gathered by German research groups.« less

  6. NASA Glenn's Acoustical Testing Laboratory Awarded Accreditation by the National Voluntary Laboratory Accreditation Program

    NASA Technical Reports Server (NTRS)

    Akers, James C.; Cooper, Beth A.

    2004-01-01

    NASA Glenn Research Center's Acoustical Testing Laboratory (ATL) provides a comprehensive array of acoustical testing services, including sound pressure level, sound intensity level, and sound-power-level testing per International Standards Organization (ISO)1 3744. Since its establishment in September 2000, the ATL has provided acoustic emission testing and noise control services for a variety of customers, particularly microgravity space flight hardware that must meet International Space Station acoustic emission requirements. The ATL consists of a 23- by 27- by 20-ft (height) convertible hemi/anechoic test chamber and a separate sound-attenuating test support enclosure. The ATL employs a personal-computer-based data acquisition system that provides up to 26 channels of simultaneous data acquisition with real-time analysis (ref. 4). Specialized diagnostic tools, including a scanning sound-intensity system, allow the ATL's technical staff to support its clients' aggressive low-noise design efforts to meet the space station's acoustic emission requirement. From its inception, the ATL has pursued the goal of developing a comprehensive ISO 17025-compliant quality program that would incorporate Glenn's existing ISO 9000 quality system policies as well as ATL-specific technical policies and procedures. In March 2003, the ATL quality program was awarded accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP) for sound-power-level testing in accordance with ISO 3744. The NVLAP program is administered by the National Institutes of Standards and Technology (NIST) of the U.S. Department of Commerce and provides third-party accreditation for testing and calibration laboratories. There are currently 24 NVLAP-accredited acoustical testing laboratories in the United States. NVLAP accreditation covering one or more specific testing procedures conducted in accordance with established test standards is awarded upon successful completion of an intensive onsite assessment that includes proficiency testing and documentation review. The ATL NVLAP accreditation currently applies specifically to its ISO 3744 soundpower- level determination procedure (see the photograph) and supporting ISO 17025 quality system, although all ATL operations are conducted in accordance with its quality system. The ATL staff is currently developing additional procedures to adapt this quality system to the testing of space flight hardware in accordance with International Space Station acoustic emission requirements.<

  7. Real-Time Rocket/Vehicle System Integrated Health Management Laboratory For Development and Testing of Health Monitoring/Management Systems

    NASA Technical Reports Server (NTRS)

    Aguilar, R.

    2006-01-01

    Pratt & Whitney Rocketdyne has developed a real-time engine/vehicle system integrated health management laboratory, or testbed, for developing and testing health management system concepts. This laboratory simulates components of an integrated system such as the rocket engine, rocket engine controller, vehicle or test controller, as well as a health management computer on separate general purpose computers. These general purpose computers can be replaced with more realistic components such as actual electronic controllers and valve actuators for hardware-in-the-loop simulation. Various engine configurations and propellant combinations are available. Fault or failure insertion capability on-the-fly using direct memory insertion from a user console is used to test system detection and response. The laboratory is currently capable of simulating the flow-path of a single rocket engine but work is underway to include structural and multiengine simulation capability as well as a dedicated data acquisition system. The ultimate goal is to simulate as accurately and realistically as possible the environment in which the health management system will operate including noise, dynamic response of the engine/engine controller, sensor time delays, and asynchronous operation of the various components. The rationale for the laboratory is also discussed including limited alternatives for demonstrating the effectiveness and safety of a flight system.

  8. High-temperature Y267 EPDM elastomer field and laboratory experiences, September 1982

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

    Hirasuna, Alan R.; Friese, Gilbert J.; Stephens, Clifford A.

    1982-10-08

    High performance elastomers were developed for hostile geothermal environments which clearly advance the state-of-the-art. The Y267 EPDM compound is eminently successful and has accumulated broad laboratory and field test experience. Over 15 separate tests are reviewed with about 95% performed independently by other organizations. The tests include a broad spectrum of environments with temperatures in excess of 320 C (608 F), differential pressures up to 138 MPa (20,000 psi) and in fluids including brine, oils, isobutane, and others.

  9. Testing practices and volume of non-Lyme tickborne diseases in the United States.

    PubMed

    Connally, Neeta P; Hinckley, Alison F; Feldman, Katherine A; Kemperman, Melissa; Neitzel, David; Wee, Siok-Bi; White, Jennifer L; Mead, Paul S; Meek, James I

    2016-02-01

    Large commercial laboratories in the United States were surveyed regarding the number of specimens tested for eight tickborne diseases in 2008. Seven large commercial laboratories reported testing a total of 2,927,881 specimens nationally (including Lyme disease). Of these, 495,585 specimens (17%) were tested for tickborne diseases other than Lyme disease. In addition to large commercial laboratories, another 1051 smaller commercial, hospital, and government laboratories in four states (CT, MD, MN, and NY) were surveyed regarding tickborne disease testing frequency, practices, and results. Ninety-two of these reported testing a total of 10,091 specimens for four tickborne diseases other than Lyme disease. We estimate the cost of laboratory diagnostic testing for non-Lyme disease tickborne diseases in 2008 to be $9.6 million. These data provide a baseline to evaluate trends in tickborne disease test utilization and insight into the burden of these diseases. Copyright © 2015 Elsevier GmbH. All rights reserved.

  10. Integrated Data Collection Analysis (IDCA) Program - SSST Testing Methods

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

    Sandstrom, Mary M.; Brown, Geoffrey W.; Preston, Daniel N.

    The Integrated Data Collection Analysis (IDCA) program is conducting a proficiency study for Small- Scale Safety and Thermal (SSST) testing of homemade explosives (HMEs). Described here are the methods used for impact, friction, electrostatic discharge, and differential scanning calorimetry analysis during the IDCA program. These methods changed throughout the Proficiency Test and the reasons for these changes are documented in this report. The most significant modifications in standard testing methods are: 1) including one specified sandpaper in impact testing among all the participants, 2) diversifying liquid test methods for selected participants, and 3) including sealed sample holders for thermal testingmore » by at least one participant. This effort, funded by the Department of Homeland Security (DHS), is putting the issues of safe handling of these materials in perspective with standard military explosives. The study is adding SSST testing results for a broad suite of different HMEs to the literature. Ultimately the study will suggest new guidelines and methods and possibly establish the SSST testing accuracies needed to develop safe handling practices for HMEs. Each participating testing laboratory uses identical test materials and preparation methods wherever possible. The testing performers involved are Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Indian Head Division, Naval Surface Warfare Center, (NSWC IHD), Sandia National Laboratories (SNL), and Air Force Research Laboratory (AFRL/RXQL). These tests are conducted as a proficiency study in order to establish some consistency in test protocols, procedures, and experiments and to compare results when these testing variables cannot be made consistent.« less

  11. Reverberation Chamber Uniformity Validation and Radiated Susceptibility Test Procedures for the NASA High Intensity Radiated Fields Laboratory

    NASA Technical Reports Server (NTRS)

    Koppen, Sandra V.; Nguyen, Truong X.; Mielnik, John J.

    2010-01-01

    The NASA Langley Research Center's High Intensity Radiated Fields Laboratory has developed a capability based on the RTCA/DO-160F Section 20 guidelines for radiated electromagnetic susceptibility testing in reverberation chambers. Phase 1 of the test procedure utilizes mode-tuned stirrer techniques and E-field probe measurements to validate chamber uniformity, determines chamber loading effects, and defines a radiated susceptibility test process. The test procedure is segmented into numbered operations that are largely software controlled. This document is intended as a laboratory test reference and includes diagrams of test setups, equipment lists, as well as test results and analysis. Phase 2 of development is discussed.

  12. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  13. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  14. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  15. Characterization of 107 Genomic DNA Reference Materials for CYP2D6, CYP2C19, CYP2C9, VKORC1, and UGT1A1

    PubMed Central

    Pratt, Victoria M.; Zehnbauer, Barbara; Wilson, Jean Amos; Baak, Ruth; Babic, Nikolina; Bettinotti, Maria; Buller, Arlene; Butz, Ken; Campbell, Matthew; Civalier, Chris; El-Badry, Abdalla; Farkas, Daniel H.; Lyon, Elaine; Mandal, Saptarshi; McKinney, Jason; Muralidharan, Kasinathan; Noll, LeAnne; Sander, Tara; Shabbeer, Junaid; Smith, Chingying; Telatar, Milhan; Toji, Lorraine; Vairavan, Anand; Vance, Carlos; Weck, Karen E.; Wu, Alan H.B.; Yeo, Kiang-Teck J.; Zeller, Markus; Kalman, Lisa

    2010-01-01

    Pharmacogenetic testing is becoming more common; however, very few quality control and other reference materials that cover alleles commonly included in such assays are currently available. To address these needs, the Centers for Disease Control and Prevention's Genetic Testing Reference Material Coordination Program, in collaboration with members of the pharmacogenetic testing community and the Coriell Cell Repositories, have characterized a panel of 107 genomic DNA reference materials for five loci (CYP2D6, CYP2C19, CYP2C9, VKORC1, and UGT1A1) that are commonly included in pharmacogenetic testing panels and proficiency testing surveys. Genomic DNA from publicly available cell lines was sent to volunteer laboratories for genotyping. Each sample was tested in three to six laboratories using a variety of commercially available or laboratory-developed platforms. The results were consistent among laboratories, with differences in allele assignments largely related to the manufacturer's assay design and variable nomenclature, especially for CYP2D6. The alleles included in the assay platforms varied, but most were identified in the set of 107 DNA samples. Nine additional pharmacogenetic loci (CYP4F2, EPHX1, ABCB1, HLAB, KIF6, CYP3A4, CYP3A5, TPMT, and DPD) were also tested. These samples are publicly available from Coriell and will be useful for quality assurance, proficiency testing, test development, and research. PMID:20889555

  16. Image-guided intervention in the coagulopathic patient.

    PubMed

    Kohli, Marc; Mayo-Smith, William; Zagoria, Ronald; Sandrasegaran, Kumar

    2016-04-01

    Determining practice parameters for interventional procedures is challenging due to many factors including unreliable laboratory tests to measure bleeding risk, variable usage of standardized terminology for adverse events, poorly defined standards for administration of blood products, and the growing numbers of anticoagulant and antiplatelet medications. We aim to address these and other issues faced by radiologists performing invasive procedures through a review of available literature, and experiential guidance from three academic medical centers. We discuss the significant limitations with respect to using prothrombin-time and international normalized ratio to measure bleeding risk, especially in patients with synthetic defects due to liver function. Factors affecting platelet function including the impact of uremia; recent advances in laboratory testing, including platelet function testing; and thromboelastography are also discussed. A review of the existing literature of fresh-frozen plasma replacement therapy is included. The literature regarding comorbidities affecting coagulation including malignancy, liver failure, and uremia are also reviewed. Finally, the authors present a set of recommendations for laboratory thresholds, corrective transfusions, as well as withholding and restarting medications.

  17. The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group.

    PubMed

    Humphries, Romney M; Kircher, Susan; Ferrell, Andrea; Krause, Kevin M; Malherbe, Rianna; Hsiung, Andre; Burnham, C A

    2018-05-09

    Expedited pathways to antimicrobial agent approval by the United States Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices. Antimicrobial disks for use with disk diffusion testing are among the first AST devices available to clinical laboratories. However, many laboratories are reluctant to implement a disk diffusion method for a variety of reasons, including dwindling proficiency with this method, interruptions to laboratory workflow, uncertainty surrounding the quality and reliability of a disk diffusion test, and perceived need to report an MIC to clinicians. This mini-review provides a report from the Clinical and Laboratory Standards Institute Working Group on Methods Development and Standardization on the current standards and clinical utility of disk diffusion testing. Copyright © 2018 American Society for Microbiology.

  18. The availability and functional status of focused antenatal care laboratory services at public health facilities in Addis Ababa, Ethiopia.

    PubMed

    Desalegn, Daniel Melese; Abay, Serebe; Taye, Bineyam

    2016-08-11

    Provision of quality laboratory services is an essential aspect of a promoting safe motherhood and better outcomes for newborn. Therefore; this study was intended to assess status of focused antenatal care (FANC) laboratory services at public health facilities in Addis Ababa, Ethiopia. Institution based, descriptive cross-sectional study was conducted from April to May 2015. The study included 13 randomly selected health facilities and 13 purposively selected laboratory service providers. The status of FANC laboratory service was assessed by using pre-tested structured questionnaire and observation checklist. The study supplemented with qualitative data through in-depth interview of laboratory service providers. The quantitative data were coded and analysed by using SPSS Version 20 software and qualitative data was transcribed, coded, categorized and thematically analysed by the principal investigator. Only 5 (38.5 %) out of 13 visited health facilities reported the availability of all types of basic FANC laboratory investigations. Comparing the availability of individual tests in the study facilities, urine dipstick, urine microscopy and stool examination were available in all institutions. However, only 7 (53.8 %) of the health facilities reported the availability of hepatitis B virus screening test. Rapid syphilis (RPR) test was found in 10 (76.9 %) facilities. All laboratory facilities had at least one or more basic FANC laboratory tests interruption for more than a day within the last 1 year due to shortage of reagent and electric power disruption. Majority of the health facilities reported incomplete provision of FANC laboratory investigations. Laboratory supply shortage and electric power disruption were the facilities' major challenge to screen pregnant women for pregnancy related health conditions. Since such conditions may affect the outcome of pregnancy, therefore extensive efforts should be targeted to avoid services interruption by taking improvement measures including the fulfilment of all FANC laboratory resources.

  19. CALiPER Report 24: OLED Luminaires

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

    Miller, N. J.; Leon, F. A.; Davis, J. L.

    2017-08-01

    This report documents an initial investigation of OLED luminaires and summarizes the key features of those products. In addition to photometric testing of four commercial products in independent laboratories, PNNL examined many of the products through teardown testing (disassemblies to identify parts and functionality) in PNNL laboratories. Results of these tests as well as results of stress testing of several OLED luminaires at RTI International have been included.

  20. EGFR T790M mutation testing within the osimertinib AURA Phase I study.

    PubMed

    Dearden, Simon; Brown, Helen; Jenkins, Suzanne; Thress, Kenneth S; Cantarini, Mireille; Cole, Rebecca; Ranson, Malcolm; Jänne, Pasi A

    2017-07-01

    Reliable epidermal growth factor receptor (EGFR) mutation testing techniques are required to identify eligible patients with EGFR mutation/T790M positive advanced non-small cell lung cancer (NSCLC), for treatment with osimertinib (AZD9291), an oral, potent, irreversible EGFR tyrosine kinase inhibitor (TKI) selective for EGFR-TKI-sensitizing and T790M resistance mutations over wild-type EGFR. There is no current consensus regarding the best method to detect EGFR T790M mutations. The aim of this study was to describe the concordance between local testing, which used a variety of methods, and central testing, using the cobas ® EGFR Mutation Test, for EGFR-sensitizing mutations and the T790M resistance mutation. Tumor samples were obtained from all patients screened for inclusion onto the osimertinib Phase I expansion component of the AURA Phase I/II study (NCT01802632). Samples underwent central laboratory testing for EGFR-sensitizing mutations and T790M resistance mutation using the cobas ® EGFR Mutation Test. Results were compared with local laboratory test results, based on other testing methodologies including Sanger sequencing, therascreen ® , PNAClamp™, and Sequenom MassARRAY ® . Central laboratory testing was successful in 99% of samples passing histopathology review and testing success rates were comparable across the three central laboratories. Concordance between central and local testing for common sensitizing mutations was high (>98%) and concordance for the T790M mutation was also high (>90%). Tumor heterogeneity, along with other technical factors may have influenced this result. Within the osimertinib AURA Phase I study, EGFR mutation testing across three centralized laboratories using the cobas ® EGFR Mutation Test was feasible and successful, with strong concordance between local and central laboratory results, including for T790M. The cobas ® EGFR Mutation Test has subsequently been approved as the companion diagnostic test for osimertinib in the USA and Japan. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. External quality assurance of HER2 fluorescence in situ hybridisation testing: results of a UK NEQAS pilot scheme.

    PubMed

    Bartlett, John M S; Ibrahim, Merdol; Jasani, Bharat; Morgan, John M; Ellis, Ian; Kay, Elaine; Magee, Hilary; Barnett, Sarah; Miller, Keith

    2007-07-01

    Trastuzumab provides clinical benefit for advanced and early breast cancer patients whose tumours over-express or have gene amplification of the HER2 oncogene. The UK National External Quality Assessment Scheme (NEQAS) for immunohistochemical testing was established to assess and improve the quality of HER2 immunohistochemical testing. However, until recently, no provision was available for HER2 fluorescence in situ hybridisation (FISH) testing. A pilot scheme was set up to review the performance of FISH testing in clinical diagnostic laboratories. FISH was performed in 6 reference and 31 participating laboratories using a cell line panel with known HER2 status. Using results from reference laboratories as a criterion for acceptable performance, 60% of all results returned by participants were appropriate and 78% either appropriate or acceptable. However, 22.4% of results returned were deemed inappropriate, including 13 cases (4.2%) where a misdiagnosis would have been made had these been clinical specimens. The results of three consecutive runs show that both reference laboratories and a proportion of routine clinical diagnostic (about 25%) centres can consistently achieve acceptable quality control of HER2 testing. Data from a significant proportion of participating laboratories show that further steps are required, including those taken via review of performance under schemes such as NEQAS, to improve quality of HER2 testing by FISH in the "real world".

  2. Results from the Operational Testing of the Eaton Smart Grid Capable Electric Vehicle Supply Equipment

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

    Bennett, Brion

    2014-10-01

    The Idaho National Laboratory conducted testing and analysis of the Eaton smart grid capable electric vehicle supply equipment (EVSE), which was a deliverable from Eaton for the U.S. Department of Energy FOA-554. The Idaho National Laboratory has extensive knowledge and experience in testing advanced conductive and wireless charging systems though INL’s support of the U.S. Department of Energy’s Advanced Vehicle Testing Activity. This document details the findings from the EVSE operational testing conducted at the Idaho National Laboratory on the Eaton smart grid capable EVSE. The testing conducted on the EVSE included energy efficiency testing, SAE J1772 functionality testing, abnormalmore » conditions testing, and charging of a plug-in vehicle.« less

  3. Results from Operational Testing of the Siemens Smart Grid-Capable Electric Vehicle Supply Equipment

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

    Bennett, Brion

    2015-05-01

    The Idaho National Laboratory conducted testing and analysis of the Siemens smart grid capable electric vehicle supply equipment (EVSE), which was a deliverable from Siemens for the U.S. Department of Energy FOA-554. The Idaho National Laboratory has extensive knowledge and experience in testing advanced conductive and wireless charging systems though INL’s support of the U.S. Department of Energy’s Advanced Vehicle Testing Activity. This document details the findings from the EVSE operational testing conducted at the Idaho National Laboratory on the Siemens smart grid capable EVSE. The testing conducted on the EVSE included energy efficiency testing, SAE J1772 functionality testing, abnormalmore » conditions testing, and charging of a plug-in vehicle.« less

  4. Laboratory Surge Response to Pandemic (H1N1) 2009 Outbreak, New York City Metropolitan Area, USA

    PubMed Central

    Crawford, James M.; Stallone, Robert; Zhang, Fan; Gerolimatos, Mary; Korologos, Diamanto D.; Sweetapple, Carolyn; de Geronimo, Marcella; Dlugacz, Yosef; Armellino, Donna M.

    2010-01-01

    The North Shore–Long Island Jewish Health System Laboratories serve 15 hospitals and affiliated regional physician practices in the New York City metropolitan area, with virus testing performed at a central reference laboratory. The influenza A pandemic (H1N1) 2009 outbreak began in this area on April 24, 2009, and within weeks respiratory virus testing increased 7.5 times. In response, laboratory and client service workforces were increased, physical plant build-out was completed, testing paradigms were converted from routine screening tests and viral culture to a high-capacity molecular assay for respiratory viruses, laboratory information system interfaces were built, and same-day epidemiologic reports were produced. Daily review by leadership of data from emergency rooms, hospital facilities, and the Health System Laboratories enabled real-time management of unfolding events. The ability of System laboratories to rapidly increase to high-volume comprehensive diagnostics, including influenza A subtyping, provided key epidemiologic information for local and state public health departments. PMID:20031036

  5. Laboratory surge response to pandemic (H1N1) 2009 outbreak, New York City metropolitan area, USA.

    PubMed

    Crawford, James M; Stallone, Robert; Zhang, Fan; Gerolimatos, Mary; Korologos, Diamanto D; Sweetapple, Carolyn; de Geronimo, Marcella; Dlugacz, Yosef; Armellino, Donna M; Ginocchio, Christine C

    2010-01-01

    The North Shore-Long Island Jewish Health System Laboratories serve 15 hospitals and affiliated regional physician practices in the New York City metropolitan area, with virus testing performed at a central reference laboratory. The influenza A pandemic (H1N1) 2009 outbreak began in this area on April 24, 2009, and within weeks respiratory virus testing increased 7.5 times. In response, laboratory and client service workforces were increased, physical plant build-out was completed, testing paradigms were converted from routine screening tests and viral culture to a high-capacity molecular assay for respiratory viruses, laboratory information system interfaces were built, and same-day epidemiologic reports were produced. Daily review by leadership of data from emergency rooms, hospital facilities, and the Health System Laboratories enabled real-time management of unfolding events. The ability of System laboratories to rapidly increase to high-volume comprehensive diagnostics, including influenza A subtyping, provided key epidemiologic information for local and state public health departments.

  6. Implications of the introduction of laboratory demand management at primary care clinics in South Africa on laboratory expenditure

    PubMed Central

    Lekalakala, Ruth; Asmall, Shaidah; Cassim, Naseem

    2016-01-01

    Background Diagnostic health laboratory services are regarded as an integral part of the national health infrastructure across all countries. Clinical laboratory tests contribute substantially to health system goals of increasing quality of care and improving patient outcomes. Objectives This study aimed to analyse current laboratory expenditures at the primary healthcare (PHC) level in South Africa as processed by the National Health Laboratory Service and to determine the potential cost savings of introducing laboratory demand management. Methods A retrospective cross-sectional analysis of laboratory expenditures for the 2013/2014 financial year across 11 pilot National Health Insurance health districts was conducted. Laboratory expenditure tariff codes were cross-tabulated to the PHC essential laboratory tests list (ELL) to determine inappropriate testing. Data were analysed using a Microsoft Access database and Excel software. Results Approximately R35 million South African Rand (10%) of the estimated R339 million in expenditures was for tests that were not listed within the ELL. Approximately 47% of expenditure was for laboratory tests that were indicated in the algorithmic management of patients on antiretroviral treatment. The other main cost drivers for non-ELL testing included full blood count and urea, as well as electrolyte profiles usually requested to support management of patients on antiretroviral treatment. Conclusions Considerable annual savings of up to 10% in laboratory expenditure are possible at the PHC level by implementing laboratory demand management. In addition, to achieve these savings, a standardised PHC laboratory request form and some form of electronic gatekeeping system that must be supported by an educational component should be implemented. PMID:28879107

  7. Clinical pathologist in Korea--training program and its roles in laboratories.

    PubMed

    Cho, Han-Ik; Lee, Kap No; Park, Jong-Woo; Park, Hyosoon; Kwak, Yun Sik

    2002-01-01

    A rapid development of practice of laboratory medicine in Korea owes its success to the clinical pathologists (CP), who have played a role of a pathfinder for laboratories. The Korean CP postgraduate education (residency) program is unique in that it is exclusively for laboratory medicine. The training program for clinical pathologists includes diagnostic hematology, diagnostic immunology, clinical microbiology, clinical chemistry, blood bank, diagnostic genetics, informatics and laboratory management. The program has produced a strong group of about 600 laboratory physicians, officially clinical pathologists since 1963. Most of Korean clinical pathologists work as laboratory directors, directors of university hospital laboratories or teaching faculty members in medical schools. The roles of clinical pathologists are laboratory management, interpretation of laboratory test results, clinical consulting services to clinicians and patients, ordering secondary tests after reviews of requested test results and utilization management. The clinical pathologists have developed clinical laboratories to be a main contributor for improved medical practice. During the last 40 years under the turbulent healthcare system, clinical pathologists have significantly contributed to safeguard the laboratory interests. The education program and the role of clinical pathologists are described.

  8. S-band range tracker and Surveillance Lab interface

    NASA Astrophysics Data System (ADS)

    Bush, B. D.

    1983-09-01

    This report documents the design, construction, test and laboratory integration of the range tracker and associated subsystems for the RADC/OC Surveillance Laboratory's S-Band tracking radar. This development was accomplished over the period from December 1981 to November 1983 and was designed, constructed and tested entirely in-house. This report contains information on the use of the range tracker, its interfaces to other laboratory equipment, the philosophy behind its design, the detailed design of the hardware (including schematics, timing and cabling diagrams), the detailed software design (including flowcharts), and the mathematical description of its algorithms. The range tracker will be used in conjunction with other equipment in the OC Surveillance Lab in the taking and recording of radar data during flight tests.

  9. Crew Systems Laboratory/Building 7. Historical Documentation

    NASA Technical Reports Server (NTRS)

    Slovinac, Patricia

    2011-01-01

    Building 7 is managed by the Crew and Thermal Systems Division of the JSC Engineering Directorate. Originally named the Life Systems Laboratory, it contained five major test facilities: two advanced environmental control laboratories and three human-rated vacuum chambers (8 , 11 , and the 20 ). These facilities supported flight crew familiarization and the testing and evaluation of hardware used in the early manned spaceflight programs, including Gemini, Apollo, and the ASTP.

  10. 40 CFR 80.126 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...% independent lab testing, the laboratory analysis shall consist of the results reported to the refinery or... trading records shall include worksheets and EPA reports showing actual and complying totals for benzene... evidencing the transfer of credits. (c) Designation records shall include laboratory analysis reports that...

  11. 40 CFR 80.126 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...% independent lab testing, the laboratory analysis shall consist of the results reported to the refinery or... trading records shall include worksheets and EPA reports showing actual and complying totals for benzene... evidencing the transfer of credits. (c) Designation records shall include laboratory analysis reports that...

  12. Corrections of clinical chemistry test results in a laboratory information system.

    PubMed

    Wang, Sihe; Ho, Virginia

    2004-08-01

    The recently released reports by the Institute of Medicine, To Err Is Human and Patient Safety, have received national attention because of their focus on the problem of medical errors. Although a small number of studies have reported on errors in general clinical laboratories, there are, to our knowledge, no reported studies that focus on errors in pediatric clinical laboratory testing. To characterize the errors that have caused corrections to have to be made in pediatric clinical chemistry results in the laboratory information system, Misys. To provide initial data on the errors detected in pediatric clinical chemistry laboratories in order to improve patient safety in pediatric health care. All clinical chemistry staff members were informed of the study and were requested to report in writing when a correction was made in the laboratory information system, Misys. Errors were detected either by the clinicians (the results did not fit the patients' clinical conditions) or by the laboratory technologists (the results were double-checked, and the worksheets were carefully examined twice a day). No incident that was discovered before or during the final validation was included. On each Monday of the study, we generated a report from Misys that listed all of the corrections made during the previous week. We then categorized the corrections according to the types and stages of the incidents that led to the corrections. A total of 187 incidents were detected during the 10-month study, representing a 0.26% error detection rate per requisition. The distribution of the detected incidents included 31 (17%) preanalytic incidents, 46 (25%) analytic incidents, and 110 (59%) postanalytic incidents. The errors related to noninterfaced tests accounted for 50% of the total incidents and for 37% of the affected tests and orderable panels, while the noninterfaced tests and panels accounted for 17% of the total test volume in our laboratory. This pilot study provided the rate and categories of errors detected in a pediatric clinical chemistry laboratory based on the corrections of results in the laboratory information system. A direct interface of the instruments to the laboratory information system showed that it had favorable effects on reducing laboratory errors.

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

    PubMed

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

    2018-02-17

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

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

    PubMed

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

    2010-12-01

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

  15. 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

  16. C-B3-03: Development and Pilot Testing of Guidelines to Monitor High-Risk Medications in the Ambulatory Setting

    PubMed Central

    Tjia, Jennifer; Field, Terry; Garber, Lawrence; Raebel, Marsha; Donovan, Jennifer; Kanaan, Abir; Fischer, Shira; Gagne, Shawn; Zhao, Yanfang; Fuller, Jackie; Gurwitz, Jerry

    2010-01-01

    Background: Inadequate laboratory monitoring of high-risk medications contributes to preventable adverse drug events. One barrier to appropriate monitoring is lack of standardized monitoring guidelines. The study aims were to develop guidelines to monitor high-risk medications and to assess the prevalence of laboratory testing for these medications in a multispecialty group practice. Methods: We developed guidelines for laboratory monitoring of high-risk medications as part of a patient safety intervention trial. An advisory committee of national experts and local leaders (clinicians, pharmacists, pharmacoepidemiologists, and patient safety experts) used a two-round, internet-based Delphi process to select guideline medications based on the importance of monitoring for efficacy, safety, and drug-drug interactions. Test frequency recommendations were developed by academic pharmacists based on literature review and local interdisciplinary consensus. To estimate the potential impact of the intervention, we determined the prevalence of high-risk drug dispensings and laboratory testing for guideline medications between January 1, 2008 and July 31, 2008. Results: Consensus on medications to include in the guidelines was achieved in two rounds. Final guidelines included 35 drugs/drug classes and 61 laboratory tests. The prevalence of monitoring ranged from <50% to >90%, with infrequently prescribed drugs having a lower prevalence of recommended testing. When more than one test was recommended for a selected medication, monitoring within a medication sometimes differed by > 50%. Conclusions: Even among drugs where there is general consensus that laboratory monitoring is important, prevalence of monitoring is highly variable. Further, infrequently prescribed medications are at higher risk for poor monitoring.

  17. Laboratory diagnosis of Ebola virus disease and corresponding biosafety considerations in the China Ebola Treatment Center.

    PubMed

    Huang, Qing; Fu, Wei-Ling; You, Jian-Ping; Mao, Qing

    2016-10-01

    Ebola virus disease (EVD), caused by Ebola virus (EBOV), is a potent acute infectious disease with a high case-fatality rate. Etiological and serological EBOV detection methods, including techniques that involve the detection of the viral genome, virus-specific antigens and anti-virus antibodies, are standard laboratory diagnostic tests that facilitate confirmation or exclusion of EBOV infection. In addition, routine blood tests, liver and kidney function tests, electrolytes and coagulation tests and other diagnostic examinations are important for the clinical diagnosis and treatment of EVD. Because of the viral load in body fluids and secretions from EVD patients, all body fluids are highly contagious. As a result, biosafety control measures during the collection, transport and testing of clinical specimens obtained from individuals scheduled to undergo EBOV infection testing (including suspected, probable and confirmed cases) are crucial. This report has been generated following extensive work experience in the China Ebola Treatment Center (ETC) in Liberia and incorporates important information pertaining to relevant diagnostic standards, clinical significance, operational procedures, safety controls and other issues related to laboratory testing of EVD. Relevant opinions and suggestions are presented in this report to provide contextual awareness associated with the development of standards and/or guidelines related to EVD laboratory testing.

  18. 2. Photographic copy of engineering drawing showing mechanical systems in ...

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

    2. Photographic copy of engineering drawing showing mechanical systems in plan and sections of Test Stand 'E,' including tunnel entrance. California Institute of Technology, Jet Propulsion Laboratory, Plant Engineering 'Bldg. E-60 Mechanical, Solid Propellant Test Stand,' sheet E60/13-4, June 20, 1961. - Jet Propulsion Laboratory Edwards Facility, Test Stand E, Edwards Air Force Base, Boron, Kern County, CA

  19. Testing the Data Assimilation Capability of the Profiler Virtual Module

    DTIC Science & Technology

    2016-02-01

    ARL-TR-7601 ● FEB 2016 US Army Research Laboratory Testing the Data Assimilation Capability of the Profiler Virtual Module by...originator. ARL-TR-7601 ● FEB 2016 US Army Research Laboratory Testing the Data Assimilation Capability of the Profiler Virtual...hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and

  20. Practical challenges related to point of care testing.

    PubMed

    Shaw, Julie L V

    2016-04-01

    Point of care testing (POCT) refers to laboratory testing that occurs near to the patient, often at the patient bedside. POCT can be advantageous in situations requiring rapid turnaround time of test results for clinical decision making. There are many challenges associated with POCT, mainly related to quality assurance. POCT is performed by clinical staff rather than laboratory trained individuals which can lead to errors resulting from a lack of understanding of the importance of quality control and quality assurance practices. POCT is usually more expensive than testing performed in the central laboratory and requires a significant amount of support from the laboratory to ensure the quality testing and meet accreditation requirements. Here, specific challenges related to POCT compliance with accreditation standards are discussed along with strategies that can be used to overcome these challenges. These areas include: documentation of POCT orders, charting of POCT results as well as training and certification of individuals performing POCT. Factors to consider when implementing connectivity between POCT instruments and the electronic medical record are also discussed in detail and include: uni-directional versus bidirectional communication, linking patient demographic information with POCT software, the importance of positive patient identification and considering where to chart POCT results in the electronic medical record.

  1. The sensitivity of laboratory tests assessing driving related skills to dose-related impairment of alcohol: A literature review.

    PubMed

    Jongen, S; Vuurman, E F P M; Ramaekers, J G; Vermeeren, A

    2016-04-01

    Laboratory tests assessing driving related skills can be useful as initial screening tools to assess potential drug induced impairment as part of a standardized behavioural assessment. Unfortunately, consensus about which laboratory tests should be included to reliably assess drug induced impairment has not yet been reached. The aim of the present review was to evaluate the sensitivity of laboratory tests to the dose dependent effects of alcohol, as a benchmark, on performance parameters. In total, 179 experimental studies were included. Results show that a cued go/no-go task and a divided attention test with primary tracking and secondary visual search were consistently sensitive to the impairing effects at medium and high blood alcohol concentrations. Driving performance assessed in a simulator was less sensitive to the effects of alcohol as compared to naturalistic, on-the-road driving. In conclusion, replicating results of several potentially useful tests and their predictive validity of actual driving impairment should deserve further research. In addition, driving simulators should be validated and compared head to head to naturalistic driving in order to increase construct validity. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  2. 27 CFR 1.60 - Use of distilled spirits.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... laboratory for use exclusively in scientific research; (3) For use at any hospital, blood bank, or sanitarium (including use in making analysis or test at such hospital, blood bank, or sanitarium), or at any pathological laboratory exclusively engaged in making analyses, or tests, for hospitals or sanitariums; or (4...

  3. The Explosive Pulsed Power Test Facility at AFRL

    DTIC Science & Technology

    2005-06-01

    Air Force Research Laboratory , AFRL /DEHP, Albuquerque...NM 87117 S. Coffey, A. Brown, B. Guffey NumerEx, Albuquerque, NM Abstract The Air Force Research Laboratory has developed and tested a...Chestnut Site on Kirtland Air Force Base. The facility is described in this paper, including details of recent upgrades. I.

  4. 77 FR 65714 - Agency Information Collection Activities: Proposed Collection; Comments Requested:

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-30

    ... Drug Samples Tested by Non-Federal (State and Local Government) Crime Laboratories ACTION: 60-Day... functions of the agency, including whether the information will have practical utility; --Evaluate the... Analysis Data on Drug Samples Tested by Non-Federal (State and Local Government) Crime Laboratories. (3...

  5. 78 FR 12323 - Announcement of the Re-Approval of the Commission on Office Laboratory Accreditation (COLA) as an...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ... subspecialty areas under CLIA: Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology... CLIA for the following specialties and subspecialties: Microbiology, including Bacteriology... requirements. The COLA requires the laboratory director to review quality control results for waived tests...

  6. A teaching intervention for reading laboratory experiments in college-level introductory chemistry

    NASA Astrophysics Data System (ADS)

    Kirk, Maria Kristine

    The purpose of this study was to determine the effects that a pre-laboratory guide, conceptualized as a "scientific story grammar," has on college chemistry students' learning when they read an introductory chemistry laboratory manual and perform the experiments in the chemistry laboratory. The participants (N = 56) were students enrolled in four existing general chemistry laboratory sections taught by two instructors at a women's liberal arts college. The pre-laboratory guide consisted of eight questions about the experiment, including the purpose, chemical species, variables, chemical method, procedure, and hypothesis. The effects of the intervention were compared with those of the traditional pre-laboratory assignment for the eight chemistry experiments. Measures included quizzes, tests, chemistry achievement test, science process skills test, laboratory reports, laboratory average, and semester grade. The covariates were mathematical aptitude and prior knowledge of chemistry and science processes, on which the groups differed significantly. The study captured students' perceptions of their experience in general chemistry through a survey and interviews with eight students. The only significant differences in the treatment group's performance were in some subscores on lecture items and laboratory items on the quizzes. An apparent induction period was noted, in that significant measures occurred in mid-semester. Voluntary study with the pre-laboratory guide by control students precluded significant differences on measures given later in the semester. The groups' responses to the survey were similar. Significant instructor effects on three survey items were corroborated by the interviews. The researcher's students were more positive about their pre-laboratory tasks, enjoyed the laboratory sessions more, and were more confident about doing chemistry experiments than the laboratory instructor's groups due to differences in scaffolding by the instructors.

  7. Syphilis testing practices in the Americas.

    PubMed

    Trinh, Thuy T; Kamb, Mary L; Luu, Minh; Ham, D Cal; Perez, Freddy

    2017-09-01

    To present the findings of the Pan American Health Organization's 2014 survey on syphilis testing policies and practices in the Americas. Representatives of national/regional reference and large, lower-level laboratories from 35 member states were invited to participate. A semi-structured, electronically administered questionnaire collected data on syphilis tests, algorithms, equipment/commodities, challenges faced and basic quality assurance (QA) strategies employed (i.e. daily controls, standard operating procedures, technician training, participating in external QA programmes, on-site evaluations). The 69 participating laboratories from 30 (86%) member states included 41 (59%) national/regional reference and 28 (41%) lower-level laboratories. Common syphilis tests conducted were the rapid plasma reagin (RPR) (62% of surveyed laboratories), venereal disease research laboratory (VDRL) (54%), fluorescent treponemal antibody absorption (FTA-ABS) (41%) and Treponema pallidum haemagglutination assay (TPHA) (32%). Only three facilities reported using direct detection methods, and 28 (41% overall, 32% of lower-level facilities) used rapid tests. Most laboratories (62%) used only traditional testing algorithms (non-treponemal screening and treponemal confirmatory testing); however, 12% used only a reverse sequence algorithm (treponemal test first), and 14% employed both algorithms. Another nine (12%) laboratories conducted only one type of serologic test. Although most reference (97%) and lower-level (89%) laboratories used at least one QA strategy, only 16% reported using all five basic strategies. Commonly reported challenges were stock-outs of essential reagents or commodities (46%), limited staff training (73%) and insufficient equipment (39%). Many reference and clinical laboratories in the Americas face challenges in conducting appropriate syphilis testing and in ensuring quality of testing. © 2017 John Wiley & Sons Ltd The Pan-American Health Organization retains copyright and all other rights in the manuscript of this article as submitted for publication.

  8. Results from the Operational Testing of the General Electric Smart Grid Capable Electric Vehicle Supply Equipment (EVSE)

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

    Carlson, Richard Barney; Scoffield, Don; Bennett, Brion

    2013-12-01

    The Idaho National Laboratory conducted testing and analysis of the General Electric (GE) smart grid capable electric vehicle supply equipment (EVSE), which was a deliverable from GE for the U.S. Department of Energy FOA-554. The Idaho National Laboratory has extensive knowledge and experience in testing advanced conductive and wireless charging systems though INL’s support of the U.S. Department of Energy’s Advanced Vehicle Testing Activity. This document details the findings from the EVSE operational testing conducted at the Idaho National Laboratory on the GE smart grid capable EVSE. The testing conducted on the EVSE included energy efficiency testing, SAE J1772 functionalitymore » testing, abnormal conditions testing, and charging of a plug-in vehicle.« less

  9. Clostridium botulinum and the clinical laboratorian: a detailed review of botulism, including biological warfare ramifications of botulinum toxin.

    PubMed

    Caya, James G; Agni, Rashmi; Miller, Joan E

    2004-06-01

    This review article is designed to thoroughly familiarize all health care professionals with the history, classification, epidemiology, clinical characteristics, differential diagnosis, diagnostic evaluation (including laboratory-based testing), treatment, and prognosis of botulism. It is especially targeted toward clinical laboratorians and includes a detailed enumeration of the important clinical laboratory contributions to the diagnosis, treatment, and monitoring of patients with botulism. Finally, the bioterrorism potential for botulism is discussed, with an emphasis on the clinical laboratory ramifications of this possibility. Included medical periodicals and textbooks accessioned from computerized and manual medical literature searches. More than 1000 medical works published from the 1800s through 2003 were retrieved and reviewed in this process. Pertinent data are presented in textual and tabular formats, the latter including 6 tables presenting detailed information regarding the clinical parameters, differential diagnosis, diagnostic studies, laboratory testing, and therapeutic approaches to botulism. Because botulism is such a rare disease, a keen awareness of its manifestations and prompt diagnosis are absolutely crucial for its successful treatment. The bioterrorism potential of botulism adds further urgency to the need for all health care professionals to be familiar with this disease, its proper evaluation, and timely treatment; the need for such urgency clearly includes the clinical laboratory.

  10. Point-of-Care Hemoglobin A1c Testing: An Evidence-Based Analysis

    PubMed Central

    2014-01-01

    Background The increasing prevalence of diabetes in Ontario means that there will be growing demand for hemoglobin A1c (HbA1c) testing to monitor glycemic control for the management of this chronic disease. Testing HbA1c where patients receive their diabetes care may improve system efficiency if the results from point-of-care HbA1c testing are comparable to those from laboratory HbA1c measurements. Objectives To review the correlation between point-of-care HbA1c testing and laboratory HbA1c measurement in patients with diabetes in clinical settings. Data Sources The literature search included studies published between January 2003 and June 2013. Search terms included glycohemoglobin, hemoglobin A1c, point of care, and diabetes. Review Methods Studies were included if participants had diabetes; if they compared point-of-care HbA1c devices (licensed by Health Canada and available in Canada) with laboratory HbA1c measurement (reference method); if they performed point-of-care HbA1c testing using capillary blood samples (finger pricks) and laboratory HbA1c measurement using venous blood samples within 7 days; and if they reported a correlation coefficient between point-of-care HbA1c and laboratory HbA1c results. Results Three point-of-care HbA1c devices were reviewed in this analysis: Bayer's A1cNow+, Bio-Rad's In2it, and Siemens’ DCA Vantage. Five observational studies met the inclusion criteria. The pooled results showed a positive correlation between point-of-care HbA1c testing and laboratory HbA1c measurement (correlation coefficient, 0.967; 95% confidence interval, 0.960–0.973). Limitations Outcomes were limited to the correlation coefficient, as this was a commonly reported measure of analytical performance in the literature. Results should be interpreted with caution due to risk of bias related to selection of participants, reference standards, and the multiple steps involved in POC HbA1c testing. Conclusions Moderate quality evidence showed a positive correlation between point-of-care HbA1c testing and laboratory HbA1c measurement. Five observational studies compared 3 point-of-care HbA1c devices with laboratory HbA1c assays, and all reported strong correlation between the 2 tests. PMID:26316922

  11. Development and validation of an immunoperoxidase antigen detection test for improved diagnosis of rabies in Indonesia.

    PubMed

    Rahmadane, Ibnu; Certoma, Andrea F; Peck, Grantley R; Fitria, Yul; Payne, Jean; Colling, Axel; Shiell, Brian J; Beddome, Gary; Wilson, Susanne; Yu, Meng; Morrissy, Chris; Michalski, Wojtek P; Bingham, John; Gardner, Ian A; Allen, John D

    2017-11-01

    Rabies continues to pose a significant threat to human and animal health in regions of Indonesia. Indonesia has an extensive network of veterinary diagnostic laboratories and the 8 National laboratories are equipped to undertake diagnostic testing for rabies using the commercially-procured direct fluorescent antibody test (FAT), which is considered the reference (gold standard) test. However, many of the Indonesian Provincial diagnostic laboratories do not have a fluorescence microscope required to undertake the FAT. Instead, certain Provincial laboratories continue to screen samples using a chemical stain-based test (Seller's stain test, SST). This test has low diagnostic sensitivity, with negative SST-tested samples being forwarded to the nearest National laboratory resulting in significant delays for completion of testing and considerable additional costs. This study sought to develop a cost-effective and diagnostically-accurate immunoperoxidase antigen detection (RIAD) test for rabies that can be readily and quickly performed by the resource-constrained Provincial laboratories. This would reduce the burden on the National laboratories and allow more rapid diagnoses and implementation of post-exposure prophylaxis. The RIAD test was evaluated using brain smears fixed with acetone or formalin and its performance was validated by comparison with established rabies diagnostic tests used in Indonesia, including the SST and FAT. A proficiency testing panel was distributed between Provincial laboratories to assess the reproducibility of the test. The performance of the RIAD test was improved by using acetone fixation of brain smears rather than formalin fixation such that it was of equivalent accuracy to that of the World Organisation for Animal Health (OIE)-recommended FAT, with both tests returning median diagnostic sensitivity and specificity values of 0.989 and 0.993, respectively. The RIAD test and FAT had higher diagnostic sensitivity than the SST (median = 0.562). Proficiency testing using a panel of 6 coded samples distributed to 16 laboratories showed that the RIAD test had good reproducibility with an overall agreement of 97%. This study describes the successful development, characterisation and use of a novel RIAD test and its fitness for purpose as a screening test for use in provincial Indonesian veterinary laboratories.

  12. Survey of laboratory practices for diagnosis of fungal infection in seven Asian countries: An Asia Fungal Working Group (AFWG) initiative.

    PubMed

    Chindamporn, Ariya; Chakrabarti, Arunaloke; Li, Ruoyu; Sun, Pei-Lun; Tan, Ban-Hock; Chua, Mitzi; Wahyuningsih, Retno; Patel, Atul; Liu, Zhengyin; Chen, Yee-Chun; Chayakulkeeree, Methee

    2018-06-01

    An online survey of mycology laboratories in seven Asian countries was conducted to assess the status, competence, and services available. Country representatives from the Asia Fungal Working Group (AFWG) contacted as many laboratories performing mycology diagnosis as possible in their respective countries, requesting that the laboratory heads complete the online survey. In total, 241 laboratories responded, including 71 in China, 104 in India, 11 in Indonesia, 26 in the Philippines, four in Singapore, 18 in Taiwan, and seven in Thailand. Overall, 129/241 (53.5%) surveyed mycology laboratories operate as separate designated mycology laboratories, 75/241 (31.1%) conduct regular formal staff training, 103/241 (42.7%) are accredited, and 88/157 (56.1%) participate in external quality assurance scheme (EQAS) programs. Microscopy and culture methods are available in nearly all laboratories, although few perform DNA sequencing (37/219; 16.9%) or use matrix-assisted laser desorption/ionization time-of-flight mass spectroscopy (MALDI-TOF MS) (27/219; 12.3%) for isolate identification. Antifungal susceptibility testing is performed in 142/241 (58.9%) laboratories, mainly for yeasts. The most commonly performed nonculture diagnostic is cryptococcal antigen testing (66 laboratories), followed by galactomannan testing (55), polymerase chain reaction (PCR) diagnosis (37), and beta-D-glucan testing (24). Therapeutic drug monitoring is conducted in 21 laboratories. There is almost no access to advanced diagnostic tests, like galactomannan, β-D-glucan, and PCR, in the surveyed laboratories in Indonesia, the Philippines, and Thailand. These results highlight the need for development of quality laboratories, accreditation and training of manpower in existing laboratories, and access to advanced non-culture-based diagnostic tests to facilitate the diagnosis of fungal infections in Asia.

  13. Between and within laboratory reliability of mouse behaviour recorded in home-cage and open-field.

    PubMed

    Robinson, Lianne; Spruijt, Berry; Riedel, Gernot

    2018-04-15

    Reproducibility of behavioural findings between laboratories is difficult due to behaviour being sensitive to environmental factors and interactions with genetics. The objective of this study was to investigate reproducibility of behavioural data between laboratories using the PhenoTyper home cage observation system and within laboratory reproducibility using different lighting regimes. The ambulatory activity of C57BL/6 and DBA/2 mice was tested in PhenoTypers in two laboratories under near identical housing and testing conditions (Exp. 1). Additionally activity and anxiety were also assessed in the open-field test. Furthermore, testing in either a normal or inverted light/dark cycle was used to determine effects of lighting regime in a within-laboratory comparison in Aberdeen (Exp. 2). Using the PhenoTyper similar circadian rhythms were observed across laboratories. Higher levels of baseline and novelty-induced activity were evident in Aberdeen compared to Utrecht although strain differences were consistent between laboratories. Open field activity was also similar across laboratories whereas strain differences in anxiety were different. Within laboratory analysis of different lighting regimes revealed that behaviour of the mice was sensitive to changes in lighting. Utilisation of a home cage observation system facilitates the reproducibility of activity but not anxiety-related behaviours across laboratories by eliminating environmental factors known to influence reproducibility in standard behavioural tests. Standardisation of housing/test conditions resulted in reproducibility of home cage and open field activity but not anxiety-related phenotypes across laboratories with some behaviours more sensitive to environmental factors. Environmental factors include lighting and time of day. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. Regional and supraregional biochemistry services in Scotland: a survey of hospital laboratory users.

    PubMed Central

    Murphy, M J; Dryburgh, F J; Shepherd, J

    1994-01-01

    AIM--To ascertain the views of Scottish hospital laboratory users on aspects of regional and supraregional biochemical services offered by the Institute of Biochemistry at Glasgow Royal Infirmary. METHODS--A questionnaire was circulated asking questions or inviting opinions under various headings, including current patterns of usage of the services provided, availability of information on specimen collection requirements and reference ranges, current arrangements for transport of specimens, turnaround times for delivery of reports, layout and content of request and report forms, quantity and quality of interpretive advice, potential changes in laboratory services, and overall impression of the services provided. Opportunities were provided for free text comment. The questionnaire was circulated in 1992 to heads of department in 23 Scottish hospital biochemistry laboratories. RESULTS--Twenty one replies were received. Services used widely included trace metals/vitamins (n = 20) and specialised endocrine tests (n = 19). Other services also used included specialised lipid tests (n = 13), toxicology (n = 12), thyroid function tests (n = nine), and tumour markers (n = eight). Fifteen laboratories used one or more of the services at least weekly. Most (n = 20) welcomed the idea of a handbook providing information on specimen collection and reference ranges. Nine identified loss of specimens as a problem. Other perceived problems included the absence of reference ranges from report forms, quantity and quality of interpretive advice, and turnaround times of some tests. Overall impressions of the service(s) offered were very good (n = 12); adequate (n = seven); poor (n = one). CONCLUSIONS--Useful information was obtained about patterns of use and transport arrangements. Areas identified as requiring follow up included provision of information, alternative ways of communicating reports, and improvement in quantity and quality of interpretive advice. PMID:8027390

  15. System reliability of randomly vibrating structures: Computational modeling and laboratory testing

    NASA Astrophysics Data System (ADS)

    Sundar, V. S.; Ammanagi, S.; Manohar, C. S.

    2015-09-01

    The problem of determination of system reliability of randomly vibrating structures arises in many application areas of engineering. We discuss in this paper approaches based on Monte Carlo simulations and laboratory testing to tackle problems of time variant system reliability estimation. The strategy we adopt is based on the application of Girsanov's transformation to the governing stochastic differential equations which enables estimation of probability of failure with significantly reduced number of samples than what is needed in a direct simulation study. Notably, we show that the ideas from Girsanov's transformation based Monte Carlo simulations can be extended to conduct laboratory testing to assess system reliability of engineering structures with reduced number of samples and hence with reduced testing times. Illustrative examples include computational studies on a 10-degree of freedom nonlinear system model and laboratory/computational investigations on road load response of an automotive system tested on a four-post test rig.

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

    PubMed

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

    2016-12-01

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

  17. Towards a rational antimicrobial testing policy in the laboratory.

    PubMed

    Banaji, N; Oommen, S

    2011-01-01

    Antimicrobial policy for prophylactic and therapeutic use of antimicrobials in a tertiary care setting has gained importance. A hospital's antimicrobial policy as laid down by its hospital infection control team needs to include inputs from the microbiology laboratory, besides the pharmacy and therapeutic committee. Therefore, it is of utmost importance that clinical microbiologists across India follow international guidelines and also take into account local settings, especially detection and presence of resistance enzymes. This article draws a framework for rational antimicrobial testing in our laboratories in tertiary care centers, from the Clinical and Laboratory Standards Institute guidelines. It does not address testing methodologies but suggests ways and means by which antimicrobial susceptibility reporting can be rendered meaningful not only to the treating physician but also to the resistance monitoring epidemiologist. It hopes to initiate some standardization in rational choice of antimicrobial testing in laboratories in the country pertaining to nonfastidious bacteria.

