Sample records for testing laboratories performing

  1. 40 CFR 799.4360 - Tributyl phosphate.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... provisions also apply: (i) Animal selection. Testing shall be performed in laboratory rats. (ii) Duration of... apply: (i) Animal selection. Testing shall be performed in laboratory rats. (ii) Duration of testing...) Animal selection. Testing shall be performed in laboratory rats. (ii) Duration of testing. Animals shall...

  2. 42 CFR 493.25 - Laboratories performing tests of high complexity.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Laboratories performing tests of high complexity. 493.25 Section 493.25 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND....25 Laboratories performing tests of high complexity. (a) A laboratory must obtain a certificate for...

  3. 42 CFR 493.25 - Laboratories performing tests of high complexity.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Laboratories performing tests of high complexity. 493.25 Section 493.25 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND....25 Laboratories performing tests of high complexity. (a) A laboratory must obtain a certificate for...

  4. 42 CFR 493.25 - Laboratories performing tests of high complexity.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Laboratories performing tests of high complexity. 493.25 Section 493.25 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Provisions § 493.25 Laboratories performing tests of high...

  5. 42 CFR 493.20 - Laboratories performing tests of moderate complexity.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Laboratories performing tests of moderate complexity. 493.20 Section 493.20 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Provisions § 493.20 Laboratories performing tests of...

  6. Laboratory and clinical evaluation of on-site urine drug testing.

    PubMed

    Beck, Olof; Carlsson, Sten; Tusic, Marinela; Olsson, Robert; Franzen, Lisa; Hulten, Peter

    2014-11-01

    Products for on-site urine drug testing offer the possibility to perform screening for drugs of abuse directly at the point-of-care. This is a well-established routine in emergency and dependency clinics but further evaluation of performance is needed due to inherent limitations with the available products. Urine drug testing by an on-site product was compared with routine laboratory methods. First, on-site testing was performed at the laboratory in addition to the routine method. Second, the on-site testing was performed at a dependency clinic and urine samples were subsequently sent to the laboratory for additional analytical investigation. The on-site testing products did not perform with assigned cut-off levels. The subjective reading between the presence of a spot (i.e. negative test result) being present or no spot (positive result) was difficult in 3.2% of the cases, and occurred for all parameters. The tests performed more accurately in drug negative samples (specificity 96%) but less accurately for detecting positives (sensitivity 79%). Of all incorrect results by the on-site test the proportion of false negatives was 42%. The overall agreement between on-site and laboratory testing was 95% in the laboratory study and 98% in the clinical study. Although a high degree of agreement was observed between on-site and routine laboratory urine drug testing, the performance of on-site testing was not acceptable due to significant number of false negative results. The limited sensitivity of on-site testing compared to laboratory testing reduces the applicability of these tests.

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

    PubMed

    Howanitz, P J

    1988-04-01

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

  8. CAP/ACMG proficiency testing for biochemical genetics laboratories: a summary of performance.

    PubMed

    Oglesbee, Devin; Cowan, Tina M; Pasquali, Marzia; Wood, Timothy C; Weck, Karen E; Long, Thomas; Palomaki, Glenn E

    2018-01-01

    PurposeTesting for inborn errors of metabolism is performed by clinical laboratories worldwide, each utilizing laboratory-developed procedures. We sought to summarize performance in the College of American Pathologists' (CAP) proficiency testing (PT) program and identify opportunities for improving laboratory quality. When evaluating PT data, we focused on a subset of laboratories that have participated in at least one survey since 2010.MethodsAn analysis of laboratory performance (2004 to 2014) on the Biochemical Genetics PT Surveys, a program administered by CAP and the American College of Medical Genetics and Genomics. Analytical and interpretive performance was evaluated for four tests: amino acids, organic acids, acylcarnitines, and mucopolysaccharides.ResultsSince 2010, 150 laboratories have participated in at least one of four PT surveys. Analytic sensitivities ranged from 88.2 to 93.4%, while clinical sensitivities ranged from 82.4 to 91.0%. Performance was higher for US participants and for more recent challenges. Performance was lower for challenges with subtle findings or complex analytical patterns.ConclusionUS clinical biochemical genetics laboratory proficiency is satisfactory, with a minority of laboratories accounting for the majority of errors. Our findings underscore the complex nature of clinical biochemical genetics testing and highlight the necessity of continuous quality management.

  9. The Relationship of Laboratory Performance Ratings, Information Achievement and Pencil-Paper Performance Test Scores in College-Level Electricity.

    ERIC Educational Resources Information Center

    Francis, Charles E.

    In this study, a pencil paper performance test (PPPT) was developed and administered to an experimental group of 46 students and a control group of 48 students to determine: (1) the difference between laboratory performance and the successful completion of a laboratory course in electricity, (2) the relationship between laboratory performance as…

  10. Long-term pavement performance project laboratory materials testing and handling guide

    DOT National Transportation Integrated Search

    2007-09-01

    The Long Term Pavement Performance (LTPP) Laboratory Material Testing Guide was originally prepared for laboratory material handling and testing of material specimens and samples of asphalt materials, portland cement concrete, aggregates, and soils u...

  11. Capability of the Gas Analysis and Testing Laboratory at the NASA Johnson Space Center

    NASA Technical Reports Server (NTRS)

    Broerman, Craig; Jimenez, Javier; Sweterlitsch, Jeff

    2012-01-01

    The Gas Analysis and Testing Laboratory is an integral part of the testing performed at the NASA Johnson Space Center. The Gas Analysis and Testing Laboratory is a high performance laboratory providing real time analytical instruments to support manned and unmanned testing. The lab utilizes precision gas chromatographs, gas analyzers and spectrophotometers to support the technology development programs within the NASA community. The Gas Analysis and Testing Laboratory works with a wide variety of customers and provides engineering support for user-specified applications in compressed gas, chemical analysis, general and research laboratory.

  12. Capability of the Gas Analysis and Testing Laboratory at the NASA Johnson Space Center

    NASA Technical Reports Server (NTRS)

    Broerman, Craig; Jimenez, Javier; Sweterlitsch, Jeff

    2011-01-01

    The Gas Analysis and Testing Laboratory is an integral part of the testing performed at the NASA Johnson Space Center. The Gas Analysis and Testing Laboratory is a high performance laboratory providing real time analytical instruments to support manned and unmanned testing. The lab utilizes precision gas chromatographs, gas analyzers and spectrophotometers to support the technology development programs within the NASA community. The Gas Analysis and Testing Laboratory works with a wide variety of customers and provides engineering support for user-specified applications in compressed gas, chemical analysis, general and research laboratory

  13. 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.

  14. 42 CFR 493.1487 - Condition: Laboratories performing high complexity testing; testing personnel.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing high complexity testing; testing personnel. 493.1487 Section 493.1487 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

  15. 42 CFR 493.1487 - Condition: Laboratories performing high complexity testing; testing personnel.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing high complexity testing; testing personnel. 493.1487 Section 493.1487 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

  16. 42 CFR 493.1441 - Condition: Laboratories performing high complexity testing; laboratory director.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing high complexity testing; laboratory director. 493.1441 Section 493.1441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

  17. 42 CFR 493.1441 - Condition: Laboratories performing high complexity testing; laboratory director.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing high complexity testing; laboratory director. 493.1441 Section 493.1441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

  18. 42 CFR 493.1449 - Standard; Technical supervisor qualifications.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... service in which the laboratory performs high complexity tests or procedures. The director of a laboratory... may perform anatomic and clinical laboratory procedures and tests in all specialties and... tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must...

  19. Laboratories | Energy Systems Integration Facility | NREL

    Science.gov Websites

    laboratories to be safely divided into multiple test stand locations (or "capability hubs") to enable Fabrication Laboratory Energy Systems High-Pressure Test Laboratory Energy Systems Integration Laboratory Energy Systems Sensor Laboratory Fuel Cell Development and Test Laboratory High-Performance Computing

  20. Laboratories | NREL

    Science.gov Websites

    | Z A Accelerated Exposure Testing Laboratory Advanced Optical Materials Laboratory Advanced Thermal Laboratory Structural Testing Laboratory Surface Analysis Laboratory Systems Performance Laboratory T Thermal Storage Materials Laboratory Thermal Storage Process and Components Laboratory Thin-Film Deposition

  1. Verification of performance specifications of a molecular test: cystic fibrosis carrier testing using the Luminex liquid bead array.

    PubMed

    Lacbawan, Felicitas L; Weck, Karen E; Kant, Jeffrey A; Feldman, Gerald L; Schrijver, Iris

    2012-01-01

    The number of clinical laboratories introducing various molecular tests to their existing test menu is continuously increasing. Prior to offering a US Food and Drug Administration-approved test, it is necessary that performance characteristics of the test, as claimed by the company, are verified before the assay is implemented in a clinical laboratory. To provide an example of the verification of a specific qualitative in vitro diagnostic test: cystic fibrosis carrier testing using the Luminex liquid bead array (Luminex Molecular Diagnostics, Inc, Toronto, Ontario). The approach used by an individual laboratory for verification of a US Food and Drug Administration-approved assay is described. Specific verification data are provided to highlight the stepwise verification approach undertaken by a clinical diagnostic laboratory. Protocols for verification of in vitro diagnostic assays may vary between laboratories. However, all laboratories must verify several specific performance specifications prior to implementation of such assays for clinical use. We provide an example of an approach used for verifying performance of an assay for cystic fibrosis carrier screening.

  2. 42 CFR 493.1467 - Condition: Laboratories performing high complexity testing; cytology general supervisor.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... testing; cytology general supervisor. 493.1467 Section 493.1467 Public Health CENTERS FOR MEDICARE....1467 Condition: Laboratories performing high complexity testing; cytology general supervisor. For the subspecialty of cytology, the laboratory must have a general supervisor who meets the qualification...

  3. 42 CFR 493.1467 - Condition: Laboratories performing high complexity testing; cytology general supervisor.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... testing; cytology general supervisor. 493.1467 Section 493.1467 Public Health CENTERS FOR MEDICARE....1467 Condition: Laboratories performing high complexity testing; cytology general supervisor. For the subspecialty of cytology, the laboratory must have a general supervisor who meets the qualification...

  4. 42 CFR 493.1467 - Condition: Laboratories performing high complexity testing; cytology general supervisor.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... testing; cytology general supervisor. 493.1467 Section 493.1467 Public Health CENTERS FOR MEDICARE....1467 Condition: Laboratories performing high complexity testing; cytology general supervisor. For the subspecialty of cytology, the laboratory must have a general supervisor who meets the qualification...

  5. 42 CFR 493.1467 - Condition: Laboratories performing high complexity testing; cytology general supervisor.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... testing; cytology general supervisor. 493.1467 Section 493.1467 Public Health CENTERS FOR MEDICARE....1467 Condition: Laboratories performing high complexity testing; cytology general supervisor. For the subspecialty of cytology, the laboratory must have a general supervisor who meets the qualification...

  6. 42 CFR 493.1467 - Condition: Laboratories performing high complexity testing; cytology general supervisor.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... testing; cytology general supervisor. 493.1467 Section 493.1467 Public Health CENTERS FOR MEDICARE....1467 Condition: Laboratories performing high complexity testing; cytology general supervisor. For the subspecialty of cytology, the laboratory must have a general supervisor who meets the qualification...

  7. Use, location, and timeliness of clinical microbiology testing in Georgia for select infectious diseases.

    PubMed

    Brzozowski, Amanda K; Silk, Benjamin J; Berkelman, Ruth L; Loveys, Deborah A; Caliendo, Angela M

    2012-01-01

    Although clinical microbiology testing facilitates both public health surveillance of infectious diseases and patient care, research on testing patterns is scant. We surveyed hospital laboratories in Georgia to assess their diagnostic testing practices. Using e-mail, all directors of hospital laboratories in Georgia were invited to participate. The survey focused on timing and location of diagnostic testing in 2006 for 6 reportable diseases: giardiasis, legionellosis, meningococcal disease, pertussis, Rocky Mountain spotted fever, and West Nile virus disease. Of 141 laboratories, 62 (44%) responded to the survey. Hospitals varied widely in their use of diagnostic testing in 2006, with 95.1% testing for meningococcal disease, but only 66.1% and 63.3% testing for legionellosis and West Nile virus disease, respectively. Most laboratories (91%) performed gram stain/culture to diagnose meningococcal disease in-house and 23% performed ova and parasite panels for giardiasis were conducted in-house. Fewer than 11% of laboratories performed in-house testing for the remaining diseases. Laboratories affiliated with small hospitals (≤100 beds) were more likely to send specimens for outside testing compared with laboratories associated with large hospitals (>250 beds). Median turnaround time for ova and parasite panel testing for giardiasis was significantly shorter for in-house testing (1.0 days) than within-system (2.25 days) or outside laboratory (3.0 days) testing (P = .0003). No laboratories reported in-house testing for meningococcal disease, pertussis, or Rocky Mountain spotted fever using polymerase chain reaction. Many hospitals did not order diagnostic tests for important infectious diseases during 2006, even for relatively common diseases. In addition, hospital laboratories were unlikely to perform diagnostic testing in-house; sending specimens to an outside laboratory may result in substantial delays in receiving results. These unsettling findings have adverse implications for both patient care and public health surveillance; they indicate an immediate need to study nationally the use and timeliness of clinical microbiologic testing.

  8. 42 CFR 493.1403 - Condition: Laboratories performing moderate complexity testing; laboratory director.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1403 Section 493.1403 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

  9. 42 CFR 493.1403 - Condition: Laboratories performing moderate complexity testing; laboratory director.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1403 Section 493.1403 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

  10. 7 CFR 91.35 - Who shall perform an appealed laboratory service.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...) COMMODITY LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Appeal of Laboratory Services § 91.35 Who shall perform an appealed laboratory service. An appealed laboratory service shall be performed... 7 Agriculture 3 2010-01-01 2010-01-01 false Who shall perform an appealed laboratory service. 91...

  11. 42 CFR 493.1453 - Condition: Laboratories performing high complexity testing; clinical consultant.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... testing; clinical consultant. 493.1453 Section 493.1453 Public Health CENTERS FOR MEDICARE & MEDICAID... Condition: Laboratories performing high complexity testing; clinical consultant. The laboratory must have a clinical consultant who meets the requirements of § 493.1455 of this subpart and provides clinical...

  12. 42 CFR 493.1415 - Condition: Laboratories performing moderate complexity testing; clinical consultant.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... complexity testing; clinical consultant. 493.1415 Section 493.1415 Public Health CENTERS FOR MEDICARE... § 493.1415 Condition: Laboratories performing moderate complexity testing; clinical consultant. The laboratory must have a clinical consultant who meets the qualification requirements of § 493.1417 of this...

  13. 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.

  14. 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.

  15. Quality Indicators of Cervical Cytopathology Tests in the Public Service in Minas Gerais, Brazil.

    PubMed

    Tobias, Alessandra Hermógenes Gomes; Amaral, Rita Goreti; Diniz, Elói Martins; Carneiro, Cláudia Martins

    2016-02-01

    The objective of this study is to assess the performance of cytopathology laboratories providing services to the Brazilian Unified Health System (Sistema Único de Saúde - SUS) in the State of Minas Gerais, Brazil. This descriptive study uses data obtained from the Cervical Cancer Information System from January to December 2012. Three quality indicators were analyzed to assess the quality of cervical cytopathology tests: positivity index, percentage of atypical squamous cells (ASCs) in abnormal tests, and percentage of tests compatible with high-grade squamous intraepithelial lesions (HSILs). Laboratories were classified according to their production scale in tests per year ≤ 5,000; from 5,001 to 10,000; from 10,001 to 15,000; and ≥ 15,001. Based on the collection of variables and the classification of laboratories according to production scale, we created and analyzed a database using Microsoft Office Excel 97-2003. In the Brazilian state of Minas Gerais, 146 laboratories provided services to the SUS in 2012 by performing a total of 1,277,018 cervical cytopathology tests. Half of these laboratories had production scales ≤ 5,000 tests/year and accounted for 13.1% of all tests performed in the entire state; in turn, 13.7% of these laboratories presented production scales of > 15,001 tests/year and accounted for 49.2% of the total of tests performed in the entire state. The positivity indexes of most laboratories providing services to the SUS in 2012, regardless of production scale, were below or well below recommended limits. Of the 20 laboratories that performed more than 15,001 tests per year, only three presented percentages of tests compatible with HSILs above the lower limit recommended by the Brazilian Ministry of Health. The majority of laboratories providing services to the SUS in Minas Gerais presented quality indicators outside the range recommended by the Brazilian Ministry of Health. Thieme Publicações Ltda Rio de Janeiro, Brazil.

  16. Molecular genetic testing for cystic fibrosis: laboratory performance on the College of American Pathologists external proficiency surveys.

    PubMed

    Lyon, Elaine; Schrijver, Iris; Weck, Karen E; Ferreira-Gonzalez, Andrea; Richards, C Sue; Palomaki, Glenn E

    2015-03-01

    Molecular testing for cystic fibrosis mutations is widespread and routine in reproductive decision making and diagnosis. Our objective was to assess the level of performance of laboratories for this test. The College of American Pathologists administers external proficiency testing with multiple DNA samples distributed biannually. RESULTS are analyzed, reviewed, and graded by the joint College of American Pathologists/American College of Medical Genetics and Genomics Biochemical and Molecular Genetics Committee. Assessment is based on genotype and associated clinical interpretation. Overall, 357 clinical laboratories participated in the proficiency testing survey between 2003 and 2013 (322 in the United States and 35 international). In 2013, US participants reported performing nearly 120,000 tests monthly. Analytical sensitivity and specificity of US laboratories were 98.8% (95% confidence interval: 98.4-99.1%) and 99.6% (95% confidence interval: 99.4-99.7%), respectively. Analytical sensitivity improved between 2003 and 2008 (from 97.9 to 99.3%; P = 0.007) and remained steady thereafter. Clinical interpretation matched the intended response for 98.8, 86.0, and 91.0% of challenges with no, one, or two mutations, respectively. International laboratories performed similarly. Laboratory testing for cystic fibrosis in the United States has improved since 2003, and these data demonstrate a high level of quality. Neither the number of samples tested nor test methodology affected performance.

  17. Shield evaluation and performance testing at the USMB`s Strategic Structures Testing Laboratory

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

    Barczak, T.M.; Gearhart, D.F.

    1996-12-31

    Historically, shield performance testing is conducted by the support manufacturers at European facilities. The U.S. Bureau of Mines (USBM) has conducted extensive research in shield Mechanics and is now opening its Strategic Structures Testing (SST) Laboratory to the mining industry for shield performance testing. The SST Laboratory provides unique shield testing capabilities using the Mine Roof Simulator (MRS) load frame. The MRS provides realistic and cost-effective shield evaluation by combining both vertical and horizontal loading into a single load cycle; whereas, several load cycles would be required to obtain this loading in a static frame. In addition to these advantages,more » the USBM acts as an independent research organization to provide an unbiased assessment of shield performance. This paper describes the USBM`s shield testing program that is designed specifically to simulate in-service mining conditions using the unique the capabilities of the SST Laboratory.« less

  18. 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.

  19. 42 CFR 493.1425 - Standard; Testing personnel responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... laboratory's quality control policies, document all quality control activities, instrument and procedural... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing Moderate Complexity Testing § 493.1425 Standard; Testing personnel...

  20. 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)

  1. Evaluation of an external quality assessment program for HIV testing in Haiti, 2006-2011.

    PubMed

    Louis, Frantz Jean; Anselme, Renette; Ndongmo, Clement; Buteau, Josiane; Boncy, Jacques; Dahourou, Georges; Vertefeuille, John; Marston, Barbara; Balajee, S Arunmozhi

    2013-12-01

    To evaluate an external quality assessment (EQA) program for human immunodeficiency virus (HIV) rapid diagnostics testing by the Haitian National Public Health Laboratory (French acronym: LNSP). Acceptable performance was defined as any proficiency testing (PT) score more than 80%. The PT database was reviewed and analyzed to assess the testing performance of the participating laboratories and the impact of the program over time. A total of 242 laboratories participated in the EQA program from 2006 through 2011; participation increased from 70 laboratories in 2006 to 159 in 2011. In 2006, 49 (70%) laboratories had a PT score of 80% or above; by 2011, 145 (97.5%) laboratories were proficient (P < .05). The EQA program for HIV testing ensures quality of testing and allowed the LNSP to document improvements in the quality of HIV rapid testing over time.

  2. 42 CFR 493.1481 - Condition: Laboratories performing high complexity testing; cytotechnologist.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing high complexity testing; cytotechnologist. 493.1481 Section 493.1481 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

  3. 42 CFR 493.20 - Laboratories performing tests of moderate complexity.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Laboratories performing tests of moderate complexity. 493.20 Section 493.20 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General...

  4. 42 CFR 493.1481 - Condition: Laboratories performing high complexity testing; cytotechnologist.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing high complexity testing; cytotechnologist. 493.1481 Section 493.1481 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

  5. 42 CFR 493.807 - Condition: Reinstatement of laboratories performing nonwaived testing.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Reinstatement of laboratories performing nonwaived testing. 493.807 Section 493.807 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS...

  6. 42 CFR 493.807 - Condition: Reinstatement of laboratories performing nonwaived testing.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Reinstatement of laboratories performing nonwaived testing. 493.807 Section 493.807 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS...

  7. 42 CFR 493.1361 - Condition: Laboratories performing PPM procedures; testing personnel.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing PPM procedures; testing personnel. 493.1361 Section 493.1361 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS...

  8. 42 CFR 493.1361 - Condition: Laboratories performing PPM procedures; testing personnel.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing PPM procedures; testing personnel. 493.1361 Section 493.1361 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS...

  9. 42 CFR 493.20 - Laboratories performing tests of moderate complexity.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Laboratories performing tests of moderate complexity. 493.20 Section 493.20 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General...

  10. Test Guideline Methods for Bed Bug Pesticide Products Now Available

    EPA Pesticide Factsheets

    EPA’s final test guidelines, 810.3900 - Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products, provides recommendations for the design and execution of laboratory studies to evaluate the performance of pesticide products.

  11. Exploration of task performance tests in a physics laboratory

    NASA Astrophysics Data System (ADS)

    Liu, Dan; El Turkey, Houssein

    2017-11-01

    In this article, we investigate the implementation of task performance tests in an undergraduate physics laboratory. Two performance tests were carried out over two semesters using the task of building a DC circuit. The first implementation in Spring 2014 had certain concerns such as the privacy of students’ testing and their ‘trial and error’ attempts. These concerns were addressed in Fall 2015 through implementing a second performance test. The second implementation was administered differently but the content of the two tests was the same. We discuss the validity of both implementations and present the correlation (or lack of) between the time that students needed to complete the tests and their grades from a paper-based laboratory assessment method.

  12. 42 CFR 493.1421 - Condition: Laboratories performing moderate complexity testing; testing personnel.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing moderate complexity testing; testing personnel. 493.1421 Section 493.1421 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

  13. 42 CFR 493.1421 - Condition: Laboratories performing moderate complexity testing; testing personnel.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing moderate complexity testing; testing personnel. 493.1421 Section 493.1421 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

  14. 42 CFR 493.1459 - Condition: Laboratories performing high complexity testing; general supervisor.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing high complexity testing; general supervisor. 493.1459 Section 493.1459 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

  15. 42 CFR 493.1453 - Condition: Laboratories performing high complexity testing; clinical consultant.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing high complexity testing; clinical consultant. 493.1453 Section 493.1453 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

  16. 42 CFR 493.1447 - Condition: Laboratories performing high complexity testing; technical supervisor.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing high complexity testing; technical supervisor. 493.1447 Section 493.1447 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

  17. 42 CFR 493.1459 - Condition: Laboratories performing high complexity testing; general supervisor.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing high complexity testing; general supervisor. 493.1459 Section 493.1459 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

  18. 42 CFR 493.1447 - Condition: Laboratories performing high complexity testing; technical supervisor.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing high complexity testing; technical supervisor. 493.1447 Section 493.1447 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY...

  19. 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.

  20. 42 CFR 493.643 - Fee for determination of program compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... laboratory's scope and volume of testing (excluding tests performed for quality control, quality assurance... procedure or examination for a single analyte. (Tests performed for quality control, quality assurance, and... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Administration...

  1. Keeping waived tests simple.

    PubMed

    2004-01-01

    Laboratories performing waived testing must follow the manufacturer's instructions as well as good laboratory practices to ensure that test results are reliable. Four things to concentrate on to maximize the performance and reliability of waived tests are to: 1. Read and follow the information found in the package inserts. 2. Follow the manufacturer's recommendations for running quality control. 3. Train staff members to perform tests correctly. 4. Follow established policies and procedures for patient testing in the practice.

  2. Verification of performance specifications for a US Food and Drug Administration-approved molecular microbiology test: Clostridium difficile cytotoxin B using the Becton, Dickinson and Company GeneOhm Cdiff assay.

    PubMed

    Schlaberg, Robert; Mitchell, Michael J; Taggart, Edward W; She, Rosemary C

    2012-01-01

    US Food and Drug Administration (FDA)-approved diagnostic tests based on molecular genetic technologies are becoming available for an increasing number of microbial pathogens. Advances in technology and lower costs have moved molecular diagnostic tests formerly performed for research purposes only into much wider use in clinical microbiology laboratories. To provide an example of laboratory studies performed to verify the performance of an FDA-approved assay for the detection of Clostridium difficile cytotoxin B compared with the manufacturer's performance standards. We describe the process and protocols used by a laboratory for verification of an FDA-approved assay, assess data from the verification studies, and implement the assay after verification. Performance data from the verification studies conducted by the laboratory were consistent with the manufacturer's performance standards and the assay was implemented into the laboratory's test menu. Verification studies are required for FDA-approved diagnostic assays prior to use in patient care. Laboratories should develop a standardized approach to verification studies that can be adapted and applied to different types of assays. We describe the verification of an FDA-approved real-time polymerase chain reaction assay for the detection of a toxin gene in a bacterial pathogen.

  3. 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.

  4. 42 CFR 493.803 - Condition: Successful participation.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... testing performance. (3) The laboratory has a poor compliance history. [57 FR 7146, Feb. 28, 1992, as... testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake...

  5. Laboratory evaluation of the pointing stability of the ASPS Vernier System

    NASA Technical Reports Server (NTRS)

    1980-01-01

    The annular suspension and pointing system (ASPS) is an end-mount experiment pointing system designed for use in the space shuttle. The results of the ASPS Vernier System (AVS) pointing stability tests conducted in a laboratory environment are documented. A simulated zero-G suspension was used to support the test payload in the laboratory. The AVS and the suspension were modelled and incorporated into a simulation of the laboratory test. Error sources were identified and pointing stability sensitivities were determined via simulation. Statistical predictions of laboratory test performance were derived and compared to actual laboratory test results. The predicted mean pointing stability during simulated shuttle disturbances was 1.22 arc seconds; the actual mean laboratory test pointing stability was 1.36 arc seconds. The successful prediction of laboratory test results provides increased confidence in the analytical understanding of the AVS magnetic bearing technology and allows confident prediction of in-flight performance. Computer simulations of ASPS, operating in the shuttle disturbance environment, predict in-flight pointing stability errors less than 0.01 arc seconds.

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

    PubMed

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

    2018-05-01

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

  7. Audit of Helicobacter pylori Testing in Microbiology Laboratories in England: To Inform Compliance with NICE Guidance and the Feasibility of Routine Antimicrobial Resistance Surveillance

    PubMed Central

    Allison, Rosalie; Lecky, Donna M.; Bull, Megan; Turner, Kim; Godbole, Gauri

    2016-01-01

    Introduction. The National Institute for Health and Clinical Excellence (NICE) guidance recommends that dyspeptic patients are tested for Helicobacter pylori using a urea breath test, stool antigen test, or serology. Antibiotic resistance in H. pylori is globally increasing, but treatment in England is rarely guided by susceptibility testing or surveillance. Aims. To determine compliance of microbiology laboratories in England with NICE guidance and whether laboratories perform culture and antibiotic susceptibility testing (AST). Methods. In 2015, 170 accredited English microbiology laboratories were surveyed, by email. Results. 121/170 (71%) laboratories responded; 96% provided H. pylori testing (78% on site). 94% provided H. pylori diagnosis using stool antigen; only four provided serology as their noninvasive test; 3/4 of these encouraged urea breath tests in their acute trusts. Only 22/94 (23%) of the laboratories performed H. pylori cultures from gastric biopsies on site; 9/22 performed AST, but the vast majority processed less than one specimen/week. Conclusions. Only five laboratories in England do not comply with NICE guidance; these will need the guidance reinforced. National surveillance needs to be implemented; culture-based AST would need to be centralised. Moving forward, detection of resistance in H. pylori from stool specimens using molecular methods (PCR) needs to be explored. PMID:27829836

  8. 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.

  9. 10 CFR 430.25 - Laboratory Accreditation Program.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Procedures § 430.25 Laboratory Accreditation Program. The testing for general service fluorescent lamps... Appendix R to this subpart. The testing for medium base compact fluorescent lamps shall be performed in accordance with Appendix W of this subpart. This testing shall be conducted by test laboratories accredited...

  10. 10 CFR 430.25 - Laboratory Accreditation Program.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Procedures § 430.25 Laboratory Accreditation Program. The testing for general service fluorescent lamps... Appendix R to this subpart. The testing for medium base compact fluorescent lamps shall be performed in accordance with Appendix W of this subpart. This testing shall be conducted by test laboratories accredited...

  11. Performance criteria and quality indicators for the post-analytical phase.

    PubMed

    Sciacovelli, Laura; Aita, Ada; Padoan, Andrea; Pelloso, Michela; Antonelli, Giorgia; Piva, Elisa; Chiozza, Maria Laura; Plebani, Mario

    2016-07-01

    Quality indicators (QIs) used as performance measurements are an effective tool in accurately estimating quality, identifying problems that may need to be addressed, and monitoring the processes over time. In Laboratory Medicine, QIs should cover all steps of the testing process, as error studies have confirmed that most errors occur in the pre- and post-analytical phase of testing. Aim of the present study is to provide preliminary results on QIs and related performance criteria in the post-analytical phase. This work was conducted according to a previously described study design based on the voluntary participation of clinical laboratories in the project on QIs of the Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Overall, data collected highlighted an improvement or stability in performances over time for all reported indicators thus demonstrating that the use of QIs is effective in the quality improvement strategy. Moreover, QIs data are an important source for defining the state-of-the-art concerning the error rate in the total testing process. The definition of performance specifications based on the state-of-the-art, as suggested by consensus documents, is a valuable benchmark point in evaluating the performance of each laboratory. Laboratory tests play a relevant role in the monitoring and evaluation of the efficacy of patient outcome thus assisting clinicians in decision-making. Laboratory performance evaluation is therefore crucial to providing patients with safe, effective and efficient care.

  12. Update on the College of American Pathologists Experience With High-Risk Human Papillomavirus Proficiency Testing for Cytology.

    PubMed

    Ghofrani, Mohiedean; Zhao, Chengquan; Davey, Diane D; Fan, Fang; Husain, Mujtaba; Laser, Alice; Ocal, Idris T; Shen, Rulong Z; Goodrich, Kelly; Souers, Rhona J; Crothers, Barbara A

    2016-12-01

    - Since 2008, the College of American Pathologists has provided the human papillomavirus for cytology laboratories (CHPV) proficiency testing program to help laboratories meet the requirements of the Clinical Laboratory Improvement Amendments of 1988. - To provide an update on trends in proficiency testing performance in the College of American Pathologists CHPV program during the 4-year period from 2011 through 2014 and to compare those trends with the preceding first 3 years of the program. - Responses of laboratories participating in the CHPV program from 2011 through 2014 were analyzed using a nonlinear mixed model to compare different combinations of testing medium and platform. - In total, 818 laboratories participated in the CHPV program at least once during the 4 years, with participation increasing during the study period. Concordance of participant responses with the target result was more than 98% (38 280 of 38 892). Overall performance with all 3 testing media-ThinPrep (Hologic, Bedford, Massachusetts), SurePath (Becton, Dickinson and Company, Franklin Lakes, New Jersey), or Digene (Qiagen, Valencia, California)-was equivalent (P = .51), and all 4 US Food and Drug Administration (FDA)-approved platforms-Hybrid Capture 2 (Qiagen), Cervista (Hologic), Aptima (Hologic), and cobas (Roche Molecular Systems, Pleasanton, California)-outperformed laboratory-developed tests, unspecified commercial kits, and other (noncommercial) methods in ThinPrep medium (P < .001). However, certain off-label combinations of platform and medium, most notably Cervista with SurePath, demonstrated suboptimal performance (P < .001). - Laboratories demonstrated proficiency in using various combinations of testing media and platforms offered in the CHPV program, with statistically significant performance differences in certain combinations. These observations may be relevant in the current discussions about FDA oversight of laboratory-developed tests.

  13. 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.

  14. Power source evaluation capabilities at Sandia National Laboratories

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

    Doughty, D.H.; Butler, P.C.

    1996-04-01

    Sandia National Laboratories maintains one of the most comprehensive power source characterization facilities in the U.S. National Laboratory system. This paper describes the capabilities for evaluation of fuel cell technologies. The facility has a rechargeable battery test laboratory and a test area for performing nondestructive and functional computer-controlled testing of cells and batteries.

  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. 42 CFR 493.1357 - Standard; laboratory director qualifications.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; laboratory director qualifications. 493... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing Provider-Performed Microscopy (ppm) Procedures § 493.1357 Standard...

  17. 42 CFR 493.1357 - Standard; laboratory director qualifications.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; laboratory director qualifications. 493... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing Provider-Performed Microscopy (ppm) Procedures § 493.1357 Standard...

  18. [Building and implementation of management system in laboratories of the National Institute of Hygiene].

    PubMed

    Rozbicka, Beata; Brulińska-Ostrowska, Elzbieta

    2008-01-01

    The rules of good laboratory practice have always been observed in the laboratories of National Institute of Hygiene (NIH) and the reliability of the results has been carefully cared after when performing tests for clients. In 2003 the laboratories performing analyses related to food safety were designated as the national reference laboratories. This, added to the necessity of compliance with work standards and requirements of EU legislation and to the need of confirmation of competence by an independent organisation, led to a decision to seek accreditation of Polish Centre of Accreditation (PCA). The following stages of building and implementation of management system were presented: training, modifications of Institute's organisational structure, elaboration of management system's documentation, renovation and refurbishment of laboratory facilities, implementation of measuring and test equipment's supervision, internal audits and management review. The importance of earlier experiences and achievements with regard to validation of analytical methods and guarding of the quality of the results through organisation and participation in proficiency tests was highlighted. Current status of accreditation of testing procedures used in NIH laboratories that perform analyses in the field of chemistry, microbiology, radiobiology and medical diagnostic tests was presented.

  19. 9 CFR 130.17 - User fees for other veterinary diagnostic laboratory tests performed at NVSL (excluding FADDL) or...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false User fees for other veterinary... FEES USER FEES § 130.17 User fees for other veterinary diagnostic laboratory tests performed at NVSL (excluding FADDL) or at authorized sites. (a) User fees for veterinary diagnostics tests performed at the...

  20. 9 CFR 130.17 - User fees for other veterinary diagnostic laboratory tests performed at NVSL (excluding FADDL) or...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false User fees for other veterinary... FEES USER FEES § 130.17 User fees for other veterinary diagnostic laboratory tests performed at NVSL (excluding FADDL) or at authorized sites. (a) User fees for veterinary diagnostics tests performed at the...

  1. Does external evaluation of laboratories improve patient safety?

    PubMed

    Noble, Michael A

    2007-01-01

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

  2. 10 CFR 430.25 - Laboratory Accreditation Program.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Procedures § 430.25 Laboratory Accreditation Program. Testing for fluorescent lamp ballasts performed in accordance with appendix Q1 to this subpart shall comply with this section § 430.25. The testing for general... performed in accordance with appendix R to this subpart. The testing for medium base compact fluorescent...

  3. Performance testing of radiobioassay laboratories: In vivo measurements, Final Report

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

    MacLellan, J.A.; Traub, R.J.; Olsen, P.C.

    1990-04-01

    A study of two rounds of in vivo laboratory performance testing was undertaken by Pacific Northwest Laboratory (PNL) to determine the appropriateness of the in vivo performance criteria of draft American National Standards Institute (ANSI) standard ANSI N13.3, Performance Criteria for Bioassay.'' The draft standard provides guidance to in vivo counting facilities regarding the sensitivity, precision, and accuracy of measurements for certain categories of commonly assayed radionuclides and critical regions of the body. This report concludes the testing program by presenting the results of the Round Two testing. Testing involved two types of measurements: chest counting for radionuclide detection inmore » the lung, and whole body counting for detection of uniformly distributed material. Each type of measurement was further divided into radionuclide categories as defined in the draft standard. The appropriateness of the draft standard criteria by measuring a laboratory's ability to attain them were judged by the results of both round One and Round Two testing. The testing determined that performance criteria are set at attainable levels, and the majority of in vivo monitoring facilities passed the criteria when complete results were submitted. 18 refs., 18 figs., 15 tabs.« less

  4. Automated cognitive testing of monkeys in social groups yields results comparable to individual laboratory-based testing.

    PubMed

    Gazes, Regina Paxton; Brown, Emily Kathryn; Basile, Benjamin M; Hampton, Robert R

    2013-05-01

    Cognitive abilities likely evolved in response to specific environmental and social challenges and are therefore expected to be specialized for the life history of each species. Specialized cognitive abilities may be most readily engaged under conditions that approximate the natural environment of the species being studied. While naturalistic environments might therefore have advantages over laboratory settings for cognitive research, it is difficult to conduct certain types of cognitive tests in these settings. We implemented methods for automated cognitive testing of monkeys (Macaca mulatta) in large social groups (Field station) and compared the performance to that of laboratory-housed monkeys (Laboratory). The Field station animals shared access to four touch-screen computers in a large naturalistic social group. Each Field station subject had an RFID chip implanted in each arm for computerized identification and individualized assignment of cognitive tests. The Laboratory group was housed and tested in a typical laboratory setting, with individual access to testing computers in their home cages. Monkeys in both groups voluntarily participated at their own pace for food rewards. We evaluated performance in two visual psychophysics tests, a perceptual classification test, a transitive inference test, and a delayed matching-to-sample memory test. Despite the differences in housing, social environment, age, and sex, monkeys in the two groups performed similarly in all tests. Semi-free ranging monkeys living in complex social environments are therefore viable subjects for cognitive testing designed to take advantage of the unique affordances of naturalistic testing environments.

  5. Automated cognitive testing of monkeys in social groups yields results comparable to individual laboratory based testing

    PubMed Central

    Gazes, Regina Paxton; Brown, Emily Kathryn; Basile, Benjamin M.; Hampton, Robert R.

