Sample records for quality control tests

  1. Survey of the prevalence and methodology of quality assurance for B-mode ultrasound image quality among veterinary sonographers.

    PubMed

    Hoscheit, Larry P; Heng, Hock Gan; Lim, Chee Kin; Weng, Hsin-Yi

    2018-05-01

    Image quality in B-mode ultrasound is important as it reflects the diagnostic accuracy and diagnostic information provided during clinical scanning. Quality assurance programs for B-mode ultrasound systems/components are comprised of initial quality acceptance testing and subsequent regularly scheduled quality control testing. The importance of quality assurance programs for B-mode ultrasound image quality using ultrasound phantoms is well documented in the human medical and medical physics literature. The purpose of this prospective, cross-sectional, survey study was to determine the prevalence and methodology of quality acceptance testing and quality control testing of image quality for ultrasound system/components among veterinary sonographers. An online electronic survey was sent to 1497 members of veterinary imaging organizations: the American College of Veterinary Radiology, the Veterinary Ultrasound Society, and the European Association of Veterinary Diagnostic Imaging, and a total of 167 responses were received. The results showed that the percentages of veterinary sonographers performing quality acceptance testing and quality control testing are 42% (64/151; 95% confidence interval 34-52%) and 26% (40/156: 95% confidence interval 19-33%) respectively. Of the respondents who claimed to have quality acceptance testing or quality control testing of image quality in place for their ultrasound system/components, 0% have performed quality acceptance testing or quality control testing correctly (quality acceptance testing 95% confidence interval: 0-6%, quality control testing 95% confidence interval: 0-11%). Further education and guidelines are recommended for veterinary sonographers in the area of quality acceptance testing and quality control testing for B-mode ultrasound equipment/components. © 2018 American College of Veterinary Radiology.

  2. 7 CFR 58.928 - Quality control tests.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to inspection for quality and condition throughout each processing operation. Quality control tests shall be...

  3. 7 CFR 58.335 - Quality control tests.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Quality control tests. 58.335 Section 58.335... Procedures § 58.335 Quality control tests. All milk, cream and related products are subject to inspection for quality and condition throughout each processing operation. Quality control tests shall be made on flow...

  4. 7 CFR 58.733 - Quality control tests.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Quality control tests. 58.733 Section 58.733... Procedures § 58.733 Quality control tests. (a) Chemical analyses. The following chemical analyses shall be... pasteurization by means of the phosphatase test, as well as any other tests necessary to assure good quality...

  5. 7 CFR 58.733 - Quality control tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Quality control tests. 58.733 Section 58.733... Procedures § 58.733 Quality control tests. (a) Chemical analyses. The following chemical analyses shall be... pasteurization by means of the phosphatase test, as well as any other tests necessary to assure good quality...

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

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

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

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  10. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  11. 7 CFR 58.928 - Quality control tests.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... quality test shall be made to determine product stability. ... 7 Agriculture 3 2013-01-01 2013-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to...

  12. 7 CFR 58.928 - Quality control tests.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... quality test shall be made to determine product stability. ... 7 Agriculture 3 2012-01-01 2012-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to...

  13. 46 CFR 160.133-15 - Production inspections, tests, quality control, and conformance of release mechanisms.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 6 2012-10-01 2012-10-01 false Production inspections, tests, quality control, and..., tests, quality control, and conformance of release mechanisms. (a) Unless the Commandant directs.... The Commandant may prescribe additional production tests and inspections necessary to maintain quality...

  14. 46 CFR 160.133-15 - Production inspections, tests, quality control, and conformance of release mechanisms.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 6 2013-10-01 2013-10-01 false Production inspections, tests, quality control, and..., tests, quality control, and conformance of release mechanisms. (a) Unless the Commandant directs.... The Commandant may prescribe additional production tests and inspections necessary to maintain quality...

  15. 46 CFR 160.170-15 - Production inspections, tests, quality control, and conformance of release mechanisms.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 6 2014-10-01 2014-10-01 false Production inspections, tests, quality control, and..., quality control, and conformance of release mechanisms. (a) Unless the Commandant directs otherwise, an... prescribe additional production tests and inspections necessary to maintain quality control and to monitor...