  18. Cost analysis in the toxicology laboratory.

    PubMed

    Travers, E M

    1990-09-01

    The process of determining laboratory sectional and departmental costs and test costs for instrument-generated and manually generated reportable results for toxicology laboratories has been outlined in this article. It is hoped that the basic principles outlined in the preceding text will clarify and elucidate one of the most important areas needed for laboratory fiscal integrity and its survival in these difficult times for health care providers. The following general principles derived from this article are helpful aids for managers of toxicology laboratories. 1. To manage a cost-effective, efficient toxicology laboratory, several factors must be considered: the laboratory's instrument configuration, test turnaround time needs, the test menu offered, the analytic methods used, the cost of labor based on time expended and the experience and educational level of the staff, and logistics that determine specimen delivery time and costs. 2. There is a wide variation in costs for toxicologic methods, which requires that an analysis of capital (equipment) purchase and operational (test performance) costs be performed to avoid waste, purchase wisely, and determine which tests consume the majority of the laboratory's resources. 3. Toxicologic analysis is composed of many complex steps. Each step must be individually cost-accounted. Screening test results must be confirmed, and the cost for both steps must be included in the cost per reportable result. 4. Total costs will vary in the same laboratory and between laboratories based on differences in salaries paid to technical staff, differences in reagent/supply costs, the number of technical staff needed to operate the analyzer or perform the method, and the inefficient use of highly paid staff to operate the analyzer or perform the method. 5. Since direct test costs vary directly with the type and number of analyzers or methods and are dependent on the operational mode designed by the manufacturer, laboratory managers should construct an actual test-cost data base for instrument or method in use to accurately compare costs using the "bottom-up" approach. 6. Laboratory expenses can be examined from three perspectives: total laboratory, laboratory section, and subsection workstation. The objective is to track all laboratory expenses through each of these levels. 7. In the final analysis, a portion of total laboratory expenses must be allocated to each unit of laboratory output--the billable procedure or, in laboratories where tests are not billed, the tests produced.(ABSTRACT TRUNCATED AT 400 WORDS)

  19. 42 CFR 493.1445 - Standard; Laboratory director responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  20. Multidimensional Screening as a Pharmacology Laboratory Experience.

    ERIC Educational Resources Information Center

    Malone, Marvin H.; And Others

    1979-01-01

    A multidimensional pharmacodynamic screening experiment that addresses drug interaction is included in the pharmacology-toxicology laboratory experience of pharmacy students at the University of the Pacific. The student handout with directions for the procedure is reproduced, drug compounds tested are listed, and laboratory evaluation results are…

  1. Tested Studies for Laboratory Teaching. Proceedings of the Workshop/Conference of the Association for Biology Laboratory Education (ABLE) (12th, Springfield, Missouri, June 4-8, 1990). Volume 12.

    ERIC Educational Resources Information Center

    Goldman, Corey A., Ed.

    The focus of the Association for Biology Laboratory Education (ABLE) is to improve the undergraduate biology laboratory experience by promoting the development and dissemination of interesting, innovative, and reliable laboratory exercises. This proceedings volume includes 13 papers: "Non-Radioactive DNA Hybridization Experiments for the…

  2. External quality assurance of HER2 fluorescence in situ hybridisation testing: results of a UK NEQAS pilot scheme

    PubMed Central

    Bartlett, John M S; Ibrahim, Merdol; Jasani, Bharat; Morgan, John M; Ellis, Ian; Kay, Elaine; Magee, Hilary; Barnett, Sarah; Miller, Keith

    2007-01-01

    Background and Aims Trastuzumab provides clinical benefit for advanced and early breast cancer patients whose tumours over‐express or have gene amplification of the HER2 oncogene. The UK National External Quality Assessment Scheme (NEQAS) for immunohistochemical testing was established to assess and improve the quality of HER2 immunohistochemical testing. However, until recently, no provision was available for HER2 fluorescence in situ hybridisation (FISH) testing. A pilot scheme was set up to review the performance of FISH testing in clinical diagnostic laboratories. Methods FISH was performed in 6 reference and 31 participating laboratories using a cell line panel with known HER2 status. Results Using results from reference laboratories as a criterion for acceptable performance, 60% of all results returned by participants were appropriate and 78% either appropriate or acceptable. However, 22.4% of results returned were deemed inappropriate, including 13 cases (4.2%) where a misdiagnosis would have been made had these been clinical specimens. Conclusions The results of three consecutive runs show that both reference laboratories and a proportion of routine clinical diagnostic (about 25%) centres can consistently achieve acceptable quality control of HER2 testing. Data from a significant proportion of participating laboratories show that further steps are required, including those taken via review of performance under schemes such as NEQAS, to improve quality of HER2 testing by FISH in the “real world”. PMID:16963466

  3. Developing laboratory networks: a practical guide and application.

    PubMed

    Kirk, Carol J; Shult, Peter A

    2010-01-01

    The role of the public health laboratory (PHL) in support of public health response has expanded beyond testing to include a number of other core functions, such as emergency response, training and outreach, communications, laboratory-based surveillance, and laboratory data management. These functions can only be accomplished by a network that includes public health and other agency laboratories and clinical laboratories. It is a primary responsibility of the PHL to develop and maintain such a network. In this article, we present practical recommendations-based on 17 years of network development experience-for the development of statewide laboratory networks. These recommendations, and examples of current laboratory networks, are provided to facilitate laboratory network development in other states. The development of laboratory networks will enhance each state's public health system and is critical to the development of a robust national Laboratory Response Network.

  4. The Effect of the Laboratory Specimen on Fatigue Crack Growth Rate

    NASA Technical Reports Server (NTRS)

    Forth, S. C.; Johnston, W. M.; Seshadri, B. R.

    2006-01-01

    Over the past thirty years, laboratory experiments have been devised to develop fatigue crack growth rate data that is representative of the material response. The crack growth rate data generated in the laboratory is then used to predict the safe operating envelope of a structure. The ability to interrelate laboratory data and structural response is called similitude. In essence, a nondimensional term, called the stress intensity factor, was developed that includes the applied stresses, crack size and geometric configuration. The stress intensity factor is then directly related to the rate at which cracks propagate in a material, resulting in the material property of fatigue crack growth response. Standardized specimen configurations and experimental procedures have been developed for laboratory testing to generate crack growth rate data that supports similitude of the stress intensity factor solution. In this paper, the authors present laboratory fatigue crack growth rate test data and finite element analyses that show similitude between standard specimen configurations tested using the constant stress ratio test method is unobtainable.

  5. The quality and scope of information provided by medical laboratories to patients before laboratory testing: Survey of the Working Group for Patient Preparation of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

    PubMed

    Nikolac, Nora; Simundic, Ana-Maria; Kackov, Sanja; Serdar, Tihana; Dorotic, Adrijana; Fumic, Ksenija; Gudasic-Vrdoljak, Jelena; Klenkar, Kornelija; Sambunjak, Jadranka; Vidranski, Valentina

    2015-10-23

    The aim of this work was to evaluate to what extent the scope and content of information provided to patients is standardized across medical biochemistry laboratories in Croatia. Two on-line self-report surveys were sent out: Survey A regarding attitudes on importance of patient preparation and Survey B on the contents of patient preparation instructions. 13/118 laboratories (11%) do not provide written instructions to patients on how to prepare for laboratory testing, and 36 (40%) do not include information about water intake in their instructions. Only half of laboratories provide instructions for prostate-specific antigen (53.8%), female sex hormones (53.7%) and therapeutic drug monitoring (TDM) (52.5%). Inadequate information about fasting status (55.0%) and 24 hour urine collection (77.9%) were frequent errors with high severity and were associated with the greatest potential to cause patient harm. Laboratory professionals in Croatia have a positive attitude towards the importance of patient preparation for laboratory testing. However, the information for laboratory testing is not standardized and frequently lacks guidance for tests related to TDM, coagulation and endocrinology. This study highlights the need for standardized, updated and evidence-based recommendations for patient preparation in order to minimize the risk for patients. Copyright © 2015 Elsevier B.V. All rights reserved.

  6. Operating and environmental characteristics of Sigma Tau hydrogen masers used in the Very Long Baseline Array (VLBA)

    NASA Technical Reports Server (NTRS)

    Tucker, T. K.

    1989-01-01

    Presented here are the results obtained from performance evaluation of a pair of Sigma Tau Standards Corporation Model VLBA-112 active hydrogen maser frequency standards. These masers were manufactured for the National Radio Astronomy Observatory (NRAO) for use on the Very Long Baseline Array (VLBA) project and were furnished to the Jet Propulsion Laboratory (JPL) for the purpose of these tests. Tests on the two masers were performed in the JPL Frequency Standards Laboratory (FSL) and included the characterization of output frequency stability versus environmental factors such as temperature, humidity, magnetic field, and barometric pressure. The performance tests also included the determination of phase noise and Allan variance using both FSL and Sigma Tau masers as references. All tests were conducted under controlled laboratory conditions, with only the desired environmental and operational parameters varied to determine sensitivity to external environment.

  7. A quality management systems approach for CD4 testing in resource-poor settings.

    PubMed

    Westerman, Larry E; Kohatsu, Luciana; Ortiz, Astrid; McClain, Bernice; Kaplan, Jonathan; Spira, Thomas; Marston, Barbara; Jani, Ilesh V; Nkengasong, John; Parsons, Linda M

    2010-10-01

    Quality assurance (QA) is a systematic process to monitor and improve clinical laboratory practices. The fundamental components of a laboratory QA program include providing a functional and safe laboratory environment, trained and competent personnel, maintained equipment, adequate supplies and reagents, testing of appropriate specimens, internal monitoring of quality, accurate reporting, and external quality assessments. These components are necessary to provide accurate and precise CD4 T-cell counts, an essential test to evaluate start of and monitor effectiveness of antiretroviral therapy for HIV-infected patients. In recent years, CD4 testing has expanded dramatically in resource-limited settings. Information on a CD4 QA program as described in this article will provide guidelines not only for clinical laboratory staff but also for managers of programs responsible for supporting CD4 testing. All agencies involved in implementing CD4 testing must understand the needs of the laboratory and provide advocacy, guidance, and financial support to established CD4 testing sites and programs. This article describes and explains the procedures that must be put in place to provide reliable CD4 determinations in a variety of settings.

  8. [Progress in assays for and new developments in autoimmune pathophysioirmen's introductory remarks].

    PubMed

    Miyazawa, Yukihisa; Shimadu, Chisato; Ohi, Kayoko

    2005-11-01

    We examined the influence of a revision of health insurance in 2004 in Teikyo University Hospital in comparison with 2003. Out to the returns of most hematological tests, especially HbA1c and TK, being included in the treatment charges of outpatients, gross laboratory test sales decreased more than expected. Increased income from judgment charges and management charges could not make up for the deficit in test sales. Therefore, total laboratory test revenues decreased substantially. In 2006, the new revision of health insurance will worsen the revenues further. Hospital laboratory test departments should take appropriate and aggressive management steps in response to these revisions in health insurance.

  9. Energy Systems Integration Laboratory | Energy Systems Integration Facility

    Science.gov Websites

    systems test hub includes a Class 1, Division 2 space for performing tests of high-pressure hydrogen Laboratory offers the following capabilities. High-Pressure Hydrogen Systems The high-pressure hydrogen infrastructure. Key Infrastructure Robotic arm; high-pressure hydrogen; natural gas supply; standalone SCADA

  10. Emissions from Southeastern U.S. Grasslands and Pine Savannas: Comparison of Aerial and Ground Field Measurements with Laboratory Burns

    EPA Science Inventory

    Emissions from prescribed burns of forest and grass stands in western Florida were measured by simultaneous aerial and ground sampling. Results were compared with biomass gathered from the same stands and tested in an open burn laboratory test facility. Measurements included pol...

  11. 46 CFR 164.008-3 - Testing procedure.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., including the retests, shall be conducted at the National Bureau of Standards or other laboratories... further definition of the time-temperature curve, see Appendix I of the ASTM Standard E119, “Fire Tests of...) The pressure in the furnace shall be equal to that in the laboratory at about one-third of the height...

  12. 46 CFR 164.008-3 - Testing procedure.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., including the retests, shall be conducted at the National Bureau of Standards or other laboratories... further definition of the time-temperature curve, see Appendix I of the ASTM Standard E119, “Fire Tests of...) The pressure in the furnace shall be equal to that in the laboratory at about one-third of the height...

  13. 46 CFR 164.008-3 - Testing procedure.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ..., including the retests, shall be conducted at the National Bureau of Standards or other laboratories... further definition of the time-temperature curve, see Appendix I of the ASTM Standard E119, “Fire Tests of...) The pressure in the furnace shall be equal to that in the laboratory at about one-third of the height...

  14. External quality assessment unravels interlaboratory differences in quality of RAS testing for anti-EGFR therapy in colorectal cancer.

    PubMed

    Tack, Véronique; Ligtenberg, Marjolijn J L; Tembuyser, Lien; Normanno, Nicola; Vander Borght, Sara; Han van Krieken, J; Dequeker, Elisabeth M C

    2015-03-01

    Regulations for the selection of patients with metastatic colorectal cancer for anti-EGFR treatment changed at the end of 2013. The set of mutations to be tested extended from KRAS codons 12 and 13 to KRAS and NRAS exons 2, 3, and 4. A European external quality assessment scheme monitored the performance of laboratories and evaluated the implementation of the new regulations. The 131 participating laboratories received 10 samples of formalin-fixed paraffin-embedded material, including RAS (exon 2, 3, 4) and BRAF mutations. Mock clinical data were provided for three cases. Using their routine methods, laboratories determined the genotypes and submitted three written reports. Assessors scored the results according to predefined evaluation criteria. Half of the participants (49.3%) had completely implemented the new test requirements (codons 12, 13, 59, 61, 117, and 146 of KRAS and NRAS), and 96 laboratories (73.3%) made no genotype mistakes. Correct nomenclature, according to the Human Genome Variation Society, was used by 82 laboratories (62.6%). Although regulations were effective for several months, many laboratories were not ready for full RAS testing in the context of anti-EGFR therapy. Nevertheless, in each participating country, there are laboratories that provide complete and correct testing. External quality assessments can be used to monitor implementation of new test regulations and to stimulate the laboratories to improve their testing procedures. Because the results of this program are available on the website of the European Society of Pathology, patients and clinicians can refer test samples to a reliable laboratory. ©AlphaMed Press.

  15. 10 CFR 60.143 - Monitoring and testing waste packages.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... package monitoring program shall include laboratory experiments which focus on the internal condition of... the laboratory experiments. (d) The waste package monitoring program shall continue as long as...

  16. 10 CFR 60.143 - Monitoring and testing waste packages.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... package monitoring program shall include laboratory experiments which focus on the internal condition of... the laboratory experiments. (d) The waste package monitoring program shall continue as long as...

  17. 10 CFR 60.143 - Monitoring and testing waste packages.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... package monitoring program shall include laboratory experiments which focus on the internal condition of... the laboratory experiments. (d) The waste package monitoring program shall continue as long as...

  18. 10 CFR 60.143 - Monitoring and testing waste packages.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... package monitoring program shall include laboratory experiments which focus on the internal condition of... the laboratory experiments. (d) The waste package monitoring program shall continue as long as...

  19. 10 CFR 60.143 - Monitoring and testing waste packages.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... package monitoring program shall include laboratory experiments which focus on the internal condition of... the laboratory experiments. (d) The waste package monitoring program shall continue as long as...

  20. Estimating implementation and operational costs of an integrated tiered CD4 service including laboratory and point of care testing in a remote health district in South Africa.

    PubMed

    Cassim, Naseem; Coetzee, Lindi M; Schnippel, Kathryn; Glencross, Deborah K

    2014-01-01

    An integrated tiered service delivery model (ITSDM) has been proposed to provide 'full-coverage' of CD4 services throughout South Africa. Five tiers are described, defined by testing volumes and number of referring health-facilities. These include: (1) Tier-1/decentralized point-of-care service (POC) in a single site; Tier-2/POC-hub servicing processing < 30-40 samples from 8-10 health-clinics; Tier-3/Community laboratories servicing ∼ 50 health-clinics, processing < 150 samples/day; high-volume centralized laboratories (Tier-4 and Tier-5) processing < 300 or > 600 samples/day and serving > 100 or > 200 health-clinics, respectively. The objective of this study was to establish costs of existing and ITSDM-tiers 1, 2 and 3 in a remote, under-serviced district in South Africa. Historical health-facility workload volumes from the Pixley-ka-Seme district, and the total volumes of CD4 tests performed by the adjacent district referral CD4 laboratories, linked to locations of all referring clinics and related laboratory-to-result turn-around time (LTR-TAT) data, were extracted from the NHLS Corporate-Data-Warehouse for the period April-2012 to March-2013. Tiers were costed separately (as a cost-per-result) including equipment, staffing, reagents and test consumable costs. A one-way sensitivity analyses provided for changes in reagent price, test volumes and personnel time. The lowest cost-per-result was noted for the existing laboratory-based Tiers- 4 and 5 ($6.24 and $5.37 respectively), but with related increased LTR-TAT of > 24-48 hours. Full service coverage with TAT < 6-hours could be achieved with placement of twenty-seven Tier-1/POC or eight Tier-2/POC-hubs, at a cost-per-result of $32.32 and $15.88 respectively. A single district Tier-3 laboratory also ensured 'full service coverage' and < 24 hour LTR-TAT for the district at $7.42 per-test. Implementing a single Tier-3/community laboratory to extend and improve delivery of services in Pixley-ka-Seme, with an estimated local ∼ 12-24-hour LTR-TAT, is ∼ $2 more than existing referred services per-test, but 2-4 fold cheaper than implementing eight Tier-2/POC-hubs or providing twenty-seven Tier-1/POCT CD4 services.

  1. Toward Better Physics Labs for Future Biologists

    NASA Astrophysics Data System (ADS)

    Giannini, John; Moore, Kim; Losert, Wolfgang

    2014-03-01

    We have developed a set of laboratories and hands on activities to accompany a new two-semester interdisciplinary physics course that has been successfully developed and tested in two small test classes of students at the University of Maryland, College Park (UMD) in 2012-2013, and is currently being used on a wider scale. We have designed the laboratories to be taken accompanying a reformed course in the student's second year, with calculus, biology, and chemistry as prerequisites. This permits the laboratories to include significant content on physics relevant to cellular scales, from chemical interactions to random motion and charge screening in fluids. One major focus of the laboratories is to introduce the students to research-grade equipment and modern physics analysis tools in contexts relevant to biology, while maintaining the pedagogically valuable open-ended laboratory structure of reformed laboratories. Lab development procedures along with some preliminary student results from these two small test classes are discussed.

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

    PubMed

    Anderson, Nancy

    2015-11-15

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

  3. The Laboratory-Based Economics Curriculum.

    ERIC Educational Resources Information Center

    King, Paul G.; LaRoe, Ross M.

    1991-01-01

    Describes the liberal arts, computer laboratory-based economics program at Denison University (Ohio). Includes as goals helping students to (1) understand deductive arguments, (2) learn to apply theory in real-world situations, and (3) test and modify theory when necessary. Notes that the program combines computer laboratory experiments for…

  4. Total laboratory automation: Do stat tests still matter?

    PubMed

    Dolci, Alberto; Giavarina, Davide; Pasqualetti, Sara; Szőke, Dominika; Panteghini, Mauro

    2017-07-01

    During the past decades the healthcare systems have rapidly changed and today hospital care is primarily advocated for critical patients and acute treatments, for which laboratory test results are crucial and need to be always reported in predictably short turnaround time (TAT). Laboratories in the hospital setting can face this challenge by changing their organization from a compartmentalized laboratory department toward a decision making-based laboratory department. This requires the implementation of a core laboratory, that exploits total laboratory automation (TLA) using technological innovation in analytical platforms, track systems and information technology, including middleware, and a number of satellite specialized laboratory sections cooperating with care teams for specific medical conditions. In this laboratory department model, the short TAT for all first-line tests performed by TLA in the core laboratory represents the key paradigm, where no more stat testing is required because all samples are handled in real-time and (auto)validated results dispatched in a time that fulfills clinical needs. To optimally reach this goal, laboratories should be actively involved in managing all the steps covering the total examination process, speeding up also extra-laboratory phases, such sample delivery. Furthermore, to warrant effectiveness and not only efficiency, all the processes, e.g. specimen integrity check, should be managed by middleware through a predefined set of rules defined in light of the clinical governance. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  5. Laboratory compliance with the American Society of Clinical Oncology/college of American Pathologists guidelines for human epidermal growth factor receptor 2 testing: a College of American Pathologists survey of 757 laboratories.

    PubMed

    Nakhleh, Raouf E; Grimm, Erin E; Idowu, Michael O; Souers, Rhona J; Fitzgibbons, Patrick L

    2010-05-01

    To ensure quality human epidermal growth receptor 2 (HER2) testing in breast cancer, the American Society of Clinical Oncology/College of American Pathologists guidelines were introduced with expected compliance by 2008. To assess the effect these guidelines have had on pathology laboratories and their ability to address key components. In late 2008, a survey was distributed with the HER2 immunohistochemistry (IHC) proficiency testing program. It included questions regarding pathology practice characteristics and assay validation using fluorescence in situ hybridization or another IHC laboratory assay and assessed pathologist HER2 scoring competency. Of the 907 surveys sent, 757 (83.5%) were returned. The median laboratory accessioned 15 000 cases and performed 190 HER2 tests annually. Quantitative computer image analysis was used by 33% of laboratories. In-house fluorescence in situ hybridization was performed in 23% of laboratories, and 60% of laboratories addressed the 6- to 48-hour tissue fixation requirement by embedding tissue on the weekend. HER2 testing was performed on the initial biopsy in 40%, on the resection specimen in 6%, and on either in 56% of laboratories. Testing was validated with only fluorescence in situ hybridization in 47% of laboratories, whereas 10% of laboratories used another IHC assay only; 13% used both assays, and 12% and 15% of laboratories had not validated their assays or chose "not applicable" on the survey question, respectively. The 90% concordance rate with fluorescence in situ hybridization results was achieved by 88% of laboratories for IHC-negative findings and by 81% of laboratories for IHC-positive cases. The 90% concordance rate for laboratories using another IHC assay was achieved by 80% for negative findings and 75% for positive cases. About 91% of laboratories had a pathologist competency assessment program. This survey demonstrates the extent and characteristics of HER2 testing. Although some American Society of Clinical Oncology/College of American Pathologists guidelines have been implemented, gaps remain in validation of HER2 IHC testing.

  6. Population-based surveillance for bacterial meningitis in China, September 2006-December 2009.

    PubMed

    Li, Yixing; Yin, Zundong; Shao, Zhujun; Li, Manshi; Liang, Xiaofeng; Sandhu, Hardeep S; Hadler, Stephen C; Li, Junhong; Sun, Yinqi; Li, Jing; Zou, Wenjing; Lin, Mei; Zuo, Shuyan; Mayer, Leonard W; Novak, Ryan T; Zhu, Bingqing; Xu, Li; Luo, Huiming

    2014-01-01

    During September 2006-December 2009, we conducted active population and sentinel laboratory-based surveillance for bacterial meningitis pathogens, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b, in 4 China prefectures. We identified 7,876 acute meningitis and encephalitis syndrome cases, including 6,388 among prefecture residents. A total of 833 resident cases from sentinel hospitals met the World Health Organization case definition for probable bacterial meningitis; 339 of these cases were among children <5 years of age. Laboratory testing confirmed bacterial meningitis in 74 of 3,391 tested cases. The estimated annual incidence (per 100,000 population) of probable bacterial meningitis ranged from 1.84 to 2.93 for the entire population and from 6.95 to 22.30 for children <5 years old. Active surveillance with laboratory confirmation has provided a population-based estimate of the number of probable bacterial meningitis cases in China, but more complete laboratory testing is needed to better define the epidemiology of the disease in this country.

  7. Incidence and Trends of Infections with Pathogens Transmitted Commonly Through Food and the Effect of Increasing Use of Culture-Independent Diagnostic Tests on Surveillance - Foodborne Diseases Active Surveillance Network, 10 U.S. Sites, 2013-2016.

    PubMed

    Marder, Ellyn P; Cieslak, Paul R; Cronquist, Alicia B; Dunn, John; Lathrop, Sarah; Rabatsky-Ehr, Therese; Ryan, Patricia; Smith, Kirk; Tobin-D'Angelo, Melissa; Vugia, Duc J; Zansky, Shelley; Holt, Kristin G; Wolpert, Beverly J; Lynch, Michael; Tauxe, Robert; Geissler, Aimee L

    2017-04-21

    Foodborne diseases represent a substantial public health concern in the United States. CDC's Foodborne Diseases Active Surveillance Network (FoodNet) monitors cases reported from 10 U.S. sites* of laboratory-diagnosed infections caused by nine enteric pathogens commonly transmitted through food. This report describes preliminary surveillance data for 2016 on the nine pathogens and changes in incidences compared with 2013-2015. In 2016, FoodNet identified 24,029 infections, 5,512 hospitalizations, and 98 deaths caused by these pathogens. The use of culture-independent diagnostic tests (CIDTs) by clinical laboratories to detect enteric pathogens has been steadily increasing since FoodNet began surveying clinical laboratories in 2010 (1). CIDTs complicate the interpretation of FoodNet surveillance data because pathogen detection could be affected by changes in health care provider behaviors or laboratory testing practices (2). Health care providers might be more likely to order CIDTs because these tests are quicker and easier to use than traditional culture methods, a circumstance that could increase pathogen detection (3). Similarly, pathogen detection could also be increasing as clinical laboratories adopt DNA-based syndromic panels, which include pathogens not often included in routine stool culture (4,5). In addition, CIDTs do not yield isolates, which public health officials rely on to distinguish pathogen subtypes, determine antimicrobial resistance, monitor trends, and detect outbreaks. To obtain isolates for infections identified by CIDTs, laboratories must perform reflex culture † ; if clinical laboratories do not, the burden of culturing falls to state public health laboratories, which might not be able to absorb that burden as the adoption of these tests increases (2). Strategies are needed to preserve access to bacterial isolates for further characterization and to determine the effect of changing trends in testing practices on surveillance.

  8. Viability testing of material derived from Mycobacterium tuberculosis prior to removal from a containment level-III laboratory as part of a Laboratory Risk Assessment Program.

    PubMed

    Blackwood, Kym S; Burdz, Tamara V; Turenne, Christine Y; Sharma, Meenu K; Kabani, Amin M; Wolfe, Joyce N

    2005-01-24

    In the field of clinical mycobacteriology, Mycobacterium tuberculosis (MTB) can be a difficult organism to manipulate due to the restrictive environment of a containment level 3 (CL3) laboratory. Tests for rapid diagnostic work involving smears and molecular methods do not require CL3 practices after the organism has been rendered non-viable. While it has been assumed that after organism deactivation these techniques can be performed outside of a CL3, no conclusive study has consistently confirmed that the organisms are noninfectious after the theoretical 'deactivation' steps. Previous studies have shown that initial steps (such as heating/chemical fixation) may not consistently kill MTB organisms. An inclusive viability study (n = 226) was undertaken to determine at which point handling of culture extraction materials does not necessitate a CL3 environment. Four different laboratory protocols tested for viability included: standard DNA extractions for IS6110 fingerprinting, crude DNA preparations for PCR by boiling and mechanical lysis, protein extractions, and smear preparations. For each protocol, laboratory staff planted a proportion of the resulting material to Bactec 12B medium that was observed for growth for 8 weeks. Of the 208 isolates initially tested, 21 samples grew within the 8-week period. Sixteen (7.7%) of these yielded positive results for MTB that included samples of: deactivated culture resuspensions exposed to 80 degrees C for 20 minutes, smear preparations and protein extractions. Test procedures were consequently modified and tested again (n = 18), resulting in 0% viability. This study demonstrates that it cannot be assumed that conventional practices (i.e. smear preparation) or extraction techniques render the organism non-viable. All methodologies, new and existing, should be examined by individual laboratories to validate the safe removal of material derived from MTB to the outside of a CL3 laboratory. This process is vital to establish in house biosafety-validated practices with the aim of protecting laboratory workers conducting these procedures.

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

    PubMed Central

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

    2017-01-01

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

  10. Laboratory evaluation of detectors of explosives' effluents

    DOT National Transportation Integrated Search

    1972-11-30

    This document contains the classification, technical description and laboratory evaluation of five commercial detectors for explosives' effluents. It includes an outline of operating principles, test and evaluation procedures. The evaluation is based...

  11. Staffing benchmarks for clinical laboratories: a College of American Pathologists Q-Probes study of laboratory staffing at 98 institutions.

    PubMed

    Jones, Bruce A; Darcy, Teresa; Souers, Rhona J; Meier, Frederick A

    2012-02-01

    Publicly available information concerning laboratory staffing benchmarks is scarce. One of the few publications on this topic summarized the findings of a Q-Probes study performed in 2004. This publication reports a similar survey with data collected in 2010. To assess the relationship between staffing levels in specified laboratory sections and test volumes in these sections and quantify management span of control. The study defined 4 laboratory sections: anatomic pathology (including cytology), chemistry/hematology/immunology, microbiology, and transfusion medicine. It divided staff into 3 categories: management, nonmanagement (operational or bench staff), and doctoral (MD, PhD) supervisory staff. People in these categories were tabulated as full-time equivalents and exclusions specified. Tests were counted in uniform formats, specified for each laboratory section, according to Medicare rules for the bundling and unbundling of tests. Ninety-eight participating institutions provided data that showed significant associations between test volumes and staffing for all 4 sections. There was wide variation in productivity based on volume. There was no relationship between testing volume per laboratory section and management span of control. Higher productivity in chemistry/hematology/immunology was associated with a higher fraction of tests coming from nonacute care patients. In both the 2004 and 2010 studies, productivity was inseparably linked to test volume. Higher test volume was associated with higher productivity ratios in chemistry/hematology/immunology and transfusion medicine sections. The impact of various testing services on productivity is section-specific.

  12. HCG blood test - qualitative

    MedlinePlus

    ... pregnancy. Other HCG tests include: HCG urine test Quantitative pregnancy test (checks specific level of HCG in ... eds. Henry's Clinical Diagnosis and Management by Laboratory Methods . 23rd ed. Philadelphia, PA: Elsevier; 2017:chap 74. ...

  13. Lipid and lipoprotein testing in resource-limited laboratories.

    PubMed

    Myers, Gary L

    2003-01-01

    The role of total cholesterol (TC) and lipoproteins in the assessment of coronary heart disease (CHD) is firmly established from population and intervention studies. Total and low-density lipoprotein cholesterol (LDLC) levels are positively associated with CHD, and high-density lipoprotein cholesterol (HDLC) levels are negatively associated with CHD. Efforts to identify and treat people at increased risk based on cholesterol and lipoprotein levels have led to more lipid testing and the need for very reliable test results. Thus, quality laboratory services are an essential component of healthcare delivery and play a vital role in any strategy to reduce morbidity and mortality from CHD. In laboratories with limited resources, establishing laboratory capability to measure CHD risk markers may be a considerable challenge. Laboratories face problems in selecting proper techniques, difficulties in equipment availability and maintenance, and shortage of supplies, staffing, and supervision. The Centers for Disease Control and Prevention (CDC) has been providing technical assistance for more than 30 years to laboratories that measure lipids and lipoproteins and is willing to provide technical assistance as needed for other laboratories to develop this capability. CDC can provide technical assistance to establish lipid and lipoprotein testing capability to support a CHD public health program in areas with limited laboratory resources. This assistance includes: selecting a suitable testing instrument; providing training for laboratory technicians; establishing a simple quality control plan; and instructing staff on how to prepare frozen serum control materials suitable for assessing accuracy of lipid and lipoprotein testing.

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

    PubMed

    Ehrmeyer, Sharon S; Laessig, Ronald H

    2004-08-02

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

  15. Battery testing at Argonne National Laboratory

    NASA Astrophysics Data System (ADS)

    Deluca, W. H.; Gillie, K. R.; Kulaga, J. E.; Smaga, J. A.; Tummillo, A. F.; Webster, C. E.

    1993-03-01

    Argonne National Laboratory's Analysis & Diagnostic Laboratory (ADL) tests advanced batteries under simulated electric and hybrid vehicle operating conditions. The ADL facilities also include a post-test analysis laboratory to determine, in a protected atmosphere if needed, component compositional changes and failure mechanisms. The ADL provides a common basis for battery performance characterization and life evaluations with unbiased application of tests and analyses. The battery evaluations and post-test examinations help identify factors that limit system performance and life and the most-promising R&D approaches for overcoming these limitations. Since 1991, performance characterizations and/or life evaluations have been conducted on eight battery technologies: Na/S, Li/S, Zn/Br, Ni/MH, Ni/Zn, Ni/Cd, Ni/Fe, and lead-acid. These evaluations were performed for the Department of Energy's. Office of Transportation Technologies, Electric and Hybrid Propulsion Division (DOE/OTT/EHP), and Electric Power Research Institute (EPRI) Transportation Program. The results obtained are discussed.

  16. An e-health driven laboratory information system to support HIV treatment in Peru: E-quity for laboratory personnel, health providers and people living with HIV.

    PubMed

    García, Patricia J; Vargas, Javier H; Caballero N, Patricia; Calle V, Javier; Bayer, Angela M

    2009-12-10

    Peru has a concentrated HIV epidemic with an estimated 76,000 people living with HIV (PLHIV). Access to highly active antiretroviral therapy (HAART) expanded between 2004-2006 and the Peruvian National Institute of Health was named by the Ministry of Health as the institution responsible for carrying out testing to monitor the effectiveness of HAART. However, a national public health laboratory information system did not exist. We describe the design and implementation of an e-health driven, web-based laboratory information system--NETLAB--to communicate laboratory results for monitoring HAART to laboratory personnel, health providers and PLHIV. We carried out a needs assessment of the existing public health laboratory system, which included the generation and subsequent review of flowcharts of laboratory testing processes to generate better, more efficient streamlined processes, improving them and eliminating duplications. Next, we designed NETLAB as a modular system, integrating key security functions. The system was implemented and evaluated. The three main components of the NETLAB system, registration, reporting and education, began operating in early 2007. The number of PLHIV with recorded CD4 counts and viral loads increased by 1.5 times, to reach 18,907. Publication of test results with NETLAB took an average of 1 day, compared to a pre-NETLAB average of 60 days. NETLAB reached 2,037 users, including 944 PLHIV and 1,093 health providers, during its first year and a half. The percentage of overall PLHIV and health providers who were aware of NETLAB and had a NETLAB password has also increased substantially. NETLAB is an effective laboratory management tool since it is directly integrated into the national laboratory system and streamlined existing processes at the local, regional and national levels. The system also represents the best possible source of timely laboratory information for health providers and PLHIV, allowing patients to access their own results and other helpful information about their health, extending the scope of HIV treatment beyond the health facility and providing a model for other countries to follow. The NETLAB system now includes 100 diseases of public health importance for which the Peruvian National Institute of Health and the network of public health laboratories provide testing and results.

  17. Evaluating performance in sweat testing in medical biochemistry laboratories in Croatia.

    PubMed

    Aralica, Merica; Krleza, Jasna Lenicek

    2017-02-15

    Sweat test has a diagnostic role in evaluation of cystic fibrosis. Its performance includes sweat stimulation, collection and analysis. All listed may be sources of inconsistencies in everyday practice. The aim of this study was an evaluation of external quality assessment (EQA) of sweat chloride measurement including sweat test performance in medical biochemistry laboratories in Croatia. EQA for sweat chloride measurement was provided by Croatian Centre for Quality Assessment in Laboratory Medicine (CROQALM) in five consecutive exercises to medical biochemistry laboratories (MBL) that offered sweat testing. A questionnaire regarding all phases of testing was mailed to involved MBL (N = 10). Survey results were compared to current guidelines for sweat test performance. Reported results of EQA in 2015 exercises showed coefficients of variation (CV) from 28.9%, 29.0% to 35.3%, respectively. An introduction of uniform sweat chloride measurement protocol resulted in CV of 15.5% and 14.7% reported in following two exercises in 2016. All MBL included in this study replied to the questionnaire. Results reported by MBL indicated: lack of patient information policy (7/10), use of unacceptable electrodes (6/9), misuse of minimum of acceptable sweat weight (6/9), lack of internal quality assessment (5/9) and recommended reference ranges (5/9 and 4/9). Agreements to guidelines were found in approach to unsuitable patients (9/10) and sweat collection (8/9). Presented results indicate major weak points of current practice in sweat test performance in Croatian MBL and stress the need for its standardization on a national level.

  18. Evaluating performance in sweat testing in medical biochemistry laboratories in Croatia

    PubMed Central

    Aralica, Merica; Krleza, Jasna Lenicek

    2017-01-01

    Introduction Sweat test has a diagnostic role in evaluation of cystic fibrosis. Its performance includes sweat stimulation, collection and analysis. All listed may be sources of inconsistencies in everyday practice. The aim of this study was an evaluation of external quality assessment (EQA) of sweat chloride measurement including sweat test performance in medical biochemistry laboratories in Croatia. Materials and methods EQA for sweat chloride measurement was provided by Croatian Centre for Quality Assessment in Laboratory Medicine (CROQALM) in five consecutive exercises to medical biochemistry laboratories (MBL) that offered sweat testing. A questionnaire regarding all phases of testing was mailed to involved MBL (N = 10). Survey results were compared to current guidelines for sweat test performance. Results Reported results of EQA in 2015 exercises showed coefficients of variation (CV) from 28.9%, 29.0% to 35.3%, respectively. An introduction of uniform sweat chloride measurement protocol resulted in CV of 15.5% and 14.7% reported in following two exercises in 2016. All MBL included in this study replied to the questionnaire. Results reported by MBL indicated: lack of patient information policy (7/10), use of unacceptable electrodes (6/9), misuse of minimum of acceptable sweat weight (6/9), lack of internal quality assessment (5/9) and recommended reference ranges (5/9 and 4/9). Agreements to guidelines were found in approach to unsuitable patients (9/10) and sweat collection (8/9). Conclusion Presented results indicate major weak points of current practice in sweat test performance in Croatian MBL and stress the need for its standardization on a national level. PMID:28392735

  19. 42 CFR 405.515 - Reimbursement for clinical laboratory services billed by physicians.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...'s bill, or a request for payment for a physician's services, includes a charge for a laboratory test... chapter): (a) If the bill or request for payment indicates that the test was personally performed or supervised either by the physician who submitted the bill (or for whose services the request for payment was...

  20. 42 CFR 405.515 - Reimbursement for clinical laboratory services billed by physicians.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...'s bill, or a request for payment for a physician's services, includes a charge for a laboratory test... chapter): (a) If the bill or request for payment indicates that the test was personally performed or supervised either by the physician who submitted the bill (or for whose services the request for payment was...

  1. 42 CFR 405.515 - Reimbursement for clinical laboratory services billed by physicians.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...'s bill, or a request for payment for a physician's services, includes a charge for a laboratory test... chapter): (a) If the bill or request for payment indicates that the test was personally performed or supervised either by the physician who submitted the bill (or for whose services the request for payment was...

  2. 42 CFR 405.515 - Reimbursement for clinical laboratory services billed by physicians.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...'s bill, or a request for payment for a physician's services, includes a charge for a laboratory test... chapter): (a) If the bill or request for payment indicates that the test was personally performed or supervised either by the physician who submitted the bill (or for whose services the request for payment was...

  3. Survey of Clinical Laboratory Practices for 2015 Middle East Respiratory Syndrome Coronavirus Outbreak in the Republic of Korea.

    PubMed

    Lee, Mi-Kyung; Kim, Sinyoung; Kim, Mi-Na; Kweon, Oh Joo; Lim, Yong Kwan; Ki, Chang-Seok; Kim, Jae-Seok; Seong, Moon-Woo; Sung, Heungsup; Yong, Dongeun; Lee, Hyukmin; Choi, Jong-Rak; Kim, Jeong-Ho

    2016-03-01

    It is crucial to understand the current status of clinical laboratory practices for the largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infections in the Republic of Korea to be well prepared for future emerging infectious diseases. We conducted a survey of 49 clinical laboratories in medical institutions and referral medical laboratories. A short questionnaire to survey clinical laboratory practices relating to MERS-CoV diagnostic testing was sent by email to the directors and clinical pathologists in charge of the clinical laboratories performing MERS-CoV testing. The survey focused on testing volume, reporting of results, resources, and laboratory safety. A total of 40 clinical laboratories responded to the survey. A total of 27,009 MERS-CoV real-time reverse transcription PCR (rRT-PCR) tests were performed. Most of the specimens were sputum (73.5%). The median turnaround time (TAT) was 5.29 hr (first and third quartile, 4.11 and 7.48 hr) in 26 medical institutions. The median TAT of more than a half of the laboratories (57.7%) was less than 6 hr. Many laboratories were able to perform tests throughout the whole week. Laboratory biosafety preparedness included class II biosafety cabinets (100%); separated pre-PCR, PCR, and post-PCR rooms (88.6%); negative pressure pretreatment rooms (48.6%); and negative pressure sputum collection rooms (20.0%). Clinical laboratories were able to quickly expand their diagnostic capacity in response to the 2015 MERS-CoV outbreak. Our results show that clinical laboratories play an important role in the maintenance and enhancement of laboratory response in preparation for future emerging infections.

  4. Survey of Clinical Laboratory Practices for 2015 Middle East Respiratory Syndrome Coronavirus Outbreak in the Republic of Korea

    PubMed Central

    Lee, Mi-Kyung; Kim, Sinyoung; Kim, Mi-Na; Kweon, Oh Joo; Lim, Yong Kwan; Ki, Chang-Seok; Kim, Jae-Seok; Seong, Moon-Woo; Sung, Heungsup; Yong, Dongeun; Lee, Hyukmin; Choi, Jong-Rak

    2016-01-01

    Background It is crucial to understand the current status of clinical laboratory practices for the largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infections in the Republic of Korea to be well prepared for future emerging infectious diseases. Methods We conducted a survey of 49 clinical laboratories in medical institutions and referral medical laboratories. A short questionnaire to survey clinical laboratory practices relating to MERS-CoV diagnostic testing was sent by email to the directors and clinical pathologists in charge of the clinical laboratories performing MERS-CoV testing. The survey focused on testing volume, reporting of results, resources, and laboratory safety. Results A total of 40 clinical laboratories responded to the survey. A total of 27,009 MERS-CoV real-time reverse transcription PCR (rRT-PCR) tests were performed. Most of the specimens were sputum (73.5%). The median turnaround time (TAT) was 5.29 hr (first and third quartile, 4.11 and 7.48 hr) in 26 medical institutions. The median TAT of more than a half of the laboratories (57.7%) was less than 6 hr. Many laboratories were able to perform tests throughout the whole week. Laboratory biosafety preparedness included class II biosafety cabinets (100%); separated pre-PCR, PCR, and post-PCR rooms (88.6%); negative pressure pretreatment rooms (48.6%); and negative pressure sputum collection rooms (20.0%). Conclusions Clinical laboratories were able to quickly expand their diagnostic capacity in response to the 2015 MERS-CoV outbreak. Our results show that clinical laboratories play an important role in the maintenance and enhancement of laboratory response in preparation for future emerging infections. PMID:26709263

  5. Kidney function tests

    MedlinePlus

    Kidney function tests are common lab tests used to evaluate how well the kidneys are working. Such tests include: ... Oh MS, Briefel G. Evaluation of renal function, water, electrolytes ... and Management by Laboratory Methods . 23rd ed. Philadelphia, ...

  6. Environmental Test Program for the Mars Exploration Rover Project

    NASA Technical Reports Server (NTRS)

    Fisher, Terry C.; VanVelzer, Paul L.

    2004-01-01

    On June 10 and July 7, 2003 the National Aeronautics and Space Administration (NASA) launched two spacecraft from Cape Canaveral, Florida for a six (6) months flight to the Red Planet, Mars. The two Mars Exploration Rover spacecraft landed safely on the planet in January 2004. Prior to the successful launch, both of the spacecraft were involved in a comprehensive test campaign that included development, qualification, and protoflight test programs. Testing was performed to simulate the environments associated with launch, inter-planetary cruise, landing on the planet and Mars surface operations. Unique test requirements included operating the spacecraft while the chamber pressure was controlled to simulate the decent to the planet from deep space, high impact landing loads and rover operations on the surface of the planet at 8 Torr and -130 C. This paper will present an overview of the test program that included vibration, pyro-shock, landing loads, acoustic noise, thermal vacuum and solar simulation testing at the Jet Propulsion Laboratory (JPL) Environmental Test Laboratory facilities in Pasadena, California.

  7. 40 CFR 1620.5 - Administrative claim; evidence and information to be submitted.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... relevant medical treatment records, laboratory and other tests, including X-Rays, MRI, CT scans and other... tests including X-Rays, MRI, CT scans and other objective evidence of medical evaluation and diagnosis...

  8. 40 CFR 1620.5 - Administrative claim; evidence and information to be submitted.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... relevant medical treatment records, laboratory and other tests, including X-Rays, MRI, CT scans and other... tests including X-Rays, MRI, CT scans and other objective evidence of medical evaluation and diagnosis...

  9. 40 CFR 1620.5 - Administrative claim; evidence and information to be submitted.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... relevant medical treatment records, laboratory and other tests, including X-Rays, MRI, CT scans and other... tests including X-Rays, MRI, CT scans and other objective evidence of medical evaluation and diagnosis...

  10. 40 CFR 1620.5 - Administrative claim; evidence and information to be submitted.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... relevant medical treatment records, laboratory and other tests, including X-Rays, MRI, CT scans and other... tests including X-Rays, MRI, CT scans and other objective evidence of medical evaluation and diagnosis...

  11. 40 CFR 1620.5 - Administrative claim; evidence and information to be submitted.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... relevant medical treatment records, laboratory and other tests, including X-Rays, MRI, CT scans and other... tests including X-Rays, MRI, CT scans and other objective evidence of medical evaluation and diagnosis...

  12. Standardizing clinical laboratory data for secondary use.

    PubMed

    Abhyankar, Swapna; Demner-Fushman, Dina; McDonald, Clement J

    2012-08-01

    Clinical databases provide a rich source of data for answering clinical research questions. However, the variables recorded in clinical data systems are often identified by local, idiosyncratic, and sometimes redundant and/or ambiguous names (or codes) rather than unique, well-organized codes from standard code systems. This reality discourages research use of such databases, because researchers must invest considerable time in cleaning up the data before they can ask their first research question. Researchers at MIT developed MIMIC-II, a nearly complete collection of clinical data about intensive care patients. Because its data are drawn from existing clinical systems, it has many of the problems described above. In collaboration with the MIT researchers, we have begun a process of cleaning up the data and mapping the variable names and codes to LOINC codes. Our first step, which we describe here, was to map all of the laboratory test observations to LOINC codes. We were able to map 87% of the unique laboratory tests that cover 94% of the total number of laboratory tests results. Of the 13% of tests that we could not map, nearly 60% were due to test names whose real meaning could not be discerned and 29% represented tests that were not yet included in the LOINC table. These results suggest that LOINC codes cover most of laboratory tests used in critical care. We have delivered this work to the MIMIC-II researchers, who have included it in their standard MIMIC-II database release so that researchers who use this database in the future will not have to do this work. Published by Elsevier Inc.

  13. Bioaccumulation of toxic substances associated with dredging and dredged material disposal: a literature review

    USGS Publications Warehouse

    Seelye, James G.; Mac, Michael J.

    1984-01-01

    A literature review of sediment bioassessment was conducted as the first step in the development of a more standardized and ecologically sound test procedure for evaluating sediment quality. Based on the review, the authors concluded that 1) a standardized laboratory bioassessment test should consist of flowthrough exposure of at least 10 days duration using more than one aquatic organism including at least an infaunal benthic invertebrate and a fish species. 2) Before adoption of a laboratory sediment bioassessment procedure, the laboratory results should be evaluated by comparison with field conditions. 3) Most current sediment bioassessment regulatory tests measure acute toxicity or bioaccumulation. Development of tests to evaluate chronic, sublethal effects is needed.

  14. Electronic reporting of all reference laboratory results: An important step toward a truly all-encompassing, integrated health record.

    PubMed

    Kratz, Alexander

    2016-09-01

    Results from reference laboratories are often not easily available in electronic health records. This article describes a multi-pronged, long-term approach that includes bringing send-out tests in-house, upgrading the laboratory information system, interfacing more send-out tests and more reference laboratories, utilizing the "miscellaneous assay" option offered by some reference laboratories, and scanning all remaining paper reports from reference laboratories for display in the electronic health record. This allowed all laboratory results obtained in association with a patient visit, whether performed in-house or at a reference laboratory, to be available in the integrated electronic health record. This was achieved without manual data entry of reference laboratory results, thereby avoiding the risk of transcription errors. A fully integrated electronic health record that contains all laboratory results can be achieved by maximizing the number of interfaced reference laboratory assays and making all non-interfaced results available as scanned documents. © The Author(s) 2015.

  15. The impact of commercial rapid respiratory virus diagnostic tests on patient outcomes and health system utilization.

    PubMed

    Ko, Fiona; Drews, Steven J

    2017-10-01

    Acute respiratory tract infections due to influenza A/B and respiratory syncytial virus (RSV) are major causes of morbidity and mortality globally. Rapid tests for detection of these pathogens include antigen detection point of care tests (POC) and newer easy to use molecular tests. From experience, these assays improve both laboratory workflow and assay interpretation issues. However, the question of the benefits of using rapid test technology compared to routine laboratory testing for respiratory viral pathogens is still often asked. Areas covered: Specifically, this review aims to; 1) identify clinical/patient indicators that can be measured prior to and following the implementation of rapid diagnostic test for influenza and RSV, 2) provide multiple perspectives on the extent of impact of a rapid diagnostic test, including direct and indirect outcomes, and 3) identify the technological advancements in the development of rapid testing, demonstrating a timeline that transitions from antigen-based assays to molecular assays. Expert commentary: Key benefits to the use of either antigen-based or molecular rapid tests for patient care, patient flow within institutions, as well as laboratory utilization are identified. Due to improved test characteristics, the authors feel that rapid molecular tests have greater benefits than antigen-based detection methods.

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

    PubMed Central

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

    2017-01-01

    Background Laboratory services are essential at all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment. Enabling access to quality services is a challenge in low-resource settings. Implementation of a strong quality management system (QMS) and laboratory accreditation are key to improving patient care. Objectives The study objective was to determine the status of QMS implementation and progress towards accreditation of National Tuberculosis Reference Laboratories (NTRLs) in the African Region. Method An online questionnaire was administered to NTRL managers in 47 World Health Organization Regional Office for Africa member states in the region, between February and April 2015, regarding the knowledge of QMS tools and progress toward implementation to inform strategies for tuberculosis diagnostic services strengthening in the region. Results A total of 21 laboratories (43.0%) had received SLMTA/TB-SLMTA training, of which 10 had also used the Global Laboratory Initiative accreditation tool. However, only 36.7% of NTRLs had received a laboratory audit, a first step in quality improvement. Most NTRLs participated in acid-fast bacilli microscopy external quality assurance (95.8%), although external quality assurance for other techniques was lower (60.4% for first-line drug susceptibility testing, 25.0% for second-line drug susceptibility testing, and 22.9% for molecular testing). Barriers to accreditation included lack of training and accreditation programmes. Only 28.6% of NTRLs had developed strategic plans and budgets which included accreditation. Conclusion Good foundations are in place on the continent from which to scale up accreditation efforts. Laboratory audits should be conducted as a first step in developing quality improvement action plans. Political commitment and strong leadership are needed to drive accreditation efforts; advocacy will require clear evidence of patient impact and cost-benefit. PMID:28879161

  17. Competency assessment of microbiology medical laboratory technologists in Ontario, Canada.

    PubMed

    Desjardins, Marc; Fleming, Christine Ann

    2014-08-01

    Accreditation in Ontario, Canada, requires that licensed clinical laboratories participate in external quality assessment (also known as proficiency testing) and perform competency evaluation of their staff. To assess the extent of ongoing competency assessment practices, the Quality Management Program--Laboratory Services (QMP-LS) Microbiology Committee surveyed all 112 licensed Ontario microbiology laboratories. The questionnaire consisted of a total of 21 questions that included yes/no, multiple-choice, and short-answer formats. Participants were asked to provide information about existing programs, the frequency of testing, what areas are evaluated, and how results are communicated to the staff. Of the 111 responding laboratories, 6 indicated they did not have a formal evaluation program since they perform only limited bacteriology testing. Of the remaining 105 respondents, 87% perform evaluations at least annually or every 2 years, and 61% include any test or task performed, whereas 16% and 10% focus only on problem areas and high-volume complex tasks, respectively. The most common methods of evaluation were review of external quality assessment (EQA) challenges, direct observation, and worksheet review. With the exception of one participant, all communicate results to staff, and most take remedial action to correct the deficiencies. Although most accredited laboratories have a program to assess the ongoing competency of their staff, the methods used are not standardized or consistently applied, indicating that there is room for improvement. The survey successfully highlighted potential areas for improvement and allowed the QMP-LS Microbiology Committee to provide guidance to Ontario laboratories for establishing or improving existing microbiology-specific competency assessment programs. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

  18. Competency Assessment of Microbiology Medical Laboratory Technologists in Ontario, Canada

    PubMed Central

    Fleming, Christine Ann

    2014-01-01

    Accreditation in Ontario, Canada, requires that licensed clinical laboratories participate in external quality assessment (also known as proficiency testing) and perform competency evaluation of their staff. To assess the extent of ongoing competency assessment practices, the Quality Management Program—Laboratory Services (QMP-LS) Microbiology Committee surveyed all 112 licensed Ontario microbiology laboratories. The questionnaire consisted of a total of 21 questions that included yes/no, multiple-choice, and short-answer formats. Participants were asked to provide information about existing programs, the frequency of testing, what areas are evaluated, and how results are communicated to the staff. Of the 111 responding laboratories, 6 indicated they did not have a formal evaluation program since they perform only limited bacteriology testing. Of the remaining 105 respondents, 87% perform evaluations at least annually or every 2 years, and 61% include any test or task performed, whereas 16% and 10% focus only on problem areas and high-volume complex tasks, respectively. The most common methods of evaluation were review of external quality assessment (EQA) challenges, direct observation, and worksheet review. With the exception of one participant, all communicate results to staff, and most take remedial action to correct the deficiencies. Although most accredited laboratories have a program to assess the ongoing competency of their staff, the methods used are not standardized or consistently applied, indicating that there is room for improvement. The survey successfully highlighted potential areas for improvement and allowed the QMP-LS Microbiology Committee to provide guidance to Ontario laboratories for establishing or improving existing microbiology-specific competency assessment programs. PMID:24899030

  19. Aquatic Toxicity Information Retrieval Data Base (ACQUIRE). Data file

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

    Not Available

    The purpose of Acquire is to provide scientists and managers quick access to a comprehensive, systematic, computerized compilation of aquatic toxicity data. Scientific papers published both nationally and internationally on the toxicity of chemicals to aquatic organisms and plants are collected and reviewed for ACQUIRE. Independently compiled data files that meet ACQUIRE parameter and quality assurance criteria are also included. Selected toxicity test results and related testing information for any individual chemical from laboratory and field aquatic toxicity effects are included for tests with freshwater and marine organisms. The total number of data records in ACQUIRE is now over 105,300.more » This includes data from 6000 references, for 5200 chemicals and 2400 test species. A major data file, Acute Toxicity of Organic Chemicals (ATOC), has been incorporated into ACQUIRE. The ATOC file contains laboratory acute test data on 525 organic chemicals using juvenile fathead minnows.« less

  20. 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...--including an assessment of Proficiency Test results; and on-site audits at least triennially). Whereas 40...