    2013-01-01

    Cognitive abilities likely evolved in response to specific environmental and social challenges and are therefore expected to be specialized for the life history of each species. Specialized cognitive abilities may be most readily engaged under conditions that approximate the natural environment of the species being studied. While naturalistic environments might therefore have advantages over laboratory settings for cognitive research, it is difficult to conduct certain types of cognitive tests in these settings. We implemented methods for automated cognitive testing of monkeys (Macaca mulatta) in large social groups (Field station) and compared the performance to that of laboratory housed monkeys (Laboratory). The Field station animals shared access to four touch screen computers in a large naturalistic social group. Each Field station subject had an RFID chip implanted in each arm for computerized identification and individualized assignment of cognitive tests. The Laboratory group was housed and tested in a typical laboratory setting, with individual access to testing computers in their home cages. Monkeys in both groups voluntarily participated at their own pace for food rewards. We evaluated performance in two visual psychophysics tests, a perceptual classification test, a transitive inference test, and a delayed matching to sample memory test. Despite differences in housing, social environment, age, and sex, monkeys in the two groups performed similarly in all tests. Semi-free ranging monkeys living in complex social environments are therefore viable subjects for cognitive testing designed to take advantage of the unique affordances of naturalistic testing environments. PMID:23263675

  6. Performance indicators and decision making for outsourcing public health laboratory services.

    PubMed

    Santos, Maria Angelica Borges dos; Moraes, Ricardo Montes de; Passos, Sonia Regina Lambert

    2012-06-01

    To develop performance indicators for outsourcing clinical laboratory services, based on information systems and public administrative records. In the municipality of Rio de Janeiro, Southern Brazil, the public health laboratory network comprised 33 laboratories with automated equipment (but no integrated information system), 90 primary care units (where sample collection was performed) and 983 employees. Information records were obtained from the administrative records of the Budget Information System for Public Health and the Outpatient and Hospital Information System of the Unified Health System. Performance indicators (production, productivity, usage and costs) were generated from data collected routinely from 2006 to 2008. The variations in production, costs and unit prices for tests were analyzed by Laspeyres and Paasche indices, which specifically measure laboratory activity, and by the Consumer Price Index from the Brazilian Institute of Geography and Statistics. A total of 10,359,111 tests were performed in 2008 (10.6% increase over 2006), and the test/employee ratio grew by 8.6%. The costs of supplies, wages and providers increased by 2.3%, 45.4% and 18.3%, respectively. The laboratory tests per visit and hospitalizations increased by 10% and 20%, respectively. The direct costs totaled R$ 63.2 million in 2008, representing an increase of 22.2% in current values during the period analyzed. The direct costs deflated by the Brazilian National Consumer Price Index (9.5% for the period) showed an 11.6% increase in production volumes. The activity-specific volume index, which considers changes in the mix of tests, showed increases of 18.5% in the test price and 3.1% in the production volume. The performance indicators, particularly the specific indices for volume and price of activity, constitute a baseline of performance potential for monitoring private laboratories and contractors. The economic performance indicators demonstrated the need for network information system integration prior to an outsourcing decision.

  7. 42 CFR 493.1359 - Standard; PPM laboratory director responsibilities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; PPM laboratory director responsibilities... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing Provider-Performed Microscopy (ppm) Procedures § 493.1359 Standard...

  8. 42 CFR 493.1443 - Standard; Laboratory director qualifications.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Laboratory director qualifications. 493.1443 Section 493.1443 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Testing Laboratories Performing High Complexity Testing § 493.1443 Standard; Laboratory director...

  9. 42 CFR 493.1443 - Standard; Laboratory director qualifications.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; Laboratory director qualifications. 493.1443 Section 493.1443 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Testing Laboratories Performing High Complexity Testing § 493.1443 Standard; Laboratory director...

  10. 42 CFR 493.1445 - Standard; Laboratory director responsibilities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; Laboratory director responsibilities. 493.1445 Section 493.1445 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Testing Laboratories Performing High Complexity Testing § 493.1445 Standard; Laboratory director...

  11. 42 CFR 493.1407 - Standard; Laboratory director responsibilities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; Laboratory director responsibilities. 493.1407 Section 493.1407 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Testing Laboratories Performing Moderate Complexity Testing § 493.1407 Standard; Laboratory director...

  12. 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.

  13. First round of external quality assessment of dengue diagnostics in the WHO Western Pacific Region, 2013.

    PubMed

    Pok, Kwoon Yong; Squires, Raynal C; Tan, Li Kiang; Takasaki, Tomohiko; Abubakar, Sazaly; Hasebe, Futoshi; Partridge, Jeffrey; Lee, Chin Kei; Lo, Janice; Aaskov, John; Ng, Lee Ching; Konings, Frank

    2015-01-01

    Accurate laboratory testing is a critical component of dengue surveillance and control. The objective of this programme was to assess dengue diagnostic proficiency among national-level public health laboratories in the World Health Organization (WHO) Western Pacific Region. Nineteen national-level public health laboratories performed routine dengue diagnostic assays on a proficiency testing panel consisting of two modules: one containing commercial serum samples spiked with cultured dengue viruses for the detection of nucleic acid and non-structural protein 1 (NS1) (Module A) and one containing human serum samples for the detection of anti-dengue virus antibodies (Module B). A review of logistics arrangements was also conducted. All 16 laboratories testing Module A performed reverse transcriptase polymerase chain reaction (RT-PCR) for both RNA and serotype detection. Of these, 15 had correct results for RNA detection and all 16 correctly serotyped the viruses. All nine laboratories performing NS1 antigen detection obtained the correct results. Sixteen of the 18 laboratories using IgM assays in Module B obtained the correct results as did the 13 laboratories that performed IgG assays. Detection of ongoing/recent dengue virus infection by both molecular (RT-PCR) and serological methods (IgM) was available in 15/19 participating laboratories. This first round of external quality assessment of dengue diagnostics was successfully conducted in national-level public health laboratories in the WHO Western Pacific Region, revealing good proficiency in both molecular and serological testing. Further comprehensive diagnostic testing for dengue virus and other priority pathogens in the Region will be assessed during future rounds.

  14. Internal quality control practice of thyroid disease related tests and imprecision analysis in China.

    PubMed

    Hu, Li-Tao; Wang, Zhi-Guo

    2014-01-01

    Internal quality control (IQC) has a long and well-established role in clinical laboratories and the quality of laboratories has achieved great improvement in China. However, the practice of IQC varies significantly between institutions and many problems still exists. Consequently, the Chinese National Center for Clinical Laboratories has been undertaking monthly nation-wide surveys of current IQC practice of tests since 2010 to monitor laboratory quality. Thyroid disease related tests were chosen for this research. Different numbers of laboratories in China participating national external quality assessment (EQA) schemes of Total Thyroxine (TT4), Total Triiodothyronine (TT3), Free Thyroxine (FT4) and Free Triiodothyronine (FT3) tests, and Thyroid Stimulating Hormone (TSH) measurements, were required to report the IQC information though the national external quality assessment (EQA) network platform. Survey data showed significant variability in all aspects of IQC practice. More than half of the laboratories are using a single concentration level of IQC material and up to 28.6% of the laboratories only use 1(2s) or 1(3s) to monitor IQC results for FT3, TT3, FT4, TT4, and TSH. The medians of the average time intervals of two control tests for FT3, TT3, FT4, TT4, and TSH are 33.6, 35.4, 33.6, 35.4, and 33.6 hours, respectively, more or less 1.4 days. When quality specifications based on biological variation are applied to imprecision evaluation, only 46.3%, 52.1%, 31.3%, 12.8%, and 5.86% laboratories meet the minimum performance for FT3, TT3, FT4, and TT4, 24.5%, 23.6%, 12.8%, and 5.86% of the all meet the desirable performance, and 4.4%, 3.9%, 2.5% and 3.0% of the all meet the optimal performance. While it shows a higher percentage of acceptable laboratories (98.1%, 87.9% and 39.0% meeting the minimum, desirable and optimal performance, respectively) for TSH. Not-well-designed IQC practices may affect the effectiveness of laboratory IQC and, thus, the adequacy of a laboratory to monitor system performance. Consequently, IQC practice should be designed according to performance of measure method and instrument. Both clinical laboratories and the government should make efforts to improve quality of clinical testing to ensure the patients' safety.

  15. Capacity building and predictors of success for HIV-1 drug resistance testing in the Asia-Pacific region and Africa

    PubMed Central

    Land, Sally; Zhou, Julian; Cunningham, Philip; Sohn, Annette H; Singtoroj, Thida; Katzenstein, David; Mann, Marita; Sayer, David; Kantor, Rami

    2013-01-01

    Background The TREAT Asia Quality Assessment Scheme (TAQAS) was developed as a quality assessment programme through expert education and training, for laboratories in the Asia-Pacific and Africa that perform HIV drug-resistance (HIVDR) genotyping. We evaluated the programme performance and factors associated with high-quality HIVDR genotyping. Methods Laboratories used their standard protocols to test panels of human immunodeficiency virus (HIV)-positive plasma samples or electropherograms. Protocols were documented and performance was evaluated according to a newly developed scoring system, agreement with panel-specific consensus sequence, and detection of drug-resistance mutations (DRMs) and mixtures of wild-type and resistant virus (mixtures). High-quality performance was defined as detection of ≥95% DRMs. Results Over 4.5 years, 23 participating laboratories in 13 countries tested 45 samples (30 HIV-1 subtype B; 15 non-B subtypes) in nine panels. Median detection of DRMs was 88–98% in plasma panels and 90–97% in electropherogram panels. Laboratories were supported to amend and improve their test outcomes as appropriate. Three laboratories that detected <80% DRMs in early panels demonstrated subsequent improvement. Sample complexity factors – number of DRMs (p<0.001) and number of DRMs as mixtures (p<0.001); and laboratory performance factors – detection of mixtures (p<0.001) and agreement with consensus sequence (p<0.001), were associated with high performance; sample format (plasma or electropherogram), subtype and genotyping protocol were not. Conclusion High-quality HIVDR genotyping was achieved in the TAQAS collaborative laboratory network. Sample complexity and detection of mixtures were associated with performance quality. Laboratories conducting HIVDR genotyping are encouraged to participate in quality assessment programmes. PMID:23845227

  16. The use of CellaVision competency software for external quality assessment and continuing professional development.

    PubMed

    Horiuchi, Yuki; Tabe, Yoko; Idei, Mayumi; Bengtsson, Hans-Inge; Ishii, Kiyoshi; Horii, Takashi; Miyake, Kazunori; Satoh, Naotake; Miida, Takashi; Ohsaka, Akimichi

    2011-07-01

    Quality assessment of blood cell morphological testing, such as white blood cell (WBC) differential and its interpretation, is one of the most important and difficult assignments in haematology laboratories. A monthly survey was performed to assess the possible role of the proficiency testing program produced by CellaVision competency software (CCS) in external quality assessment (EQA) of the clinical laboratories of affiliated university hospitals and the effective utilisation of this program in continuing professional development (CPD). Four monthly proficiency surveys were conducted in collaboration with four clinical laboratories affiliated with the teaching hospitals of Juntendo University of Medicine in Japan. EQA results by the CCS proficiency testing program revealed a difference of performance levels of WBC differential and morphological interpretation and a discrepancy in the WBC differential criteria among laboratories. With regard to the utilisation of this proficiency program as a tool for CPD, this program successfully improved the performance of the low-scoring laboratories and less experienced individuals. The CCS proficiency testing program was useful for the quality assessment of laboratory performance, for education, and for the storage and distribution of cell images to be utilised for further standardisation and education.

  17. Diagnostic performances of clinical laboratory tests using Triton X-100 to reduce the biohazard associated with routine testing of Ebola virus-infected patients.

    PubMed

    Tempestilli, Massimo; Pucci, Luigia; Notari, Stefania; Di Caro, Antonino; Castilletti, Concetta; Rivelli, Maria Rosaria; Agrati, Chiara; Pucillo, Leopoldo Paolo

    2015-11-01

    Ebola virus, an enveloped virus, is the cause of the largest and most complex Ebola virus disease (EVD) outbreak in West Africa. Blood or body fluids of an infected person may represent a biohazard to laboratory workers. Laboratory tests of virus containing specimens should be conducted in referral centres at biosafety level 4, but based on the severity of clinical symptoms, basic laboratories might be required to execute urgent tests for patients suspected of EVD. The aim of this work was to compare the analytical performances of laboratory tests when Triton X-100, a chemical agent able to inactivate other enveloped viruses, was added to specimens. Results of clinical chemistry, coagulation and haematology parameters on samples before and after the addition of 0.1% (final concentration) of Triton X-100 and 1 h of incubation at room temperature were compared. Overall, results showed very good agreement by all statistical analyses. Triton X-100 at 0.1% did not significantly affect the results for the majority of the analytes tested. Triton X-100 at 0.1% can be used to reduce the biohazard in performing laboratory tests on samples from patients with EVD without affecting clinical decisions.

  18. 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.

  19. 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

  20. 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.

  1. [User's requests (from a practitioner's perspective)].

    PubMed

    Ohnishi, T

    1997-08-01

    As a practitioner, I have to rely on outside clinical laboratories and affiliated hospitals to perform laboratory tests. In this abstract, I describe specific problems I have encountered with third-party laboratories, and propose solutions for these problems to optimize use of laboratory tests. BLOOD TESTS: The most frequent problem in ordering blood tests is the lack of detailed information regarding sampling conditions. I often have to call laboratories to check whether the sample should be serum or plasma, what volume is needed, whether the sample should be cooled, etc. I propose that clinical laboratories should provide practitioners' manuals that describe specific sampling information. Most laboratories do not keep the data from ultrasonographic tests. The lack of these is most problematic when test results are interpreted differently by laboratories and by practitioners. Retaining the data would also help private laboratories improve the quality of the test by enabling them to compare their interpretations with others'. ANNUAL MEDICAL SCREENING: Even if an abnormal finding is detected at medical screening clinics, the final diagnosis is usually not sent back to the screening facilities. This is highly recommended to establish an official system that mediates the feedback to screening centers. MRI: Due to miscommunication between practitioners and radiologists, the test is sometimes performed inappropriately. A thorough consultation should occur before the test to clarify specific goals for each patient. PATHOLOGICAL TESTS: Interpretation of results is often inconsistent among laboratories. Independent clinical laboratories tend to report results without indicating sample problems, while pathology departments at affiliated hospitals tend to emphasize sample problems instead of diagnosis or suggesting ways to improve sample quality. Mutual communication among laboratories would help standardize the quality of pathological tests.

  2. A comparison of relative toxicity rankings by some small-scale laboratory tests

    NASA Technical Reports Server (NTRS)

    Hilado, C. J.; Cumming, H. J.

    1977-01-01

    Small-scale laboratory tests for fire toxicity, suitable for use in the average laboratory hood, are needed for screening and ranking materials on the basis of relative toxicity. The performance of wool, cotton, and aromatic polyamide under several test procedures is presented.

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

    PubMed

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

    2011-04-01

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

  4. Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories.

    PubMed

    Jang, Mi Ae; Yoon, Young Ahn; Song, Junghan; Kim, Jeong Ho; Min, Won Ki; Lee, Ji Sung; Lee, Yong Wha; Lee, You Kyoung

    2017-05-01

    Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests. We analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP. Compared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different. These results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing. © The Korean Society for Laboratory Medicine

  5. Clinical microbiology laboratories do not always detect resistance of Haemophilus influenzae with disk or tablet diffusion methods. Finnish Study Group for Antimicrobial Resistance (FiRe).

    PubMed

    Manninen, R; Huovinen, P; Nissinen, A

    1998-04-01

    The performance of disk diffusion testing of Haemophilus influenzae was evaluated in 20 laboratories. Thirteen disk-medium-breakpoint-inoculum modifications were used in Finnish clinical microbiology laboratories. The performance of various methods was evaluated by testing a susceptible control strain and one with non-beta-lactamase-mediated ampicillin resistance 10 times in 16 laboratories. Gaps in millimeters were measured between these two groups of results. The strains were separated by a gap of at least 5 mm in 8/16 laboratories testing ampicillin, in 7/15 laboratories testing cefaclor, in 5/ 16 laboratories testing cefuroxime, and in 15/16 laboratories testing trimethoprim-sulfa. Detection of ampicillin resistance was better with 2.5 microg tablets than with 10 microg disks or 33 microg tablets. For MIC-determinations, 785 isolates and their disk diffusion results were collected. None of the 12 clinical isolates with non-beta-lactamase-mediated ampicillin resistance was detected as resistant in the participating laboratories. The ampicillin and cefaclor results of the isolates were no better even when a laboratory was able to separate the control strains. Cefaclor results were unreliable because of poor disk diffusion-MIC correspondence and incoherent breakpoint references. Interlaboratory variation of the zone diameters caused false intermediate results of cefuroxime-susceptible strains. When ampicillin, cefaclor and cefuroxime were tested, the discrimination of laboratories using disks and tablets was equal, whereas the laboratories using paper disks were better able to detect trimethoprim-sulfa resistance.

  6. 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.

  7. Development and Validation of Targeted Next-Generation Sequencing Panels for Detection of Germline Variants in Inherited Diseases.

    PubMed

    Santani, Avni; Murrell, Jill; Funke, Birgit; Yu, Zhenming; Hegde, Madhuri; Mao, Rong; Ferreira-Gonzalez, Andrea; Voelkerding, Karl V; Weck, Karen E

    2017-06-01

    - The number of targeted next-generation sequencing (NGS) panels for genetic diseases offered by clinical laboratories is rapidly increasing. Before an NGS-based test is implemented in a clinical laboratory, appropriate validation studies are needed to determine the performance characteristics of the test. - To provide examples of assay design and validation of targeted NGS gene panels for the detection of germline variants associated with inherited disorders. - The approaches used by 2 clinical laboratories for the development and validation of targeted NGS gene panels are described. Important design and validation considerations are examined. - Clinical laboratories must validate performance specifications of each test prior to implementation. Test design specifications and validation data are provided, outlining important steps in validation of targeted NGS panels by clinical diagnostic laboratories.

  8. Classifying performance impairment in response to sleep loss using pattern recognition algorithms on single session testing

    PubMed Central

    St. Hilaire, Melissa A.; Sullivan, Jason P.; Anderson, Clare; Cohen, Daniel A.; Barger, Laura K.; Lockley, Steven W.; Klerman, Elizabeth B.

    2012-01-01

    There is currently no “gold standard” marker of cognitive performance impairment resulting from sleep loss. We utilized pattern recognition algorithms to determine which features of data collected under controlled laboratory conditions could most reliably identify cognitive performance impairment in response to sleep loss using data from only one testing session, such as would occur in the “real world” or field conditions. A training set for testing the pattern recognition algorithms was developed using objective Psychomotor Vigilance Task (PVT) and subjective Karolinska Sleepiness Scale (KSS) data collected from laboratory studies during which subjects were sleep deprived for 26 – 52 hours. The algorithm was then tested in data from both laboratory and field experiments. The pattern recognition algorithm was able to identify performance impairment with a single testing session in individuals studied under laboratory conditions using PVT, KSS, length of time awake and time of day information with sensitivity and specificity as high as 82%. When this algorithm was tested on data collected under real-world conditions from individuals whose data were not in the training set, accuracy of predictions for individuals categorized with low performance impairment were as high as 98%. Predictions for medium and severe performance impairment were less accurate. We conclude that pattern recognition algorithms may be a promising method for identifying performance impairment in individuals using only current information about the individual’s behavior. Single testing features (e.g., number of PVT lapses) with high correlation with performance impairment in the laboratory setting may not be the best indicators of performance impairment under real-world conditions. Pattern recognition algorithms should be further tested for their ability to be used in conjunction with other assessments of sleepiness in real-world conditions to quantify performance impairment in response to sleep loss. PMID:22959616

  9. Comparison of results of fluconazole disk diffusion testing for Candida species with results from a central reference laboratory in the ARTEMIS global antifungal surveillance program.

    PubMed

    Pfaller, M A; Hazen, K C; Messer, S A; Boyken, L; Tendolkar, S; Hollis, R J; Diekema, D J

    2004-08-01

    The accuracy of antifungal susceptibility tests is important for accurate resistance surveillance and for the clinical management of patients with serious infections. Our main objective was to compare the results of fluconazole disk diffusion testing of Candida spp. performed by ARTEMIS participating centers with disk diffusion and MIC results obtained by the central reference laboratory. A total of 2,949 isolates of Candida spp. were tested by NCCLS disk diffusion and reference broth microdilution methods in the central reference laboratory. These results were compared to the results of disk diffusion testing performed in the 54 participating centers. All tests were performed and interpreted following NCCLS recommendations. Overall categorical agreement between participant disk diffusion test results and reference laboratory MIC results was 87.4%, with 0.2% very major errors (VME) and 3.3% major errors (ME). The categorical agreement between the disk diffusion test results obtained in the reference laboratory with the MIC test results was similar: 92.8%. Likewise, good agreement was observed between participant disk diffusion test results and reference laboratory disk diffusion test results: 90.4%, 0.4% VME, and 3.4% ME. The disk diffusion test was especially reliable in detecting those isolates of Candida spp. that were characterized as resistant by reference MIC testing. External quality assurance data obtained by surveillance programs such as the ARTEMIS Global Antifungal Surveillance Program ensure the generation of useful surveillance data and result in the continued improvement of antifungal susceptibility testing practices.

  10. 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.

  11. Take a Tour of Our Facility | Energy Systems Integration Facility | NREL

    Science.gov Websites

    Take a Tour of Our Facility Take a Tour of Our Facility The Energy Systems Integration Facility Optical Characterization Laboratory System Performance Laboratory Power Systems Integration Laboratory Control Room Energy Storage Laboratory Outdoor Testing Areas Outdoor Testing Areas Energy Systems

  12. Current practice in laboratory diagnostics of autoimmune diseases in Croatia. 
Survey of the Working group for laboratory diagnostics of autoimmune diseases of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

    PubMed

    Kuna, Andrea Tešija; Đerek, Lovorka; Kozmar, Ana; Drvar, Vedrana

    2016-10-15

    With the trend of increasing incidence of autoimmune diseases, laboratories are faced with exponential growth of the requests for tests relating the diagnosis of these diseases. Unfortunately, the lack of laboratory personnel experienced in this specific discipline of laboratory diagnostic, as well as an unawareness of a method limitation often results in confusion for clinicians. The aim was to gain insight into number and type of Croatian laboratories that perform humoral diagnostics with the final goal to improve and harmonize laboratory diagnostics of autoimmune diseases in Croatia. In order to get insight into current laboratory practice two questionnaires, consisting of 42 questions in total, were created. Surveys were conducted using SurveyMonkey application and were sent to 88 medical biochemistry laboratories in Croatia for the first survey. Out of 33 laboratories that declared to perform diagnostic from the scope, 19 were selected for the second survey based on the tests they pleaded to perform. The survey comprised questions regarding autoantibody hallmarks of systemic autoimmune diseases while regarding organ-specific autoimmune diseases was limited to diseases of liver, gastrointestinal and nervous system. Response rate was high with 80 / 88 (91%) laboratories which answered the first questionnaire, and 19 / 19 (1.0) for the second questionnaire. Obtained results of surveys indicate high heterogeneity in the performance of autoantibody testing among laboratories in Croatia. Results indicate the need of creating recommendations and algorithms in order to harmonize the approach to laboratory diagnostics of autoimmune diseases in Croatia.

  13. 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

  14. External quality assessment for CD4 + T-lymphocyte count test

    PubMed Central

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

    2018-01-01

    Abstract The National Network for CD4+ T-lymphocyte counting of Brazil comprises 93 laboratories. This study reports the laboratory performances achieved in external quality assessment (EQA) rounds provides by Ministry of Health to evaluate the quality of the kits used and the performance of test by the technicians. Ten EQA rounds were analyzed according the EQA criteria aimed to evaluate individual laboratory performance on the basis of the accuracy of their results compared to the general mean obtained by all participating laboratories and the reproducibility of the results obtained between 2 samples from the same donor. The percentage of approved and failed laboratories in the EQAs tends to follow a uniform pattern. Since 2011, approval has remained above 80% and the failure rate has never exceeded 15%. EQA is very important to evaluate the performance of the laboratories, to identify monitor, and to resolve errors as quickly as possible. PMID:29794603

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

    PubMed

    Guzel, Omer; Guner, Ebru Ilhan

    2009-03-01

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

  16. Comparison of multianalyte proficiency test results by sum of ranking differences, principal component analysis, and hierarchical cluster analysis.

    PubMed

    Škrbić, Biljana; Héberger, Károly; Durišić-Mladenović, Nataša

    2013-10-01

    Sum of ranking differences (SRD) was applied for comparing multianalyte results obtained by several analytical methods used in one or in different laboratories, i.e., for ranking the overall performances of the methods (or laboratories) in simultaneous determination of the same set of analytes. The data sets for testing of the SRD applicability contained the results reported during one of the proficiency tests (PTs) organized by EU Reference Laboratory for Polycyclic Aromatic Hydrocarbons (EU-RL-PAH). In this way, the SRD was also tested as a discriminant method alternative to existing average performance scores used to compare mutlianalyte PT results. SRD should be used along with the z scores--the most commonly used PT performance statistics. SRD was further developed to handle the same rankings (ties) among laboratories. Two benchmark concentration series were selected as reference: (a) the assigned PAH concentrations (determined precisely beforehand by the EU-RL-PAH) and (b) the averages of all individual PAH concentrations determined by each laboratory. Ranking relative to the assigned values and also to the average (or median) values pointed to the laboratories with the most extreme results, as well as revealed groups of laboratories with similar overall performances. SRD reveals differences between methods or laboratories even if classical test(s) cannot. The ranking was validated using comparison of ranks by random numbers (a randomization test) and using seven folds cross-validation, which highlighted the similarities among the (methods used in) laboratories. Principal component analysis and hierarchical cluster analysis justified the findings based on SRD ranking/grouping. If the PAH-concentrations are row-scaled, (i.e., z scores are analyzed as input for ranking) SRD can still be used for checking the normality of errors. Moreover, cross-validation of SRD on z scores groups the laboratories similarly. The SRD technique is general in nature, i.e., it can be applied to any experimental problem in which multianalyte results obtained either by several analytical procedures, analysts, instruments, or laboratories need to be compared.

  17. Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories

    PubMed Central

    Jang, Mi-Ae; Yoon, Young Ahn; Song, Junghan; Kim, Jeong-Ho; Min, Won-Ki; Lee, Ji Sung

    2017-01-01

    Background Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests. Methods We analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP. Results Compared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different. Conclusions These results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing. PMID:28224767

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

    PubMed

    Weykamp, Cas; Siebelder, Carla

    2017-11-01

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

  19. 42 CFR 493.1200 - Introduction.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... (that is, preanalytic, analytic, and postanalytic) as well as general laboratory systems. (b) The...) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing § 493.1200 Introduction. (a) Each laboratory that performs nonwaived testing must establish and maintain written policies...

  20. 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".

  1. 42 CFR 493.1409 - Condition: Laboratories performing moderate complexity testing; technical consultant.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing moderate complexity testing; technical consultant. 493.1409 Section 493.1409 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

  2. 42 CFR 493.1409 - Condition: Laboratories performing moderate complexity testing; technical consultant.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing moderate complexity testing; technical consultant. 493.1409 Section 493.1409 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

  3. 42 CFR 493.1415 - Condition: Laboratories performing moderate complexity testing; clinical consultant.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Laboratories performing moderate complexity testing; clinical consultant. 493.1415 Section 493.1415 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION...

  4. 42 CFR 493.807 - Condition: Reinstatement of laboratories performing nonwaived testing.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ..., subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two... reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or...

  5. 42 CFR 493.807 - Condition: Reinstatement of laboratories performing nonwaived testing.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two... reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or...

  6. 42 CFR 493.807 - Condition: Reinstatement of laboratories performing nonwaived testing.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two... reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or...

  7. Pretreatment Engineering Platform Phase 1 Final Test Report

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

    Kurath, Dean E.; Hanson, Brady D.; Minette, Michael J.

    2009-12-23

    Pacific Northwest National Laboratory (PNNL) was tasked by Bechtel National Inc. (BNI) on the River Protection Project, Hanford Tank Waste Treatment and Immobilization Plant (RPP-WTP) project to conduct testing to demonstrate the performance of the WTP Pretreatment Facility (PTF) leaching and ultrafiltration processes at an engineering-scale. In addition to the demonstration, the testing was to address specific technical issues identified in Issue Response Plan for Implementation of External Flowsheet Review Team (EFRT) Recommendations - M12, Undemonstrated Leaching Processes.( ) Testing was conducted in a 1/4.5-scale mock-up of the PTF ultrafiltration system, the Pretreatment Engineering Platform (PEP). Parallel laboratory testing wasmore » conducted in various PNNL laboratories to allow direct comparison of process performance at an engineering-scale and a laboratory-scale. This report presents and discusses the results of those tests.« less

  8. 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.

  9. Integrated Data Collection Analysis (IDCA) Program - Final Review September 12, 2012 at DHS

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

    Sandstrom, Mary M.; Brown, Geoffrey W.; Warner, Kirstin F.

    The Integrated Data Collection Analysis (IDCA) program conducted a final program review at the Department of Homeland Security on September 12, 2012. The review was focused on the results of the program over the complete performance period. A summary presentation delineating the accomplished tasks started the meeting, followed by technical presentations on various issues that arose during the performance period. The presentations were completed with a statistical evaluation of the testing results from all the participants in the IDCA Proficiency Test study. The meeting closed with a discussion of potential sources of funding for continuing work to resolve some ofmore » these technical issues. This effort, funded by the Department of Homeland Security (DHS), put the issues of safe handling of these materials in perspective with standard military explosives. The study added Small-Scale Safety and Thermal (SSST) testing results for a broad suite of different HMEs to the literature, and suggested new guidelines and methods to develop safe handling practices for HMEs. Each participating testing laboratory used identical test materials and preparation methods wherever possible. Note, however, the test procedures differ among the laboratories. The results were compared among the laboratories and then compared to historical data from various sources. The testing performers involved were Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Naval Surface Warfare Center, Indian Head Division (NSWC IHD), Sandia National Laboratories (SNL), and Air Force Research Laboratory, Tyndall AFB (AFRL/RXQL). These tests were 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

  10. The impact of repeat-testing of common chemistry analytes at critical concentrations.

    PubMed

    Onyenekwu, Chinelo P; Hudson, Careen L; Zemlin, Annalise E; Erasmus, Rajiv T

    2014-12-01

    Early notification of critical values by the clinical laboratory to the treating physician is a requirement for accreditation and is essential for effective patient management. Many laboratories automatically repeat a critical value before reporting it to prevent possible misdiagnosis. Given today's advanced instrumentation and quality assurance practices, we questioned the validity of this approach. We performed an audit of repeat-testing in our laboratory to assess for significant differences between initial and repeated test results, estimate the delay caused by repeat-testing and to quantify the cost of repeating these assays. A retrospective audit of repeat-tests for sodium, potassium, calcium and magnesium in the first quarter of 2013 at Tygerberg Academic Laboratory was conducted. Data on the initial and repeat-test values and the time that they were performed was extracted from our laboratory information system. The Clinical Laboratory Improvement Amendment criteria for allowable error were employed to assess for significant difference between results. A total of 2308 repeated tests were studied. There was no significant difference in 2291 (99.3%) of the samples. The average delay ranged from 35 min for magnesium to 42 min for sodium and calcium. At least 2.9% of laboratory running costs for the analytes was spent on repeating them. The practice of repeating a critical test result appears unnecessary as it yields similar results, delays notification to the treating clinician and increases laboratory running costs.

  11. Electric Vehicle and Wireless Charging Laboratory

    DOT National Transportation Integrated Search

    2018-03-23

    Wireless charging tests of electric vehicles (EV) have been conducted at the EVTC Wireless Laboratory located at the Florida Solar Energy Center, Cocoa, FL. These tests were performed to document testing protocols, evaluate standards and evaluate ope...

  12. Evaluation of the performance of the OneTouch Select Plus blood glucose test system against ISO 15197:2013.

    PubMed

    Setford, Steven; Smith, Antony; McColl, David; Grady, Mike; Koria, Krisna; Cameron, Hilary

    2015-01-01

    Assess laboratory and in-clinic performance of the OneTouch Select(®) Plus test system against ISO 15197:2013 standard for measurement of blood glucose. System performance assessed in laboratory against key patient, environmental and pharmacologic factors. User performance was assessed in clinic by system-naïve lay-users. Healthcare professionals assessed system accuracy on diabetes subjects in clinic. The system demonstrated high levels of performance, meeting ISO 15197:2013 requirements in laboratory testing (precision, linearity, hematocrit, temperature, humidity and altitude). System performance was tested against 28 interferents, with an adverse interfering effect only being recorded for pralidoxime iodide. Clinic user performance results fulfilled ISO 15197:2013 accuracy criteria. Subjects agreed that the color range indicator clearly showed if they were low, in-range or high and helped them better understand glucose results. The system evaluated is accurate and meets all ISO 15197:2013 requirements as per the tests described. The color range indicator helped subjects understand glucose results and supports patients in following healthcare professional recommendations on glucose targets.

  13. Use of a Commercially Available Flight Simulator during Aircrew Performance Testing.

    DTIC Science & Technology

    1991-11-01

    Automiated Battery of Performance-based Tests, NAMRL 1354, Naval Aerospace Medical Research Laboratory, Pensacola, FL, 1990. 13. Human Performance...ability of an aircraft to remain airborne well beyond the limits of its human operator. This capacity for longer flights, coupled with a tendency for short...Measurement, Final Report, Air Force Human Resources Laboratory, Brooks AFB, TX, 1983. 5. Stein, E.S., Measurement of Pilot Performance: A Master Journeyman

  14. 42 CFR 493.1281 - Standard: Comparison of test results.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Standard: Comparison of test results. 493.1281... Testing Analytic Systems § 493.1281 Standard: Comparison of test results. (a) If a laboratory performs the... between test results using the different methodologies, instruments, or testing sites. (b) The laboratory...

  15. 42 CFR 493.1281 - Standard: Comparison of test results.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Comparison of test results. 493.1281... Testing Analytic Systems § 493.1281 Standard: Comparison of test results. (a) If a laboratory performs the... between test results using the different methodologies, instruments, or testing sites. (b) The laboratory...

  16. 42 CFR 493.1281 - Standard: Comparison of test results.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Standard: Comparison of test results. 493.1281... Testing Analytic Systems § 493.1281 Standard: Comparison of test results. (a) If a laboratory performs the... between test results using the different methodologies, instruments, or testing sites. (b) The laboratory...

  17. 42 CFR 493.1281 - Standard: Comparison of test results.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Standard: Comparison of test results. 493.1281... Testing Analytic Systems § 493.1281 Standard: Comparison of test results. (a) If a laboratory performs the... between test results using the different methodologies, instruments, or testing sites. (b) The laboratory...

  18. 42 CFR 493.1281 - Standard: Comparison of test results.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Standard: Comparison of test results. 493.1281... Testing Analytic Systems § 493.1281 Standard: Comparison of test results. (a) If a laboratory performs the... between test results using the different methodologies, instruments, or testing sites. (b) The laboratory...

  19. Resident training in point-of-care testing.

    PubMed

    Campbell, Sheldon; Howanitz, Peter J

    2007-06-01

    Although central laboratory testing has been the norm for the last few decades and point-of-care testing (POCT) is considered an emerging area, physicians were performing POCT long before the existence of central laboratory testing. As medical directors of POCT programs, pathologists need the basic knowledge and skills associated with directing laboratory-based testing programs as well as additional knowledge and skills about testing at the point of care. Although the essential elements of quality testing are the same for laboratory-based and POCT, the enormous variety of settings, technologies, and workers involved present unique challenges.

  20. Current practice in laboratory diagnostics of autoimmune diseases in Croatia. 
Survey of the Working group for laboratory diagnostics of autoimmune diseases of the Croatian Society of Medical Biochemistry and Laboratory Medicine

    PubMed Central

    Kuna, Andrea Tešija; Đerek, Lovorka; Kozmar, Ana; Drvar, Vedrana

    2016-01-01

    Introduction With the trend of increasing incidence of autoimmune diseases, laboratories are faced with exponential growth of the requests for tests relating the diagnosis of these diseases. Unfortunately, the lack of laboratory personnel experienced in this specific discipline of laboratory diagnostic, as well as an unawareness of a method limitation often results in confusion for clinicians. The aim was to gain insight into number and type of Croatian laboratories that perform humoral diagnostics with the final goal to improve and harmonize laboratory diagnostics of autoimmune diseases in Croatia. Materials and methods In order to get insight into current laboratory practice two questionnaires, consisting of 42 questions in total, were created. Surveys were conducted using SurveyMonkey application and were sent to 88 medical biochemistry laboratories in Croatia for the first survey. Out of 33 laboratories that declared to perform diagnostic from the scope, 19 were selected for the second survey based on the tests they pleaded to perform. The survey comprised questions regarding autoantibody hallmarks of systemic autoimmune diseases while regarding organ-specific autoimmune diseases was limited to diseases of liver, gastrointestinal and nervous system. Results Response rate was high with 80 / 88 (91%) laboratories which answered the first questionnaire, and 19 / 19 (1.0) for the second questionnaire. Obtained results of surveys indicate high heterogeneity in the performance of autoantibody testing among laboratories in Croatia. Conclusions Results indicate the need of creating recommendations and algorithms in order to harmonize the approach to laboratory diagnostics of autoimmune diseases in Croatia. PMID:27812306

  1. An audit of Cryptosporidium and Giardia detection in Scottish National Health Service Diagnostic Microbiology Laboratories.

    PubMed

    Alexander, C L; Currie, S; Pollock, K; Smith-Palmer, A; Jones, B L

    2017-06-01

    Giardia duodenalis and Cryptosporidium species are protozoan parasites capable of causing gastrointestinal disease in humans and animals through the ingestion of infective faeces. Whereas Cryptosporidium species can be acquired locally or through foreign travel, there is the mis-conception that giardiasis is considered to be largely travel-associated, which results in differences in laboratory testing algorithms. In order to determine the level of variation in testing criteria and detection methods between diagnostic laboratories for both pathogens across Scotland, an audit was performed. Twenty Scottish diagnostic microbiology laboratories were invited to participate with questions on sample acceptance criteria, testing methods, testing rates and future plans for pathogen detection. Reponses were received from 19 of the 20 laboratories representing each of the 14 territorial Health Boards. Detection methods varied between laboratories with the majority performing microscopy, one using a lateral flow immunochromatographic antigen assay, another using a manually washed plate-based enzyme immunoassay (EIA) and one laboratory trialling a plate-based EIA automated with an EIA plate washer. Whereas all laboratories except one screened every stool for Cryptosporidium species, an important finding was that significant variation in the testing algorithm for detecting Giardia was noted with only four laboratories testing all diagnostic stools. The most common criteria were 'travel history' (11 laboratories) and/or 'when requested' (14 laboratories). Despite only a small proportion of stools being examined in 15 laboratories for Giardia (2%-18% of the total number of stools submitted), of interest is the finding that a higher positivity rate was observed for Giardia than Cryptosporidium in 10 of these 15 laboratories. These findings highlight that the underreporting of Giardia in Scotland is likely based on current selection and testing algorithms.

  2. Diagnostic tests in HIV management: a review of clinical and laboratory strategies to monitor HIV-infected individuals in developing countries.

    PubMed Central

    Kimmel, April D.; Losina, Elena; Freedberg, Kenneth A.; Goldie, Sue J.

    2006-01-01

    We conducted a systematic review on the performance of diagnostic tests for clinical and laboratory monitoring of HIV-infected adults in developing countries. Diagnostic test information collected from computerized databases, bibliographies and the Internet were categorized as clinical (non-laboratory patient information), immunologic (information from immunologic laboratory tests), or virologic (information from virologic laboratory tests). Of the 51 studies selected for the review 28 assessed immunologic tests, 12 virologic tests and seven clinical and immunologic tests. Methods of performance evaluation were primarily sensitivity and specificity for the clinical category and correlation coefficients for immunologic and virologic categories. In the clinical category, the majority of test performance measures was reported as >70% sensitive and >65% specific. In the immunologic category, correlation coefficients ranged from r=0.54 to r=0.99 for different CD4 count enumeration techniques, while correlation for CD4 and total lymphocyte counts was between r=0.23 and r=0.74. In the virologic category, correlation coefficients for different human immunodeficiency virus (HIV) ribonucleic acid (RNA) quantification techniques ranged from r=0.54 to r=0.90. Future research requires consensus on designing studies, and collecting and reporting data useful for decision-makers. We recommend classifying information into clinically relevant categories, using a consistent definition of disease across studies and providing measures of both association and accuracy. PMID:16878233

  3. 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.