  16. 46 CFR 160.170-15 - Production inspections, tests, quality control, and conformance of release mechanisms.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 6 2012-10-01 2012-10-01 false Production inspections, tests, quality control, and..., quality control, and conformance of release mechanisms. (a) Unless the Commandant directs otherwise, an... prescribe additional production tests and inspections necessary to maintain quality control and to monitor...

  17. 46 CFR 160.133-15 - Production inspections, tests, quality control, and conformance of release mechanisms.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 6 2014-10-01 2014-10-01 false Production inspections, tests, quality control, and..., quality control, and conformance of release mechanisms. (a) Unless the Commandant directs otherwise, an... prescribe additional production tests and inspections necessary to maintain quality control and to monitor...

  18. 46 CFR 160.170-15 - Production inspections, tests, quality control, and conformance of release mechanisms.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 6 2013-10-01 2013-10-01 false Production inspections, tests, quality control, and..., quality control, and conformance of release mechanisms. (a) Unless the Commandant directs otherwise, an... prescribe additional production tests and inspections necessary to maintain quality control and to monitor...

  19. 46 CFR 160.115-15 - Production inspections, tests, quality control, and conformance of winches.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 6 2013-10-01 2013-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Winches § 160.115-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

  20. 46 CFR 160.115-15 - Production inspections, tests, quality control, and conformance of winches.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 6 2014-10-01 2014-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Winches § 160.115-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

  1. 46 CFR 160.132-15 - Production inspections, tests, quality control, and conformance of davits.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 6 2013-10-01 2013-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Davits § 160.132-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

  2. 46 CFR 160.115-15 - Production inspections, tests, quality control, and conformance of winches.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 6 2012-10-01 2012-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Winches § 160.115-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

  3. 46 CFR 160.132-15 - Production inspections, tests, quality control, and conformance of davits.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 6 2014-10-01 2014-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Davits § 160.132-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

  4. 46 CFR 160.132-15 - Production inspections, tests, quality control, and conformance of davits.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 6 2012-10-01 2012-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Davits § 160.132-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

  5. 21 CFR 640.56 - Quality control test for potency.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... quality control test for potency may be performed by a clinical laboratory which meets the standards of... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Quality control test for potency. 640.56 Section...) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Cryoprecipitate § 640.56 Quality control...

  6. 30 CFR 28.33 - Quality control test methods, equipment, and records; review by MSHA; revocation of approval.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Quality control test methods, equipment, and... USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.33 Quality control test methods, equipment, and records; review by MSHA; revocation...

  7. 30 CFR 28.33 - Quality control test methods, equipment, and records; review by MSHA; revocation of approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Quality control test methods, equipment, and... USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.33 Quality control test methods, equipment, and records; review by MSHA; revocation...

  8. 30 CFR 28.33 - Quality control test methods, equipment, and records; review by MSHA; revocation of approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality control test methods, equipment, and... USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.33 Quality control test methods, equipment, and records; review by MSHA; revocation...

  9. 30 CFR 28.33 - Quality control test methods, equipment, and records; review by MSHA; revocation of approval.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality control test methods, equipment, and... USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.33 Quality control test methods, equipment, and records; review by MSHA; revocation...

  10. 30 CFR 28.33 - Quality control test methods, equipment, and records; review by MSHA; revocation of approval.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality control test methods, equipment, and... USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.33 Quality control test methods, equipment, and records; review by MSHA; revocation...

  11. 40 CFR Appendix A to Subpart S of... - Calibrations, Adjustments and Quality Control

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... average of the pre-test and post-test ambient background levels shall be compared to the permissible...—Calibrations, Adjustments and Quality Control (I) Steady-State Test Equipment States may opt to use transient emission test equipment for steady-state tests and follow the quality control requirements in paragraph (II...

  12. 40 CFR Appendix A to Subpart S of... - Calibrations, Adjustments and Quality Control

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... average of the pre-test and post-test ambient background levels shall be compared to the permissible...—Calibrations, Adjustments and Quality Control (I) Steady-State Test Equipment States may opt to use transient emission test equipment for steady-state tests and follow the quality control requirements in paragraph (II...