  1. Technical standards and guidelines: prenatal screening for Down syndrome that includes first-trimester biochemistry and/or ultrasound measurements.

    PubMed

    Palomaki, Glenn E; Lee, Jo Ellen S; Canick, Jacob A; McDowell, Geraldine A; Donnenfeld, Alan E

    2009-09-01

    This statement is intended to augment the current general ACMG Standards and Guidelines for Clinical Genetics Laboratories and to address guidelines specific to first-trimester screening for Down syndrome. The aim is to provide the laboratory the necessary information to ensure accurate and reliable Down syndrome screening results given a screening protocol (e.g., combined first trimester and integrated testing). Information about various test combinations and their expected performance are provided, but other issues such as availability of reagents, patient interest in early test results, access to open neural tube defect screening, and availability of chorionic villus sampling are all contextual factors in deciding which screening protocol(s) will be selected by individual health care providers. Individual laboratories are responsible for meeting the quality assurance standards described by the Clinical Laboratory Improvement Act, the College of American Pathologists, and other regulatory agencies, with respect to appropriate sample documentation, assay validation, general proficiency, and quality control measures. These guidelines address first-trimester screening that includes ultrasound measurement and interpretation of nuchal translucency thickness and protocols that combine markers from both the first and second trimesters. Laboratories can use their professional judgment to make modification or additions.

  2. Practical recommendations for strengthening national and regional laboratory networks in Africa in the Global Health Security era.

    PubMed

    Best, Michele; Sakande, Jean

    2016-01-01

    The role of national health laboratories in support of public health response has expanded beyond laboratory testing to include a number of other core functions such as emergency response, training and outreach, communications, laboratory-based surveillance and data management. These functions can only be accomplished by an efficient and resilient national laboratory network that includes public health, reference, clinical and other laboratories. It is a primary responsibility of the national health laboratory in the Ministry of Health to develop and maintain the national laboratory network in the country. In this article, we present practical recommendations based on 17 years of network development experience for the development of effective national laboratory networks. These recommendations and examples of current laboratory networks, are provided to facilitate laboratory network development in other states. The development of resilient, integrated laboratory networks will enhance each state's public health system and is critical to the development of a robust national laboratory response network to meet global health security threats.

  3. Practical recommendations for strengthening national and regional laboratory networks in Africa in the Global Health Security era

    PubMed Central

    2016-01-01

    The role of national health laboratories in support of public health response has expanded beyond laboratory testing to include a number of other core functions such as emergency response, training and outreach, communications, laboratory-based surveillance and data management. These functions can only be accomplished by an efficient and resilient national laboratory network that includes public health, reference, clinical and other laboratories. It is a primary responsibility of the national health laboratory in the Ministry of Health to develop and maintain the national laboratory network in the country. In this article, we present practical recommendations based on 17 years of network development experience for the development of effective national laboratory networks. These recommendations and examples of current laboratory networks, are provided to facilitate laboratory network development in other states. The development of resilient, integrated laboratory networks will enhance each state’s public health system and is critical to the development of a robust national laboratory response network to meet global health security threats. PMID:28879137

  4. The changing face of hemostasis testing in modern laboratories: consolidation, automation, and beyond.

    PubMed

    Lippi, Giuseppe; Plebani, Mario; Favaloro, Emmanuel J

    2015-04-01

    The reality of laboratory diagnostics as a whole, and hemostasis testing in particular, is evolving under new paradigms of efficiency. The driving forces of health care and laboratory diagnostics in the third millennium are mainly represented by macro- and microeconomics. In a world with limited resources, shattered by an unprecedented economic crisis, laboratory diagnostics is undergoing a substantial reorganization, with emergence of new models under the imperative of terms, such as bedside testing, consolidation, and networking. The paradigms under which these changes are being developed include a variety of environment, preanalytical, technological, professional, and health-care aspects. The maintenance of continued quality is indeed the major challenge to be faced in the foreseeable future. In fact, some challenges prepotently emerge during a consolidation process, which basically involve delayed testing, centrifugation, transportation, and stability of the specimens, as well as the potential mismatch of sample matrix. This article is aimed to provide an overview of the current economic scenario of laboratory diagnostics and discuss the changing face of hemostasis testing in modern laboratories, providing a synthetic overview about potential drawbacks of actualized solutions. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  5. Laboratory Experiences in Marine Biology for Upper Elementary and Secondary School Grades, Teachers Edition.

    ERIC Educational Resources Information Center

    Raimist, Roger J.

    Designed to assist the teacher who wishes to use marine organisms for biological laboratory investigations, this manual includes general information on maintaining marine aquaria and collecting marine organisms as well as five tested laboratory exercises. The exercises deal with the measurement of oxygen consumption (giving techniques for…

  6. To Enhance Collaborative Learning and Practice Network Knowledge with a Virtualization Laboratory and Online Synchronous Discussion

    ERIC Educational Resources Information Center

    Hwang, Wu-Yuin; Kongcharoen, Chaknarin; Ghinea, Gheorghita

    2014-01-01

    Recently, various computer networking courses have included additional laboratory classes in order to enhance students' learning achievement. However, these classes need to establish a suitable laboratory where each student can connect network devices to configure and test functions within different network topologies. In this case, the Linux…

  7. [Logistics of collection and transportation of biological samples and the organization of the central laboratory in the ELSA-Brasil].

    PubMed

    Fedeli, Ligia G; Vidigal, Pedro G; Leite, Claudia Mendes; Castilhos, Cristina D; Pimentel, Robércia Anjos; Maniero, Viviane C; Mill, Jose Geraldo; Lotufo, Paulo A; Pereira, Alexandre C; Bensenor, Isabela M

    2013-06-01

    The ELSA (Estudo Longitudinal de Saúde do Adulto - Brazilian Longitudinal Study for Adult Health) is a multicenter cohort study which aims at the identification of risk factors associated with type 2 diabetes and cardiovascular diseases in the Brazilian population. The paper describes the strategies for the collection, processing, transportation, and quality control of blood and urine tests in the ELSA. The study decided to centralize the tests at one single laboratory. The processing of the samples was performed at the local laboratories, reducing the weight of the material to be transported, and diminishing the costs of transportation to the central laboratory at the Universidade de São Paulo Hospital. The study included tests for the evaluation of diabetes, insulin resistance, dyslipidemia, electrolyte abnormalities, thyroid hormones, uric acid, hepatic enzyme abnormalities, inflammation, and total blood cell count. In addition, leukocyte DNA, urine, plasma and serum samples were stored. The central laboratory performed approximately 375,000 tests.

  8. Test Preparation: Your Role

    MedlinePlus

    ... transport the sample from home to the lab. Examples of some common laboratory tests that require advance preparation include: Glucose tolerance, fasting, and two-hour post-prandial blood glucose tests : fasting or eating meals ...

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

    Forman, S. E.; Themelis, M. P.

    The Department of Energy has set a 20-year lifetime goal for terrestrial photovoltaic modules. Massachusetts Institute of Technology's Lincoln Laboratory, in its capacity as a Photovoltaic Field Tests and Applications Center, has established various experimental test sites in the United States ranging in size from 0.1 to 25 kW of peak power. These sites serve as test beds for photovoltaic system components and include modules from several manufacturers. This report summarizes the activities of the Materials, Processes and Testing Laboratory of the Solar Photovoltaic Project during a three-month (10/1/78--12/31/78) period. Particular attention is given to testing and analysis of solarmore » modules from the Mead, Nebraska site, which contains a 25-kW array. A trip to the site was made, where various testing and inspection procedures were followed, in order to ascertain the physical and electrical degradation which had occurred in modules. In addition, several modules were removed for more detailed testing and inspection in the Laboratory. The results of both the field testing and laboratory analyses are reported here.« less

  10. Residue analysis of tetracyclines in poultry muscle: shortcomings revealed by a proficiency test.

    PubMed

    Berendsen, B J A; Van Rhijn, J A

    2006-11-01

    A proficiency test for tetracycline drug residues in poultry muscle was organized according to the guidelines of International Laboratory Accreditation Cooperation (ILAC) ILAC-G13:2000 (2000). For the proficiency test, three test materials were prepared. The homogeneity and stability of the materials during the study were demonstrated. Sixteen laboratories accepted the invitation to participate in the proficiency test; 11 laboratories reported results within the time frame of the study. Most notably, only four of the participating laboratories complied with the definition of the maximum residue limit (MRL) concerning the inclusion of 4-epimers as stated in European Commission Regulation 281/96 (1996). Most participants reported values for the decision limit (CCalpha) and detection capability (CCbeta) and hence were already in compliance with European Commission 2002/657/EC (2002) for this aspect of method validation. However, some CCalpha and CCbeta values were not in agreement with the actual within-laboratory reproducibility calculated from the results reported in this proficiency test. Although most laboratories obtained satisfactory results, it is clear that an effort is needed to include 4-epiOTC, 4-epiTC and 4-epiCTC in the analytical methods. Moreover, reconsideration of values determined for CCalpha and CCbeta with respect to their accuracy may be necessary in some cases.

  11. Laboratory Capacity for Antimicrobial Susceptibility Surveillance of Neisseria gonorrhoeae-District of Columbia, 2007-2012.

    PubMed

    Garrett, Tiana A; Davies-Cole, John; Furness, Bruce

    2015-08-01

    In the District of Columbia (DC), Neisseria gonorrhoeae (gonorrhea) infections accounted for more than 25% of 9321 incident sexually transmitted infections reported in 2011; untreated infections can lead to reproductive complications and a higher risk for HIV transmission. In DC, limited capacity to measure the prevalence of antibiotic-resistant N. gonorrhoeae is available; culture-based antibiotic susceptibility testing (AST) is needed to monitor antimicrobial resistance. We examined the capacity of laboratories that report to the DC Department of Health to perform AST for ongoing surveillance of antibiotic-resistant N. gonorrhoeae and to identify suspected treatment failures. We created a survey about diagnostic methods for gonorrhea testing and identified 33 laboratories that reported gonorrhea results to Department of Health in 2007 to 2012. Laboratories were assessed for use of bacterial culture or nucleic acid amplification testing (NAAT) for gonorrhea testing, prevalence of AST on gonorrhea-positive cultures, and types of antibiotics tested during AST. We estimated the prevalence of laboratory practices on the basis of self-report by staff. Nineteen (58%) laboratories completed the survey, representing 92% of the gonorrhea reporting. Seventeen (89%) of 19 laboratories conducted testing by culture; only 6 (35%) performed AST; 79% performed NAAT. Barriers to AST included longer completion times and limited number of provider requests for AST. Commercial laboratories (32%) were more likely to conduct both culture and NAAT, compared with health care facilities (11%). We report a low prevalence of laboratories performing AST because of multiple barriers. State-specific strategies addressing these barriers are needed to improve detection of antibiotic-resistant gonorrhea stains circulating among the population.

  12. Global Measles and Rubella Laboratory Network Support for Elimination Goals, 2010-2015.

    PubMed

    Mulders, Mick N; Rota, Paul A; Icenogle, Joseph P; Brown, Kevin E; Takeda, Makoto; Rey, Gloria J; Ben Mamou, Myriam C; Dosseh, Annick R G A; Byabamazima, Charles R; Ahmed, Hinda J; Pattamadilok, Sirima; Zhang, Yan; Gacic-Dobo, Marta; Strebel, Peter M; Goodson, James L

    2016-05-06

    In 2012, the World Health Assembly endorsed the Global Vaccine Action Plan (GVAP)* with the objective to eliminate measles and rubella in five World Health Organization (WHO) regions by 2020. In September 2013, countries in all six WHO regions had established measles elimination goals, and additional goals for elimination of rubella and congenital rubella syndrome were established in three regions (1). Capacity for surveillance, including laboratory confirmation, is fundamental to monitoring and verifying elimination. The 2012-2020 Global Measles and Rubella Strategic Plan of the Measles and Rubella Initiative(†) calls for effective case-based surveillance with laboratory testing for case confirmation (2). In 2000, the WHO Global Measles and Rubella Laboratory Network (GMRLN) was established to provide high quality laboratory support for surveillance (3). The GMRLN is the largest globally coordinated laboratory network, with 703 laboratories supporting surveillance in 191 countries. During 2010-2015, 742,187 serum specimens were tested, and 27,832 viral sequences were reported globally. Expansion of the capacity of the GMRLN will support measles and rubella elimination efforts as well as surveillance for other vaccine-preventable diseases (VPDs), including rotavirus, and for emerging pathogens of public health concern.

  13. The Daniel K. Inouye College of Pharmacy Scripts: Updates on Clostridium difficile Infection: Advances in Laboratory Testing to Aid Diagnosis and Treatment.

    PubMed

    Lteif, Louis

    2017-02-01

    Clostridium difficile remains a major source of nosocomial infections and associated diarrhea. More recently, community-acquired cases are on the rise creating a concern for a serious public health threat. Appropriate infection control precautions as well as prevention and optimal management may help to avoid detrimental outbreaks. A key step is utilizing laboratory testing for quick and accurate diagnosis of potential cases. This overview article describes Clostridium difficile infection control and prevention methods and updates the most recent management strategies including a focus on the utilization and interpretation of laboratory diagnostic testing and appropriate treatment.

  14. Results of the first provisional technical secretariat interlaboratory comparison test

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

    Stuff, J.R.; Hoffland, L.

    1995-06-01

    The principal task of this laboratory in the first Provisional Technical Secretariat (PTS) Interlaboratory Comparison Test was to verify and test the extraction and preparation procedures outlined in the Recommended Operating Procedures for Sampling and Analysis in the Verification of Chemical Disarmament in addition to our laboratory extraction methods and our laboratory analysis methods. Sample preparation began on 16 May 1994 and analysis was completed on 12 June 1994. The analytical methods used included NMR ({sup 1}H and {sup 31}P) GC/AED, GC/MS (EI and methane CI), GC/IRD, HPLC/IC, HPLC/TSP/MS, MS/MS(Electrospray), and CZE.

  15. Developing a laboratory protocol for asphalt binder recovery.

    DOT National Transportation Integrated Search

    2014-10-01

    Asphalt binder extraction and recovery are common laboratory procedures used to provide material for research and quality : assurance testing. The most common methods of recovery performed today include the Abson method and the rotary evaporator : (o...

  16. 42 CFR 493.1777 - Standard: Inspection of laboratories that have requested or have been issued a certificate of...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... inspections on the laboratory's compliance history. (c) Provider-performed microscopy procedures. The inspection sample for review may include testing in the subcategory of provider-performed microscopy...

  17. 42 CFR 493.1777 - Standard: Inspection of laboratories that have requested or have been issued a certificate of...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... inspections on the laboratory's compliance history. (c) Provider-performed microscopy procedures. The inspection sample for review may include testing in the subcategory of provider-performed microscopy...

  18. 42 CFR 493.1777 - Standard: Inspection of laboratories that have requested or have been issued a certificate of...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... inspections on the laboratory's compliance history. (c) Provider-performed microscopy procedures. The inspection sample for review may include testing in the subcategory of provider-performed microscopy...

  19. 42 CFR 493.1777 - Standard: Inspection of laboratories that have requested or have been issued a certificate of...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... inspections on the laboratory's compliance history. (c) Provider-performed microscopy procedures. The inspection sample for review may include testing in the subcategory of provider-performed microscopy...

  20. 42 CFR 493.1777 - Standard: Inspection of laboratories that have requested or have been issued a certificate of...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... inspections on the laboratory's compliance history. (c) Provider-performed microscopy procedures. The inspection sample for review may include testing in the subcategory of provider-performed microscopy...

  1. Emerging Technologies for the Clinical Microbiology Laboratory

    PubMed Central

    Buchan, Blake W.

    2014-01-01

    SUMMARY In this review we examine the literature related to emerging technologies that will help to reshape the clinical microbiology laboratory. These topics include nucleic acid amplification tests such as isothermal and point-of-care molecular diagnostics, multiplexed panels for syndromic diagnosis, digital PCR, next-generation sequencing, and automation of molecular tests. We also review matrix-assisted laser desorption ionization–time of flight (MALDI-TOF) and electrospray ionization (ESI) mass spectrometry methods and their role in identification of microorganisms. Lastly, we review the shift to liquid-based microbiology and the integration of partial and full laboratory automation that are beginning to impact the clinical microbiology laboratory. PMID:25278575

  2. Testing the performance of microbiological safety cabinets used in microbiology laboratories in South Korea.

    PubMed

    Hwang, S H; Yi, T W; Cho, K H; Lee, I M; Yoon, C S

    2011-09-01

    To test a performance of the microbiological safety cabinets (MSCs) according to the type of MSCs in microbial laboratories. Tests were carried out to assess the performance of 31 MSCs in 14 different facilities, including six different biological test laboratories in six hospitals and eight different laboratories in three universities. The following tests were performed on the MSCs: the downflow test, intake velocity test, high-efficiency particulate air filter leak test and the airflow smoke pattern test. These performance tests were carried out in accordance with the standard procedures. Only 23% of Class II A1 (8), A2 (19) and unknown MSCs (4) passed these performance tests. The main reasons for the failure of MSCs were inappropriate intake velocity (65%), leakage in the HEPA filter sealing (50%), unbalanced airflow smoke pattern in the cabinets (39%) and inappropriate downflow (27%). This study showed that routine checks of MSCs are important to detect and strengthen the weak spots that frequently develop, as observed during the evaluation of the MSCs of various institutions. Routine evaluation and maintenance of MSCs are critical for optimizing performance. © 2011 The Authors. Letters in Applied Microbiology © 2011 The Society for Applied Microbiology.

  3. CTBTO Contractor Laboratory Test Sample Production Report

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

    Bob Hague; Tracy Houghton; Nick Mann

    2013-08-01

    In October 2012 scientists from both Idaho National Laboratory (INL) and the CTBTO contact laboratory at Seibersdorf, Austria designed a system and capability test to determine if the INL could produce and deliver a short lived radio xenon standard in time for the standard to be measured at the CTBTO contact laboratory at Seibersdorf, Austria. The test included sample standard transportation duration and potential country entrance delays at customs. On October 23, 2012 scientists at the Idaho National Laboratory (INL) prepared and shipped a Seibersdorf contract laboratory supplied cylinder. The canister contained 1.0 scc of gas that consisted of 70%more » xenon and 30% nitrogen by volume. The t0 was October 24, 2012, 1200 ZULU. The xenon content was 0.70 +/ 0.01 scc at 0 degrees C. The 133mXe content was 4200 +/ 155 dpm per scc of stable xenon on t0 (1 sigma uncertainty). The 133Xe content was 19000 +/ 800 dpm per scc of stable xenon on t0 (1 sigma uncertainty).« less

  4. Estimating Implementation and Operational Costs of an Integrated Tiered CD4 Service including Laboratory and Point of Care Testing in a Remote Health District in South Africa

    PubMed Central

    Cassim, Naseem; Coetzee, Lindi M.; Schnippel, Kathryn; Glencross, Deborah K.

    2014-01-01

    Background An integrated tiered service delivery model (ITSDM) has been proposed to provide ‘full-coverage’ of CD4 services throughout South Africa. Five tiers are described, defined by testing volumes and number of referring health-facilities. These include: (1) Tier-1/decentralized point-of-care service (POC) in a single site; Tier-2/POC-hub servicing processing <30–40 samples from 8–10 health-clinics; Tier-3/Community laboratories servicing ∼50 health-clinics, processing <150 samples/day; high-volume centralized laboratories (Tier-4 and Tier-5) processing <300 or >600 samples/day and serving >100 or >200 health-clinics, respectively. The objective of this study was to establish costs of existing and ITSDM-tiers 1, 2 and 3 in a remote, under-serviced district in South Africa. Methods Historical health-facility workload volumes from the Pixley-ka-Seme district, and the total volumes of CD4 tests performed by the adjacent district referral CD4 laboratories, linked to locations of all referring clinics and related laboratory-to-result turn-around time (LTR-TAT) data, were extracted from the NHLS Corporate-Data-Warehouse for the period April-2012 to March-2013. Tiers were costed separately (as a cost-per-result) including equipment, staffing, reagents and test consumable costs. A one-way sensitivity analyses provided for changes in reagent price, test volumes and personnel time. Results The lowest cost-per-result was noted for the existing laboratory-based Tiers- 4 and 5 ($6.24 and $5.37 respectively), but with related increased LTR-TAT of >24–48 hours. Full service coverage with TAT <6-hours could be achieved with placement of twenty-seven Tier-1/POC or eight Tier-2/POC-hubs, at a cost-per-result of $32.32 and $15.88 respectively. A single district Tier-3 laboratory also ensured ‘full service coverage’ and <24 hour LTR-TAT for the district at $7.42 per-test. Conclusion Implementing a single Tier-3/community laboratory to extend and improve delivery of services in Pixley-ka-Seme, with an estimated local ∼12–24-hour LTR-TAT, is ∼$2 more than existing referred services per-test, but 2–4 fold cheaper than implementing eight Tier-2/POC-hubs or providing twenty-seven Tier-1/POCT CD4 services. PMID:25517412

  5. Acoustic Treatment Design Scaling Methods. Volume 3; Test Plans, Hardware, Results, and Evaluation

    NASA Technical Reports Server (NTRS)

    Yu, J.; Kwan, H. W.; Echternach, D. K.; Kraft, R. E.; Syed, A. A.

    1999-01-01

    The ability to design, build, and test miniaturized acoustic treatment panels on scale-model fan rigs representative of the full-scale engine provides not only a cost-savings, but an opportunity to optimize the treatment by allowing tests of different designs. To be able to use scale model treatment as a full-scale design tool, it is necessary that the designer be able to reliably translate the scale model design and performance to an equivalent full-scale design. The primary objective of the study presented in this volume of the final report was to conduct laboratory tests to evaluate liner acoustic properties and validate advanced treatment impedance models. These laboratory tests include DC flow resistance measurements, normal incidence impedance measurements, DC flow and impedance measurements in the presence of grazing flow, and in-duct liner attenuation as well as modal measurements. Test panels were fabricated at three different scale factors (i.e., full-scale, half-scale, and one-fifth scale) to support laboratory acoustic testing. The panel configurations include single-degree-of-freedom (SDOF) perforated sandwich panels, SDOF linear (wire mesh) liners, and double-degree-of-freedom (DDOF) linear acoustic panels.

  6. 32 CFR 199.18 - Uniform HMO Benefit.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... schedule, including frequency or age specifications for: (i) Laboratory and x-ray tests, including blood lead, rubella, cholesterol, fecal occult blood testing, and mammography; (ii) Pap smears; (iii) Eye exams; (iv) Immunizations; (v) Periodic health promotion and disease prevention exams; (vi) Blood...

  7. 32 CFR 199.18 - Uniform HMO Benefit.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... schedule, including frequency or age specifications for: (i) Laboratory and x-ray tests, including blood lead, rubella, cholesterol, fecal occult blood testing, and mammography; (ii) Pap smears; (iii) Eye exams; (iv) Immunizations; (v) Periodic health promotion and disease prevention exams; (vi) Blood...

  8. 32 CFR 199.18 - Uniform HMO Benefit.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... schedule, including frequency or age specifications for: (i) Laboratory and x-ray tests, including blood lead, rubella, cholesterol, fecal occult blood testing, and mammography; (ii) Pap smears; (iii) Eye exams; (iv) Immunizations; (v) Periodic health promotion and disease prevention exams; (vi) Blood...

  9. Enhanced Verification Test Suite for Physics Simulation Codes

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

    Kamm, J R; Brock, J S; Brandon, S T

    2008-10-10

    This document discusses problems with which to augment, in quantity and in quality, the existing tri-laboratory suite of verification problems used by Los Alamos National Laboratory (LANL), Lawrence Livermore National Laboratory (LLNL), and Sandia National Laboratories (SNL). The purpose of verification analysis is demonstrate whether the numerical results of the discretization algorithms in physics and engineering simulation codes provide correct solutions of the corresponding continuum equations. The key points of this document are: (1) Verification deals with mathematical correctness of the numerical algorithms in a code, while validation deals with physical correctness of a simulation in a regime of interest.more » This document is about verification. (2) The current seven-problem Tri-Laboratory Verification Test Suite, which has been used for approximately five years at the DOE WP laboratories, is limited. (3) Both the methodology for and technology used in verification analysis have evolved and been improved since the original test suite was proposed. (4) The proposed test problems are in three basic areas: (a) Hydrodynamics; (b) Transport processes; and (c) Dynamic strength-of-materials. (5) For several of the proposed problems we provide a 'strong sense verification benchmark', consisting of (i) a clear mathematical statement of the problem with sufficient information to run a computer simulation, (ii) an explanation of how the code result and benchmark solution are to be evaluated, and (iii) a description of the acceptance criterion for simulation code results. (6) It is proposed that the set of verification test problems with which any particular code be evaluated include some of the problems described in this document. Analysis of the proposed verification test problems constitutes part of a necessary--but not sufficient--step that builds confidence in physics and engineering simulation codes. More complicated test cases, including physics models of greater sophistication or other physics regimes (e.g., energetic material response, magneto-hydrodynamics), would represent a scientifically desirable complement to the fundamental test cases discussed in this report. The authors believe that this document can be used to enhance the verification analyses undertaken at the DOE WP Laboratories and, thus, to improve the quality, credibility, and usefulness of the simulation codes that are analyzed with these problems.« less

  10. Test Operations Procedure (TOP) 10-2-022A Chemical Vapor and Aerosol System-Level Testing of Chemical/Biological Protective Suits

    DTIC Science & Technology

    2013-12-16

    p. Pretest and posttest physiological data on the TPs. q. Logbooks from test chamber and laboratory operators and laboratory QA chemist. TOP...shown on the videotape of the actual exercises performed. TPs will be identified by the TIIN of the suit worn. g. Pretest and posttest ...information, including suggestions for reducing this burden, to Department of Defense, Washington Headquarters Services, Directorate for information on

  11. Establishing benchmarks and metrics for disruptive technologies, inappropriate and obsolete tests in the clinical laboratory.

    PubMed

    Kiechle, Frederick L; Arcenas, Rodney C; Rogers, Linda C

    2014-01-01

    Benchmarks and metrics related to laboratory test utilization are based on evidence-based medical literature that may suffer from a positive publication bias. Guidelines are only as good as the data reviewed to create them. Disruptive technologies require time for appropriate use to be established before utilization review will be meaningful. Metrics include monitoring the use of obsolete tests and the inappropriate use of lab tests. Test utilization by clients in a hospital outreach program can be used to monitor the impact of new clients on lab workload. A multi-disciplinary laboratory utilization committee is the most effective tool for modifying bad habits, and reviewing and approving new tests for the lab formulary or by sending them out to a reference lab. Copyright © 2013 Elsevier B.V. All rights reserved.

  12. Establishing a cost-per-result of laboratory-based, reflex Cryptococcal antigenaemia screening (CrAg) in HIV+ patients with CD4 counts less than 100 cells/μl using a Lateral Flow Assay (LFA) at a typical busy CD4 laboratory in South Africa.

    PubMed

    Cassim, Naseem; Schnippel, Kathryn; Coetzee, Lindi Marie; Glencross, Deborah Kim

    2017-01-01

    Cryptococcal meningitis is a major cause of mortality and morbidity in countries with high HIV prevalence, primarily affecting patients whose CD4 are < = 100 cells/μl. Routine Cryptococcal Antigen (CrAg) screening is thus recommended in the South African HIV treatment guidelines for all patients with CD4 counts < = 100 cells/μl, followed by pre-emptive anti-fungal therapy where CrAg results are positive. A laboratory-based reflexed CrAg screening approach, using a Lateral Flow Assay (LFA) on remnant EDTA CD4 blood samples, was piloted at three CD4 laboratories. This study aimed to assess the cost-per-result of laboratory-based reflexed CrAg screening at one pilot CD4 referral laboratory. CD4 test volumes from 2014 were extracted to estimate percentage of CD4 < = 100 cells/μl. Daily average volumes were derived, assuming 12 months per/year and 21.73 working days per/month. Costing analyses were undertaken using Microsoft Excel and Stata with a provider prospective. The cost-per-result was estimated using a bottom-up method, inclusive of test kits and consumables (reagents), laboratory equipment and technical effort costs. The ZAR/$ exchange of 14.696/$1 was used, where applicable. One-way sensitivity analyses on the cost-per-result were conducted for possible error rates (3%- 8%, reductions or increases in reagent costs as well as test volumes (ranging from -60% to +60%). The pilot CD4 laboratory performed 267000 CD4 tests in 2014; ~ 9.3% (27500) reported CD4< = 100 cells/μl, equivalent to 106 CrAg tests performed daily. A batch of 30-tests could be performed in 1.6 hours, including preparation and analysis time. A cost-per-result of $4.28 was reported, with reagents contributing $3.11 (72.8%), while technical effort and laboratory equipment overheads contributed $1.17 (27.2%) and $0.03 (<1%) respectively. One-way sensitivity analyses including increasing or decreasing test volumes by 60% revealed a cost-per-result range of $3.84 to $6.03. A cost-per-result of $4.28 was established in a typical CD4 service laboratory to enable local budgetary cost projections and programmatic cost-effectiveness modelling. Varying reagent costs linked to currency exchange and varying test volumes in different levels of service can lead to varying cost-per-test and technical effort to manage workload, with an inverse relationship of higher costs expected at lower volumes of tests.

  13. Fuel alcohol production from agricultural lignocellulosic feedstocks

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

    Farina, G.E.; Barrier, J.W.; Forsythe, M.L.

    1988-01-01

    A two-stage, low-temperature, ambient pressure, acid hydrolysis process that utilizes separate unit operations to convert hemicellulose and cellulose in agricultural residues and crops to fermentable sugars is being developed and tested. Based on the results of the bench-scale tests, an acid hydrolysis experimental plant to demonstrate the concepts of low-temperature acid hydrolysis on a much larger scale was built. Plant tests using corn stover have been conducted for more that a year and conversion efficiences have equaled those achieved in the laboratory. Laboratory tests to determine the potential for low-temperature acid hydrolysis of other feedstocks - including red clover, alfalfa,more » kobe lespedeza, winter rape, and rye grass - are being conducted. Where applicable, process modifications to include extraction before or after hydrolysis also are being studied. This paper describes the experimental plant and process, results obtained in the plant, results of alternative feedstocks testing in the laboratory, and a plan for an integrated system that will produce other fuels, feed, and food from crops grown on marginal land.« less

  14. Laboratory and field performance of FOS sensors in static and dynamic strain monitoring in concrete bridge decks

    NASA Astrophysics Data System (ADS)

    Benmokrane, B.; Debaiky, A.; El-Ragaby, A.; Roy, R.; El-Gamal, S.; El-Salakawy, E.

    2006-03-01

    There is a growing need for designing and constructing innovative concrete bridges using FRP reinforcing bars as internal reinforcement to avoid the corrosion problems and high costs of maintenance and repair. For efficient use and to increase the lifetime of these bridges, it is important to develop efficient monitoring systems for such innovative structures. Fabry-Perot and Bragg fibre optic sensors (FOS) that can measure the strains and temperature are promising candidates for life-long health monitoring of these structures. This article reports laboratory and field performance of Fabry-Perot and Bragg FOS sensors as well as electrical strain gauges in static and dynamic strain monitoring in concrete bridge decks. The laboratory tests include tensile testing of glass FRP bars and testing of full-scale concrete bridge deck slabs reinforced with glass and carbon FRP bars under static and cyclic concentrated loads. The field tests include static and dynamic testing of two bridges reinforced with steel and glass FRP bars. The obtained strain results showed satisfactory agreement between the different gauges.

  15. Recommendations for Filler Material Composition and Delivery Method for Bench-Scale Testing

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

    Hardin, Ernest; Brady, Patrick Vane

    This report supplements Joint Workplan on Filler Investigations for DPCs (SNL 2017) providing new and some corrected information for use in planning Phase 1 laboratory testing of slurry cements as possible DPC fillers. The scope description is to "Describe a complete laboratory testing program for filler composition, delivery, emplacement in surrogate canisters, and post-test examination. To the extent possible specify filler material and equipment sources." This report includes results from an independent expert review (Dr. Arun Wagh, retired from Argonne National Laboratory and contracted by Sandia) that helped to narrow the range of cement types for consideration, and to providemore » further guidance on mix variations to optimize injectability, durability, and other aspects of filler performance.« less

  16. A Manpower Study of Technical Personnel in Hospital Clinical Laboratories. Final Report.

    ERIC Educational Resources Information Center

    Harkness, James P., And Others

    As one of the efforts related to closing the gap between the growing demands for clinical laboratory workers and the supply of well-trained workers, the volume and quality of laboratory procedures and the general characteristics of workers in North Carolina hospitals were studied. Approaches to the study included tests on "unknowns" by…

  17. Cookstove Laboratory Research - Fiscal Year 2016 Report

    EPA Science Inventory

    This report provides an overview of the work conducted by the EPA cookstove laboratory research team in Fiscal Year 2016. The report describes research and activities including (1) ISO standards development, (2) capacity building for international testing and knowledge centers, ...

  18. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  19. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  20. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  1. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  2. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  3. Comparison of a standardized procedure with current laboratory practices for the detection of lupus anticoagulant in France. Working Group on Hemostasis of the Société Française de Biologie Clinique.

    PubMed

    1993-11-15

    A multicenter study involving 13 laboratories was designed to compare a common procedure for screening lupus anticoagulants (LA) to the different practices currently in use in these laboratories. The common procedure combined 3 phospholipid-dependent assays, including mixing studies and a phospholipid neutralizing test. Due to the heterogeneity of LA expression, an abnormal result in at least one of the tests was sufficient to classify a sample as positive for LA. Consecutive samples referred for LA diagnosis were evaluated in parallel by each participant and the data found using the common procedure were analyzed independently according to mutually agreed cut-offs and criteria for sample classification. Within a period of 3 months, 535 samples were included, of which 147 were judged LA positive, 29 undetermined and 359 negative by the respective laboratories using their current practice. When using the common procedure, 149 plasmas were said to be positive, 38 undetermined and 348 negative. Absolute concordance occurred for 81% of the specimen population and absolute discordance (positive versus negative) for 7%. The level of agreement between the common procedure and the current practices, assessed by kappa indexes, indicated noticeable variations in the rates of detection from laboratory to laboratory. Among the different tests used in the common procedure, regular APTT was the least sensitive (about 50% detection) but none of the other tests alone recognized more than 73% of specimens from the LA positive population. This yield increased to about 90% with any combination of 2 sensitive tests.(ABSTRACT TRUNCATED AT 250 WORDS)

  4. Silver-Teflon coating improvement

    NASA Technical Reports Server (NTRS)

    Reed, M. W.

    1976-01-01

    Approximately forty adhesives were subjected to laboratory screening. Seven candidate adhesives were selected from the screening tests and evaluated in a thermal vacuum test on radiator panels similar to the anticipated flight hardware configuration. Several classes of adhesives based on epoxide, polyester, silicone, and urethane resin systems were tested. These included contact adhesives, heat cured adhesives, heat and pressure cured adhesives, pressure sensitive adhesives, and two part paint-on or spray-on adhesives. The panels were tested in a space environmental simulation laboratory chamber during the July 9-20, 1973 time span.

  5. [Antimicrobial resistance testing in clinical practice].

    PubMed

    Doi, Yohei

    2012-02-01

    Previously unrecognized or underrecognized antimicrobial resistant bacteria, including NDM-1-producing Enterobacteriaceae and multidrug-resistant Acinetobacter baumannii, were recently identified in health care facilities in Japan. Vigilance in the clinical microbiology laboratory for these organisms is the key to early recognition of their emergence. Many of these organisms can be confirmed or at least suspected through routine susceptibility testing, which can then be referred to reference laboratories for further phenotypic or genetic testing. Antimicrobial resistance testing plays a crucial role in patient management, infection control and monitoring of local as well as national and international epidemiology.

  6. Benefits and Limitations of Prenatal Screening for Prader-Willi Syndrome

    PubMed Central

    Butler, Merlin G.

    2016-01-01

    This review the status of genetic laboratory testing in Prader-Willi syndrome (PWS) due to different genetic subtypes, most often a paternally derived 15q11-q13 deletion, with benefits and limitations related to prenatal screening. Medical literature was searched for prenatal screening and genetic laboratory testing methods in use or under development and discussed in relationship to PWS. Genetic testing includes six established laboratory diagnostic approaches for PWS with direct application to prenatal screening. Ultrasonographic, obstetric and cytogenetic reports were summarized in relationship to the cause of Prader-Willi syndrome and identification of specific genetic subtypes including maternal disomy 15. Advances in genetic technology were described for diagnosing PWS specifically DNA methylation and high-resolution chromosomal SNP microarrays as current tools for genetic screening and incorporating next generation DNA sequencing for noninvasive prenatal testing (NIPT) using cell-free fetal DNA. Positive experiences are reported with NIPT for detection of numerical chromosomal problems (aneuploidies) but not for structural problems (microdeletions). These reports will be discussed along with future directions for genetic screening of PWS. In summary, this review describes and discusses the status of established and ongoing genetic testing options for PWS applicable in prenatal screening including NIPT and future directions for early diagnosis in Prader-Willi syndrome. PMID:27537837

  7. Benefits and limitations of prenatal screening for Prader-Willi syndrome.

    PubMed

    Butler, Merlin G

    2017-01-01

    This review summarizes the status of genetic laboratory testing in Prader-Willi syndrome (PWS) with different genetic subtypes, most often a paternally derived 15q11-q13 deletion and discusses benefits and limitations related to prenatal screening. Medical literature was searched for prenatal screening and genetic laboratory testing methods in use or under development and discussed in relationship to PWS. Genetic testing includes six established laboratory diagnostic approaches for PWS with direct application to prenatal screening. Ultrasonographic, obstetric and cytogenetic reports were summarized in relationship to the cause of PWS and identification of specific genetic subtypes including maternal disomy 15. Advances in genetic technology were described for diagnosing PWS specifically DNA methylation and high-resolution chromosomal SNP microarrays as current tools for genetic screening and incorporating next generation DNA sequencing for noninvasive prenatal testing (NIPT) using cell-free fetal DNA. Positive experiences are reported with NIPT for detection of numerical chromosomal problems (aneuploidies) but not for structural problems (microdeletions). These reports will be discussed along with future directions for genetic screening of PWS. In summary, this review describes and discusses the status of established and ongoing genetic testing options for PWS applicable in prenatal screening including NIPT and future directions for early diagnosis in PWS. © 2016 John Wiley & Sons, Ltd. © 2016 John Wiley & Sons, Ltd.

  8. Viability testing of material derived from Mycobacterium tuberculosis prior to removal from a Containment Level-III Laboratory as part of a Laboratory Risk Assessment Program

    PubMed Central

    Blackwood, Kym S; Burdz, Tamara V; Turenne, Christine Y; Sharma, Meenu K; Kabani, Amin M; Wolfe, Joyce N

    2005-01-01

    Background In the field of clinical mycobacteriology, Mycobacterium tuberculosis (MTB) can be a difficult organism to manipulate due to the restrictive environment of a containment level 3 (CL3) laboratory. Tests for rapid diagnostic work involving smears and molecular methods do not require CL3 practices after the organism has been rendered non-viable. While it has been assumed that after organism deactivation these techniques can be performed outside of a CL3, no conclusive study has consistently confirmed that the organisms are noninfectious after the theoretical 'deactivation' steps. Previous studies have shown that initial steps (such as heating /chemical fixation) may not consistently kill MTB organisms. Methods An inclusive viability study (n = 226) was undertaken to determine at which point handling of culture extraction materials does not necessitate a CL3 environment. Four different laboratory protocols tested for viability included: standard DNA extractions for IS6110 fingerprinting, crude DNA preparations for PCR by boiling and mechanical lysis, protein extractions, and smear preparations. For each protocol, laboratory staff planted a proportion of the resulting material to Bactec 12B medium that was observed for growth for 8 weeks. Results Of the 208 isolates initially tested, 21 samples grew within the 8-week period. Sixteen (7.7%) of these yielded positive results for MTB that included samples of: deactivated culture resuspensions exposed to 80°C for 20 minutes, smear preparations and protein extractions. Test procedures were consequently modified and tested again (n = 18), resulting in 0% viability. Conclusions This study demonstrates that it cannot be assumed that conventional practices (i.e. smear preparation) or extraction techniques render the organism non-viable. All methodologies, new and existing, should be examined by individual laboratories to validate the safe removal of material derived from MTB to the outside of a CL3 laboratory. This process is vital to establish in house biosafety-validated practices with the aim of protecting laboratory workers conducting these procedures. PMID:15667662

  9. National and international veterinary reference laboratories for infectious diseases.

    PubMed

    Edwards, S; Alexander, D

    1998-08-01

    Reference laboratories play an increasingly important role in the harmonisation of laboratory diagnostic tests and the standardisation of veterinary vaccines. This is particularly important in building confidence between international trading partners. The authors review aspects of the organisation, designation and support of reference laboratories for infectious diseases of animals and discuss the principal activities which such laboratories would normally perform. These activities include advice and consultancy, publications and communication, training, research, disease surveillance, maintenance of culture collections, evaluation of reference methods, preparation of reference materials and organisation of inter-laboratory comparisons.

  10. Clinical Chemistry Laboratory Automation in the 21st Century - Amat Victoria curam (Victory loves careful preparation)

    PubMed Central

    Armbruster, David A; Overcash, David R; Reyes, Jaime

    2014-01-01

    The era of automation arrived with the introduction of the AutoAnalyzer using continuous flow analysis and the Robot Chemist that automated the traditional manual analytical steps. Successive generations of stand-alone analysers increased analytical speed, offered the ability to test high volumes of patient specimens, and provided large assay menus. A dichotomy developed, with a group of analysers devoted to performing routine clinical chemistry tests and another group dedicated to performing immunoassays using a variety of methodologies. Development of integrated systems greatly improved the analytical phase of clinical laboratory testing and further automation was developed for pre-analytical procedures, such as sample identification, sorting, and centrifugation, and post-analytical procedures, such as specimen storage and archiving. All phases of testing were ultimately combined in total laboratory automation (TLA) through which all modules involved are physically linked by some kind of track system, moving samples through the process from beginning-to-end. A newer and very powerful, analytical methodology is liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS). LC-MS/MS has been automated but a future automation challenge will be to incorporate LC-MS/MS into TLA configurations. Another important facet of automation is informatics, including middleware, which interfaces the analyser software to a laboratory information systems (LIS) and/or hospital information systems (HIS). This software includes control of the overall operation of a TLA configuration and combines analytical results with patient demographic information to provide additional clinically useful information. This review describes automation relevant to clinical chemistry, but it must be recognised that automation applies to other specialties in the laboratory, e.g. haematology, urinalysis, microbiology. It is a given that automation will continue to evolve in the clinical laboratory, limited only by the imagination and ingenuity of laboratory scientists. PMID:25336760

  11. Clinical Chemistry Laboratory Automation in the 21st Century - Amat Victoria curam (Victory loves careful preparation).

    PubMed

    Armbruster, David A; Overcash, David R; Reyes, Jaime

    2014-08-01

    The era of automation arrived with the introduction of the AutoAnalyzer using continuous flow analysis and the Robot Chemist that automated the traditional manual analytical steps. Successive generations of stand-alone analysers increased analytical speed, offered the ability to test high volumes of patient specimens, and provided large assay menus. A dichotomy developed, with a group of analysers devoted to performing routine clinical chemistry tests and another group dedicated to performing immunoassays using a variety of methodologies. Development of integrated systems greatly improved the analytical phase of clinical laboratory testing and further automation was developed for pre-analytical procedures, such as sample identification, sorting, and centrifugation, and post-analytical procedures, such as specimen storage and archiving. All phases of testing were ultimately combined in total laboratory automation (TLA) through which all modules involved are physically linked by some kind of track system, moving samples through the process from beginning-to-end. A newer and very powerful, analytical methodology is liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS). LC-MS/MS has been automated but a future automation challenge will be to incorporate LC-MS/MS into TLA configurations. Another important facet of automation is informatics, including middleware, which interfaces the analyser software to a laboratory information systems (LIS) and/or hospital information systems (HIS). This software includes control of the overall operation of a TLA configuration and combines analytical results with patient demographic information to provide additional clinically useful information. This review describes automation relevant to clinical chemistry, but it must be recognised that automation applies to other specialties in the laboratory, e.g. haematology, urinalysis, microbiology. It is a given that automation will continue to evolve in the clinical laboratory, limited only by the imagination and ingenuity of laboratory scientists.

  12. Scarecrow

    NASA Image and Video Library

    2007-10-04

    The team developing NASA Mars Science Laboratory calls this test rover Scarecrow because the vehicle does not include a computer brain. Mobility engineers use this test rover to evaluate mobility and suspension performance.

  13. Vehicle and Fuel Emissions Testing

    EPA Pesticide Factsheets

    EPA's National Vehicle and Fuel Emissions Laboratory's primary responsibilities include: evaluating emission control technology; testing vehicles, engines and fuels; and determining compliance with federal emissions and fuel economy standards.

  14. Cost evaluation of clinical laboratory in Taiwan's National Health System by using activity-based costing.

    PubMed

    Su, Bin-Guang; Chen, Shao-Fen; Yeh, Shu-Hsing; Shih, Po-Wen; Lin, Ching-Chiang

    2016-11-01

    To cope with the government's policies to reduce medical costs, Taiwan's healthcare service providers are striving to survive by pursuing profit maximization through cost control. This article aimed to present the results of cost evaluation using activity-based costing performed in the laboratory in order to throw light on the differences between costs and the payment system of National Health Insurance (NHI). This study analyzed the data of costs and income of the clinical laboratory. Direct costs belong to their respective sections of the department. The department's shared costs, including public expenses and administrative assigned costs, were allocated to the department's respective sections. A simple regression equation was created to predict profit and loss, and evaluate the department's break-even point, fixed cost, and contribution margin ratio. In clinical chemistry and seroimmunology sections, the cost per test was lower than the NHI payment and their major laboratory tests had revenues with the profitability ratio of 8.7%, while the other sections had a higher cost per test than the NHI payment and their major tests were in deficit. The study found a simple linear regression model as follows: "Balance=-84,995+0.543×income (R2=0.544)". In order to avoid deficit, laboratories are suggested to increase test volumes, enhance laboratory test specialization, and become marginal scale. A hospital could integrate with regional medical institutions through alliances or OEM methods to increase volumes to reach marginal scale and reduce laboratory costs, enhancing the level and quality of laboratory medicine.

  15. Development and laboratory testing of a 138-kV PPP-insulated joint for commercial application

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

    Walldorf, S.P.; Chu, H.; Elbadaly, H.

    1990-04-01

    This paper describes the design, development and laboratory testing of a high voltage PPP (paper polypropylene/paper laminate) insulated joint for commercial application on 138-kV PPP-insulated cable. The design approach taken is conservative and addresses the typical variations in field conditions and in skill and workmanship of the splicing. Joint construction details, including choice of connector, taping structure, and joint mechanical reinforcement, are discussed. The test criteria are described and results are presented.

  16. Development of a Dielectric-Loaded Accelerator Test Facility Based on an X-Band Magnicon Amplifier

    NASA Astrophysics Data System (ADS)

    Gold, S. H.; Kinkead, A. K.; Gai, W.; Power, J. G.; Konecny, R.; Jing, C.; Tantawi, S. G.; Nantista, C. D.; Hu, Y.; Du, X.; Tang, C.; Lin, Y.; Bruce, R. W.; Bruce, R. L.; Fliflet, A. W.; Lewis, D.

    2006-01-01

    The Naval Research Laboratory (NRL) and Argonne National Laboratory (ANL), in collaboration with the Stanford Linear Accelerator Center (SLAC), are developing a dielectric-loaded accelerator (DLA) test facility powered by the 11.424-GHz magnicon amplifier that was developed jointly by NRL and Omega-P, Inc. Thus far, DLA structures developed by ANL have been tested at the NRL Magnicon Facility without injected electrons, including tests of alumina and magnesium calcium titanate structures at gradients up to ˜8 MV/m. The next step is to inject electrons in order to build a compact DLA test accelerator. The Accelerator Laboratory of Tsinghua University in Beijing, China has developed a 5-MeV electron injector for the accelerator, and SLAC is developing a means to combine the two magnicon output arms, and to drive the injector and an accelerator section with separate control of the power ratio and relative phase. Also, RWBruce Associates, working with NRL, is developing a means to join ceramic tubes to produce long accelerating sections using a microwave brazing process. The installation and commissioning of the first dielectric-loaded test accelerator, including injector, DLA structure, and spectrometer, should take place within the next year.

  17. Resilient modulus testing of materials from MN/Road : phase 1

    DOT National Transportation Integrated Search

    1996-09-01

    The U.S. Army Cold Regions Research and Engineering Laboratory (CRREL) conducted resilient modulus tests on materials from the MN/ROAD test site for the Minnesota Department of Transportation. Materials tested included samples of the lean clay subgra...

  18. Harmonization in laboratory medicine: Requests, samples, measurements and reports.

    PubMed

    Plebani, Mario

    2016-01-01

    In laboratory medicine, the terms "standardization" and "harmonization" are frequently used interchangeably as the final goal is the same: the equivalence of measurement results among different routine measurement procedures over time and space according to defined analytical and clinical quality specifications. However, the terms define two distinct, albeit closely linked, concepts based on traceability principles. The word "standardization" is used when results for a measurement are equivalent and traceable to the International System of Units (SI) through a high-order primary reference material and/or a reference measurement procedure (RMP). "Harmonization" is generally used when results are equivalent, but neither a high-order primary reference material nor a reference measurement procedure is available. Harmonization is a fundamental aspect of quality in laboratory medicine as its ultimate goal is to improve patient outcomes through the provision of accurate and actionable laboratory information. Patients, clinicians and other healthcare professionals assume that clinical laboratory tests performed by different laboratories at different times on the same sample and specimen can be compared, and that results can be reliably and consistently interpreted. Unfortunately, this is not necessarily the case, because many laboratory test results are still highly variable and poorly standardized and harmonized. Although the initial focus was mainly on harmonizing and standardizing analytical processes and methods, the scope of harmonization now also includes all other aspects of the total testing process (TTP), such as terminology and units, report formats, reference intervals and decision limits as well as tests and test profiles, requests and criteria for interpretation. Several projects and initiatives aiming to improve standardization and harmonization in the testing process are now underway. Laboratory professionals should therefore step up their efforts to provide interchangeable and comparable laboratory information in order to ultimately assure better diagnosis and treatment in patient care.

  19. Effects of Electric Vehicle Fast Charging on Battery Life and Vehicle Performance

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

    Matthew Shirk; Jeffrey Wishart

    2015-04-01

    As part of the U.S. Department of Energy’s Advanced Vehicle Testing Activity, four new 2012 Nissan Leaf battery electric vehicles were instrumented with data loggers and operated over a fixed on-road test cycle. Each vehicle was operated over the test route, and charged twice daily. Two vehicles were charged exclusively by AC level 2 EVSE, while two were exclusively DC fast charged with a 50 kW charger. The vehicles were performance tested on a closed test track when new, and after accumulation of 50,000 miles. The traction battery packs were removed and laboratory tested when the vehicles were new, andmore » at 10,000-mile intervals. Battery tests include constant-current discharge capacity, electric vehicle pulse power characterization test, and low peak power tests. The on-road testing was carried out through 70,000 miles, at which point the final battery tests were performed. The data collected over 70,000 miles of driving, charging, and rest are analyzed, including the resulting thermal conditions and power and cycle demands placed upon the battery. Battery performance metrics including capacity, internal resistance, and power capability obtained from laboratory testing throughout the test program are analyzed. Results are compared within and between the two groups of vehicles. Specifically, the impacts on battery performance, as measured by laboratory testing, are explored as they relate to battery usage and variations in conditions encountered, with a primary focus on effects due to the differences between AC level 2 and DC fast charging. The contrast between battery performance degradation and the effect on vehicle performance is also explored.« less

  20. Utilization of stat test priority in the clinical laboratory: a College of American Pathologists q-probes study of 52 institutions.