  4. 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.

  5. Development and implementation of an international proficiency testing program for a neutralizing antibody assay for HIV-1 in TZM-bl cells.

    PubMed

    Todd, Christopher A; Greene, Kelli M; Yu, Xuesong; Ozaki, Daniel A; Gao, Hongmei; Huang, Yunda; Wang, Maggie; Li, Gary; Brown, Ronald; Wood, Blake; D'Souza, M Patricia; Gilbert, Peter; Montefiori, David C; Sarzotti-Kelsoe, Marcella

    2012-01-31

    Recent advances in assay technology have led to major improvements in how HIV-1 neutralizing antibodies are measured. A luciferase reporter gene assay performed in TZM-bl (JC53bl-13) cells has been optimized and validated. Because this assay has been adopted by multiple laboratories worldwide, an external proficiency testing program was developed to ensure data equivalency across laboratories performing this neutralizing antibody assay for HIV/AIDS vaccine clinical trials. The program was optimized by conducting three independent rounds of testing, with an increased level of stringency from the first to third round. Results from the participating domestic and international laboratories improved each round as factors that contributed to inter-assay variability were identified and minimized. Key contributors to increased agreement were experience among laboratories and standardization of reagents. A statistical qualification rule was developed using a simulation procedure based on the three optimization rounds of testing, where a laboratory qualifies if at least 25 of the 30 ID50 values lie within the acceptance ranges. This ensures no more than a 20% risk that a participating laboratory fails to qualify when it should, as defined by the simulation procedure. Five experienced reference laboratories were identified and tested a series of standardized reagents to derive the acceptance ranges for pass-fail criteria. This Standardized Proficiency Testing Program is the first available for the evaluation and documentation of assay equivalency for laboratories performing HIV-1 neutralizing antibody assays and may provide guidance for the development of future proficiency testing programs for other assay platforms. Copyright © 2011 Elsevier B.V. All rights reserved.

  6. 7 CFR 91.4 - Kinds of services.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... in performing commodity testing services. (c) Quality assurance reviews. The Science and Technology..., Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS.... Analytical laboratory testing services under the regulations in this subchapter consist of microbiological...

  7. 7 CFR 91.4 - Kinds of services.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... in performing commodity testing services. (c) Quality assurance reviews. The Science and Technology..., Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS.... Analytical laboratory testing services under the regulations in this subchapter consist of microbiological...

  8. 7 CFR 91.4 - Kinds of services.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... in performing commodity testing services. (c) Quality assurance reviews. The Science and Technology..., Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS.... Analytical laboratory testing services under the regulations in this subchapter consist of microbiological...

  9. 7 CFR 91.4 - Kinds of services.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... in performing commodity testing services. (c) Quality assurance reviews. The Science and Technology..., Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS.... Analytical laboratory testing services under the regulations in this subchapter consist of microbiological...

  10. 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

  11. Multi-Laboratory Study of Five Methods for the Determination of Brevetoxins in Shellfish Tissue Extracts.

    PubMed

    Dickey, Robert W; Plakas, Steven M; Jester, Edward L E; El Said, Kathleen R; Johannessen, Jan N; Flewelling, Leanne J; Scott, Paula; Hammond, Dan G; Van Dolah, Frances M; Leighfield, Tod A; Bottein Dachraoui, Marie-Yasmine; Ramsdell, John S; Pierce, Richard H; Henry, Mike S; Poli, Mark A; Walker, Calvin; Kurtz, Jan; Naar, Jerome; Baden, Daniel G; Musser, Steve M; White, Kevin D; Truman, Penelope; Miller, Aaron; Hawryluk, Timothy P; Wekell, Marleen M; Stirling, David; Quilliam, Michael A; Lee, Jung K

    A thirteen-laboratory comparative study tested the performance of four methods as alternatives to mouse bioassay for the determination of brevetoxins in shellfish. The methods were N2a neuroblastoma cell assay, two variations of the sodium channel receptor binding assay, competitive ELISA, and LC/MS. Three to five laboratories independently performed each method using centrally prepared spiked and naturally incurred test samples. Competitive ELISA and receptor binding (96-well format) compared most favorably with mouse bioassay. Between-laboratory relative standard deviations (RSDR) ranged from 10 to 20% for ELISA and 14 to 31% for receptor binding. Within-laboratory (RSDr) ranged from 6 to 15% for ELISA, and 5 to 31% for receptor binding. Cell assay was extremely sensitive but data variation rendered it unsuitable for statistical treatment. LC/MS performed as well as ELISA on spiked test samples but was inordinately affected by lack of toxin-metabolite standards, uniform instrumental parameters, or both, on incurred test samples. The ELISA and receptor binding assay are good alternatives to mouse bioassay for the determination of brevetoxins in shellfish.

  12. Emergency radiobioassay preparedness exercises through the NIST radiochemistry intercomparison program.

    PubMed

    Nour, Svetlana; LaRosa, Jerry; Inn, Kenneth G W

    2011-08-01

    The present challenge for the international emergency radiobioassay community is to analyze contaminated samples rapidly while maintaining high quality results. The National Institute of Standards and Technology (NIST) runs a radiobioassay measurement traceability testing program to evaluate the radioanalytical capabilities of participating laboratories. The NIST Radiochemistry Intercomparison Program (NRIP) started more than 10 years ago, and emergency performance testing was added to the program seven years ago. Radiobioassay turnaround times under the NRIP program for routine production and under emergency response scenarios are 60 d and 8 h, respectively. Because measurement accuracy and sample turnaround time are very critical in a radiological emergency, response laboratories' analytical systems are best evaluated and improved through traceable Performance Testing (PT) programs. The NRIP provides participant laboratories with metrology tools to evaluate their performance and to improve it. The program motivates the laboratories to optimize their methodologies and minimize the turnaround time of their results. Likewise, NIST has to make adjustments and periodical changes in the bioassay test samples in order to challenge the participating laboratories continually. With practice, radioanalytical measurements turnaround time can be reduced to 3-4 h.

  13. Modeling Canadian Quality Control Test Program for Steroid Hormone Receptors in Breast Cancer: Diagnostic Accuracy Study.

    PubMed

    Pérez, Teresa; Makrestsov, Nikita; Garatt, John; Torlakovic, Emina; Gilks, C Blake; Mallett, Susan

    The Canadian Immunohistochemistry Quality Control program monitors clinical laboratory performance for estrogen receptor and progesterone receptor tests used in breast cancer treatment management in Canada. Current methods assess sensitivity and specificity at each time point, compared with a reference standard. We investigate alternative performance analysis methods to enhance the quality assessment. We used 3 methods of analysis: meta-analysis of sensitivity and specificity of each laboratory across all time points; sensitivity and specificity at each time point for each laboratory; and fitting models for repeated measurements to examine differences between laboratories adjusted by test and time point. Results show 88 laboratories participated in quality control at up to 13 time points using typically 37 to 54 histology samples. In meta-analysis across all time points no laboratories have sensitivity or specificity below 80%. Current methods, presenting sensitivity and specificity separately for each run, result in wide 95% confidence intervals, typically spanning 15% to 30%. Models of a single diagnostic outcome demonstrated that 82% to 100% of laboratories had no difference to reference standard for estrogen receptor and 75% to 100% for progesterone receptor, with the exception of 1 progesterone receptor run. Laboratories with significant differences to reference standard identified with Generalized Estimating Equation modeling also have reduced performance by meta-analysis across all time points. The Canadian Immunohistochemistry Quality Control program has a good design, and with this modeling approach has sufficient precision to measure performance at each time point and allow laboratories with a significantly lower performance to be targeted for advice.

  14. 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.

  15. Multi-center evaluation of the cobas® Liat® Influenza A/B & RSV assay for rapid point of care diagnosis.

    PubMed

    Gibson, Jane; Schechter-Perkins, Elissa M; Mitchell, Patricia; Mace, Sharon; Tian, Yu; Williams, Kemi; Luo, Robert; Yen-Lieberman, Belinda

    2017-10-01

    Point of Care Testing (POCT) provides the capability for rapid laboratory test results in patient care environments where a traditional clinical laboratory is not available. POCTs have shorter turn-around times (TATs), they may be performed by non-laboratory personnel, and the need for transport time is eliminated. The Food and Drug Administration (FDA) recently granted Clinical Laboratory Improvements Amendment (CLIA) waiver status to the cobas ® Influenza A/B & RSV assay, a rapid, accurate point-of-care test for Influenza and respiratory syncytial virus (RSV) performed on the Liat ® System. The performance characteristics of this test were determined though a multi-site study consisting of different point of care testing environments. Prospectively collected Nasopharyngeal (NP) swabs from 1361 patients seen at 8 primary care clinics and 4 emergency departments (EDs) and 295 retrospectively identified specimens were tested for Influenza A/B and RSV on the cobas ® Liat ® platform. Performance characteristics were determined through comparison to ProFlu+, a laboratory-based PCR test for Influenza A/B and RSV (reference test). Discordant specimens were adjudicated following bi-directional sequencing. The cobas ® Influenza A/B and RSV assay showed sensitivities of 99.6%, 99.3%, and 96.8% for Influenza A, Influenza B, and RSV, respectively as determined from percent positive agreement (PPA) following comparison to the reference test. Sequencing confirmed cobas ® Influenza A/B and RSV results in 49.2% of reference test discordant specimens, while crossing threshold data suggest increased sensitivity compared to the reference test. The cobas ® Influenza A/B and RSV assay was found to be a rapid, sensitive POCT for the detection of these viruses, and provides laboratory-quality PCR-based diagnostic results in point of care settings. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. Evaluation of Mycology Laboratory Proficiency Testing

    PubMed Central

    Reilly, Andrew A.; Salkin, Ira F.; McGinnis, Michael R.; Gromadzki, Sally; Pasarell, Lester; Kemna, Maggi; Higgins, Nancy; Salfinger, Max

    1999-01-01

    Changes over the last decade in overt proficiency testing (OPT) regulations have been ostensibly directed at improving laboratory performance on patient samples. However, the overt (unblinded) format of the tests and regulatory penalties associated with incorrect values allow and encourage laboratorians to take extra precautions with OPT analytes. As a result OPT may measure optimal laboratory performance instead of the intended target of typical performance attained during routine patient testing. This study addresses this issue by evaluating medical mycology OPT and comparing its fungal specimen identification error rates to those obtained in a covert (blinded) proficiency testing (CPT) program. Identifications from 188 laboratories participating in the New York State mycology OPT from 1982 to 1994 were compared with the identifications of the same fungi recovered from patient specimens in 1989 and 1994 as part of the routine procedures of 88 of these laboratories. The consistency in the identification of OPT specimens was sufficient to make accurate predictions of OPT error rates. However, while the error rates in OPT and CPT were similar for Candida albicans, significantly higher error rates were found in CPT for Candida tropicalis, Candida glabrata, and other common pathogenic fungi. These differences may, in part, be due to OPT’s use of ideal organism representatives cultured under optimum growth conditions. This difference, as well as the organism-dependent error rate differences, reflects the limitations of OPT as a means of assessing the quality of routine laboratory performance in medical mycology. PMID:10364601

  17. [Survey results of medical insurance reimbursement system for independent medical laboratories in Korea].

    PubMed

    Bae, Sook Young; Kwon, Jung Ah; Kim, Jang Su; Yoon, Soo Young; Lee, Chang Kyu; Lee, Kap No; Kim, Dae Won; Min, Won Ki; Cha, Young Joo; Chae, Seok Lae; Hwang, Yoo Sung

    2007-04-01

    A questionnaire survey was performed to perceive the problem of the current medical insurance reimbursement system for laboratory tests referred to independent medical laboratories; then, we intended to find a way to improve the reimbursement system. Questionnaires were distributed to 220 independent medical laboratories and 700 laboratory physicians from July through October 2005. Frequency analysis was used to analyse the replies from 109 respondents to 25 questionnaire items regarding the current medical insurance reimbursement system for referral tests, problems with the system, and suggestions for the improvement of the system. Among the 109 respondents to this survey, 49 (45.8%) considered the current reimbursement system to be unsatisfactory, while only 16 (15.0%) answered satisfactory. The problem was that the referral clinics-not the laboratories that performed the tests--would first receive their reimbursement for the laboratory tests from Health Insurance Review Agency (HIRA) and then give a portion of the laboratory test fees to the independent medical laboratories after the deduction of administrative fees. They (62.5% of the respondents) would prefer a separated reimbursement system by which the referral clinic-as well as the independent medical laboratory-would receive their reimbursement directly from HIRA through an Electronic Data Interchange (EDI) system. In this new system, 34% of the respondents expected the quality of the laboratory tests to be improved; however, 41.6% answered that the income of the referral clinic is expected to decrease. For the improvement of the medical insurance reimbursement system, the administrative fee for the referral clinic and the test fee for the independent medical laboratory should be reimbursed directly to the respective organizations. These changes could be made possible with the proper analysis of medical costs and the development of an effective EDI reimbursement system.

  18. 42 CFR 410.32 - Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Procedural Terminology published by the American Medical Association. (vii) Diagnostic tests performed by a... & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services § 410.32 Diagnostic x-ray tests, diagnostic laboratory...

  19. 42 CFR 410.32 - Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Procedural Terminology published by the American Medical Association. (vii) Diagnostic tests performed by a... & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services § 410.32 Diagnostic x-ray tests, diagnostic laboratory...

  20. 42 CFR 493.959 - Immunohematology.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... challenges per testing event a program must provide for each analyte or test procedure is five. Analyte or... Compatibility testing Antibody identification (d) Evaluation of a laboratory's analyte or test performance. HHS... program must compare the laboratory's response for each analyte with the response that reflects agreement...

  1. 42 CFR 493.959 - Immunohematology.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... challenges per testing event a program must provide for each analyte or test procedure is five. Analyte or... Compatibility testing Antibody identification (d) Evaluation of a laboratory's analyte or test performance. HHS... program must compare the laboratory's response for each analyte with the response that reflects agreement...

  2. 42 CFR 493.959 - Immunohematology.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... challenges per testing event a program must provide for each analyte or test procedure is five. Analyte or... Compatibility testing Antibody identification (d) Evaluation of a laboratory's analyte or test performance. HHS... program must compare the laboratory's response for each analyte with the response that reflects agreement...

  3. 42 CFR 493.959 - Immunohematology.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... challenges per testing event a program must provide for each analyte or test procedure is five. Analyte or... Compatibility testing Antibody identification (d) Evaluation of a laboratory's analyte or test performance. HHS... program must compare the laboratory's response for each analyte with the response that reflects agreement...

  4. 23 CFR 637.209 - Laboratory and sampling and testing personnel qualifications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... sampling and testing personnel. (c) Conflict of interest. In order to avoid an appearance of a conflict of interest, any qualified non-STD laboratory shall perform only one of the following types of testing on the...

  5. Prevalence of Traditional and Reverse-Algorithm Syphilis Screening in Laboratory Practice: A Survey of Participants in the College of American Pathologists Syphilis Serology Proficiency Testing Program.

    PubMed

    Rhoads, Daniel D; Genzen, Jonathan R; Bashleben, Christine P; Faix, James D; Ansari, M Qasim

    2017-01-01

    -Syphilis serology screening in laboratory practice is evolving. Traditionally, the syphilis screening algorithm begins with a nontreponemal immunoassay, which is manually performed by a laboratory technologist. In contrast, the reverse algorithm begins with a treponemal immunoassay, which can be automated. The Centers for Disease Control and Prevention has recognized both approaches, but little is known about the current state of laboratory practice, which could impact test utilization and interpretation. -To assess the current state of laboratory practice for syphilis serologic screening. -In August 2015, a voluntary questionnaire was sent to the 2360 laboratories that subscribe to the College of American Pathologists syphilis serology proficiency survey. -Of the laboratories surveyed, 98% (2316 of 2360) returned the questionnaire, and about 83% (1911 of 2316) responded to at least some questions. Twenty-eight percent (378 of 1364) reported revision of their syphilis screening algorithm within the past 2 years, and 9% (170 of 1905) of laboratories anticipated changing their screening algorithm in the coming year. Sixty-three percent (1205 of 1911) reported using the traditional algorithm, 16% (304 of 1911) reported using the reverse algorithm, and 2.5% (47 of 1911) reported using both algorithms, whereas 9% (169 of 1911) reported not performing a reflex confirmation test. Of those performing the reverse algorithm, 74% (282 of 380) implemented a new testing platform when introducing the new algorithm. -The majority of laboratories still perform the traditional algorithm, but a significant minority have implemented the reverse-screening algorithm. Although the nontreponemal immunologic response typically wanes after cure and becomes undetectable, treponemal immunoassays typically remain positive for life, and it is important for laboratorians and clinicians to consider these assay differences when implementing, using, and interpreting serologic syphilis screening algorithms.

  6. Field-test of a date-rape drug detection device.

    PubMed

    Quest, Dale W; Horsley, Joanne

    2007-01-01

    Drink Safe Technology Version 1.2 is an inexpensive color-change reagent test marketed internationally for use by consumers in settings such as a night club to detect potentially incapacitating concentrations of gamma-hydroxybutyric acid (GHB) and ketamine in beverages. The objective of this study was to compare product performance in the laboratory and performance in the hands of consumers in the field. Product performance in the laboratory adhered to the protocol defined by the manufacturer. Product performance in the hands of consumers in field settings allowed browsing participants to pipette an aliquot of their own drinks into randomly coded vials containing authentic drugs, or pure water, so as to yield the same concentrations of GHB or ketamine specified in the manufacturer-defined protocol, or blanks. Consumers were to proceed according to the directions printed on the product, and to record their results on a card with a code corresponding with the vial to which they had added an aliquot of their beverage. Diagnostic performance was calculated using two-way analysis. In the laboratory, Drink Safe Technology Version 1.2 reliably detected GHB and ketamine at concentrations specified by the manufacturer's protocol. The reactive color change denoting a positive test for GHB was rapid, but a positive test for ketamine required substantially more time to resolve. Nonetheless, test accuracy following the manufacturer's protocol in the laboratory was 100%. In the field, based on 101 paired-test results recorded by consumers, the test efficiency was 65.1%, sensitivity 50%, and specificity 91.6%. The product performed much better in the laboratory than it did in the hand of consumers in the field. There seems to be considerable potential for consumers to misinterpret a test result. The potential for consumers to record a false-negative test result for a spiked drink is cause for concern.

  7. High Power Magnetohydrodynamic System

    DTIC Science & Technology

    1978-07-01

    AFAPL/POD as the Program Manager. Dr. Daniel W. Swallom and Dr. Otto K. Sonju of Maxwell Laboratories, Inc. were responsible for the technical work. The...fabricated and tested. Figure 1 shows this hardware installed at the Santa Susana Field Laboratory (SSFL) for develop- ment testing. The cooled wall...development test program was conducted at Santa Susana Field Laboratory (SSFL) and a performance test program is to be conducted at AEDC. AEDC is to

  8. 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.

  9. Performance of Clinical Laboratories in South African Parasitology Proficiency Testing Surveys between 2004 and 2010

    PubMed Central

    Dini, Leigh; Frean, John

    2012-01-01

    Performance in proficiency testing (PT) schemes is an objective measure of a laboratory's best performance. We examined the performance of participants in two parasitology PT schemes in South Africa from 2004 through 2010. The average rates of acceptable scores over the period were 58% and 66% for the stool and blood parasite schemes, respectively. In our setting, participation in PT alone is insufficient to improve performance; a policy that provides additional resources and training seems necessary. PMID:22814470

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

    PubMed

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

    2007-11-01

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

  11. [How to Interpret and Use Routine Laboratory Data--Our Methods to Interpret Routine Laboratory Data--Chairmen's Introductory Remarks].

    PubMed

    Honda, Takayuki; Tozuka, Minoru

    2015-09-01

    In the reversed clinicopathological conference (R-CPC), three specialists in laboratory medicine interpreted routine laboratory data independently in order to understand the detailed state of a patient. R-CPC is an educational method to use laboratory data appropriately, and it is also important to select differential diagnoses in a process of clinical reasoning in addition to the present illness and physical examination. Routine laboratory tests can be performed repeatedly at a relatively low cost, and their time-series analysis can be performed. Interpretation of routine laboratory data is almost the same as taking physical findings. General findings are initially checked and then the state of each organ is examined. Although routine laboratory tests cost little, we can gain much more information from them about the patient than physical examinations.

  12. 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.

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

    PubMed

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

    2008-04-01

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

  14. Gold Standard Testing of Motion Based Tracking Systems

    DTIC Science & Technology

    2017-03-15

    NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER H0L0 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) 8. PERFORMING ORGANIZATION REPORT NUMBER 9...LABORATORY 711TH HUMAN PERFORMANCE WING, AIRMAN SYSTEMS DIRECTORATE, WRIGHT-PATTERSON AIR FORCE BASE, OH 45433 AIR FORCE MATERIEL COMMAND UNITED STATES AIR...711th Human Performance Wing 711th Human Performance Wing Air Force Research Laboratory Air Force Research Laboratory This report is published in the

  15. Grid Modernization Laboratory Consortium - Testing and Verification

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

    Kroposki, Benjamin; Skare, Paul; Pratt, Rob

    This paper highlights some of the unique testing capabilities and projects being performed at several national laboratories as part of the U. S. Department of Energy Grid Modernization Laboratory Consortium. As part of this effort, the Grid Modernization Laboratory Consortium Testing Network isbeing developed to accelerate grid modernization by enablingaccess to a comprehensive testing infrastructure and creating a repository of validated models and simulation tools that will be publicly available. This work is key to accelerating thedevelopment, validation, standardization, adoption, and deployment of new grid technologies to help meet U. S. energy goals.

  16. 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.

  17. Clinical laboratory: bigger is not always better.

    PubMed

    Plebani, Mario

    2018-06-27

    Laboratory services around the world are undergoing substantial consolidation and changes through mechanisms ranging from mergers, acquisitions and outsourcing, primarily based on expectations to improve efficiency, increasing volumes and reducing the cost per test. However, the relationship between volume and costs is not linear and numerous variables influence the end cost per test. In particular, the relationship between volumes and costs does not span the entire platter of clinical laboratories: high costs are associated with low volumes up to a threshold of 1 million test per year. Over this threshold, there is no linear association between volumes and costs, as laboratory organization rather than test volume more significantly affects the final costs. Currently, data on laboratory errors and associated diagnostic errors and risk for patient harm emphasize the need for a paradigmatic shift: from a focus on volumes and efficiency to a patient-centered vision restoring the nature of laboratory services as an integral part of the diagnostic and therapy process. Process and outcome quality indicators are effective tools to measure and improve laboratory services, by stimulating a competition based on intra- and extra-analytical performance specifications, intermediate outcomes and customer satisfaction. Rather than competing with economic value, clinical laboratories should adopt a strategy based on a set of harmonized quality indicators and performance specifications, active laboratory stewardship, and improved patient safety.

  18. Advanced application flight experiments precision attitude determination system. Volume 2: System tests

    NASA Technical Reports Server (NTRS)

    1976-01-01

    The performance capability of each of two precision attitude determination systems (PADS), one using a strapdown star tracker, and the other using a single-axis gimbal star tracker was measured in the laboratory under simulated orbit conditions. The primary focus of the evaluation was on the contribution to the total system accuracy by the star trackers, and the effectiveness of the software algorithms in functioning with actual sensor signals. A brief description of PADS, the laboratory test configuration and the test facility, is given along with a discussion of the data handling and display, laboratory computer programs, PADS performance evaluation programs, and the strapdown and gimbal system tests. Results are presented and discussed.

  19. The role of total laboratory automation in a consolidated laboratory network.

    PubMed

    Seaberg, R S; Stallone, R O; Statland, B E

    2000-05-01

    In an effort to reduce overall laboratory costs and improve overall laboratory efficiencies at all of its network hospitals, the North Shore-Long Island Health System recently established a Consolidated Laboratory Network with a Core Laboratory at its center. We established and implemented a centralized Core Laboratory designed around the Roche/Hitachi CLAS Total Laboratory Automation system to perform the general and esoteric laboratory testing throughout the system in a timely and cost-effective fashion. All remaining STAT testing will be performed within the Rapid Response Laboratories (RRLs) at each of the system's hospitals. Results for this laboratory consolidation and implementation effort demonstrated a decrease in labor costs and improved turnaround time (TAT) at the core laboratory. Anticipated system savings are approximately $2.7 million. TATs averaged 1.3 h within the Core Laboratory and less than 30 min in the RRLs. When properly implemented, automation systems can reduce overall laboratory expenses, enhance patient services, and address the overall concerns facing the laboratory today: job satisfaction, decreased length of stay, and safety. The financial savings realized are primarily a result of labor reductions.

  20. Standardized Laboratory Test Requirements for Hardening Equipment to Withstand Wave Impact Shock in Small High Speed Craft

    DTIC Science & Technology

    2017-02-06

    and methodology for transitioning craft acceleration data to laboratory shock test requirements are summarized and example requirements for...engineering rationale, assumptions, and methodology for transitioning craft acceleration data to laboratory shock test requirements are summarized and... Methodologies for Small High-Speed Craft Structure, Equipment, Shock Isolation Seats, and Human Performance At-Sea, 10 th Symposium on High

  1. Seven Q-Tracks monitors of laboratory quality drive general performance improvement: experience from the College of American Pathologists Q-Tracks program 1999-2011.

    PubMed

    Meier, Frederick A; Souers, Rhona J; Howanitz, Peter J; Tworek, Joseph A; Perrotta, Peter L; Nakhleh, Raouf E; Karcher, Donald S; Bashleben, Christine; Darcy, Teresa P; Schifman, Ron B; Jones, Bruce A

    2015-06-01

    Many production systems employ standardized statistical monitors that measure defect rates and cycle times, as indices of performance quality. Clinical laboratory testing, a system that produces test results, is amenable to such monitoring. To demonstrate patterns in clinical laboratory testing defect rates and cycle time using 7 College of American Pathologists Q-Tracks program monitors. Subscribers measured monthly rates of outpatient order-entry errors, identification band defects, and specimen rejections; median troponin order-to-report cycle times and rates of STAT test receipt-to-report turnaround time outliers; and critical values reporting event defects, and corrected reports. From these submissions Q-Tracks program staff produced quarterly and annual reports. These charted each subscriber's performance relative to other participating laboratories and aggregate and subgroup performance over time, dividing participants into best and median performers and performers with the most room to improve. Each monitor's patterns of change present percentile distributions of subscribers' performance in relation to monitoring durations and numbers of participating subscribers. Changes over time in defect frequencies and the cycle duration quantify effects on performance of monitor participation. All monitors showed significant decreases in defect rates as the 7 monitors ran variously for 6, 6, 7, 11, 12, 13, and 13 years. The most striking decreases occurred among performers who initially had the most room to improve and among subscribers who participated the longest. All 7 monitors registered significant improvement. Participation effects improved between 0.85% and 5.1% per quarter of participation. Using statistical quality measures, collecting data monthly, and receiving reports quarterly and yearly, subscribers to a comparative monitoring program documented significant decreases in defect rates and shortening of a cycle time for 6 to 13 years in all 7 ongoing clinical laboratory quality monitors.

  2. Fundamental Properties of Soils for Complex Dynamic Loadings: Dynamic Constitutive Modeling of Sandy Soils.

    DTIC Science & Technology

    1983-04-01

    1.0 INTRODUCTION AND SCOPE 1 2.0 PROGRESS SUMMARY 3 2.1 Soil Element Model Development 3 2.2 U.S. Any Engineer Waterways Experiment Station (WES...LABORATORY BEHAVIOR OF SAND 8 3.1 Introduction 8 3.2 Material Description 8 3.3 Laboratory Tests Performed 9 3.4 Laboratory Test Results 14 4.0 MODELING THE... INTRODUCTION AND SCOPE The subject of this annual report is constitutive modeling of cohesionless soil, for both laboratory standard static test conditions

  3. 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.

  4. 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

  5. B-type natriuretic peptide and its clinical utility in patients with heart failure.

    PubMed

    Wu, A H

    2001-10-01

    The implementation of entirely new clinical laboratory tests such as BNP assays is much more difficult today than it ever has been in the past. Medicare and Medicaid have been operating for many years on fixed reimbursements based on Diagnosis Related Groups (DRGs). Many third-party payers now have capitated contracts, i.e., a fixed reimbursement per member per month, regardless of the number of tests ordered and performed. Laboratories are now cost centers and not sources of revenue, thus the limited amount of income from fee-for-service reimbursements may not sufficient to cover the expenses for performing all testing. Therefore, in order to justify BNP testing, laboratory directors and hospital administrators must be able to demonstrate that implementation of BNP testing results in a savings for the hospital as a whole, even if the laboratory has a negative cost balance. If BNP testing can lead to a reduction or elimination of other tests, or if it improves the efficiency and accuracy of CHF diagnosis so that the number of inappropriate admissions is reduced, the test may be justified. Table 2 lists some specific areas where BNP might impact the other clinical areas. Outcome studies should be performed to determine if any of these changes in clinical practices can be justified.

  6. 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.

  7. Study of LTPP laboratory resilient modulus test data and response characteristics.

    DOT National Transportation Integrated Search

    2002-10-01

    The resilient modulus of every unbound structural layer of the Long Term Pavement Performance (LTPP) Specific Pavement and : General Pavement Studies Test Sections is being measured in the laboratory using LTPP test protocol P46. A total of 2,014 : r...

  8. Moving from the laboratory to the field: Adding natural environmental conditions to toxicology testing

    EPA Science Inventory

    While laboratory toxicology tests are generally easy to perform, cost effective and readily interpreted, they have been criticized for being unrealistic. In contrast, field tests are considered realistic while producing results that are difficult to interpret and expensive. To ...

  9. 76 FR 80905 - TRICARE Evaluation of Centers for Medicare & Medicaid Services Approved Laboratory Developed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ... potential high utilization and potential high clinical impact on TRICARE beneficiaries. If no submission is... reviewed in numerical order beginning with the test listed as having the highest priority. Those selected... laboratories that use LDTs as well as FDA approved tests. Laboratories performing moderate or high complexity...

  10. Microdamage healing in asphalt and asphalt concrete, Volume 2 : laboratory and field testing to assess and evaluate microdamage and microdamage healing

    DOT National Transportation Integrated Search

    2001-06-01

    Volume 2 documents laboratory and field testing that provides the evidence that microdamage healing is real and measurable and that it has a significant impact on pavement performance. Part of the laboratory experiments to evaluate the impact of rest...

  11. The Effect of Degrees of Direction in the Qualitative Analysis Laboratory on Retention of Learning

    ERIC Educational Resources Information Center

    Holcomb, Charlie M.

    1971-01-01

    Students given sufficient information to be able to design chemical separations of cations performed better on a post-test, and on a four-month retention test on chemical knowledge and laboratory procedures, than students given a detailed laboratory guide listing the steps to follow. (AL)

  12. 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...

  13. [Uniform analyzes of drugs in urine needed for rule of law].

    PubMed

    Hansson, Therese; Helander, Anders; Beck, Olof; Elmgren, Anders; Kugelberg, Fredrik; Kronstrand, Robert

    2015-09-22

    Drugs of abuse testing is used in various areas of society for detection and follow-up of drug use. In routine laboratory drug testing, immunoassays are employed for initial screening of specimens to indicate the presence of drugs. To confirm a positive screening test, a secondary analysis by mass spectrometry is performed. The "cut-off" is the pre-defined concentration threshold of a drug or drug metabolite above which the sample is considered positive. A reading below this level implies a negative test result. Swedish drug testing laboratories currently employ varying cut-offs to distinguish between a positive and a negative test result. Because a positive drug test may have serious legal consequences to the individual, it is of importance that testing is performed and judged equally, regardless of where it is performed. A national harmonization of cut-offs is therefore warranted. Based on data from four major Swedish drug testing laboratories, and considering the recommendations in international guidelines, a proposal for national harmonization of urine cut-offs for the most common set of drugs of abuse is presented.

  14. Evaluation of Troxler model 3411 nuclear gage.

    DOT National Transportation Integrated Search

    1978-01-01

    The performance of the Troxler Electronics Laboratory Model 3411 nuclear gage was evaluated through laboratory tests on the Department's density and moisture standards and field tests on various soils, base courses, and bituminous concrete overlays t...

  15. [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.

  16. Choosing the right laboratory: a review of clinical and forensic toxicology services for urine drug testing in pain management.

    PubMed

    Reisfield, Gary M; Goldberger, Bruce A; Bertholf, Roger L

    2015-01-01

    Urine drug testing (UDT) services are provided by a variety of clinical, forensic, and reference/specialty laboratories. These UDT services differ based on the principal activity of the laboratory. Clinical laboratories provide testing primarily focused on medical care (eg, emergency care, inpatients, and outpatient clinics), whereas forensic laboratories perform toxicology tests related to postmortem and criminal investigations, and drug-free workplace programs. Some laboratories now provide UDT specifically designed for monitoring patients on chronic opioid therapy. Accreditation programs for clinical laboratories have existed for nearly half a century, and a federal certification program for drug-testing laboratories was established in the 1980s. Standards of practice for forensic toxicology services other than workplace drug testing have been established in recent years. However, no accreditation program currently exists for UDT in pain management, and this review considers several aspects of laboratory accreditation and certification relevant to toxicology services, with the intention to provide guidance to clinicians in their selection of the appropriate laboratory for UDT surveillance of their patients on opioid therapy.

  17. Integrated Data Collection Analysis (IDCA) Program - RDX Type II Class 5 Standard, Data Set 1

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

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

    This document describes the results of the first reference sample material—RDX Type II Class 5—examined in the proficiency study for small-scale safety and thermal (SSST) testing of explosive materials for the Integrated Data Collection Analysis (IDCA) Program. The IDCA program is conducting proficiency testing on homemade explosives (HMEs). The reference sample materials are being studied to establish the accuracy of traditional explosives safety testing for each performing laboratory. These results will be used for comparison to results from testing HMEs. This effort, funded by the Department of Homeland Security (DHS), ultimately will put the issues of safe handling of thesemore » materials in perspective with standard military explosives. The results of the study will add SSST testing results for a broad suite of different HMEs to the literature, potentially suggest new guidelines and methods for HME testing, and possibly establish what are the needed accuracies in SSST testing to develop safe handling practices. Described here are the results for impact, friction, electrostatic discharge, and scanning calorimetry analysis of a reference sample of RDX Type II Class 5. The results from each participating testing laboratory are compared using identical test material and preparation methods wherever possible. Note, however, the test procedures differ among the laboratories. These results are then compared to historical data from various sources. The performers involved are Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Air Force Research Laboratory/ RXQL (AFRL), Indian Head Division, Naval Surface Warfare Center, (IHD-NSWC), and Sandia National Laboratories (SNL). These tests are conducted as a proficiency study in order to establish some consistency in test protocols, procedures, and experiments and to understand how to compare results when test protocols are not identical.« less

  18. Doubling immunochemistry laboratory testing efficiency with the cobas e 801 module while maintaining consistency in analytical performance.

    PubMed

    Findeisen, P; Zahn, I; Fiedler, G M; Leichtle, A B; Wang, S; Soria, G; Johnson, P; Henzell, J; Hegel, J K; Bendavid, C; Collet, N; McGovern, M; Klopprogge, K

    2018-06-04

    The new immunochemistry cobas e 801 module (Roche Diagnostics) was developed to meet increasing demands on routine laboratories to further improve testing efficiency, while maintaining high quality and reliable data. During a non-interventional multicenter evaluation study, the overall performance, functionality and reliability of the new module was investigated under routine-like conditions. It was tested as a dedicated immunochemistry system at four sites and as a consolidator combined with clinical chemistry at three sites. We report on testing efficiency and analytical performance of the new module. Evaluation of sample workloads with site-specific routine request patterns demonstrated increased speed and almost doubled throughput (maximal 300 tests per h), thus revealing that one cobas e 801 module can replace two cobas e 602 modules while saving up to 44% floor space. Result stability was demonstrated by QC analysis per assay throughout the study. Precision testing over 21 days yielded excellent results within and between labs, and, method comparison performed versus the cobas e 602 module routine results showed high consistency of results for all assays under study. In a practicability assessment related to performance and handling, 99% of graded features met (44%) or even exceeded (55%) laboratory expectations, with enhanced reagent management and loading during operation being highlighted. By nearly doubling immunochemistry testing efficiency on the same footprint as a cobas e 602 module, the new module has a great potential to further consolidate and enhance laboratory testing while maintaining high quality analytical performance with Roche platforms. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  19. 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.

  20. Laboratory and field evaluation of the impact of exercise on the performance of regular and polymer-based deet repellents.

    PubMed

    Schofield, Steven; Tepper, Martin; Gadawski, Randy

    2007-11-01

    Studies were done in Manitoba, Canada, to evaluate the impact of exercise on repellent performance against mosquitoes. Two products containing the active ingredient N,N-diethyl-3-methylbenzamide (deet) were tested; one product was a polymer-based cream (3M Ultrathon Insect Repellent) and the other product was an alcohol-based pump spray formulation (Muskol Insect Repellent). Assessments were done in the laboratory using Aedes aegypti (L.) and in the field with naturally occurring populations of mosquitoes. Repellent was applied to the forearms (laboratory) or a lower leg (field) of test subjects at 1.5 g of test product per 600 cm2 surface area (0.75 or 0.83 mg deet/cm2). For a given test day, subjects exercised or did not. Exposure to mosquito attack was for 1 min at 30-min intervals in laboratory procedures, and it was continuous in field tests. Performance was measured as complete protection time (CPT). Moderate levels of physical activity resulted in a >40% decline in mean CPT, from 468 to 267 min in the laboratory experiments and from 359 to 203 min in field tests. Repellent product did not affect the magnitude of the decline. Mean biting pressure during field trials was 21.3 bites per min, and mosquito collections were made up primarily of Ochlerotatus sticticus (Meigen) and Aedes vexans (Meigen).

  1. Contrasting effects of chloride on growth, reproduction, and toxicant sensitivity in two genetically distinct strains of Hyalella azteca.

    PubMed

    Soucek, David J; Mount, David R; Dickinson, Amy; Hockett, J Russell; McEwen, Abigail R

    2015-10-01

    The strain of Hyalella azteca (Saussure: Amphipoda) commonly used for aquatic toxicity testing in the United States has been shown to perform poorly in some standardized reconstituted waters frequently used for other test species. In 10-d and 42-d experiments, the growth and reproduction of the US laboratory strain of H. azteca was shown to vary strongly with chloride concentration in the test water, with declining performance observed below 15 mg/L to 20 mg/L. In contrast to the chloride-dependent performance of the US laboratory strain of H. azteca, growth of a genetically distinct strain of H. azteca obtained from an Environment Canada laboratory in Burlington, Ontario, Canada, was not influenced by chloride concentration. In acute toxicity tests with the US laboratory strain of H. azteca, the acute toxicity of sodium nitrate increased with decreasing chloride in a pattern similar not only to that observed for control growth, but also to previous acute toxicity testing with sodium sulfate. Subsequent testing with the Burlington strain showed no significant relationship between chloride concentration and the acute toxicity of sodium nitrate or sodium sulfate. These findings suggest that the chloride-dependent toxicity shown for the US laboratory strain may be an unusual feature of that strain and perhaps not broadly representative of aquatic organisms as a whole. © 2015 SETAC.

  2. Parabolic trough receiver heat loss and optical efficiency round robin 2015/2016

    NASA Astrophysics Data System (ADS)

    Pernpeintner, Johannes; Schiricke, Björn; Sallaberry, Fabienne; de Jalón, Alberto García; López-Martín, Rafael; Valenzuela, Loreto; de Luca, Antonio; Georg, Andreas

    2017-06-01

    A round robin for parabolic trough receiver heat loss and optical efficiency in the laboratory was performed between five institutions using five receivers in 2015/2016. Heat loss testing was performed at three cartridge heater test benches and one Joule heating test bench in the temperature range between 100 °C and 550 °C. Optical efficiency testing was performed with two spectrometric test bench and one calorimetric test bench. Heat loss testing results showed standard deviations at the order of 6% to 12 % for most temperatures and receivers and a standard deviation of 17 % for one receiver at 100 °C. Optical efficiency is presented normalized for laboratories showing standard deviations of 0.3 % to 1.3 % depending on the receiver.

  3. Analytic Validation of Immunohistochemistry Assays: New Benchmark Data From a Survey of 1085 Laboratories.

    PubMed

    Stuart, Lauren N; Volmar, Keith E; Nowak, Jan A; Fatheree, Lisa A; Souers, Rhona J; Fitzgibbons, Patrick L; Goldsmith, Jeffrey D; Astles, J Rex; Nakhleh, Raouf E

    2017-09-01

    - A cooperative agreement between the College of American Pathologists (CAP) and the United States Centers for Disease Control and Prevention was undertaken to measure laboratories' awareness and implementation of an evidence-based laboratory practice guideline (LPG) on immunohistochemical (IHC) validation practices published in 2014. - To establish new benchmark data on IHC laboratory practices. - A 2015 survey on IHC assay validation practices was sent to laboratories subscribed to specific CAP proficiency testing programs and to additional nonsubscribing laboratories that perform IHC testing. Specific questions were designed to capture laboratory practices not addressed in a 2010 survey. - The analysis was based on responses from 1085 laboratories that perform IHC staining. Ninety-six percent (809 of 844) always documented validation of IHC assays. Sixty percent (648 of 1078) had separate procedures for predictive and nonpredictive markers, 42.7% (220 of 515) had procedures for laboratory-developed tests, 50% (349 of 697) had procedures for testing cytologic specimens, and 46.2% (363 of 785) had procedures for testing decalcified specimens. Minimum case numbers were specified by 85.9% (720 of 838) of laboratories for nonpredictive markers and 76% (584 of 768) for predictive markers. Median concordance requirements were 95% for both types. For initial validation, 75.4% (538 of 714) of laboratories adopted the 20-case minimum for nonpredictive markers and 45.9% (266 of 579) adopted the 40-case minimum for predictive markers as outlined in the 2014 LPG. The most common method for validation was correlation with morphology and expected results. Laboratories also reported which assay changes necessitated revalidation and their minimum case requirements. - Benchmark data on current IHC validation practices and procedures may help laboratories understand the issues and influence further refinement of LPG recommendations.

  4. Validation of a Rapid Rabies Diagnostic Tool for Field Surveillance in Developing Countries

    PubMed Central

    Léchenne, Monique; Naïssengar, Kemdongarti; Lepelletier, Anthony; Alfaroukh, Idriss Oumar; Bourhy, Hervé; Zinsstag, Jakob; Dacheux, Laurent

    2016-01-01

    Background One root cause of the neglect of rabies is the lack of adequate diagnostic tests in the context of low income countries. A rapid, performance friendly and low cost method to detect rabies virus (RABV) in brain samples will contribute positively to surveillance and consequently to accurate data reporting, which is presently missing in the majority of rabies endemic countries. Methodology/Principal findings We evaluated a rapid immunodiagnostic test (RIDT) in comparison with the standard fluorescent antibody test (FAT) and confirmed the detection of the viral RNA by real time reverse transcription polymerase chain reaction (RT-qPCR). Our analysis is a multicentre approach to validate the performance of the RIDT in both a field laboratory (N’Djamena, Chad) and an international reference laboratory (Institut Pasteur, Paris, France). In the field laboratory, 48 samples from dogs were tested and in the reference laboratory setting, a total of 73 samples was tested, representing a wide diversity of RABV in terms of animal species tested (13 different species), geographical origin of isolates with special emphasis on Africa, and different phylogenetic clades. Under reference laboratory conditions, specificity was 93.3% and sensitivity was 95.3% compared to the gold standard FAT test. Under field laboratory conditions, the RIDT yielded a higher reliability than the FAT test particularly on fresh and decomposed samples. Viral RNA was later extracted directly from the test filter paper and further used successfully for sequencing and genotyping. Conclusion/Significance The RIDT shows excellent performance qualities both in regard to user friendliness and reliability of the result. In addition, the test cassettes can be used as a vehicle to ship viral RNA to reference laboratories for further laboratory confirmation of the diagnosis and for epidemiological investigations using nucleotide sequencing. The potential for satisfactory use in remote locations is therefore very high to improve the global knowledge of rabies epidemiology. However, we suggest some changes to the protocol, as well as careful further validation, before promotion and wider use. PMID:27706156

  5. Prediction of practical performance in preclinical laboratory courses - the return of wire bending for admission of dental students in Hamburg.

    PubMed

    Kothe, Christian; Hissbach, Johanna; Hampe, Wolfgang

    2014-01-01

    Although some recent studies concluded that dexterity is not a reliable predictor of performance in preclinical laboratory courses in dentistry, they could not disprove earlier findings which confirmed the worth of manual dexterity tests in dental admission. We developed a wire bending test (HAM-Man) which was administered during dental freshmen's first week in 2008, 2009, and 2010. The purpose of our study was to evaluate if the HAM-Man is a useful selection criterion additional to the high school grade point average (GPA) in dental admission. Regression analysis revealed that GPA only accounted for a maximum of 9% of students' performance in preclinical laboratory courses, in six out of eight models the explained variance was below 2%. The HAM-Man incrementally explained up to 20.5% of preclinical practical performance over GPA. In line with findings from earlier studies the HAM-Man test of manual dexterity showed satisfactory incremental validity. While GPA has a focus on cognitive abilities, the HAM-Man reflects learning of unfamiliar psychomotor skills, spatial relationships, and dental techniques needed in preclinical laboratory courses. The wire bending test HAM-Man is a valuable additional selection instrument for applicants of dental schools.

  6. Misleading biochemical laboratory test results

    PubMed Central

    Nanji, Amin A.

    1984-01-01

    This article reviews the general and specific factors that interfere with the performance of common biochemical laboratory tests and the interpretation of their results. The clinical status of the patient, drug interactions, and in-vivo and in-vitro biochemical interactions and changes may alter the results obtained from biochemical analysis of blood constituents. Failure to recognize invalid laboratory test results may lead to injudicious and dangerous management of patients. PMID:6375845

  7. Flight Testing the Landing Radar for Mars Science Laboratory

    NASA Image and Video Library

    2011-06-21

    A NASA Dryden Flight Research Center F/A-18 852 aircraft performs a roll during June 2011 flight tests of a Mars landing radar. A test model of the landing radar for NASA Mars Science Laboratory mission is inside a pod under the aircraft left wing.

  8. Test set readings predict clinical performance to a limited extent: preliminary findings

    NASA Astrophysics Data System (ADS)

    Soh, BaoLin P.; Lee, Warwick M.; Kench, Peter L.; Reed, Warren M.; McEntee, Mark F.; Brennan, Patrick C.

    2013-03-01

    Aim: To investigate the level of agreement between test sets and actual clinical reading Background: The performance of screen readers in detecting breast cancer is being assessed in some countries by using mammographic test sets. However, previous studies have provided little evidence that performance assessed by test sets strongly correlate to performance in clinical reading. Methods: Five clinicians from BreastScreen New South Wales participated in this study. Each clinician was asked to read 200 de-identified mammographic examinations gathered from their own case history within the BreastScreen NSW Digital Imaging Library. All test sets were designed with specific proportions of true positive, true negative, false positive and false negative examinations from the previous actual clinical reads of each reader. A prior mammogram examination for comparison (when available) was also provided for each case. Results: Preliminary analyses have shown that there is a moderate level of agreement (Kappa 0.42-0.56, p < 0.001) between laboratory test sets and actual clinical reading. In addition, a mean increase of 38% in sensitivity in the laboratory test sets as compared to their actual clinical readings was demonstrated. Specificity is similar between the laboratory test sets and actual clinical reading. Conclusion: This study demonstrated a moderate level of agreement between actual clinical reading and test set reading, which suggests that test sets have a role in reflecting clinical performance.

  9. Implementation of a new 'community' laboratory CD4 service in a rural health district in South Africa extends laboratory services and substantially improves local reporting turnaround time.

    PubMed

    Coetzee, L M; Cassim, N; Glencross, D K

    2015-12-16

    The CD4 integrated service delivery model (ITSDM) provides for reasonable access to pathology services across South Africa (SA) by offering three new service tiers that extend services into remote, under-serviced areas. ITSDM identified Pixley ka Seme as such an under-serviced district. To address the poor service delivery in this area, a new ITSDM community (tier 3) laboratory was established in De Aar, SA. Laboratory performance and turnaround time (TAT) were monitored post implementation to assess the impact on local service delivery. Using the National Health Laboratory Service Corporate Data Warehouse, CD4 data were extracted for the period April 2012-July 2013 (n=11,964). Total mean TAT (in hours) was calculated and pre-analytical and analytical components assessed. Ongoing testing volumes, as well as external quality assessment performance across ten trials, were used to indicate post-implementation success. Data were analysed using Stata 12. Prior to the implementation of CD4 testing at De Aar, the total mean TAT was 20.5 hours. This fell to 8.2 hours post implementation, predominantly as a result of a lower pre-analytical mean TAT reducing from a mean of 18.9 to 1.8 hours. The analytical testing TAT remained unchanged after implementation and monthly test volumes increased by up to 20%. External quality assessment indicated adequate performance. Although subjective, questionnaires sent to facilities reported improved service delivery. Establishing CD4 testing in a remote community laboratory substantially reduces overall TAT. Additional community CD4 laboratories should be established in under-serviced areas, especially where laboratory infrastructure is already in place.

  10. The recording of student performance in the microbiology laboratory as a training, tutorial, and motivational tool.

    PubMed

    Lipson, Steven M; Gair, Marina

    2011-01-01

    The laboratory component of a microbiology course consists of exercises which mandate a level of proficiency and manual dexterity equal to and often beyond that recognized among other biology courses. Bacterial growth, maintenance, identification (e.g., Gram stain, biochemical tests, genomics), as well as the continuous need to maintain laboratory safety and sterile technique, are only a few skills/responsibilities critical to the discipline of microbiology. Performance of the Gram stain remains one of the most basic and pivotal skills that must be mastered in the microbiology laboratory. However, a number of students continually have difficulty executing the Gram stain and preparative procedures associated with the test. In order to address this issue, we incorporated real-time digital recording as a supplemental teaching aid in the microbiology laboratory. Our use of the digital movie camera in the teaching setting served to enhance interest, motivate students, and in general, improve student performance.

  11. Laboratory testing of gross solids removal devices.

    DOT National Transportation Integrated Search

    2005-05-01

    This report details the outcome of tests carried out at the Hydraulics Laboratory : of the University of California, Davis to assess the performance of three : alternative Gross Solids Removal Devices (GSRDs) developed by Caltrans to : remove litter ...

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

    PubMed

    Ishibashi, Midori

    2015-01-01

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

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

    Chiaro, PJ

    The Environmental Effects Laboratory of the Engineering Science and Technology Division of Oak Ridge National Laboratory performed a series of tests to further evaluate and characterize the radiological response of a ''Cricket'' radiation detection system. The Cricket, manufactured by Rad/Comm Systems Corporation of Ontario, Canada, is designed to detect radioactive material that may be contained in scrap metal. The Cricket's detection unit is designed to be mounted to the base of a grappler, allowing it to monitor material while the material is being held by the grappler tines. The Cricket was tested for background stability, energy response, spherical response, surfacemore » uniformity, angular dependence, and alarm actuation. Some of these tests were repeated from a prior test of a Cricket at the Environmental Effects Laboratory as reported in ORNL/TM-2002/94. Routine environmental tests--normal temperature and relatively humidity--were also performed as part of this testing process. Overall, the Cricket performed well during the testing process. The design of the instrument and the inherent photon energy of the radionuclides had some affect on portions of the tests but do not detract from the value-added benefits of the Cricket's detection capabilities.« less

  14. A microcomputer-based testing station for dynamic and static testing of protective relay systems

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

    Lee, W.J.; Li, R.J.; Gu, J.C.

    1995-12-31

    Dynamic and static relay performance testing before installation in the field is a subject of great interest to utility relay engineers. The common practice in utility testing of new relays is to put the new unit to be tested in parallel with an existing functioning relay in the system, wait until an actual transient occurs and then observe and analyze the performance of new relay. It is impossible to have a thorough test of the protective relay system through this procedure. An equipment, Microcomputer-Based Testing Station (or PC-Based Testing Station), that can perform both static and dynamic testing of themore » relay is described in this paper. The Power System Simulation Laboratory at the University of Texas at Arlington is a scaled-down, three-phase, physical power system which correlates well with the important components for a real power system and is an ideal facility for the dynamic and static testing of protective relay systems. A brief introduction to the configuration of this laboratory is presented. Test results of several protective functions by using this laboratory illustrate the usefulness of this test set-up.« less

  15. The changing face of clinical laboratories.

    PubMed

    Plebani, M

    1999-07-01

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

  16. 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.

  17. Comparison of Refractory Performance in Black Liquor Gasifiers and a Smelt Test System

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

    Peascoe, RA

    2001-09-25

    Prior laboratory corrosion studies along with experience at the black liquor gasifier in New Bern, North Carolina, clearly demonstrate that serious material problems exist with the gasifier's refractory lining. Mullite-based and alumina-based refractories used at the New Bern facility suffered significant degradation even though they reportedly performed adequately in smaller scale systems. Oak Ridge National Laboratory's involvement in the failure analysis, and the initial exploration of suitable replacement materials, led to the realization that a simple and reliable, complementary method for refractory screening was needed. The development of a laboratory test system and its suitability for simulating the environment ofmore » black liquor gasifiers was undertaken. Identification and characterization of corrosion products were used to evaluate the test system as a rapid screening tool for refractory performance and as a predictor of refractory lifetime. Results from the test systems and pl ants were qualitatively similar.« less

  18. 42 CFR 493.1423 - Standard; Testing personnel qualifications.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 5 2013-10-01 2013-10-01 false Standard; Testing personnel qualifications. 493... Testing Laboratories Performing Moderate Complexity Testing § 493.1423 Standard; Testing personnel qualifications. Each individual performing moderate complexity testing must— (a) Possess a current license issued...

  19. 42 CFR 493.1423 - Standard; Testing personnel qualifications.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 5 2011-10-01 2011-10-01 false Standard; Testing personnel qualifications. 493... Testing Laboratories Performing Moderate Complexity Testing § 493.1423 Standard; Testing personnel qualifications. Each individual performing moderate complexity testing must— (a) Possess a current license issued...

  20. 42 CFR 493.1423 - Standard; Testing personnel qualifications.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 5 2014-10-01 2014-10-01 false Standard; Testing personnel qualifications. 493... Testing Laboratories Performing Moderate Complexity Testing § 493.1423 Standard; Testing personnel qualifications. Each individual performing moderate complexity testing must— (a) Possess a current license issued...

  1. 42 CFR 493.1423 - Standard; Testing personnel qualifications.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 5 2012-10-01 2012-10-01 false Standard; Testing personnel qualifications. 493... Testing Laboratories Performing Moderate Complexity Testing § 493.1423 Standard; Testing personnel qualifications. Each individual performing moderate complexity testing must— (a) Possess a current license issued...

  2. 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…

  3. 42 CFR 493.55 - Application for registration certificate and certificate of accreditation.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... government laboratories that engage in limited (not more than a combination of 15 moderately complex or... performed by the laboratory including— (i) The name and total number of tests and examinations performed...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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

  10. Facility and Laboratory Equipment | Energy Systems Integration Facility |

    Science.gov Websites

    Energy Systems Integration Facility is its infrastructure. In addition to extensive fixed laboratory . Photo of researchers testing building loads and power networks in the Systems Performance Laboratory

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

    USDA-ARS?s Scientific Manuscript database

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

  12. 10 CFR 430.25 - Laboratory Accreditation Program.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Procedures § 430.25 Laboratory Accreditation Program. Testing for fluorescent lamp ballasts performed in accordance with appendix Q1 to this subpart shall comply with this § 430.25. The testing for general service... accordance with Appendix R to this subpart. The testing for medium base compact fluorescent lamps shall be...

  13. 10 CFR 430.25 - Laboratory Accreditation Program.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Procedures § 430.25 Laboratory Accreditation Program. Testing for fluorescent lamp ballasts performed in accordance with appendix Q1 to this subpart shall comply with this § 430.25. The testing for general service... accordance with Appendix R to this subpart. The testing for medium base compact fluorescent lamps shall be...

  14. Key results of battery performance and life tests 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.

    1991-12-01

    Advanced battery technology evaluations are performed under simulated electric vehicle operating conditions at Argonne National Laboratory's & Diagnostic Laboratory (ADL). The ADL provide a common basis for both performance characterization and life evaluation with unbiased application of tests and analyses. This paper summarizes the performance characterizations and life evaluations conducted in 1991 on twelve single cells and eight 3- to 360-cell modules that encompass six battery technologies (Na/S, Li/MS, Ni/MH, Zn/Br, Ni/Fe, and Pb-Acid). These evaluations were performed for the Department of Energy, Office of Transportation Technologies, Electric and Hybrid Propulsion Division. The results measure progress in battery R & D programs, compare battery technologies, and provide basic data for modeling and continuing R & D to battery users, developers, and program managers.

  15. 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.

  16. 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

  17. Development of a Fan-Filter Unit Test Standard, LaboratoryValidations, and its Applications across Industries

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

    Xu, Tengfang

    2006-10-20

    Lawrence Berkeley National Laboratory (LBNL) is now finalizing the Phase 2 Research and Demonstration Project on characterizing 2-foot x 4-foot (61-cm x 122-cm) fan-filter units in the market using the first-ever standard laboratory test method developed at LBNL.[1][2][3] Fan-filter units deliver re-circulated air and provide particle filtration control for clean environments. Much of the energy in cleanrooms (and minienvironments) is consumed by 2-foot x 4-foot (61-cm x 122-cm) or 4-foot x 4-foot (122-cm x 122-cm) fan-filter units that are typically located in the ceiling (25-100% coverage) of cleanroom controlled environments. Thanks to funding support by the California Energy Commission's Industrialmore » Program of the Public Interest Energy Research (PIER) Program, and significant participation from manufacturers and users of fan-filter units from around the world, LBNL has developed and performed a series of standard laboratory tests and reporting on a variety of 2-foot x 4-foot (61-cm x 122-cm) fan-filter units (FFUs). Standard laboratory testing reports have been completed and reported back to anonymous individual participants in this project. To date, such reports on standard testing of FFU performance have provided rigorous and useful data for suppliers and end users to better understand, and more importantly, to quantitatively characterize performance of FFU products under a variety of operating conditions.[1] In the course of the project, the standard laboratory method previously developed at LBNL has been under continuous evaluation and update.[2][3] Based upon the updated standard, it becomes feasible for users and suppliers to characterize and evaluate energy performance of FFUs in a consistent way.« less

  18. OB's high voltage laboratory

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

    Not Available

    1966-01-01

    The January issue of Hi-Tension News provides a detailed description of the advanced surge test facilities and procedures in daily operation at the OB High Voltage Laboratory in Barberton, Ohio. Technical competences achieved in this laboratory contribute to the essential factors of design confirmation to basic studies of ehv insulation systems, conductor and hardware performance, and optimum tower construction. Known throughout the industry for authenticity of its full scale, all weather outdoor testing, OB's High Voltage Laboratory is a full-fledged participant in the NEMA-sponsored program to make testing facilities available on a cooperative basis.

  19. Non-destructive testing of concrete.

    DOT National Transportation Integrated Search

    1979-11-01

    This research project was initiated to evaluate the performance of an ultrasonic testing device device in predicting compressive strengths from tests performed on samples of fresh concrete. : The initial phase of this study involved laboratory perora...

  20. Immunohistochemistry practices of cytopathology laboratories: a survey of participants in the College of American Pathologists Nongynecologic Cytopathology Education Program.

    PubMed

    Fischer, Andrew H; Schwartz, Mary R; Moriarty, Ann T; Wilbur, David C; Souers, Rhona; Fatheree, Lisa; Booth, Christine N; Clayton, Amy C; Kurtyz, Daniel F I; Padmanabhan, Vijayalakshmi; Crothers, Barbara A

    2014-09-01

    Immunohistochemistry (IHC) is important for cytology but poses special challenges because preanalytic conditions may differ from the conditions of IHC-positive controls. To broadly survey cytology laboratories to quantify preanalytic platforms for cytology IHC and identify problems with particular platforms or antigens. To discover how validation guidelines for HER2 testing have affected cytology. A voluntary survey of cytology IHC practices was sent to 1899 cytology laboratories participating in the College of American Pathologists Nongynecologic Cytopathology Education Program in the fall of 2009. A total of 818 laboratories (43%) responded to the survey by April 2010. Three hundred fourty-five of 791 respondents (44%) performed IHC on cytology specimens. Seventeen different fixation and processing platforms prior to antibody reaction were reported. A total of 59.2% of laboratories reported differences between the platforms for cytology specimens and positive controls, but most (155 of 184; 84%) did not alter antibody dilutions or antigen retrieval for cytology IHC. When asked to name 2 antibodies for which staining conditions differed between cytology and surgical samples, there were 18 responses listing 14 antibodies. A total of 30.6% of laboratories performing IHC offered HER2 testing before publication of the 2007 College of American Pathologists/American Society of Clinical Oncologists guidelines, compared with 33.6% afterward, with increased performance of testing by reference laboratories. Three laboratories validated a nonformalin HER2 platform. The platforms for cytology IHC and positive controls differ for most laboratories, yet conditions are uncommonly adjusted for cytology specimens. Except for the unsuitability of air-dried smears for HER2 testing, the survey did not reveal evidence of systematic problems with any antibody or platform.

  1. 42 CFR 493.1253 - Standard: Establishment and verification of performance specifications.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... establish performance specifications for any test system used by the laboratory before April 24, 2003. (b)(1... approved test system must do the following before reporting patient test results: (i) Demonstrate that it... following performance characteristics: (A) Accuracy. (B) Precision. (C) Reportable range of test results for...

  2. 42 CFR 493.1253 - Standard: Establishment and verification of performance specifications.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... establish performance specifications for any test system used by the laboratory before April 24, 2003. (b)(1... approved test system must do the following before reporting patient test results: (i) Demonstrate that it... following performance characteristics: (A) Accuracy. (B) Precision. (C) Reportable range of test results for...

  3. 42 CFR 493.1253 - Standard: Establishment and verification of performance specifications.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... establish performance specifications for any test system used by the laboratory before April 24, 2003. (b)(1... approved test system must do the following before reporting patient test results: (i) Demonstrate that it... following performance characteristics: (A) Accuracy. (B) Precision. (C) Reportable range of test results for...

  4. 42 CFR 493.1253 - Standard: Establishment and verification of performance specifications.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... establish performance specifications for any test system used by the laboratory before April 24, 2003. (b)(1... approved test system must do the following before reporting patient test results: (i) Demonstrate that it... following performance characteristics: (A) Accuracy. (B) Precision. (C) Reportable range of test results for...

  5. Durability of hardboard siding

    Treesearch

    Anton TenWolde; Charles Carll

    2004-01-01

    In response to concerns about hardboard siding failures, a study was performed to assess if performance in a current hardboard industry quality assurance test procedure correlated with in-service performance and how well this performance might be predicted by use of alternative or additional test procedures. A variety of laboratory tests were performed on a large...

  6. 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

  7. 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.

  8. 42 CFR 493.15 - Laboratories performing waived tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...) Pose no reasonable risk of harm to the patient if the test is performed incorrectly. (c) Certificate of... by single analyte instruments with self-contained or component features to perform specimen/reagent...

  9. 42 CFR 493.15 - Laboratories performing waived tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) Pose no reasonable risk of harm to the patient if the test is performed incorrectly. (c) Certificate of... by single analyte instruments with self-contained or component features to perform specimen/reagent...

  10. 42 CFR 493.15 - Laboratories performing waived tests.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...) Pose no reasonable risk of harm to the patient if the test is performed incorrectly. (c) Certificate of... by single analyte instruments with self-contained or component features to perform specimen/reagent...

  11. PDC-bit performance under simulated borehole conditions

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

    Anderson, E.E.; Azar, J.J.

    1993-09-01

    Laboratory drilling tests were used to investigate the effects of pressure on polycrystalline-diamond-compact (PDC) drill-bit performance. Catoosa shale core samples were drilled with PDC and roller-cone bits at up to 1,750-psi confining pressure. All tests were conducted in a controlled environment with a full-scale laboratory drilling system. Test results indicate, that under similar operating conditions, increases in confining pressure reduce PDC-bit performance as much as or more than conventional-rock-bit performance. Specific energy calculations indicate that a combination of rock strength, chip hold-down, and bit balling may have reduced performance. Quantifying the degree to which pressure reduces PDC-bit performance will helpmore » researchers interpret test results and improve bit designs and will help drilling engineers run PDC bits more effectively in the field.« less

  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. 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.

  14. Lack of grading agreement among international hemostasis external quality assessment programs

    PubMed Central

    Olson, John D.; Jennings, Ian; Meijer, Piet; Bon, Chantal; Bonar, Roslyn; Favaloro, Emmanuel J.; Higgins, Russell A.; Keeney, Michael; Mammen, Joy; Marlar, Richard A.; Meley, Roland; Nair, Sukesh C.; Nichols, William L.; Raby, Anne; Reverter, Joan C.; Srivastava, Alok; Walker, Isobel

    2018-01-01

    Laboratory quality programs rely on internal quality control and external quality assessment (EQA). EQA programs provide unknown specimens for the laboratory to test. The laboratory's result is compared with other (peer) laboratories performing the same test. EQA programs assign target values using a variety of methods statistical tools and performance assessment of ‘pass’ or ‘fail’ is made. EQA provider members of the international organization, external quality assurance in thrombosis and hemostasis, took part in a study to compare outcome of performance analysis using the same data set of laboratory results. Eleven EQA organizations using eight different analytical approaches participated. Data for a normal and prolonged activated partial thromboplastin time (aPTT) and a normal and reduced factor VIII (FVIII) from 218 laboratories were sent to the EQA providers who analyzed the data set using their method of evaluation for aPTT and FVIII, determining the performance for each laboratory record in the data set. Providers also summarized their statistical approach to assignment of target values and laboratory performance. Each laboratory record in the data set was graded pass/fail by all EQA providers for each of the four analytes. There was a lack of agreement of pass/fail grading among EQA programs. Discordance in the grading was 17.9 and 11% of normal and prolonged aPTT results, respectively, and 20.2 and 17.4% of normal and reduced FVIII results, respectively. All EQA programs in this study employed statistical methods compliant with the International Standardization Organization (ISO), ISO 13528, yet the evaluation of laboratory results for all four analytes showed remarkable grading discordance. PMID:29232255

  15. Laboratory based instruction in Pakistan: Comparative evaluation of three laboratory instruction methods in biological science at higher secondary school level

    NASA Astrophysics Data System (ADS)

    Cheema, Tabinda Shahid

    This study of laboratory based instruction at higher secondary school level was an attempt to gain some insight into the effectiveness of three laboratory instruction methods: cooperative group instruction method, individualised instruction method and lecture demonstration method on biology achievement and retention. A Randomised subjects, Pre-test Post-test Comparative Methods Design was applied. Three groups of students from a year 11 class in Pakistan conducted experiments using the different laboratory instruction methods. Pre-tests, achievement tests after the experiments and retention tests one month later were administered. Results showed no significant difference between the groups on total achievement and retention, nor was there any significant difference on knowledge and comprehension test scores or skills performance. Future research investigating a similar problem is suggested.

  16. 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.

  17. 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.

  18. 42 CFR 493.1271 - Standard: Immunohematology.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... further testing in the event of transfusion reactions. The laboratory must promptly dispose of blood not... reactions. (1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in...

  19. 32 CFR 555.6 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... OF ENGINEERS, RESEARCH AND DEVELOPMENT, LABORATORY RESEARCH AND DEVELOPMENT AND TESTS, WORK FOR OTHERS § 555.6 Authority. The following delegations of authority to perform research and development and tests apply. (a) Major Corps of Engineers Research and Development Laboratories. The major Corps of...

  20. PIE on Safety-Tested Loose Particles from Irradiated Compact 4-4-2

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

    Hunn, John D.; Gerczak, Tyler J.; Morris, Robert Noel

    2016-04-01

    Post-irradiation examination (PIE) is being performed in support of tristructural isotropic (TRISO) coated particle fuel development and qualification for High Temperature Gas-cooled Reactors (HTGRs). This work is sponsored by the Department of Energy Office of Nuclear Energy (DOE-NE) through the Advanced Reactor Technologies (ART) Office under the Advanced Gas Reactor Fuel Development and Qualification (AGR) Program. The AGR-1 experiment was the first in a series of TRISO fuel irradiation tests initiated in 2006. The AGR-1 TRISO particles and fuel compacts were fabricated at Oak Ridge National Laboratory (ORNL) in 2006 using laboratory-scale equipment and irradiated for 3 years in themore » Advanced Test Reactor (ATR) at Idaho National Laboratory (INL) to demonstrate and evaluate fuel performance under HTGR irradiation conditions. Post-irradiation examination was performed at INL and ORNL to study how the fuel behaved during irradiation, and to test fuel performance during exposure to elevated temperatures at or above temperatures that could occur during a depressurized conduction cooldown event. This report summarizes safety testing and post-safety testing PIE conducted at ORNL on loose particles extracted from irradiated AGR-1 Compact 4-4-2.« less

  1. Performance specifications for the extra-analytical phases of laboratory testing: Why and how.

    PubMed

    Plebani, Mario

    2017-07-01

    An important priority in the current healthcare scenario should be to address errors in laboratory testing, which account for a significant proportion of diagnostic errors. Efforts made in laboratory medicine to enhance the diagnostic process have been directed toward improving technology, greater volumes and more accurate laboratory tests being achieved, but data collected in the last few years highlight the need to re-evaluate the total testing process (TTP) as the unique framework for improving quality and patient safety. Valuable quality indicators (QIs) and extra-analytical performance specifications are required for guidance in improving all TTP steps. Yet in literature no data are available on extra-analytical performance specifications based on outcomes, and nor is it possible to set any specification using calculations involving biological variability. The collection of data representing the state-of-the-art based on quality indicators is, therefore, underway. The adoption of a harmonized set of QIs, a common data collection and standardised reporting method is mandatory as it will not only allow the accreditation of clinical laboratories according to the International Standard, but also assure guidance for promoting improvement processes and guaranteeing quality care to patients. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  2. A Reference Method for Measuring Emissions of SVOCs in ...

    EPA Pesticide Factsheets

    Semivolatile organic compounds (SVOCs) are indoor air pollutants that may may have significant adverse effects on human health, and emission of SVOCs from building materials and consumer products is of growing concern. Few chamber studies have been conducted due to the challenges associated with SVOC analysis and the lack of validation procedures. Thus there is an urgent need for a reliable and accurate chamber test method to verify the performance of these measurements. A reference method employing a specially-designed chamber and experimental protocol has been developed and is undergoing extensive evaluation. A pilot interlaboratory study (ILS) has been conducted with five laboratories performing chamber tests under identical conditions. Results showed inter-laboratory variations at 25% for SVOC emission rates, with greater agreement observed between intra-laboratory measurements for most of the participating laboratories. The measured concentration profiles also compared reasonably well to the mechanistic model, demonstrating the feasibility of the proposed reference method to independently assess laboratory performance and validate SVOC emission tests. There is an urgent need for improved understanding of the measurement uncertainties associated with SVOC emissions testing. The creation of specially-designed chambers and well-characterized materials serves as a critical prerequisite for improving the procedure used to measure SVOCs emitted from indoor

  3. Quarterly Research Performance Progress Report (2015 Q3). Ultrasonic Phased Arrays and Interactive Reflectivity Tomography for Nondestructive Inspection of Injection and Production Wells in Geothermal Energy Systems

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

    Santos-Villalobos, Hector J; Polsky, Yarom; Kisner, Roger A

    2015-09-01

    For the past quarter, we have placed our effort in implementing the first version of the ModelBased Iterative Reconstruction (MBIR) algorithm, assembling and testing the electronics, designing transducers mounts, and defining our laboratory test samples. We have successfully developed the first implementation of MBIR for ultrasound imaging. The current algorithm was tested with synthetic data and we are currently making new modifications for the reconstruction of real ultrasound data. Beside assembling and testing the electronics, we developed a LabView graphic user interface (GUI) to fully control the ultrasonic phased array, adjust the time-delays of the transducers, and store the measuredmore » reflections. As part of preparing for a laboratory-scale demonstration, the design and fabrication of the laboratory samples has begun. Three cement blocks with embedded objects will be fabricated, characterized, and used to demonstrate the capabilities of the system. During the next quarter, we will continue to improve the current MBIR forward model and integrate the reconstruction code with the LabView GUI. In addition, we will define focal laws for the ultrasonic phased array and perform the laboratory demonstration. We expect to perform laboratory demonstration by the end of October 2015.« less

  4. 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.

  5. 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.

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

    PubMed

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

    2016-03-01

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

  7. 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.

  8. 21 CFR 58.213 - Public disclosure of information regarding disqualification.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... SERVICES GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Disqualification of Testing... such disclosure would further the public interest or would promote compliance with the good laboratory... Food and Drug Administration that nonclinical laboratory studies performed by the facility will not be...

  9. The Italian pilot external quality assessment program for cystic fibrosis sweat test.

    PubMed

    Salvatore, Marco; Floridia, Giovanna; Amato, Annalisa; Censi, Federica; Carta, Claudio; de Stefano, Maria Chiara; Ferrari, Gianluca; Tosto, Fabrizio; Capoluongo, Ettore; Caruso, Ubaldo; Castaldo, Giuseppe; Cirilli, Natalia; Corbetta, Carlo; Padoan, Rita; Raia, Valeria; Taruscio, Domenica

    2016-05-01

    Sweat chloride test is the gold standard test for cystic fibrosis (CF) diagnosis. In 2014 the Istituto Superiore di Sanità established the Italian pilot external quality assessment program for CF sweat test (IEQA-ST). Ten laboratories, included among the 33 Italian CF Referral Centers, were selected and enrolled on the basis of their attitude to perform sweat test (ST) analysis by using methods recommended by the Italian Guidelines. They received three different sweat-like samples (normal, borderline and pathologic chloride concentration), with mock clinical indications, for analysis according to routine procedures. Assessment, performed by a panel of experts, covered analytical performance, interpretation and reporting of results; categories of "poor" and "satisfactory" performance were not defined. All data were managed through a web utility. The program identified important areas of interest and, in some case, of concern. It is important to underline that results are referred to a small proportion, i.e. about 30%, of Italian laboratories performing CF ST in the context of the Referral Centers. Data collected highlight the importance of participation in EQA programs as it may improve laboratory/clinical performance; our study represents a model for the setting up of a large-scale EQA scheme for ST. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  10. Reproducibility of risk figures in 2nd-trimester maternal serum screening for down syndrome: comparison of 2 laboratories.

    PubMed

    Benn, Peter A; Makowski, Gregory S; Egan, James F X; Wright, Dave

    2006-11-01

    Analytical error affects 2nd-trimester maternal serum screening for Down syndrome risk estimation. We analyzed the between-laboratory reproducibility of risk estimates from 2 laboratories. Laboratory 1 used Bayer ACS180 immunoassays for alpha-fetoprotein (AFP) and human chorionic gonadotropin (hCG), Diagnostic Systems Laboratories (DSL) RIA for unconjugated estriol (uE3), and DSL enzyme immunoassay for inhibin-A (INH-A). Laboratory 2 used Beckman immunoassays for AFP, hCG, and uE3, and DSL enzyme immunoassay for INH-A. Analyte medians were separately established for each laboratory. We used the same computational algorithm for all risk calculations, and we used Monte Carlo methods for computer modeling. For 462 samples tested, risk figures from the 2 laboratories differed >2-fold for 44.7%, >5-fold for 7.1%, and >10-fold for 1.7%. Between-laboratory differences in analytes were greatest for uE3 and INH-A. The screen-positive rates were 9.3% for laboratory 1 and 11.5% for laboratory 2, with a significant difference in the patients identified as screen-positive vs screen-negative (McNemar test, P<0.001). Computer modeling confirmed the large between-laboratory risk differences. Differences in performance of assays and laboratory procedures can have a large effect on patient-specific risks. Screening laboratories should minimize test imprecision and ensure that each assay performs in a manner similar to that assumed in the risk computational algorithm.

  11. 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.

  12. 7 CFR 91.5 - Where services are offered.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...) Science and Technology Programs National Science Laboratory. A variety of proximate, chemical, microbiological and biomolecular tests and laboratory analyses performed on fruits and vegetables, poultry, meat and meat products, fiber products and processed foods are performed at the Science and Technology...

  13. Association between laboratory capacities and world-cup performance in Nordic combined

    PubMed Central

    Fudel, Ronny; Kocbach, Jan; Moen, Frode; Ettema, Gertjan; Sandbakk, Øyvind

    2017-01-01

    Background Nordic combined (NC) is an Olympic winter-sport performed as a ski jumping (SJ) event followed by a cross-country (XC) pursuit race employing the skating style. Purpose To elucidate the associations between sport-specific laboratory capacities and SJ, XC skiing, and overall NC performance in a world-cup NC event. Methods Twelve international world-cup NC athletes from 8 nations performed laboratory testing one day prior to participating in a world-cup NC event. Squat jumps and SJ imitations (IMIT) were performed on a three-dimensional force plate, whereas XC skiing-specific physiological characteristics were obtained from roller ski skating tests on a treadmill and an all-out double poling (DP) test. Finally, body composition was measured. Laboratory capacities were correlated against performance in SJ, 10-km XC skiing, and overall NC in the world-cup event. Multiple regression analysis was used to determine the best suited laboratory variables for predicting performance. Results Vertical IMIT velocity together with body-mass provided the best prediction for SJ performance (r2 = 0.70, p<0.01), while body-mass-normalized V˙O2peak and DP power provided the best prediction for XC performance (r2 = 0.68, p<0.05). Body-mass-normalized V˙O2peak was the only significant correlate with overall NC performance (r2 = 0.43, p<0.05) in this competition. Conclusion Overall, the concurrent development of V˙O2peak, upper-body power, and SJ-specific vertical jump capacity while minimizing body-mass within the BMI limit set by FIS should be considered in the seasonal training of NC athletes. PMID:28662163

  14. Fitness testing of tennis players: How valuable is it?

    PubMed Central

    Fernandez-Fernandez, Jaime; Ulbricht, Alexander; Ferrauti, Alexander

    2014-01-01

    In tennis, sport-specific technical skills are predominant factors, although a complex profile of physical performance factors is also required. The fitness test batteries assist in examining tennis players’ capabilities for performance at different levels in the laboratory as well as in the field, in the junior or elite level. While laboratory tests can be, and are, used to evaluate basic performance characteristics of athletes in most individual sports, in a more specific approach, field-based methods are better suited to the demands of complex intermittent sports like tennis. A regular test battery performed at different periods of the year allows to obtain an individual's performance profile, as well as the ability to prescribe individual training interventions. Thus, the aim of the present review was to describe and evaluate the different physical tests recommended and used by practitioners, sports scientists and institutions (national tennis federations). PMID:24668375

  15. 46 CFR 160.064-7 - Recognized laboratory.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Recognized laboratory. 160.064-7 Section 160.064-7...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Marine Buoyant Devices § 160.064-7 Recognized laboratory. (a) A... laboratory. The following laboratories are recognized under § 159.010-7 of this part, to perform testing and...