    PubMed

    Volmar, Keith E; Wilkinson, David S; Wagar, Elizabeth A; Lehman, Christopher M

    2013-02-01

    Utilization of stat testing priority is a balance between safe, efficient patient management and resource expenditure. To determine the rate of stat testing, compare rates among institutions, and determine the distribution of turnaround time expectations for different turnaround time priorities. During a 7-day period, participants prospectively determined the total number of chemistry, hematology, and coagulation billable tests from inpatients and emergency department patients. Among these, the total numbers of billable tests performed stat were identified. Laboratories also reported the levels of test priority they offered and turnaround expectations for each level of test priority. Fifty institutions submitted data for the study, with 2 additional participants submitting partial results. Participants identified 639 589 chemistry, hematology, and coagulation billable tests, with 229 896 (35.9%) performed stat. The stat rate varied from 21.3% at the 10th percentile to 55.4% at the 90th percentile, with a median of 37.0% of participants' tests performed stat. Laboratories include a mean of 206 tests in chemistry, hematology, and coagulation test menus, with 67% of these tests offered stat. The fraction of the test menu offered stat varied from 29.0% at the 10th percentile to 97.8% at the 90th percentile, with a median of 73.3% of tests on the menu offered stat. The most common number of testing priorities offered by participating laboratories was 3 (44.2%). Among the 52 participating laboratories, the median stat testing rate was 37.0% and a median 73.3% of the test menu was offered stat.

  1. Laboratory performance of sweat conductivity for the screening of cystic fibrosis.

    PubMed

    Greaves, Ronda F; Jolly, Lisa; Massie, John; Scott, Sue; Wiley, Veronica C; Metz, Michael P; Mackay, Richard J

    2018-03-28

    There are several complementary English-language guidelines for the performance of the sweat chloride test. These guidelines also incorporate information for the collection of conductivity samples. However, recommendations for the measurement and reporting of sweat conductivity are less clear than for sweat chloride. The aim of the study was to develop an understanding of the testing and reporting practices of sweat conductivity in Australasian laboratories. A survey specifically directed at conductivity testing was sent to the 12 laboratories registered with the Royal College of Pathologists of Australasia Quality Assurance Programs. Nine (75%) laboratories participated in the survey, seven of whom used Wescor Macroduct® for collecting sweat and the Wescor SWEAT·CHEK™ for conductivity testing, and the remaining two used the Wescor Nanoduct®. There was considerable variation in frequency and staffing for this test. Likewise, criteria about which patients it was inappropriate to test, definitions of adequate collection sweat rate, cutoffs and actions recommended on the basis of the result showed variations between laboratories. Variations in sweat conductivity testing and reporting reflect many of the same issues that were revealed in sweat chloride test audits and have the potential to lead to uncertainty about the result and the proper action in response to the result. We recommend that sweat testing guidelines should include clearer statements about the use of sweat conductivity.

  2. The total laboratory solution: a new laboratory E-business model based on a vertical laboratory meta-network.

    PubMed

    Friedman, B A

    2001-08-01

    Major forces are now reshaping all businesses on a global basis, including the healthcare and clinical laboratory industries. One of the major forces at work is information technology (IT), which now provides the opportunity to create a new economic and business model for the clinical laboratory industry based on the creation of an integrated vertical meta-network, referred to here as the "total laboratory solution" (TLS). Participants at the most basic level of such a network would include a hospital-based laboratory, a reference laboratory, a laboratory information system/application service provider/laboratory portal vendor, an in vitro diagnostic manufacturer, and a pharmaceutical/biotechnology manufacturer. It is suggested that each of these participants would add value to the network primarily in its area of core competency. Subvariants of such a network have evolved over recent years, but a TLS comprising all or most of these participants does not exist at this time. Although the TLS, enabled by IT and closely akin to the various e-businesses that are now taking shape, offers many advantages from a theoretical perspective over the current laboratory business model, its success will depend largely on (a) market forces, (b) how the collaborative networks are organized and managed, and (c) whether the network can offer healthcare organizations higher quality testing services at lower cost. If the concept is successful, new demands will be placed on hospital-based laboratory professionals to shift the range of professional services that they offer toward clinical consulting, integration of laboratory information from multiple sources, and laboratory information management. These information management and integration tasks can only increase in complexity in the future as new genomic and proteomics testing modalities are developed and come on-line in clinical laboratories.

  3. Consensus and controversies in best practices for molecular genetic testing of spinocerebellar ataxias

    PubMed Central

    Sequeiros, Jorge; Seneca, Sara; Martindale, Joanne

    2010-01-01

    Many laboratories worldwide are offering molecular genetic testing for spinocerebellar ataxias (SCAs). This is essential for differential diagnosis and adequate genetic counselling. The European Molecular Genetics Quality Network (EMQN) started an SCA external quality assessment scheme in 2004. There was a clear need for updated laboratory guidelines. EMQN and EuroGentest organized a Best Practice (BP) meeting to discuss current practices and achieve consensus. A pre-meeting survey showed that 36 laboratories (20 countries) conducted nearly 18 000 SCA tests the year before, and identified issues to discuss. Draft guidelines were produced immediately after the meeting and discussed online for several months. The final version was endorsed by EMQN, and harmonized with guidelines from other oligonucleotide repeat disorders. We present the procedures taken to organize the survey, BP meeting, as well as drafting and approval of BP guidelines. We emphasize the most important recommendations on (1) pre-test requirements, (2) appropriate methodologies and (3) interpretation and reporting, and focus on the discussion of controversial issues not included in the final document. In addition, after an extensive review of scientific literature, and responding to recommendations made, we now produce information that we hope will facilitate the activities of diagnostic laboratories and foster quality SCA testing. For the main loci, this includes (1) a list of repeat sequences, as originally published; (2) primers in use; and (3) an evidence-based description of the normal and pathogenic repeat-size ranges, including those of reduced penetrance and those in which there is still some uncertainty. This information will be maintained and updated in http://www.scabase.eu. PMID:20179748

  4. Use of Lean response to improve pandemic influenza surge in public health laboratories.

    PubMed

    Isaac-Renton, Judith L; Chang, Yin; Prystajecky, Natalie; Petric, Martin; Mak, Annie; Abbott, Brendan; Paris, Benjamin; Decker, K C; Pittenger, Lauren; Guercio, Steven; Stott, Jeff; Miller, Joseph D

    2012-01-01

    A novel influenza A (H1N1) virus detected in April 2009 rapidly spread around the world. North American provincial and state laboratories have well-defined roles and responsibilities, including providing accurate, timely test results for patients and information for regional public health and other decision makers. We used the multidisciplinary response and rapid implementation of process changes based on Lean methods at the provincial public health laboratory in British Columbia, Canada, to improve laboratory surge capacity in the 2009 influenza pandemic. Observed and computer simulating evaluation results from rapid processes changes showed that use of Lean tools successfully expanded surge capacity, which enabled response to the 10-fold increase in testing demands.

  5. Computerized provider order entry in the clinical laboratory

    PubMed Central

    Baron, Jason M.; Dighe, Anand S.

    2011-01-01

    Clinicians have traditionally ordered laboratory tests using paper-based orders and requisitions. However, paper orders are becoming increasingly incompatible with the complexities, challenges, and resource constraints of our modern healthcare systems and are being replaced by electronic order entry systems. Electronic systems that allow direct provider input of diagnostic testing or medication orders into a computer system are known as Computerized Provider Order Entry (CPOE) systems. Adoption of laboratory CPOE systems may offer institutions many benefits, including reduced test turnaround time, improved test utilization, and better adherence to practice guidelines. In this review, we outline the functionality of various CPOE implementations, review the reported benefits, and discuss strategies for using CPOE to improve the test ordering process. Further, we discuss barriers to the implementation of CPOE systems that have prevented their more widespread adoption. PMID:21886891

  6. The Pathology Laboratory Act 2007 explained.

    PubMed

    Looi, Lai-Meng

    2008-06-01

    The past century has seen tremendous changes in the scope and practice of pathology laboratories in tandem with the development of the medical services in Malaysia. Major progress was made in the areas of training and specialization of pathologists and laboratory technical staff. Today the pathology laboratory services have entered the International arena, and are propelled along the wave of globalization. Many new challenges have emerged as have new players in the field. Landmark developments over the past decade include the establishment of national quality assurance programmes, the mushrooming of private pathology laboratories, the establishment of a National Accreditation Standard for medical testing laboratories based on ISO 15189, and the passing of the Pathology Laboratory Act in Parliament in mid-2007. The Pathology Laboratory Act 2007 seeks to ensure that the pathology laboratory is accountable to the public, meets required standards of practice, participates in Quality Assurance programmes, is run by qualified staff, complies with safety requirements and is subject to continuous audit. The Act is applicable to all private laboratories (stand alone or hospital) and laboratories in statutory bodies (Universities, foundations). It is not applicable to public laboratories (established and operated by the government) and side-room laboratories established in clinics of registered medical or dental practitioners for their own patients (tests as in the First and Second Schedules respectively). Tests of the Third Schedule (home test blood glucose, urine glucose, urine pregnancy test) are also exempted. The Act has 13 Parts and provides for control of the pathology laboratory through approval (to establish and maintain) and licensing (to operate or provide). The approval or license may only be issued to a sole proprietor, partnership or body corporate, and then only if the entity includes a registered medical practitioner. Details of personnel qualifications and laboratory practices are left to be specified by the Director-General of Health, providing for a formal recognition process and room for revision as pathology practices evolve. Encompassed in the responsibilities of the licensee is the requirement that samples are received and results issued through, and management vested in, a registered medical or dental practitioner. This effectively prohibits "walk-ins" to the laboratory and indiscriminate public screening. The requirement for a person-in-charge in accordance with class and speciality of laboratory ensures that the laboratory is under the charge of the pathology profession. Examined carefully, the requirements of the Act are similar to laboratory accreditation, but are backed by legislation. Many of these details will be spelt out in the Regulations, and these in turn are likely to fall back on National professional guidelines, as accreditation does. Although not at first obvious, enforcement of the Act is based on self-regulation by pathology laboratory professionals. Sincere professional input is thus required to embrace its philosophy, ensure rational and transparent enforcement of legislation, and develop National guidelines for good pathology practices upon which enforcement may be based.

  7. Clinical utility of routine laboratory testing to identify possible secondary causes in older men with osteoporosis: the Osteoporotic Fractures in Men (MrOS) Study

    PubMed Central

    Fink, Howard A.; Litwack-Harrison, Stephanie; Taylor, Brent C.; Bauer, Douglas C.; Orwoll, Eric S.; Lee, Christine G.; Barrett-Connor, Elizabeth; Schousboe, John T.; Kado, Deborah M.; Garimella, Pranav S.; Ensrud, Kristine E.

    2016-01-01

    Purpose To evaluate the utility of recommended laboratory testing to identify secondary causes in older men with osteoporosis, we examined prevalence of laboratory abnormalities in older men with and without osteoporosis. Methods 1572 men aged ≥65 years in the Osteoporotic Fractures in Men study completed bone mineral density (BMD) testing and a battery of laboratory measures, including serum calcium, phosphorus, alkaline phosphatase, parathyroid hormone (PTH), thyroid-stimulating hormone (TSH), 25-OH vitamin D, total testosterone, spot urine calcium/creatinine ratio, spot urine albumin-creatinine ratio, creatinine-derived estimate glomerular filtration rate, 24-hour urine calcium, and 24-hour urine free cortisol. Using cross-sectional analyses, we calculated prevalence ratios (PR) and 95% confidence intervals (CI) for the association of any and specific laboratory abnormalities with osteoporosis, and the number of men with osteoporosis needed to test to identify one additional laboratory abnormality compared to testing men without osteoporosis. Results Approximately 60% of men had ≥1 laboratory abnormality in both men with and without osteoporosis. Among individual tests, only vitamin D insufficiency (PR, 1.13; 95% CI, 1.05–1.22) and high alkaline phosphatase (PR, 3.05; 95% CI, 1.52–6.11) were more likely in men with osteoporosis. Hypercortisolism and hyperthyroidism were uncommon and not significantly more frequent in men with osteoporosis. No osteoporotic men had hypercalciuria. Conclusions Though most of these older men had ≥1 laboratory abnormality, few routinely recommended individual tests were more common in men with osteoporosis than in those without osteoporosis. Possibly excepting vitamin D and alkaline phosphatase, benefit of routine laboratory testing to identify possible secondary causes in older osteoporotic men appears low. Results may not be generalizable to younger men or to older men in whom history and exam findings raise clinical suspicion for a secondary cause of osteoporosis. PMID:26458388

  8. Testing activities at the National Battery Test Laboratory

    NASA Astrophysics Data System (ADS)

    Hornstra, F.; Deluca, W. H.; Mulcahey, T. P.

    The National Battery Test Laboratory (NBTL) is an Argonne National Laboratory facility for testing, evaluating, and studying advanced electric storage batteries. The facility tests batteries developed under Department of Energy programs and from private industry. These include batteries intended for future electric vehicle (EV) propulsion, electric utility load leveling (LL), and solar energy storage. Since becoming operational, the NBTL has evaluated well over 1400 cells (generally in the form of three- to six-cell modules, but up to 140-cell batteries) of various technologies. Performance characterization assessments are conducted under a series of charge/discharge cycles with constant current, constant power, peak power, and computer simulated dynamic load profile conditions. Flexible charging algorithms are provided to accommodate the specific needs of each battery under test. Special studies are conducted to explore and optimize charge procedures, to investigate the impact of unique load demands on battery performance, and to analyze the thermal management requirements of battery systems.

  9. National survey on intra-laboratory turnaround time for some most common routine and stat laboratory analyses in 479 laboratories in China.

    PubMed

    Fei, Yang; Zeng, Rong; Wang, Wei; He, Falin; Zhong, Kun; Wang, Zhiguo

    2015-01-01

    To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones. 479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires. The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479/1307), 38% (228/598), and 36% (449/1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories. Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them.

  10. National survey on intra-laboratory turnaround time for some most common routine and stat laboratory analyses in 479 laboratories in China

    PubMed Central

    Fei, Yang; Zeng, Rong; Wang, Wei; He, Falin; Zhong, Kun

    2015-01-01

    Introduction To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones. Materials and methods 479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires. Results The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479 / 1307), 38% (228 / 598), and 36% (449 / 1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories. Conclusions Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them. PMID:26110033

  11. A composite CBRN surveillance and testing service

    NASA Astrophysics Data System (ADS)

    Niemeyer, Debra M.

    2004-08-01

    The terrorist threat coupled with a global military mission necessitates quick and accurate identification of environmental hazards, and CBRN early warning. The Air Force Institute for Operational Health (AFIOH) provides fundamental support to protect personnel from and mitigate the effects of untoward hazards exposures. Sustaining healthy communities since 1955, the organizational charter is to enhance warfighter mission effectiveness, protect health, improve readiness and reduce costs, assess and manage risks to human heath and safety, operational performance and the environment. The AFIOH Surveillance Directorate provides forward deployed and reach-back surveillance, agent identification, and environ-mental regulatory compliance testing. Three unique laboratories process and analyze over two million environmental samples and clinical specimens per year, providing analytical chemistry, radiological assessment, and infectious disease testing, in addition to supporting Air Force and Department of Defense (DoD) clinical reference laboratory and force health protection testing. Each laboratory has an applied or investigational testing section where new technologies and techniques are evaluated, and expert consultative support to assist in technology assessments and test analyses. The Epidemiology Surveillance Laboratory and Analytical Chemistry Laboratory are critical assets of the Centers for Disease Control and Prevention (CDC) National Laboratory Response Network. Deployable assets provide direct support to the Combatant Commander and include the Air Force Radiological Assessment Team, and the Biological Augmentation Team. A diverse directorate, the synergistic CBRN response capabilities are a commander"s force protection tool, critical to maintaining combat power.

  12. Toward better physics labs for future biologists

    NASA Astrophysics Data System (ADS)

    Moore, K.; Giannini, J.; Losert, W.

    2014-05-01

    We have developed a set of laboratories and hands on activities to accompany a new two-semester interdisciplinary physics course that has been developed and tested in two small test classes at the University of Maryland, College Park (UMD) in 2012-2013. We have designed the laboratories to be taken accompanying a reformed course in the student's second year, with calculus, biology, and chemistry as prerequisites. These prerequisites permit the laboratories to include significant content on physics relevant to cellular scales, from chemical interactions to random motion and charge screening in fluids. We also introduce students to research-grade equipment and modern physics analysis tools in contexts relevant to biology while maintaining the pedagogically valuable open-ended laboratory structure of reformed laboratories. Preliminary student response results from these two classes are discussed.

  13. Description and test results of a variable speed, constant frequency generating system

    NASA Astrophysics Data System (ADS)

    Brady, F. J.

    1985-12-01

    The variable-speed, constant frequency generating system developed for the Mod-0 wind turbine is presented. This report describes the system as it existed at the conclusion of the project. The cycloconverter control circuit is described including the addition of field-oriented control. The laboratory test and actual wind turbine test results are included.

  14. Description of the MHS Health Level 7 Microbiology Laboratory for Public Health Surveillance

    DTIC Science & Technology

    2012-10-01

    included, among others, respiratory infections (e.g., pandemic influenza, pertussis), skin and soft tissue infections (e.g., methicillin resistant ... Staphylococcus aureus ) and gastrointestinal infections (e.g., salmonellosis, norovirus). Positive microbiology results can be matched with outpatient or... Staphylococcus aureus . Laboratory Test Result Due to the structure of the laboratory data, results could be identified across multiple variables and

  15. Serving the Nation for Fifty Years: 1952 - 2002 Lawrence Livermore National Laboratory [LLNL], Fifty Years of Accomplishments

    DOE R&D Accomplishments Database

    2002-01-01

    For 50 years, Lawrence Livermore National Laboratory has been making history and making a difference. The outstanding efforts by a dedicated work force have led to many remarkable accomplishments. Creative individuals and interdisciplinary teams at the Laboratory have sought breakthrough advances to strengthen national security and to help meet other enduring national needs. The Laboratory's rich history includes many interwoven stories -- from the first nuclear test failure to accomplishments meeting today's challenges. Many stories are tied to Livermore's national security mission, which has evolved to include ensuring the safety, security, and reliability of the nation's nuclear weapons without conducting nuclear tests and preventing the proliferation and use of weapons of mass destruction. Throughout its history and in its wide range of research activities, Livermore has achieved breakthroughs in applied and basic science, remarkable feats of engineering, and extraordinary advances in experimental and computational capabilities. From the many stories to tell, one has been selected for each year of the Laboratory's history. Together, these stories give a sense of the Laboratory -- its lasting focus on important missions, dedication to scientific and technical excellence, and drive to made the world more secure and a better place to live.

  16. An electronic thesaurus of Evidence Based Laboratory Medicine hematological and biochemical diagnostic tests.

    PubMed

    Dorizzi, R M; Maconi, M; Giavarina, D; Loza, G; Aman, M; Moreira, J; Bisoffi, Z; Gennuso, C

    2009-10-01

    The adoption of Evidence Based Laboratory Medicine (EBLM) has been hampered until today by the lack of effective tools. The SIMeL EBLM e-Thesaurus (on-line Repertoire of the diagnostic effectiveness of the laboratory, radiology and cardiology test) provides a useful support to clinical laboratory professionals and to clinicians for the interpretation of the diagnostic tests. The e-Thesaurus is an application developed using Microsoft Active Server Pages technology and carried out with Web Server Microsoft Internet Information Server and is available at the SIMeL website using a browser running JavaScript scripts (Internet Explorer is recommended). It contains a database (in Italian, English and Spanish) of the sensitivity and specificity (including the 95% confidence interval), the positive and negative likelihood ratios, the Diagnostic Odds Ratio and the Number Needed to Diagnose of more than 2000 diagnostic (most laboratory but also cardiology and radiology) tests. The e-Thesaurus improves the previous SIMeL paper and CD Thesaurus; its main features are a three languages search and a continuous and an easy updating capability.

  17. An audit of the laboratory diagnosis of cryptosporidiosis in England and Wales.

    PubMed

    Chalmers, Rachel M; Atchison, Christina; Barlow, Katrina; Young, Yvonne; Roche, Anita; Manuel, Rohini

    2015-07-01

    To assess the level of practice consistent with UK national standards for Cryptosporidium testing, an audit was performed of 156 publicly funded clinical microbiology laboratories in England and Wales between August 2013 and April 2014. Responses were received from 85 (54 %) laboratories. First line diagnostic methods used were mainly microscopy with modified Ziehl-Neelsen (mZN) or auramine phenol (AP) staining (68/85, 80 %), enzyme immunoassays (EIAs) (16/85, 19 %) or in-house PCR (1/85, 1 %). The use of EIAs was more widespread than reported previously. Various methods were used for confirmation of positive EIA reactions and laboratories frequently resorted to sending samples to the national reference laboratory for this purpose, indicating that guidance is required for performance monitoring and confirmation of positive reactions. Laboratory positivity rates were related to the diagnostic test used, with highest median rates reported by those using PCR, EIAs or AP microscopy, and the lowest by those using mZN microscopy. One-third of responding laboratories (28/85, 33 %) routinely tested all stools for Cryptosporidium. However, 16 (19 %) laboratories used stool consistency to decide whether to test for this parasite. Other selection criteria included patient age (n = 18; 21 % laboratories), history or clinical details (n = 40; 47 %), duration of hospitalization (n = 18; 21 %) or clinician requests (n = 25; 29 %). To encourage laboratories to test all stools submitted for the investigation of diarrhoeal illness for Cryptosporidium, revision of the guidance in the national standards is under way. This will enable improved assessment of the burden of illness and ability to monitor outbreaks, and measure changes in reported cases.

  18. Subacute thyroiditis

    MedlinePlus

    ... may release too little hormone, causing symptoms of hypothyroidism , including: Cold intolerance Constipation Fatigue Weight gain Dry ... often returns to normal. But in rare cases, hypothyroidism may be permanent. Exams and Tests Laboratory tests ...

  19. Guidelines for point-of-care testing: haematology.

    PubMed

    Briggs, Carol; Guthrie, David; Hyde, Keith; Mackie, Ian; Parker, Norman; Popek, Mary; Porter, Neil; Stephens, Clare

    2008-09-01

    This guideline provides a framework for the arrangement of point-of-care testing (POCT) services, previously known as near patient testing (patient self-testing not covered). POCT is defined as any analytical test performed outside the laboratory. Primary users are often non-laboratory healthcare workers. The guidance applies to units within hospitals as well as general practioner surgeries, community clinics and pharmacies. The head of the haematology laboratory or a point of care coordinator must take responsibility for all aspects of the POCT service, including quality and training. Depending on the size and nature of the POCT practice, a local POCT manager may also be required. Equipment selected should have received a successful independent performance evaluation. If an independent evaluation has not been performed the purchaser should assess the device according to the protocol in this document. POCT devices should generate results that are comparable to those of the local laboratory. An accredited external quality assessment programme and internal quality control system must be established. Manufacturers promoting POCT devices designed for non-laboratory sites, e.g. pharmacies, should undertake training and annual competency assessment, perhaps using a web-based system. A diagram to illustrate the stages for the implementation of a POCT service is illustrated.

  20. Long-term stability of amorphous-silicon modules

    NASA Technical Reports Server (NTRS)

    Ross, R. G., Jr.

    1986-01-01

    The Jet Propulsion Laboratory (JPL) program of developing qualification tests necessary for amorphous silicon modules, including appropriate accelerated environmental tests reveal degradation due to illumination. Data were given which showed the results of temperature-controlled field tests and accelerated tests in an environmental chamber.

  1. Syndromic Surveillance and Outbreak Detection Using Automated Microbiologic Laboratory Test Order Data

    DTIC Science & Technology

    2007-06-15

    Laboratory Test Order Data" Ph.D. Degrees Interdisciplinary -Emerging Infectious Diseases -Molecular & Cell Biology -Neuroscience Departmental...for surveillance even though I was unable to attend his workshop. J.D. Malone’s tremendous knowledge of both infectious diseases and the DoD...can reduce morbidity and mortality. The course of many infectious diseases includes a nonspecific prodrome in which symptoms of the disease may be

  2. Serum Uric Acid Laboratory Test Request Patterns in Primary Care: How Panels May Contribute to Overutilization and Treatment of Asymptomatic Patients.

    PubMed

    Salinas, Maria; López-Garrigós, Maite; Flores, Emilio; Leiva-Salinas, Carlos

    2017-12-22

    To study the variability in the request of serum uric acid (SUA) in primary care. A cross-sectional study was designed and conducted at a main core laboratory. Spanish laboratories were invited to report their number of serum glucose (SG) and SUA tests requested from primary care during 2014. A survey was sent to every participant in November 2016 regarding the inclusion of SUA in order profiles/panels. The ratio of SUA/SG requests (SUA/SG) was calculated and compared between regions, and laboratories depending on whether SUA was included or not in a health check profile. 110 laboratories participated in the study (59.8% Spanish population). The median SUA/SG ratio was 0.82 (IQR: 0.25), and 41 laboratories had a ratio over 0.9. There was a significant regional variability (P = .008). Laboratories where SUA was not included in the "health check profile" had lower SUA/SG indicators (P = .003). There was significant regional variability in the request of SUA, and an overall over-request. Different regional customs or habits and the inclusion of SUA in the health check profile were probable causes behind the observed over-request. © American Society for Clinical Pathology, 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  3. A survey of current practices for genomic sequencing test interpretation and reporting processes in US laboratories.

    PubMed

    O'Daniel, Julianne M; McLaughlin, Heather M; Amendola, Laura M; Bale, Sherri J; Berg, Jonathan S; Bick, David; Bowling, Kevin M; Chao, Elizabeth C; Chung, Wendy K; Conlin, Laura K; Cooper, Gregory M; Das, Soma; Deignan, Joshua L; Dorschner, Michael O; Evans, James P; Ghazani, Arezou A; Goddard, Katrina A; Gornick, Michele; Farwell Hagman, Kelly D; Hambuch, Tina; Hegde, Madhuri; Hindorff, Lucia A; Holm, Ingrid A; Jarvik, Gail P; Knight Johnson, Amy; Mighion, Lindsey; Morra, Massimo; Plon, Sharon E; Punj, Sumit; Richards, C Sue; Santani, Avni; Shirts, Brian H; Spinner, Nancy B; Tang, Sha; Weck, Karen E; Wolf, Susan M; Yang, Yaping; Rehm, Heidi L

    2017-05-01

    While the diagnostic success of genomic sequencing expands, the complexity of this testing should not be overlooked. Numerous laboratory processes are required to support the identification, interpretation, and reporting of clinically significant variants. This study aimed to examine the workflow and reporting procedures among US laboratories to highlight shared practices and identify areas in need of standardization. Surveys and follow-up interviews were conducted with laboratories offering exome and/or genome sequencing to support a research program or for routine clinical services. The 73-item survey elicited multiple choice and free-text responses that were later clarified with phone interviews. Twenty-one laboratories participated. Practices highly concordant across all groups included consent documentation, multiperson case review, and enabling patient opt-out of incidental or secondary findings analysis. Noted divergence included use of phenotypic data to inform case analysis and interpretation and reporting of case-specific quality metrics and methods. Few laboratory policies detailed procedures for data reanalysis, data sharing, or patient access to data. This study provides an overview of practices and policies of experienced exome and genome sequencing laboratories. The results enable broader consideration of which practices are becoming standard approaches, where divergence remains, and areas of development in best practice guidelines that may be helpful.Genet Med advance online publication 03 Novemeber 2016.

  4. A Selected Bibliography on Microbiological Laboratory Design.

    ERIC Educational Resources Information Center

    Laboratory Design Notes, 1967

    1967-01-01

    Reference sources on microbiological laboratory design are cited. Subjects covered include--(1) policies and general requirements, (2) ventilated cabinets, (3) animal isolation equipment, (4) air handling, ventilation, and filtration, (5) germicidal ultraviolet irradiation, (6) aerosol test facilities, (7) process production of microorganisms, and…

  5. The State of Retrieval System Evaluation.

    ERIC Educational Resources Information Center

    Salton, Gerald

    1992-01-01

    The current state of information retrieval (IR) evaluation is reviewed with criticisms directed at the available test collections and the research and evaluation methodologies used, including precision and recall rates for online searches and laboratory tests not including real users. Automatic text retrieval systems are also discussed. (32…

  6. To test or not to test? Laboratory support for the diagnosis of Lyme borreliosis: a position paper of ESGBOR, the ESCMID study group for Lyme borreliosis.

    PubMed

    Dessau, R B; van Dam, A P; Fingerle, V; Gray, J; Hovius, J W; Hunfeld, K-P; Jaulhac, B; Kahl, O; Kristoferitsch, W; Lindgren, P-E; Markowicz, M; Mavin, S; Ornstein, K; Rupprecht, T; Stanek, G; Strle, F

    2018-02-01

    Lyme borreliosis (LB) is a tick-borne infection caused by Borrelia burgdorferi sensu lato. The most frequent clinical manifestations are erythema migrans and Lyme neuroborreliosis. Currently, a large volume of diagnostic testing for LB is reported, whereas the incidence of clinically relevant disease manifestations is low. This indicates overuse of diagnostic testing for LB with implications for patient care and cost-effective health management. The recommendations provided in this review are intended to support both the clinical diagnosis and initiatives for a more rational use of laboratory testing in patients with clinically suspected LB. This is a narrative review combining various aspects of the clinical and laboratory diagnosis with an educational purpose. The literature search was based on existing systematic reviews, national and international guidelines and supplemented with specific citations. The main recommendations according to current European case definitions for LB are as follows. Typical erythema migrans should be diagnosed clinically and does not require laboratory testing. The diagnosis of Lyme neuroborreliosis requires laboratory investigation of the spinal fluid including intrathecal antibody production, and the remaining disease manifestations require testing for serum antibodies to B. burgdorferi. Testing individuals with non-specific subjective symptoms is not recommended, because of a low positive predictive value. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

  7. Preferred Names, Preferred Pronouns, and Gender Identity in the Electronic Medical Record and Laboratory Information System: Is Pathology Ready?

    PubMed

    Imborek, Katherine L; Nisly, Nicole L; Hesseltine, Michael J; Grienke, Jana; Zikmund, Todd A; Dreyer, Nicholas R; Blau, John L; Hightower, Maia; Humble, Robert M; Krasowski, Matthew D

    2017-01-01

    Electronic medical records (EMRs) and laboratory information systems (LISs) commonly utilize patient identifiers such as legal name, sex, medical record number, and date of birth. There have been recommendations from some EMR working groups (e.g., the World Professional Association for Transgender Health) to include preferred name, pronoun preference, assigned sex at birth, and gender identity in the EMR. These practices are currently uncommon in the United States. There has been little published on the potential impact of these changes on pathology and LISs. We review the available literature and guidelines on the use of preferred name and gender identity on pathology, including data on changes in laboratory testing following gender transition treatments. We also describe pathology and clinical laboratory challenges in the implementation of preferred name at our institution. Preferred name, pronoun preference, and gender identity have the most immediate impact on the areas of pathology with direct patient contact such as phlebotomy and transfusion medicine, both in terms of interaction with patients and policies for patient identification. Gender identity affects the regulation and policies within transfusion medicine including blood donor risk assessment and eligibility. There are limited studies on the impact of gender transition treatments on laboratory tests, but multiple studies have demonstrated complex changes in chemistry and hematology tests. A broader challenge is that, even as EMRs add functionality, pathology computer systems (e.g., LIS, middleware, reference laboratory, and outreach interfaces) may not have functionality to store or display preferred name and gender identity. Implementation of preferred name, pronoun preference, and gender identity presents multiple challenges and opportunities for pathology.

  8. Preferred Names, Preferred Pronouns, and Gender Identity in the Electronic Medical Record and Laboratory Information System: Is Pathology Ready?

    PubMed Central

    Imborek, Katherine L.; Nisly, Nicole L.; Hesseltine, Michael J.; Grienke, Jana; Zikmund, Todd A.; Dreyer, Nicholas R.; Blau, John L.; Hightower, Maia; Humble, Robert M.; Krasowski, Matthew D.

    2017-01-01

    Background: Electronic medical records (EMRs) and laboratory information systems (LISs) commonly utilize patient identifiers such as legal name, sex, medical record number, and date of birth. There have been recommendations from some EMR working groups (e.g., the World Professional Association for Transgender Health) to include preferred name, pronoun preference, assigned sex at birth, and gender identity in the EMR. These practices are currently uncommon in the United States. There has been little published on the potential impact of these changes on pathology and LISs. Methods: We review the available literature and guidelines on the use of preferred name and gender identity on pathology, including data on changes in laboratory testing following gender transition treatments. We also describe pathology and clinical laboratory challenges in the implementation of preferred name at our institution. Results: Preferred name, pronoun preference, and gender identity have the most immediate impact on the areas of pathology with direct patient contact such as phlebotomy and transfusion medicine, both in terms of interaction with patients and policies for patient identification. Gender identity affects the regulation and policies within transfusion medicine including blood donor risk assessment and eligibility. There are limited studies on the impact of gender transition treatments on laboratory tests, but multiple studies have demonstrated complex changes in chemistry and hematology tests. A broader challenge is that, even as EMRs add functionality, pathology computer systems (e.g., LIS, middleware, reference laboratory, and outreach interfaces) may not have functionality to store or display preferred name and gender identity. Conclusions: Implementation of preferred name, pronoun preference, and gender identity presents multiple challenges and opportunities for pathology. PMID:29114436

  9. Further Development and Validation of the frog Embryo Teratogenesis Assay - Xenopus (FETAX)

    DTIC Science & Technology

    1991-02-28

    abnormalities.39 40 The teratogenic effects of serotonin in the laboratory rat include anophthalmia , hydrocephalus, exencephaly, omphalocoele and vacuolization...kinky tail. ZnSO4 in Xenopus, should be tested in parallel with hemangioma. anophthalmia and scoliosis). Skeletal a metabolic activation system to show...teratogenic effects of 0 serotonin in the laboratory rat include anophthalmia , hydrocephalus, exencephaly, omphalocele and vacuolization of myocardial cells.41

  10. Antimicrobial Susceptibility Testing, Drug Resistance Mechanisms, and Therapy of Infections with Nontuberculous Mycobacteria

    PubMed Central

    Nash, Kevin A.; Wallace, Richard J.

    2012-01-01

    Summary: Within the past 10 years, treatment and diagnostic guidelines for nontuberculous mycobacteria have been recommended by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA). Moreover, the Clinical and Laboratory Standards Institute (CLSI) has published and recently (in 2011) updated recommendations including suggested antimicrobial and susceptibility breakpoints. The CLSI has also recommended the broth microdilution method as the gold standard for laboratories performing antimicrobial susceptibility testing of nontuberculous mycobacteria. This article reviews the laboratory, diagnostic, and treatment guidelines together with established and probable drug resistance mechanisms of the nontuberculous mycobacteria. PMID:22763637

  11. Clinically expedient reporting of rapid diagnostic test information.

    PubMed

    Doern, G V

    1986-03-01

    With the development of rapid diagnostic tests in the clinical microbiology laboratory has come an awareness of the importance of rapid results reporting. Clearly, the potential clinical impact of rapid diagnostic tests is dependent on expeditious reporting. Traditional manual reporting systems are encumbered by the necessity of transcription of test information onto hard copy reports and then the subsequent distribution of such reports into the hands of the user. Laboratory computers when linked directly to CRTs located in nursing stations, ambulatory clinics, or physician's offices, both inside and outside of the hospital, permit essentially instantaneous transfer of test results from the laboratory to the clinician. Computer-assisted results reporting, while representing a significant advance over manual reporting systems is not, however, without problems. Concerns include validation of test information, authorization of users with access to test information, mechanical integrity, and cost. These issues notwithstanding, computerized results reporting will undoubtedly play a central role in optimizing the clinical impact of rapid diagnostic tests.

  12. Facilities to Support Beamed Energy Launch Testing at the Laser Hardened Materials Evaluation Laboratory (LHMEL)

    NASA Astrophysics Data System (ADS)

    Lander, Michael L.

    2003-05-01

    The Laser Hardened Materials Evaluation Laboratory (LHMEL) has been characterizing material responses to laser energy in support of national defense programs and the aerospace industry for the past 26 years. This paper reviews the overall resources available at LHMEL to support fundamental materials testing relating to impulse coupling measurement and to explore beamed energy launch concepts. Located at Wright-Patterson Air Force Base, Ohio, LHMEL is managed by the Air Force Research Laboratory Materials Directorate AFRL/MLPJ and operated by Anteon Corporation. The facility's advanced hardware is centered around carbon dioxide lasers producing output power up to 135kW and neodymium glass lasers producing up to 10 kilojoules of repetitively pulsed output. The specific capabilities of each laser device and related optical systems are discussed. Materials testing capabilities coupled with the laser systems are also described including laser output and test specimen response diagnostics. Environmental simulation capabilities including wind tunnels and large-volume vacuum chambers relevant to beamed energy propulsion are also discussed. This paper concludes with a summary of the procedures and methods by which the facility can be accessed.

  13. Toxicity of materials in fire situations: Laboratory data obtained at the University of San Francisco

    NASA Technical Reports Server (NTRS)

    Hilado, C. J.; Casey, C. J.; Kourtides, D. A.; Parker, J. A.

    1977-01-01

    Approximately 300 materials were evaluated using a specific set of test conditions. Materials tested included wood, fibers, fabrics and synthetic polymers. Data obtained using 10 different sets of test conditions are presented.

  14. ["How can hospitals develop a beneficial relationship with laboratory testing companies?" - Chairmen's introductory remarks].

    PubMed

    Morita, Toshisuke; Kawano, Seiji

    2014-12-01

    The symposium was held with the Japanese Society of Laboratory Medicine and JACLaP to discuss the way to develop a beneficial relationship between hospitals and laboratory testing companies with co-chairing by Seiji Kawano, Kobe University and Toshisuke Morita, Toho University. Clinical testing is considered to be essential for medical diagnosis and treatment; however, it is difficult for a hospital to perform all clinical testing for various reasons, including cost-effectiveness. In this session, 4 guest speakers gave a talk from their viewpoints. Doctor Kawano talked about the results of a questionnaire filled out by 114 university hospitals on how to develop a beneficial relationship between hospitalsoand laboratory testing companies. Next, Mr. Shinji Ogawa, president and CEO of SRL, talked about favorable ways to utilize laboratory testing companies, sayingthat such companies, which have a variety of skills, are expected to offer new and advanced technologies to hospitals continuously, and abundant data which laboratory testing companies have should be used for the advancement of community medicine. Professor Koshiba, Hyogo Medical School, expressed his apprehension to develop a so-called branch lab. in university hospitals from his own experience, and concluded that a beneficial relationship with companies to perform tasks required by hospitals should be sought. The last speaker, Yuichi Setoyama, Mitsubishi Chemical Medience, talked about the new relationship between hospitals and laboratory testing companies, and emphasized that hospitals and such companies should know the strong and weak points of each other and build a mutually complementary system. After all presentations were over, a discussion with participants was held. Doctors of clinics said that the role of laboratory testing companies for large hospitals is different from that for small clinics, and such companies are indispensable for his everyday medical activities. Each medical institute has its own medical mission, and, therefore, what constitutes a beneficial relationship varies with each medical institute. The key to the success of building a win-win relationship with laboratory testing companies is held by each hospital. (Review).

  15. International Seed Testing Association List of stabilized plant names, edition 6

    USDA-ARS?s Scientific Manuscript database

    Seed-testing laboratories determine the quality of seed lots in national and international seed commerce. Those services most commonly requested include purity analysis, noxious-weed seed detection, and viability tests. Rigorous procedures for performing various tests on specific crops have been est...

  16. 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

  17. Laboratory Performance Evaluation Report of SEL 421 Phasor Measurement Unit

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

    Huang, Zhenyu; faris, Anthony J.; Martin, Kenneth E.

    2007-12-01

    PNNL and BPA have been in close collaboration on laboratory performance evaluation of phasor measurement units for over ten years. A series of evaluation tests are designed to confirm accuracy and determine measurement performance under a variety of conditions that may be encountered in actual use. Ultimately the testing conducted should provide parameters that can be used to adjust all measurements to a standardized basis. These tests are performed with a standard relay test set using recorded files of precisely generated test signals. The test set provides test signals at a level and in a format suitable for input tomore » a PMU that accurately reproduces the signals in both signal amplitude and timing. Test set outputs are checked to confirm the accuracy of the output signal. The recorded signals include both current and voltage waveforms and a digital timing track used to relate the PMU measured value with the test signal. Test signals include steady-state waveforms to test amplitude, phase, and frequency accuracy, modulated signals to determine measurement and rejection bands, and step tests to determine timing and response accuracy. Additional tests are included as necessary to fully describe the PMU operation. Testing is done with a BPA phasor data concentrator (PDC) which provides communication support and monitors data input for dropouts and data errors.« less

  18. Miniaturization and globalization of clinical laboratory activities.

    PubMed

    Melo, Murilo R; Clark, Samantha; Barrio, Daniel

    2011-04-01

    Clinical laboratories provide an invaluable service to millions of people around the world in the form of quality diagnostic care. Within the clinical laboratory industry the impetus for change has come from technological development (miniaturization, nanotechnology, and their collective effect on point-of-care testing; POCT) and the increasingly global nature of laboratory services. Potential technological gains in POCT include: the development of bio-sensors, microarrays, genetics and proteomics testing, and enhanced web connectivity. In globalization, prospective opportunities lie in: medical tourism, the migration of healthcare workers, cross-border delivery of testing, and the establishment of accredited laboratories in previously unexplored markets. Accompanying these impressive opportunities are equally imposing challenges. Difficulty transitioning from research to clinical use, poor infrastructure in developing countries, cultural differences and national barriers to global trade are only a few examples. Dealing with the issues presented by globalization and the impact of developing technology on POCT, and on the clinical laboratory services industry in general, will be a daunting task. Despite such concerns, with appropriate countermeasures it will be possible to address the challenges posed. Future laboratory success will be largely dependent on one's ability to adapt in this perpetually shifting landscape.

  19. LABORATORY EVALUATION OF OIL SPILL BIOREMEDIATION PRODUCTS IN SALT AND FRESHWATER SYSTEMS

    EPA Science Inventory

    Ten oil spill bioremediation products were tested in the laboratory for their ability to enhance biodegradation of weathered Alaskan North Slope crude oil in both fresh and salt-water media. The products included: nutrients to stimulate inoculated microorganisms, nutrients plus a...

  20. Open-Ended Laboratory Investigations with Drosophila.

    ERIC Educational Resources Information Center

    Mertens, Thomas R.

    1983-01-01

    Background information, laboratory procedures (including matings performed), and results are presented for an open-ended investigation using the fruitfly Drosophila melanogaster. Once data are collected, students develop hypotheses to explain results as well as devise additional experiments to test their hypotheses. Calculation of chi-square for…

  1. President's Remarks. More about Animals in Research.

    ERIC Educational Resources Information Center

    Bird, Stephanie J.

    1990-01-01

    Discussed is the complexity of the issue concerning the use of live animals as subjects in laboratory tests. Included is a column written by Dr. Suzanne L. Epstein that discusses some of the advantages and disadvantages of use of tissue culture to replace laboratory animals. (CW)

  2. Computer Series, 61: Bits & Pieces, 24.

    ERIC Educational Resources Information Center

    Moore, John W., Ed.

    1985-01-01

    Describes: (1) laboratory information science in the clinical chemistry curriculum; (2) testing Boyle's Law, a context for statistical methods in undergraduate laboratories; (3) acquiring chemical concepts using microcomputers as tutees; and (4) using Data Interchange Format files for Apple microcomputers. Includes feedback from a previous article…

  3. 42 CFR 493.941 - Hematology (including routine hematology and coagulation).

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... of a laboratory's responses for qualitative and quantitative hematology tests or analytes, the...) of this section. (2) For quantitative hematology tests or analytes, the program must determine the...

  4. 42 CFR 493.941 - Hematology (including routine hematology and coagulation).

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... of a laboratory's responses for qualitative and quantitative hematology tests or analytes, the...) of this section. (2) For quantitative hematology tests or analytes, the program must determine the...

  5. 42 CFR 493.941 - Hematology (including routine hematology and coagulation).

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... of a laboratory's responses for qualitative and quantitative hematology tests or analytes, the...) of this section. (2) For quantitative hematology tests or analytes, the program must determine the...

  6. 42 CFR 493.941 - Hematology (including routine hematology and coagulation).

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... of a laboratory's responses for qualitative and quantitative hematology tests or analytes, the...) of this section. (2) For quantitative hematology tests or analytes, the program must determine the...

  7. 42 CFR 493.941 - Hematology (including routine hematology and coagulation).

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... of a laboratory's responses for qualitative and quantitative hematology tests or analytes, the...) of this section. (2) For quantitative hematology tests or analytes, the program must determine the...

  8. Sandia National Laboratories, Tonopah Test Range Fire Control Bunker (Building 09-51): Photographs and Written Historical and Descriptive Data

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

    Ullrich, Rebecca A.

    The Fire Control Bunker (Building 09-51) is a contributing element to the Sandia National Laboratories (SNL) Tonopah Test Range (TTR) Historic District. The SNL TTR Historic District played a significant role in U.S. Cold War history in the areas of stockpile surveillance and non-nuclear field testing of nuclear weapons design. The district covers approximately 179,200 acres and illustrates Cold War development testing of nuclear weapons components and systems. This report includes historical information, architectural information, sources of information, project information, maps, blueprints, and photographs.

  9. Sandia National Laboratories, Tonopah Test Range Assembly Building 9B (Building 09-54): Photographs and Written Historical and Descriptive Data

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

    Ullrich, Rebecca A.

    Assembly Building 9B (Building 09-54) is a contributing element to the Sandia National Laboratories (SNL) Tonopah Test Range (TTR) Historic District. The SNL TTR Historic District played a significant role in U.S. Cold War history in the areas of stockpile surveillance and non-nuclear field testing of nuclear weapons designs. The district covers approximately 179,200 acres and illustrates Cold War development testing of nuclear weapons components and systems. This report includes historical information, architectural information, sources of information, project information, maps, blueprints, and photographs.

  10. Economic evaluation of laboratory testing strategies for hospital-associated Clostridium difficile infection.

    PubMed

    Schroeder, Lee F; Robilotti, Elizabeth; Peterson, Lance R; Banaei, Niaz; Dowdy, David W

    2014-02-01

    Clostridium difficile infection (CDI) is the most common cause of infectious diarrhea in health care settings, and for patients presumed to have CDI, their isolation while awaiting laboratory results is costly. Newer rapid tests for CDI may reduce this burden, but the economic consequences of different testing algorithms remain unexplored. We used decision analysis from the hospital perspective to compare multiple CDI testing algorithms for adult inpatients with suspected CDI, assuming patient management according to laboratory results. CDI testing strategies included combinations of on-demand PCR (odPCR), batch PCR, lateral-flow diagnostics, plate-reader enzyme immunoassay, and direct tissue culture cytotoxicity. In the reference scenario, algorithms incorporating rapid testing were cost-effective relative to nonrapid algorithms. For every 10,000 symptomatic adults, relative to a strategy of treating nobody, lateral-flow glutamate dehydrogenase (GDH)/odPCR generated 831 true-positive results and cost $1,600 per additional true-positive case treated. Stand-alone odPCR was more effective and more expensive, identifying 174 additional true-positive cases at $6,900 per additional case treated. All other testing strategies were dominated by (i.e., more costly and less effective than) stand-alone odPCR or odPCR preceded by lateral-flow screening. A cost-benefit analysis (including estimated costs of missed cases) favored stand-alone odPCR in most settings but favored odPCR preceded by lateral-flow testing if a missed CDI case resulted in less than $5,000 of extended hospital stay costs and <2 transmissions, if lateral-flow GDH diagnostic sensitivity was >93%, or if the symptomatic carrier proportion among the toxigenic culture-positive cases was >80%. These results can aid guideline developers and laboratory directors who are considering rapid testing algorithms for diagnosing CDI.

  11. Economic Evaluation of Laboratory Testing Strategies for Hospital-Associated Clostridium difficile Infection

    PubMed Central

    Robilotti, Elizabeth; Peterson, Lance R.; Banaei, Niaz; Dowdy, David W.

    2014-01-01

    Clostridium difficile infection (CDI) is the most common cause of infectious diarrhea in health care settings, and for patients presumed to have CDI, their isolation while awaiting laboratory results is costly. Newer rapid tests for CDI may reduce this burden, but the economic consequences of different testing algorithms remain unexplored. We used decision analysis from the hospital perspective to compare multiple CDI testing algorithms for adult inpatients with suspected CDI, assuming patient management according to laboratory results. CDI testing strategies included combinations of on-demand PCR (odPCR), batch PCR, lateral-flow diagnostics, plate-reader enzyme immunoassay, and direct tissue culture cytotoxicity. In the reference scenario, algorithms incorporating rapid testing were cost-effective relative to nonrapid algorithms. For every 10,000 symptomatic adults, relative to a strategy of treating nobody, lateral-flow glutamate dehydrogenase (GDH)/odPCR generated 831 true-positive results and cost $1,600 per additional true-positive case treated. Stand-alone odPCR was more effective and more expensive, identifying 174 additional true-positive cases at $6,900 per additional case treated. All other testing strategies were dominated by (i.e., more costly and less effective than) stand-alone odPCR or odPCR preceded by lateral-flow screening. A cost-benefit analysis (including estimated costs of missed cases) favored stand-alone odPCR in most settings but favored odPCR preceded by lateral-flow testing if a missed CDI case resulted in less than $5,000 of extended hospital stay costs and <2 transmissions, if lateral-flow GDH diagnostic sensitivity was >93%, or if the symptomatic carrier proportion among the toxigenic culture-positive cases was >80%. These results can aid guideline developers and laboratory directors who are considering rapid testing algorithms for diagnosing CDI. PMID:24478478

  12. 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.

  13. Population-based Surveillance for Bacterial Meningitis in China, September 2006–December 2009

    PubMed Central

    Li, Yixing; Yin, Zundong; Shao, Zhujun; Li, Manshi; Liang, Xiaofeng; Sandhu, Hardeep S.; Hadler, Stephen C.; Li, Junhong; Sun, Yinqi; Li, Jing; Zou, Wenjing; Lin, Mei; Zuo, Shuyan; Mayer, Leonard W.; Novak, Ryan T.; Zhu, Bingqing; Xu, Li

    2014-01-01

    During September 2006–December 2009, we conducted active population and sentinel laboratory–based surveillance for bacterial meningitis pathogens, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b, in 4 China prefectures. We identified 7,876 acute meningitis and encephalitis syndrome cases, including 6,388 among prefecture residents. A total of 833 resident cases from sentinel hospitals met the World Health Organization case definition for probable bacterial meningitis; 339 of these cases were among children <5 years of age. Laboratory testing confirmed bacterial meningitis in 74 of 3,391 tested cases. The estimated annual incidence (per 100,000 population) of probable bacterial meningitis ranged from 1.84 to 2.93 for the entire population and from 6.95 to 22.30 for children <5 years old. Active surveillance with laboratory confirmation has provided a population-based estimate of the number of probable bacterial meningitis cases in China, but more complete laboratory testing is needed to better define the epidemiology of the disease in this country. PMID:24377388

  14. A modern space simulation facility to accommodate high production acceptance testing

    NASA Technical Reports Server (NTRS)

    Glover, J. D.

    1986-01-01

    A space simulation laboratory that supports acceptance testing of spacecraft and associated subsystems at throughput rates as high as nine per year is discussed. The laboratory includes a computer operated 27' by 30' space simulation, a 20' by 20' by 20' thermal cycle chamber and an eight station thermal cycle/thermal vacuum test system. The design philosophy and unique features of each system are discussed. The development of operating procedures, test team requirements, test team integration, and other peripheral activation details are described. A discussion of special accommodations for the efficient utilization of the systems in support of high rate production is presented.

  15. LAPR: An experimental aircraft pushbroom scanner

    NASA Technical Reports Server (NTRS)

    Wharton, S. W.; Irons, J. I.; Heugel, F.

    1980-01-01

    A three band Linear Array Pushbroom Radiometer (LAPR) was built and flown on an experimental basis by NASA at the Goddard Space Flight Center. The functional characteristics of the instrument and the methods used to preprocess the data, including radiometric correction, are described. The radiometric sensitivity of the instrument was tested and compared to that of the Thematic Mapper and the Multispectral Scanner. The radiometric correction procedure was evaluated quantitatively, using laboratory testing, and qualitatively, via visual examination of the LAPR test flight imagery. Although effective radiometric correction could not yet be demonstrated via laboratory testing, radiometric distortion did not preclude the visual interpretation or parallel piped classification of the test imagery.