  16. 46 CFR 160.064-7 - Recognized laboratory.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 6 2011-10-01 2011-10-01 false Recognized laboratory. 160.064-7 Section 160.064-7...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Marine Buoyant Devices § 160.064-7 Recognized laboratory. (a) A... laboratory. The following laboratories are recognized under § 159.010-7 of this part, to perform testing and...

  17. Translating Research on Myoelectric Control into Clinics-Are the Performance Assessment Methods Adequate?

    PubMed

    Vujaklija, Ivan; Roche, Aidan D; Hasenoehrl, Timothy; Sturma, Agnes; Amsuess, Sebastian; Farina, Dario; Aszmann, Oskar C

    2017-01-01

    Missing an upper limb dramatically impairs daily-life activities. Efforts in overcoming the issues arising from this disability have been made in both academia and industry, although their clinical outcome is still limited. Translation of prosthetic research into clinics has been challenging because of the difficulties in meeting the necessary requirements of the market. In this perspective article, we suggest that one relevant factor determining the relatively small clinical impact of myocontrol algorithms for upper limb prostheses is the limit of commonly used laboratory performance metrics. The laboratory conditions, in which the majority of the solutions are being evaluated, fail to sufficiently replicate real-life challenges. We qualitatively support this argument with representative data from seven transradial amputees. Their ability to control a myoelectric prosthesis was tested by measuring the accuracy of offline EMG signal classification, as a typical laboratory performance metrics, as well as by clinical scores when performing standard tests of daily living. Despite all subjects reaching relatively high classification accuracy offline, their clinical scores varied greatly and were not strongly predicted by classification accuracy. We therefore support the suggestion to test myocontrol systems using clinical tests on amputees, fully fitted with sockets and prostheses highly resembling the systems they would use in daily living, as evaluation benchmark. Agreement on this level of testing for systems developed in research laboratories would facilitate clinically relevant progresses in this field.

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

    PubMed

    Fulga, Netta

    2013-06-01

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

  19. 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.

  20. Performance evaluation : balloon-type breath alcohol self tester for personal use

    DOT National Transportation Integrated Search

    1984-01-01

    The accuracy of the only breath alcohol balloon-type self test device being marketed for personal use (Luckey Laboratories DM-2) was assessed in the laboratory. Data regarding this self-test device's ability to accurately classify an individual as ha...

  1. Laboratory study - laboratory testing of bridge deck mixes

    DOT National Transportation Integrated Search

    2003-03-01

    The purpose of this investigation was to develop bridge deck mixes that will improve field performance and minimize cracking potential compared to MoDOT's current (B-2) bridge deck mix design. The mix designs developed in this study were tested and c...

  2. An audit of immunofixation requesting practices at a South African referral laboratory

    PubMed Central

    Rampursat, Yashna

    2014-01-01

    Background It is common practice in most chemical pathology laboratories for reflective immunofixation electrophoresis (IFE) to occur following the detection or suspicion of a paraprotein on serum protein electrophoresis (SPEP). The chemical pathology laboratory at Inkosi Albert Luthuli Central Hospital (IALCH) in Durban, South Africa, is currently the only non-private laboratory in the KwaZulu Natal province that performs SPEP analysis, with current practice requiring that the clinician request IFE following suggestion by the laboratory after a suspicious SPEP result. Objectives To review the current process for IFE at IALCH in the context of reflective testing and to examine the use of the alpha-2-globulin/alpha-1-globulin ratio as a predictor of a positive IFE result. Methods Data for 1260 consecutive SPEP tests performed at the IALCH National Health Laboratory Service were collected between February and July 2011. SPEP and IFE were performed with a Sebia Hydrasys automated electrophoresis system. The alpha-2-globulin/alpha-1-globulin ratio was calculated using density of corresponding fractions on SPEP. Results Analysis revealed that of the 1260 SPEPs performed during the analysis period, 304 IFEs were suggested by the reviewing pathologist. A total of 45 (15%) of the suggested IFEs were subsequently requested by the attending clinicians. Almost half (46.5%) (n = 20) of the suggested IFEs that were performed revealed the presence of a paraprotein. There was no statistically-significant difference between the alpha-2-globulin/alpha-1-globulin ratio for patients with positive or negative IFEs (p-value = 0.2). Conclusions This study reveals the need for reflective addition of IFE testing by the laboratory following suspicious findings on SPEP. PMID:29043173

  3. Prediction of practical performance in preclinical laboratory courses – the return of wire bending for admission of dental students in Hamburg

    PubMed Central

    Kothe, Christian; Hissbach, Johanna; Hampe, Wolfgang

    2014-01-01

    Although some recent studies concluded that dexterity is not a reliable predictor of performance in preclinical laboratory courses in dentistry, they could not disprove earlier findings which confirmed the worth of manual dexterity tests in dental admission. We developed a wire bending test (HAM-Man) which was administered during dental freshmen’s first week in 2008, 2009, and 2010. The purpose of our study was to evaluate if the HAM-Man is a useful selection criterion additional to the high school grade point average (GPA) in dental admission. Regression analysis revealed that GPA only accounted for a maximum of 9% of students’ performance in preclinical laboratory courses, in six out of eight models the explained variance was below 2%. The HAM-Man incrementally explained up to 20.5% of preclinical practical performance over GPA. In line with findings from earlier studies the HAM-Man test of manual dexterity showed satisfactory incremental validity. While GPA has a focus on cognitive abilities, the HAM-Man reflects learning of unfamiliar psychomotor skills, spatial relationships, and dental techniques needed in preclinical laboratory courses. The wire bending test HAM-Man is a valuable additional selection instrument for applicants of dental schools. PMID:24872857

  4. 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.

  5. 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

  6. Predictive performance and inter-laboratory reproducibility in assessing eye irritation potential of water- and oil-soluble mixtures using the Short Time Exposure test method.

    PubMed

    Abo, Takayuki; Hilberer, Allison; Behle-Wagner, Christine; Watanabe, Mika; Cameron, David; Kirst, Annette; Nukada, Yuko; Yuki, Takuo; Araki, Daisuke; Sakaguchi, Hitoshi; Itagaki, Hiroshi

    2018-04-01

    The Short Time Exposure (STE) test method is an alternative method for assessing eye irritation potential using Statens Seruminstitut Rabbit Cornea cells and has been adopted as test guideline 491 by the Organisation for Economic Co-operation and Development. Its good predictive performance in identifying the Globally Harmonized System (GHS) No Category (NC) or Irritant Category has been demonstrated in evaluations of water-soluble substances, oil-soluble substances, and water-soluble mixtures. However, the predictive performance for oil-soluble mixtures was not evaluated. Twenty-four oil-soluble mixtures were evaluated using the STE test method. The GHS NC or Irritant Category of 22 oil-soluble mixtures were consistent with that of a Reconstructed human Cornea-like Epithelium (RhCE) test method. Inter-laboratory reproducibility was then confirmed using 20 water- and oil-soluble mixtures blind-coded. The concordance in GHS NC or Irritant Category among four laboratories was 90%-100%. In conclusion, the concordance in comparison with the results of RhCE test method using 24 oil-soluble mixtures and inter-laboratory reproducibility using 20 water- and oil-soluble mixtures blind-coded were good, indicating that the STE test method is a suitable alternative for predicting the eye irritation potential of both substances and mixtures. Copyright © 2018 Elsevier Ltd. All rights reserved.

  7. A combined field and laboratory design for assessing the impact of night shift work on police officer operational performance.

    PubMed

    Waggoner, Lauren B; Grant, Devon A; Van Dongen, Hans P A; Belenky, Gregory; Vila, Bryan

    2012-11-01

    This study assessed the utility of a combined field and laboratory research design for measuring the impact of consecutive night shift work on the sleepiness, vigilance, and driving performance of police patrol officers. For police patrol officers working their normal night shift duty cycles, simulated driving performance and psychomotor vigilance were measured in a laboratory on two separate occasions: in the morning after the last of five consecutive 10.7-h night shifts, and at the same time in the morning after three consecutive days off duty. Order of participation in conditions was randomized among subjects. Subjects experienced manipulation of sleep schedules due to working night shifts in a real operational environment, but performance testing was conducted under controlled laboratory conditions. N = 29 active-duty police patrol officers (27 male, 2 female; age 37.1 ± 6.3 years) working night shift schedules participated in this study. Simulated driving performance, psychomotor vigilance, and subjective sleepiness were significantly degraded following 5 consecutive night shifts as compared to 3 consecutive days off duty, indicating that active-duty police officers are susceptible to performance degradation as a consequence of working nights. This combined field and laboratory research design succeeded in bridging the gap between the realism of the operational environment and the control of laboratory performance testing, demonstrating that this is a useful approach for addressing the relationship between shift work induced fatigue and critical operational task performance.

  8. Development of the Global Measles Laboratory Network.

    PubMed

    Featherstone, David; Brown, David; Sanders, Ray

    2003-05-15

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

  9. Performance Evaluation of State of the Art Systems for Physical Activity Classification of Older Subjects Using Inertial Sensors in a Real Life Scenario: A Benchmark Study

    PubMed Central

    Awais, Muhammad; Palmerini, Luca; Bourke, Alan K.; Ihlen, Espen A. F.; Helbostad, Jorunn L.; Chiari, Lorenzo

    2016-01-01

    The popularity of using wearable inertial sensors for physical activity classification has dramatically increased in the last decade due to their versatility, low form factor, and low power requirements. Consequently, various systems have been developed to automatically classify daily life activities. However, the scope and implementation of such systems is limited to laboratory-based investigations. Furthermore, these systems are not directly comparable, due to the large diversity in their design (e.g., number of sensors, placement of sensors, data collection environments, data processing techniques, features set, classifiers, cross-validation methods). Hence, the aim of this study is to propose a fair and unbiased benchmark for the field-based validation of three existing systems, highlighting the gap between laboratory and real-life conditions. For this purpose, three representative state-of-the-art systems are chosen and implemented to classify the physical activities of twenty older subjects (76.4 ± 5.6 years). The performance in classifying four basic activities of daily life (sitting, standing, walking, and lying) is analyzed in controlled and free living conditions. To observe the performance of laboratory-based systems in field-based conditions, we trained the activity classification systems using data recorded in a laboratory environment and tested them in real-life conditions in the field. The findings show that the performance of all systems trained with data in the laboratory setting highly deteriorates when tested in real-life conditions, thus highlighting the need to train and test the classification systems in the real-life setting. Moreover, we tested the sensitivity of chosen systems to window size (from 1 s to 10 s) suggesting that overall accuracy decreases with increasing window size. Finally, to evaluate the impact of the number of sensors on the performance, chosen systems are modified considering only the sensing unit worn at the lower back. The results, similarly to the multi-sensor setup, indicate substantial degradation of the performance when laboratory-trained systems are tested in the real-life setting. This degradation is higher than in the multi-sensor setup. Still, the performance provided by the single-sensor approach, when trained and tested with real data, can be acceptable (with an accuracy above 80%). PMID:27973434

  10. 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.

  11. District, state or regional veterinary diagnostic laboratories.

    PubMed

    Gosser, H S; Morehouse, L G

    1998-08-01

    The district, regional or state laboratory is the local laboratory to which veterinarian practitioners usually submit samples, and consequently these laboratories are usually the first to observe a suspected disease problem. In most countries, these laboratories are under the jurisdiction of the State or region in which they are located. In the United States of America (USA), most veterinary diagnostic laboratories are State-associated and operate under the aegis of either the State Department of Agriculture or a university. The national laboratory provides reference assistance to the State laboratories. In the USA, the national Laboratory (the National Veterinary Services Laboratories) acts as a consultant to confirm difficult diagnoses and administer performance tests for State-associated laboratories. District, state or regional laboratories need to share information regarding technological advances in diagnostic procedures. This need was met in the USA by the formation of the American Association of Veterinary Laboratory Diagnosticians (AAVLD) in the late 1950s. Another requirement of district, state or regional diagnostic laboratories is a method to confirm quality assurance, which was fulfilled in the USA by an accreditation programme established through the AAVLD. The Accreditation Committee evaluates laboratories (on request) in terms of organisation, personnel, physical facilities and equipment, records, finance and budget. Those laboratories which meet the standards as established in the 'Essential Requirements for Accreditation' are given accreditation status, which indicates that they have the expertise and facilities to perform tests on food-producing animals for shipment in national or international commerce and on companion, laboratory or zoo animals. While confidentiality of test records is most important, it is becoming necessary to release certain types of animal disease test information if a country is to participate in the exportation of animals and animal products. As district, state and regional laboratories operate under many different administrative entities (i.e., universities, State governments and the Federal government), various checks at different administrative levels provide safeguards and reduce the possibility of faulty disease reporting.

  12. Italian external quality assessment program for cystic fibrosis sweat chloride test: a 2015 and 2016 results comparison.

    PubMed

    Salvatore, Marco; Floridia, Giovanna; Amato, Annalisa; Censi, Federica; de Stefano, Maria Chiara; Ferrari, Gianluca; Tosto, Fabrizio; Taruscio, Domenica

    2017-01-01

    Diagnostic testing in cystic fibrosis (CF) is based on the sweat chloride test (SCT) in the context of appropriate signs and symptoms of disease and results of the gene mutation analysis. In 2014 the Istituto Superiore di Sanità (ISS) established a pilot Italian external quality assessment program for CF sweat chloride test (Italian EQA-SCT). In 2015 this activity was recognized as a third party service carried out by the ISS. The aim of the paper is to compare 2015 and 2016 results and experiences. The scheme is prospective; enrollment is voluntary and the payment of a fee is required. Participants are registered and identified by a specific Identification Number (ID) through a dedicated web-facility. Assessment covers analysis, interpretation and reporting of results. Thirteen and fifteen laboratories, participated in the 2015 and 2016 round respectively. Seven laboratories participated constantly from 2014, eleven participated both in 2015 and 2016 and four participated in 2016 for the first time. Variability in scores of chloride titration and heterogeneity in interpretation/reporting results were detected in both rounds. A total of 18 critical errors in chloride titration were made by eight different participants. Four laboratories made errors in chloride titration in 2015 but drastically improved their performance in 2016. In 2016 poor performance criteria were established and adopted. Even though results show variability in performance of laboratories, constant and mandatory participation may contribute to the improvement of performance and quality reached by laboratory.

  13. 7 CFR 91.5 - Where services are offered.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ...) Science and Technology Programs National Science Laboratory. A variety of proximate for composition, chemical, physical, microbiological and biomolecular (DNA-based) tests and laboratory analyses performed on..., honey, meat and meat products, fiber products and processed foods are performed at the Science and...

  14. 7 CFR 91.5 - Where services are offered.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ...) Science and Technology Programs National Science Laboratory. A variety of proximate for composition, chemical, physical, microbiological and biomolecular (DNA-based) tests and laboratory analyses performed on..., honey, meat and meat products, fiber products and processed foods are performed at the Science and...

  15. 7 CFR 91.5 - Where services are offered.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ...) Science and Technology Programs National Science Laboratory. A variety of proximate for composition, chemical, physical, microbiological and biomolecular (DNA-based) tests and laboratory analyses performed on..., honey, meat and meat products, fiber products and processed foods are performed at the Science and...

  16. 7 CFR 91.5 - Where services are offered.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ...) Science and Technology Programs National Science Laboratory. A variety of proximate for composition, chemical, physical, microbiological and biomolecular (DNA-based) tests and laboratory analyses performed on..., honey, meat and meat products, fiber products and processed foods are performed at the Science and...

  17. Clinical performance of amalgam as predicted by physical property tests.

    PubMed

    Gale, E N; Osborne, J W

    1980-01-01

    For a number of years, dentistry has relied upon laboratory data to select and to certify the materials to be used in restorations. The data obtained from laboratory studies are used as criteria for clinical performance and also for sales promotion.

  18. Electromedical devices test laboratories accreditation

    NASA Astrophysics Data System (ADS)

    Murad, C.; Rubio, D.; Ponce, S.; Álvarez Abri, A.; Terrón, A.; Vicencio, D.; Fascioli, E.

    2007-11-01

    In the last years, the technology and equipment at hospitals have been increase in a great way as the risks of their implementation. Safety in medical equipment must be considered an important issue to protect patients and their users. For this reason, test and calibrations laboratories must verify the correct performance of this kind of devices under national and international standards. Is an essential mission for laboratories to develop their measurement activities taking into account a quality management system. In this article, we intend to transmit our experience working to achieve an accredited Test Laboratories for medical devices in National technological University.

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

    PubMed

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

    2016-11-01

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

  20. Evaluation of the performance of a micromethod for measuring urinary iodine by using six sigma quality metrics.

    PubMed

    Hussain, Husniza; Khalid, Norhayati Mustafa; Selamat, Rusidah; Wan Nazaimoon, Wan Mohamud

    2013-09-01

    The urinary iodine micromethod (UIMM) is a modification of the conventional method and its performance needs evaluation. UIMM performance was evaluated using the method validation and 2008 Iodine Deficiency Disorders survey data obtained from four urinary iodine (UI) laboratories. Method acceptability tests and Sigma quality metrics were determined using total allowable errors (TEas) set by two external quality assurance (EQA) providers. UIMM obeyed various method acceptability test criteria with some discrepancies at low concentrations. Method validation data calculated against the UI Quality Program (TUIQP) TEas showed that the Sigma metrics were at 2.75, 1.80, and 3.80 for 51±15.50 µg/L, 108±32.40 µg/L, and 149±38.60 µg/L UI, respectively. External quality control (EQC) data showed that the performance of the laboratories was within Sigma metrics of 0.85-1.12, 1.57-4.36, and 1.46-4.98 at 46.91±7.05 µg/L, 135.14±13.53 µg/L, and 238.58±17.90 µg/L, respectively. No laboratory showed a calculated total error (TEcalc)

  1. Fluid infusion system

    NASA Technical Reports Server (NTRS)

    1974-01-01

    Performance testing carried out in the development of the prototype zero-g fluid infusion system is described and summarized. Engineering tests were performed in the course of development, both on the original breadboard device and on the prototype system. This testing was aimed at establishing baseline system performance parameters and facilitating improvements. Acceptance testing was then performed on the prototype system to verify functional performance. Acceptance testing included a demonstration of the fluid infusion system on a laboratory animal.

  2. Vibration Testing of the Pluto/New Horizons Radioisotope Thermoelectric Generator

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

    Charles D. Griffin

    The Radioisotopic Thermal Generator (RTG) for the Pluto/New Horizons spacecraft was subjected to a flight dynamic acceptance test to demonstrate that it would perform successfully following launch. Seven RTGs of this type had been assembled and tested at Mound, Ohio from 1984 to 1997. This paper chronicles major events in establishing a new vibration test laboratory at the Idaho National Laboratory and the nineteen days of dynamic testing.

  3. 77 FR 41188 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-12

    ... technological advances, such as new test methods and the electronic transmission of laboratory information... potential need for educational materials and resources for sites that test under a Provider-performed Microscopy Certificate; and the increased use of culture-independent microbiology diagnostics and the impact...

  4. Preventing Boredom in the Language Laboratory

    ERIC Educational Resources Information Center

    Obanya, Pai

    1978-01-01

    An experimental year of oral testing using the language laboratory at Victoria University is described. A new first-year 12-credit course is primarily a language course based on audiovisual/lingual methods. The content, evaluation, and administration of oral expression tests and performance tapes are covered. (SW)

  5. Integrated Data Collection Analysis (IDCA) Program - KClO 4/Carbon Mixture

    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 results for impact, friction, electrostatic discharge, and differential scanning calorimetry analysis of a mixture of KClO 4 and activated carbon—KClO 4/C mixture. This material was selected because of the challenge of performing SSST testing of a mixture of two solids. The mixture was found to be insensitive to impact, friction, and thermal stimulus, and somewhat sensitive to spark discharge. This effort, funded by the Department of Homeland Security (DHS), ultimately will putmore » 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 has the potential to 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. Note, however, the test procedures differ among the laboratories. The results are compared among the laboratories and then compared to historical data from various sources. The testing performers involved for the KClO 4/carbon mixture are Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Indian Head Division, Naval Surface Warfare Center, (NSWC IHD), 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 understand how to compare results when these testing variables cannot be made consistent.« less

  6. Validation of "laboratory-supported" criteria for functional (psychogenic) tremor.

    PubMed

    Schwingenschuh, Petra; Saifee, Tabish A; Katschnig-Winter, Petra; Macerollo, Antonella; Koegl-Wallner, Mariella; Culea, Valeriu; Ghadery, Christine; Hofer, Edith; Pendl, Tamara; Seiler, Stephan; Werner, Ulrike; Franthal, Sebastian; Maurits, Natasha M; Tijssen, Marina A; Schmidt, Reinhold; Rothwell, John C; Bhatia, Kailash P; Edwards, Mark J

    2016-04-01

    In a small group of patients, we have previously shown that a combination of electrophysiological tests was able to distinguish functional (psychogenic) tremor and organic tremor with excellent sensitivity and specificity. This study aims to validate an electrophysiological test battery as a tool to diagnose patients with functional tremor with a "laboratory-supported" level of certainty. For this prospective data collection study, we recruited 38 new patients with functional tremor (mean age 37.9 ± 24.5 years; mean disease duration 5.9 ± 9.0 years) and 73 new patients with organic tremor (mean age 55.4 ± 25.4 years; mean disease duration 15.8 ± 17.7 years). Tremor was recorded at rest, posture (with and without loading), action, while performing tapping tasks (1, 3, and 5 Hz), and while performing ballistic movements with the less-affected hand. Electrophysiological tests were performed by raters blinded to the clinical diagnosis. We calculated a sum score for all performed tests (maximum of 10 points) and used a previously suggested cut-off score of 3 points for a diagnosis of laboratory-supported functional tremor. We demonstrated good interrater reliability and test-retest reliability. Patients with functional tremor had a higher average score on the test battery when compared with patients with organic tremor (3.6 ± 1.4 points vs 1.0 ± 0.8 points; P < .001), and the predefined cut-off score for laboratory-supported functional tremor yielded a test sensitivity of 89.5% and a specificity of 95.9%. We now propose this test battery as the basis of laboratory-supported criteria for the diagnosis of functional tremor, and we encourage its use in clinical and research practice. © 2016 International Parkinson and Movement Disorder Society.

  7. Evaluating laboratory approaches to the identification of lupus anticoagulants: a diagnostic challenge from the RCPA Haematology QAP.

    PubMed

    Bonar, Roslyn; Favaloro, Emmanuel; Zebeljan, Diane; Rosenfeld, David; Kershaw, Geoff; Mohammed, Soma; Marsden, Katherine; Hertzberg, Mark

    2012-04-01

    Laboratory identification of lupus anticoagulants (LA), an important component of the clinical diagnosis of the autoimmune disorder antiphospholipid syndrome (APS), is challenged by the heterogeneity of tests available, the diagnostic and laboratory approach undertaken, and the heterogeneity of the autoantibodies present. : To assess the laboratory approach for investigation of LA, as well as the utility of various tests and test approaches, given a difficult clinical scenario in which LA might or might not be present. Ninety-three participants in the Royal College of Pathologists of Australasia (RCPA) Haematology Quality Assurance Program (QAP) were sent 4  mL of a complex but strongly positive LA sample blinded to the nature of the abnormality. Seventy-three (79%) participants returned results and in most cases diagnostic interpretations. The laboratory approach to LA investigation of this sample was quite varied: 34.7% of participants concluded the sample was LA negative, with 91.7% of these performing dilute Russell viper venom time (dRVVT) testing without mixing, whereas 43.5% of participants identified a strong LA, with 96.7% of these having performed mixing studies. Most laboratories reporting negative LA instead identified the false presence of specific factor inhibitors against a variety of factors, including II, V and VIII. For this difficult challenge, performance of non-mixing dRVVT was associated with a high false negative LA rate. (C) 2012 Royal College of Pathologists of Australasia.

  8. Lupus anticoagulants: first French interlaboratory Etalonorme survey.

    PubMed

    Roussi, J; Roisin, J P; Goguel, A

    1996-06-01

    In 1994, the, French National Quality Control Group for Hematology, Etalonorme, conducted a large-scale interlaboratory survey concerning the detection of lupus anticoagulants (LA) involving all the 4,500 French laboratories. Each laboratory received the same batch of a lyophilized citrated plasma (94B3) prepared from a patient with LA that had been confirmed by all the techniques used in the intralaboratory study. In the interlaboratory survey, the screening test was activated partial thromboplastin time (APTT); mean APTT calculated from the results reported by 4,029 labs was prolonged (clotting ratio = 1.44) with a large dispersion (coefficients of variation = 18.8%). APTT of the mixture 94B3 + normal plasma were performed by 2,698 laboratories. No correction of APTT was obtained (R = 1.36, Rosner index = 24) with a wide variation between reagents (17 < Rosner index < 39). Only 15% of the participants performed confirmatory tests; dilute tissue thromboplastin inhibition test (TTI) performed by 509 laboratories gave 75% positive results. Tests with an increased amount of phospholipids (Staclot LA and Staclot PNP from Diagnostica Stago), used by 116 and 72 laboratories, gave 88% and 61% positive results, respectively. A total of 1,862 laboratories made the diagnosis of LA. The majority of those who failed in diagnosing LA used an APTT reagent largely used in France, containing kaolin. This survey allowed Etalonorme to inform French biologists and draft an educational program for the biologic detection of LA and the identification of its mechanism of action.

  9. Information and consent in internet paternity testing: focus on minors' protection in Italy.

    PubMed

    Caenazzo, Luciana; Tozzo, Pamela; Benciolini, Paolo; Rodriguez, Daniele

    2008-12-01

    Paternity testing in Italy is usually performed by private laboratories and universities having direct contacts with the applicants. Recently, the number of paternity tests offered through laboratory websites has increased in Italy and Europe. The execution of genetic tests, including paternity testing based on DNA analysis, represents a complex act, which contains three main steps. Paternity analyses carried out by laboratories via Internet are performed on samples collected by the applicants and then mailed back to the laboratories without any patient-physician relationship. Information is given to the subjects through the laboratory's website or mailed with the test order form. The execution of "household" DNA analysis without technical precautions may provide an incorrect response with severe consequences on the individual who has undergone testing, on the family involved, and on society in general. The problems connected with this kind of analysis are not technical, but ethical and deontological. In this work, we will discuss the problems related to information and consent by way of outlining the relevant Italian laws and codes of medical ethics. The Italian Privacy's Guarantor is assessing the ethical and legal implications, but regulations are not yet in place. We believe that adequate information related to this practice cannot be given via Internet, and, consequently, the validity of the consent expressed during this kind of procedure can be uncertain. Further, we will analyze issues regarding the importance of minors' protection when a paternity test is performed via Internet. In our opinion, the complexity of the situations and expectations linked to paternity investigations require a special sensitivity in dealing with each case, based on a patient-physician relationship in the decision-making process especially referring to the defense of the minors' well-being.

  10. 42 CFR 493.1407 - Standard; Laboratory director responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  11. Mounted Smartphones as Measurement and Control Platforms for Motor-Based Laboratory Test-Beds †

    PubMed Central

    Frank, Jared A.; Brill, Anthony; Kapila, Vikram

    2016-01-01

    Laboratory education in science and engineering often entails the use of test-beds equipped with costly peripherals for sensing, acquisition, storage, processing, and control of physical behavior. However, costly peripherals are no longer necessary to obtain precise measurements and achieve stable feedback control of test-beds. With smartphones performing diverse sensing and processing tasks, this study examines the feasibility of mounting smartphones directly to test-beds to exploit their embedded hardware and software in the measurement and control of the test-beds. This approach is a first step towards replacing laboratory-grade peripherals with more compact and affordable smartphone-based platforms, whose interactive user interfaces can engender wider participation and engagement from learners. Demonstrative cases are presented in which the sensing, computation, control, and user interaction with three motor-based test-beds are handled by a mounted smartphone. Results of experiments and simulations are used to validate the feasibility of mounted smartphones as measurement and feedback control platforms for motor-based laboratory test-beds, report the measurement precision and closed-loop performance achieved with such platforms, and address challenges in the development of platforms to maintain system stability. PMID:27556464

  12. Mounted Smartphones as Measurement and Control Platforms for Motor-Based Laboratory Test-Beds.

    PubMed

    Frank, Jared A; Brill, Anthony; Kapila, Vikram

    2016-08-20

    Laboratory education in science and engineering often entails the use of test-beds equipped with costly peripherals for sensing, acquisition, storage, processing, and control of physical behavior. However, costly peripherals are no longer necessary to obtain precise measurements and achieve stable feedback control of test-beds. With smartphones performing diverse sensing and processing tasks, this study examines the feasibility of mounting smartphones directly to test-beds to exploit their embedded hardware and software in the measurement and control of the test-beds. This approach is a first step towards replacing laboratory-grade peripherals with more compact and affordable smartphone-based platforms, whose interactive user interfaces can engender wider participation and engagement from learners. Demonstrative cases are presented in which the sensing, computation, control, and user interaction with three motor-based test-beds are handled by a mounted smartphone. Results of experiments and simulations are used to validate the feasibility of mounted smartphones as measurement and feedback control platforms for motor-based laboratory test-beds, report the measurement precision and closed-loop performance achieved with such platforms, and address challenges in the development of platforms to maintain system stability.

  13. Internal quality control in serological tests for syphilis.

    PubMed Central

    Wasley, G D

    1985-01-01

    The importance of syphilis serological tests demands that laboratory reports are reliable. Internal quality control applied to the organisation of a syphilis serology service improves laboratory bench performance and reporting. Described here are internal quality control procedures of a department that serves a genitourinary medicine clinic and conducts 70 000 tests a year to investigate for syphilis. PMID:3884487

  14. Bench model surgical skill training improves novice ability to multitask: a randomized controlled study.

    PubMed

    Grierson, Lawrence; Melnyk, Megan; Jowlett, Nathan; Backstein, David; Dubrowski, Adam

    2011-01-01

    Skills training in simulation laboratories is becoming increasingly common. However, the educational benefit of these laboratories remains unclear. This study examined whether such training enables better performance on the simultaneous execution of technical skill and knowledge retention. Twenty-four novice trainees completed the elliptical excision on baseline testing. Following baseline testing twelve of the novices completed a technical practice (simulation training group) session, while the other twelve did not (control group). One week later, all participants returned for dual-task follow up testing in which they performed the excision while listening to a didactic lesson on the staging and treatment of cutaneous melanoma. The dual-tasking during the post test was standardized, whereby excision sutures 3 and 5 were performed alone (single), and sutures 4 and 6 were performed concurrently with the didactic lecture (dual). Seven additional trainees also participated as controls that were randomized to listen to the didactic lesson alone (knowledge retention alone group). Knowledge retention was assessed by a multiple choice questionnaire (MCQ). Technical performance was evaluated with computer and expert-based measures. Time to complete the performance improved among both groups completing the elliptical excision on follow-up testing (p<0.01). The simulation training group demonstrated superior hand motion performance on simultaneous didactic lesson testing (p<0.01). Novices from the no-training group performed statistically worse while suturing concurrently with the didactic lesson (p<0.01). The pretraining of novices in surgical skills laboratories leads to improved technical performance during periods of increased attention demands.

  15. NCAT test track design, construction, and performance

    DOT National Transportation Integrated Search

    2002-11-01

    Empirical laboratory tests have been used for years to test hot mix asphalt (HMA) to determine the potential for various mixtures to perform well. As the amount of traffic has increased (higher volumes, higher loads, and increased tire pressures) the...

  16. International Space Station Carbon Dioxide Removal Assembly Testing

    NASA Technical Reports Server (NTRS)

    Knox, James C.

    2000-01-01

    Performance testing of the International Space Station Carbon Dioxide Removal Assembly flight hardware in the United States Laboratory during 1999 is described. The CDRA exceeded carbon dioxide performance specifications and operated flawlessly. Data from this test is presented.

  17. 42 CFR 493.1256 - Standard: Control procedures.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Systems § 493.1256 Standard: Control procedures. (a) For each test system, the laboratory is responsible... test system failure, adverse environmental conditions, and operator performance. (2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system...

  18. 42 CFR 493.1256 - Standard: Control procedures.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Systems § 493.1256 Standard: Control procedures. (a) For each test system, the laboratory is responsible... test system failure, adverse environmental conditions, and operator performance. (2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system...

  19. 42 CFR 493.1256 - Standard: Control procedures.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Systems § 493.1256 Standard: Control procedures. (a) For each test system, the laboratory is responsible... test system failure, adverse environmental conditions, and operator performance. (2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system...

  20. 42 CFR 493.1256 - Standard: Control procedures.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Systems § 493.1256 Standard: Control procedures. (a) For each test system, the laboratory is responsible... test system failure, adverse environmental conditions, and operator performance. (2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system...

  1. Multi-mode evaluation of power-maximizing cross-flow turbine controllers

    DOE PAGES

    Forbush, Dominic; Cavagnaro, Robert J.; Donegan, James; ...

    2017-09-21

    A general method for predicting and evaluating the performance of three candidate cross-flow turbine power-maximizing controllers is presented in this paper using low-order dynamic simulation, scaled laboratory experiments, and full-scale field testing. For each testing mode and candidate controller, performance metrics quantifying energy capture (ability of a controller to maximize power), variation in torque and rotation rate (related to drive train fatigue), and variation in thrust loads (related to structural fatigue) are quantified for two purposes. First, for metrics that could be evaluated across all testing modes, we considered the accuracy with which simulation or laboratory experiments could predict performancemore » at full scale. Second, we explored the utility of these metrics to contrast candidate controller performance. For these turbines and set of candidate controllers, energy capture was found to only differentiate controller performance in simulation, while the other explored metrics were able to predict performance of the full-scale turbine in the field with various degrees of success. Finally, effects of scale between laboratory and full-scale testing are considered, along with recommendations for future improvements to dynamic simulations and controller evaluation.« less

  2. Multi-mode evaluation of power-maximizing cross-flow turbine controllers

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

    Forbush, Dominic; Cavagnaro, Robert J.; Donegan, James

    A general method for predicting and evaluating the performance of three candidate cross-flow turbine power-maximizing controllers is presented in this paper using low-order dynamic simulation, scaled laboratory experiments, and full-scale field testing. For each testing mode and candidate controller, performance metrics quantifying energy capture (ability of a controller to maximize power), variation in torque and rotation rate (related to drive train fatigue), and variation in thrust loads (related to structural fatigue) are quantified for two purposes. First, for metrics that could be evaluated across all testing modes, we considered the accuracy with which simulation or laboratory experiments could predict performancemore » at full scale. Second, we explored the utility of these metrics to contrast candidate controller performance. For these turbines and set of candidate controllers, energy capture was found to only differentiate controller performance in simulation, while the other explored metrics were able to predict performance of the full-scale turbine in the field with various degrees of success. Finally, effects of scale between laboratory and full-scale testing are considered, along with recommendations for future improvements to dynamic simulations and controller evaluation.« less

  3. Photovoltaic module certification and laboratory accreditation criteria development

    NASA Astrophysics Data System (ADS)

    Osterwald, Carl R.; Zerlaut, Gene; Hammond, Robert; D'Aiello, Robert

    1996-01-01

    This paper overviews a model product certification and test laboratory accreditation program for photovoltaic (PV) modules that was recently developed by the National Renewable Energy Laboratory and Arizona State University. The specific objective of this project was to produce a document that details the equipment, facilities, quality assurance procedures, and technical expertise an accredited laboratory needs for performance and qualification testing of PV modules, along with the specific tests needed for a module design to be certified. The document was developed in conjunction with a criteria development committee consisting of representatives from 30 U.S. PV manufacturers, end users, standards and codes organizations, and testing laboratories. The intent is to lay the groundwork for a future U.S. PV certification and accreditation program that will be beneficial to the PV industry as a whole.

  4. Results of advanced battery technology evaluations for electric vehicle applications

    NASA Astrophysics Data System (ADS)

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

    1992-10-01

    Advanced battery technology evaluations are performed under simulated electric-vehicle operating conditions at the Analysis and 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 1991-1992 on both single cells and multi-cell modules that encompass eight battery technologies (Na/S, Li/MS (M=metal), Ni/MH, Ni/Cd, Ni/Zn, Ni/Fe, Zn/Br, and Pb-acid). 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.

  5. Interlaboratory comparison of immunohistochemical testing for HER2: results of the 2004 and 2005 College of American Pathologists HER2 Immunohistochemistry Tissue Microarray Survey.

    PubMed

    Fitzgibbons, Patrick L; Murphy, Douglas A; Dorfman, David M; Roche, Patrick C; Tubbs, Raymond R

    2006-10-01

    Correct assessment of human epidermal growth factor receptor 2 (HER2) status is essential in managing patients with invasive breast carcinoma, but few data are available on the accuracy of laboratories performing HER2 testing by immunohistochemistry (IHC). To review the results of the 2004 and 2005 College of American Pathologists HER2 Immunohistochemistry Tissue Microarray Survey. The HER2 survey is designed for laboratories performing immunohistochemical staining and interpretation for HER2. The survey uses tissue microarrays, each consisting of ten 3-mm tissue cores obtained from different invasive breast carcinomas. All cases are also analyzed by fluorescence in situ hybridization. Participants receive 8 tissue microarrays (80 cases) with instructions to perform immunostaining for HER2 using the laboratory's standard procedures. The laboratory interprets the stained slides and returns results to the College of American Pathologists for analysis. In 2004 and 2005, a core was considered "graded" when at least 90% of laboratories agreed on the result--negative (0, 1+) versus positive (2+, 3+). This interlaboratory comparison survey included 102 laboratories in 2004 and 141 laboratories in 2005. Of the 160 cases in both surveys, 111 (69%) achieved 90% consensus (graded). All 43 graded cores scored as IHC-positive were fluorescence in situ hybridization-positive, whereas all but 3 of the 68 IHC-negative graded cores were fluorescence in situ hybridization-negative. Ninety-seven (95%) of 102 laboratories in 2004 and 129 (91%) of 141 laboratories in 2005 correctly scored at least 90% of the graded cores. Performance among laboratories performing HER2 IHC in this tissue microarray-based survey was excellent. Cores found to be IHC-positive or IHC-negative by participant consensus can be used as validated benchmarks for interlaboratory comparison, allowing laboratories to assess their performance and determine if improvements are needed.

  6. Mindfulness, anxiety, and high-stakes mathematics performance in the laboratory and classroom.

    PubMed

    Bellinger, David B; DeCaro, Marci S; Ralston, Patricia A S

    2015-12-01

    Mindfulness enhances emotion regulation and cognitive performance. A mindful approach may be especially beneficial in high-stakes academic testing environments, in which anxious thoughts disrupt cognitive control. The current studies examined whether mindfulness improves the emotional response to anxiety-producing testing situations, freeing working memory resources, and improving performance. In Study 1, we examined performance in a high-pressure laboratory setting. Mindfulness indirectly benefited math performance by reducing the experience of state anxiety. This benefit occurred selectively for problems that required greater working memory resources. Study 2 extended these findings to a calculus course taken by undergraduate engineering majors. Mindfulness indirectly benefited students' performance on high-stakes quizzes and exams by reducing their cognitive test anxiety. Mindfulness did not impact performance on lower-stakes homework assignments. These findings reveal an important mechanism by which mindfulness benefits academic performance, and suggest that mindfulness may help attenuate the negative effects of test anxiety. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. Testing of small and large sign support systems FOIL test number : 92F011

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 20 mi/h (8.9 m/s), test 92FOll. The vehicle used for these t...

  8. Testing of small and large sign support systems FOIL test number : 92F036

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 60 mi/h (96.6 km/h), test 92F036. The vehicle used for this ...

  9. Testing of small and large sign support systems FOIL test number : 92F016

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor : Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign : support system at 20 mi/h (8.9 m/s), test 92F016. The vehicle used for the...

  10. Testing of small and large sign support systems FOIL test number : 92F035

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 20 mi/h (32.2 km/h), test 92F035. The vehicle used for this ...

  11. Testing of small and large sign support systems FOIL test number : 92F038

    DOT National Transportation Integrated Search

    1994-01-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 60 mi/h (96.6 km/h), test 92F038. The vehicle used for this ...

  12. Testing of small and large sign support systems FOIL test number : 92F037

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 20 mi/h (32.2 km/h), test 92F037. The vehicle used for this ...

  13. Testing of small and large sign support systems FOIL test number : 92F022

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact laboratory (FOIL) in Mclean, Virginia. The test was performed on a small sign support system at 20 mi/h (8.9 m/s) , test 92F022. The vehicle used for this t...

  14. Testing of small and large sign support systems FOIL test numbers : 92F040

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 60 mi/h (96.6 km/h), test 92F040. The vehicle used for this ...

  15. Testing of small and large sign support systems FOIL test number : 92F039

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 20 mi/h (32.2 km/h) , test 92F039. The vehicle used for this...

  16. 76 FR 6796 - Proposed Data Collections Submitted for Public Comment and Recommendations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-08

    ... perform the ``Quantitative Survey of Physician Practices in Laboratory Test Ordering and Interpretation... technology. Written comments should be received within 60 days of this notice. Proposed Project Quantitative Survey of Physician Practices in Laboratory Test Ordering and Interpretation-NEW-the Office of...

  17. ["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).

  18. A SIMPLE METHOD FOR EVALUATING DATA FROM AN INTERLABORATORY STUDY

    EPA Science Inventory

    Large-scale laboratory-and method-performance studies involving more than about 30 laboratories may be evaluated by calculating the HORRAT ratio for each test sample (HORRAT=[experimentally found among-laboratories relative standard deviation] divided by [relative standard deviat...

  19. Mobile CARS - IRS Instrument for Simultaneous Spectroscopic Measurement of Multiple Properties in Gaseous Flows

    NASA Technical Reports Server (NTRS)

    Bivolaru, Daniel; Lee, Joseph W.; Jones, Stephen B.; Tedder, Sarah A.; Danehy, Paul M.; Weikl, M. C.; Magnotti, G.; Cutler, Andrew D.

    2007-01-01

    This paper describes a measurement system based on the dual-pump coherent anti-Stokes Raman spectroscopy (CARS) and interferometric Rayleigh scattering (IRS) methods. The IRS measurement is performed simultaneously with the CARS measurement using a common green laser beam as a narrow-band light source. The mobile CARS-IRS instrument is designed for the use both in laboratories as well as in ground-based combustion test facilities. Furthermore, it is designed to be easily transported between laboratory and test facility. It performs single-point spatially and temporally resolved simultaneous measurements of temperature, species mole fraction of N2, O2, and H2, and two-components of velocity. A mobile laser system can be placed inside or outside the test facility, while a beam receiving and monitoring system is placed near the measurement location. Measurements in a laboratory small-scale Mach 1.6 H2-air combustion-heated supersonic jet were performed to test the capability of the system. Final setup and pretests of a larger scale reacting jet are ongoing at NASA Langley Research Center s Direct Connect Supersonic Combustor Test Facility (DCSCTF).

  20. Strength, Endurance, Throwing Velocity and in-Water Jump Performance of Elite German Water Polo Players

    PubMed Central

    Zinner, Christoph; Sperlich, Billy; Krueger, Malte; Focke, Tim; Reed, Jennifer; Mester, Joachim

    2015-01-01

    The purpose of this study was threefold: 1) to assess the eggbeater kick and throwing performance using a number of water polo specific tests, 2) to explore the relation between the eggbeater kick and throwing performance, and 3) to investigate the relation between the eggbeater kick in the water and strength tests performed in a controlled laboratory setting in elite water polo players. Fifteen male water polo players of the German National Team completed dynamic and isometric strength tests for muscle groups (adductor, abductor, abdominal, pectoralis) frequently used during water polo. After these laboratory strength tests, six water polo specific in-water tests were conducted. The eggbeater kick assessed leg endurance and agility, maximal throwing velocity and jump height. A 400 m test and a sprint test examined aerobic and anaerobic performance. The strongest correlation was found between jump height and arm length (p < 0.001, r = 0.89). The laboratory diagnostics of important muscles showed positive correlations with the results of the in-water tests (p < 0.05, r = 0.52–0.70). Muscular strength of the adductor, abdominal and pectoralis muscles was positively related to in-water endurance agility as assessed by the eggbeater kick (p < 0.05; r = 0.53–0.66). Findings from the current study emphasize the need to assess indices of water polo performance both in and out of the water as well as the relation among these parameters to best assess the complex profile of water polo players. PMID:25964818

  1. Simple Flame Test Techniques Using Cotton Swabs

    ERIC Educational Resources Information Center

    Sanger, Michael J.; Phelps, Amy J.; Banks, Catherine

    2004-01-01

    Three alternative methods for performing flame tests using cheaply and easily available cotton swabs are described. These flame tests are useful for chemical demonstrations or laboratory experiments because they are quick and easy to perform with easy cleanup and disposal methods.

  2. ICSH guidelines for the verification and performance of automated cell counters for body fluids.

    PubMed

    Bourner, G; De la Salle, B; George, T; Tabe, Y; Baum, H; Culp, N; Keng, T B

    2014-12-01

    One of the many challenges facing laboratories is the verification of their automated Complete Blood Count cell counters for the enumeration of body fluids. These analyzers offer improved accuracy, precision, and efficiency in performing the enumeration of cells compared with manual methods. A patterns of practice survey was distributed to laboratories that participate in proficiency testing in Ontario, Canada, the United States, the United Kingdom, and Japan to determine the number of laboratories that are testing body fluids on automated analyzers and the performance specifications that were performed. Based on the results of this questionnaire, an International Working Group for the Verification and Performance of Automated Cell Counters for Body Fluids was formed by the International Council for Standardization in Hematology (ICSH) to prepare a set of guidelines to help laboratories plan and execute the verification of their automated cell counters to provide accurate and reliable results for automated body fluid counts. These guidelines were discussed at the ICSH General Assemblies and reviewed by an international panel of experts to achieve further consensus. © 2014 John Wiley & Sons Ltd.

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

    PubMed Central

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

    2010-01-01

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

  4. 42 CFR 493.643 - Fee for determination of program compliance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... sets the fee amounts annually on a calendar year basis. Laboratories are inspected biennially... additional fee is based on the actual resources and time necessary to perform the activities. (c..., and proficiency testing purposes). (i) (A) Schedule A Low Volume. The laboratory performs not more...

  5. 42 CFR 493.643 - Fee for determination of program compliance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... sets the fee amounts annually on a calendar year basis. Laboratories are inspected biennially... additional fee is based on the actual resources and time necessary to perform the activities. (c..., and proficiency testing purposes). (i) (A) Schedule A Low Volume. The laboratory performs not more...

  6. 42 CFR 493.643 - Fee for determination of program compliance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... sets the fee amounts annually on a calendar year basis. Laboratories are inspected biennially... additional fee is based on the actual resources and time necessary to perform the activities. (c..., and proficiency testing purposes). (i) (A) Schedule A Low Volume. The laboratory performs not more...

  7. Sensitivity, specificity, and reproducibility of four measures of laboratory turnaround time.

    PubMed

    Valenstein, P N; Emancipator, K

    1989-04-01

    The authors studied the performance of four measures of laboratory turnaround time: the mean, median, 90th percentile, and proportion of tests reported within a predetermined cut-off interval (proportion of acceptable tests [PAT]). Measures were examined with the use of turnaround time data from 11,070 stat partial thromboplastin times, 16,761 urine cultures, and 28,055 stat electrolyte panels performed by a single laboratory. For laboratories with long turnaround times, the most important quality of a turnaround time measure is high reproducibility, so that improvement in reporting speed can be distinguished from random variation resulting from sampling. The mean was found to be the most reproducible of the four measures, followed by the median. The mean achieved acceptable precision with sample sizes of 100-500 tests. For laboratories with normally rapid turnaround times, the most important quality of a measure is high sensitivity and specificity for detecting whether turnaround time has dropped below standards. The PAT was found to be the best measure of turnaround time in this setting but required sample sizes of at least 500 tests to achieve acceptable accuracy. Laboratory turnaround time may be measured for different reasons. The method of measurement should be chosen with an eye toward its intended application.

  8. Verification of an Automated, Digital Dispensing Platform for At-Will Broth Microdilution-Based Antimicrobial Susceptibility Testing.

    PubMed

    Smith, Kenneth P; Kirby, James E

    2016-09-01

    With rapid emergence of multidrug-resistant bacteria, there is often a need to perform susceptibility testing for less commonly used or newer antimicrobial agents. Such testing can often be performed only by using labor-intensive, manual dilution methods and lies outside the capacity of most clinical labs, necessitating reference laboratory testing and thereby delaying the availability of susceptibility data. To address the compelling clinical need for microbiology laboratories to perform such testing in-house, we explored a novel, automated, at-will broth microdilution-based susceptibility testing platform. Specifically, we used the modified inkjet printer technology in the HP D300 digital dispensing system to dispense, directly from stock solutions into a 384-well plate, the 2-fold serial dilution series required for broth microdilution testing. This technology was combined with automated absorbance readings and data analysis to determine MICs. Performance was verified by testing members of the Enterobacteriaceae for susceptibility to ampicillin, cefazolin, ciprofloxacin, colistin, gentamicin, meropenem, and tetracycline in comparison to the results obtained with a broth microdilution reference standard. In precision studies, essential and categorical agreement levels were 96.8% and 98.3%, respectively. Furthermore, significantly fewer D300-based measurements were outside ±1 dilution from the modal MIC, suggesting enhanced reproducibility. In accuracy studies performed using a panel of 80 curated clinical isolates, rates of essential and categorical agreement and very major, major, and minor errors were 94%, 96.6%, 0%, 0%, and 3.4%, respectively. Based on these promising initial results, it is anticipated that the D300-based methodology will enable hospital-based clinical microbiology laboratories to perform at-will broth microdilution testing of antimicrobials and to address a critical testing gap. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  9. Evaluation of staff performance and interpretation of the screening program for prevention of thalassemia.

    PubMed

    Prommetta, Simaporn; Sanchaisuriya, Kanokwan; Fucharoen, Goonnapa; Yamsri, Supawadee; Chaiboonroeng, Attawut; Fucharoen, Supan

    2017-06-15

    Thalassemia screening program has been implemented for years in Southeast Asia, but no external quality assessment program has been established. We have developed and initiated the proficiency testing (PT) program for the first time in Thailand with the aim to assess the screening performance of laboratory staff and their competency in interpretation of the screening results. Three PT cycles per year were organized. From the first to the third cycle of the PT scheme, a total number of participant laboratories increased from 59 to 67. In each cycle, 2 PT items (assigned as blood samples of the couple) were provided. Performance evaluation was based on the accuracy of screening results, i.e . mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH) and the dichlorophenolindophenol (DCIP) test for haemoglobin E, including the competency in interpretation of screening results and assessment of foetal risk. Performance was assessed by comparing the participants' result against the assigned value. Of all 3 cycles, most laboratories reported acceptable MCV and MCH values. From the first to the third cycle, incorrect DCIP test and misinterpretation rates were decreased while incorrect risk assessment varied by cycle to cycle. Combining the accuracy of thalassemia screening and the competency in interpretation and risk assessment, approximately half of participants showed excellent performance. Improved performance observed in many laboratories reflects the achievement and benefit of the PT program which should be regularly provided.

  10. Catch-up validation study of an in vitro skin irritation test method based on an open source reconstructed epidermis (phase II).

    PubMed

    Groeber, F; Schober, L; Schmid, F F; Traube, A; Kolbus-Hernandez, S; Daton, K; Hoffmann, S; Petersohn, D; Schäfer-Korting, M; Walles, H; Mewes, K R

    2016-10-01

    To replace the Draize skin irritation assay (OECD guideline 404) several test methods based on reconstructed human epidermis (RHE) have been developed and were adopted in the OECD test guideline 439. However, all validated test methods in the guideline are linked to RHE provided by only three companies. Thus, the availability of these test models is dependent on the commercial interest of the producer. To overcome this limitation and thus to increase the accessibility of in vitro skin irritation testing, an open source reconstructed epidermis (OS-REp) was introduced. To demonstrate the capacity of the OS-REp in regulatory risk assessment, a catch-up validation study was performed. The participating laboratories used in-house generated OS-REp to assess the set of 20 reference substances according to the performance standards amending the OECD test guideline 439. Testing was performed under blinded conditions. The within-laboratory reproducibility of 87% and the inter-laboratory reproducibility of 85% prove a high reliability of irritancy testing using the OS-REp protocol. In addition, the prediction capacity was with an accuracy of 80% comparable to previous published RHE based test protocols. Taken together the results indicate that the OS-REp test method can be used as a standalone alternative skin irritation test replacing the OECD test guideline 404. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

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

    PubMed

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

    2012-03-01

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

  12. Quality Improvement Intervention for Reduction of Redundant Testing.

    PubMed

    Ducatman, Alan M; Tacker, Danyel H; Ducatman, Barbara S; Long, Dustin; Perrotta, Peter L; Lawther, Hannah; Pennington, Kelly; Lander, Owen; Warden, Mary; Failinger, Conard; Halbritter, Kevin; Pellegrino, Ronald; Treese, Marney; Stead, Jeffrey A; Glass, Eric; Cianciaruso, Lauren; Nau, Konrad C

    2017-01-01

    Laboratory data are critical to analyzing and improving clinical quality. In the setting of residual use of creatine kinase M and B isoenzyme testing for myocardial infarction, we assessed disease outcomes of discordant creatine kinase M and B isoenzyme +/troponin I (-) test pairs in order to address anticipated clinician concerns about potential loss of case-finding sensitivity following proposed discontinuation of routine creatine kinase and creatine kinase M and B isoenzyme testing. Time-sequenced interventions were introduced. The main outcome was the percentage of cardiac marker studies performed within guidelines. Nonguideline orders dominated at baseline. Creatine kinase M and B isoenzyme testing in 7496 order sets failed to detect additional myocardial infarctions but was associated with 42 potentially preventable admissions/quarter. Interruptive computerized soft stops improved guideline compliance from 32.3% to 58% ( P < .001) in services not receiving peer leader intervention and to >80% ( P < .001) with peer leadership that featured dashboard feedback about test order performance. This successful experience was recapitulated in interrupted time series within 2 additional services within facility 1 and then in 2 external hospitals (including a critical access facility). Improvements have been sustained postintervention. Laboratory cost savings at the academic facility were estimated to be ≥US$635 000 per year. National collaborative data indicated that facility 1 improved its order patterns from fourth to first quartile compared to peer norms and imply that nonguideline orders persist elsewhere. This example illustrates how pathologists can provide leadership in assisting clinicians in changing laboratory ordering practices. We found that clinicians respond to local laboratory data about their own test performance and that evidence suggesting harm is more compelling to clinicians than evidence of cost savings. Our experience indicates that interventions done at an academic facility can be readily instituted by private practitioners at external facilities. The intervention data also supplement existing literature that electronic order interruptions are more successful when combined with modalities that rely on peer education combined with dashboard feedback about laboratory order performance. The findings may have implications for the role of the pathology laboratory in the ongoing pivot from quantity-based to value-based health care.

  13. Impact of Hearing Aid Technology on Outcomes in Daily Life III: Localization.

    PubMed

    Johnson, Jani A; Xu, Jingjing; Cox, Robyn M

    Compared to basic-feature hearing aids, premium-feature hearing aids have more advanced technologies and sophisticated features. The objective of this study was to explore the difference between premium-feature and basic-feature hearing aids in horizontal sound localization in both laboratory and daily life environments. We hypothesized that premium-feature hearing aids would yield better localization performance than basic-feature hearing aids. Exemplars of premium-feature and basic-feature hearing aids from two major manufacturers were evaluated. Forty-five older adults (mean age 70.3 years) with essentially symmetrical mild to moderate sensorineural hearing loss were bilaterally fitted with each of the four pairs of hearing aids. Each pair of hearing aids was worn during a 4-week field trial and then evaluated using laboratory localization tests and a standardized questionnaire. Laboratory localization tests were conducted in a sound-treated room with a 360°, 24-loudspeaker array. Test stimuli were high frequency and low frequency filtered short sentences. The localization test in quiet was designed to assess the accuracy of front/back localization, while the localization test in noise was designed to assess the accuracy of locating sound sources throughout a 360° azimuth in the horizontal plane. Laboratory data showed that unaided localization was not significantly different from aided localization when all hearing aids were combined. Questionnaire data showed that aided localization was significantly better than unaided localization in everyday situations. Regarding the difference between premium-feature and basic-feature hearing aids, laboratory data showed that, overall, the premium-feature hearing aids yielded more accurate localization than the basic-feature hearing aids when high-frequency stimuli were used, and the listening environment was quiet. Otherwise, the premium-feature and basic-feature hearing aids yielded essentially the same performance in other laboratory tests and in daily life. The findings were consistent for both manufacturers. Laboratory tests for two of six major manufacturers showed that premium-feature hearing aids yielded better localization performance than basic-feature hearing aids in one out of four laboratory conditions. There was no difference between the two feature levels in self-reported everyday localization. Effectiveness research with different hearing aid technologies is necessary, and more research with other manufacturers' products is needed. Furthermore, these results confirm previous observations that research findings in laboratory conditions might not translate to everyday life.

  14. Single-breath diffusing capacity for carbon monoxide instrument accuracy across 3 health systems.

    PubMed

    Hegewald, Matthew J; Markewitz, Boaz A; Wilson, Emily L; Gallo, Heather M; Jensen, Robert L

    2015-03-01

    Measuring diffusing capacity of the lung for carbon monoxide (DLCO) is complex and associated with wide intra- and inter-laboratory variability. Increased D(LCO) variability may have important clinical consequences. The objective of the study was to assess instrument performance across hospital pulmonary function testing laboratories using a D(LCO) simulator that produces precise and repeatable D(LCO) values. D(LCO) instruments were tested with CO gas concentrations representing medium and high range D(LCO) values. The absolute difference between observed and target D(LCO) value was used to determine measurement accuracy; accuracy was defined as an average deviation from the target value of < 2.0 mL/min/mm Hg. Accuracy of inspired volume measurement and gas sensors were also determined. Twenty-three instruments were tested across 3 healthcare systems. The mean absolute deviation from the target value was 1.80 mL/min/mm Hg (range 0.24-4.23) with 10 of 23 instruments (43%) being inaccurate. High volume laboratories performed better than low volume laboratories, although the difference was not significant. There was no significant difference among the instruments by manufacturers. Inspired volume was not accurate in 48% of devices; mean absolute deviation from target value was 3.7%. Instrument gas analyzers performed adequately in all instruments. D(LCO) instrument accuracy was unacceptable in 43% of devices. Instrument inaccuracy can be primarily attributed to errors in inspired volume measurement and not gas analyzer performance. D(LCO) instrument performance may be improved by regular testing with a simulator. Caution should be used when comparing D(LCO) results reported from different laboratories. Copyright © 2015 by Daedalus Enterprises.

  15. GATE AND VACUUM FLUSHING OF SEWER SEDIMENT: LABORATORY TESTING

    EPA Science Inventory

    The objective of this study was to test the performance of a traditional gate-flushing device and a newly-designed vacuum-flushing device in removing sediment from combined sewers and CSO storage tanks. A laboratory hydraulic flume was used to simulate a reach of sewer or storag...

  16. 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...

  17. 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...

  18. 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.

  19. 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.

  20. The "hospital central laboratory": automation, integration and clinical usefulness.

    PubMed

    Zaninotto, Martina; Plebani, Mario

    2010-07-01

    Recent technological developments in laboratory medicine have led to a major challenge, maintaining a close connection between the search of efficiency through automation and consolidation and the assurance of effectiveness. The adoption of systems that automate most of the manual tasks characterizing routine activities has significantly improved the quality of laboratory performance; total laboratory automation being the paradigm of the idea that "human-less" robotic laboratories may allow for better operation and insuring less human errors. Furthermore, even if ongoing technological developments have considerably improved the productivity of clinical laboratories as well as reducing the turnaround time of the entire process, the value of qualified personnel remains a significant issue. Recent evidence confirms that automation allows clinical laboratories to improve analytical performances only if trained staff operate in accordance with well-defined standard operative procedures, thus assuring continuous monitoring of the analytical quality. In addition, laboratory automation may improve the appropriateness of test requests through the use of algorithms and reflex testing. This should allow the adoption of clinical and biochemical guidelines. In conclusion, in laboratory medicine, technology represents a tool for improving clinical effectiveness and patient outcomes, but it has to be managed by qualified laboratory professionals.

  1. 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.

  2. Continual planning and scheduling for managing patient tests in hospital laboratories.

    PubMed

    Marinagi, C C; Spyropoulos, C D; Papatheodorou, C; Kokkotos, S

    2000-10-01

    Hospital laboratories perform examination tests upon patients, in order to assist medical diagnosis or therapy progress. Planning and scheduling patient requests for examination tests is a complicated problem because it concerns both minimization of patient stay in hospital and maximization of laboratory resources utilization. In the present paper, we propose an integrated patient-wise planning and scheduling system which supports the dynamic and continual nature of the problem. The proposed combination of multiagent and blackboard architecture allows the dynamic creation of agents that share a set of knowledge sources and a knowledge base to service patient test requests.

  3. ISS and STS Commercial Off-the-Shelf Router Testing

    NASA Technical Reports Server (NTRS)

    Ivancie, William D.; Bell, Terry L.; Shell, Dan

    2002-01-01

    This report documents the results of testing performed with commercial off-the-shelf (COTS) routers and Internet Protocols (IPs) to determine if COTS equipment and IP could be utilized to upgrade NASA's current Space Transportation System (STS), the Shuttle, and the International Space Station communication infrastructure. Testing was performed by NASA Glenn Research Center (GRC) personnel within the Electronic Systems Test Laboratory (ESTE) with cooperation from the Mission Operations Directorate (MOD) Qualification and Utilization of Electronic System Technology (QUEST) personnel. The ESTE testing occurred between November 1 and 9, 2000. Additional testing was performed at NASA Glenn Research Center in a laboratory environment with equipment configured to emulate the STS. This report documents those tests and includes detailed test procedures, equipment interface requirements, test configurations and test results. The tests showed that a COTS router and standard Transmission Control Protocols and Internet Protocols (TCP/IP) could be used for both the Shuttle and the Space Station if near-error-free radio links are provided.

  4. Performance of different mono- and multiplex nucleic acid amplification tests on a multipathogen external quality assessment panel.

    PubMed

    Loens, K; van Loon, A M; Coenjaerts, F; van Aarle, Y; Goossens, H; Wallace, P; Claas, E J C; Ieven, M

    2012-03-01

    An external quality assessment (EQA) panel consisting of a total of 48 samples in bronchoalveolar lavage (BAL) fluid or transport medium was prepared in collaboration with Quality Control for Molecular Diagnostics (QCMD) (www.qcmd.org). The panel was used to assess the proficiency of the three laboratories that would be responsible for examining the 6,000 samples to be collected in the GRACE Network of Excellence (www.grace-lrti.org). The main objective was to decide on the best-performing testing approach for the detection of influenza viruses A and B, parainfluenza virus types 1 to 3, respiratory syncytial virus (RSV), human metapneumovirus, coronavirus, rhinovirus, adenovirus, Chlamydophila pneumoniae, Mycoplasma pneumoniae, and Legionella pneumophila by nucleic acid amplification techniques (NAATs). Two approaches were chosen: (i) laboratories testing samples using their in-house procedures for extraction and amplification and (ii) laboratories using their in-house amplification procedures on centrally extracted samples. Furthermore, three commercially available multiplex NAAT tests-the ResPlex (Qiagen GmbH, Hilden, Germany), RespiFinder plus (PathoFinder, Maastricht, The Netherlands), and RespiFinder Smart 21 (PathoFinder) tests-were evaluated by examination of the same EQA panel by the manufacturer. No large differences among the 3 laboratories were noticed when the performances of the assays developed in-house in combination with the in-house extraction procedures were compared. Also, the extraction procedure (central versus local) had little effect on performance. However, large differences in amplification efficacy were found between the commercially available tests; acceptable results were obtained by using the PathoFinder assays.

  5. Public health consequences of a false-positive laboratory test result for Brucella--Florida, Georgia, and Michigan, 2005.

    PubMed

    2008-06-06

    Human brucellosis, a nationally notifiable disease, is uncommon in the United States. Most human cases have occurred in returned travelers or immigrants from regions where brucellosis is endemic, or were acquired domestically from eating illegally imported, unpasteurized fresh cheeses. In January 2005, a woman aged 35 years who lived in Nassau County, Florida, received a diagnosis of brucellosis, based on results of a Brucella immunoglobulin M (IgM) enzyme immunoassay (EIA) performed in a commercial laboratory using analyte specific reagents (ASRs); this diagnosis prompted an investigation of dairy products in two other states. Subsequent confirmatory antibody testing by Brucella microagglutination test (BMAT) performed at CDC on the patient's serum was negative. The case did not meet the CDC/Council of State and Territorial Epidemiologists' (CSTE) definition for a probable or confirmed brucellosis case, and the initial EIA result was determined to be a false positive. This report summarizes the case history, laboratory findings, and public health investigations. CDC recommends that Brucella serology testing only be performed using tests cleared or approved by the Food and Drug Administration (FDA) or validated under the Clinical Laboratory Improvement Amendments (CLIA) and shown to reliably detect the presence of Brucella infection. Results from these tests should be considered supportive evidence for recent infection only and interpreted in the context of a clinically compatible illness and exposure history. EIA is not considered a confirmatory Brucella antibody test; positive screening test results should be confirmed by Brucella-specific agglutination (i.e., BMAT or standard tube agglutination test) methods.

  6. Research on the Error Characteristics of a 110 kV Optical Voltage Transformer under Three Conditions: In the Laboratory, Off-Line in the Field and During On-Line Operation

    PubMed Central

    Xiao, Xia; Hu, Haoliang; Xu, Yan; Lei, Min; Xiong, Qianzhu

    2016-01-01

    Optical voltage transformers (OVTs) have been applied in power systems. When performing accuracy performance tests of OVTs large differences exist between the electromagnetic environment and the temperature variation in the laboratory and on-site. Therefore, OVTs may display different error characteristics under different conditions. In this paper, OVT prototypes with typical structures were selected to be tested for the error characteristics with the same testing equipment and testing method. The basic accuracy, the additional error caused by temperature and the adjacent phase in the laboratory, the accuracy in the field off-line, and the real-time monitoring error during on-line operation were tested. The error characteristics under the three conditions—laboratory, in the field off-line and during on-site operation—were compared and analyzed. The results showed that the effect of the transportation process, electromagnetic environment and the adjacent phase on the accuracy of OVTs could be ignored for level 0.2, but the error characteristics of OVTs are dependent on the environmental temperature and are sensitive to the temperature gradient. The temperature characteristics during on-line operation were significantly superior to those observed in the laboratory. PMID:27537895

  7. Research on the Error Characteristics of a 110 kV Optical Voltage Transformer under Three Conditions: In the Laboratory, Off-Line in the Field and During On-Line Operation.

    PubMed

    Xiao, Xia; Hu, Haoliang; Xu, Yan; Lei, Min; Xiong, Qianzhu

    2016-08-16

    Optical voltage transformers (OVTs) have been applied in power systems. When performing accuracy performance tests of OVTs large differences exist between the electromagnetic environment and the temperature variation in the laboratory and on-site. Therefore, OVTs may display different error characteristics under different conditions. In this paper, OVT prototypes with typical structures were selected to be tested for the error characteristics with the same testing equipment and testing method. The basic accuracy, the additional error caused by temperature and the adjacent phase in the laboratory, the accuracy in the field off-line, and the real-time monitoring error during on-line operation were tested. The error characteristics under the three conditions-laboratory, in the field off-line and during on-site operation-were compared and analyzed. The results showed that the effect of the transportation process, electromagnetic environment and the adjacent phase on the accuracy of OVTs could be ignored for level 0.2, but the error characteristics of OVTs are dependent on the environmental temperature and are sensitive to the temperature gradient. The temperature characteristics during on-line operation were significantly superior to those observed in the laboratory.

  8. Body fluid analysis: clinical utility and applicability of published studies to guide interpretation of today's laboratory testing in serous fluids.

    PubMed

    Block, Darci R; Algeciras-Schimnich, Alicia

    2013-01-01

    Requests for testing various analytes in serous fluids (e.g., pleural, peritoneal, pericardial effusions) are submitted daily to clinical laboratories. Testing of these fluids deviates from assay manufacturers' specifications, as most laboratory assays are optimized for testing blood or urine specimens. These requests add a burden to clinical laboratories, which need to validate assay performance characteristics in these fluids to exclude matrix interferences (given the different composition of body fluids) while maintaining regulatory compliance. Body fluid testing for a number of analytes has been reported in the literature; however, understanding the clinical utility of these analytes is critical because laboratories must address the analytic and clinical validation requirements, while educating clinicians on proper test utilization. In this article, we review the published data to evaluate the clinical utility of testing for numerous analytes in body fluid specimens. We also highlight the pre-analytic and analytic variables that need to be considered when reviewing published studies in body fluid testing. Finally, we provide guidance on how published studies might (or might not) guide interpretation of test results in today's clinical laboratories.

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

    PubMed

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

    2017-09-01

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

  10. 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

  11. 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.

  12. Crush Testing at Oak Ridge National Laboratory

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

    Feldman, Matthew R

    2011-01-01

    The dynamic crush test is required in the certification testing of some small Type B transportation packages. International Atomic Energy Agency regulations state that the test article must be 'subjected to a dynamic crush test by positioning the specimen on the target so as to suffer maximum damage.' Oak Ridge National Laboratory (ORNL) Transportation Technologies Group performs testing of Type B transportation packages, including the crush test, at the National Transportation Research Center in Knoxville, Tennessee (United States). This paper documents ORNL's experiences performing crush tests on several different Type B packages. ORNL has crush tested five different drum-type packagemore » designs, continuing its 60 year history of RAM package testing. A total of 26 crush tests have been performed in a wide variety of package orientations and crush plate CG alignments. In all cases, the deformation of the outer drum created by the crush test was significantly greater than the deformation damage caused by the 9 m drop test. The crush test is a highly effective means for testing structural soundness of smaller nondense Type B shipping package designs. Further regulatory guidance could alleviate the need to perform the crush test in a wide range of orientations and crush plate CG alignments.« less

  13. 75 FR 62401 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-08

    ... collection; Title of Information Collection: Clinical Laboratory Improvement Amendment (CLIA) of 1988 and... laboratories that perform testing on human beings to meet performance requirements (quality standards) in order... functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity...

  14. Testing of small and large sign support systems FOIL test number : 92F017

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 20 mi/h (8.9 m/s), test 92F017. The vehicle used for this te...

  15. Testing of small and large sign support systems FOIL test number : 92F026

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 20 mi/h (8.9 m/s), test 92F026. The vehicle used for this te...

  16. Testing of small and large sign support systems FOIL test number : 92F018

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 20 mi/h (8.9 m/s), test 92F018. The vehicle used for this te...

  17. Testing of small and large sign support systems FOIL test number : 92F015

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 20 mi/h (8.9 m/s), test 92F015. The vehicle used for these t...

  18. Testing of small and large sign support systems FOIL test number : 92F012

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 20 mi/h (8.9 m/s), test 92F012. The vehicle used for these t...

  19. Testing of small and large sign support systems FOIL test number : 92F023

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 20 mi/h (8.9 m/s), test 92F023. The vehicle used for this te...

  20. Testing of small and large sign support systems FOIL test number : 92F019

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 20 mi/h (8.9 m/s), test 92F019. The vehicle used for this te...

  1. Testing of small and large sign support systems FOIL test number : 92F014

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of a crash test performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The test was performed on a small sign support system at 20 mi/h (8.9 m/s), test 92F014. The vehicle used for these t...

  2. A comprehensive evaluation of strip performance in multiple blood glucose monitoring systems.

    PubMed

    Katz, Laurence B; Macleod, Kirsty; Grady, Mike; Cameron, Hilary; Pfützner, Andreas; Setford, Steven

    2015-05-01

    Accurate self-monitoring of blood glucose is a key component of effective self-management of glycemic control. Accurate self-monitoring of blood glucose results are required for optimal insulin dosing and detection of hypoglycemia. However, blood glucose monitoring systems may be susceptible to error from test strip, user, environmental and pharmacological factors. This report evaluated 5 blood glucose monitoring systems that each use Verio glucose test strips for precision, effect of hematocrit and interferences in laboratory testing, and lay user and system accuracy in clinical testing according to the guidelines in ISO15197:2013(E). Performance of OneTouch(®) VerioVue™ met or exceeded standards described in ISO15197:2013 for precision, hematocrit performance and interference testing in a laboratory setting. Performance of OneTouch(®) Verio IQ™, OneTouch(®) Verio Pro™, OneTouch(®) Verio™, OneTouch(®) VerioVue™ and Omni Pod each met or exceeded accuracy standards for user performance and system accuracy in a clinical setting set forth in ISO15197:2013(E).

  3. Electric Vehicle Communications Standards Testing and Validation - Phase II: SAE J2931/1

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

    Pratt, Richard M.; Gowri, Krishnan

    Vehicle to grid communication standards enable interoperability among vehicles, charging stations and utility providers and provide the capability to implement charge management. Several standards initiatives by the Society of Automobile Engineers (SAE), International Standards Organization and International Electrotechnical Commission (ISO/IEC), and ZigBee/HomePlug Alliance are developing requirements for communication messages and protocols. Recent work by the Electric Power Research Institute (EPRI) in collaboration with SAE and automobile manufacturers has identified vehicle to grid communication performance requirements and developed a test plan as part of SAE J2931/1 committee work. This laboratory test plan was approved by the SAE J2931/1 committee and includedmore » test configurations, test methods, and performance requirements to verify reliability, robustness, repeatability, maximum communication distance, and authentication features of power line carrier (PLC) communication modules at the internet protocol layer level. The goal of the testing effort was to select a communication technology that would enable automobile manufacturers to begin the development and implementation process. The EPRI/Argonne National Laboratory (ANL)/Pacific Northwest National Laboratory (PNNL) testing teams divided the testing so that results for each test could be presented by two teams, performing the tests independently. The PNNL team performed narrowband PLC testing including the Texas Instruments (TI) Concerto, Ariane Controls AC-CPM1, and the MAXIM Tahoe 2 evaluation boards. The scope of testing was limited to measuring the vendor systems communication performance between Electric Vehicle Support Equipment (EVSE) and plug-in electric vehicles (PEV). The testing scope did not address PEV’s CAN bus to PLC or PLC to EVSE (Wi-Fi, cellular, PLC Mains, etc.) communication integration. In particular, no evaluation was performed to delineate the effort needed to translate the IPv6/SEP2.0 messages to PEV’s CAN bus. The J2931/1 laboratory test results were presented to the SAE membership on March 20-22, 2012. The SAE committee decided to select HomePlug GreenPHY (HPGP) as the communication technology to use between the PEV and EVSE. No technology completely met all performance requirements. Both the MAXIM Tahoe 2 and TI Concerto met the 100Kbps throughput requirement, are estimated to meet the latency measurement performance, and met the control pilot impairment requirements. But HPGP demonstrated the potential to provide a data throughput rate of 10x of the requirement and either met or showed the potential to meet the other requirements with further development.« less

  4. 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.

  5. VHF Transceiver Emissions in the GPS L1 Band

    DOT National Transportation Integrated Search

    1995-02-27

    VHF transceiver tests described in this report were performed at the Volpe National Transportation Systems Center under Federal Aviation Administration (FAA) sponsorship. Laboratory tests were performed on ten different panel-mount type, General Avia...

  6. 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...

  7. A Laboratory Course in Technological Chemistry.

    ERIC Educational Resources Information Center

    Wiseman, P.

    1986-01-01

    Describes a laboratory course taught at the University of Manchester Institute of Science and Technology (United Kingdom) which focuses on the preparation, properties, and applications of end-use products of the chemical industry. Outlines laboratory experiments on dyes, fibers, herbicides, performance testing, antioxidants, and surface active…

  8. 42 CFR 493.1 - Basis and scope.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... AND CERTIFICATION LABORATORY REQUIREMENTS General Provisions § 493.1 Basis and scope. This part sets forth the conditions that all laboratories must meet to be certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). It implements sections 1861...

  9. 42 CFR 493.1 - Basis and scope.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... AND CERTIFICATION LABORATORY REQUIREMENTS General Provisions § 493.1 Basis and scope. This part sets forth the conditions that all laboratories must meet to be certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). It implements sections 1861...

  10. Fecal Calprotectin Test Performed at Home: A Prospective Study of Pediatric Patients With Inflammatory Bowel Disease.

    PubMed

    Piekkala, Maija; Alfthan, Henrik; Merras-Salmio, Laura; Puustinen Wikström, Anne; Heiskanen, Kaarina; Jaakkola, Tytti; Klemetti, Paula; Md, Martti Färkkilä; Kolho, Kaija-Leena

    2018-06-01

    Measuring fecal calprotectin (FC) in a laboratory is time-consuming and that is why home tests have been developed. We studied the use of an FC home test in pediatric patients with inflammatory bowel disease (PIBD) in real-life settings. The patients were asked to perform the IBDoc FC home test monthly for 6 months and to report their clinical disease activity at testing. Clinical decision-making, however, was guided by routine FC enzyme-linked immunosorbent assay (ELISA) for patients with raised IBDoc values. Spare frozen samples were analyzed using ELISA and IBDoc in the laboratory. The participants completed a questionnaire about FC testing at the start and end of the study. Of the 52 patients, 35 (67%) ages 5 to 18 years completed the study, and 197 home tests were performed. Of these, 15% failed, mainly because of technical reasons. Just under half of the patients (47%) considered home testing comparable or superior to routine testing. In contrast, the parents were unsatisfied (61%), mostly because the IBDoc results were significantly different from ELISA and they found the phone application difficult to handle but whenever the IBDoc was performed by a laboratory professional it was comparable with ELISA, suggesting that practical issues hampered home testing. Despite their reservations, more than 80% of parents felt that home testing would improve disease management. PIBD patients and their families were interested in FC home monitoring and willing to adopt testing as a part of their disease management, but this approach requires thorough guidance.

  11. Comparison of RPR 'teardrop' card test, VDRL and FTA-ABS tests results on sera from persons with suspected yaws in Columbia.

    PubMed

    Hopkins, D R; Florez, D

    1977-08-01

    A small study comparing results of the rapid plasma reagin (RPR) teardrop card test performed in the field, with results of Venereal Disease Research Laboratory (VDRL) and fluorescent treponemal antibody absorption (FTA-ABS) tests performed in the laboratory on venous blood specimens from the same suspected yaws patients was undertaken in Columbia in July 1975. The results suggest that the RPR teardrop card test may be used to screen for infectious, or potentially infectious, yaws patients under field conditions, but that it will not reliably detect patients with VDRL titres of 1:2 or less, or all patients in whom sera are reactive in the FTA-ABS test.