  16. Sensor Acquisition for Water Utilities: A Survey and Technology List

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

    Alai, M; Glascoe, L; Love, A

    2005-03-07

    The early detection of the deliberate biological and chemical contamination of water distribution systems is a necessary capability for securing the nation's water supply. Current and emerging early-detection technology capabilities and shortcomings need to be identified and assessed to provide government agencies and water utilities with an improved methodology for assessing the value of installing these technologies. The Department of Homeland Security (DHS) has tasked a multi-laboratory team to evaluate current and future needs to protect the nation's water distribution infrastructure by supporting an objective evaluation of current and new technologies. The primary deliverables from this Operational Technology Demonstration (OTD)more » are the following: (1) establishment of an advisory board for review and approval of testing protocols, technology acquisition processes and recommendations for technology test and evaluation in laboratory and field settings; (2) development of a technology acquisition process; (3) creation of laboratory and field testing and evaluation capability; and (4) testing of candidate technologies for insertion into a water early warning system. The initial phase of this study involves the development of two separate but complementary strategies to be reviewed by the advisory board: (1) a technology acquisition strategy, and (2) a technology evaluation strategy. Lawrence Livermore National Laboratory and Sandia National Laboratories are tasked with the first strategy, while Los Alamos, Pacific Northwest, and Oak Ridge National Laboratories are tasked with the second strategy. The first goal of the acquisition strategy is the development of a technology survey process that includes a review of previous sensor surveys and current test programs and then the development of a method to solicit and select existing and emerging sensor technologies for evaluation and testing. In this paper we discuss a survey of previous efforts by governmental agencies and private companies with the aim of facilitating a water sensor technology acquisition procedure. We provide a survey of previous sensor studies with regard to the use of Early Warning Systems (EWS) including earlier surveys, testing programs, and response studies. In the project we extend this earlier work by developing a list of important sensor specifications that are then used to help assemble a sensor selection criteria. A list of sensor technologies with their specifications is appended to this document. This list will assist the second goal of the project which is a recommendation of candidate technologies for laboratory and field testing.« less

  17. Alkali deposits found in biomass power plants: A preliminary investigation of their extent and nature. Volume 1

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

    Miles, T.R.; Miles, T.R. Jr.; Baxter, L.L.

    1995-04-15

    Alkali in the ash of annual crop biomass fuels creates serious fouling and slagging in conventional boilers. Even with the use of sorbents and other additives, power plants can only fire limited amounts of these fuels in combination with wood. The National Renewable Energy Laboratory (NREL), US Department of Energy, and the biomass power industry carried out eight full-scale firing tests and several laboratory experiments to study the nature and occurrence of deposits with the goal of increasing the quantities of these biofuels that can be used. This report describes the results of the laboratory and power plant tests thatmore » included: tracking and analyzing fuels and deposits by various methods; recording operating conditions; and extensive laboratory testing. The paper describes the occurrence of deposits, fuel and deposit analyses, boiler design and operation, fouling and slagging indicators, and recommendations. 37 refs., 41 figs., 17 tabs.« less

  18. Do we really need in-situ bioassays?

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

    Salazar, M.H.; Salazar, S.M.

    1995-12-31

    In-situ bioassays are needed to validate the results from laboratory testing and to understand biological interactions. Standard laboratory protocols provide reproducible test results, and the precision of those tests can be mathematically defined. Significant correlations between toxic substances and levels of response (bioaccumulation and bioeffects) have also been demonstrated with natural field populations and suggest that the laboratory results can accurately predict field responses. An equal number of studies have shown a lack of correlation between laboratory bioassay results and responses of natural field populations. The best way to validate laboratory results is with manipulative field testing; i.e., in-situ bioassaysmore » with caged organisms. Bioaccumulation in transplanted bivalves has probably been the most frequently used form of an in-situ bioassay. The authors have refined those methods to include synoptic measurements of bioaccumulation and growth. Growth provides an easily-measured bioeffects endpoint and a means of calibrating bioaccumulation. Emphasis has been on minimizing the size range of test animals, repetitive measurements of individuals and standardization of test protocols for a variety of applications. They are now attempting to standardize criteria for accepting and interpreting data in the same way that laboratory bioassays have been standardized. Others have developed methods for in-situ bioassays using eggs, larvae, unicellular organisms, crustaceans, benthic invertebrates, bivalves, and fish. In the final analysis, the in-situ approach could be considered as an exposure system where any clinical measurements are possible. The most powerful approach would be to use the same species in laboratory and field experiments with the same endpoints.« less

  19. UHPC for Blast and Ballistic Protection, Explosion Testing and Composition Optimization

    NASA Astrophysics Data System (ADS)

    Bibora, P.; Drdlová, M.; Prachař, V.; Sviták, O.

    2017-10-01

    The realization of high performance concrete resistant to detonation is the aim and expected outcome of the presented project, which is oriented to development of construction materials for larger objects as protective walls and bunkers. Use of high-strength concrete (HSC / HPC - “high strength / performance concrete”) and high-fiber reinforced concrete (UHPC / UHPFC -“Ultra High Performance Fiber Reinforced Concrete”) seems to be optimal for this purpose of research. The paper describes the research phase of the project, in which we focused on the selection of specific raw materials and chemical additives, including determining the most suitable type and amount of distributed fiber reinforcement. Composition of UHPC was optimized during laboratory manufacture of test specimens to obtain the best desired physical- mechanical properties of developed high performance concretes. In connection with laboratory testing, explosion field tests of UHPC specimens were performed and explosion resistance of laboratory produced UHPC testing boards was investigated.

  20. Solid Rocket Testing at AFRL (Briefing Charts)

    DTIC Science & Technology

    2016-10-21

    Force Research Laboratory (AFMC) AFRL /RQRO 8 Draco Drive Edwards AFB, CA 93524-7135 Air Force Research Laboratory (AFMC) AFRL /RQR 5 Pollux Drive...19b. TELEPHONE NUMBER (Include area code) 10/21/2016 Briefing Charts 01 October 2016 - 31 October 2016 Solid Rocket Testing at AFRL Robert Antypas Air ...Space Dominance MOJAVE BORONHWY 58 LANCASTER H IG H W A Y 14 RESERVATION BOUNDARY 0 5 10SCALE IN MILES HWY 395 EDWARDS

  1. Fiber-linked telescope array: description and laboratory tests of a two-channel prototype

    NASA Astrophysics Data System (ADS)

    Alleman, J. J.; Reynaud, F.; Connes, P.

    1995-05-01

    We present a complete two-telescope version of a fiber-linked coherent array that is meant to be used for mounting on the dish of a radio telescope. This was built with 20-cm amateur telescopes and includes three different servo subsystems for guiding, nulling of the air path difference, and fiber length control. Laboratory tests of the fully integrated system in front of a star simulator are described.

  2. AQUIRE: Aquatic Toxicity Information Retrieval data base. Data file

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

    Anderson, E.; Pilli, A.

    The purpose of Aquatic Toxicity Information Retrieval (AQUIRE) data base is to provide scientists and managers quick access to a comprehensive, systematic, computerized compilation of aquatic toxicity data. Scientific papers published both nationally and internationally on the toxicity of chemicals to aquatic organisms and plants are collected and reviewed for AQUIRE. Independently compiled data files that meet AQUIRE parameter and quality assurance criteria are also included. Selected toxicity-test results and related testing information for any individual chemical from laboratory and field aquatic toxicity tests are extracted and added to AQUIRE. Acute, sublethal, and bioconcentration effects are included for tests withmore » freshwater and marine organisms. The total number of data records in AQUIRE now equals 104,500. This includes data from 6000 references, for 5200 chemicals and 2400 test species. A major data file, Acute Toxicity of Organic Chemicals (ATOC), has been incorporated into AQUIRE. The ATOC file contains laboratory acute test data on 525 organic chemicals using juvenile fathead minnows. The complete data file can be accessed by requesting review code 5 as a search parameter.« less

  3. The WHO/PEPFAR collaboration to prepare an operations manual for HIV prevention, care, and treatment at primary health centers in high-prevalence, resource-constrained settings: defining laboratory services.

    PubMed

    Spira, Thomas; Lindegren, Mary Lou; Ferris, Robert; Habiyambere, Vincent; Ellerbrock, Tedd

    2009-06-01

    The expansion of HIV/AIDS care and treatment in resource-constrained countries, especially in sub-Saharan Africa, has generally developed in a top-down manner. Further expansion will involve primary health centers where human and other resources are limited. This article describes the World Health Organization/President's Emergency Plan for AIDS Relief collaboration formed to help scale up HIV services in primary health centers in high-prevalence, resource-constrained settings. It reviews the contents of the Operations Manual developed, with emphasis on the Laboratory Services chapter, which discusses essential laboratory services, both at the center and the district hospital level, laboratory safety, laboratory testing, specimen transport, how to set up a laboratory, human resources, equipment maintenance, training materials, and references. The chapter provides specific information on essential tests and generic job aids for them. It also includes annexes containing a list of laboratory supplies for the health center and sample forms.

  4. A study of facilities and fixtures for testing of a high speed civil transport wing component

    NASA Technical Reports Server (NTRS)

    Cerro, J. A.; Vause, R. F.; Bowman, L. M.; Jensen, J. K.; Martin, C. J., Jr.; Stockwell, A. E.; Waters, W. A., Jr.

    1996-01-01

    A study was performed to determine the feasibility of testing a large-scale High Speed Civil Transport wing component in the Structures and Materials Testing Laboratory in Building 1148 at NASA Langley Research Center. The report includes a survey of the electrical and hydraulic resources and identifies the backing structure and floor hard points which would be available for reacting the test loads. The backing structure analysis uses a new finite element model of the floor and backstop support system in the Structures Laboratory. Information on the data acquisition system and the thermal power requirements is also presented. The study identified the hardware that would be required to test a typical component, including the number and arrangement of hydraulic actuators required to simulate expected flight loads. Load introduction and reaction structure concepts were analyzed to investigate the effects of experimentally induced boundary conditions.

  5. A summary of laboratory testing performed to characterize and select an elastomeric O-ring material to be used in the redesigned solid rocket motors of the space transportation system

    NASA Technical Reports Server (NTRS)

    Turner, J. E.

    1993-01-01

    An elastomeric O-ring material is used in the joints of the redesigned solid motors (RSRM's) of the National Space Transportation System (NSTS). The selection of the O-ring material used in the RSRM's was a very thorough process that included efforts by NASA's Marshall Space Flight Center and the Langley Research Center, and the Thiokol Corporation. One of the efforts performed at MSFC was an extensive in-house laboratory test regime to screen potential O-ring materials and ultimately to characterize the elastomeric material that was chosen to be used in the RSRM's. The laboratory tests performed at MSFC are summarized.

  6. Accelerated testing for studying pavement design and performance (FY 2002) : research summary.

    DOT National Transportation Integrated Search

    2004-01-01

    This report covers the Fiscal Year 2002 project conducted at the Accelerated Testing : Laboratory at Kansas State University. The project was selected and funded by the : Midwest States Accelerated Testing Pooled Fund Program, which includes Iowa, Ka...

  7. Use of Lean Response to Improve Pandemic Influenza Surge in Public Health Laboratories

    PubMed Central

    Chang, Yin; Prystajecky, Natalie; Petric, Martin; Mak, Annie; Abbott, Brendan; Paris, Benjamin; Decker, K.C.; Pittenger, Lauren; Guercio, Steven; Stott, Jeff; Miller, Joseph D.

    2012-01-01

    A novel influenza A (H1N1) virus detected in April 2009 rapidly spread around the world. North American provincial and state laboratories have well-defined roles and responsibilities, including providing accurate, timely test results for patients and information for regional public health and other decision makers. We used the multidisciplinary response and rapid implementation of process changes based on Lean methods at the provincial public health laboratory in British Columbia, Canada, to improve laboratory surge capacity in the 2009 influenza pandemic. Observed and computer simulating evaluation results from rapid processes changes showed that use of Lean tools successfully expanded surge capacity, which enabled response to the 10-fold increase in testing demands. PMID:22257385

  8. Laboratory Automation and Intra-Laboratory Turnaround Time: Experience at the University Hospital Campus Bio-Medico of Rome.

    PubMed

    Angeletti, Silvia; De Cesaris, Marina; Hart, Jonathan George; Urbano, Michele; Vitali, Massimiliano Andrea; Fragliasso, Fulvio; Dicuonzo, Giordano

    2015-12-01

    Intra-laboratory turnaround time (TAT) is a key indicator of laboratory performance. Improving TAT is a complex task requiring staff education, equipment acquisition, and adequate TAT monitoring. The aim of the present study was to evaluate the intra-laboratory TAT after laboratory automation implementation (June 2013-June 2014) and to compare it to that in the preautomation period (July 2012-May 2013). Intra-laboratory TAT was evaluated both as the mean TAT registered and the percentage of outlier (OP) exams. The mean TAT was 36, 38, and 34 min during the study periods, respectively. These values respected the goal TAT established at 45 min. The OP, calculated at 45 min as well as at 60 min, decreased from 26 to 21 and from 11 to 5, respectively. From a focused analysis on blood count cell, troponin I, and prothrombin (PT) test, TAT improvement was more evident for tests requiring longer preanalytical process. The follow-up of TAT from June 2013 to June 2014 revealed the reduction of the mean TAT as well as of the OP exams after automation implementation and that automation more strongly affects the test in the preanalytical phase including centrifugation of the sample, such as troponin I and PT. © 2015 Society for Laboratory Automation and Screening.

  9. Are laboratory tests always needed? Frequency and causes of laboratory overuse in a hospital setting.

    PubMed

    Cadamuro, Janne; Gaksch, Martin; Wiedemann, Helmut; Lippi, Giuseppe; von Meyer, Alexander; Pertersmann, Astrid; Auer, Simon; Mrazek, Cornelia; Kipman, Ulrike; Felder, Thomas K; Oberkofler, Hannes; Haschke-Becher, Elisabeth

    2018-04-01

    Inappropriate utilization of laboratory resources is an increasing concern especially in high-throughput facilities. Until now, no reliable information has been published addressing to which extent laboratory results are actually used for clinical decision-making. Therefore, we aimed to close this gap using a novel retrospective approach including a survey of clinicians and nurses. We retrospectively evaluated the number of re-orders for potassium (K), lactate dehydrogenase (LD), aspartate-aminotransferase (AST), activated partial thromboplastin-time (APTT) and prothrombin-time/INR (PT/INR), after the initial order had to be cancelled due to preanalytical non-conformities. We analyzed subgroups regarding time to re-order, ward and sample priority (urgent vs. routine). Subsequently, we surveyed clinicians and nurses, asking for their estimate of the amount of failed re-orders as well as for possible reasons. From initially cancelled tests, only ~20% of K, LD, AST and ~30% of APTT and PT/INR tests were re-ordered within 24 h. 70% of the investigated clinical chemistry and 60% of coagulation tests were re-ordered one week after cancellation or not at all. Survey participants quite accurately estimated these numbers. Routine laboratory panels, short stay of out-patients, obsolete test results and avoiding additional phlebotomies were the main reasons for not re-ordering cancelled tests. Overall, 60-70% of test results in the investigated assays ordered in a high throughput laboratory are potentially inappropriate or of doubtful clinically importance. Although clinicians and nurses are aware of this situation, it is the duty of laboratory specialists to overcome overutilization in close collaboration with all involved healthcare workers. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  10. Multifaceted intervention including education, rounding checklist implementation, cost feedback, and financial incentives reduces inpatient laboratory costs.

    PubMed

    Yarbrough, Peter M; Kukhareva, Polina V; Horton, Devin; Edholm, Karli; Kawamoto, Kensaku

    2016-05-01

    Inappropriate laboratory testing is a contributor to waste in healthcare. To evaluate the impact of a multifaceted laboratory reduction intervention on laboratory costs. A retrospective, controlled, interrupted time series (ITS) study. University of Utah Health Care, a 500-bed academic medical center in Salt Lake City, Utah. All patients 18 years or older admitted to the hospital to a service other than obstetrics, rehabilitation, or psychiatry. Multifaceted quality-improvement initiative in a hospitalist service including education, process change, cost feedback, and financial incentive. Primary outcomes of lab cost per day and per visit. Secondary outcomes of number of basic metabolic panel (BMP), comprehensive metabolic panel (CMP), complete blood count (CBC), and prothrombin time/international normalized ratio tests per day; length of stay (LOS); and 30-day readmissions. A total of 6310 hospitalist patient visits (intervention group) were compared to 25,586 nonhospitalist visits (control group). Among the intervention group, the unadjusted mean cost per day was reduced from $138 before the intervention to $123 after the intervention (P < 0.001), and the unadjusted mean cost per visit decreased from $618 to $558 (P = 0.005). The ITS analysis showed significant reductions in cost per day, cost per visit, and the number of BMP, CMP, and CBC tests per day (P = 0.034, 0.02, <0.001, 0.004, and <0.001). LOS was unchanged and 30-day readmissions decreased in the intervention group. A multifaceted approach to laboratory reduction demonstrated a significant reduction in laboratory cost per day and per visit, as well as common tests per day at a major academic medical center. Journal of Hospital Medicine 2016;11:348-354. © 2016 Society of Hospital Medicine. © 2016 Society of Hospital Medicine.

  11. Rapid access to information resources in clinical biochemistry: medical applications of Personal Digital Assistants (PDA).

    PubMed

    Serdar, Muhittin A; Turan, Mustafa; Cihan, Murat

    2008-06-01

    Laboratory specialists currently need to access scientific-based information at anytime and anywhere. A considerable period of time and too much effort are required to access this information through existing accumulated data. Personal digital assistants (PDA) are supposed to provide an effective solution with commercial software for this problem. In this study, 11 commercial software products (UpToDate, ePocrates, Inforetrive, Pepid, eMedicine, FIRST Consult, and 5 laboratory e-books released by Skyscape and/or Isilo) were selected and the benefits of their use were evaluated by seven laboratory specialists. The assessment of the software was performed based on the number of the tests included, the software content of detailed information for each test-like process, method, interpretation of results, reference ranges, critical values, interferences, equations, pathophysiology, supplementary technical details such as sample collection principles, and additional information such as linked references, evidence-based data, test cost, etc. In terms of technique, the following items are considered: the amount of memory required to run the software, the graphical user interface, which is a user-friendly instrument, and the frequency of new and/or up-date releases. There is still no perfect program, as we have anticipated. Interpretation of laboratory results may require software with an integrated program. However, methodological data are mostly not included in the software evaluated. It seems that these shortcomings will be fixed in the near future, and PDAs and relevant medical applications will also become indispensable for all physicians including laboratory specialists in the field of training/education and in patient care.

  12. Forest Herbicide Washoff From Foliar Applications

    Treesearch

    J.L. Michael; Kevin L. Talley; H.C. Fishburn

    1992-01-01

    Field and laboratory experiments were conducted to develop and test methods for determining washoff of foliar applied herbicides typically used in forestry in the South.Preliminary results show good agreement between results of laboratory methods used and observations from field experiments on actual precipitation events. Methods included application of...

  13. Earth Control and Investigations: Training Course 1974.

    ERIC Educational Resources Information Center

    Department of the Interior, Denver, CO. Engineering and Research Center.

    This document contains the outlines of each of 34 lectures given in the Earth Control and Investigations course sponsored by the Denver Laboratories. Topics covered include construction control of earth dams, canals, and filters; field and laboratory test procedures; soil classification and logging; and field investigations. (DT)

  14. Severe congenital toxoplasmosis in the United States: clinical and serologic findings in untreated infants.

    PubMed

    Olariu, Tudor Rares; Remington, Jack S; McLeod, Rima; Alam, Ambereen; Montoya, Jose G

    2011-12-01

    Congenital toxoplasmosis can cause significant neurologic manifestations and other untoward sequelae. The Palo Alto Medical Foundation Toxoplasma Serology Laboratory database was searched for data on infants 0 to 180 days old, in whom congenital toxoplasmosis had been confirmed and who had been tested for Toxoplasma gondii-specific immunoglobulin G (IgG), IgM, and IgA antibodies, between 1991 and 2005. Their clinical findings were confirmed at the National Collaborative Chicago-based Congenital Toxoplasmosis Study center. We reviewed available clinical data and laboratory profiles of 164 infants with congenital toxoplasmosis whose mothers had not been treated for the parasite during gestation. One or more severe clinical manifestations of congenital toxoplasmosis were reported in 84% of the infants and included eye disease (92.2%), brain calcifications (79.6%), and hydrocephalus (67.7%). In 61.6% of the infants, eye disease, brain calcifications, and hydrocephalus were present concurrently. T. gondii-specific IgM, IgA, and IgE antibodies were demonstrable in 86.6%, 77.4%, and 40.2% of the infants, respectively. Testing for IgM and IgA antibodies increased the sensitivity of making the diagnosis of congenital toxoplasmosis to 93% compared with testing for IgM or IgA individually. IgM and IgA antibodies were still present in 43.9% of infants diagnosed between 1 and 6 months of life. Our study reveals that severe clinical signs of congenital toxoplasmosis including hydrocephalus, eye disease, or intracranial calcifications occurred in 85% infants whose sera were referred to our reference Toxoplasma Serology Laboratory during a period of 15 years. Laboratory tests, including serologic and polymerase chain reaction tests, were critical for diagnosis in the infants. Our results contrast remarkably with those of European investigators who rarely observe severe clinical signs in infants with congenital toxoplasmosis.

  15. Selecting clinical quality indicators for laboratory medicine.

    PubMed

    Barth, Julian H

    2012-05-01

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

  16. Laboratory or field tests for evaluating firefighters' work capacity?

    PubMed

    Lindberg, Ann-Sofie; Oksa, Juha; Malm, Christer

    2014-01-01

    Muscle strength is important for firefighters work capacity. Laboratory tests used for measurements of muscle strength, however, are complicated, expensive and time consuming. The aims of the present study were to investigate correlations between physical capacity within commonly occurring and physically demanding firefighting work tasks and both laboratory and field tests in full time (N = 8) and part-time (N = 10) male firefighters and civilian men (N = 8) and women (N = 12), and also to give recommendations as to which field tests might be useful for evaluating firefighters' physical work capacity. Laboratory tests of isokinetic maximal (IM) and endurance (IE) muscle power and dynamic balance, field tests including maximal and endurance muscle performance, and simulated firefighting work tasks were performed. Correlations with work capacity were analyzed with Spearman's rank correlation coefficient (rs). The highest significant (p<0.01) correlations with laboratory and field tests were for Cutting: IE trunk extension (rs = 0.72) and maximal hand grip strength (rs = 0.67), for Stairs: IE shoulder flexion (rs = -0.81) and barbell shoulder press (rs = -0.77), for Pulling: IE shoulder extension (rs = -0.82) and bench press (rs = -0.85), for Demolition: IE knee extension (rs = 0.75) and bench press (rs = 0.83), for Rescue: IE shoulder flexion (rs = -0.83) and bench press (rs = -0.82), and for the Terrain work task: IE trunk flexion (rs = -0.58) and upright barbell row (rs = -0.70). In conclusion, field tests may be used instead of laboratory tests. Maximal hand grip strength, bench press, chin ups, dips, upright barbell row, standing broad jump, and barbell shoulder press were strongly correlated (rs≥0.7) with work capacity and are therefore recommended for evaluating firefighters work capacity.

  17. Diagnostic trends in Clostridium difficile detection in Finnish microbiology laboratories.

    PubMed

    Könönen, Eija; Rasinperä, Marja; Virolainen, Anni; Mentula, Silja; Lyytikäinen, Outi

    2009-12-01

    Due to increased interest directed to Clostridium difficile-associated infections, a questionnaire survey of laboratory diagnostics of toxin-producing C. difficile was conducted in Finland in June 2006. Different aspects pertaining to C. difficile diagnosis, such as requests and criteria used for testing, methods used for its detection, yearly changes in diagnostics since 1996, and the total number of investigations positive for C. difficile in 2005, were asked in the questionnaire, which was sent to 32 clinical microbiology laboratories, including all hospital-affiliated and the relevant private clinical microbiology laboratories in Finland. The situation was updated by phone and email correspondence in September 2008. In June 2006, 28 (88%) laboratories responded to the questionnaire survey; 24 of them reported routinely testing requested stool specimens for C. difficile. Main laboratory methods included toxin detection (21/24; 88%) and/or anaerobic culture (19/24; 79%). In June 2006, 18 (86%) of the 21 laboratories detecting toxins directly from feces, from the isolate, or both used methods for both toxin A (TcdA) and B (TcdB), whereas only one laboratory did so in 1996. By September 2008, all of the 23 laboratories performing diagnostics for C. difficile used methods for both TcdA and TcdB. In 2006, the number of specimens processed per 100,000 population varied remarkably between different hospital districts. In conclusion, culturing C. difficile is common and there has been a favorable shift in toxin detection practice in Finnish clinical microbiology laboratories. However, the variability in diagnostic activity reported in 2006 creates a challenge for national monitoring of the epidemiology of C. difficile and related diseases.

  18. KENNEDY SPACE CENTER, FLA. - Dr. Paul Hintze (left) explains to Center Director Jim Kennedy a project he is working at the KSC Beach Corrosion Test Site. Hitze is doing post-graduate work for the National Research Council. The test facility site was established in the 1960s and has provided more than 30 years of historical information on the long-term performance of many materials in use at KSC and other locations around the world. Located 100 feet from the Atlantic Ocean approximately 1 mile south of the Space Shuttle launch sites, the test facility includes an atmospheric exposure site, a flowing seawater exposure site, and an on-site electrochemistry laboratory and monitoring station. The beach laboratory is used to conduct real-time corrosion experiments and provides for the remote monitoring of surrounding weather conditions. The newly added flowing seawater immersion facility provides for the immersion testing of materials and devices under controlled conditions.

    NASA Image and Video Library

    2003-08-21

    KENNEDY SPACE CENTER, FLA. - Dr. Paul Hintze (left) explains to Center Director Jim Kennedy a project he is working at the KSC Beach Corrosion Test Site. Hitze is doing post-graduate work for the National Research Council. The test facility site was established in the 1960s and has provided more than 30 years of historical information on the long-term performance of many materials in use at KSC and other locations around the world. Located 100 feet from the Atlantic Ocean approximately 1 mile south of the Space Shuttle launch sites, the test facility includes an atmospheric exposure site, a flowing seawater exposure site, and an on-site electrochemistry laboratory and monitoring station. The beach laboratory is used to conduct real-time corrosion experiments and provides for the remote monitoring of surrounding weather conditions. The newly added flowing seawater immersion facility provides for the immersion testing of materials and devices under controlled conditions.

  19. Electronic Systems Test Laboratory (ESTL) User Test Planning Guide

    NASA Technical Reports Server (NTRS)

    Robinson, Neil

    2011-01-01

    Test process, milestones and inputs are unknowns to first-time users of the ESTL. The User Test Planning Guide aids in establishing expectations for both NASA and non-NASA facility customers. The potential audience for this guide includes both internal and commercial spaceflight hardware/software developers. It is intended to assist their test engineering personnel in test planning and execution. Material covered includes a roadmap of the test process, roles and responsibilities of facility and user, major milestones, facility capabilities, and inputs required by the facility. Samples of deliverables, test article interfaces, and inputs necessary to define test scope, cost, and schedule are included as an appendix to the guide.

  20. Structures Test Laboratory (STL). User Test Planning Guide

    NASA Technical Reports Server (NTRS)

    Zipay, John J.

    2011-01-01

    Test process, milestones and inputs are unknowns to first-time users of the STL. The User Test Planning Guide aids in establishing expectations for both NASA and non-NASA facility customers. The potential audience for this guide includes both internal and commercial spaceflight hardware/software developers. It is intended to assist their test engineering personnel in test planning and execution. Material covered includes a roadmap of the test process, roles and responsibilities of facility and user, major milestones, facility capabilities, and inputs required by the facility. Samples of deliverables, test article interfaces, and inputs necessary to define test scope, cost, and schedule are included as an appendix to the guide.

  1. Anti-doping analyses at the Sochi Olympic and Paralympic Games 2014.

    PubMed

    Sobolevsky, Tim; Krotov, Grigory; Dikunets, Marina; Nikitina, Maria; Mochalova, Elena; Rodchenkov, Grigory

    2014-01-01

    The laboratory anti-doping services during XXII Winter Olympic and XI Paralympic games in Sochi in 2014 were provided by a satellite laboratory facility located within the strictly secured Olympic Park. This laboratory, established and operated by the personnel of Antidoping Center, Moscow, has been authorized by the World Anti-Doping Agency (WADA) to conduct doping control analyses. The 4-floor building accommodated the most advanced analytical instrumentation and became a place of attraction for more than 50 Russian specialists and 25 foreign experts, including independent observers. In total, 2134 urine and 479 blood samples were delivered to the laboratory and analyzed during the Olympic Games (OG), and 403 urine and 108 blood samples - during the Paralympic Games (PG). The number of erythropoietin tests requested in urine was 946 and 166 at the OG and PG, respectively. Though included in the test distribution plan, a growth hormone analysis was cancelled by the Organizing Committee just before the Games. Several adverse analytical findings have been reported including pseudoephedrine (1 case), methylhexaneamine (4 cases), trimetazidine (1 case), dehydrochloromethyltestosterone (1 case), clostebol (1 case), and a designer stimulant N-ethyl-1-phenylbutan-2-amine (1 case). Copyright © 2014 John Wiley & Sons, Ltd.

  2. 42 CFR 493.863 - Standard; Compatibility testing.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Compatibility testing. 493.863 Section 493.863 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... for Laboratories Performing Tests of Moderate Complexity (including the Subcategory), High Complexity...

  3. 42 CFR 493.863 - Standard; Compatibility testing.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; Compatibility testing. 493.863 Section 493.863 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... for Laboratories Performing Tests of Moderate Complexity (including the Subcategory), High Complexity...

  4. Materials and Nondestructive Evaluation Laboratoriers: User Test Planning Guide

    NASA Technical Reports Server (NTRS)

    Schaschl, Leslie

    2011-01-01

    The Materials and Nondestructive Evaluation Laboratory process, milestones and inputs are unknowns to first-time users. The Materials and Nondestructive Evaluation Laboratory Planning Guide aids in establishing expectations for both NASA and non- NASA facility customers. The potential audience for this guide includes both internal and commercial spaceflight hardware developers. It is intended to assist their project engineering personnel in materials analysis planning and execution. Material covered includes a roadmap of the analysis process, roles and responsibilities of facility and user, major milestones, facility capabilities, and inputs required by the facility. Samples of deliverables, products, and inputs necessary to define scope of analysis, cost, and schedule are included as an appendix to the guide.

  5. Utilization of Genetic Testing Prior to Subspecialist Referral for Cerebellar Ataxia

    PubMed Central

    Fogel, Brent L.; Vickrey, Barbara G.; Walton-Wetzel, Jenny; Lieber, Eli

    2013-01-01

    Objective: To evaluate the utilization of laboratory testing in the diagnosis of cerebellar ataxia, including the completeness of initial standard testing for acquired causes, the early use of genetic testing, and associated clinical and nonclinical factors, among a cohort referred for subspecialty consultation. Methods: Data were abstracted from records of 95 consecutive ataxia patients referred to one neurogenetics subspecialist from 2006–2010 and linked to publicly available data on characteristics of referral clinicians. Multivariable logistic and linear regression models were used to analyze unique associations of clinical and nonclinical factors with laboratory investigation of acquired causes and with early genetic testing prior to referral. Results: At referral, 27 of 95 patients lacked evidence of any of 14 laboratory studies suggested for initial work-up of an acquired cause for ataxia (average number of tests=4.5). In contrast, 92% of patients had undergone brain magnetic resonance imaging prior to referral. Overall, 41.1% (n=39) had genetic testing prior to referral; there was no association between family history of ataxia and obtaining genetic testing prior to referral (p=0.39). The level of early genetic testing was 31.6%, primarily due to genetic testing despite an incomplete laboratory evaluation for acquired causes and no family history. A positive family history was consistently associated with less extensive laboratory testing (p=0.004), and referral by a neurologist was associated with higher levels of early genetic testing. Conclusions: Among consecutive referrals to a single center, a substantial proportion of sporadic cases had genetic testing without evidence of a work-up for acquired causes. Better strategies to guide decision making and subspecialty referrals in rare neurologic disorders are needed, given the cost and consequences of genetic testing. PMID:23725007

  6. Integrated Optoelectronics for Parallel Microbioanalysis

    NASA Technical Reports Server (NTRS)

    Stirbl, Robert; Moynihan, Philip; Bearman, Gregory; Lane, Arthur

    2003-01-01

    Miniature, relatively inexpensive microbioanalytical systems ("laboratory-on-achip" devices) have been proposed for the detection of hazardous microbes and toxic chemicals. Each system of this type would include optoelectronic sensors and sensor-output-processing circuitry that would simultaneously look for the optical change, fluorescence, delayed fluorescence, or phosphorescence signatures from multiple redundant sites that have interacted with the test biomolecules in order to detect which one(s) was present in a given situation. These systems could be used in a variety of settings that could include doctors offices, hospitals, hazardous-material laboratories, biological-research laboratories, military operations, and chemical-processing plants.

  7. 78 FR 20695 - Walk-Through Metal Detectors and Hand-Held Metal Detectors Test Method Validation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ... Detectors and Hand-Held Metal Detectors Test Method Validation AGENCY: National Institute of Justice, DOJ... ensure that the test methods in the standards are properly documented, NIJ is requesting proposals (including price quotes) for test method validation efforts from testing laboratories. NIJ is also seeking...

  8. 45 CFR 304.20 - Availability and rate of Federal financial participation.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... development of evidence including the use of the polygraph and genetic tests; (C) Pre-trial discovery; (ii... regulations having the effect of law; (iii) Identifying competent laboratories that perform genetic tests as... transporting blood and other samples of genetic material, repeated testing when necessary, analysis of test...

  9. 45 CFR 304.20 - Availability and rate of Federal financial participation.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... development of evidence including the use of the polygraph and genetic tests; (C) Pre-trial discovery; (ii... regulations having the effect of law; (iii) Identifying competent laboratories that perform genetic tests as... transporting blood and other samples of genetic material, repeated testing when necessary, analysis of test...

  10. 45 CFR 304.20 - Availability and rate of Federal financial participation.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... development of evidence including the use of the polygraph and genetic tests; (C) Pre-trial discovery; (ii... regulations having the effect of law; (iii) Identifying competent laboratories that perform genetic tests as... transporting blood and other samples of genetic material, repeated testing when necessary, analysis of test...

  11. 40 CFR 60.533 - Compliance and certification.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., including the complete test report and, for all test runs: Raw data sheets, laboratory technician notes... each test run in a certification test series, two photographs of the fuel load: One before and one... of blower motors and the fan blade size. (3) Any change in the materials used for the following...

  12. 40 CFR 60.533 - Compliance and certification.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., including the complete test report and, for all test runs: Raw data sheets, laboratory technician notes... each test run in a certification test series, two photographs of the fuel load: One before and one... of blower motors and the fan blade size. (3) Any change in the materials used for the following...

  13. 40 CFR 60.533 - Compliance and certification.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., including the complete test report and, for all test runs: Raw data sheets, laboratory technician notes... each test run in a certification test series, two photographs of the fuel load: One before and one... of blower motors and the fan blade size. (3) Any change in the materials used for the following...

  14. 40 CFR 60.533 - Compliance and certification.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., including the complete test report and, for all test runs: Raw data sheets, laboratory technician notes... each test run in a certification test series, two photographs of the fuel load: One before and one... of blower motors and the fan blade size. (3) Any change in the materials used for the following...

  15. 40 CFR 60.533 - Compliance and certification.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., including the complete test report and, for all test runs: Raw data sheets, laboratory technician notes... each test run in a certification test series, two photographs of the fuel load: One before and one... of blower motors and the fan blade size. (3) Any change in the materials used for the following...

  16. Hanford High-Level Waste Vitrification Program at the Pacific Northwest National Laboratory: technology development - annotated bibliography

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

    Larson, D.E.

    1996-09-01

    This report provides a collection of annotated bibliographies for documents prepared under the Hanford High-Level Waste Vitrification (Plant) Program. The bibliographies are for documents from Fiscal Year 1983 through Fiscal Year 1995, and include work conducted at or under the direction of the Pacific Northwest National Laboratory. The bibliographies included focus on the technology developed over the specified time period for vitrifying Hanford pretreated high-level waste. The following subject areas are included: General Documentation; Program Documentation; High-Level Waste Characterization; Glass Formulation and Characterization; Feed Preparation; Radioactive Feed Preparation and Glass Properties Testing; Full-Scale Feed Preparation Testing; Equipment Materials Testing; Meltermore » Performance Assessment and Evaluations; Liquid-Fed Ceramic Melter; Cold Crucible Melter; Stirred Melter; High-Temperature Melter; Melter Off-Gas Treatment; Vitrification Waste Treatment; Process, Product Control and Modeling; Analytical; and Canister Closure, Decontamination, and Handling« less

  17. Seeking excellence: An evaluation of 235 international laboratories conducting water isotope analyses by isotope-ratio and laser-absorption spectrometry.

    PubMed

    Wassenaar, L I; Terzer-Wassmuth, S; Douence, C; Araguas-Araguas, L; Aggarwal, P K; Coplen, T B

    2018-03-15

    Water stable isotope ratios (δ 2 H and δ 18 O values) are widely used tracers in environmental studies; hence, accurate and precise assays are required for providing sound scientific information. We tested the analytical performance of 235 international laboratories conducting water isotope analyses using dual-inlet and continuous-flow isotope ratio mass spectrometers and laser spectrometers through a water isotope inter-comparison test. Eight test water samples were distributed by the IAEA to international stable isotope laboratories. These consisted of a core set of five samples spanning the common δ-range of natural waters, and three optional samples (highly depleted, enriched, and saline). The fifth core sample contained unrevealed trace methanol to assess analyst vigilance to the impact of organic contamination on water isotopic measurements made by all instrument technologies. For the core and optional samples ~73 % of laboratories gave acceptable results within 0.2 ‰ and 1.5 ‰ of the reference values for δ 18 O and δ 2 H, respectively; ~27 % produced unacceptable results. Top performance for δ 18 O values was dominated by dual-inlet IRMS laboratories; top performance for δ 2 H values was led by laser spectrometer laboratories. Continuous-flow instruments yielded comparatively intermediate results. Trace methanol contamination of water resulted in extreme outlier δ-values for laser instruments, but also affected reactor-based continuous-flow IRMS systems; however, dual-inlet IRMS δ-values were unaffected. Analysis of the laboratory results and their metadata suggested inaccurate or imprecise performance stemmed mainly from skill- and knowledge-based errors including: calculation mistakes, inappropriate or compromised laboratory calibration standards, poorly performing instrumentation, lack of vigilance to contamination, or inattention to unreasonable isotopic outcomes. To counteract common errors, we recommend that laboratories include 1-2 'known' control standards in all autoruns; laser laboratories should screen each autorun for spectral contamination; and all laboratories should evaluate whether derived d-excess values are realistic when both isotope ratios are measured. Combined, these data evaluation strategies should immediately inform the laboratory about fundamental mistakes or compromised samples. Copyright © 2018 John Wiley & Sons, Ltd.

  18. Seeking excellence: An evaluation of 235 international laboratories conducting water isotope analyses by isotope-ratio and laser-absorption spectrometry

    USGS Publications Warehouse

    Wassenaar, L. I.; Terzer-Wassmuth, S.; Douence, C.; Araguas-Araguas, L.; Aggarwal, P. K.; Coplen, Tyler B.

    2018-01-01

    RationaleWater stable isotope ratios (δ2H and δ18O values) are widely used tracers in environmental studies; hence, accurate and precise assays are required for providing sound scientific information. We tested the analytical performance of 235 international laboratories conducting water isotope analyses using dual-inlet and continuous-flow isotope ratio mass spectrometers and laser spectrometers through a water isotope inter-comparison test.MethodsEight test water samples were distributed by the IAEA to international stable isotope laboratories. These consisted of a core set of five samples spanning the common δ-range of natural waters, and three optional samples (highly depleted, enriched, and saline). The fifth core sample contained unrevealed trace methanol to assess analyst vigilance to the impact of organic contamination on water isotopic measurements made by all instrument technologies.ResultsFor the core and optional samples ~73 % of laboratories gave acceptable results within 0.2 ‰ and 1.5 ‰ of the reference values for δ18O and δ2H, respectively; ~27 % produced unacceptable results. Top performance for δ18O values was dominated by dual-inlet IRMS laboratories; top performance for δ2H values was led by laser spectrometer laboratories. Continuous-flow instruments yielded comparatively intermediate results. Trace methanol contamination of water resulted in extreme outlier δ-values for laser instruments, but also affected reactor-based continuous-flow IRMS systems; however, dual-inlet IRMS δ-values were unaffected.ConclusionsAnalysis of the laboratory results and their metadata suggested inaccurate or imprecise performance stemmed mainly from skill- and knowledge-based errors including: calculation mistakes, inappropriate or compromised laboratory calibration standards, poorly performing instrumentation, lack of vigilance to contamination, or inattention to unreasonable isotopic outcomes. To counteract common errors, we recommend that laboratories include 1–2 'known' control standards in all autoruns; laser laboratories should screen each autorun for spectral contamination; and all laboratories should evaluate whether derived d-excess values are realistic when both isotope ratios are measured. Combined, these data evaluation strategies should immediately inform the laboratory about fundamental mistakes or compromised samples.

  19. Locomotion with loads: practical techniques for predicting performance outcomes

    DTIC Science & Technology

    including load), speed, and grade algorithms proposed will allow walking metabolic rates to be predicted to within 6.0 and 12.0 in laboratory and field...speeds to be predicted to within6.0 in both laboratory and field settings. Respective load-carriage algorithms for walking energy expenditure and...running speed will be developed and tested( Technical Objectives 1.0 and 2.0) in the laboratory and the field.

  20. HOMOLOGOUS MEASURES OF COGNITIVE FUNCTION IN HUMAN INFANTS AND LABORATORY ANIMALS TO IDENTIFY ENVIRONMENTAL HEALTH RISKS TO CHILDREN

    EPA Science Inventory

    The importance of including neurodevelopmental endpoints in environmental studies is clear. A validated measure of cognitive fucntion in human infants that also has a parallel test in laboratory animal studies will provide a valuable approach for largescale studies. Such a ho...

  1. EFFECTS OF SEDIMENT TYPE ON BENTHIC MACROINFAUNAL COLONIZATION OF LABORATORY MICROCOSMS

    EPA Science Inventory

    We tested the effects of four different sediment types on macroinfaunal colonization and community development in our laboratory flow-thru microcosm system (all microcosms were 20 cm side-1 and sediment depth was 5 cm) over a period of 41 days. Sediments included Santa Rosa Islan...

  2. NWTC Helps Guide U.S. Offshore R&D; NREL (National Renewable Energy Laboratory)

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

    None

    2015-07-01

    The National Wind Technology Center (NWTC) at the National Renewable Energy Laboratory (NREL) is helping guide our nation's research-and-development effort in offshore renewable energy, which includes: Design, modeling, and analysis tools; Device and component testing; Resource characterization; Economic modeling and analysis; Grid integration.

  3. 76 FR 38342 - Medicare Program; Clinical Laboratory Fee Schedule: Signature on Requisition

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-30

    ... cases, the physician may keep abreast of the patient's condition by calling the nursing staff. If a patient's condition indicates that a clinical diagnostic laboratory test is required, the nursing staff... signature on the requisition. Another example that occurs in many settings, including nursing homes, all...

  4. Biomagnetic Pair Therapy and Typhoid Fever: A Pilot Study.

    PubMed

    Frank, Bryan L

    2017-10-01

    Objective: This pilot study examined the laboratory responses of patients with laboratory-documented typhoid fever who were treated with Biomagnetic Pair Therapy (BPT; medical biomagnetism), a specific application of pairs of magnets for various ailments that are infectious and otherwise. Materials and Methods: This study was an assessment of patients' response to treatment with only BPT for Salmonella typhi infections (typhoid fever) using standard conventional laboratory techniques. The research was conducted in an outpatient village clinic in Kenya. There were 52 participants who were evaluated for possible systemic illness, including typhoid fever, from an open-label study. Participants who felt sick and requested testing for possible typhoid fever were tested with a standard Widal test by a certified laboratory technician. Participants who tested positive (13 patients) were then treated with BPT (a "First Aid" approach) only. These participants then returned for follow-up laboratory and clinical evaluations after 2 days. Results: Most of the participants (10 of 13) retested as negative, and all patients reported symptomatic clinical improvement. Conclusions: As a significant majority of participants demonstrated clearing of their S. typhi after BPT, this technique should be studied further in larger trials for its efficacy in treating typhoid fever.

  5. Battery testing at Argonne National Laboratory

    NASA Astrophysics Data System (ADS)

    Deluca, W. H.; Gillie, K. R.; Kulaga, J. E.; Smaga, J. A.; Tummillo, A. F.; Webster, C. E.

    Advanced battery technology evaluations are performed under simulated electric-vehicle operating conditions at the Analysis & Diagnostic Laboratory (ADL) of Argonne National Laboratory. The ADL results provide insight into those factors that limit battery performance and life. The ADL facilities include a test laboratory to conduct battery experimental evaluations under simulated application conditions and a post-test analysis laboratory to determine, in a protected atmosphere if needed, component compositional changes and failure mechanisms. This paper summarizes the performance characterizations and life evaluations conducted during FY-92 on both single cells and multi-cell modules that encompass six battery technologies (Na/S, Li/FeS, Ni/Metal-Hydride, Ni/Zn, Ni/Cd, Ni/Fe). These evaluations were performed for the Department of Energy, Office of Transportation Technologies, Electric and Hybrid Propulsion Division, and the Electric Power Research Institute. The ADL provides a common basis for battery performance characterization and life evaluations with unbiased application of tests and analyses. The results help identify the most promising R&D approaches for overcoming battery limitations, and provide battery users, developers, and program managers with a measure of the progress being made in battery R&D programs, a comparison of battery technologies, and basic data for modeling.

  6. Implementation science: the laboratory as a command centre.

    PubMed

    Boeras, Debrah I; Nkengasong, John N; Peeling, Rosanna W

    2017-03-01

    Recent advances in point-of-care technologies to ensure universal access to affordable quality-assured diagnostics have the potential to transform patient management, surveillance programmes, and control of infectious diseases. Decentralization of testing can put tremendous stresses on fragile health systems if the laboratory is not involved in the planning, introduction, and scale-up strategies. The impact of investments in novel technologies can only be realized if these tests are evaluated, adopted, and scaled up within the healthcare system with appropriate planning and understanding of the local contexts in which these technologies will be used. In this digital age, the laboratory needs to take on the role of the Command Centre for technology introduction and implementation. Implementation science is needed to understand the political, cultural, economic, and behavioural context for technology introduction. The new paradigm should include: building a comprehensive system of laboratories and point-of-care testing sites to provide quality-assured diagnostic services with good laboratory-clinic interface to build trust in test results and linkage to care; building and coordinating a comprehensive national surveillance and communication system for disease control and global health emergencies; conducting research to monitor the impact of new tools and interventions on improving patient care.

  7. Laboratory- and field-based testing as predictors of skating performance in competitive-level female ice hockey.

    PubMed

    Henriksson, Tommy; Vescovi, Jason D; Fjellman-Wiklund, Anncristine; Gilenstam, Kajsa

    2016-01-01

    The purpose of this study was to examine whether field-based and/or laboratory-based assessments are valid tools for predicting key performance characteristics of skating in competitive-level female hockey players. Cross-sectional study. Twenty-three female ice hockey players aged 15-25 years (body mass: 66.1±6.3 kg; height: 169.5±5.5 cm), with 10.6±3.2 years playing experience volunteered to participate in the study. The field-based assessments included 20 m sprint, squat jump, countermovement jump, 30-second repeated jump test, standing long jump, single-leg standing long jump, 20 m shuttle run test, isometric leg pull, one-repetition maximum bench press, and one-repetition maximum squats. The laboratory-based assessments included body composition (dual energy X-ray absorptiometry), maximal aerobic power, and isokinetic strength (Biodex). The on-ice tests included agility cornering s-turn, cone agility skate, transition agility skate, and modified repeat skate sprint. Data were analyzed using stepwise multivariate linear regression analysis. Linear regression analysis was used to establish the relationship between key performance characteristics of skating and the predictor variables. Regression models (adj R (2)) for the on-ice variables ranged from 0.244 to 0.663 for the field-based assessments and from 0.136 to 0.420 for the laboratory-based assessments. Single-leg tests were the strongest predictors for key performance characteristics of skating. Single leg standing long jump alone explained 57.1%, 38.1%, and 29.1% of the variance in skating time during transition agility skate, agility cornering s-turn, and modified repeat skate sprint, respectively. Isokinetic peak torque in the quadriceps at 90° explained 42.0% and 32.2% of the variance in skating time during agility cornering s-turn and modified repeat skate sprint, respectively. Field-based assessments, particularly single-leg tests, are an adequate substitute to more expensive and time-consuming laboratory assessments if the purpose is to gain knowledge about key performance characteristics of skating.

  8. Laboratory- and field-based testing as predictors of skating performance in competitive-level female ice hockey

    PubMed Central

    Henriksson, Tommy; Vescovi, Jason D; Fjellman-Wiklund, Anncristine; Gilenstam, Kajsa

    2016-01-01

    Objectives The purpose of this study was to examine whether field-based and/or laboratory-based assessments are valid tools for predicting key performance characteristics of skating in competitive-level female hockey players. Design Cross-sectional study. Methods Twenty-three female ice hockey players aged 15–25 years (body mass: 66.1±6.3 kg; height: 169.5±5.5 cm), with 10.6±3.2 years playing experience volunteered to participate in the study. The field-based assessments included 20 m sprint, squat jump, countermovement jump, 30-second repeated jump test, standing long jump, single-leg standing long jump, 20 m shuttle run test, isometric leg pull, one-repetition maximum bench press, and one-repetition maximum squats. The laboratory-based assessments included body composition (dual energy X-ray absorptiometry), maximal aerobic power, and isokinetic strength (Biodex). The on-ice tests included agility cornering s-turn, cone agility skate, transition agility skate, and modified repeat skate sprint. Data were analyzed using stepwise multivariate linear regression analysis. Linear regression analysis was used to establish the relationship between key performance characteristics of skating and the predictor variables. Results Regression models (adj R2) for the on-ice variables ranged from 0.244 to 0.663 for the field-based assessments and from 0.136 to 0.420 for the laboratory-based assessments. Single-leg tests were the strongest predictors for key performance characteristics of skating. Single leg standing long jump alone explained 57.1%, 38.1%, and 29.1% of the variance in skating time during transition agility skate, agility cornering s-turn, and modified repeat skate sprint, respectively. Isokinetic peak torque in the quadriceps at 90° explained 42.0% and 32.2% of the variance in skating time during agility cornering s-turn and modified repeat skate sprint, respectively. Conclusion Field-based assessments, particularly single-leg tests, are an adequate substitute to more expensive and time-consuming laboratory assessments if the purpose is to gain knowledge about key performance characteristics of skating. PMID:27574474

  9. Audio Development Laboratory (ADL) User Test Planning Guide

    NASA Technical Reports Server (NTRS)

    Romero, Andy

    2012-01-01

    Test process, milestones and inputs are unknowns to first-time users of the ADL. The User Test Planning Guide aids in establishing expectations for both NASA and non-NASA facility customers. The potential audience for this guide includes both internal and commercial spaceflight hardware/software developers. It is intended to assist their test engineering personnel in test planning and execution. Material covered includes a roadmap of the test process, roles and responsibilities of facility and user, major milestones, facility capabilities, and inputs required by the facility. Samples of deliverables, test article interfaces, and inputs necessary to define test scope, cost, and schedule are included as an appendix to the guide.

  10. A guide to utilization of the microbiology laboratory for diagnosis of infectious diseases: 2013 recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM)(a).

    PubMed

    Baron, Ellen Jo; Miller, J Michael; Weinstein, Melvin P; Richter, Sandra S; Gilligan, Peter H; Thomson, Richard B; Bourbeau, Paul; Carroll, Karen C; Kehl, Sue C; Dunne, W Michael; Robinson-Dunn, Barbara; Schwartzman, Joseph D; Chapin, Kimberle C; Snyder, James W; Forbes, Betty A; Patel, Robin; Rosenblatt, Jon E; Pritt, Bobbi S

    2013-08-01

    The critical role of the microbiology laboratory in infectious disease diagnosis calls for a close, positive working relationship between the physician and the microbiologists who provide enormous value to the health care team. This document, developed by both laboratory and clinical experts, provides information on which tests are valuable and in which contexts, and on tests that add little or no value for diagnostic decisions. Sections are divided into anatomic systems, including Bloodstream Infections and Infections of the Cardiovascular System, Central Nervous System Infections, Ocular Infections, Soft Tissue Infections of the Head and Neck, Upper Respiratory Infections, Lower Respiratory Tract infections, Infections of the Gastrointestinal Tract, Intraabdominal Infections, Bone and Joint Infections, Urinary Tract Infections, Genital Infections, and Skin and Soft Tissue Infections; or into etiologic agent groups, including Tickborne Infections, Viral Syndromes, and Blood and Tissue Parasite Infections. Each section contains introductory concepts, a summary of key points, and detailed tables that list suspected agents; the most reliable tests to order; the samples (and volumes) to collect in order of preference; specimen transport devices, procedures, times, and temperatures; and detailed notes on specific issues regarding the test methods, such as when tests are likely to require a specialized laboratory or have prolonged turnaround times. There is redundancy among the tables and sections, as many agents and assay choices overlap. The document is intended to serve as a reference to guide physicians in choosing tests that will aid them to diagnose infectious diseases in their patients.

  11. Executive summary: a guide to utilization of the microbiology laboratory for diagnosis of infectious diseases: 2013 recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM)(a).