  12. Comparison of RPR 'teardrop' card test, VDRL and FTA-ABS tests results on sera from persons with suspected yaws in Columbia.

    PubMed Central

    Hopkins, D R; Florez, D

    1977-01-01

    A small study comparing results of the rapid plasma reagin (RPR) teardrop card test performed in the field, with results of Venereal Disease Research Laboratory (VDRL) and fluorescent treponemal antibody absorption (FTA-ABS) tests performed in the laboratory on venous blood specimens from the same suspected yaws patients was undertaken in Columbia in July 1975. The results suggest that the RPR teardrop card test may be used to screen for infectious, or potentially infectious, yaws patients under field conditions, but that it will not reliably detect patients with VDRL titres of 1:2 or less, or all patients in whom sera are reactive in the FTA-ABS test. PMID:336143

  13. Using the e-Chasqui, web-based information system, to determine laboratory guidelines and data available to clinical staff.

    PubMed

    Blaya, Joaquin A; Yagui, Martin; Contreras, Carmen C; Palma, Betty; Shin, Sonya S; Yale, Gloria; Suarez, Carmen; Fraser, Hamish S F

    2008-11-06

    13% of all drug susceptibility tests (DSTs) performed at a public laboratory in Peru were duplicate. To determine reasons for duplicate requests an online survey was implemented in the e-Chasqui laboratory information system. Results showed that 59.6% of tests were ordered because clinical staff was unaware of ordering guidelines or of a previous result. This shows a benefit of using a web-based system and the lack of laboratory information available to clinical staff in Peru.

  14. 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.

  15. Ranking protective coatings: Laboratory vs. field experience

    NASA Astrophysics Data System (ADS)

    Conner, Jeffrey A.; Connor, William B.

    1994-12-01

    Environmentally protective coatings are used on a wide range of gas turbine components for survival in the harsh operating conditions of engines. A host of coatings are commercially available to protect hot-section components, ranging from simple aluminides to designer metallic overlays and ceramic thermal barrier coatings. A variety of coating-application processes are available, and they range from simple pack cementation processing to complex physical vapor deposition, which requires multimillion dollar facilities. Detailed databases are available for most coatings and coating/process combinations for a range of laboratory tests. Still, the analysis of components actually used in engines often yields surprises when compared against predicted coating behavior from laboratory testing. This paper highlights recent work to develop new laboratory tests that better simulate engine environments. Comparison of in-flight coating performance as well as industrial and factory engine testing on a range of hardware is presented along with laboratory predictions from standard testing and from recently developed cyclic burner-rig testing.

  16. 42 CFR 493.1269 - Standard: Hematology.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... materials must be tested in duplicate. (b) For all nonmanual coagulation test systems, the laboratory must...) For manual coagulation tests— (1) Each individual performing tests must test two levels of control...

  17. 42 CFR 493.1269 - Standard: Hematology.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... materials must be tested in duplicate. (b) For all nonmanual coagulation test systems, the laboratory must...) For manual coagulation tests— (1) Each individual performing tests must test two levels of control...

  18. 42 CFR 493.1269 - Standard: Hematology.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... materials must be tested in duplicate. (b) For all nonmanual coagulation test systems, the laboratory must...) For manual coagulation tests— (1) Each individual performing tests must test two levels of control...

  19. 42 CFR 493.1269 - Standard: Hematology.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... materials must be tested in duplicate. (b) For all nonmanual coagulation test systems, the laboratory must...) For manual coagulation tests— (1) Each individual performing tests must test two levels of control...

  20. 42 CFR 493.1269 - Standard: Hematology.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... materials must be tested in duplicate. (b) For all nonmanual coagulation test systems, the laboratory must...) For manual coagulation tests— (1) Each individual performing tests must test two levels of control...

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

    PubMed

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

    2015-12-01

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

  2. An Examination of Career Satisfaction for Medical Laboratory Professionals Using Wlodkowski's Motivational Framework

    ERIC Educational Resources Information Center

    Kenwright, Kathleen M.

    2016-01-01

    Medical laboratory science professionals are healthcare practitioners who provide laboratory data that aids in the diagnosis, treatment, and prevention of disease. However, there is a large shortage of these professionals who perform the laboratory tests behind the scenes with very minimal patient contact. The purpose of this research was to…

  3. Finite element analysis of constrained total Condylar Knee Prosthesis

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

    NONE

    1998-07-13

    Exactech, Inc., is a prosthetic joint manufacturer based in Gainesville, FL. The company set the goal of developing a highly effective prosthetic articulation, based on scientific principles, not trial and error. They developed an evolutionary design for a total knee arthroplasty system that promised improved performance. They performed static load tests in the laboratory with similar previous designs, but dynamic laboratory testing was both difficult to perform and prohibitively expensive for a small business to undertake. Laboratory testing also cannot measure stress levels in the interior of the prosthesis where failures are known to initiate. To fully optimize their designsmore » for knee arthroplasty revisions, they needed range-of-motion stress/strain data at interior as well as exterior locations within the prosthesis. LLNL developed computer software (especially NIKE3D) specifically designed to perform stress/strain computations (finite element analysis) for complex geometries in large displacement/large deformation conditions. Additionally, LLNL had developed a high fidelity knee model for other analytical purposes. The analysis desired by Exactech could readily be performed using NIKE3D and a modified version of the high fidelity knee that contained the geometry of the condylar knee components. The LLNL high fidelity knee model was a finite element computer model which would not be transferred to Exactech during the course of this CRADA effort. The previously performed laboratory studies by Exactech were beneficial to LLNL in verifying the analytical capabilities of NIKE3D for human anatomical modeling. This, in turn, gave LLNL further entree to perform work-for-others in the prosthetics field. There were two purposes to the CRADA (1) To modify the LLNL High Fidelity Knee Model to accept the geometry of the Exactech Total Knee; and (2) To perform parametric studies of the possible design options in appropriate ranges of motion so that an optimum design could be selected for production. Because of unanticipated delays in the CRADA funding, the knee design had to be finalized before the analysis could be accomplished. Thus, the scope of work was modified by the industrial partner. It was decided that it would be most beneficial to perform FEA that would closely replicate the lab tests that had been done as the basis of the design. Exactech was responsible for transmitting the component geometries to Livermore, as well as providing complete data from the quasi-static laboratory loading tests that were performed on various designs. LLNL was responsible for defining the basic finite element mesh and carrying out the analysis. We performed the initial computer simulation and verified model integrity, using the laboratory data. After performing the parametric studies, the results were reviewed with Exactech. Also, the results were presented at the Orthopedic Research Society meeting in a poster session.« less

  4. 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

  5. Comparison Between Simulated and Experimentally Measured Performance of a Four Port Wave Rotor

    NASA Technical Reports Server (NTRS)

    Paxson, Daniel E.; Wilson, Jack; Welch, Gerard E.

    2007-01-01

    Performance and operability testing has been completed on a laboratory-scale, four-port wave rotor, of the type suitable for use as a topping cycle on a gas turbine engine. Many design aspects, and performance estimates for the wave rotor were determined using a time-accurate, one-dimensional, computational fluid dynamics-based simulation code developed specifically for wave rotors. The code follows a single rotor passage as it moves past the various ports, which in this reference frame become boundary conditions. This paper compares wave rotor performance predicted with the code to that measured during laboratory testing. Both on and off-design operating conditions were examined. Overall, the match between code and rig was found to be quite good. At operating points where there were disparities, the assumption of larger than expected internal leakage rates successfully realigned code predictions and laboratory measurements. Possible mechanisms for such leakage rates are discussed.

  6. 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

  7. Impact of clinical awareness and diagnostic tests on the underdiagnosis of Clostridium difficile infection.

    PubMed

    Alcalá, L; Reigadas, E; Marín, M; Martín, A; Catalán, P; Bouza, E

    2015-08-01

    A multicenter study of Clostridium difficile infection (CDI) performed during 2008 in Spain revealed that two of every three episodes went undiagnosed or were misdiagnosed owing to nonsensitive diagnostic tests or lack of clinical suspicion and request. Since then, efforts have been made to improve the diagnostic tests used by laboratories and to increase the awareness of this disease among both clinicians and microbiologists. Our objective was to evaluate the impact of these efforts by assessing the current magnitude of underdiagnosis of CDI in Spain using two point-prevalence studies performed on one day each in January and July of 2013. A total of 111 Spanish laboratories selected all unformed stool specimens received for microbiological diagnosis on these days, and toxigenic culture was performed at a central reference laboratory. Toxigenic isolates were characterized both pheno- and genotypically. The reference laboratory detected 103 episodes of CDI in patients aged 2 years or more. Half (50.5 %) of the episodes were not diagnosed in the participating laboratories, owing to insensitive diagnostic tests (15.5 %) or the lack of clinical suspicion and request (35.0 %). The main ribotypes were 014, 078/126, 001/072, and 106. Ribotype 027 caused 2.9 % of all cases. Despite all the interventions undertaken, CDI remains a highly neglected disease because of the lack of sensitive diagnostic tests in some institutions and, especially, the absence of clinical suspicion, mainly in patients with community-associated CDI. Toxigenic C. difficile should be routinely sought in unformed stools sent for microbiological diagnosis, regardless of their origin.

  8. 9 CFR 147.52 - Approved tests.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... for use. The cooperating laboratories must perform the assay exactly as stated in the supplied instructions. Each laboratory must test a panel of at least 25 known positive clinical samples supplied by the...) H7L4S3. (3) DuPont Qualicon BAX Polymerase Chain Reaction (PCR)-based assay for Salmonella, DuPont...

  9. 9 CFR 147.52 - Approved tests.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... for use. The cooperating laboratories must perform the assay exactly as stated in the supplied instructions. Each laboratory must test a panel of at least 25 known positive clinical samples supplied by the...) H7L4S3. (3) DuPont Qualicon BAX Polymerase Chain Reaction (PCR)-based assay for Salmonella, DuPont...

  10. 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

  11. 77 FR 56846 - Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-14

    ... certificate from the Secretary of Health and Human Services (the Secretary), before accepting materials derived from the human body for laboratory tests (42 U.S.C. 263a(b)). Laboratories that perform only tests... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0937...

  12. 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.

  13. 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

  14. 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

  15. 33 CFR 209.340 - Laboratory investigations and materials testing.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... hydraulic laboratories, and to the Inter-Agency Sedimentation Project. (c) References. (1) AR 37-20. (2) AR... ordinary business channels. (3) Performance of the work will not interfere with provisions of services... with the same procedures as apply to Division Materials Laboratories. (3) Inter-Agency Sedimentation...

  16. 33 CFR 209.340 - Laboratory investigations and materials testing.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... hydraulic laboratories, and to the Inter-Agency Sedimentation Project. (c) References. (1) AR 37-20. (2) AR... ordinary business channels. (3) Performance of the work will not interfere with provisions of services... with the same procedures as apply to Division Materials Laboratories. (3) Inter-Agency Sedimentation...

  17. Blood-alcohol proficiency test program

    DOT National Transportation Integrated Search

    1975-01-01

    A preliminary survey has been performed to ascertain the validity of the blood alcohol analysis performed by a number of laboratories on a voluntary basis. Values of accuracy and precision of the tests are presented. /Abstract from report summary pag...

  18. Asphalt mixture performance characterization using small-scale cylindrical specimens.

    DOT National Transportation Integrated Search

    2015-06-01

    The results of dynamic modulus testing have become one of the primarily used performance criteria to evaluate the : laboratory properties of asphalt mixtures. This test is commonly conducted to characterize asphalt mixtures mechanistically : using an...

  19. Performance of the High-Energy Single-Event Effects Test Facility (SEETF) at Michigan State University's National Superconducting Cyclotron Laboratory (NSCL)

    NASA Technical Reports Server (NTRS)

    Ladbury, R.; Reed, R. A.; Marshall, P. W.; LaBel, K. A.; Anantaraman, R.; Fox, R.; Sanderson, D. P.; Stolz, A.; Yurkon, J.; Zeller, A. F.; hide

    2004-01-01

    The performance of Michigan State University's Single-Event Effects Test Facility (SEETF) during its inaugural runs is evaluated. Beam profiles and other diagnostics are presented, and prospects for future development and testing are discussed.

  20. Testing of small and large sign support systems FOIL test numbers : 92F009 and 92F010

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of two crash tests performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The/tests were performed on a small sign support system at 20 rni/h (8.9 m/s), test 92F009 and 60 mi/h (26.8 m/s),...

  1. Testing of small and large sign support systems FOIL test numbers : 92F024 and 92F025

    DOT National Transportation Integrated Search

    1994-07-01

    This test report contains the results of two crash tests performed at the Federal Outdoor Impact Laboratory (FOIL) in McLean, Virginia. The tests were performed on a small sign support system at 20 mi/h (8.9 m/s), test 92F024, and 60 mi/h (26.8 m/s),...

  2. Cost-price estimation of clinical laboratory services based on activity-based costing: A case study from a developing country.

    PubMed

    Mouseli, Ali; Barouni, Mohsen; Amiresmaili, Mohammadreza; Samiee, Siamak Mirab; Vali, Leila

    2017-04-01

    It is believed that laboratory tariffs in Iran don't reflect the real costs. This might expose private laboratories at financial hardship. Activity Based Costing is widely used as a cost measurement instrument to more closely approximate the true cost of operations. This study aimed to determine the real price of different clinical tests of a selected private clinical laboratory. This study was a cross sectional study carried out in 2015. The study setting was the private laboratories in the city of Kerman, Iran. Of 629 tests in the tariff book of the laboratory (relative value), 188 tests were conducted in the laboratory that used Activity Based Costing (ABC) methodology to estimate cost-price. Analyzing and cost-price estimating of laboratory services were performed by MY ABCM software Version 5.0. In 2015, the total costs were $641,645. Direct and indirect costs were 78.3% and 21.7% respectively. Laboratory consumable costs by 37% and personnel costs by 36.3% had the largest share of the costing. Also, group of hormone tests cost the most $147,741 (23.03%), and other tests group cost the least $3,611 (0.56%). Also after calculating the cost of laboratory services, a comparison was made between the calculated price and the private sector's tariffs in 2015. This study showed that there was a difference between costs and tariffs in the private laboratory. One way to overcome this problem is to increase the number of laboratory tests with regard to capacity of the laboratories.

  3. Cost-price estimation of clinical laboratory services based on activity-based costing: A case study from a developing country

    PubMed Central

    Mouseli, Ali; Barouni, Mohsen; Amiresmaili, Mohammadreza; Samiee, Siamak Mirab; Vali, Leila

    2017-01-01

    Background It is believed that laboratory tariffs in Iran don’t reflect the real costs. This might expose private laboratories at financial hardship. Activity Based Costing is widely used as a cost measurement instrument to more closely approximate the true cost of operations. Objective This study aimed to determine the real price of different clinical tests of a selected private clinical laboratory. Methods This study was a cross sectional study carried out in 2015. The study setting was the private laboratories in the city of Kerman, Iran. Of 629 tests in the tariff book of the laboratory (relative value), 188 tests were conducted in the laboratory that used Activity Based Costing (ABC) methodology to estimate cost-price. Analyzing and cost-price estimating of laboratory services were performed by MY ABCM software Version 5.0. Results In 2015, the total costs were $641,645. Direct and indirect costs were 78.3% and 21.7% respectively. Laboratory consumable costs by 37% and personnel costs by 36.3% had the largest share of the costing. Also, group of hormone tests cost the most $147,741 (23.03%), and other tests group cost the least $3,611 (0.56%). Also after calculating the cost of laboratory services, a comparison was made between the calculated price and the private sector’s tariffs in 2015. Conclusion This study showed that there was a difference between costs and tariffs in the private laboratory. One way to overcome this problem is to increase the number of laboratory tests with regard to capacity of the laboratories. PMID:28607638

  4. 42 CFR 493.1495 - Standard; Testing personnel responsibilities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... experience, and technical abilities. (b) Each individual performing high complexity testing must— (1) Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and...

  5. Learning in the Laboratory: How Group Assignments Affect Motivation and Performance

    ERIC Educational Resources Information Center

    Belanger, John R.

    2016-01-01

    Team projects can optimize educational resources in a laboratory, but also create the potential for social loafing. Allowing students to choose their own groups could increase their motivation to learn and improve academic performance. To test this hypothesis, final grades and feedback from students were compared for the same course in two…

  6. Lithium-Ion Battery Demonstrated for NASA Desert Research and Technology Studies

    NASA Technical Reports Server (NTRS)

    Bennett, William R.; Baldwin, Richard S.

    2008-01-01

    Lithium-ion batteries have attractive performance characteristics that are well suited to a number of NASA applications. These rechargeable batteries produce compact, lightweight energy-storage systems with excellent cycle life, high charge/discharge efficiency, and low self-discharge rate. NASA Glenn Research Center's Electrochemistry Branch designed and produced five lithium-ion battery packs configured to power the liquid-air backpack (LAB) on spacesuit simulators. The demonstration batteries incorporated advanced, NASA-developed electrolytes with enhanced low-temperature performance characteristics. The objectives of this effort were to (1) demonstrate practical battery performance under field-test conditions and (2) supply laboratory performance data under controlled laboratory conditions. Advanced electrolyte development is being conducted under the Exploration Technology Development Program by the NASA Jet Propulsion Laboratory. Three field trials were successfully completed at Cinder Lake from September 10 to 12, 2007. Extravehicular activities of up to 1 hr and 50 min were supported, with residual battery capacity sufficient for 30 min of additional run time. Additional laboratory testing of batteries and cells is underway at Glenn s Electrochemical Branch.

  7. 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

  8. Poly(2,5-bis(N-Methyl-N-Hexylamino)Phenylene Vinylene) (BAM-PPV) as Pretreatment Coating for Aerospace Applications: Laboratory and Field Studies

    PubMed Central

    Zarras, Peter; Buhrmaster, Diane; Webber, Cindy; Anderson, Nicole; Stenger-Smith, John D.; Goodman, Paul A.

    2014-01-01

    In this study, an electroactive polymer (EAP), poly(2,5-bis(N-methyl-N-hexylamino)phenylene vinylene) (BAM-PPV) was investigated as a potential alternative surface pretreatment for hexavalent chromium (Cr(VI))-based aerospace coatings. BAM-PPV was tested as a pretreatment coating on an aerospace aluminum alloy (AA2024-T3) substrate in combination with a non-Cr(VI) epoxy primer and a polyurethane Advanced Performance Coating (APC) topcoat. This testing was undertaken to determine BAM-PPV’s adhesion, corrosion-inhibition, compatibility and survivability in laboratory testing and during outdoor field-testing. BAM-PPV showed excellent adhesion and acceptable corrosion performance in laboratory testing. The BAM-PPV aerospace coating system (BAM-PPV, non-Cr(VI) epoxy primer and polyurethane APC topcoat) was field tested for one year on the rear hatch door of the United States Air Force C-5 cargo plane. After one year of field testing there was no evidence of delamination or corrosion of the BAM-PPV aerospace coating system. PMID:28788292

  9. Poly(2,5-bis(N-Methyl-N-Hexylamino)Phenylene Vinylene) (BAM-PPV) as Pretreatment Coating for Aerospace Applications: Laboratory and Field Studies.

    PubMed

    Zarras, Peter; Buhrmaster, Diane; Webber, Cindy; Anderson, Nicole; Stenger-Smith, John D; Goodman, Paul A

    2014-12-17

    In this study, an electroactive polymer (EAP), poly(2,5-bis( N -methyl- N -hexylamino)phenylene vinylene) (BAM-PPV) was investigated as a potential alternative surface pretreatment for hexavalent chromium (Cr(VI))-based aerospace coatings. BAM-PPV was tested as a pretreatment coating on an aerospace aluminum alloy (AA2024-T3) substrate in combination with a non-Cr(VI) epoxy primer and a polyurethane Advanced Performance Coating (APC) topcoat. This testing was undertaken to determine BAM-PPV's adhesion, corrosion-inhibition, compatibility and survivability in laboratory testing and during outdoor field-testing. BAM-PPV showed excellent adhesion and acceptable corrosion performance in laboratory testing. The BAM-PPV aerospace coating system (BAM-PPV, non-Cr(VI) epoxy primer and polyurethane APC topcoat) was field tested for one year on the rear hatch door of the United States Air Force C-5 cargo plane. After one year of field testing there was no evidence of delamination or corrosion of the BAM-PPV aerospace coating system.

  10. Comparative Validation of Five Quantitative Rapid Test Kits for the Analysis of Salt Iodine Content: Laboratory Performance, User- and Field-Friendliness

    PubMed Central

    Rohner, Fabian; Kangambèga, Marcelline O.; Khan, Noor; Kargougou, Robert; Garnier, Denis; Sanou, Ibrahima; Ouaro, Bertine D.; Petry, Nicolai; Wirth, James P.; Jooste, Pieter

    2015-01-01

    Background Iodine deficiency has important health and development consequences and the introduction of iodized salt as national programs has been a great public health success in the past decades. To render national salt iodization programs sustainable and ensure adequate iodization levels, simple methods to quantitatively assess whether salt is adequately iodized are required. Several methods claim to be simple and reliable, and are available on the market or are in development. Objective This work has validated the currently available quantitative rapid test kits (quantRTK) in a comparative manner for both their laboratory performance and ease of use in field settings. Methods Laboratory performance parameters (linearity, detection and quantification limit, intra- and inter-assay imprecision) were conducted on 5 quantRTK. We assessed inter-operator imprecision using salt of different quality along with the comparison of 59 salt samples from across the globe; measurements were made both in a laboratory and a field setting by technicians and non-technicians. Results from the quantRTK were compared against iodometric titration for validity. An ‘ease-of-use’ rating system was developed to identify the most suitable quantRTK for a given task. Results Most of the devices showed acceptable laboratory performance, but for some of the devices, use by non-technicians revealed poorer performance when working in a routine manner. Of the quantRTK tested, the iCheck® and I-Reader® showed most consistent performance and ease of use, and a newly developed paper-based method (saltPAD) holds promise if further developed. Conclusions User- and field-friendly devices are now available and the most appropriate quantRTK can be selected depending on the number of samples and the budget available. PMID:26401655

  11. Verification of examination procedures in clinical laboratory for imprecision, trueness and diagnostic accuracy according to ISO 15189:2012: a pragmatic approach.

    PubMed

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

    2017-08-28

    Background The International Standard ISO 15189 is recognized as a valuable guide in ensuring high quality clinical laboratory services and promoting the harmonization of accreditation programmes in laboratory medicine. Examination procedures must be verified in order to guarantee that their performance characteristics are congruent with the intended scope of the test. The aim of the present study was to propose a practice model for implementing procedures employed for the verification of validated examination procedures already used for at least 2 years in our laboratory, in agreement with the ISO 15189 requirement at the Section 5.5.1.2. Methods In order to identify the operative procedure to be used, approved documents were identified, together with the definition of performance characteristics to be evaluated for the different methods; the examination procedures used in laboratory were analyzed and checked for performance specifications reported by manufacturers. Then, operative flow charts were identified to compare the laboratory performance characteristics with those declared by manufacturers. Results The choice of performance characteristics for verification was based on approved documents used as guidance, and the specific purpose tests undertaken, a consideration being made of: imprecision and trueness for quantitative methods; diagnostic accuracy for qualitative methods; imprecision together with diagnostic accuracy for semi-quantitative methods. Conclusions The described approach, balancing technological possibilities, risks and costs and assuring the compliance of the fundamental component of result accuracy, appears promising as an easily applicable and flexible procedure helping laboratories to comply with the ISO 15189 requirements.

  12. 7 CFR 90.102 - Quality assurance review.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

  13. 7 CFR 90.102 - Quality assurance review.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

  14. 7 CFR 90.102 - Quality assurance review.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

  15. 7 CFR 90.102 - Quality assurance review.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

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

    Ahrens, J.S.

    For over fifteen years Sandia National Laboratories has been involved in laboratory testing of biometric identification devices. The key concept of biometric identification devices is the ability for the system to identify some unique aspect of the individual rather than some object a person may be carrying or some password they are required to know. Tests were conducted to verify manufacturer`s performance claims, to determine strengths/weaknesses of devices, and to determine devices that meet the US Department of energy`s needs. However, during recent field installation, significantly different performance was observed than was predicted by laboratory tests. Although most people usingmore » the device believed it operated adequately, the performance observed was over an order of magnitude worse than predicted. The search for reasons behind this gap between the predicted and the actual performance has revealed many possible contributing factors. As engineers, the most valuable lesson to be learned from this experience is the value of scientists and engineers with (1) common sense, (2) knowledge of human behavior, (3) the ability to observe the real world, and (4) the capability to realize the significant differences between controlled experiments and actual installations.« less

  17. Interactive laboratory classes enhance neurophysiological knowledge in Thai medical students.

    PubMed

    Wongjarupong, Nicha; Niyomnaitham, Danai; Vilaisaktipakorn, Pitchamol; Suksiriworaboot, Tanawin; Qureshi, Shaun Peter; Bongsebandhu-Phubhakdi, Saknan

    2018-03-01

    Interactive laboratory class (ILC) is a two-way communication teaching method that encourages students to correlate laboratory findings with materials from lectures. In Thai medical education, active learning methods are uncommon. This paper aims to establish 1) if ILCs would effectively promote physiology learning; 2) if effectiveness would be found in both previously academically high-performing and low-performing students; and 3) the acceptability of ILCs to Thai medical students as a novel learning method. Two hundred seventy-eight second-year medical students were recruited to this study. We conducted three ILC sessions, which followed corresponding lectures. We carried out multiple-choice pre- and post-ILC assessments of knowledge and compared by repeated-measures ANOVA and unpaired t-test. Subgroup analysis was performed to compare high-performance (HighP) and low-performance (LowP) students. After the ILCs, participants self-rated their knowledge and satisfaction. Post-ILC test scores increased significantly compared with pre-ILC test scores in all three sessions. Mean scores of each post-ILC test increased significantly from pre-ILC test in both LowP and HighP groups. More students self-reported a "very high" and "high" level of knowledge after ILCs. Most students agreed that ILCs provided more discussion opportunity, motivated their learning, and made lessons more enjoyable. As an adjunct to lectures, ILCs can enhance knowledge in medical students, regardless of previous academic performance. Students perceived ILC as useful and acceptable. This study supports the active learning methods in physiology education, regardless of cultural context.

  18. Selective testing of women based on age for genital Chlamydia trachomatis and Neisseria gonorrhoeae infection in a centralized regional microbiology laboratory.

    PubMed

    Church, Deirdre L; Amante, L; Semeniuk, H; Gregson, D B

    2007-04-01

    Calgary Laboratory Services, Alberta, Canada, provides microbiology services via a centralized laboratory to the Calgary Health Region. A selective genital Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (GC) testing policy for women >35 years was implemented. The changes in physician ordering practice, the rate of detection of infections, and the test turnaround times were monitored. The volume of tests, the cost/test, and the total service costs accrued in the year before and after this policy change were compared. An immediate impact was a 30% decrease in tests performed due to the laboratory rejecting samples from older women. Subsequently, physicians' practice changed so that tests were ordered when test criteria were met. Detection rates did not change in any age group. A 27.9% decrease in the total service costs resulted in a labor reduction of 0.2 FTE. Selective testing of women >35 years with a low prevalence of CT/GC infection is clinically relevant and cost-effective.

  19. Thermal comfort of aeroplane seats: influence of different seat materials and the use of laboratory test methods.

    PubMed

    Bartels, Volkmar T

    2003-07-01

    This study determined the influence of different cover and cushion materials on the thermal comfort of aeroplane seats. Different materials as well as ready made seats were investigated by the physiological laboratory test methods Skin Model and seat comfort tester. Additionally, seat trials with human test subjects were performed in a climatic chamber. Results show that a fabric cover produces a considerably higher sweat transport than leather. A three-dimensional knitted spacer fabric turns out to be the better cushion alternative in comparison to a moulded foam pad. Results from the physiological laboratory test methods nicely correspond to the seat trials with human test subjects.

  20. Assessing students' learning outcomes, self-efficacy and attitudes toward the integration of virtual science laboratory in general physics

    NASA Astrophysics Data System (ADS)

    Ghatty, Sundara L.

    Over the past decade, there has been a dramatic rise in online delivery of higher education in the United States. Recent developments in web technology and access to the internet have led to a vast increase in online courses. For people who work during the day and whose complicated lives prevent them from taking courses on campus, online courses are the only alternatives by which they may achieve their goals in education. The laboratory courses are the major requirements for college and university students who want to pursue degree and certification programs in science. It is noted that there is a lack of laboratory courses in online physics courses. The present study addressed the effectiveness of a virtual science laboratory in physics instruction in terms of learning outcomes, attitudes, and self-efficacy of students in a Historically Black University College. The study included fifty-eight students (36 male and 22 female) of different science majors who were enrolled in a general physics laboratory course. They were divided into virtual and traditional groups. Three experiments were selected from the syllabus. The traditional group performed one experiment in a traditional laboratory, while the virtual group performed the same experiment in a virtual laboratory. For the second experiment, the use of laboratories by both groups was exchanged. Learner's Assessment Test (LAT), Attitudes Toward Physics Laboratories (ATPL), and Self-Efficacy Survey (SES) instruments were used. Additionally, quantitative methods such as an independent t-test, a paired t-test, and correlation statistics were used to analyze the data. The results of the first experiment indicated the learning outcomes were higher in the Virtual Laboratory than in the traditional laboratory, whereas there was no significant difference in learning outcomes with either type of lab instruction. However, significant self-efficacy gains were observed. Students expressed positive attitudes in terms of liking as well as interests in performing experiments in virtual laboratories. No gender differences were observed in learning outcomes or self-efficacy. The results of the study indicated that virtual laboratories may be a substitute for traditional laboratories to some extent, and may play a vital role in online science courses.

  1. NACA Photographer Films a Ramjet Test

    NASA Image and Video Library

    1946-10-21

    A National Advisory Committee for Aeronautics (NACA) photographer films the test of a ramjet engine at the Lewis Flight Propulsion Laboratory. The laboratory had an arsenal of facilities to test the engines and their components, and immersed itself in the study of turbojet and ramjet engines during the mid-1940s. Combustion, fuel injection, flameouts, and performance at high altitudes were of particular interest to researchers. They devised elaborate schemes to instrument the engines in order to record temperature, pressure, and other data. Many of the tests were also filmed so Lewis researchers could visually review the combustion performance along with the data. The photographer in this image was using high-speed film to document a thrust augmentation study at Lewis’ Jet Static Propulsion Laboratory. The ramjet in this photograph was equipped with a special afterburner as part of a general effort to improve engine performance. Lewis’ Photo Lab was established in 1942. The staff was expanded over the next few years as more test facilities became operational. The Photo Lab’s staff and specialized equipment have been key research tools for decades. They accompany pilots on test flights, use high-speed cameras to capture fleeting processes like combustion, and work with technology, such as the Schlieren camera, to capture supersonic aerodynamics. In addition, the group has documented construction projects, performed publicity work, created images for reports, and photographed data recording equipment.

  2. Development of a wideband pulse quaternary modulation system. [for an operational 400 Mbps baseband laser communication system

    NASA Technical Reports Server (NTRS)

    Federhofer, J. A.

    1974-01-01

    Laboratory data verifying the pulse quaternary modulation (PQM) theoretical predictions is presented. The first laboratory PQM laser communication system was successfully fabricated, integrated, tested and demonstrated. System bit error rate tests were performed and, in general, indicated approximately a 2 db degradation from the theoretically predicted results. These tests indicated that no gross errors were made in the initial theoretical analysis of PQM. The relative ease with which the entire PQM laboratory system was integrated and tested indicates that PQM is a viable candidate modulation scheme for an operational 400 Mbps baseband laser communication system.

  3. The Ships Below-Decks Electromagnetic Compatibility (EMC) Program. A compilation of Papers Presented at the 1987 IEEE International Symposium on EMC

    DTIC Science & Technology

    1987-09-30

    were producing below-deck environ - such that after 24 hours the performance loss ranged mental levels exceeding the "normal" environmental from 13 to...SGA performance environmental EMI testing in the electromagnetically measurements b- made in the laboratory. However, it quiet laboratory environments ... Environmentally Sealed SGAs.................................... 1-1 Need for Long Term SGA Performance Evaluation .................... 1-2 Performance

  4. Analytic Validation of Immunohistochemical Assays: A Comparison of Laboratory Practices Before and After Introduction of an Evidence-Based Guideline.

    PubMed

    Fitzgibbons, Patrick L; Goldsmith, Jeffrey D; Souers, Rhona J; Fatheree, Lisa A; Volmar, Keith E; Stuart, Lauren N; Nowak, Jan A; Astles, J Rex; Nakhleh, Raouf E

    2017-09-01

    - Laboratories must demonstrate analytic validity before any test can be used clinically, but studies have shown inconsistent practices in immunohistochemical assay validation. - To assess changes in immunohistochemistry analytic validation practices after publication of an evidence-based laboratory practice guideline. - A survey on current immunohistochemistry assay validation practices and on the awareness and adoption of a recently published guideline was sent to subscribers enrolled in one of 3 relevant College of American Pathologists proficiency testing programs and to additional nonsubscribing laboratories that perform immunohistochemical testing. The results were compared with an earlier survey of validation practices. - Analysis was based on responses from 1085 laboratories that perform immunohistochemical staining. Of 1057 responses, 65.4% (691) were aware of the guideline recommendations before this survey was sent and 79.9% (550 of 688) of those have already adopted some or all of the recommendations. Compared with the 2010 survey, a significant number of laboratories now have written validation procedures for both predictive and nonpredictive marker assays and specifications for the minimum numbers of cases needed for validation. There was also significant improvement in compliance with validation requirements, with 99% (100 of 102) having validated their most recently introduced predictive marker assay, compared with 74.9% (326 of 435) in 2010. The difficulty in finding validation cases for rare antigens and resource limitations were cited as the biggest challenges in implementing the guideline. - Dissemination of the 2014 evidence-based guideline validation practices had a positive impact on laboratory performance; some or all of the recommendations have been adopted by nearly 80% of respondents.

  5. Using pathology-specific laboratory profiles in Clinical Pathology to reduce inappropriate test requesting: two completed audit cycles

    PubMed Central

    2012-01-01

    Background Systematic reviews have shown that, although well prepared, the Consensus Guidelines have failed to change clinical practice. In the healthcare district of Castelnovo né Monti (Reggio Emilia, Italy), it became necessary for the GPs and Clinical Pathologists to work together to jointly define laboratory profiles. Methods Observational study with two cycles of retrospective audit on test request forms, in a primary care setting. Objectives of the study were to develop pathology-specific laboratory profiles and to increase the number of provisional diagnoses on laboratory test request forms. A Multiprofessional Multidisciplinary Inter-hospital Work Team developed pathology-specific laboratory profiles for more effective test requesting. After 8 training sessions that used a combined strategy with multifaceted interventions, the 23 General Practitioners (GPs) in the trial district (Castelnovo nè Monti) tested the profiles; the 21 GPs in the Puianello district were the control group; all GPs in both districts participated in the trial. All laboratory tests for both healthcare districts are performed at the Laboratory located in the trial district. A baseline and a 1-year audit were performed in both districts on the GPs’ request forms. Results Seven pathology-specific laboratory profiles for outpatients were developed. In the year after the first audit cycle: 1) the number of tests requested in the trial district was distinctly lower than that in the previous year, with a decrease of about 5% (p < 0.001); 2) the provisional diagnosis on the request forms was 52.8% in the trial district and 42% in the control district (P < 0.001); 3) the decrease of the number of tests on each request form was much more marked in the trial district (8.73 vs. 10.77; p < 0.001). Conclusions The first audit cycle showed a significant decrease in the number of tests ordered only in the trial district. The combined strategy used in this study improved the prescriptive compliance of most of the GPs involved. The presence of the clinical pathologist is seen as an added value. PMID:22759353

  6. Using pathology-specific laboratory profiles in clinical pathology to reduce inappropriate test requesting: two completed audit cycles.

    PubMed

    Baricchi, Roberto; Zini, Michele; Nibali, Maria Grazia; Vezzosi, Walter; Insegnante, Vincenzo; Manfuso, Clotilde; Polese, Alessandra; Costoli, Valmer; Spelti, Antonio; Formisano, Debora; Orlandini, Danilo; Nicolini, Fausto; Poli, Antonio

    2012-07-03

    Systematic reviews have shown that, although well prepared, the Consensus Guidelines have failed to change clinical practice. In the healthcare district of Castelnovo né Monti (Reggio Emilia, Italy), it became necessary for the GPs and Clinical Pathologists to work together to jointly define laboratory profiles. Observational study with two cycles of retrospective audit on test request forms, in a primary care setting. Objectives of the study were to develop pathology-specific laboratory profiles and to increase the number of provisional diagnoses on laboratory test request forms. A Multiprofessional Multidisciplinary Inter-hospital Work Team developed pathology-specific laboratory profiles for more effective test requesting. After 8 training sessions that used a combined strategy with multifaceted interventions, the 23 General Practitioners (GPs) in the trial district (Castelnovo nè Monti) tested the profiles; the 21 GPs in the Puianello district were the control group; all GPs in both districts participated in the trial. All laboratory tests for both healthcare districts are performed at the Laboratory located in the trial district. A baseline and a 1-year audit were performed in both districts on the GPs' request forms. Seven pathology-specific laboratory profiles for outpatients were developed. In the year after the first audit cycle: 1) the number of tests requested in the trial district was distinctly lower than that in the previous year, with a decrease of about 5% (p < 0.001); 2) the provisional diagnosis on the request forms was 52.8% in the trial district and 42% in the control district (P < 0.001); 3) the decrease of the number of tests on each request form was much more marked in the trial district (8.73 vs. 10.77; p < 0.001). The first audit cycle showed a significant decrease in the number of tests ordered only in the trial district. The combined strategy used in this study improved the prescriptive compliance of most of the GPs involved. The presence of the clinical pathologist is seen as an added value.

  7. Integrated Data Collection Analysis (IDCA) program--KClO 4/Dodecane Mixture

    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 results for impact, friction, electrostatic discharge, and differential scanning calorimetry analysis of a mixture of KClO 4 and dodecane—KClO 4/dodecane mixture. This material was selected because of the challenge of performing SSST testing of a mixture of solid and liquid materials. The mixture was found to: 1) be less sensitive to impact than RDX, and PETN, 2) less sensitive to friction than RDX and PETN, and 3) less sensitive to spark thanmore » RDX and PETN. The thermal analysis showed little or no exothermic features suggesting that the dodecane volatilized at low temperatures. A prominent endothermic feature was observed and assigned to a phase transition of KClO 4. This effort, funded by the Department of Homeland Security (DHS), ultimately will put 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 has the potential to 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. Note, however, the test procedures differ among the laboratories. The results are compared among the laboratories and then compared to historical data from various sources. The testing performers involved for the KClO 4/dodecane mixture are Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Indian Head Division, Naval Surface Warfare Center, (NSWC IHD), 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 understand how to compare results when these testing variables cannot be made consistent.« less

  8. Corrosion Performance of New Generation Aluminum-Lithium Alloys for Aerospace Applications

    NASA Astrophysics Data System (ADS)

    Moran, James P.; Bovard, Francine S.; Chrzan, James D.; Vandenburgh, Peter

    Over the past several years, a new generation of aluminum-lithium alloys has been developed. These alloys are characterized by excellent strength, low density, and high modulus of elasticity and are therefore of interest for lightweight structural materials applications particularly for construction of current and future aircraft. These new alloys have also demonstrated significant improvements in corrosion resistance when compared with the legacy and incumbent alloys. This paper documents the superior corrosion resistance of the current commercial tempers of these materials and also discusses the corrosion performance as a function of the degree of artificial aging. Results from laboratory corrosion tests are compared with results from exposures in a seacoast atmosphere to assess the predictive capability of the laboratory tests. The correlations that have been developed between the laboratory tests and the seacoast exposures provide confidence that a set of available methods can provide an accurate assessment of the corrosion performance of this new generation of alloys.