    PubMed

    Baron, Ellen Jo; Miller, J Michael; Weinstein, Melvin P; Richter, Sandra S; Gilligan, Peter H; Thomson, Richard B; Bourbeau, Paul; Carroll, Karen C; Kehl, Sue C; Dunne, W Michael; Robinson-Dunn, Barbara; Schwartzman, Joseph D; Chapin, Kimberle C; Snyder, James W; Forbes, Betty A; Patel, Robin; Rosenblatt, Jon E; Pritt, Bobbi S

    2013-08-01

    The critical role of the microbiology laboratory in infectious disease diagnosis calls for a close, positive working relationship between the physician and the microbiologists who provide enormous value to the health care team. This document, developed by both laboratory and clinical experts, provides information on which tests are valuable and in which contexts, and on tests that add little or no value for diagnostic decisions. Sections are divided into anatomic systems, including Bloodstream Infections and Infections of the Cardiovascular System, Central Nervous System Infections, Ocular Infections, Soft Tissue Infections of the Head and Neck, Upper Respiratory Infections, Lower Respiratory Tract infections, Infections of the Gastrointestinal Tract, Intraabdominal Infections, Bone and Joint Infections, Urinary Tract Infections, Genital Infections, and Skin and Soft Tissue Infections; or into etiologic agent groups, including Tickborne Infections, Viral Syndromes, and Blood and Tissue Parasite Infections. Each section contains introductory concepts, a summary of key points, and detailed tables that list suspected agents; the most reliable tests to order; the samples (and volumes) to collect in order of preference; specimen transport devices, procedures, times, and temperatures; and detailed notes on specific issues regarding the test methods, such as when tests are likely to require a specialized laboratory or have prolonged turnaround times. There is redundancy among the tables and sections, as many agents and assay choices overlap. The document is intended to serve as a reference to guide physicians in choosing tests that will aid them to diagnose infectious diseases in their patients.

  12. A Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2013 Recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM)a

    PubMed Central

    Baron, Ellen Jo; Miller, J. Michael; Weinstein, Melvin P.; Richter, Sandra S.; Gilligan, Peter H.; Thomson, Richard B.; Bourbeau, Paul; Carroll, Karen C.; Kehl, Sue C.; Dunne, W. Michael; Robinson-Dunn, Barbara; Schwartzman, Joseph D.; Chapin, Kimberle C.; Snyder, James W.; Forbes, Betty A.; Patel, Robin; Rosenblatt, Jon E.; Pritt, Bobbi S.

    2013-01-01

    The critical role of the microbiology laboratory in infectious disease diagnosis calls for a close, positive working relationship between the physician and the microbiologists who provide enormous value to the health care team. This document, developed by both laboratory and clinical experts, provides information on which tests are valuable and in which contexts, and on tests that add little or no value for diagnostic decisions. Sections are divided into anatomic systems, including Bloodstream Infections and Infections of the Cardiovascular System, Central Nervous System Infections, Ocular Infections, Soft Tissue Infections of the Head and Neck, Upper Respiratory Infections, Lower Respiratory Tract infections, Infections of the Gastrointestinal Tract, Intraabdominal Infections, Bone and Joint Infections, Urinary Tract Infections, Genital Infections, and Skin and Soft Tissue Infections; or into etiologic agent groups, including Tickborne Infections, Viral Syndromes, and Blood and Tissue Parasite Infections. Each section contains introductory concepts, a summary of key points, and detailed tables that list suspected agents; the most reliable tests to order; the samples (and volumes) to collect in order of preference; specimen transport devices, procedures, times, and temperatures; and detailed notes on specific issues regarding the test methods, such as when tests are likely to require a specialized laboratory or have prolonged turnaround times. There is redundancy among the tables and sections, as many agents and assay choices overlap. The document is intended to serve as a reference to guide physicians in choosing tests that will aid them to diagnose infectious diseases in their patients. PMID:23845951

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

    PubMed

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

    2015-09-03

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

  14. Emerging Resistance, New Antimicrobial Agents  …  but No Tests! The Challenge of Antimicrobial Susceptibility Testing in the Current US Regulatory Landscape.

    PubMed

    Humphries, R M; Hindler, J A

    2016-07-01

    Accurate and timely performance of antimicrobial susceptibility testing (AST) by the clinical laboratory is paramount to combating antimicrobial resistance. The ability of laboratories in the United States to effectively perform ASTs is challenged by several factors. Some, such as new resistance mechanisms and the associated evolution of testing recommendations and breakpoints, are inevitable. Others are entirely man-made. These include unnecessarily strict US Food and Drug Administration (FDA) limitations on how commercial AST systems can be used for diagnostic testing, the absence of up-to-date performance data on these systems, and the lack of commercially available FDA-cleared tests for newer antimicrobial agents or for older agents with updated breakpoints. This viewpoint will highlight contemporary AST challenges faced by the clinical laboratory, and propose some solutions. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  15. The cobas® 6800/8800 System: a new era of automation in molecular diagnostics.

    PubMed

    Cobb, Bryan; Simon, Christian O; Stramer, Susan L; Body, Barbara; Mitchell, P Shawn; Reisch, Natasa; Stevens, Wendy; Carmona, Sergio; Katz, Louis; Will, Stephen; Liesenfeld, Oliver

    2017-02-01

    Molecular diagnostics is a key component of laboratory medicine. Here, the authors review key triggers of ever-increasing automation in nucleic acid amplification testing (NAAT) with a focus on specific automated Polymerase Chain Reaction (PCR) testing and platforms such as the recently launched cobas® 6800 and cobas® 8800 Systems. The benefits of such automation for different stakeholders including patients, clinicians, laboratory personnel, hospital administrators, payers, and manufacturers are described. Areas Covered: The authors describe how molecular diagnostics has achieved total laboratory automation over time, rivaling clinical chemistry to significantly improve testing efficiency. Finally, the authors discuss how advances in automation decrease the development time for new tests enabling clinicians to more readily provide test results. Expert Commentary: The advancements described enable complete diagnostic solutions whereby specific test results can be combined with relevant patient data sets to allow healthcare providers to deliver comprehensive clinical recommendations in multiple fields ranging from infectious disease to outbreak management and blood safety solutions.

  16. Results of Testing the Relative Oxidizing Hazard of Wipes and KMI Zeolite

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

    Ams, Bridget Elaine

    This report includes the results from testing performed on the relative oxidizing hazard of a number of organic sorbing wipe materials, as well as KMI zeolite. These studies were undertaken to address a need by the Los Alamos National Laboratory (LANL) Hazardous Materials Management group, which requires a material that can sorb small spills in a glovebox without creating a disposal hazard due to the potential for oxidation reactions, as requested in Request for Testing of Wipes and Zeolite for Los Alamos National Laboratory Hazardous Materials Group (NPl-7) (NPl-7-17-002) and Request for Testing of Chamois Material for Los Alamos Nationalmore » Laboratory Hazardous Materials Group (NPl-7) (NPl-7-17-005). This set oftests is a continuation of previous testing described in Results from Preparation and Testing of Sorbents Mixed with (DWT-RPT-003), which provided data for the Waste Isolation Pilot Plant's Basis of Knowledge. The Basis of Knowledge establishes criteria for evaluating transuranic (TRU) waste that contains oxidizing chemicals.« less

  17. A comparison between on-site immunoassay drug-testing devices and laboratory results.

    PubMed

    Grönholm, M; Lillsunde, P

    2001-09-15

    The aim with this study was to evaluate the accuracy of several on-site testing devices on the market. A part of this study is included in the European Union's (EU's) roadside testing assessment project (ROSITA). An other request for this kind of study came from the Finnish prison department in the Ministry of Justice. The evaluation was performed on both urine assays and oral fluid assays. The on-site test results were compared with laboratory results (gas chromatography-mass spectrometry (GC/MS)). The samples were tested on amphetamines (AMP), cannabinoids (THC), opiates (OPI) and cocaine metabolites (COC). Some of the tests also included a metamphetamine (MET) and a benzodiazepine (BZO) test. Both positive and negative samples were tested. A total of 800 persons and eight on-site devices for urine and two for oral fluid testing were included in this study. Good results were obtained for the urine on-site devices, with accuracies of 93-99% for amphetamines, 97-99% for cannabinoids, 94-98% for opiates and 90-98% for benzodiazepines. However, differences in the ease of performance and interpretation of test result were observed. It was possible to detect amphetamines and opiates in oral fluid by the used on-site devices, but the benzodiazepines and cannabinoids did not fulfil the needs of sensitivity.

  18. Integrating Point-of-Care Testing into a Community Emergency Department: A Mixed-Methods Evaluation.

    PubMed

    Pines, Jesse M; Zocchi, Mark S; Carter, Caitlin; Marriott, Charles Z; Bernard, Matthew; Warner, Leah H

    2018-05-13

    Point-of-care testing (POCT) is a commonly used technology that hastens the time to laboratory results in emergency departments (ED). We evaluated an ED-based POCT program on ED length of stay and time to care, coupled with qualitative interviews of local ED stakeholders. We conducted a mixed-methods study (2012-16) to examine the impact of point-of-care testing in a single, community ED. The quantiative analysis involved an observational before-after study comparing time to laboratory test result (POC troponin or POC chemistry) and ED length of stay after implementation of POCT, using a propensity-weighted interrupted time series analysis (ITSA). A complementary qualitative analysis involved five semi-structured interviews with staff using grounded theory on the benefits and challenges to ED POCT. A total of 47,399 ED visits were included in the study (24,705 in pre-intervention period and 22,694 in post-intervention). After POCT implementation, overall laboratory testing increased marginally from 61 to 62%. Central laboratory troponin and chemistry declined by >50% and was replaced by POCT. Prior to POCT implementation, time to troponin and chemistry had declined steadily due to other improvements in laboratory efficiency. After POCT implementation, there was an immediate 20 minute further decline (p<0.001) in both time to troponin and time to chemistry results using the propensity-weighted comparisons. However, the declining trend observed prior to POCT implementation did not continue at the same rate post implementation. Similarly, prior to POCT implementation, ED length of stay (LOS) declined due to other quality improvements. After POCT implementation, LOS continued declined at a similar rate. Because of this prior trend, the ITSA did not show a significant decline in LOS attributable to POCT. Common benefits of POCT perceived by staff in qualitative interviews included improved quality of care (64%), and reductions in time to test results (44%). Common challenges included concerns over POCT accuracy (32%), and technical barriers (29%). In the study ED, implementation of POCT was associated with a reduction in time to test result for both troponin and chemistry. Local staff felt that faster time to test result improved quality of care; however, concerns were raised with POCT accuracy. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  19. External quality assessment for KRAS testing is needed: setup of a European program and report of the first joined regional quality assessment rounds.

    PubMed

    Bellon, Ellen; Ligtenberg, Marjolijn J L; Tejpar, Sabine; Cox, Karen; de Hertogh, Gert; de Stricker, Karin; Edsjö, Anders; Gorgoulis, Vassilis; Höfler, Gerald; Jung, Andreas; Kotsinas, Athanassios; Laurent-Puig, Pierre; López-Ríos, Fernando; Hansen, Tine Plato; Rouleau, Etienne; Vandenberghe, Peter; van Krieken, Johan J M; Dequeker, Elisabeth

    2011-01-01

    The use of epidermal growth factor receptor-targeting antibodies in metastatic colorectal cancer has been restricted to patients with wild-type KRAS tumors by the European Medicines Agency since 2008, based on data showing a lack of efficacy and potential harm in patients with mutant KRAS tumors. In an effort to ensure optimal, uniform, and reliable community-based KRAS testing throughout Europe, a KRAS external quality assessment (EQA) scheme was set up. The first large assessment round included 59 laboratories from eight different European countries. For each country, one regional scheme organizer prepared and distributed the samples for the participants of their own country. The samples included unstained sections of 10 invasive colorectal carcinomas with known KRAS mutation status. The samples were centrally validated by one of two reference laboratories. The laboratories were allowed to use their own preferred method for histological evaluation, DNA isolation, and mutation analysis. In this study, we analyze the setup of the KRAS scheme. We analyzed the advantages and disadvantages of the regional scheme organization by analyzing the outcome of genotyping results, analysis of tumor percentage, and written reports. We conclude that only 70% of laboratories correctly identified the KRAS mutational status in all samples. Both the false-positive and false-negative results observed negatively affect patient care. Reports of the KRAS test results often lacked essential information. We aim to further expand this program to more laboratories to provide a robust estimate of the quality of KRAS testing in Europe, and provide the basis for remedial measures and harmonization.

  20. [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.

  1. LOINC, a universal standard for identifying laboratory observations: a 5-year update.

    PubMed

    McDonald, Clement J; Huff, Stanley M; Suico, Jeffrey G; Hill, Gilbert; Leavelle, Dennis; Aller, Raymond; Forrey, Arden; Mercer, Kathy; DeMoor, Georges; Hook, John; Williams, Warren; Case, James; Maloney, Pat

    2003-04-01

    The Logical Observation Identifier Names and Codes (LOINC) database provides a universal code system for reporting laboratory and other clinical observations. Its purpose is to identify observations in electronic messages such as Health Level Seven (HL7) observation messages, so that when hospitals, health maintenance organizations, pharmaceutical manufacturers, researchers, and public health departments receive such messages from multiple sources, they can automatically file the results in the right slots of their medical records, research, and/or public health systems. For each observation, the database includes a code (of which 25 000 are laboratory test observations), a long formal name, a "short" 30-character name, and synonyms. The database comes with a mapping program called Regenstrief LOINC Mapping Assistant (RELMA(TM)) to assist the mapping of local test codes to LOINC codes and to facilitate browsing of the LOINC results. Both LOINC and RELMA are available at no cost from http://www.regenstrief.org/loinc/. The LOINC medical database carries records for >30 000 different observations. LOINC codes are being used by large reference laboratories and federal agencies, e.g., the CDC and the Department of Veterans Affairs, and are part of the Health Insurance Portability and Accountability Act (HIPAA) attachment proposal. Internationally, they have been adopted in Switzerland, Hong Kong, Australia, and Canada, and by the German national standards organization, the Deutsches Instituts für Normung. Laboratories should include LOINC codes in their outbound HL7 messages so that clinical and research clients can easily integrate these results into their clinical and research repositories. Laboratories should also encourage instrument vendors to deliver LOINC codes in their instrument outputs and demand LOINC codes in HL7 messages they get from reference laboratories to avoid the need to lump so many referral tests under the "send out lab" code.

  2. First external quality assurance program of the Italian HLA-B*57:01 Network assessing the performance of clinical virology laboratories in HLA-B*57:01 testing.

    PubMed

    Meini, Genny; Dello Russo, Cinzia; Allice, Tiziano; Barresi, Renata; D'Arrigo, Roberta; Falasca, Francesca; Lipsi, Maria Rosaria; Paolucci, Stefania; Zanussi, Stefania; Antonetti, Raffaele; Baldanti, Fausto; Basaglia, Giancarlo; Bruzzone, Bianca; Polilli, Ennio; Ghisetti, Valeria; Pucillo, Leopoldo Paolo; Turriziani, Ombretta; Pirazzoli, Antonella; Navarra, Pierluigi; Zazzi, Maurizio

    2016-05-01

    Since the HLA-B*57:01 allele is strongly associated with abacavir hypersensitivity reaction, testing for the presence of HLA-B*57:01 is mandatory before administration of abacavir. While HLA-B*57:01 testing is usually provided by pharmacogenetics, genetics or blood transfusion services, clinical virology laboratories can be an optimal opportunity for HLA-B*57:01 testing since they receive blood samples for routine HIV monitoring and have the expertise for convenient and less expensive PCR-based point mutation assays. The Italian HLA-B*57:01 Network gathers accredited clinical virology laboratories offering HLA-B*57:01 testing in Italy with the aim to share protocols, test new methods, develop and maintain external quality assurance (EQA) programs. A panel of 9HLA-B*57:01-positive and 16HLA-B*57:01-negative frozen blood samples were blindly distributed to 10 units including 9 clinical virology laboratories and one reference pharmacology laboratory. Each laboratory was free to use its own routine method for DNA extraction and HLA-B*57:01 testing. DNA was extracted by automated workstations in 6 units and by manual spin columns in 4. Eight units used the Duplicα Real Time HLA-B*57:01 kit by Euroclone and two units used two different PCR homemade protocols. All the 10 units correctly identified all the 25 samples. The first HLA-B*57:01 EQA program run in Italy showed that clinical virology units are equipped and proficient for providing HLA-B*57:01 testing by inexpensive assays easy to integrate into their routine. Copyright © 2016 Elsevier B.V. All rights reserved.

  3. Comparing the field and laboratory emission cell (FLEC) with traditional emissions testing chambers

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

    Roache, N.F.; Guo, Z.; Fortmann, R.

    1996-12-31

    A series of tests was designed to evaluate the performance of the field and laboratory emission cell (FLEC) as applied to the testing of emissions from two indoor coating materials, floor wax and latex paint. These tests included validation of the repeatability of the test method, evaluation of the effect of different air velocities on source emissions, and a comparison of FLEC versus small chamber characterization of emissions. The FLEC exhibited good repeatability in characterization of emissions when applied to both sources under identical conditions. Tests with different air velocities showed significant effects on the emissions from latex paint, yetmore » little effect on emissions from the floor wax. Comparisons of data from the FLEC and small chamber show good correlation for measurements involving floor wax, but less favorable results for emissions from latex paint. The procedures and findings are discussed; conclusions are limited and include emphasis on the need for additional study and development of a standard method.« less

  4. Designation, diligence and drift: understanding laboratory expenditure increases in British Columbia, 1996/97 to 2005/06.

    PubMed

    Sivananthan, Saskia N; Peterson, Sandra; Lavergne, Ruth; Barer, Morris L; McGrail, Kimberlyn M

    2012-12-21

    Laboratory testing is one of the fastest growing areas of health services spending in Canada. We examine the extent to which increases in laboratory expenditures might be explained by testing that is consistent with guidelines for the management of chronic conditions, by analyzing fee-for-service physician payment data in British Columbia from 1996/97 and 2005/06. We used direct standardization to quantify the effect on laboratory expenditures from changes in: fee levels; population growth; population aging; treatment prevalence; expenditure on recommended tests for those conditions; and expenditure on other tests. The chronic conditions selected were those with guidelines containing laboratory recommendations developed by the BC Guidelines and Protocol Advisory Committee: diabetes, hypertension, congestive heart failure, renal failure, liver disease, rheumatoid arthritis, osteoarthritis and dementia. Laboratory service expenditures increased by $98 million in 2005/06 compared to 1996/97, or 3.6% per year after controlling for population growth and aging. Testing consistent with guideline-recommended care for chronic conditions explained one-third (1.2% per year) of this growth. Changes in treatment prevalence were just as important, contributing 1.5% per year. Hypertension was the most common condition, but renal failure and dementia showed the largest changes in prevalence over time. Changes in other laboratory expenditure including for those without chronic conditions accounted for the remaining 0.9% growth per year. Increases in treatment prevalence were the largest driver of laboratory cost increases between 1996/97 and 2005/06. There are several possible contributors to increasing treatment prevalence, all of which can be expected to continue to put pressure on health care expenditures.

  5. Evaluating Laboratory Performance on Point-of-Care Glucose Testing with Six Sigma Metric for 151 Institutions in China.

    PubMed

    Fei, Yang; Wang, Wei; He, Falin; Zhong, Kun; Wang, Zhiguo

    2015-10-01

    The aim of this study was to use Six Sigma(SM) (Motorola Trademark Holdings, Libertyville, IL) techniques to analyze the quality of point-of-care (POC) glucose testing measurements quantitatively and to provide suggestions for improvement. In total, 151 laboratories in China were included in this investigation in 2014. Bias and coefficient of variation were collected from an external quality assessment and an internal quality control program, respectively, for POC glucose testing organized by the National Center for Clinical Laboratories. The σ values and the Quality Goal Index were used to evaluate the performance of POC glucose meters. There were 27, 30, 57, and 37 participants in the groups using Optium Xceed™ (Abbott Diabetes Care, Alameda, CA), Accu-Chek(®) Performa (Roche, Basel, Switzerland), One Touch Ultra(®) (Abbott), and "other" meters, respectively. The median of the absolute value of percentage difference varied among different lots and different groups. Among all the groups, the Abbott One Touch Ultra group had the smallest median of absolute value of percentage difference except for lot 201411, whereas the "other" group had the largest median in all five lots. More than 85% of participate laboratories satisfied the total allowable error (TEa) requirement in International Organization for Standardization standard 15197:2013, and 85.43% (129/151) of laboratories obtained intralaboratory coefficient of variations less than 1/3TEa. However, Six Sigma techniques suggested that 41.72% (63/151) to 65.56% (99/151) of the laboratories needed to improve their POC glucose testing performance, in either precision, trueness, or both. Laboratories should pay more attention on the practice of POC glucose testing and take actions to improve their performance. Only in this way can POC glucose testing really function well in clinical practice.

  6. Analysis of laboratory testing results collected in an enhanced chlamydia surveillance system in Australia, 2008-2010.

    PubMed

    Dimech, Wayne; Lim, Megan S C; Van Gemert, Caroline; Guy, Rebecca; Boyle, Douglas; Donovan, Basil; Hellard, Margaret

    2014-06-12

    Chlamydial infection is the most common notifiable disease in Australia, Europe and the US. Australian notifications of chlamydia rose four-fold from 20,274 cases in 2002 to 80,846 cases in 2011; the majority of cases were among young people aged less than 29 years. Along with test positivity rates, an understanding of the number of tests performed and the demographics of individuals being tested are key epidemiological indicators. The ACCESS Laboratory Network was established in 2008 to address this issue. The ACCESS Laboratory Network collected chlamydia testing data from 15 laboratories around Australia over a three-year period using data extraction software. All chlamydia testing data from participating laboratories were extracted from the laboratory information system; patient identifiers converted to a unique, non-reversible code and de-identified data sent to a single database. Analysis of data by anatomical site included all specimens, but in age and sex specific analysis, only one testing episode was counted. From 2008 to 2010 a total of 628,295 chlamydia tests were referred to the 15 laboratories. Of the 592,626 individual episodes presenting for testing, 70% were from female and 30% from male patients. In female patients, chlamydia positivity rate was 6.4% overall; the highest rate in 14 year olds (14.3%). In male patients, the chlamydia positivity rate was 9.4% overall; the highest in 19 year olds (16.5%). The most common sample type was urine (57%). In 3.2% of testing episodes, multiple anatomical sites were sampled. Urethral swabs gave the highest positivity rate for all anatomical sites in both female (7.7%) and male patients (14%), followed by urine (7.6% and 9.4%, respectively) and eye (6.3% and 7.9%, respectively). The ACCESS Laboratory Network data are unique in both number and scope and are representative of chlamydia testing in both general practice and high-risk clinics. The findings from these data highlight much lower levels of testing in young people aged 20 years or less; in particular female patients aged less than 16 years, despite being the group with the highest positivity rate. Strategies are needed to increase the uptake of testing in this high-risk group.

  7. Analysis of laboratory testing results collected in an enhanced chlamydia surveillance system in Australia, 2008–2010

    PubMed Central

    2014-01-01

    Background Chlamydial infection is the most common notifiable disease in Australia, Europe and the US. Australian notifications of chlamydia rose four-fold from 20,274 cases in 2002 to 80,846 cases in 2011; the majority of cases were among young people aged less than 29 years. Along with test positivity rates, an understanding of the number of tests performed and the demographics of individuals being tested are key epidemiological indicators. The ACCESS Laboratory Network was established in 2008 to address this issue. Methods The ACCESS Laboratory Network collected chlamydia testing data from 15 laboratories around Australia over a three-year period using data extraction software. All chlamydia testing data from participating laboratories were extracted from the laboratory information system; patient identifiers converted to a unique, non-reversible code and de-identified data sent to a single database. Analysis of data by anatomical site included all specimens, but in age and sex specific analysis, only one testing episode was counted. Results From 2008 to 2010 a total of 628,295 chlamydia tests were referred to the 15 laboratories. Of the 592,626 individual episodes presenting for testing, 70% were from female and 30% from male patients. In female patients, chlamydia positivity rate was 6.4% overall; the highest rate in 14 year olds (14.3%). In male patients, the chlamydia positivity rate was 9.4% overall; the highest in 19 year olds (16.5%). The most common sample type was urine (57%). In 3.2% of testing episodes, multiple anatomical sites were sampled. Urethral swabs gave the highest positivity rate for all anatomical sites in both female (7.7%) and male patients (14%), followed by urine (7.6% and 9.4%, respectively) and eye (6.3% and 7.9%, respectively). Conclusions The ACCESS Laboratory Network data are unique in both number and scope and are representative of chlamydia testing in both general practice and high-risk clinics. The findings from these data highlight much lower levels of testing in young people aged 20 years or less; in particular female patients aged less than 16 years, despite being the group with the highest positivity rate. Strategies are needed to increase the uptake of testing in this high-risk group. PMID:24920016

  8. How Well Does Physician Selection of Microbiologic Tests Identify Clostridium difficile and other Pathogens in Paediatric Diarrhoea? Insights Using Multiplex PCR-Based Detection

    PubMed Central

    Stockmann, Chris; Rogatcheva, Margarita; Harrel, Brian; Vaughn, Mike; Crisp, Rob; Poritz, Mark; Thatcher, Stephanie; Korgenski, Ernest K; Barney, Trenda; Daly, Judy; Pavia, Andrew T

    2014-01-01

    The objective of this study was to compare the aetiologic yield of standard of care microbiologic testing ordered by physicians with that of a multiplex PCR platform. Stool specimens obtained from children and young adults with gastrointestinal illness were evaluated by standard laboratory methods and a developmental version of the FilmArray Gastrointestinal Diagnostic System (FilmArray GI Panel), a rapid multiplex PCR platform that detects 23 bacterial, viral, and protozoal agents. Results were classified according to the microbiologic tests requested by the treating physician. A median of 3 (range 1-10) microbiologic tests were performed by the clinical laboratory during 378 unique diarrhoeal episodes. A potential aetiologic agent was identified in 46% of stool specimens by standard laboratory methods and in 65% of specimens tested using the FilmArray GI Panel (P<0.001). For those patients who only had Clostridium difficile testing requested, an alternative pathogen was identified in 29% of cases with the FilmArray GI Panel. Notably, 11 (12%) cases of norovirus were identified among children who only had testing for C. difficile ordered. Among those who had C. difficile testing ordered in combination with other tests, an additional pathogen was identified in 57% of stool specimens with the FilmArray GI Panel. For patients who had no C. difficile testing performed, the FilmArray GI Panel identified a pathogen in 63% of cases, including C. difficile in 8%. Physician-specified laboratory testing may miss important diarrhoeal pathogens. Additionally, standard laboratory testing is likely to underestimate co-infections with multiple infectious diarrhoeagenic agents. PMID:25599941

  9. External quality assessment of dengue and chikungunya diagnostics in the Asia Pacific region, 2015

    PubMed Central

    Soh, Li Ting; Squires, Raynal C; Tan, Li Kiang; Pok, Kwoon Yong; Yang, HuiTing; Liew, Christina; Shah, Aparna Singh; Aaskov, John; Abubakar, Sazaly; Hasabe, Futoshi; Ng, Lee Ching

    2016-01-01

    Objective To conduct an external quality assessment (EQA) of dengue and chikungunya diagnostics among national-level public health laboratories in the Asia Pacific region following the first round of EQA for dengue diagnostics in 2013. Methods Twenty-four national-level public health laboratories performed routine diagnostic assays on a proficiency testing panel consisting of two modules. Module A contained serum samples spiked with cultured dengue virus (DENV) or chikungunya virus (CHIKV) for the detection of nucleic acid and DENV non-structural protein 1 (NS1) antigen. Module B contained human serum samples for the detection of anti-DENV antibodies. Results Among 20 laboratories testing Module A, 17 (85%) correctly detected DENV RNA by reverse transcription polymerase chain reaction (RT–PCR), 18 (90%) correctly determined serotype and 19 (95%) correctly identified CHIKV by RT–PCR. Ten of 15 (66.7%) laboratories performing NS1 antigen assays obtained the correct results. In Module B, 18/23 (78.3%) and 20/20 (100%) of laboratories correctly detected anti-DENV IgM and IgG, respectively. Detection of acute/recent DENV infection by both molecular (RT–PCR) and serological methods (IgM) was available in 19/24 (79.2%) participating laboratories. Discussion Accurate laboratory testing is a critical component of dengue and chikungunya surveillance and control. This second round of EQA reveals good proficiency in molecular and serological diagnostics of these diseases in the Asia Pacific region. Further comprehensive diagnostic testing, including testing for Zika virus, should comprise future iterations of the EQA. PMID:27508088

  10. 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.

  11. Developing a competency framework for U.S. state food and feed testing laboratory personnel.

    PubMed

    Kaml, Craig; Weiss, Christopher C; Dezendorf, Paul; Ishida, Maria; Rice, Daniel H; Klein, Ron; Salfinger, Yvonne

    2014-01-01

    A competency-based training curriculum framework for U.S. state food and feed testing laboratories personnel is being developed by the International Food Protection Training Institute (IFPTI) and three partners. The framework will help laboratories catalog existing training courses/modules, identify training gaps, inform training curricula, and create career-spanning professional development learning paths, ensuring consistent performance expectations and increasing confidence in shared test results. Ultimately, the framework will aid laboratories in meeting the requirements of ISO/IEC 17025 (2005) international accreditation and the U.S. Food Safety Modernization Act (U.S. Public Law 111-353). In collaboration with the Association of Food and Drug Officials, the Association of Public Health Laboratories, and the Association of American Feed Control Officials, IFPTI is carrying out the project in two phases. In 2013, an expert panel of seven subject matter experts developed competency and curriculum frameworks for five professional levels (entry, mid-level, expert, supervisor/manager, and senior administration) across four competency domains (technical, communication, programmatic, and leadership) including approximately 80 competencies. In 2014 the expert panel will elicit feedback from peers and finalize the framework.

  12. Review of laboratory-based terrestrial bioaccumulation assessment approaches for organic chemicals: Current status and future possibilities.

    PubMed

    Hoke, Robert; Huggett, Duane; Brasfield, Sandra; Brown, Becky; Embry, Michelle; Fairbrother, Anne; Kivi, Michelle; Paumen, Miriam Leon; Prosser, Ryan; Salvito, Dan; Scroggins, Rick

    2016-01-01

    In the last decade, interest has been renewed in approaches for the assessment of the bioaccumulation potential of chemicals, principally driven by the need to evaluate large numbers of chemicals as part of new chemical legislation, while reducing vertebrate test organism use called for in animal welfare legislation. This renewed interest has inspired research activities and advances in bioaccumulation science for neutral organic chemicals in aquatic environments. In January 2013, ILSI Health and Environmental Sciences Institute convened experts to identify the state of the science and existing shortcomings in terrestrial bioaccumulation assessment of neutral organic chemicals. Potential modifications to existing laboratory methods were identified, including areas in which new laboratory approaches or test methods could be developed to address terrestrial bioaccumulation. The utility of "non-ecotoxicity" data (e.g., mammalian laboratory data) was also discussed. The highlights of the workshop discussions are presented along with potential modifications in laboratory approaches and new test guidelines that could be used for assessing the bioaccumulation of chemicals in terrestrial organisms. © 2015 SETAC.

  13. Role of Urine Drug Testing in the Current Opioid Epidemic.

    PubMed

    Mahajan, Gagan

    2017-12-01

    While the evidence for urine drug testing for patients on chronic opioid therapy is weak, the guidelines created by numerous medical societies and state and federal regulatory agencies recommend that it be included as one of the tools used to monitor patients for compliance with chronic opioid therapy. To get the most comprehensive results, clinicians should order both an immunoassay screen and confirmatory urine drug test. The immunoassay screen, which can be performed as an in-office point-of-care test or as a laboratory-based test, is a cheap and convenient study to order. Limitations of an immunoassay screen, however, include having a high threshold of detectability and only providing qualitative information about a select number of drug classes. Because of these restrictions, clinicians should understand that immunoassay screens have high false-positive and false-negative rates. Despite these limitations, though, the results can assist the clinician with making preliminary treatment decisions. In comparison, a confirmatory urine drug test, which can only be performed as a laboratory-based test, has a lower threshold of detectability and provides both qualitative and quantitative information. A urine drug test's greater degree of specificity allows for a relatively low false-negative and false-positive rate in contrast to an immunoassay screen. Like any other diagnostic test, an immunoassay screen and a confirmatory urine drug test both possess limitations. Clinicians must keep this in mind when interpreting an unexpected test result and consult with their laboratory when in doubt about the meaning of the test result to avoid making erroneous decisions that negatively impact both the patient and clinician.

  14. Wildlife specimen collection, preservation, and shipment

    USGS Publications Warehouse

    White, C. LeAnn; Dusek, Robert J.; Franson, J. Christian; Friend, Milton; Gibbs, Samantha E.J.; Wild, Margaret A.

    2015-01-01

    Prior to collecting samples, it is important to determine the capabilities and submission criteria of the laboratory receiving the samples. Some laboratories may specialize in a limited number of tests, be equipped to accept only certain types of tissues (instead of entire carcasses), or specialize in particular species or group of animals (e.g., reptiles, birds, mammals). Diagnostic laboratories have specific requirements regarding preparation, labeling, and shipping of samples. Adherence to these requirements helps ensure the usefulness of any submitted specimens. Although laboratories may vary in the cost and turnaround times for diagnostic tests, some laboratories may be able to prioritize samples and accommodate accelerated time frames if communicated at the time of submission. Keeping a prepacked kit with basic carcass-collection supplies, including a paper copy of the specimen history form (available for download from the Web sites of most diagnostic laboratories), in the office or vehicle will decrease the chances of forgetting an essential item and decrease response time for arriving at an event.

  15. A Study on the Effects of Sympathetic Skin Response Parameters in Diagnosis of Fibromyalgia Using Artificial Neural Networks.

    PubMed

    Ozkan, Ozhan; Yildiz, Murat; Arslan, Evren; Yildiz, Sedat; Bilgin, Suleyman; Akkus, Selami; Koyuncuoglu, Hasan R; Koklukaya, Etem

    2016-03-01

    Fibromyalgia syndrome (FMS), usually observed commonly in females over age 30, is a rheumatic disease accompanied by extensive chronic pain. In the diagnosis of the disease non-objective psychological tests and physiological tests and laboratory test results are evaluated and clinical experiences stand out. However, these tests are insufficient in differentiating FMS with similar diseases that demonstrate symptoms of extensive pain. Thus, objective tests that would help the diagnosis are needed. This study analyzes the effect of sympathetic skin response (SSR) parameters on the auxiliary tests used in FMS diagnosis, the laboratory tests and physiological tests. The study was conducted in Suleyman Demirel University, Faculty of Medicine, Physical Medicine and Rehabilitation Clinic in Turkey with 60 patients diagnosed with FMS for the first time and a control group of 30 healthy individuals. In the study all participants underwent laboratory tests (blood tests), certain physiological tests (pulsation, skin temperature, respiration) and SSR measurements. The test data and SSR parameters obtained were classified using artificial neural network (ANN). Finally, in the ANN framework, where only laboratory and physiological test results were used as input, a simulation result of 96.51 % was obtained, which demonstrated diagnostic accuracy. This data, with the addition of SSR parameter values obtained increased to 97.67 %. This result including SSR parameters - meaning a higher diagnostic accuracy - demonstrated that SSR could be a new auxillary diagnostic method that could be used in the diagnosis of FMS.

  16. Development of optimized PPP insulated pipe-cable systems in the commercial voltage range

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

    Allam, E.M.; McKean, A.L.

    1992-05-01

    The primary objectives of this project included the development of an alternate domestic source of Paper-Polypropylene-Paper (PPP) laminate and the development of optimized designs for PPP-insulated pipe-type cable systems in the commercial voltage range. The development of a domestic source of PPP laminate was successfully completed. This laminate was utilized throughout the program for fabrication of full-size prototype cables submitted for laboratory qualification tests. Selected cables at rated voltages of 138, 230 and 345kV have been designed, fabricated and subjected to the series of qualification tests leading to full laboratory qualification. An optimized design of 2000 kcmil, 345kV cable insulatedmore » with 600 mils of domestic PPP laminate was fabricated and successfully passed all laboratory qualification tests. This cable design was subsequently installed at Waltz Mill to undergo the series of field tests leading to full commercial qualification.« less

  17. Development of optimized PPP insulated pipe-cable systems in the commercial voltage range. Final report

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

    Allam, E.M.; McKean, A.L.

    1992-05-01

    The primary objectives of this project included the development of an alternate domestic source of Paper-Polypropylene-Paper (PPP) laminate and the development of optimized designs for PPP-insulated pipe-type cable systems in the commercial voltage range. The development of a domestic source of PPP laminate was successfully completed. This laminate was utilized throughout the program for fabrication of full-size prototype cables submitted for laboratory qualification tests. Selected cables at rated voltages of 138, 230 and 345kV have been designed, fabricated and subjected to the series of qualification tests leading to full laboratory qualification. An optimized design of 2000 kcmil, 345kV cable insulatedmore » with 600 mils of domestic PPP laminate was fabricated and successfully passed all laboratory qualification tests. This cable design was subsequently installed at Waltz Mill to undergo the series of field tests leading to full commercial qualification.« less

  18. Validation of Dissolution Testing with Biorelevant Media: An OrBiTo Study.

    PubMed

    Mann, James; Dressman, Jennifer; Rosenblatt, Karin; Ashworth, Lee; Muenster, Uwe; Frank, Kerstin; Hutchins, Paul; Williams, James; Klumpp, Lukas; Wielockx, Kristina; Berben, Philippe; Augustijns, Patrick; Holm, Rene; Hofmann, Michael; Patel, Sanjaykumar; Beato, Stefania; Ojala, Krista; Tomaszewska, Irena; Bruel, Jean-Luc; Butler, James

    2017-12-04

    Dissolution testing with biorelevant media has become widespread in the pharmaceutical industry as a means of better understanding how drugs and formulations behave in the gastrointestinal tract. Until now, however, there have been few attempts to gauge the reproducibility of results obtained with these methods. The aim of this study was to determine the interlaboratory reproducibility of biorelevant dissolution testing, using the paddle apparatus (USP 2). Thirteen industrial and three academic laboratories participated in this study. All laboratories were provided with standard protocols for running the tests: dissolution in FaSSGF to simulate release in the stomach, dissolution in a single intestinal medium, FaSSIF, to simulate release in the small intestine, and a "transfer" (two-stage) protocol to simulate the concentration profile when conditions are changed from the gastric to the intestinal environment. The test products chosen were commercially available ibuprofen tablets and zafirlukast tablets. The biorelevant dissolution tests showed a high degree of reproducibility among the participating laboratories, even though several different batches of the commercially available medium preparation powder were used. Likewise, results were almost identicalbetween the commercial biorelevant media and those produced in-house. Comparing results to previous ring studies, including those performed with USP calibrator tablets or commercially available pharmaceutical products in a single medium, the results for the biorelevant studies were highly reproducible on an interlaboratory basis. Interlaboratory reproducibility with the two-stage test was also acceptable, although the variability was somewhat greater than with the single medium tests. Biorelevant dissolution testing is highly reproducible among laboratories and can be relied upon for cross-laboratory comparisons.

  19. Nevada National Security Site Underground Radionuclide Inventory, 1951-1992: Accounting for Radionuclide Decay through September 30, 2012

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

    Finnegan, David Lawrence; Bowen, Scott Michael; Thompson, Joseph L.

    This report is an update of report LA-13859-MS (Bowen et al., 2001). In that original report, the underground radionuclide inventory at the Nevada National Security Site (NNSS) was decay corrected to September 23, 1992, the date of the last underground nuclear test at the NNSS. In this report, the inventory is updated to account for the decay of radionuclides over two additional decades (1992-2012) and revised tritium, fission product and actinide inventory figures and tables are presented. The maximum contaminant levels for radionuclides were also updated to Safe Drinking Water Act Maximum Contaminant Levels (MCLs) (CFR, 2013). Also, a numbermore » of minor errata found in the original publication were corrected. An inventory of radionuclides produced by 828 underground nuclear tests conducted at the NNSS by the Lawrence Livermore National Laboratory, the Los Alamos National Laboratory, and the Department of the Defense from 1951 to 1992 includes tritium, fission products, actinides, and activation products. The inventory presented in this report provides an estimate of radioactivity remaining underground at the NNSS after nuclear testing. The original test inventory is decayed to September 30, 2012, and predictions of inventory decay over the subsequent 1000 years are presented. For the purposes of summary and publication, the Los Alamos National Laboratory and Lawrence Livermore National Laboratory authors of this report subdivided the inventory into five areas corresponding to the principal geographic test centers at the NNSS. The five areas roughly correspond to Underground Test Area “Corrective Action Units” (CAUs) for remediation of groundwater. In addition, the inventory is further subdivided for the Yucca Flat region by tests where the working point depth is more than 328 feet (100 meters) above the water table and tests that were detonated below that level. Water levels used were those from the U. S. Department of Energy, Nevada Operations Office (1997), now called the Nevada Field Office. Curie activities and atoms are reported as of September 30, 2012. This inventory is strictly a compilation of the residual radiologic inventory remaining from the underground nuclear tests conducted by Lawrence Livermore National Laboratory, Los Alamos National Laboratory and the Department of the Defense from 1951 to 1992 and does not include radioactivity from other types of nuclear testing (e.g., atmospheric, reactors, rocket engines). A companion classified report (Miller et al., 2002) contains test-specific data for each test performed at the NNSS. This work has been sponsored by the U. S. Department of Energy, National Nuclear Security Administration Nevada Field Office.« less

  20. Lyme disease: why the controversy?

    PubMed

    Beaman, M H

    2016-12-01

    Some Australians have become convinced of the existence of locally acquired Lyme disease (LD). The history of LD, since its recognition in the early 1970s, is reviewed as a model for investigative approaches to unknown syndromes. Australian Management Guidelines for LD include the requirement for diagnostic testing by National Association of Testing Authorities-accredited laboratories using Therapeutic Goods Administration-licensed tests, which result in the efficient diagnosis of LD in overseas travellers. Despite this, patients who have not left Australia pay many thousands of dollars for non-specialist consultations and testing at overseas laboratories. Unproven long-term therapy with multiple antibiotics has resulted in serious complications, including allergies, line sepsis, pancreatitis and pseudomembranous colitis. Studies have shown that LD vectors are not found in Australia, and Lyme Borrelia has not been found in Australian vectors, animals or patients with autochthonous illnesses. I propose that (i) A non-controversial name for the chronic syndrome should be adopted, 'Australian Multisystem Disorder'. (ii) Research funding should enable the development of a consensus case definition and studies of the epidemiology of this syndrome with laboratory investigations to identify an aetiology and surrogate markers of disease. Prospective, randomised treatment studies could then be undertaken using ethical protocols. © 2016 Royal Australasian College of Physicians.

  1. Establishing Ebola Virus Disease (EVD) diagnostics using GeneXpert technology at a mobile laboratory in Liberia: Impact on outbreak response, case management and laboratory systems strengthening

    PubMed Central

    Condell, Orla; Wasunna, Christine; Kpaka, Jonathan; Zwizwai, Ruth; Nuha, Mahmood; Fallah, Mosoka; Freeman, Maxwell; Harris, Victoria; Miller, Mark; Baller, April; Massaquoi, Moses; Katawera, Victoria; Saindon, John; Bemah, Philip; Hamblion, Esther; Castle, Evelyn; Williams, Desmond; Gasasira, Alex; Nyenswah, Tolbert

    2018-01-01

    The 2014–16 Ebola Virus Disease (EVD) outbreak in West Africa highlighted the necessity for readily available, accurate and rapid diagnostics. The magnitude of the outbreak and the re-emergence of clusters of EVD cases following the declaration of interrupted transmission in Liberia, reinforced the need for sustained diagnostics to support surveillance and emergency preparedness. We describe implementation of the Xpert Ebola Assay, a rapid molecular diagnostic test run on the GeneXpert platform, at a mobile laboratory in Liberia and the subsequent impact on EVD outbreak response, case management and laboratory system strengthening. During the period of operation, site coordination, management and operational capacity was supported through a successful collaboration between Ministry of Health (MoH), World Health Organization (WHO) and international partners. A team of Liberian laboratory technicians were trained to conduct EVD diagnostics and the laboratory had capacity to test 64–100 blood specimens per day. Establishment of the laboratory significantly increased the daily testing capacity for EVD in Liberia, from 180 to 250 specimens at a time when the effectiveness of the surveillance system was threatened by insufficient diagnostic capacity. During the 18 months of operation, the laboratory tested a total of 9,063 blood specimens, including 21 EVD positives from six confirmed cases during two outbreaks. Following clearance of the significant backlog of untested EVD specimens in November 2015, a new cluster of EVD cases was detected at the laboratory. Collaboration between surveillance and laboratory coordination teams during this and a later outbreak in March 2016, facilitated timely and targeted response interventions. Specimens taken from cases during both outbreaks were analysed at the laboratory with results informing clinical management of patients and discharge decisions. The GeneXpert platform is easy to use, has relatively low running costs and can be integrated into other national diagnostic algorithms. The technology has on average a 2-hour sample-to-result time and allows for single specimen testing to overcome potential delays of batching. This model of a mobile laboratory equipped with Xpert Ebola test, staffed by local laboratory technicians, could serve to strengthen outbreak preparedness and response for future outbreaks of EVD in Liberia and the region. PMID:29304039

  2. Establishing Ebola Virus Disease (EVD) diagnostics using GeneXpert technology at a mobile laboratory in Liberia: Impact on outbreak response, case management and laboratory systems strengthening.

    PubMed

    Raftery, Philomena; Condell, Orla; Wasunna, Christine; Kpaka, Jonathan; Zwizwai, Ruth; Nuha, Mahmood; Fallah, Mosoka; Freeman, Maxwell; Harris, Victoria; Miller, Mark; Baller, April; Massaquoi, Moses; Katawera, Victoria; Saindon, John; Bemah, Philip; Hamblion, Esther; Castle, Evelyn; Williams, Desmond; Gasasira, Alex; Nyenswah, Tolbert

    2018-01-01

    The 2014-16 Ebola Virus Disease (EVD) outbreak in West Africa highlighted the necessity for readily available, accurate and rapid diagnostics. The magnitude of the outbreak and the re-emergence of clusters of EVD cases following the declaration of interrupted transmission in Liberia, reinforced the need for sustained diagnostics to support surveillance and emergency preparedness. We describe implementation of the Xpert Ebola Assay, a rapid molecular diagnostic test run on the GeneXpert platform, at a mobile laboratory in Liberia and the subsequent impact on EVD outbreak response, case management and laboratory system strengthening. During the period of operation, site coordination, management and operational capacity was supported through a successful collaboration between Ministry of Health (MoH), World Health Organization (WHO) and international partners. A team of Liberian laboratory technicians were trained to conduct EVD diagnostics and the laboratory had capacity to test 64-100 blood specimens per day. Establishment of the laboratory significantly increased the daily testing capacity for EVD in Liberia, from 180 to 250 specimens at a time when the effectiveness of the surveillance system was threatened by insufficient diagnostic capacity. During the 18 months of operation, the laboratory tested a total of 9,063 blood specimens, including 21 EVD positives from six confirmed cases during two outbreaks. Following clearance of the significant backlog of untested EVD specimens in November 2015, a new cluster of EVD cases was detected at the laboratory. Collaboration between surveillance and laboratory coordination teams during this and a later outbreak in March 2016, facilitated timely and targeted response interventions. Specimens taken from cases during both outbreaks were analysed at the laboratory with results informing clinical management of patients and discharge decisions. The GeneXpert platform is easy to use, has relatively low running costs and can be integrated into other national diagnostic algorithms. The technology has on average a 2-hour sample-to-result time and allows for single specimen testing to overcome potential delays of batching. This model of a mobile laboratory equipped with Xpert Ebola test, staffed by local laboratory technicians, could serve to strengthen outbreak preparedness and response for future outbreaks of EVD in Liberia and the region.

  3. US/Russian Joint Film Test

    NASA Technical Reports Server (NTRS)

    Slater, Richard

    1996-01-01

    A joint U.S./Russian film test was conducted during MIR Mission 18 to evaluate the effects of radiation on photographic film during long-duration space flights. Two duplicate sets of film were flown on this MIR mission: one set was processed and evaluated by the NASA/JSC Photographic Laboratory, and the other by the RKK Energia's Photographic Laboratory in Moscow. This preliminary report includes only the results of the JSC evaluation (excluding the SN-10 film which was not available for evaluation at the time this report was written). The final report will include an evaluation by JSC of the SN-10 film and an evaluation of the test data by the RKK Energia. ISC's evaluation of the test data showed the positive film flown was damaged very little when exposed to approximately 8 rads of radiation. Two of the three negative films were significantly damaged and the third film was damaged only moderately.

  4. US/Russian Joint Film Test

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

    Slater, R.

    1996-04-01

    A joint U.S./Russian film test was conducted during MIR Mission 18 to evaluate the effects of radiation on photographic film during long-duration space flights. Two duplicate sets of film were flown on this MIR mission: one set was processed and evaluated by the NASA/JSC Photographic Laboratory, and the other by the RKK Energia`s Photographic Laboratory in Moscow. This preliminary report includes only the results of the JSC evaluation (excluding the SN-10 film which was not available for evaluation at the time this report was written). The final report will include an evaluation by JSC of the SN-10 film and anmore » evaluation of the test data by the RKK Energia. ISC`s evaluation of the test data showed the positive film flown was damaged very little when exposed to approximately 8 rads of radiation. Two of the three negative films were significantly damaged and the third film was damaged only moderately.« less

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

    PubMed

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

    2006-06-01

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

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

    Warpinski, N.R.; Branagan, P.T.; Sattler, A.R.

    This paper is a case study of the stimulation and testing of tight, lenticular sands in the paludal interval of the Mesaverde group in the Piceance basin at DOE's Multiwell Experiment (MWX) site in Colorado. Topics discussed include geologic data, stress test results, well testing, laboratory core studies, stimulation and stimulation analyses, and postfracture operations.

  7. Laboratory-based versus non-laboratory-based method for assessment of cardiovascular disease risk: the NHANES I Follow-up Study cohort

    PubMed Central

    Gaziano, Thomas A; Young, Cynthia R; Fitzmaurice, Garrett; Atwood, Sidney; Gaziano, J Michael

    2008-01-01

    Summary Background Around 80% of all cardiovascular deaths occur in developing countries. Assessment of those patients at high risk is an important strategy for prevention. Since developing countries have limited resources for prevention strategies that require laboratory testing, we assessed if a risk prediction method that did not require any laboratory tests could be as accurate as one requiring laboratory information. Methods The National Health and Nutrition Examination Survey (NHANES) was a prospective cohort study of 14 407 US participants aged between 25–74 years at the time they were first examined (between 1971 and 1975). Our follow-up study population included participants with complete information on these surveys who did not report a history of cardiovascular disease (myocardial infarction, heart failure, stroke, angina) or cancer, yielding an analysis dataset N=6186. We compared how well either method could predict first-time fatal and non-fatal cardiovascular disease events in this cohort. For the laboratory-based model, which required blood testing, we used standard risk factors to assess risk of cardiovascular disease: age, systolic blood pressure, smoking status, total cholesterol, reported diabetes status, and current treatment for hypertension. For the non-laboratory-based model, we substituted body-mass index for cholesterol. Findings In the cohort of 6186, there were 1529 first-time cardiovascular events and 578 (38%) deaths due to cardiovascular disease over 21 years. In women, the laboratory-based model was useful for predicting events, with a c statistic of 0·829. The c statistic of the non-laboratory-based model was 0·831. In men, the results were similar (0·784 for the laboratory-based model and 0·783 for the non-laboratory-based model). Results were similar between the laboratory-based and non-laboratory-based models in both men and women when restricted to fatal events only. Interpretation A method that uses non-laboratory-based risk factors predicted cardiovascular events as accurately as one that relied on laboratory-based values. This approach could simplify risk assessment in situations where laboratory testing is inconvenient or unavailable. PMID:18342687

  8. A review of the UK methodology used for monitoring cigarette smoke yields, aspects of analytical data variability and their impact on current and future regulatory compliance.

    PubMed

    Purkis, Stephen W; Drake, Linda; Meger, Michael; Mariner, Derek C

    2010-04-01

    The European Union (EU) requires that tobacco products are regulated by Directive 2001/37/EC through testing and verification of results on the basis of standards developed by the International Organization for Standardization (ISO). In 2007, the European Commission provided guidance to EU Member States by issuing criteria for competent laboratories which includes accreditation to ISO 17025:2005. Another criterion requires regular laboratory participation in collaborative studies that predict the measurement tolerance that must be observed to conclude that test results on any particular product are different. However, differences will always occur when comparing overall data across products between different laboratories. A forum for technical discussion between laboratories testing products as they are manufactured and a Government appointed verification laboratory gives transparency, ensures consistency and reduces apparent compliance issues to the benefit of all parties. More than 30years ago, such a forum was set up in the UK that continued until 2007 and will be described in this document. Anticipating further testing requirements in future product regulation as proposed by the Framework Convention on Tobacco Control, cooperation between accredited laboratories, whether for testing or verification, should be established to share know-how, to ensure a standardised level of quality and to offer competent technical dialogue in the best interest of regulators and manufacturers alike. Copyright 2009 Elsevier Inc. All rights reserved.

  9. Multidrug-resistant typhoid fever with neurologic findings on the Malawi-Mozambique border.

    PubMed

    Lutterloh, Emily; Likaka, Andrew; Sejvar, James; Manda, Robert; Naiene, Jeremias; Monroe, Stephan S; Khaila, Tadala; Chilima, Benson; Mallewa, Macpherson; Kampondeni, Sam D; Lowther, Sara A; Capewell, Linda; Date, Kashmira; Townes, David; Redwood, Yanique; Schier, Joshua G; Nygren, Benjamin; Tippett Barr, Beth; Demby, Austin; Phiri, Abel; Lungu, Rudia; Kaphiyo, James; Humphrys, Michael; Talkington, Deborah; Joyce, Kevin; Stockman, Lauren J; Armstrong, Gregory L; Mintz, Eric

    2012-04-01

    Salmonella enterica serovar Typhi causes an estimated 22 million cases of typhoid fever and 216 000 deaths annually worldwide. We investigated an outbreak of unexplained febrile illnesses with neurologic findings, determined to be typhoid fever, along the Malawi-Mozambique border. The investigation included active surveillance, interviews, examinations of ill and convalescent persons, medical chart reviews, and laboratory testing. Classification as a suspected case required fever and ≥1 other finding (eg, headache or abdominal pain); a probable case required fever and a positive rapid immunoglobulin M antibody test for typhoid (TUBEX TF); a confirmed case required isolation of Salmonella Typhi from blood or stool. Isolates underwent antimicrobial susceptibility testing and subtyping by pulsed-field gel electrophoresis (PFGE). We identified 303 cases from 18 villages with onset during March-November 2009; 214 were suspected, 43 were probable, and 46 were confirmed cases. Forty patients presented with focal neurologic abnormalities, including a constellation of upper motor neuron signs (n = 19), ataxia (n = 22), and parkinsonism (n = 8). Eleven patients died. All 42 isolates tested were resistant to ampicillin, chloramphenicol, and trimethoprim-sulfamethoxazole; 4 were also resistant to nalidixic acid. Thirty-five of 42 isolates were indistinguishable by PFGE. The unusual neurologic manifestations posed a diagnostic challenge that was resolved through rapid typhoid antibody testing in the field and subsequent blood culture confirmation in the Malawi national reference laboratory. Extending laboratory diagnostic capacity, including blood culture, to populations at risk for typhoid fever in Africa will improve outbreak detection, response, and clinical treatment.

  10. GRC Ground Support Facilities

    NASA Technical Reports Server (NTRS)

    SaintOnge, Thomas H.

    2010-01-01

    The ISS Program is conducting an "ISS Research Academy' at JSC the first week of August 2010. This Academy will be a tutorial for new Users of the International Space Station, focused primarily on the new ISS National Laboratory and its members including Non-Profit Organizations, other government agencies and commercial users. Presentations on the on-orbit research facilities accommodations and capabilities will be made, as well as ground based hardware development, integration and test facilities and capabilities. This presentation describes the GRC Hardware development, test and laboratory facilities.

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

    Lundstrom, Blake; Chakraborty, Sudipta; Lauss, Georg

    This paper presents a concise description of state-of-the-art real-time simulation-based testing methods and demonstrates how they can be used independently and/or in combination as an integrated development and validation approach for smart grid DERs and systems. A three-part case study demonstrating the application of this integrated approach at the different stages of development and validation of a system-integrated smart photovoltaic (PV) inverter is also presented. Laboratory testing results and perspectives from two international research laboratories are included in the case study.

  12. Air Flow Modeling in the Wind Tunnel of the FHWA Aerodynamics Laboratory at Turner-Fairbank Highway Research Center

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

    Sitek, M. A.; Lottes, S. A.; Bojanowski, C.

    Computational fluid dynamics (CFD) modeling is widely used in industry for design and in the research community to support, compliment, and extend the scope of experimental studies. Analysis of transportation infrastructure using high performance cluster computing with CFD and structural mechanics software is done at the Transportation Research and Analysis Computing Center (TRACC) at Argonne National Laboratory. These resources, available at TRACC, were used to perform advanced three-dimensional computational simulations of the wind tunnel laboratory at the Turner-Fairbank Highway Research Center (TFHRC). The goals were to verify the CFD model of the laboratory wind tunnel and then to use versionsmore » of the model to provide the capability to (1) perform larger parametric series of tests than can be easily done in the laboratory with available budget and time, (2) to extend testing to wind speeds that cannot be achieved in the laboratory, and (3) to run types of tests that are very difficult or impossible to run in the laboratory. Modern CFD software has many physics models and domain meshing options. Models, including the choice of turbulence and other physics models and settings, the computational mesh, and the solver settings, need to be validated against measurements to verify that the results are sufficiently accurate for use in engineering applications. The wind tunnel model was built and tested, by comparing to experimental measurements, to provide a valuable tool to perform these types of studies in the future as a complement and extension to TFHRC’s experimental capabilities. Wind tunnel testing at TFHRC is conducted in a subsonic open-jet wind tunnel with a 1.83 m (6 foot) by 1.83 m (6 foot) cross section. A three component dual force-balance system is used to measure forces acting on tested models, and a three degree of freedom suspension system is used for dynamic response tests. Pictures of the room are shown in Figure 1-1 to Figure 1-4. A detailed CAD geometry and CFD model of the wind tunnel laboratory at TFHRC was built and tested. Results were compared against experimental wind velocity measurements at a large number of locations around the room. This testing included an assessment of the air flow uniformity provided by the tunnel to the test zone and assessment of room geometry effects, such as influence of the proximity the room walls, the non-symmetrical position of the tunnel in the room, and the influence of the room setup on the air flow in the room. This information is useful both for simplifying the computational model and in deciding whether or not moving, or removing, some of the furniture or other movable objects in the room will change the flow in the test zone.« less

  13. Determination of Glucosamine in Raw Materials and Dietary Supplements Containing Glucosamine Sulfate and/or Glucosamine Hydrochloride by High-Performance Liquid Chromatography with FMOC-Su Derivatization: Collaborative Study

    PubMed Central

    Zhou, Joseph Ziqi; Waszkuc, Ted; Mohammed, Felicia

    2008-01-01

    A collaborative study was conducted for determination of glucosamine in raw materials and dietary supplements containing glucosamine sulfate and/or glucosamine hydrochloride by high-performance liquid Chromatography (HPLC) with N-(9-fluorenyl-methoxycarbonyloxy) succinimide (FMOC-Su) derivatization. Thirteen blind materials, one pair of which were duplicates, were tested by 12 collaborating laboratories. The test samples consisted of various commercial products, including tablets, capsules, drink mix, and liquids as well as raw materials, blanks, and those for spike recovery analyses. The tests with blank products and products spiked with glucosamine showed good specificity of the method. The average recoveries at spike levels of 100 and 150% of the declared amount were 99.0% with a relative standard deviation (RSD) of 2.1%, and 101% with an RSD of 2.3%, respectively. The test results between laboratories on each commercial product were reproducible with RSD values of no more than 4.0%, and the results were repeatable in the same laboratory with an average RSD of 0.7%. HorRat values ranged from 0.5 to 1.7 on both tests of spike recovery and reproducibility between laboratories on commercial products. The average determination coefficient of the calibration curves from the laboratories was 0.9995 with an RSD of 0.03%. All of the 12 collaborating laboratories succeeded in the study and none of their reported test results were outliers, partly indicating the robustness of the method. It is recommended that the method be accepted by AOAC INTERNATIONAL as Official First Action. PMID:16152919

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

    Rodriguez, J.R.; Ahrens, J.S.; Lowe, D.L.

    Throughout the years, Sandia National Laboratories (SNL) has performed various laboratory evaluations of entry control devices, including biometric identity verifiers. The reports which resulted from this testing have been very well received by the physical security community. This same community now requires equally informative field study data. To meet this need we have conducted a field study in an effort to develop the tools and methods which our customers can use to translate laboratory data into operational field performance. The field testing described in this report was based on the Recognition Systems Inc.`s (RSI) model ID3D HandKey biometric verifier. Thismore » device was selected because it is referenced in DOE documents such as the Guide for Implementation of the DOE Standard Badge and is the de facto biometric standard for the DOE. The ID3D HandKey is currently being used at several DOE sites such as Hanford, Rocky Flats, Pantex, Savannah River, and Idaho Nuclear Engineering Laboratory. The ID3D HandKey was laboratory tested at SNL. It performed very well during this test, exhibiting an equal error point of 0.2 percent. The goals of the field test were to identify operational characteristics and design guidelines to help system engineers translate laboratory data into field performance. A secondary goal was to develop tools which could be used by others to evaluate system effectiveness or improve the performance of their systems. Operational characteristics were determined by installing a working system and studying its operation over a five month period. Throughout this test we developed tools which could be used by others to similarly gauge system effectiveness.« less

  15. [Complicated urinary tract infections--from the perspective of the medical technologist].

    PubMed

    Nagasawa, Zenzo

    2002-07-01

    We would like to propose re-establishment of the protocol for ordering a clinical microbiology laboratory test after a bedside screening test using urine reagent strip when urinary tract infection is suspected. Media for isolation shall be chosen by the clinical microbiology laboratory after checking turbidity and microscopic examination of the urine specimen. In cases of complicated urinary tract infections, quantitative culture should be performed to investigate changes in the number of microorganism to grasp condition of super infection. In such infections, there are many cases in which multiple microorganism growth including glucose non-fermenting gram-negative bacilli can be recognized. Therefore, it is necessary to inspect colonies on media as long as possible (24 hrs culture may be short in some cases). The protocol for microorganism identification and susceptibility test for such specimen varies in each laboratory, considering the Health Insurance Point System (reimbursement system by MHW). It is necessary to communicate with physicians and to refer to past results to proceed with the laboratory test properly. Therefore, a Certified Clinical Microbiology Medical Technologist is needed and the role played by such staff is important.

  16. An examination of speech reception thresholds measured in a simulated reverberant cafeteria environment.

    PubMed

    Best, Virginia; Keidser, Gitte; Buchholz, Jörg M; Freeston, Katrina

    2015-01-01

    There is increasing demand in the hearing research community for the creation of laboratory environments that better simulate challenging real-world listening environments. The hope is that the use of such environments for testing will lead to more meaningful assessments of listening ability, and better predictions about the performance of hearing devices. Here we present one approach for simulating a complex acoustic environment in the laboratory, and investigate the effect of transplanting a speech test into such an environment. Speech reception thresholds were measured in a simulated reverberant cafeteria, and in a more typical anechoic laboratory environment containing background speech babble. The participants were 46 listeners varying in age and hearing levels, including 25 hearing-aid wearers who were tested with and without their hearing aids. Reliable SRTs were obtained in the complex environment, but led to different estimates of performance and hearing-aid benefit from those measured in the standard environment. The findings provide a starting point for future efforts to increase the real-world relevance of laboratory-based speech tests.

  17. An examination of speech reception thresholds measured in a simulated reverberant cafeteria environment

    PubMed Central

    Best, Virginia; Keidser, Gitte; Buchholz, J(x004E7)rg M.; Freeston, Katrina

    2016-01-01

    Objective There is increasing demand in the hearing research community for the creation of laboratory environments that better simulate challenging real-world listening environments. The hope is that the use of such environments for testing will lead to more meaningful assessments of listening ability, and better predictions about the performance of hearing devices. Here we present one approach for simulating a complex acoustic environment in the laboratory, and investigate the effect of transplanting a speech test into such an environment. Design Speech reception thresholds were measured in a simulated reverberant cafeteria, and in a more typical anechoic laboratory environment containing background speech babble. Study Sample The participants were 46 listeners varying in age and hearing levels, including 25 hearing-aid wearers who were tested with and without their hearing aids. Results Reliable SRTs were obtained in the complex environment, but led to different estimates of performance and hearing aid benefit from those measured in the standard environment. Conclusions The findings provide a starting point for future efforts to increase the real-world relevance of laboratory-based speech tests. PMID:25853616

  18. COMPARABLE MEASURES OF COGNITIVE FUNCTION IN HUMAN INFANTS AND LABORATORY ANIMALS TO IDENTIFY ENVIRONMENTAL HEALTH RISKS TO CHILDREN

    EPA Science Inventory

    The importance of including neurodevelopmental end points in environmental studies is clear. A validated measure of cognitive function in human infants that also has a homologous or parallel test in laboratory animal studies will provide a valuable approach for large-scale studie...

  19. Space shuttle program: Shuttle Avionics Integration Laboratory. Volume 7: Logistics management plan

    NASA Technical Reports Server (NTRS)

    1974-01-01

    The logistics management plan for the shuttle avionics integration laboratory defines the organization, disciplines, and methodology for managing and controlling logistics support. Those elements requiring management include maintainability and reliability, maintenance planning, support and test equipment, supply support, transportation and handling, technical data, facilities, personnel and training, funding, and management data.

  20. A Laboratory Exercise on Photoperiodic Changes in the Testes of the Mongolian Gerbil.

    ERIC Educational Resources Information Center

    Treagust, David F.; And Others

    1980-01-01

    A laboratory exercise using a gerbil is described for use in the high school biology class and in accordance with the National Science Teachers Association guidelines. The authors cite references that deal with current awareness of the moral status concerning animals. The exercise includes measurement and calculations. (SA)

  1. 75 FR 30041 - Medicare Program; Public Meeting in Calendar Year 2010 for New Clinical Laboratory Tests Payment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1340-N... CY 2011 Clinical Laboratory Fee Schedule. The first method, called ``cross-walking,'' is used when a...-walk or gap-fill. II. Format This meeting to receive comments and recommendations (including...

  2. Report on the Project for Establishment of the Standardized Korean Laboratory Terminology Database, 2015.

    PubMed

    Jung, Bo Kyeung; Kim, Jeeyong; Cho, Chi Hyun; Kim, Ju Yeon; Nam, Myung Hyun; Shin, Bong Kyung; Rho, Eun Youn; Kim, Sollip; Sung, Heungsup; Kim, Shinyoung; Ki, Chang Seok; Park, Min Jung; Lee, Kap No; Yoon, Soo Young

    2017-04-01

    The National Health Information Standards Committee was established in 2004 in Korea. The practical subcommittee for laboratory test terminology was placed in charge of standardizing laboratory medicine terminology in Korean. We aimed to establish a standardized Korean laboratory terminology database, Korea-Logical Observation Identifier Names and Codes (K-LOINC) based on former products sponsored by this committee. The primary product was revised based on the opinions of specialists. Next, we mapped the electronic data interchange (EDI) codes that were revised in 2014, to the corresponding K-LOINC. We established a database of synonyms, including the laboratory codes of three reference laboratories and four tertiary hospitals in Korea. Furthermore, we supplemented the clinical microbiology section of K-LOINC using an alternative mapping strategy. We investigated other systems that utilize laboratory codes in order to investigate the compatibility of K-LOINC with statistical standards for a number of tests. A total of 48,990 laboratory codes were adopted (21,539 new and 16,330 revised). All of the LOINC synonyms were translated into Korean, and 39,347 Korean synonyms were added. Moreover, 21,773 synonyms were added from reference laboratories and tertiary hospitals. Alternative strategies were established for mapping within the microbiology domain. When we applied these to a smaller hospital, the mapping rate was successfully increased. Finally, we confirmed K-LOINC compatibility with other statistical standards, including a newly proposed EDI code system. This project successfully established an up-to-date standardized Korean laboratory terminology database, as well as an updated EDI mapping to facilitate the introduction of standard terminology into institutions. © 2017 The Korean Academy of Medical Sciences.

  3. Impact of providing fee data on laboratory test ordering: a controlled clinical trial.

    PubMed

    Feldman, Leonard S; Shihab, Hasan M; Thiemann, David; Yeh, Hsin-Chieh; Ardolino, Margaret; Mandell, Steven; Brotman, Daniel J

    2013-05-27

    Inpatient care providers often order laboratory tests without any appreciation for the costs of the tests. To determine whether we could decrease the number of laboratory tests ordered by presenting providers with test fees at the time of order entry in a tertiary care hospital, without adding extra steps to the ordering process. Controlled clinical trial. Tertiary care hospital. All providers, including physicians and nonphysicians, who ordered laboratory tests through the computerized provider order entry system at The Johns Hopkins Hospital. We randomly assigned 61 diagnostic laboratory tests to an "active" arm (fee displayed) or to a control arm (fee not displayed). During a 6-month baseline period (November 10, 2008, through May 9, 2009), we did not display any fee data. During a 6-month intervention period 1 year later (November 10, 2009, through May 9, 2010), we displayed fees, based on the Medicare allowable fee, for active tests only. We examined changes in the total number of orders placed, the frequency of ordered tests (per patient-day), and total charges associated with the orders according to the time period (baseline vs intervention period) and by study group (active test vs control). For the active arm tests, rates of test ordering were reduced from 3.72 tests per patient-day in the baseline period to 3.40 tests per patient-day in the intervention period (8.59% decrease; 95% CI, -8.99% to -8.19%). For control arm tests, ordering increased from 1.15 to 1.22 tests per patient-day from the baseline period to the intervention period (5.64% increase; 95% CI, 4.90% to 6.39%) (P < .001 for difference over time between active and control tests). Presenting fee data to providers at the time of order entry resulted in a modest decrease in test ordering. Adoption of this intervention may reduce the number of inappropriately ordered diagnostic tests.

  4. Use of laboratory testing for genital chlamydial infection in Norway.

    PubMed Central

    Aavitsland, P

    1993-01-01

    OBJECTIVE--To assess the use of laboratory tests for genital chlamydial infection in Norway. DESIGN--Questionnaire survey of general practitioners' practice in chlamydial testing, retrospective survey of laboratory records, 1986-91, and prospective study of testing in one laboratory during four weeks. SETTING--All 18 microbiological laboratories in Norway (4.2 million population), including one serving all doctors in Vestfold county (0.2 million population). SUBJECTS--302 general practitioners. MAIN MEASURES--GPs' routine practice, methods used for testing, 1986-91, and sex specific and age group specific testing in 1991. RESULTS--201(69%) GPs replied to the questionnaire: 101(51%) would test all women younger than 25 years at routine pelvic examination, 107(54%) all girls at first pelvic examination, 131(66%) all pregnant women, and 106(54%) all men whose female partner had urogenital complaints. Nationwide in 1986, 122,000 tests were performed (2.9 per 100 population); 10% were positive and 51% were cell culture tests. In 1991, 341,000 tests were performed (8.0 per 100 population); 4.5% were positive and 15% were cell culture tests. 13,184 tests were performed in Vestfold in 1991 (6.6 per 100 population). The age group specific rates (per 100 population) among women were: age 15-19 years, 22.0(95% confidence interval 18.2 to 25.8); 20-24 years, 47.2(42.1 to 52.3); 25-29 years, 42.3(37.1 to 47.5); 30-34 years, 29.8(25.4 to 34.2); and 35-39 years, 12.5(9.5 to 15.5). CONCLUSIONS--GPs use liberal indications for testing. The dramatic increase in testing, especially by enzyme immunoassays, in populations with a low prevalence of infection results in low cost effectiveness and low predictive value of positive tests, which in women over 29 years is estimated as 17-36%. IMPLICATIONS--Doctors should be educated about the limitations of enzyme immunoassays in screening low prevalence populations, and laboratories should apply a confirmatory test to specimens testing positive with such assays. PMID:10131639

  5. 42 CFR 486.344 - Condition: Evaluation and management of potential donors and organ placement and recovery.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... potential donor (including point-of-care testing and blood typing) are conducted by a laboratory that is... chapter. (3) Ensure that the potential donor's blood is typed using two separate blood samples. (4) Document potential donor's record with all test results, including blood type, before organ recovery. (d...

  6. 42 CFR 486.344 - Condition: Evaluation and management of potential donors and organ placement and recovery.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... potential donor (including point-of-care testing and blood typing) are conducted by a laboratory that is... chapter. (3) Ensure that the potential donor's blood is typed using two separate blood samples. (4) Document potential donor's record with all test results, including blood type, before organ recovery. (d...

  7. 42 CFR 486.344 - Condition: Evaluation and management of potential donors and organ placement and recovery.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... potential donor (including point-of-care testing and blood typing) are conducted by a laboratory that is... chapter. (3) Ensure that the potential donor's blood is typed using two separate blood samples. (4) Document potential donor's record with all test results, including blood type, before organ recovery. (d...

  8. Hydraulic manipulator design, analysis, and control at Oak Ridge National Laboratory

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

    Kress, R.L.; Jansen, J.F.; Love, L.J.

    1996-09-01

    To meet the increased payload capacities demanded by present-day tasks, manipulator designers have turned to hydraulics as a means of actuation. Hydraulics have always been the actuator of choice when designing heavy-life construction and mining equipment such as bulldozers, backhoes, and tunneling devices. In order to successfully design, build, and deploy a new hydraulic manipulator (or subsystem) sophisticated modeling, analysis, and control experiments are usually needed. To support the development and deployment of new hydraulic manipulators Oak Ridge National Laboratory (ORNL) has outfitted a significant experimental laboratory and has developed the software capability for research into hydraulic manipulators, hydraulic actuators,more » hydraulic systems, modeling of hydraulic systems, and hydraulic controls. The hydraulics laboratory at ORNL has three different manipulators. First is a 6-Degree-of-Freedom (6-DoF), multi-planer, teleoperated, flexible controls test bed used for the development of waste tank clean-up manipulator controls, thermal studies, system characterization, and manipulator tracking. Finally, is a human amplifier test bed used for the development of an entire new class of teleoperated systems. To compliment the hardware in the hydraulics laboratory, ORNL has developed a hydraulics simulation capability including a custom package to model the hydraulic systems and manipulators for performance studies and control development. This paper outlines the history of hydraulic manipulator developments at ORNL, describes the hydraulics laboratory, discusses the use of the equipment within the laboratory, and presents some of the initial results from experiments and modeling associated with these hydraulic manipulators. Included are some of the results from the development of the human amplifier/de-amplifier concepts, the characterization of the thermal sensitivity of hydraulic systems, and end-point tracking accuracy studies. Experimental and analytical results are included.« less

  9. Laboratory compliance with the American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 testing guidelines: a 3-year comparison of validation procedures.

    PubMed

    Dyhdalo, Kathryn S; Fitzgibbons, Patrick L; Goldsmith, Jeffery D; Souers, Rhona J; Nakhleh, Raouf E

    2014-07-01

    The American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) published guidelines in 2007 regarding testing accuracy, interpretation, and reporting of results for HER2 studies. A 2008 survey identified areas needing improved compliance. To reassess laboratory response to those guidelines following a full accreditation cycle for an updated snapshot of laboratory practices regarding ASCO/CAP guidelines. In 2011, a survey was distributed with the HER2 immunohistochemistry (IHC) proficiency testing program identical to the 2008 survey. Of the 1150 surveys sent, 977 (85.0%) were returned, comparable to the original survey response in 2008 (757 of 907; 83.5%). New participants submitted 124 of 977 (12.7%) surveys. The median laboratory accession rate was 14,788 cases with 211 HER2 tests performed annually. Testing was validated with fluorescence in situ hybridization in 49.1% (443 of 902) of the laboratories; 26.3% (224 of 853) of the laboratories used another IHC assay. The median number of cases to validate fluorescence in situ hybridization (n = 40) and IHC (n = 27) was similar to those in 2008. Ninety-five percent concordance with fluorescence in situ hybridization was achieved by 76.5% (254 of 332) of laboratories for IHC(-) findings and 70.4% (233 of 331) for IHC(+) cases. Ninety-five percent concordance with another IHC assay was achieved by 71.1% (118 of 168) of the laboratories for negative findings and 69.6% (112 of 161) of the laboratories for positive cases. The proportion of laboratories interpreting HER2 IHC using ASCO/CAP guidelines (86.6% [798 of 921] in 2011; 83.8% [605 of 722] in 2008) remains similar. Although fixation time improvements have been made, assay validation deficiencies still exist. The results of this survey were shared within the CAP, including the Laboratory Accreditation Program and the ASCO/CAP panel revising the HER2 guidelines published in October 2013. The Laboratory Accreditation Program checklist was changed to strengthen HER2 validation practices.

  10. [Laboratory diagnosis of lipid imbalance].

    PubMed

    Siemianowicz, K

    1996-01-01

    Accurate diagnosis of hyperlipidaemia is necessary for the effective treatment. Measurements in serum or plasma obtained after an overnight fast of over 16 hours should include total cholesterol, triglycerides and HDL-cholesterol concentrations; LDL-cholesterol can be calculated using the Friedelwald's formula. Lipoprotein electrophoresis is used to define different phenotypes of hyperlipoproteinaemia according to the Fredrickson's classification. More sophisticated tests include apolipoprotein analysis, determination of Lp(a) concentration, activities of enzymes involved in lipid metabolism and genetic studies. Secondary causes of hyperlipidaemia, including liver, kidney, endocrine disorders should be excluded using the laboratory methods.

  11. Materials Science Laboratory

    NASA Technical Reports Server (NTRS)

    Jackson, Dionne

    2005-01-01

    The NASA Materials Science Laboratory (MSL) provides science and engineering services to NASA and Contractor customers at KSC, including those working for the Space Shuttle. International Space Station. and Launch Services Programs. These services include: (1) Independent/unbiased failure analysis (2) Support to Accident/Mishap Investigation Boards (3) Materials testing and evaluation (4) Materials and Processes (M&P) engineering consultation (5) Metrology (6) Chemical analysis (including ID of unknown materials) (7) Mechanical design and fabrication We provide unique solutions to unusual and urgent problems associated with aerospace flight hardware, ground support equipment and related facilities.

  12. International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants.

    PubMed

    Gosselin, Robert C; Adcock, Dorothy M; Bates, Shannon M; Douxfils, Jonathan; Favaloro, Emmanuel J; Gouin-Thibault, Isabelle; Guillermo, Cecilia; Kawai, Yohko; Lindhoff-Last, Edelgard; Kitchen, Steve

    2018-03-01

    This guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH) for providing haemostasis-related guidance documents for clinical laboratories. This inaugural coagulation ICSH document was developed by an ad hoc committee, comprised of international clinical and laboratory direct acting oral anticoagulant (DOAC) experts. The committee developed consensus recommendations for laboratory measurement of DOACs (dabigatran, rivaroxaban, apixaban and edoxaban), which would be germane for laboratories assessing DOAC anticoagulation. This guidance document addresses all phases of laboratory DOAC measurements, including pre-analytical (e.g. preferred time sample collection, preferred sample type, sample stability), analytical (gold standard method, screening and quantifying methods) and post analytical (e.g. reporting units, quality assurance). The committee addressed the use and limitations of screening tests such as prothrombin time, activated partial thromboplastin time as well as viscoelastic measurements of clotting blood and point of care methods. Additionally, the committee provided recommendations for the proper validation or verification of performance of laboratory assays prior to implementation for clinical use, and external quality assurance to provide continuous assessment of testing and reporting method. Schattauer GmbH Stuttgart.

  13. Effects of the pyrethroid insecticide gamma-cyhalothrin on aquatic invertebrates in laboratory and outdoor microcosm tests.

    PubMed

    van Wijngaarden, René P A; Barber, Ian; Brock, Theo C M

    2009-02-01

    The sensitivity of a range of freshwater lentic invertebrates to gamma-cyhalothrin (GCH), a single enantiomer of the synthetic pyrethroid lambda-cyhalothrin, was assessed in single species laboratory tests and an outdoor multi-species ecosystem test. The most sensitive species in the laboratory single species tests with GCH was Chaoborus obscuripes (96 h EC(50): 3.8 ng/l). The species sensitivity distribution curve, based on the laboratory 96 h EC(50) acute toxicity data for eight species, gave a median HC(5) value for GCH of 2.12 ng/l. The NOEC(community) derived from the multi-species ecosystem test was 5 ng/l, and the insects Chaoborus sp. and Caenis sp. were identified as the most sensitive species. The results indicate that the median HC(5), based on eight species selected to include those known to be sensitive to pyrethroids, provided a good estimation of the NOEC(community) for GCH. Furthermore, the results for GCH indicated that the endpoints typically used in higher-tier risk assessments for pesticides in Europe (HC(5) and NOEC(community)) were consistent with expectations when compared to the equivalent endpoints for the racemate LCH.

  14. Modelling of LOCA Tests with the BISON Fuel Performance Code

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

    Williamson, Richard L; Pastore, Giovanni; Novascone, Stephen Rhead

    2016-05-01

    BISON is a modern finite-element based, multidimensional nuclear fuel performance code that is under development at Idaho National Laboratory (USA). Recent advances of BISON include the extension of the code to the analysis of LWR fuel rod behaviour during loss-of-coolant accidents (LOCAs). In this work, BISON models for the phenomena relevant to LWR cladding behaviour during LOCAs are described, followed by presentation of code results for the simulation of LOCA tests. Analysed experiments include separate effects tests of cladding ballooning and burst, as well as the Halden IFA-650.2 fuel rod test. Two-dimensional modelling of the experiments is performed, and calculationsmore » are compared to available experimental data. Comparisons include cladding burst pressure and temperature in separate effects tests, as well as the evolution of fuel rod inner pressure during ballooning and time to cladding burst. Furthermore, BISON three-dimensional simulations of separate effects tests are performed, which demonstrate the capability to reproduce the effect of azimuthal temperature variations in the cladding. The work has been carried out in the frame of the collaboration between Idaho National Laboratory and Halden Reactor Project, and the IAEA Coordinated Research Project FUMAC.« less

  15. Comparison of current meters used for stream gaging

    USGS Publications Warehouse

    Fulford, Janice M.; Thibodeaux, Kirk G.; Kaehrle, William R.

    1994-01-01

    The U.S. Geological Survey (USGS) is field and laboratory testing the performance of several current meters used throughout the world for stream gaging. Meters tested include horizontal-axis current meters from Germany, the United Kingdom, and the People's Republic of China, and vertical-axis and electromagnetic current meters from the United States. Summarized are laboratory test results for meter repeatability, linearity, and response to oblique flow angles and preliminary field testing results. All current meters tested were found to under- and over-register velocities; errors usually increased as the velocity and angle of the flow increased. Repeatability and linearity of all meters tested were good. In the field tests, horizontal-axis meters, except for the two meters from the People's Republic of China, registered higher velocity than did the vertical-axis meters.

  16. System for Informatics in the Molecular Pathology Laboratory: An Open-Source End-to-End Solution for Next-Generation Sequencing Clinical Data Management.

    PubMed

    Kang, Wenjun; Kadri, Sabah; Puranik, Rutika; Wurst, Michelle N; Patil, Sushant A; Mujacic, Ibro; Benhamed, Sonia; Niu, Nifang; Zhen, Chao Jie; Ameti, Bekim; Long, Bradley C; Galbo, Filipo; Montes, David; Iracheta, Crystal; Gamboa, Venessa L; Lopez, Daisy; Yourshaw, Michael; Lawrence, Carolyn A; Aisner, Dara L; Fitzpatrick, Carrie; McNerney, Megan E; Wang, Y Lynn; Andrade, Jorge; Volchenboum, Samuel L; Furtado, Larissa V; Ritterhouse, Lauren L; Segal, Jeremy P

    2018-04-24

    Next-generation sequencing (NGS) diagnostic assays increasingly are becoming the standard of care in oncology practice. As the scale of an NGS laboratory grows, management of these assays requires organizing large amounts of information, including patient data, laboratory processes, genomic data, as well as variant interpretation and reporting. Although several Laboratory Information Systems and/or Laboratory Information Management Systems are commercially available, they may not meet all of the needs of a given laboratory, in addition to being frequently cost-prohibitive. Herein, we present the System for Informatics in the Molecular Pathology Laboratory, a free and open-source Laboratory Information System/Laboratory Information Management System for academic and nonprofit molecular pathology NGS laboratories, developed at the Genomic and Molecular Pathology Division at the University of Chicago Medicine. The System for Informatics in the Molecular Pathology Laboratory was designed as a modular end-to-end information system to handle all stages of the NGS laboratory workload from test order to reporting. We describe the features of the system, its clinical validation at the Genomic and Molecular Pathology Division at the University of Chicago Medicine, and its installation and testing within a different academic center laboratory (University of Colorado), and we propose a platform for future community co-development and interlaboratory data sharing. Copyright © 2018. Published by Elsevier Inc.

  17. Clinical protein science developments for patient monitoring in hospital central laboratories.

    PubMed

    Malm, Johan; Marko-Varga, György

    2016-12-01

    Patient care relies heavily on standardized tests performed in hospital laboratories, typically including clinical chemistry, pathology and microbiology. With the introduction of personalized medicine tremendous efforts have been made to identify new biomarkers of disease with various omics technologies, often including mass spectrometry. In order to validate new biomarkers and perform clinical studies high quality biobank samples are of key importance. In this editorial different aspects of mass spectrometry in future personalized medicine are discussed.

  18. Continuous-flow automation and hemolysis index: a crucial combination.

    PubMed

    Lippi, Giuseppe; Plebani, Mario

    2013-04-01

    A paradigm shift has occurred in the role and organization of laboratory diagnostics over the past decades, wherein consolidation or networking of small laboratories into larger factories and point-of-care testing have simultaneously evolved and now seem to favorably coexist. There is now evidence, however, that the growing implementation of continuous-flow automation, especially in closed systems, has not eased the identification of hemolyzed specimens since the integration of preanalytical and analytical workstations would hide them from visual scrutiny, with an inherent risk that unreliable test results may be released to the stakeholders. Along with other technical breakthroughs, the new generation of laboratory instrumentation is increasingly equipped with systems that can systematically and automatically be tested for a broad series of interferences, the so-called serum indices, which also include the hemolysis index. The routine implementation of these technical tools in clinical laboratories equipped with continuous-flow automation carries several advantages and some drawbacks that are discussed in this article.

  19. Evaluations of Mechanisms for Pu Uptake and Retention within Spherical Resorcinol-Formaldehyde Resin Columns

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

    Delegard, Calvin H.; Levitskaia, Tatiana G.; Fiskum, Sandra K.

    The unexpected uptake and retention of plutonium (Pu) onto columns containing spherical resorcinol-formaldehyde (sRF) resin during ion exchange testing of Cs (Cs) removal from alkaline tank waste was observed in experiments at both the Pacific Northwest National Laboratory (PNNL) and the Savannah River National Laboratory (SRNL). These observations have raised concern regarding the criticality safety of the Cs removal unit operation within the low-activity waste pretreatment system (LAWPS). Accordingly, studies have been initiated at Washington River Protection Solutions (WRPS), who manages the operations of the Hanford Site tank farms, including the LAWPS, PNNL, and elsewhere to investigate these findings. Asmore » part of these efforts, PNNL has prepared the present report to summarize the laboratory testing observations, evaluate these phenomena in light of published and unpublished technical information, and outline future laboratory testing, as deemed appropriate based on the literature studies, with the goal to elucidate the mechanisms for the observed Pu uptake and retention.« less

  20. 42 CFR 493.1251 - Standard: Procedure manual.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic... intervals (normal values). (11) Imminently life-threatening test results, or panic or alert values. (12... reporting patient results including, when appropriate, the protocol for reporting imminently life...

  1. 42 CFR 493.1251 - Standard: Procedure manual.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic... intervals (normal values). (11) Imminently life-threatening test results, or panic or alert values. (12... reporting patient results including, when appropriate, the protocol for reporting imminently life...

  2. 42 CFR 493.1251 - Standard: Procedure manual.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic... intervals (normal values). (11) Imminently life-threatening test results, or panic or alert values. (12... reporting patient results including, when appropriate, the protocol for reporting imminently life...

  3. An evaluation of bituminized fiber pipe culverts.

    DOT National Transportation Integrated Search

    1970-01-01

    This report describes the results to date in a limited study, including laboratory tests and field evaluations, of the suitability of bituminized fiber pipe for use as highway culverts. Crushing strength data obtained from three-edge bearing tests in...

  4. Interlaboratory Study of Quality Control Isolates for a Broth Microdilution Method (Modified CLSI M38-A) for Testing Susceptibilities of Dermatophytes to Antifungals▿

    PubMed Central

    Ghannoum, M. A.; Arthington-Skaggs, B.; Chaturvedi, V.; Espinel-Ingroff, A.; Pfaller, M. A.; Rennie, R.; Rinaldi, M. G.; Walsh, T. J.

    2006-01-01

    The Clinical and Laboratory Standards Institute (CLSI; formerly National Committee for Clinical Laboratory Standards, or NCCLS) M38-A standard for the susceptibility testing of filamentous fungi does not specifically address the testing of dermatophytes. In 2003, a multicenter study investigated the reproducibility of the microdilution method developed at the Center for Medical Mycology, Cleveland, Ohio, for testing the susceptibility of dermatophytes. Data from that study supported the introduction of this method for testing dermatophytes in the future version of the CLSI M38-A standard. In order for the method to be accepted by CLSI, appropriate quality control isolates needed to be identified. To that end, an interlaboratory study, involving the original six laboratories plus two additional sites, was conducted to evaluate potential candidates for quality control isolates. These candidate strains included five Trichophyton rubrum strains known to have elevated MICs to terbinafine and five Trichophyton mentagrophytes strains. Antifungal agents tested included ciclopirox, fluconazole, griseofulvin, itraconazole, posaconazole, terbinafine, and voriconazole. Based on the data generated, two quality control isolates, one T. rubrum isolate and one T. mentagrophytes isolate, were identified and submitted to the American Type Culture Collection (ATCC) for inclusion as reference strains. Ranges encompassing 95.2 to 97.9% of all data points for all seven drugs were established. PMID:17050812

  5. The ACVD task force on canine atopic dermatitis (XVI): laboratory evaluation of dogs with atopic dermatitis with serum-based "allergy" tests.

    PubMed

    DeBoer, D J; Hillier, A

    2001-09-20

    Serum-based in vitro "allergy tests" are commercially available to veterinarians, and are widely used in diagnostic evaluation of a canine atopic patient. Following initial clinical diagnosis, panels of allergen-specific IgE measurements may be performed in an attempt to identify to which allergens the atopic dog is hypersensitive. Methodology for these tests varies by laboratory; few critical studies have evaluated performance of these tests, and current inter-laboratory standardization and quality control measures are inadequate. Other areas where information is critically limited include the usefulness of these tests in diagnosis of food allergy, the effect of extrinsic factors such as season of the year on results, and the influence of corticosteroid treatment on test results. Allergen-specific IgE serological tests are never completely sensitive, nor completely specific. There is only partial correlation between the serum tests and intradermal testing; however, the significance of discrepant results is unknown and unstudied. Variation in test methodologies along with the absence of universal standardization and reporting procedures have created confusion, varying study results, and an inability to compare between studies performed by different investigators.

  6. Mission Information and Test Systems Summary of Accomplishments, 2011

    NASA Technical Reports Server (NTRS)

    McMorrow, Sean E.; Sherrard, Roberta B.

    2013-01-01

    This annual report covers the activities of the NASA DRFC Mission Information and Test Systems, which includes the Western Aeronautical Test Range, the Simulation Engineering Branch, the Information Services and the Dryden Technical Laboratory (Flight Loads Lab). This report contains highlights, current projects and various awards achieved during in 2011

  7. 47 CFR 15.717 - TVBDs that rely on spectrum sensing.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... under this section must demonstrate with an extremely high degree of confidence that they will not cause... § 0.459 of this chapter. This public notice will include proposed test procedures and methodologies. (ii) The Commission will conduct laboratory and field tests of the pre-production device. This testing...

  8. Accelerated testing for studying pavement design and performance (FY 2002) : performance of foamed asphalt stabilized base in full depth reclaimed asphalt pavement.

    DOT National Transportation Integrated Search

    2004-08-01

    This report covers the Fiscal Year 2002 project conducted at the Accelerated Testing Laboratory at Kansas : State University. The project was selected and funded by the Midwest Accelerated Testing Pooled Fund Program , : which includes Iowa, Kansas, ...

  9. 6 CFR 25.6 - Procedures for designation of qualified anti-terrorism technologies.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... available or can be feasibly conducted or obtained, including test results produced by an independent laboratory or other entity engaged to test or verify the safety, utility, performance, in order to assess the...; (ii) Classified and otherwise confidential studies; (iii) Studies, tests, or other performance records...

  10. 6 CFR 25.6 - Procedures for designation of qualified anti-terrorism technologies.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... available or can be feasibly conducted or obtained, including test results produced by an independent laboratory or other entity engaged to test or verify the safety, utility, performance, in order to assess the...; (ii) Classified and otherwise confidential studies; (iii) Studies, tests, or other performance records...

  11. Energy Systems Test Area (ESTA) Electrical Power Systems Test Operations: User Test Planning Guide

    NASA Technical Reports Server (NTRS)

    Salinas, Michael J.

    2012-01-01

    Test process, milestones and inputs are unknowns to first-time users of the ESTA Electrical Power Systems Test Laboratory. The User Test Planning Guide aids in establishing expectations for both NASA and non-NASA facility customers. The potential audience for this guide includes both internal and commercial spaceflight hardware/software developers. It is intended to assist their test engineering personnel in test planning and execution. Material covered includes a roadmap of the test process, roles and responsibilities of facility and user, major milestones, facility capabilities, and inputs required by the facility. Samples of deliverables, test article interfaces, and inputs necessary to define test scope, cost, and schedule are included as an appendix to the guide.

  12. European Society of Clinical Microbiology and Infectious Diseases: update of the diagnostic guidance document for Clostridium difficile infection.

    PubMed

    Crobach, M J T; Planche, T; Eckert, C; Barbut, F; Terveer, E M; Dekkers, O M; Wilcox, M H; Kuijper, E J

    2016-08-01

    In 2009 the first European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guideline for diagnosing Clostridium difficile infection (CDI) was launched. Since then newer tests for diagnosing CDI have become available, especially nucleic acid amplification tests. The main objectives of this update of the guidance document are to summarize the currently available evidence concerning laboratory diagnosis of CDI and to formulate and revise recommendations to optimize CDI testing. This update is essential to improve the diagnosis of CDI and to improve uniformity in CDI diagnosis for surveillance purposes among Europe. An electronic search for literature concerning the laboratory diagnosis of CDI was performed. Studies evaluating a commercial laboratory test compared to a reference test were also included in a meta-analysis. The commercial tests that were evaluated included enzyme immunoassays (EIAs) detecting glutamate dehydrogenase, EIAs detecting toxins A and B and nucleic acid amplification tests. Recommendations were formulated by an executive committee, and the strength of recommendations and quality of evidence were graded using the Grades of Recommendation Assessment, Development and Evaluation (GRADE) system. No single commercial test can be used as a stand-alone test for diagnosing CDI as a result of inadequate positive predictive values at low CDI prevalence. Therefore, the use of a two-step algorithm is recommended. Samples without free toxin detected by toxins A and B EIA but with positive glutamate dehydrogenase EIA, nucleic acid amplification test or toxigenic culture results need clinical evaluation to discern CDI from asymptomatic carriage. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. Results and harmonization guidelines from two large-scale international Elispot proficiency panels conducted by the Cancer Vaccine Consortium (CVC/SVI).

    PubMed

    Janetzki, Sylvia; Panageas, Katherine S; Ben-Porat, Leah; Boyer, Jean; Britten, Cedrik M; Clay, Timothy M; Kalos, Michael; Maecker, Holden T; Romero, Pedro; Yuan, Jianda; Kast, W Martin; Hoos, Axel

    2008-03-01

    The Cancer Vaccine Consortium of the Sabin Vaccine Institute (CVC/SVI) is conducting an ongoing large-scale immune monitoring harmonization program through its members and affiliated associations. This effort was brought to life as an external validation program by conducting an international Elispot proficiency panel with 36 laboratories in 2005, and was followed by a second panel with 29 participating laboratories in 2006 allowing for application of learnings from the first panel. Critical protocol choices, as well as standardization and validation practices among laboratories were assessed through detailed surveys. Although panel participants had to follow general guidelines in order to allow comparison of results, each laboratory was able to use its own protocols, materials and reagents. The second panel recorded an overall significantly improved performance, as measured by the ability to detect all predefined responses correctly. Protocol choices and laboratory practices, which can have a dramatic effect on the overall assay outcome, were identified and lead to the following recommendations: (A) Establish a laboratory SOP for Elispot testing procedures including (A1) a counting method for apoptotic cells for determining adequate cell dilution for plating, and (A2) overnight rest of cells prior to plating and incubation, (B) Use only pre-tested serum optimized for low background: high signal ratio, (C) Establish a laboratory SOP for plate reading including (C1) human auditing during the reading process and (C2) adequate adjustments for technical artifacts, and (D) Only allow trained personnel, which is certified per laboratory SOPs to conduct assays. Recommendations described under (A) were found to make a statistically significant difference in assay performance, while the remaining recommendations are based on practical experiences confirmed by the panel results, which could not be statistically tested. These results provide initial harmonization guidelines to optimize Elispot assay performance to the immunotherapy community. Further optimization is in process with ongoing panels.

  14. GMOseek: a user friendly tool for optimized GMO testing.

    PubMed

    Morisset, Dany; Novak, Petra Kralj; Zupanič, Darko; Gruden, Kristina; Lavrač, Nada; Žel, Jana

    2014-08-01

    With the increasing pace of new Genetically Modified Organisms (GMOs) authorized or in pipeline for commercialization worldwide, the task of the laboratories in charge to test the compliance of food, feed or seed samples with their relevant regulations became difficult and costly. Many of them have already adopted the so called "matrix approach" to rationalize the resources and efforts used to increase their efficiency within a limited budget. Most of the time, the "matrix approach" is implemented using limited information and some proprietary (if any) computational tool to efficiently use the available data. The developed GMOseek software is designed to support decision making in all the phases of routine GMO laboratory testing, including the interpretation of wet-lab results. The tool makes use of a tabulated matrix of GM events and their genetic elements, of the laboratory analysis history and the available information about the sample at hand. The tool uses an optimization approach to suggest the most suited screening assays for the given sample. The practical GMOseek user interface allows the user to customize the search for a cost-efficient combination of screening assays to be employed on a given sample. It further guides the user to select appropriate analyses to determine the presence of individual GM events in the analyzed sample, and it helps taking a final decision regarding the GMO composition in the sample. GMOseek can also be used to evaluate new, previously unused GMO screening targets and to estimate the profitability of developing new GMO screening methods. The presented freely available software tool offers the GMO testing laboratories the possibility to select combinations of assays (e.g. quantitative real-time PCR tests) needed for their task, by allowing the expert to express his/her preferences in terms of multiplexing and cost. The utility of GMOseek is exemplified by analyzing selected food, feed and seed samples from a national reference laboratory for GMO testing and by comparing its performance to existing tools which use the matrix approach. GMOseek proves superior when tested on real samples in terms of GMO coverage and cost efficiency of its screening strategies, including its capacity of simple interpretation of the testing results.

  15. Armored RNA as Virus Surrogate in a Real-Time Reverse Transcriptase PCR Assay Proficiency Panel

    PubMed Central

    Hietala, S. K.; Crossley, B. M.

    2006-01-01

    In recent years testing responsibilities for high-consequence pathogens have been expanded from national reference laboratories into networks of local and regional laboratories in order to support enhanced disease surveillance and to test for surge capacity. This movement of testing of select agents and high-consequence pathogens beyond reference laboratories introduces a critical need for standardized, noninfectious surrogates of disease agents for use as training and proficiency test samples. In this study, reverse transcription-PCR assay RNA targets were developed and packaged as armored RNA for use as a noninfectious, quantifiable synthetic substitute for four high-consequence animal pathogens: classical swine fever virus; foot-and-mouth disease virus; vesicular stomatitis virus, New Jersey serogroup; and vesicular stomatitis virus, Indiana serogroup. Armored RNA spiked into oral swab fluid specimens mimicked virus-positive clinical material through all stages of the reverse transcription-PCR testing process, including RNA recovery by four different commercial extraction procedures, reverse transcription, PCR amplification, and real-time detection at target concentrations consistent with the dynamic ranges of the existing real-time PCR assays. The armored RNA concentrations spiked into the oral swab fluid specimens were stable under storage conditions selected to approximate the extremes of time and temperature expected for shipping and handling of proficiency panel samples, including 24 h at 37°C and 2 weeks at temperatures ranging from ambient room temperature to −70°C. The analytic test performance, including the reproducibility over the dynamic range of the assays, indicates that armored RNA can provide a noninfectious, quantifiable, and stable virus surrogate for specific assay training and proficiency test purposes. PMID:16390950

  16. Laboratory simulation of space plasma phenomena*

    NASA Astrophysics Data System (ADS)

    Amatucci, B.; Tejero, E. M.; Ganguli, G.; Blackwell, D.; Enloe, C. L.; Gillman, E.; Walker, D.; Gatling, G.

    2017-12-01

    Laboratory devices, such as the Naval Research Laboratory's Space Physics Simulation Chamber, are large-scale experiments dedicated to the creation of large-volume plasmas with parameters realistically scaled to those found in various regions of the near-Earth space plasma environment. Such devices make valuable contributions to the understanding of space plasmas by investigating phenomena under carefully controlled, reproducible conditions, allowing for the validation of theoretical models being applied to space data. By working in collaboration with in situ experimentalists to create realistic conditions scaled to those found during the observations of interest, the microphysics responsible for the observed events can be investigated in detail not possible in space. To date, numerous investigations of phenomena such as plasma waves, wave-particle interactions, and particle energization have been successfully performed in the laboratory. In addition to investigations such as plasma wave and instability studies, the laboratory devices can also make valuable contributions to the development and testing of space plasma diagnostics. One example is the plasma impedance probe developed at NRL. Originally developed as a laboratory diagnostic, the sensor has now been flown on a sounding rocket, is included on a CubeSat experiment, and will be included on the DoD Space Test Program's STP-H6 experiment on the International Space Station. In this presentation, we will describe several examples of the laboratory investigation of space plasma waves and instabilities and diagnostic development. *This work supported by the NRL Base Program.

  17. Optimization and proficiency testing of a pseudovirus-based assay for detection of HIV-1 neutralizing antibody in China.

    PubMed

    Nie, Jianhui; Wang, Wenbo; Wen, Zhiheng; Song, Aijing; Hong, Kunxue; Lu, Shan; Zhong, Ping; Xu, Jianqing; Kong, Wei; Li, Jingyun; Shang, Hong; Ling, Hong; Ruan, Li; Wang, Youchun

    2012-11-01

    Among the neutralizing antibody evaluation assays, the single-cycle pseudovirus infection assay is high-throughput and can provide rapid, sensitive and reproducible measurements after a single cycle of infection. Cell counts, pseudovirus inoculation levels, amount of diethylaminoethyl-dextran (DEAE-dextran), and the nonspecific effects of serum and plasma were tested to identify the optimal conditions for a neutralizing antibody assay based on pseudoviruses. Optimal conditions for cell counts, pseudovirus inoculation, and amount of DEAE-dextran were 1 × 10(4)cells/well, 200TCID(50)/well, and 15 μg/ml, respectively. Compared with serum samples, high-concentration anticoagulants reduced the relative light unit (RLU) value. The RLU value increased sharply initially but then decreased slowly with dilution of the plasma sample. Test kits containing 10 HIV-1 CRF07/08_BC pseudovirus strains and 10 plasma samples from individuals infected with HIV-1 CRF07/08_BC were assembled into two packages and distributed to nine laboratories with a standard operating procedure included. For the 10 laboratories that evaluated the test, 17 of 44 (37%) laboratory pairs were considered equivalent. A statistical qualification rule was developed based on the testing results from 5 experienced laboratories, where a laboratory qualified if at least 83% of values lied within the acceptable range. Copyright © 2012 Elsevier B.V. All rights reserved.

  18. KENNEDY SPACE CENTER, FLA. - Louis MacDowell (right), Testbed manager, explains to Center Director Jim Kennedy the use of astmospheric calibration specimens. Placed at various locations, they can rank the corrosivity of the given environment. The KSC Beach Corrosion Test Site was established in the 1960s and has provided more than 30 years of historical information on the long-term performance of many materials in use at KSC and other locations around the world. Located 100 feet from the Atlantic Ocean approximately 1 mile south of the Space Shuttle launch sites, the test facility includes an atmospheric exposure site, a flowing seawater exposure site, and an on-site electrochemistry laboratory and monitoring station. The beach laboratory is used to conduct real-time corrosion experiments and provides for the remote monitoring of surrounding weather conditions. The newly added flowing seawater immersion facility provides for the immersion testing of materials and devices under controlled conditions.

    NASA Image and Video Library

    2003-08-21

    KENNEDY SPACE CENTER, FLA. - Louis MacDowell (right), Testbed manager, explains to Center Director Jim Kennedy the use of astmospheric calibration specimens. Placed at various locations, they can rank the corrosivity of the given environment. The KSC Beach Corrosion Test Site was established in the 1960s and has provided more than 30 years of historical information on the long-term performance of many materials in use at KSC and other locations around the world. Located 100 feet from the Atlantic Ocean approximately 1 mile south of the Space Shuttle launch sites, the test facility includes an atmospheric exposure site, a flowing seawater exposure site, and an on-site electrochemistry laboratory and monitoring station. The beach laboratory is used to conduct real-time corrosion experiments and provides for the remote monitoring of surrounding weather conditions. The newly added flowing seawater immersion facility provides for the immersion testing of materials and devices under controlled conditions.

  19. An analysis of reference laboratory (send out) testing: an 8-year experience in a large academic medical center.

    PubMed

    MacMillan, Donna; Lewandrowski, Elizabeth; Lewandrowski, Kent

    2004-01-01

    Utilization of outside reference laboratories for selected laboratory testing is common in the United States. However, relatively little data exist in the literature describing the scope and impact of these services. In this study, we reviewed use of reference laboratory testing at the Massachusetts General Hospital, a large urban academic medical center in Boston, Massachusetts. A retrospective review of hospital and laboratory administrative records over an 8-year period from fiscal years (FY) 1995-2002. Over the 8 years studied, reference laboratory expenses increased 4.2-fold and totaled 12.4% of the total laboratory budget in FY 2002. Total reference laboratory test volume increased 4-fold to 68,328 tests in FY 2002 but represented only 1.06% of the total test volume in the hospital. The menu of reference laboratory tests comprised 946 tests (65.7% of the hospital test menu) compared to 494 (34.3%) of tests performed in house. The average unit cost of reference laboratory tests was essentially unchanged but was approximately 13 times greater than the average unit cost in the hospital laboratory. Much of the growth in reference laboratory cost can be attributed to the addition of new molecular, genetic, and microbiological assays. Four of the top 10 tests with the highest total cost in 2002 were molecular diagnostic tests that were recently added to the test menu. Reference laboratory testing comprises a major component of hospital clinical laboratory services. Although send out tests represent a small percentage of the total test volume, these services account for the majority of the hospital laboratory test menu and a disproportionate percentage of laboratory costs.