  9. Occupational Survey Report, Cardiopulmonary Laboratory, AFSC 4H0X1, OSSN: 2541

    DTIC Science & Technology

    2004-02-01

    patients within facility 97 E0211 Set up humidifiers 97 E0175 Instruct patients in use of incentive spirometers 97 A0031 Obtain sputum samples 97 A0026...D0137 Calibrate pulmonary function testing equipment 100 D0150 Perform routine spirometry tests 100 D0146 Perform lung diffusion tests 100 A0042 Perform...consultations, or procedures 31 D0150 Perform routine spirometry tests 23 35 TABLE A2 REPRESENTATIVE TASKS PERFORMED BY MEMBERS IN THE SUPERVISION AND

  10. Determination of dissolved oxygen in the cryosphere: a comprehensive laboratory and field evaluation of fiber optic sensors.

    PubMed

    Bagshaw, E A; Wadham, J L; Mowlem, M; Tranter, M; Eveness, J; Fountain, A G; Telling, J

    2011-01-15

    Recent advances in the Cryospheric Sciences have shown that icy environments are host to consortia of microbial communities, whose function and dynamics are often controlled by the concentrations of dissolved oxygen (DO) in solution. To date, only limited spot determinations of DO have been possible in these environments. They reveal the potential for rates of change that exceed realistic manual sampling rates, highlighting the need to explore methods for the continuous measurement of DO concentrations. We report the first comprehensive field and laboratory performance tests of fiber-optic sensors (PreSens, Regensburg, Germany) for measuring DO in icy ecosystems. A series of laboratory tests performed at low and standard temperatures (-5 to 20 °C) demonstrates high precision (0.3% at 50 μmol/kg and 1.3% at 300 μmol/kg), rapid response times (<20 s), and minimal drift (<0.4%). Survival of freeze thaw was problematic, unless the sensor film was mechanically fixed to the fiber and protected by a stainless steel sheath. Results of two field deployments of sensors to the Swiss Alps and Antarctica largely demonstrate a performance consistent with laboratory tests and superior to traditional methods.

  11. Investigation of Primary Dew-Point Saturator Efficiency in Two Different Thermal Environments

    NASA Astrophysics Data System (ADS)

    Zvizdic, D.; Heinonen, M.; Sestan, D.

    2015-08-01

    The aim of this paper is to describe the evaluation process of the performance of the low-range saturator (LRS), when exposed to two different thermal environments. The examined saturator was designed, built, and tested at MIKES (Centre for Metrology and Accreditation, Finland), and then transported to the Laboratory for Process Measurement (LPM) in Croatia, where it was implemented in a new dew-point calibration system. The saturator works on a single-pressure-single-pass generation principle in the dew/frost-point temperature range between and . The purpose of the various tests performed at MIKES was to examine the efficiency and non-ideality of the saturator. As a test bath facility in Croatia differs from the one used in Finland, the same tests were repeated at LPM, and the effects of different thermal conditions on saturator performance were examined. Thermometers, pressure gauges, an air preparation system, and water for filling the saturator at LPM were also different than those used at MIKES. Results obtained by both laboratories indicate that the efficiency of the examined saturator was not affected either by the thermal conditions under which it was tested or by equipment used for the tests. Both laboratories concluded that LRS is efficient enough for a primary realization of the dew/frost-point temperature scale in the range from to , with flow rates between and . It is also shown that a considerable difference of the pre-saturator efficiency, indicated by two laboratories, did not have influence to the overall performance of the saturator. The results of the research are presented in graphical and tabular forms. This paper also gives a brief description of the design and operation principle of the investigated low-range saturator.

  12. 42 CFR 493.903 - Administrative responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) Provide HHS or its designees and participating laboratories with an electronic or a hard copy, or both, of reports of proficiency testing results and all scores for each laboratory's performance in a format as...

  13. 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.

  14. 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

  15. 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, ...

  16. 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...

  17. 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...

  18. Performance of laboratories analysing welding fume on filter samples: results from the WASP proficiency testing scheme.

    PubMed

    Stacey, Peter; Butler, Owen

    2008-06-01

    This paper emphasizes the need for occupational hygiene professionals to require evidence of the quality of welding fume data from analytical laboratories. The measurement of metals in welding fume using atomic spectrometric techniques is a complex analysis often requiring specialist digestion procedures. The results from a trial programme testing the proficiency of laboratories in the Workplace Analysis Scheme for Proficiency (WASP) to measure potentially harmful metals in several different types of welding fume showed that most laboratories underestimated the mass of analyte on the filters. The average recovery was 70-80% of the target value and >20% of reported recoveries for some of the more difficult welding fume matrices were <50%. This level of under-reporting has significant implications for any health or hygiene studies of the exposure of welders to toxic metals for the types of fumes included in this study. Good laboratories' performance measuring spiked WASP filter samples containing soluble metal salts did not guarantee good performance when measuring the more complex welding fume trial filter samples. Consistent rather than erratic error predominated, suggesting that the main analytical factor contributing to the differences between the target values and results was the effectiveness of the sample preparation procedures used by participating laboratories. It is concluded that, with practice and regular participation in WASP, performance can improve over time.

  19. Perchlorate in Fertilizers

    DTIC Science & Technology

    1999-09-01

    Harrington , showed that with respect to mixed water analysis containing TDS at greater 1,000 ppm, the performance of the AS-5 column is not as robust...to note, these raw test materials were heterogeneous. Regardless of mixing time and mesh quality, dividing the raw test materials for laboratory...raw test material was prepared and shipped to seven laboratories for blind analysis. The suspension was prepared by 4 mixing the solid sample with

  20. Monitoring and root cause analysis of clinical biochemistry turn around time at an academic hospital.

    PubMed

    Chauhan, Kiran P; Trivedi, Amit P; Patel, Dharmik; Gami, Bhakti; Haridas, N

    2014-10-01

    Quality can be defined as the ability of a product or service to satisfy the needs and expectations of the customer. Laboratories are more focusing on technical and analytical quality for reliability and accuracy of test results. Patients and clinicians however are interested in rapid, reliable and efficient service from laboratory. Turn around time (TAT), the timeliness with which laboratory personnel deliver test results, is one of the most noticeable signs of laboratory service and is often used as a key performance indicator of laboratory performance. This study is aims to provide clue for laboratory TAT monitoring and root cause analysis. In a 2 year period a total of 75,499 specimens of outdoor patient department were monitor, of this a total of 4,142 specimens exceeded TAT. With consistent efforts to monitor, root cause analysis and corrective measures, we are able to decreased the specimens exceeding TAT from 7-8 to 3.7 %. Though it is difficult task to monitor TAT with the help of laboratory information system, real time documentation and authentic data retrievable, along with identification of causes for delays and its remedial measures, improve laboratory TAT and thus patient satisfaction.

  1. Improving Gram stain proficiency in hospital and satellite laboratories that do not have microbiology.

    PubMed

    Guarner, Jeannette; Street, Cassandra; Matlock, Margaret; Cole, Lisa; Brierre, Francoise

    2017-03-01

    Consolidation of laboratories has left many hospitals and satellite laboratories with minimal microbiologic testing. In many hospitals and satellite laboratories, Gram stains on primary specimens are still performed despite difficultly in maintaining proficiency. To maintain Gram stain proficiency at a community 450-bed hospital with an active emergency room we designed bimonthly challenges that require reporting Gram staining and morphology of different organisms. The challenges consist of five specimens prepared by the reference microbiology laboratory from cultures and primary specimens. Twenty to 23 medical laboratory scientists participate reading the challenges. Results from the challenges are discussed with each medical laboratory scientists. In addition, printed images from the challenges are presented at huddle to add microbiology knowledge. On the first three challenges, Gram staining was read correctly in 71%-77% of the time while morphology 53%-66%. In the last six challenges correct answers for Gram stain were 77%-99% while morphology 73%-96%. We observed statistically significant improvement when reading Gram stains by providing frequent challenges to medical laboratory scientists. The clinical importance of Gram stain results is emphasized during huddle presentations increasing knowledge and motivation to perform the test for patients.

  2. Preliminary Report on Oak Ridge National Laboratory Testing of Drake/ACSS/MA2/E3X

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

    Irminger, Philip; King, Daniel J.; Herron, Andrew N.

    2016-01-01

    A key to industry acceptance of a new technology is extensive validation in field trials. The Powerline Conductor Accelerated Test facility (PCAT) at Oak Ridge National Laboratory (ORNL) is specifically designed to evaluate the performance and reliability of a new conductor technology under real world conditions. The facility is set up to capture large amounts of data during testing. General Cable used the ORNL PCAT facility to validate the performance of TransPowr with E3X Technology a standard overhead conductor with an inorganic high emissivity, low absorptivity surface coating. Extensive testing has demonstrated a significant improvement in conductor performance across amore » wide range of operating temperatures, indicating that E3X Technology can provide a reduction in temperature, a reduction in sag, and an increase in ampacity when applied to the surface of any overhead conductor. This report provides initial results of that testing.« less

  3. Interlaboratory evaluation of Hyalella azteca and Chironomus tentans short-term and long-term sediment toxicity tests

    USGS Publications Warehouse

    Norberg-King, T. J.; Sibley, P.K.; Burton, G.A.; Ingersoll, C.G.; Kemble, N.E.; Ireland, S.; Mount, D.R.; Rowland, C.D.

    2006-01-01

    Methods for assessing the long-term toxicity of sediments to Hyalella azteca and Chironomus tentans can significantly enhance the capacity to assess sublethal effects of contaminated sediments through multiple endpoints. Sublethal tests allow us to begin to understand the relationship between short-term and long-term effects for toxic sediments. We present an interlaboratory evaluation with long-term and 10-d tests using control and contaminated sediments in which we assess whether proposed and existing performance criteria (test acceptability criteria [TAC]) could be achieved. Laboratories became familiar with newly developed, long-term protocols by testing two control sediments in phase 1. In phase 2, the 10-d and long-term tests were examined with several sediments. Laboratories met the TACs, but results varied depending on the test organism, test duration, and endpoints. For the long-term tests in phase 1, 66 to 100% of the laboratories consistently met the TACs for survival, growth, or reproduction using H. azteca, and 70 to 100% of the laboratories met the TACs for survival and growth, emergence, reproduction, and hatchability using C. tentans. In phase 2, fewer laboratories participated in long-term tests: 71 to 88% of the laboratories met the TAC for H. azteca, whereas 50 to 67% met the TAC for C. tentans. In the 10-d tests with H. azteca, and C. tentans, 82 and 88% of the laboratories met the TAC for survival, respectively, and 80% met the TAC for C. tentans growth. For the 10-d and long-term tests, laboratories predicted similar toxicity. Overall, the interlaboratory evaluation showed good precision of the methods, appropriate endpoints were incorporated into the test protocols, and tests effectively predicted the toxicity of sediments.

  4. Verification testing of the PKI collector at Sandia National Laboratories, Albuquerque, New Mexico

    NASA Technical Reports Server (NTRS)

    Hauger, J. S.; Pond, S. L.

    1982-01-01

    Verification testing of a solar collector was undertaken prior to its operation as part of an industrial process heat plant at Capitol Concrete Products in Topeka, Kansas. Testing was performed at a control plant installed at Sandia National Laboratory, Albuquerque, New Mexico (SNLA). Early results show that plant performance is even better than anticipated and far in excess of test criteria. Overall plant efficiencies of 65 to 80 percent were typical during hours of good insolation. A number of flaws and imperfections were detected during operability testing, the most important being a problem in elevation drive alignment due to a manufacturing error. All problems were corrected as they occurred and the plant, with over 40 hours of operation, is currently continuing operability testing in a wholly-automatic mode.

  5. Verification testing of the PKI collector at Sandia National Laboratories, Albuquerque, New Mexico

    NASA Astrophysics Data System (ADS)

    Hauger, J. S.; Pond, S. L.

    1982-07-01

    Verification testing of a solar collector was undertaken prior to its operation as part of an industrial process heat plant at Capitol Concrete Products in Topeka, Kansas. Testing was performed at a control plant installed at Sandia National Laboratory, Albuquerque, New Mexico (SNLA). Early results show that plant performance is even better than anticipated and far in excess of test criteria. Overall plant efficiencies of 65 to 80 percent were typical during hours of good insolation. A number of flaws and imperfections were detected during operability testing, the most important being a problem in elevation drive alignment due to a manufacturing error. All problems were corrected as they occurred and the plant, with over 40 hours of operation, is currently continuing operability testing in a wholly-automatic mode.

  6. Characterization, performance, and prediction of a lead-acid battery under simulated electric vehicle driving requirements

    NASA Technical Reports Server (NTRS)

    Ewashinka, J. G.; Bozek, J. M.

    1981-01-01

    A state-of-the-art 6-V battery module in current use by the electric vehicle industry was tested at the NASA Lewis Research Center to determine its performance characteristics under the SAE J227a driving schedules B, C, and D. The primary objective of the tests was to determine the effects of periods of recuperation and long and short periods of electrical regeneration in improving the performance of the battery module and hence extendng the vehicle range. A secondary objective was to formulate a computer program that would predict the performance of this battery module for the above driving schedules. The results show excellent correlation between the laboratory tests and predicted results. The predicted performance compared with laboratory tests was within +2.4 to -3.7 percent for the D schedule, +0.5 to -7.1 percent for the C schedule, and better than -11.4 percent for the B schedule.

  7. Characterization, performance, and prediction of a lead-acid battery under simulated electric vehicle driving requirements

    NASA Astrophysics Data System (ADS)

    Ewashinka, J. G.; Bozek, J. M.

    1981-05-01

    A state-of-the-art 6-V battery module in current use by the electric vehicle industry was tested at the NASA Lewis Research Center to determine its performance characteristics under the SAE J227a driving schedules B, C, and D. The primary objective of the tests was to determine the effects of periods of recuperation and long and short periods of electrical regeneration in improving the performance of the battery module and hence extendng the vehicle range. A secondary objective was to formulate a computer program that would predict the performance of this battery module for the above driving schedules. The results show excellent correlation between the laboratory tests and predicted results. The predicted performance compared with laboratory tests was within +2.4 to -3.7 percent for the D schedule, +0.5 to -7.1 percent for the C schedule, and better than -11.4 percent for the B schedule.

  8. 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.

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. [Laboratory medicine in the obligatory postgraduate clinical training system--common clinical training program in the department of laboratory medicine in our prefectural medical university hospital].

    PubMed

    Okamoto, Yasuyuki

    2003-04-01

    I propose a postgraduate common clinical training program to be provided by the department of laboratory medicine in our prefectural medical university hospital. The program has three purposes: first, mastering basic laboratory tests; second, developing the skills necessary to accurately interpret laboratory data; third, learning specific techniques in the field of laboratory medicine. For the first purpose, it is important that medical trainees perform testing of their own patients at bedside or in the central clinical laboratory. When testing at the central clinical laboratory, instruction by expert laboratory technicians is helpful. The teaching doctors in the department of laboratory medicine are asked to advise the trainees on the interpretation of data. Consultation will be received via interview or e-mail. In addition, the trainees can participate in various conferences, seminars, and meetings held at the central clinical laboratory. Finally, in order to learn specific techniques in the field of laboratory medicine, several special courses lasting a few months will be prepared. I think this program should be closely linked to the training program in internal medicine.

  15. AFNOR validation of Premi Test, a microbiological-based screening tube-test for the detection of antimicrobial residues in animal muscle tissue.

    PubMed

    Gaudin, Valerie; Juhel-Gaugain, Murielle; Morétain, Jean-Pierre; Sanders, Pascal

    2008-12-01

    Premi Test contains viable spores of a strain of Bacillus stearothermophilus which is sensitive to antimicrobial residues, such as beta-lactams, tetracyclines, macrolides and sulphonamides. The growth of the strain is inhibited by the presence of antimicrobial residues in muscle tissue samples. Premi Test was validated according to AFNOR rules (French Association for Normalisation). The AFNOR validation was based on the comparison of reference methods (French Official method, i.e. four plate test (FPT) and the STAR protocol (five plate test)) with the alternative method (Premi Test). A preliminary study was conducted in an expert laboratory (Community Reference Laboratory, CRL) on both spiked and incurred samples (field samples). Several method performance criteria (sensitivity, specificity, relative accuracy) were estimated and are discussed, in addition to detection capabilities. Adequate agreement was found between the alternative method and the reference methods. However, Premi Test was more sensitive to beta-lactams and sulphonamides than the FPT. Subsequently, a collaborative study with 11 laboratories was organised by the CRL. Blank and spiked meat juice samples were sent to participants. The expert laboratory (CRL) statistically analysed the results. It was concluded that Premi Test could be used for the routine determination of antimicrobial residues in muscle of different animal origin with acceptable analytical performance. The detection capabilities of Premi Test for beta-lactams (amoxicillin, ceftiofur), one macrolide (tylosin) and tetracycline were at the level of the respective maximum residue limits (MRL) in muscle samples or even lower.

  16. Results of a collaborative study on DNA identification of aged bone samples

    PubMed Central

    Vanek, Daniel; Budowle, Bruce; Dubska-Votrubova, Jitka; Ambers, Angie; Frolik, Jan; Pospisek, Martin; Al Afeefi, Ahmed Anwar; Al Hosani, Khalid Ismaeil; Allen, Marie; Al Naimi, Khudooma Saeed; Al Salafi, Dina; Al Tayyari, Wafa Ali Rashid; Arguetaa, Wendy; Bottinelli, Michel; Bus, Magdalena M.; Cemper-Kiesslich, Jan; Cepil, Olivier; De Cock, Greet; Desmyter, Stijn; El Amri, Hamid; El Ossmani, Hicham; Galdies, Ruth; Grün, Sebastian; Guidet, Francois; Hoefges, Anna; Iancu, Cristian Bogdan; Lotz, Petra; Maresca, Alessandro; Nagy, Marion; Novotny, Jindrich; Rachid, Hajar; Rothe, Jessica; Stenersen, Marguerethe; Stephenson, Mishel; Stevanovitch, Alain; Strien, Juliane; Sumita, Denilce R.; Vella, Joanna; Zander, Judith

    2017-01-01

    Aim A collaborative exercise with several institutes was organized by the Forensic DNA Service (FDNAS) and the Institute of the Legal Medicine, 2nd Faculty of Medicine, Charles University in Prague, Czech Republic, with the aim to test performance of different laboratories carrying out DNA analysis of relatively old bone samples. Methods Eighteen laboratories participating in the collaborative exercise were asked to perform DNA typing of two samples of bone powder. Two bone samples provided by the National Museum and the Institute of Archaelogy in Prague, Czech Republic, came from archeological excavations and were estimated to be approximately 150 and 400 years old. The methods of genetic characterization including autosomal, gonosomal, and mitochondrial markers was selected solely at the discretion of the participating laboratory. Results Although the participating laboratories used different extraction and amplification strategies, concordant results were obtained from the relatively intact 150 years old bone sample. Typing was more problematic with the analysis of the 400 years old bone sample due to poorer quality. Conclusion The laboratories performing identification DNA analysis of bone and teeth samples should regularly test their ability to correctly perform DNA-based identification on bone samples containing degraded DNA and potential inhibitors and demonstrate that risk of contamination is minimized. PMID:28613037

  17. Theoretical and practical considerations for teaching diagnostic electronic-nose technologies to clinical laboratory technicians

    Treesearch

    Alphus D. Wilson

    2012-01-01

    The rapid development of new electronic technologies and instruments, utilized to perform many current clinical operations in the biomedical field, is changing the way medical health care is delivered to patients. The majority of test results from laboratory analyses, performed with these analytical instruments often prior to clinical examinations, are frequently used...

  18. CONFOCAL MICROSCOPY SYSTEM PERFORMANCE: QA TESTS, QUANTITATION AND SPECTROSCOPY

    EPA Science Inventory

    Confocal Microscopy System Performance: QA tests, Quantitation and Spectroscopy.

    Robert M. Zucker 1 and Jeremy M. Lerner 2,
    1Reproductive Toxicology Division, National Health and Environmental Effects Research Laboratory, Office of Research Development, U.S. Environmen...

  19. 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.

  20. Thermal Performance Testing of Order Dependancy of Aerogels Multilayered Insulation

    NASA Technical Reports Server (NTRS)

    Johnson, Wesley L.; Fesmire, James E.; Demko, J. A.

    2009-01-01

    Robust multilayer insulation systems have long been a goal of many research projects. Such insulation systems must provide some degree of structural support and also mechanical integrity during loss of vacuum scenarios while continuing to provide insulative value to the vessel. Aerogel composite blankets can be the best insulation materials in ambient pressure environments; in high vacuum, the thermal performance of aerogel improves by about one order of magnitude. Standard multilayer insulation (MU) is typically 50% worse at ambient pressure and at soft vacuum, but as much as two or three orders of magnitude better at high vacuum. Different combinations of aerogel and multilayer insulation systems have been tested at Cryogenics Test Laboratory of NASA Kennedy Space Center. Analysis performed at Oak Ridge National Laboratory showed an importance to the relative location of the MU and aerogel blankets. Apparent thermal conductivity testing under cryogenic-vacuum conditions was performed to verify the analytical conclusion. Tests results are shown to be in agreement with the analysis which indicated that the best performance is obtained with aerogel layers located in the middle of the blanket insulation system.

  1. RECENT ADVANCES IN HIGH TEMPERATURE ELECTROLYSIS AT IDAHO NATIONAL LABORATORY: SINGLE CELL TESTS

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

    X. Zhang; J. E. O'Brien; R. C. O'Brien

    2012-07-01

    An experimental investigation on the performance and durability of single solid oxide electrolysis cells (SOECs) is under way at the Idaho National Laboratory. In order to understand and mitigate the degradation issues in high temperature electrolysis, single SOECs with different configurations from several manufacturers have been evaluated for initial performance and long-term durability. A new test apparatus has been developed for single cell and small stack tests from different vendors. Single cells from Ceramatec Inc. show improved durability compared to our previous stack tests. Single cells from Materials and Systems Research Inc. (MSRI) demonstrate low degradation both in fuel cellmore » and electrolysis modes. Single cells from Saint Gobain Advanced Materials (St. Gobain) show stable performance in fuel cell mode, but rapid degradation in the electrolysis mode. Electrolyte-electrode delamination is found to have significant impact on degradation in some cases. Enhanced bonding between electrolyte and electrode and modification of the microstructure help to mitigate degradation. Polarization scans and AC impedance measurements are performed during the tests to characterize the cell performance and degradation.« less

  2. 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

  3. 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.

  4. An inter- laboratory proficiency testing exercise for rabies diagnosis in Latin America and the Caribbean

    PubMed Central

    Clavijo, Alfonso; Freire de Carvalho, Mary H.; Orciari, Lillian A.; Velasco-Villa, Andres; Ellison, James A.; Greenberg, Lauren; Yager, Pamela A.; Green, Douglas B.; Vigilato, Marco A.; Cosivi, Ottorino; Del Rio-Vilas, Victor J.

    2017-01-01

    The direct fluorescent antibody test (DFA), is performed in all rabies reference laboratories across Latin America and the Caribbean (LAC). Despite DFA being a critical capacity in the control of rabies, there is not a standardized protocol in the region. We describe the results of the first inter-laboratory proficiency exercise of national rabies laboratories in LAC countries as part of the regional efforts towards dog-maintained rabies elimination in the American region. Twenty three laboratories affiliated to the Ministries of Health and Ministries of Agriculture participated in this exercise. In addition, the laboratories completed an online questionnaire to assess laboratory practices. Answers to the online questionnaire indicated large variability in the laboratories throughput, equipment used, protocols availability, quality control standards and biosafety requirements. Our results will inform actions to improve and harmonize laboratory rabies capacities across LAC in support for the regional efforts towards elimination of dog-maintained rabies. PMID:28369139

  5. Can MOND type hypotheses be tested in a free fall laboratory environment?

    NASA Astrophysics Data System (ADS)

    Das, Saurya; Patitsas, S. N.

    2013-05-01

    The extremely small accelerations of objects required for the onset of modified Newtonian dynamics, or modified Newtonian dynamics (MOND), makes testing the hypothesis in conventional terrestrial laboratories virtually impossible. This is due to the large background acceleration of Earth, which is transmitted to the acceleration of test objects within an apparatus. We show, however, that it may be possible to test MOND-type hypotheses with experiments using a conventional apparatus capable of tracking very small accelerations of its components but performed in locally inertial frames such as artificial satellites and other freely falling laboratories. For example, experiments involving an optical interferometer or a torsion balance in these laboratories would show nonlinear dynamics and displacement amplitudes larger than expected. These experiments may also be able to test potential violations of the strong equivalence principle by MOND and to distinguish between its two possible interpretations (modified inertia and modified gravity).

  6. Accuracy of a point-of-care ELISA test kit for predicting the presence of protective canine parvovirus and canine distemper virus antibody concentrations in dogs.

    PubMed

    Litster, A L; Pressler, B; Volpe, A; Dubovi, E

    2012-08-01

    Canine parvovirus (CPV) and canine distemper virus (CDV) are highly infectious and often fatal diseases with worldwide distributions, and are important population management considerations in animal shelters. A point-of-care ELISA test kit is available to detect serum antibodies to CPV and CDV, and presumptively to predict protective status. The aim of this study was to determine the diagnostic accuracy of the test compared to CPV hemagglutination inhibition titers and CDV serum neutralization titers determined by a reference laboratory, using sera collected from dogs housed at animal shelters. The ELISA test was used under both field and laboratory conditions and duplicate specimens were processed using an extra wash step. The test kit yielded accurate results (CPV: sensitivity 92.3%, specificity 93.5%; CDV: sensitivity 75.7%, specificity 91.8%) under field conditions. CDV sensitivity was improved by performing the test under laboratory conditions and using an optical density (OD) meter (laboratory performed 94.0%; OD 88.1%). Point-of-care ELISA testing for serum CPV and CDV antibody titers was demonstrated to be a useful tool for determining antibody status when making decisions regarding the need for CPV and/or CDV vaccination and also in animal shelters for population management. Copyright © 2012 Elsevier Ltd. All rights reserved.

  7. 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.

  8. Successful Performance of Laboratory Investigations with Blood Glucose Meters Employing a Dynamic Electrochemistry-Based Correction Algorithm Is Dependent on Careful Sample Handling.

    PubMed

    Demircik, Filiz; Klonoff, David; Musholt, Petra B; Ramljak, Sanja; Pfützner, Andreas

    2016-10-01

    Devices employing electrochemistry-based correction algorithms (EBCAs) are optimized for patient use and require special handling procedures when tested in the laboratory. This study investigated the impact of sample handling on the results of an accuracy and hematocrit interference test performed with BG*Star, iBG*Star; OneTouch Verio Pro and Accu-Chek Aviva versus YSI Stat 2300. Venous heparinized whole blood was manipulated to contain three different blood glucose concentrations (64-74, 147-163, and 313-335 mg/dL) and three different hematocrit levels (30%, 45%, and 60%). Sample preparation was done by either a very EBCA-experienced laboratory testing team (A), a group experienced with other meters but not EBCAs (B), or a team inexperienced with meter testing (C). Team A ensured physiological pO 2 and specific sample handling requirements, whereas teams B and C did not consider pO 2 . Each sample was tested four times with each device. In a separate experiment, a different group similar to group B performed the experiment before (D1) and after (D2) appropriate sample handling training. Mean absolute deviation from YSI was calculated as a metrix for all groups and devices. Mean absolute relative difference was 4.3% with team A (B: 9.2%, C: 5.2%). Team B had much higher readings and team C produced 100% of "sample composition" errors with high hematocrit levels. In a separate experiment, group D showed a result similar to group B before the training and improved significantly when considering the sample handling requirements (D1: 9.4%, D2: 4.5%, P < 0.05). Laboratory performance testing of EBCA devices should only be performed by trained staff considering specific sample handling requirements. The results suggest that healthcare centers should evaluate EBCA-based devices with capillary blood from patients in accordance with the instructions for use to achieve reliable results.

  9. [Reference values for the blood coagulation tests in Mexico: usefulness of the pooled plasma from blood donors].

    PubMed

    Calzada-Contreras, Adriana; Moreno-Hernández, Manuel; Castillo-Torres, Noemi Patricia; Souto-Rosillo, Guadalupe; Hernández-Juárez, Jesús; Ricardo-Moreno, María Tania; Sánchez-Fernández, Maria Guadalupe de Jesús; García-González, América; Majluf-Cruz, Abraham

    2012-01-01

    The blood coagulation system maintains the blood in a liquid state and bleeding and thrombosis are the manifestations of its malfunction. Blood coagulation laboratory evaluates the physiology of this system. To establish both, the reference values for several tests performed at the blood coagulation laboratory as well as the utility of the pooled plasma to perform these assays. MATERIAL AND: In this descriptive, cross-sectional, randomized study, we collected plasma from Mexican Mestizos. Each pooled plasma was prepared with the plasma from at least 20 blood donors. We performed screening and special tests and the Levey-Jennings graphs were built and interpreted after each pass. Results of the tests were analyzed and their distribution was established using the Kolmogorov-Smirnov test. To establish the reference values we used 95% confidence intervals. We collected 72 pooled plasmas. The distribution for PT, APTT, and TT tests was abnormal. Although the PT test showed a bimodal distribution it was normal for factor VII. The reference values for the hemostatic, anticoagulant, and fibrinolytic factors were different from those suggested by the manufacturers. We established the reference values for the blood coagulation tests in the adult Mexican population. We have shown that the pooled plasma must be used for the screening tests. We suggest that each clinical laboratory should establish its own reference values (at least for the screening tests). To reach this objective, we encourage the use of the pooled plasma.

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

    Glosser, D.; Kutchko, B.; Benge, G.

    Foamed cement is a critical component for wellbore stability. The mechanical performance of a foamed cement depends on its microstructure, which in turn depends on the preparation method and attendant operational variables. Determination of cement stability for field use is based on laboratory testing protocols governed by API Recommended Practice 10B-4 (API RP 10B-4, 2015). However, laboratory and field operational variables contrast considerably in terms of scale, as well as slurry mixing and foaming processes. Here in this paper, laboratory and field operational processes are characterized within a physics-based framework. It is shown that the “atomization energy” imparted by themore » high pressure injection of nitrogen gas into the field mixed foamed cement slurry is – by a significant margin – the highest energy process, and has a major impact on the void system in the cement slurry. There is no analog for this high energy exchange in current laboratory cement preparation and testing protocols. Quantifying the energy exchanges across the laboratory and field processes provides a basis for understanding relative impacts of these variables on cement structure, and can ultimately lead to the development of practices to improve cement testing and performance.« less

  11. Performance evaluation of Louisiana superpave mixtures.

    DOT National Transportation Integrated Search

    2008-12-01

    This report documents the performance of Louisiana Superpave mixtures through laboratory mechanistic tests, mixture : volumetric properties, gradation analysis, and early field performance. Thirty Superpave mixtures were evaluated in this : study. Fo...

  12. Test Results of a 200 W Class Hall Thruster

    NASA Technical Reports Server (NTRS)

    Jacobson, David; Jankovsky, Robert S.

    1999-01-01

    The performance of a 200 W class Hall thruster was evaluated. Performance measurements were taken at power levels between 90 W and 250 W. At the nominal 200 W design point, the measured thrust was 11.3 mN. and the specific impulse was 1170 s excluding cathode flow in the calculation. A laboratory model 3 mm diameter hollow cathode was used for all testing. The engine was operated on laboratory power supplies in addition to a breadboard power processing unit fabricated from commercially available DC to DC converters.

  13. Window acoustic study for advanced turboprop aircraft

    NASA Technical Reports Server (NTRS)

    Prydz, R. A.; Balena, F. J.

    1984-01-01

    An acoustic analysis was performed to establish window designs for advanced turboprop powered aircraft. The window transmission loss requirements were based on A-weighted interior noise goals of 80 and 75 dBA. The analytical results showed that a triple pane window consisting of two glass outer panes and an inner pane of acrylic would provide the required transmission loss and meet the sidewall space limits. Two window test articles were fabricated for laboratory evaluation and verification of the predicted transmission loss. Procedures for performing laboratory tests are presented.

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

    SAMS TL; GUILLOT S

    Scoping laboratory scale tests were performed at the Chemical Engineering Department of the Georgia Institute of Technology (Georgia Tech), and the Hanford 222-S Laboratory, involving double-shell tank (DST) and single-shell tank (SST) Hanford waste simulants. These tests established the viability of the Lithium Hydrotalcite precipitation process as a solution to remove aluminum and recycle sodium hydroxide from the Hanford tank waste, and set the basis of a validation test campaign to demonstrate a Technology Readiness Level of 3.

  15. Five years' experience of classical swine fever polymerase chain reaction ring trials in France.

    PubMed

    Po, F; Le Dimna, M; Le Potier, M F

    2011-12-01

    Since 2004, the French National Reference Laboratory for classical swine fever (CSF) has conducted an annual proficiency test (PT) to evaluate the ability of local veterinary laboratories to perform real-time polymerase chain reaction (PCR) for CSF virus. The results of five years of testing (2004-2008) are described here. The PT was conducted under blind conditions on 20 samples. The same batch of samples was used for all five years. The number of laboratories that analysed the samples increased from four in 2004 to 13 in 2008. The results of the PT showed the following: cross-contamination between samples and deficiencies in RNA preparation can occur even in experienced laboratories; sample homogeneity should be checked carefully before selection; samples stored at-80 degrees C for several years remain stable; and poor shipment conditions do not damage the samples with regard to detection of CSF virus genome. These results will enable redesign of the panel to improve the overall quality of the PT, which will encourage laboratories to check and improve their PCR procedures and expertise. This is an excellent way to determine laboratory performance.

  16. 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

  17. Proficiency testing of Hb A1c: a 4-year experience in Taiwan and the Asian Pacific region.

    PubMed

    Shiesh, Shu-Chu; Wiedmeyer, Hsiao-Mei; Kao, Jau-Tsuen; Vasikaran, Samuel D; Lopez, Joseph B

    2009-10-01

    The correlation between hemoglobin A(1c) (Hb A(1c)) and risk for complications in diabetic patients heightens the need to measure Hb A(1c) with accuracy. We evaluated the current performance for measuring Hb A(1c) in the Asian and Pacific region by examining data submitted by laboratories participating in the Taiwan proficiency-testing program. Five fresh-pooled blood samples were sent to participating laboratories twice each year. The results were evaluated against target values assigned by the National Glycohemoglobin Standardization Program network laboratories; a passing criterion of +/-7% of the target value was used. Measurement uncertainty at Hb A(1c) concentrations of 7.0% and 8.0% were determined. A total of 276 laboratories from 11 countries took part in the Hb A(1c) survey. At the Hb A(1c) concentrations tested method-specific interlaboratory imprecision (CVs) were 1.1%-13.9% in 2005, 1.3%-10.1% in 2006, 1.2%-8.2% in 2007, and 1.1%-6.1% in 2008. Differences between target values and median values from the commonly used methods ranged from -0.24% to 0.22% Hb A(1c) in 2008. In 2005 83% of laboratories passed the survey, and in 2008 93% passed. At 7.0% Hb A(1c), measurement uncertainty was on average 0.49% Hb A(1c). The use of accuracy-based proficiency testing with stringent quality criteria has improved the performance of Hb A(1c) testing in the Asian and Pacific laboratories during the 4 years of assessment.

  18. Development of an evidence-based approach to external quality assurance for breast cancer hormone receptor immunohistochemistry: comparison of reference values.

    PubMed

    Makretsov, Nikita; Gilks, C Blake; Alaghehbandan, Reza; Garratt, John; Quenneville, Louise; Mercer, Joel; Palavdzic, Dragana; Torlakovic, Emina E

    2011-07-01

    External quality assurance and proficiency testing programs for breast cancer predictive biomarkers are based largely on traditional ad hoc design; at present there is no universal consensus on definition of a standard reference value for samples used in external quality assurance programs. To explore reference values for estrogen receptor and progesterone receptor immunohistochemistry in order to develop an evidence-based analytic platform for external quality assurance. There were 31 participating laboratories, 4 of which were previously designated as "expert" laboratories. Each participant tested a tissue microarray slide with 44 breast carcinomas for estrogen receptor and progesterone receptor and submitted it to the Canadian Immunohistochemistry Quality Control Program for analysis. Nuclear staining in 1% or more of the tumor cells was a positive score. Five methods for determining reference values were compared. All reference values showed 100% agreement for estrogen receptor and progesterone receptor scores, when indeterminate results were excluded. Individual laboratory performance (agreement rates, test sensitivity, test specificity, positive predictive value, negative predictive value, and κ value) was very similar for all reference values. Identification of suboptimal performance by all methods was identical for 30 of 31 laboratories. Estrogen receptor assessment of 1 laboratory was discordant: agreement was less than 90% for 3 of 5 reference values and greater than 90% with the use of 2 other reference values. Various reference values provide equivalent laboratory rating. In addition to descriptive feedback, our approach allows calculation of technical test sensitivity and specificity, positive and negative predictive values, agreement rates, and κ values to guide corrective actions.

  19. Remote control circuit breaker evaluation testing. [for space shuttles

    NASA Technical Reports Server (NTRS)

    Bemko, L. M.

    1974-01-01

    Engineering evaluation tests were performed on several models/types of remote control circuit breakers marketed in an attempt to gain some insight into their potential suitability for use on the space shuttle vehicle. Tests included the measurement of several electrical and operational performance parameters under laboratory ambient, space simulation, acceleration and vibration environmental conditions.

  20. Cell-Free DNA Analysis in Maternal Blood: Differences in Estimates between Laboratories with Different Methodologies Using a Propensity Score Approach.

    PubMed

    Bevilacqua, Elisa; Jani, Jacques C; Letourneau, Alexandra; Duiella, Silvia F; Kleinfinger, Pascale; Lohmann, Laurence; Resta, Serena; Cos Sanchez, Teresa; Fils, Jean-François; Mirra, Marilyn; Benachi, Alexandra; Costa, Jean-Marc

    2018-06-13

    To evaluate the failure rate and performance of cell-free DNA (cfDNA) testing, mainly in terms of detection rates for trisomy 21, performed by 2 laboratories using different analytical methods. cfDNA testing was performed on 2,870 pregnancies with the HarmonyTM Prenatal Test using the targeted digital analysis of selected regions (DANSR) method, and on 2,635 pregnancies with the "Cerba test" using the genome-wide massively parallel sequencing (GW-MPS) method, with available outcomes. Propensity score analysis was used to match patients between the 2 groups. A comparison of the detection rates for trisomy 21 between the 2 laboratories was made. In all, 2,811 patients in the Harmony group and 2,530 patients in the Cerba group had no trisomy 21, 18, or 13. Postmatched comparisons of the patient characteristics indicated a higher no-result rate in the Harmony group (1.30%) than in the Cerba group (0.75%; p = 0.039). All 41 cases of trisomy 21 in the Harmony group and 93 cases in the Cerba group were detected. Both methods of cfDNA testing showed low no-result rates and a comparable performance in detecting trisomy 21; yet GW-MPS had a slightly lower no-result rate than the DANSR method. © 2018 S. Karger AG, Basel.

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