  20. Systems integration for the Kennedy Space Center (KSC) Robotics Applications Development Laboratory (RADL)

    NASA Technical Reports Server (NTRS)

    Davis, V. Leon; Nordeen, Ross

    1988-01-01

    A laboratory for developing robotics technology for hazardous and repetitive Shuttle and payload processing activities is discussed. An overview of the computer hardware and software responsible for integrating the laboratory systems is given. The center's anthropomorphic robot is placed on a track allowing it to be moved to different stations. Various aspects of the laboratory equipment are described, including industrial robot arm control, smart systems integration, the supervisory computer, programmable process controller, real-time tracking controller, image processing hardware, and control display graphics. Topics of research include: automated loading and unloading of hypergolics for space vehicles and payloads; the use of mobile robotics for security, fire fighting, and hazardous spill operations; nondestructive testing for SRB joint and seal verification; Shuttle Orbiter radiator damage inspection; and Orbiter contour measurements. The possibility of expanding the laboratory in the future is examined.

  1. The utility of the AusEd driving simulator in the clinical assessment of driver fatigue.

    PubMed

    Desai, Anup V; Wilsmore, Brad; Bartlett, Delwyn J; Unger, Gunnar; Constable, Ben; Joffe, David; Grunstein, Ronald R

    2007-08-01

    Several driving simulators have been developed which range in complexity from PC based driving tasks to advanced "real world" simulators. The AusEd driving simulator is a PC based task, which was designed to be conducive to and test for driver fatigue. This paper describes the AusEd driving simulator in detail, including the technical requirements, hardware, screen and file outputs, and analysis software. Some aspects of the test are standardized, while others can be modified to suit the experimental situation. The AusEd driving simulator is sensitive to performance decrement from driver fatigue in the laboratory setting, potentially making it useful as a laboratory or office based test for driver fatigue risk management. However, more research is still needed to correlate laboratory based simulator performance with real world driving performance and outcomes.

  2. Advancing the education in molecular diagnostics: the IFCC-Initiative "Clinical Molecular Biology Curriculum" (C-CMBC); a ten-year experience.

    PubMed

    Lianidou, Evi; Ahmad-Nejad, Parviz; Ferreira-Gonzalez, Andrea; Izuhara, Kenji; Cremonesi, Laura; Schroeder, Maria-Eugenia; Richter, Karin; Ferrari, Maurizio; Neumaier, Michael

    2014-09-25

    Molecular techniques are becoming commonplace in the diagnostic laboratory. Their applications influence all major phases of laboratory medicine including predisposition/genetic risk, primary diagnosis, therapy stratification and prognosis. Readily available laboratory hardware and wetware (i.e. consumables and reagents) foster rapid dissemination to countries that are just establishing molecular testing programs. Appropriate skill levels extending beyond the technical procedure are required for analytical and diagnostic proficiency that is mandatory in molecular genetic testing. An international committee (C-CMBC) of the International Federation for Clinical Chemistry (IFCC) was established to disseminate skills in molecular genetic testing in member countries embarking on the respective techniques. We report the ten-year experience with different teaching and workshop formats for beginners in molecular diagnostics. Copyright © 2014 Elsevier B.V. All rights reserved.

  3. LPT. Plot plan and site layout. Includes shield test pool/EBOR ...

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

    LPT. Plot plan and site layout. Includes shield test pool/EBOR facility. (TAN-645 and -646) low power test building (TAN-640 and -641), water storage tanks, guard house (TAN-642), pump house (TAN-644), driveways, well, chlorination building (TAN-643), septic system. Ralph M. Parsons 1229-12 ANP/GE-7-102. November 1956. Approved by INEEL Classification Office for public release. INEEL index code no. 038-0102-00-693-107261 - Idaho National Engineering Laboratory, Test Area North, Scoville, Butte County, ID

  4. A Profilometry-Based Dentifrice Abrasion Method for V8 Brushing Machines Part III: Multi-Laboratory Validation Testing of RDA-PE.

    PubMed

    Schneiderman, Eva; Colón, Ellen L; White, Donald J; Schemehorn, Bruce; Ganovsky, Tara; Haider, Amir; Garcia-Godoy, Franklin; Morrow, Brian R; Srimaneepong, Viritpon; Chumprasert, Sujin

    2017-09-01

    We have previously reported on progress toward the refinement of profilometry-based abrasivity testing of dentifrices using a V8 brushing machine and tactile or optical measurement of dentin wear. The general application of this technique may be advanced by demonstration of successful inter-laboratory confirmation of the method. The objective of this study was to explore the capability of different laboratories in the assessment of dentifrice abrasivity using a profilometry-based evaluation technique developed in our Mason laboratories. In addition, we wanted to assess the interchangeability of human and bovine specimens. Participating laboratories were instructed in methods associated with Radioactive Dentin Abrasivity-Profilometry Equivalent (RDA-PE) evaluation, including site visits to discuss critical elements of specimen preparation, masking, profilometry scanning, and procedures. Laboratories were likewise instructed on the requirement for demonstration of proportional linearity as a key condition for validation of the technique. Laboratories were provided with four test dentifrices, blinded for testing, with a broad range of abrasivity. In each laboratory, a calibration curve was developed for varying V8 brushing strokes (0, 4,000, and 10,000 strokes) with the ISO abrasive standard. Proportional linearity was determined as the ratio of standard abrasion mean depths created with 4,000 and 10,000 strokes (2.5 fold differences). Criteria for successful calibration within the method (established in our Mason laboratory) was set at proportional linearity = 2.5 ± 0.3. RDA-PE was compared to Radiotracer RDA for the four test dentifrices, with the latter obtained by averages from three independent Radiotracer RDA sites. Individual laboratories and their results were compared by 1) proportional linearity and 2) acquired RDA-PE values for test pastes. Five sites participated in the study. One site did not pass proportional linearity objectives. Data for this site are not reported at the request of the researchers. Three of the remaining four sites reported herein tested human dentin and all three met proportional linearity objectives for human dentin. Three of four sites participated in testing bovine dentin and all three met the proportional linearity objectives for bovine dentin. RDA-PE values for test dentifrices were similar between sites. All four sites that met proportional linearity requirement successfully identified the dentifrice formulated above the industry standard 250 RDA (as RDA-PE). The profilometry method showed at least as good reproducibility and differentiation as Radiotracer assessments. It was demonstrated that human and bovine specimens could be used interchangeably. The standardized RDA-PE method was reproduced in multiple laboratories in this inter-laboratory study. Evidence supports that this method is a suitable technique for ISO method 11609 Annex B.

  5. External Quality Assessment for KRAS Testing Is Needed: Setup of a European Program and Report of the First Joined Regional Quality Assessment Rounds

    PubMed Central

    Bellon, Ellen; Ligtenberg, Marjolijn J.L.; Tejpar, Sabine; Cox, Karen; de Hertogh, Gert; de Stricker, Karin; Edsjö, Anders; Gorgoulis, Vassilis; Höfler, Gerald; Jung, Andreas; Kotsinas, Athanassios; Laurent-Puig, Pierre; López-Ríos, Fernando; Hansen, Tine Plato; Rouleau, Etienne; Vandenberghe, Peter; van Krieken, Johan J.M.

    2011-01-01

    The use of epidermal growth factor receptor–targeting antibodies in metastatic colorectal cancer has been restricted to patients with wild-type KRAS tumors by the European Medicines Agency since 2008, based on data showing a lack of efficacy and potential harm in patients with mutant KRAS tumors. In an effort to ensure optimal, uniform, and reliable community-based KRAS testing throughout Europe, a KRAS external quality assessment (EQA) scheme was set up. The first large assessment round included 59 laboratories from eight different European countries. For each country, one regional scheme organizer prepared and distributed the samples for the participants of their own country. The samples included unstained sections of 10 invasive colorectal carcinomas with known KRAS mutation status. The samples were centrally validated by one of two reference laboratories. The laboratories were allowed to use their own preferred method for histological evaluation, DNA isolation, and mutation analysis. In this study, we analyze the setup of the KRAS scheme. We analyzed the advantages and disadvantages of the regional scheme organization by analyzing the outcome of genotyping results, analysis of tumor percentage, and written reports. We conclude that only 70% of laboratories correctly identified the KRAS mutational status in all samples. Both the false-positive and false-negative results observed negatively affect patient care. Reports of the KRAS test results often lacked essential information. We aim to further expand this program to more laboratories to provide a robust estimate of the quality of KRAS testing in Europe, and provide the basis for remedial measures and harmonization. PMID:21441573

  6. Risk prediction for chronic kidney disease progression using heterogeneous electronic health record data and time series analysis.

    PubMed

    Perotte, Adler; Ranganath, Rajesh; Hirsch, Jamie S; Blei, David; Elhadad, Noémie

    2015-07-01

    As adoption of electronic health records continues to increase, there is an opportunity to incorporate clinical documentation as well as laboratory values and demographics into risk prediction modeling. The authors develop a risk prediction model for chronic kidney disease (CKD) progression from stage III to stage IV that includes longitudinal data and features drawn from clinical documentation. The study cohort consisted of 2908 primary-care clinic patients who had at least three visits prior to January 1, 2013 and developed CKD stage III during their documented history. Development and validation cohorts were randomly selected from this cohort and the study datasets included longitudinal inpatient and outpatient data from these populations. Time series analysis (Kalman filter) and survival analysis (Cox proportional hazards) were combined to produce a range of risk models. These models were evaluated using concordance, a discriminatory statistic. A risk model incorporating longitudinal data on clinical documentation and laboratory test results (concordance 0.849) predicts progression from state III CKD to stage IV CKD more accurately when compared to a similar model without laboratory test results (concordance 0.733, P<.001), a model that only considers the most recent laboratory test results (concordance 0.819, P < .031) and a model based on estimated glomerular filtration rate (concordance 0.779, P < .001). A risk prediction model that takes longitudinal laboratory test results and clinical documentation into consideration can predict CKD progression from stage III to stage IV more accurately than three models that do not take all of these variables into consideration. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association.

  7. Rapid deployment of a mobile biosafety level-3 laboratory in Sierra Leone during the 2014 Ebola virus epidemic

    PubMed Central

    Zhang, Yi; Gong, Yan; Wang, Chengyu; Liu, Wensen; Wang, Zhongyi; Xia, Zhiping; Bu, Zhaoyang; Lu, Huijun; Sun, Yang; Zhang, Xiaoguang; Cao, Yuxi; Yang, Fan; Su, Haoxiang; Hu, Yi; Deng, Yongqiang; Zhou, Bo; Zhao, Zongzheng; Fu, Yingying; Kargbo, David; Dafae, Foday; Kargbo, Brima; Kanu, Alex; Qian, Jun; Guo, Zhendong

    2017-01-01

    Background Ebola virus emerged in West Africa in December 2013. The high population mobility and poor public health infrastructure in this region led to the development of the largest Ebola virus disease (EVD) outbreak to date. Methodology/Principal findings On September 26, 2014, China dispatched a Mobile Biosafety Level-3 Laboratory (MBSL-3 Lab) and a well-trained diagnostic team to Sierra Leone to assist in EVD diagnosis using quantitative real-time PCR, which allowed the diagnosis of suspected EVD cases in less than 4 hours from the time of sample receiving. This laboratory was composed of three container vehicles equipped with advanced ventilation system, communication system, electricity and gas supply system. We strictly applied multiple safety precautions to reduce exposure risks. Personnel, materials, water and air flow management were the key elements of the biosafety measures in the MBSL-3 Lab. Air samples were regularly collected from the MBSL-3 Lab, but no evidence of Ebola virus infectious aerosols was detected. Potentially contaminated objects were also tested by collecting swabs. On one occasion, a pipette tested positive for EVD. A total of 1,635 suspected EVD cases (824 positive [50.4%]) were tested from September 28 to November 11, 2014, and no member of the diagnostic team was infected with Ebola virus or other pathogens, including Lassa fever. The specimens tested included blood (69.2%) and oral swabs (30.8%) with positivity rates of 54.2% and 41.9%, respectively. The China mobile laboratory was thus instrumental in the EVD outbreak response by providing timely and reliable diagnostics. Conclusions/Significance The MBSL-3 Lab significantly contributed to establishing a suitable laboratory response capacity during the emergence of EVD in Sierra Leone. PMID:28505171

  8. Rapid deployment of a mobile biosafety level-3 laboratory in Sierra Leone during the 2014 Ebola virus epidemic.

    PubMed

    Zhang, Yi; Gong, Yan; Wang, Chengyu; Liu, Wensen; Wang, Zhongyi; Xia, Zhiping; Bu, Zhaoyang; Lu, Huijun; Sun, Yang; Zhang, Xiaoguang; Cao, Yuxi; Yang, Fan; Su, Haoxiang; Hu, Yi; Deng, Yongqiang; Zhou, Bo; Zhao, Zongzheng; Fu, Yingying; Kargbo, David; Dafae, Foday; Kargbo, Brima; Kanu, Alex; Liu, Linna; Qian, Jun; Guo, Zhendong

    2017-05-01

    Ebola virus emerged in West Africa in December 2013. The high population mobility and poor public health infrastructure in this region led to the development of the largest Ebola virus disease (EVD) outbreak to date. On September 26, 2014, China dispatched a Mobile Biosafety Level-3 Laboratory (MBSL-3 Lab) and a well-trained diagnostic team to Sierra Leone to assist in EVD diagnosis using quantitative real-time PCR, which allowed the diagnosis of suspected EVD cases in less than 4 hours from the time of sample receiving. This laboratory was composed of three container vehicles equipped with advanced ventilation system, communication system, electricity and gas supply system. We strictly applied multiple safety precautions to reduce exposure risks. Personnel, materials, water and air flow management were the key elements of the biosafety measures in the MBSL-3 Lab. Air samples were regularly collected from the MBSL-3 Lab, but no evidence of Ebola virus infectious aerosols was detected. Potentially contaminated objects were also tested by collecting swabs. On one occasion, a pipette tested positive for EVD. A total of 1,635 suspected EVD cases (824 positive [50.4%]) were tested from September 28 to November 11, 2014, and no member of the diagnostic team was infected with Ebola virus or other pathogens, including Lassa fever. The specimens tested included blood (69.2%) and oral swabs (30.8%) with positivity rates of 54.2% and 41.9%, respectively. The China mobile laboratory was thus instrumental in the EVD outbreak response by providing timely and reliable diagnostics. The MBSL-3 Lab significantly contributed to establishing a suitable laboratory response capacity during the emergence of EVD in Sierra Leone.

  9. Fusion Safety Program annual report, fiscal year 1994

    NASA Astrophysics Data System (ADS)

    Longhurst, Glen R.; Cadwallader, Lee C.; Dolan, Thomas J.; Herring, J. Stephen; McCarthy, Kathryn A.; Merrill, Brad J.; Motloch, Chester C.; Petti, David A.

    1995-03-01

    This report summarizes the major activities of the Fusion Safety Program in fiscal year 1994. The Idaho National Engineering Laboratory (INEL) is the designated lead laboratory and Lockheed Idaho Technologies Company is the prime contractor for this program. The Fusion Safety Program was initiated in 1979. Activities are conducted at the INEL, at other DOE laboratories, and at other institutions, including the University of Wisconsin. The technical areas covered in this report include tritium safety, beryllium safety, chemical reactions and activation product release, safety aspects of fusion magnet systems, plasma disruptions, risk assessment failure rate data base development, and thermalhydraulics code development and their application to fusion safety issues. Much of this work has been done in support of the International Thermonuclear Experimental Reactor (ITER). Also included in the report are summaries of the safety and environmental studies performed by the Fusion Safety Program for the Tokamak Physics Experiment and the Tokamak Fusion Test Reactor and of the technical support for commercial fusion facility conceptual design studies. A major activity this year has been work to develop a DOE Technical Standard for the safety of fusion test facilities.

  10. Special environmental control and life support equipment test analyses and hardware

    NASA Technical Reports Server (NTRS)

    Callahan, David M.

    1995-01-01

    This final report summarizes NAS8-38250 contract events, 'Special Environmental Control and Life Support Systems Test Analysis and Hardware'. This report is technical and includes programmatic development. Key to the success of this contract was the evaluation of Environmental Control and Life Support Systems (ECLSS) test results via sophisticated laboratory analysis capabilities. The history of the contract, including all subcontracts, is followed by the support and development of each Task.

  11. Rapid C-reactive protein and white cell tests decrease cost and shorten emergency visits.

    PubMed

    Kokko, Eeva; Korppi, Matti; Helminen, Merja; Hutri-Kähönen, Nina

    2014-10-01

    Elevated white blood cells (WBC) in blood and C-reactive protein (CRP) in serum are often used as non-specific markers for bacterial etiology of infection in children. The aim of the present study was to evaluate how rapid WBC and CRP testing influences patient flow and cost in the pediatric emergency room (ER). This study was a retrospective chart review. In all, 166 children who were treated during 3 months in the ER of a children's hospital, and in whom rapid tests for WBC and CRP were done, were included. The association between rapid testing and length of ER stay was evaluated, and the cost of rapid tests was compared with the corresponding cost if done in the hospital laboratory. Median ER stay was 147.5 min, if no examinations other than rapid CRP and WBC tests were done and if no emergency treatment was given, compared with 201.5 min for laboratory tests or emergency treatment given (P < 0.001). The respective figures were 142.5 min and 179.5 min in those 96 children discharged home (P = 0.003). The cost of rapid testing was only 41.5% of the corresponding laboratory cost. The simultaneous rapid testing of CRP and WBC in children with presumable infection decreased cost and shortened the length of ER stay, if no other examinations or emergency treatment were needed. The cost of rapid testing was less than half of the corresponding cost in laboratory. © 2014 Japan Pediatric Society.

  12. Variations in pretransfusion practices.

    PubMed

    Padget, B J; Hannon, J L

    2003-01-01

    A variety of pretransfusion tests have been developed to improve the safety and effectiveness of transfusion. Recently, a number of traditional tests have been shown to offer limited clinical benefit and have been eliminated in many facilities. A survey of pretransfusion test practices was distributed to 116 hospital transfusion services. Routine test practices and facility size were analyzed. Ninety-one responses were received. Many smaller laboratories include tests such as anti-A,B, an autocontrol, and DAT, and immediate spin and 37 degrees Celsius microscopic readings. Nine percent never perform an Rh control with anti-D typing on patient samples. Various antibody screening and crossmatch methods are utilized. Individual laboratory test practices should be periodically assessed to ensure that they comply with standards, represent the recognized best practice, and are cost-effective. The survey responses indicate that many laboratories perform tests that are not necessary or cost-effective. These facilities should review their processes to determine which tests contribute to transfusion safety. Smaller facilities may be reluctant to change or lack the expertise necessary for this decision making and often continue to perform tests that have been eliminated in larger facilities. Consultation with larger hospital transfusion services may provide guidance for this change.

  13. Testing and Evaluating Student Success with Laboratory Blocks, A Resource Book for Teachers.

    ERIC Educational Resources Information Center

    Lee, Addison E.

    Guidelines are given for the preparation of test items and tests for BSCS (Biological Sciences Curriculum Study) biology, including examples of items testing four major kinds of abilities: ability to repeat or use information and meanings, ability to apply principles, ability to apply intellectual skills crucial to the understanding of biological…

  14. An international inter-laboratory ring trial to evaluate a real-time PCR assay for the detection of bovine herpesvirus 1 in extended bovine semen.

    PubMed

    Wang, Jianning; O'Keefe, Joseph; Orr, Della; Loth, Leo; Banks, Malcolm; Wakeley, Philip; West, Donna; Card, Roderick; Ibata, Georgina; Van Maanen, Kees; Thoren, Peter; Isaksson, Mats; Kerkhofs, Pierre

    2008-01-01

    Six laboratories participated in a ring trial to evaluate the reliability of a real-time PCR assay for the detection of bovine herpesvirus 1 (BoHV-1) from extended bovine semen. Sets of coded samples were prepared and distributed to each of the laboratories. The sample panel contained semen from naturally and artificially infected bulls, serial dilutions of positive semen with negative semen, semen from uninfected seronegative bulls, negative semen spiked with virus, as well as serial dilutions of reference virus. The samples were tested using a previously validated real-time PCR assay for the detection of BoHV-1 in each participating laboratory. The PCR tests were conducted with four different real-time PCR amplification platforms, including RotorGene 3000, Stratagene MX 3000/4000, ABI 7900, and Roche LightCycler 2.0. Virus isolation using one set of samples was performed in one laboratory. The results of the laboratories were compared with one another, and with those of virus isolation. It was found that the sensitivity and specificity of the real-time PCR test was greater than those of virus isolation (82.7% versus 53.6% and 93.6% versus 84.6%, respectively). A high level of agreement on PCR testing results between the laboratories was achieved (kappa value 0.59-0.95). The results of this study indicate that the real-time PCR assay is suitable for the detection of BoHV-1 in extended semen, and would be a good substitute for the slow and laborious virus isolation, for the screening testing at artificial insemination centres and for international trade.

  15. Simple and inexpensive point-of-care tests improve diagnosis of vaginal infections in resource constrained settings.

    PubMed

    Madhivanan, Purnima; Krupp, Karl; Hardin, Jill; Karat, Chitra; Klausner, Jeffrey D; Reingold, Arthur L

    2009-06-01

    Bacterial vaginosis (BV) and Trichomonas vaginalis infection (TV) have been associated with adverse birth outcomes and increased risk for HIV. We compare the performance of simple inexpensive point-of-care (POC) tests to laboratory diagnosis and syndromic management of BV and TV in poor settings. Between November 2005 and March 2006, 898 sexually active women attending two reproductive health clinics in Mysore, India were recruited into a cohort study investigating the relationship between vaginal flora and HSV-2 infection. Participants were interviewed and screened for reproductive tract infections. Laboratory tests included serology for HSV-2; cultures for TV, Candida sp., and Neisseria gonorrhoeae; Gram stains; and two POC tests: vaginal pH; and Whiff test. Of the 898 participants, 411 [45.7%, 95% confidence interval (95% CI): 42.4-49.0%] had any laboratory diagnosed vaginal infection. BV was detected in 165 women (19.1%, 95%CI: 16.5-21.9%) using Nugent score. TV was detected in 76 women (8.5%, 95%CI: 6.7-10.4%) using culture. Among the entire study population, POC correctly detected 82% of laboratory diagnosed BV cases, and 83% of laboratory diagnosed TV infections. Among women with complaints of vulval itching, burning, abnormal vaginal discharge, and/or sores (445/898), POC correctly detected 83% (60 of 72 cases) of laboratory diagnosed BV cases vs. 40% (29 of 72 cases) correctly managed using the syndromic approach (P < 0.001). Similarly, POC would have detected 82% (37 of 45 cases) of TV cases vs. 51% (23 of 45 cases) correctly managed using the syndromic approach (P = 0.001). In the absence of laboratory diagnostics, POC is not only inexpensive and practical, but also significantly more sensitive than the syndromic management approach, resulting in less overtreatment. .

  16. An innovative educational approach to professional development of medical laboratory scientists in Botswana.

    PubMed

    Magowe, Mabel Km; Ledikwe, Jenny H; Kasvosve, Ishmael; Martin, Robert; Thankane, Kabo; Semo, Bazghina-Werq

    2014-01-01

    To address the shortage of laboratory scientists in Botswana, an innovative, one-year academic bridging program was initiated at the University of Botswana, to advance diploma-holding laboratory technicians towards becoming laboratory scientists holding Bachelor's degrees. An evaluation was conducted, which described the outcomes of the program and the lessons learned from this novel approach to meeting human resource needs. This was a cross-sectional, mixed-methods evaluation. Qualitative interviews were conducted with graduates of the Bachelor of Science (BSc) Medical Laboratory Sciences (MLS) bridging program, along with the graduates' current supervisors, and key informants who were involved in program development or implementation. The quantitative data collected included a written questionnaire, completed by program graduates, with a retrospective pre-test/post-test survey of graduates' confidence, in terms of key laboratory competencies. The BSc MLS bridging program produced thirty-three laboratory scientists over 3 years. There was a significant increase in confidence among graduates, for specified competencies, after the program (P<0.05). Graduates reported acquiring new skills and, often, accepting new responsibilities at their former workplace, particularly in relationship to leadership and management. Five graduates enrolled in advanced degree programs. Most graduates assumed increased responsibility. However, only two graduates were promoted after completing the training program. The lessons learned include: the importance of stakeholder involvement, the need for data to identify local needs, financial sustainability, catering for the needs of adult learners, and ensuring a technically challenging work environment, conducive to the application of skills learned during training. A strong public health and clinical laboratory system is essential for the rapid detection and control of emerging health threats, and for patient care. However, there is a need to adequately prepare laboratory human resources, to ensure efficient and effective laboratory services. Advancement of laboratory technicians towards becoming laboratory scientists, through a bridging program, can provide the necessary skills within a short time.

  17. Testing Plastic Deformations of Materials in the Introductory Undergraduate Mechanics Laboratory

    ERIC Educational Resources Information Center

    Romo-Kroger, C. M.

    2012-01-01

    Normally, a mechanics laboratory at the undergraduate level includes an experiment to verify compliance with Hooke's law in materials, such as a steel spring and an elastic rubber band. Stress-strain curves are found for these elements. Compression in elastic bands is practically impossible to achieve due to flaccidity. A typical experiment for…

  18. The CGE-PLATO Electronic Laboratory Instructional Programs. (August 1, 1972 Through June 30, 1975).

    ERIC Educational Resources Information Center

    Neal, J. P.

    Twelve PLATO lessons are reproduced in this document to show the status of computer guided experimentation (CGE) instructional programs. The lesson topics include a description of the CGE-PLATO instructional laboratory, an introduction to CGE-PLATO tests and special software routines, router lesson for two electrical engineering courses, and an…

  19. Classroom Experiences in an Engineering Design Graphics Course with a CAD/CAM Extension.

    ERIC Educational Resources Information Center

    Barr, Ronald E.; Juricic, Davor

    1997-01-01

    Reports on the development of a new CAD/CAM laboratory experience for an Engineering Design Graphics (EDG) course. The EDG curriculum included freehand sketching, introduction to Computer-Aided Design and Drafting (CADD), and emphasized 3-D solid modeling. Reviews the project and reports on the testing of the new laboratory components which were…

  20. 18. VIEW OF THE GENERAL CHEMISTRY LAB. THE LABORATORY PROVIDED ...

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

    18. VIEW OF THE GENERAL CHEMISTRY LAB. THE LABORATORY PROVIDED GENERAL ANALYTICAL AND STANDARDS CALIBRATION, AS WELL AS DEVELOPMENT OPERATIONS INCLUDING WASTE TECHNOLOGY DEVELOPMENT AND DEVELOPMENT AND TESTING OF MECHANICAL SYSTEMS FOR WEAPONS SYSTEMS. (4/4/66) - Rocky Flats Plant, General Manufacturing, Support, Records-Central Computing, Southern portion of Plant, Golden, Jefferson County, CO

  1. Using fee-for-service testing to generate revenue for the 21st century public health laboratory.

    PubMed

    Loring, Carol; Neil, R Brock; Gillim-Ross, Laura; Bashore, Matthew; Shah, Sandip

    2013-01-01

    The decrease in appropriations for state public health laboratories (SPHLs) has become a major concern as tax revenues and, subsequently, state and federal funding, have decreased. These reductions have forced SPHLs to pursue revenue-generating opportunities to support their work. We describe the current state of funding in a sampling of SPHLs and the challenges these laboratories face as they implement or expand fee-for-service testing. We conducted surveys of SPHLs to collect data concerning laboratory funding sources, test menus, fee-for-service testing, and challenges to implementing fee-for-service testing. Most SPHLS receive funding through three revenue sources: state appropriation, federal funding, and fee-for-service testing (cash funds). Among SPHLs, state appropriations ranged from $0 to more than $6 per capita, federal funding ranged from $0.10 to $5 per capita, and revenue from fee-for-service testing ranged from $0 to $4 per capita. The tests commonly performed on a fee-for-service basis included assays for sexually transmitted diseases, mycobacterial cultures, newborn screening, and water testing. We found that restrictive legislation, staffing shortages, inadequate software for billing fee-for-service testing, and regulations on how SPHLs use their generated revenue are impediments to implementing fee-for-service testing. Some SPHLs are considering implementing or expanding fee-for-service testing as a way to recapture funds lost as a result of state and federal budget cuts. This analysis revealed many of the obstacles to implementing fee-for-service testing in SPHLs and the potential impact on SPHLs of continued decreases in funding.

  2. Laboratory or Field Tests for Evaluating Firefighters' Work Capacity?

    PubMed Central

    Lindberg, Ann-Sofie; Oksa, Juha; Malm, Christer

    2014-01-01

    Muscle strength is important for firefighters work capacity. Laboratory tests used for measurements of muscle strength, however, are complicated, expensive and time consuming. The aims of the present study were to investigate correlations between physical capacity within commonly occurring and physically demanding firefighting work tasks and both laboratory and field tests in full time (N = 8) and part-time (N = 10) male firefighters and civilian men (N = 8) and women (N = 12), and also to give recommendations as to which field tests might be useful for evaluating firefighters' physical work capacity. Laboratory tests of isokinetic maximal (IM) and endurance (IE) muscle power and dynamic balance, field tests including maximal and endurance muscle performance, and simulated firefighting work tasks were performed. Correlations with work capacity were analyzed with Spearman's rank correlation coefficient (rs). The highest significant (p<0.01) correlations with laboratory and field tests were for Cutting: IE trunk extension (rs = 0.72) and maximal hand grip strength (rs = 0.67), for Stairs: IE shoulder flexion (rs = −0.81) and barbell shoulder press (rs = −0.77), for Pulling: IE shoulder extension (rs = −0.82) and bench press (rs = −0.85), for Demolition: IE knee extension (rs = 0.75) and bench press (rs = 0.83), for Rescue: IE shoulder flexion (rs = −0.83) and bench press (rs = −0.82), and for the Terrain work task: IE trunk flexion (rs = −0.58) and upright barbell row (rs = −0.70). In conclusion, field tests may be used instead of laboratory tests. Maximal hand grip strength, bench press, chin ups, dips, upright barbell row, standing broad jump, and barbell shoulder press were strongly correlated (rs≥0.7) with work capacity and are therefore recommended for evaluating firefighters work capacity. PMID:24614596

  3. Advanced Stirling Convertor Dual Convertor Controller Testing at NASA Glenn Research Center in the Radioisotope Power Systems System Integration Laboratory

    NASA Technical Reports Server (NTRS)

    Dugala, Gina M.; Taylor, Linda M.; Bell, Mark E.; Dolce, James L.; Fraeman, Martin; Frankford, David P.

    2015-01-01

    NASA Glenn Research Center developed a nonnuclear representation of a Radioisotope Power System (RPS) consisting of a pair of Advanced Stirling Convertors (ASCs), Dual Convertor Controller (DCC) EMs (engineering models) 2 and 3, and associated support equipment, which were tested in the Radioisotope Power Systems System Integration Laboratory (RSIL). The DCC was designed by the Johns Hopkins University Applied Physics Laboratory (JHU/APL) to actively control a pair of ASCs. The first phase of testing included a Dual Advanced Stirling Convertor Simulator (DASCS), which was developed by JHU/APL and simulates the operation and electrical behavior of a pair of ASCs in real time via a combination of hardware and software. RSIL provides insight into the electrical interactions between a representative radioisotope power generator, its associated control schemes, and realistic electric system loads. The first phase of integration testing included the following spacecraft bus configurations: capacitive, battery, and super-capacitor. A load profile, created based on data from several missions, tested the RPS's and RSIL's ability to maintain operation during load demands above and below the power provided by the RPS. The integration testing also confirmed the DCC's ability to disconnect from the spacecraft when the bus voltage dipped below 22 volts or exceeded 36 volts. Once operation was verified with the DASCS, the tests were repeated with actual operating ASCs. The goal of this integration testing was to verify operation of the DCC when connected to a spacecraft and to verify the functionality of the newly designed RSIL. The results of these tests are presented in this paper.

  4. Collection and Characterization of Samples for Establishment of a Serum Repository for Lyme Disease Diagnostic Test Development and Evaluation

    PubMed Central

    Molins, Claudia R.; Sexton, Christopher; Young, John W.; Ashton, Laura V.; Pappert, Ryan; Beard, Charles B.

    2014-01-01

    Serological assays and a two-tiered test algorithm are recommended for laboratory confirmation of Lyme disease. In the United States, the sensitivity of two-tiered testing using commercially available serology-based assays is dependent on the stage of infection and ranges from 30% in the early localized disease stage to near 100% in late-stage disease. Other variables, including subjectivity in reading Western blots, compliance with two-tiered recommendations, use of different first- and second-tier test combinations, and use of different test samples, all contribute to variation in two-tiered test performance. The availability and use of sample sets from well-characterized Lyme disease patients and controls are needed to better assess the performance of existing tests and for development of improved assays. To address this need, the Centers for Disease Control and Prevention and the National Institutes of Health prospectively collected sera from patients at all stages of Lyme disease, as well as healthy donors and patients with look-alike diseases. Patients and healthy controls were recruited using strict inclusion and exclusion criteria. Samples from all included patients were retrospectively characterized by two-tiered testing. The results from two-tiered testing corroborated the need for novel and improved diagnostics, particularly for laboratory diagnosis of earlier stages of infection. Furthermore, the two-tiered results provide a baseline with samples from well-characterized patients that can be used in comparing the sensitivity and specificity of novel diagnostics. Panels of sera and accompanying clinical and laboratory testing results are now available to Lyme disease serological test users and researchers developing novel tests. PMID:25122862

  5. SRC-I demonstration plant analytical laboratory methods manual. Final technical report

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

    Klusaritz, M.L.; Tewari, K.C.; Tiedge, W.F.

    1983-03-01

    This manual is a compilation of analytical procedures required for operation of a Solvent-Refined Coal (SRC-I) demonstration or commercial plant. Each method reproduced in full includes a detailed procedure, a list of equipment and reagents, safety precautions, and, where possible, a precision statement. Procedures for the laboratory's environmental and industrial hygiene modules are not included. Required American Society for Testing and Materials (ASTM) methods are cited, and ICRC's suggested modifications to these methods for handling coal-derived products are provided.

  6. Laboratory practice at the periphery in developing countries.

    PubMed

    Lewis, S M

    2002-08-01

    An effective national health service structure requires a comprehensive programme for primary health care in peripheral and rural areas. This is especially important in under-resourced countries where facilities are sparse, the population is widely dispersed and transport is limited. Haematology has a key role in diagnosis and patient management by selecting tests for their clinical relevance and utility for the specific circumstances, and ensuring their technical reliability when used in health clinics and point-of-care testing. WHO has proposed a basic menu of tests in three categories: (a) tests such as haemoglobin screen which can be performed by nurses, midwives, health-aides or community doctors, (b) tests such as haemoglobinometry, microhaematocrit and microscopic examination of stained preparations which can be performed by a technician or laboratory assistant in a health centre, (c) tests requiring greater technical expertise of a laboratory technician or trained doctor. The peripheral health clinics and district laboratories must be familiar with the guidelines on standardized methods for collecting and storing specimens and transporting them to a regional laboratory or a reference centre. A training syllabus should be provided at the health centres and district laboratories, and this should include on-site instruction from supervisors and access to training manuals and distance-learning material. A co-ordinated programme of quality assurance and standardization of test methods should be established by a reference centre or national health authority with a network which encompasses all laboratories and health clinics undertaking any tests. Each regional laboratory should foster lower level laboratories or clinics within its neighbourhood. Of particular concern is the reliable diagnosis and management of anaemia. WHO reports indicate that 40% of the world population suffer from anaemia, especially affecting pregnant women, and a high proportion of infants and children in developing countries. The Haemoglobin Colour Scale (HCS) was recently developed for WHO as a simple, cheap and portable device which reads haemoglobin within 1 g/dl of the true value. It has been validated in a number of studies and is now manufactured commercially in accordance with WHO specifications under control of a WHO Collaborating Centre. It has an important potential role in the resource-limited environment where anaemia screening presently usually depends on unreliable clinical examination.

  7. Point-of-care syndrome-based, rapid diagnosis of infections on commercial ships.

    PubMed

    Bouricha, Mehdi; Samad, Marc Abdul; Levy, Pierre-Yves; Raoult, Didier; Drancourt, Michel

    2014-01-01

    Suspicion of contagious disease on commercial ships tends to be poorly managed, as there is little capacity to confirm a case on board except for malaria. Here we implemented a point-of-care (POC) laboratory on one container ship and one cruise ship for the rapid syndrome-based diagnosis of infectious diseases on board. In 2012 we implemented a POC laboratory on board a freight ship and on board a cruise ship. The POC laboratory ran a total of six different color-coded, syndrome-based kits incorporating 10 different commercially available immunochromatographic tests. The POC tests were taught within 1-hour as part of training to staff without any previous knowledge in microbiology. Compared with terrestrial POCs, specific constraints included the necessity to secure POC devices into the motile ship, to use robust devices, to overcome difficulties in communicating with the core laboratory, and to overcome limited intimacy of patients. However, a total of 36 POC tests were easily performed and yielded contributive negative results. This first experiment indicates that it is possible to run POC laboratories by nonexpert staff after providing rapid teaching course on board commercial ships. Generalization of on-board POC laboratories is expected to help in improving the medical management of staff and passengers. © 2013 International Society of Travel Medicine.

  8. Laboratory diagnosis of creatine deficiency syndromes: a technical standard and guideline of the American College of Medical Genetics and Genomics.

    PubMed

    Sharer, J Daniel; Bodamer, Olaf; Longo, Nicola; Tortorelli, Silvia; Wamelink, Mirjam M C; Young, Sarah

    2017-02-01

    Disclaimer: These ACMG Standards and Guidelines are intended as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to these standards and guidelines is voluntary and does not necessarily assure a successful medical outcome. These Standards and Guidelines should not be considered inclusive of all proper procedures and tests or exclusive of others that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, clinical laboratory geneticists should apply their professional judgment to the specific circumstances presented by the patient or specimen. Clinical laboratory geneticists are encouraged to document in the patient's record the rationale for the use of a particular procedure or test, whether or not it is in conformance with these Standards and Guidelines. They also are advised to take notice of the date any particular guideline was adopted, and to consider other relevant medical and scientific information that becomes available after that date. It also would be prudent to consider whether intellectual property interests may restrict the performance of certain tests and other procedures.Cerebral creatine deficiency syndromes are neurometabolic conditions characterized by intellectual disability, seizures, speech delay, and behavioral abnormalities. Several laboratory methods are available for preliminary and confirmatory diagnosis of these conditions, including measurement of creatine and related metabolites in biofluids using liquid chromatography-tandem mass spectrometry or gas chromatography-mass spectrometry, enzyme activity assays in cultured cells, and DNA sequence analysis. These guidelines are intended to standardize these procedures to help optimize the diagnosis of creatine deficiency syndromes. While biochemical methods are emphasized, considerations for confirmatory molecular testing are also discussed, along with variables that influence test results and interpretation.Genet Med 19 2, 256-263.

  9. Development and validation of an OECD reproductive toxicity test guideline with the pond snail Lymnaea stagnalis (Mollusca, Gastropoda).

    PubMed

    Ducrot, Virginie; Askem, Clare; Azam, Didier; Brettschneider, Denise; Brown, Rebecca; Charles, Sandrine; Coke, Maïra; Collinet, Marc; Delignette-Muller, Marie-Laure; Forfait-Dubuc, Carole; Holbech, Henrik; Hutchinson, Thomas; Jach, Arne; Kinnberg, Karin L; Lacoste, Cédric; Le Page, Gareth; Matthiessen, Peter; Oehlmann, Jörg; Rice, Lynsey; Roberts, Edward; Ruppert, Katharina; Davis, Jessica Elphinstone; Veauvy, Clemence; Weltje, Lennart; Wortham, Ruth; Lagadic, Laurent

    2014-12-01

    The OECD test guideline development program has been extended in 2011 to establish a partial life-cycle protocol for assessing the reproductive toxicity of chemicals to several mollusk species, including the great pond snail Lymnaea stagnalis. In this paper, we summarize the standard draft protocol for a reproduction test with this species, and present inter-comparison results obtained in a 56-day prevalidation ring-test using this protocol. Seven European laboratories performed semi-static tests with cultured snails of the strain Renilys® exposed to nominal concentrations of cadmium chloride (from 53 to 608μgCdL(-1)). Cd concentrations in test solutions were analytically determined to confirm accuracy in the metal exposure concentrations in all laboratories. Physico-chemical and biological validity criteria (namely dissolved oxygen content >60% ASV, water temperature 20±1°C, control snail survival >80% and control snail fecundity >8 egg-masses per snail over the test period) were met in all laboratories which consistently demonstrated the reproductive toxicity of Cd in snails using the proposed draft protocol. Effect concentrations for fecundity after 56days were reproducible between laboratories (68

  10. Physician Satisfaction With Clinical Laboratory Services: A College of American Pathologists Q-Probes Study of 81 Institutions.

    PubMed

    McCall, Shannon J; Souers, Rhona J; Blond, Barbara; Massie, Larry

    2016-10-01

    -Assessment of customer satisfaction is a vital component of the laboratory quality improvement program. -To survey the level of physician satisfaction with hospital clinical laboratory services. -Participating institutions provided demographic information and survey results of physician satisfaction, with specific features of clinical laboratory services individually rated on a scale of 5 (excellent) to 1 (poor). -Eighty-one institutions submitted 2425 surveys. The median overall satisfaction score was 4.2 (10th percentile, 3.6; 90th percentile, 4.6). Of the 16 surveyed areas receiving the highest percentage of excellent/good ratings (combined scores of 4 and 5), quality of results was highest along with test menu adequacy, staff courtesy, and overall satisfaction. Of the 4 categories receiving the lowest percentage values of excellent/good ratings, 3 were related to turnaround time for inpatient "STAT" (tests performed immediately), outpatient STAT, and esoteric tests. The fourth was a new category presented in this survey: ease of electronic order entry. Here, 11.4% (241 of 2121) of physicians assigned below-average (2) or poor (1) scores. The 5 categories deemed most important to physicians included quality of results, turnaround times for inpatient STAT, routine, and outpatient STAT tests, and clinical report format. Overall satisfaction as measured by physician willingness to recommend their laboratory to another physician remains high at 94.5% (2160 of 2286 respondents). -There is a continued trend of high physician satisfaction and loyalty with clinical laboratory services. Physician dissatisfaction with ease of electronic order entry represents a new challenge. Test turnaround times are persistent areas of dissatisfaction, representing areas for improvement.

  11. Going GLP: Conducting Toxicology Studies in Compliance with Good Laboratory Practices.

    PubMed

    Carroll, Erica Eggers

    2016-01-01

    Good laboratory practice standards are US federal regulations enacted as part of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR Part 160), the Toxic Substance Control Act (40 CFR Part 792), and the Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58) to support protection of public health in the areas of pesticides, chemicals, and drug investigations in response to allegations of inaccurate data acquisition. Essentially, good laboratory practices (GLPs) are a system of management controls for nonclinical research studies involving animals to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of data collected as part of chemical (including pharmaceuticals) tests, from in vitro through acute to chronic toxicity tests. The GLPs were established in the United States in 1978 as a result of the Industrial Bio-Test Laboratory scandal which led to congressional hearings and actions to prevent fraudulent data reporting and collection. Although the establishment of infrastructure for GLPs compliance is labor-intensive and time-consuming, achievement and maintenance of GLP compliance ensures the accuracy of the data collected from each study, which is critical for defending results, advancing science, and protecting human and animal health. This article describes how and why those in the US Army Medical Department responsible for protecting the public health of US Army and other military personnel made the policy decision to have its toxicology laboratory achieve complete compliance with GLP standards, the first such among US Army laboratories. The challenges faced and how they were overcome are detailed.

  12. Low nasal bridge

    MedlinePlus

    ... ask questions about your child's family and medical history. Laboratory studies may include: Chromosome studies Enzyme assays (blood tests to ... References Farrior RT, Farrior EH, Eisler LS. Special ...

  13. Radionuclide observables during the Integrated Field Exercise of the Comprehensive Nuclear-Test-Ban Treaty

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

    Burnett, Jonathan L.; Miley, Harry S.; Milbrath, Brian D.

    In 2014 the Comprehensive Nuclear-Test-Ban Treaty Organization (CTBTO) undertook the Integrated Field Exercise (IFE) in Jordan. The exercise consisted of a simulated 0.5 – 2 kT underground explosion triggering an On-site Inspection (OSI) to search for evidence of a Treaty violation. This research evaluates two of the OSI techniques, including laboratory-based gamma-spectrometry of soil samples and in situ gamma-spectrometry for 17 particulate radionuclides indicative of nuclear weapon tests. The detection sensitivity is evaluated using real IFE and model data. It indicates that higher sensitivity laboratory measurements are the optimum technique during the IFE and OSI timeframes.

  14. Benefits of a Pharmacology Antimalarial Reference Standard and Proficiency Testing Program Provided by the Worldwide Antimalarial Resistance Network (WWARN)

    PubMed Central

    Lourens, Chris; Lindegardh, Niklas; Barnes, Karen I.; Guerin, Philippe J.; Sibley, Carol H.; White, Nicholas J.

    2014-01-01

    Comprehensive assessment of antimalarial drug resistance should include measurements of antimalarial blood or plasma concentrations in clinical trials and in individual assessments of treatment failure so that true resistance can be differentiated from inadequate drug exposure. Pharmacometric modeling is necessary to assess pharmacokinetic-pharmacodynamic relationships in different populations to optimize dosing. To accomplish both effectively and to allow comparison of data from different laboratories, it is essential that drug concentration measurement is accurate. Proficiency testing (PT) of laboratory procedures is necessary for verification of assay results. Within the Worldwide Antimalarial Resistance Network (WWARN), the goal of the quality assurance/quality control (QA/QC) program is to facilitate and sustain high-quality antimalarial assays. The QA/QC program consists of an international PT program for pharmacology laboratories and a reference material (RM) program for the provision of antimalarial drug standards, metabolites, and internal standards for laboratory use. The RM program currently distributes accurately weighed quantities of antimalarial drug standards, metabolites, and internal standards to 44 pharmacology, in vitro, and drug quality testing laboratories. The pharmacology PT program has sent samples to eight laboratories in four rounds of testing. WWARN technical experts have provided advice for correcting identified problems to improve performance of subsequent analysis and ultimately improved the quality of data. Many participants have demonstrated substantial improvements over subsequent rounds of PT. The WWARN QA/QC program has improved the quality and value of antimalarial drug measurement in laboratories globally. It is a model that has potential to be applied to strengthening laboratories more widely and improving the therapeutics of other infectious diseases. PMID:24777099

  15. Laboratory Diagnosis of Zika Virus Infection.

    PubMed

    Landry, Marie Louise; St George, Kirsten

    2017-01-01

    -The rapid and accurate diagnosis of Zika virus infection is an international priority. -To review current recommendations, methods, limitations, and priorities for Zika virus testing. -Sources include published literature, public health recommendations, laboratory procedures, and testing experience. -Until recently, the laboratory diagnosis of Zika infection was confined to public health or research laboratories that prepared their own reagents, and test capacity has been limited. Furthermore, Zika cross-reacts serologically with other flaviviruses, such as dengue, West Nile, and yellow fever. Current or past infection, or even vaccination with another flavivirus, will often cause false-positive or uninterpretable Zika serology results. Detection of viral RNA during acute infection using nucleic acid amplification tests provides more specific results, and a number of commercial nucleic acid amplification tests have received emergency use authorization. In addition to serum, testing of whole blood and urine is recommended because of the higher vial loads and longer duration of shedding. However, nucleic acid amplification testing has limited utility because many patients are asymptomatic or present for testing after the brief period of Zika shedding has passed. Thus, the greatest need and most difficult challenge is development of accurate antibody tests for the diagnosis of recent Zika infection. Research is urgently needed to identify Zika virus epitopes that do not cross-react with other flavivirus antigens. New information is emerging at a rapid pace and, with ongoing public-private and international collaborations and government support, it is hoped that rapid progress will be made in developing robust and widely applicable diagnostic tools.

  16. Make versus buy: a financial perspective.

    PubMed

    Kisner, Harold J

    2003-01-01

    Clinical laboratories are often faced with the decision to either perform a service in-house using their own assets or outsource the service to another vendor. This decision affects many aspects of the laboratory's business, from the macroeconomic perspective of outsourcing the laboratory service to a laboratory vendor, to the microeconomics of determining whether to refer a test out to their reference laboratory or perform the test in-house. The basis for decision making includes many variables, but a detailed financial analysis is usually the basis for the decision, especially when the decision only affects the laboratory and not the rest of the institution. Other factors often come into play, and depending on the magnitude, the "make versus buy" decision could be based more on strategic or political factors than economics. Even when noneconomic factors are involved, an effort usually is made to quantify those factors so that the make versus buy decision is reduced to financial terms. The previous article in this issue, "Effectively Managing Your Reference Laboratory Relationship" by Ronald L. Weiss, M.D., focused on the "buy" decision relating to managing the reference laboratory relationship. Although that article took a more clinical perspective through the eyes of the reference laboratory, this article looks at the make versus buy decision from a financial perspective through the eyes of the buying party.

  17. Towards a standardization of biomethane potential tests.

    PubMed

    Holliger, Christof; Alves, Madalena; Andrade, Diana; Angelidaki, Irini; Astals, Sergi; Baier, Urs; Bougrier, Claire; Buffière, Pierre; Carballa, Marta; de Wilde, Vinnie; Ebertseder, Florian; Fernández, Belén; Ficara, Elena; Fotidis, Ioannis; Frigon, Jean-Claude; de Laclos, Hélène Fruteau; Ghasimi, Dara S M; Hack, Gabrielle; Hartel, Mathias; Heerenklage, Joern; Horvath, Ilona Sarvari; Jenicek, Pavel; Koch, Konrad; Krautwald, Judith; Lizasoain, Javier; Liu, Jing; Mosberger, Lona; Nistor, Mihaela; Oechsner, Hans; Oliveira, João Vítor; Paterson, Mark; Pauss, André; Pommier, Sébastien; Porqueddu, Isabella; Raposo, Francisco; Ribeiro, Thierry; Rüsch Pfund, Florian; Strömberg, Sten; Torrijos, Michel; van Eekert, Miriam; van Lier, Jules; Wedwitschka, Harald; Wierinck, Isabella

    2016-12-01

    Production of biogas from different organic materials is a most interesting source of renewable energy. The biomethane potential (BMP) of these materials has to be determined to get insight in design parameters for anaerobic digesters. Although several norms and guidelines for BMP tests exist, inter-laboratory tests regularly show high variability of BMPs for the same substrate. A workshop was held in June 2015, in Leysin, Switzerland, with over 40 attendees from 30 laboratories around the world, to agree on common solutions to the conundrum of inconsistent BMP test results. This paper presents the consensus of the intense roundtable discussions and cross-comparison of methodologies used in respective laboratories. Compulsory elements for the validation of BMP results were defined. They include the minimal number of replicates, the request to carry out blank and positive control assays, a criterion for the test duration, details on BMP calculation, and last but not least criteria for rejection of the BMP tests. Finally, recommendations on items that strongly influence the outcome of BMP tests such as inoculum characteristics, substrate preparation, test setup, and data analysis are presented to increase the probability of obtaining validated and reproducible results.

  18. PROJECT HEAD START MEDICAL--A GUIDE FOR DIRECTION OF CHILD DEVELOPMENT CENTERS.

    ERIC Educational Resources Information Center

    Office of Economic Opportunity, Washington, DC.

    HEALTH SERVICES OF PROJECT HEAD START CHILD DEVELOPMENT CENTERS PROVIDE--A MEDICAL EVALUATION OF EACH CHILD INCLUDING MEDICAL HISTORY, DEVELOPMENTAL ASSESSMENT, AND PHYSICAL EXAMINATION, SCREENING TESTS FOR VISION, HEARING, SPEECH, AND TUBERCULOSIS, LABORATORY TESTS OF URINE FOR ALBUMIN AND TESTS OF SUGAR AND BLOOD FOR ANEMIA, DENTAL ASSESSMENT,…

  19. Removal of phosphorus using AMD-treated lignocellulosic material

    Treesearch

    James S. Han; Soo-Hong Min; Yeong-Kwan Kim

    2005-01-01

    Excess nutrients, including phosphorus, can cause eutrophication in surface water and reservoirs. We tested the phosphate removal capacity of juniper fiber through isotherm, kinetic, column, and field tests. Heavy metals from an acid mine drainage (AMD) site were precipitated on the surface ofjuniper fiber. The modified fiber was tested in laboratory- caled batch and...

  20. Unit: Sticking Together, First Trial Materials, Inspection Set.

    ERIC Educational Resources Information Center

    Australian Science Education Project, Toorak, Victoria.

    These materials, including teacher's guide, student test booklet and laboratory guide, student workbook, test booklet, and a booklet explaining the answers to the questions in the test booklet, are first trial versions of a unit that will form part of the Australian Science Education Project instructional materials for grades seven through ten.…

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