  13. 40 CFR Appendix A to Subpart S of... - Calibrations, Adjustments and Quality Control

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... average of the pre-test and post-test ambient background levels shall be compared to the permissible...—Calibrations, Adjustments and Quality Control (I) Steady-State Test Equipment States may opt to use transient emission test equipment for steady-state tests and follow the quality control requirements in paragraph (II...

  14. 40 CFR Appendix A to Subpart S of... - Calibrations, Adjustments and Quality Control

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... average of the pre-test and post-test ambient background levels shall be compared to the permissible...—Calibrations, Adjustments and Quality Control (I) Steady-State Test Equipment States may opt to use transient emission test equipment for steady-state tests and follow the quality control requirements in paragraph (II...

  15. 40 CFR Appendix A to Subpart S of... - Calibrations, Adjustments and Quality Control

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... average of the pre-test and post-test ambient background levels shall be compared to the permissible...—Calibrations, Adjustments and Quality Control (I) Steady-State Test Equipment States may opt to use transient emission test equipment for steady-state tests and follow the quality control requirements in paragraph (II...

  16. [The establishment and application of internal quality control system for real-time quantitative PCR detection of BCR-ABL (P210) transcript levels].

    PubMed

    Zhong, C Q; He, N; Hua, M Q; Wei, X D; Ma, D X; Ji, C Y

    2016-09-14

    Objective: To set internal quality control system of BCR-ABL (P210) transcript levels for real-time quantitative PCR (RQ-PCR). Methods: Using K562 cells and HL-60 cells, we prepared high- and low-level BCR-ABL internal quality control substance. The BCR-ABL (P210) transcript levels of internal quality control substance have been determined for 184 times together with clinical samples from August 2013 to October 2015. The slope rate, intercept and correlation coefficient of standard curve were calculated according to different reagent lots (lots number 20130303, 20131212, 20140411 and 20150327 are called R1、R2、R3 and R4 for short respectively), and the detection results of quality control substance were calculated according to different reagent lots and quality control substance lots (lots number 20130725, 20140611 are called Q1、Q2 for short respectively). Then the results were analyzed by Levey-Jennings quality control chart combined with Westgard multi-rules theory. Results: ①We analyzed the slope rate and intercept of standard curve. Fifty-three times of the R1 reagent detection, 80 times of the R3 reagent detection and 14 times of the R4 reagent detection were all under control. For 37 times detection of R2 reagent, the slope rate was out of control for 6 times. It was lower than x - s for the 2-8 tests and upper the average for the 12-37 tests. The intercept was out of control for 9 times, upper the x + s for the 1-8 tests and lower the average for the 12-37 tests. ② According to the detection results of quality control substance, for Q1 quality control substance, 49 tests by R1 reagent were under control, and 1 out of 23 tests by R2 reagent was out of control. For Q2 quality control substance, 14 tests by R2 reagent detection, 72 tests by R3 reagent detection and 14 tests by R4 reagent were all under control. Conclusion: The preparation of high- and low-level quality control substance using K562 and HL-60 cells was convenient and the detection results were reliable and stable. The application of quality control substance combined with slope rate and intercept in the internal quality control may contribute to quality assurance for quantitative detection of BCR-ABL (P210) transcript levels.

  17. ENVIRONMENTAL TECHNOLOGY VERIFICATION REPORT, MIRATECH CORPORATIONM GECO 3001 AIR/FUEL RATIO CONTROLLER

    EPA Science Inventory

    Details on the verification test design, measurement test procedures, and Quality assurance/Quality Control (QA/QC) procedures can be found in the test plan titled Testing and Quality Assurance Plan, MIRATECH Corporation GECO 3100 Air/Fuel Ratio Controller (SRI 2001). It can be d...

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

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  20. 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. 46 CFR 160.135-15 - Production inspections, tests, quality control, and conformance of lifeboats.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... materials are as per the plans approved under § 160.135-13(h) of this subpart. (2) Post assembly tests and... 46 Shipping 6 2013-10-01 2013-10-01 false Production inspections, tests, quality control, and... Lifeboats (SOLAS) § 160.135-15 Production inspections, tests, quality control, and conformance of lifeboats...

  2. 46 CFR 160.135-15 - Production inspections, tests, quality control, and conformance of lifeboats.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... materials are as per the plans approved under § 160.135-13(h) of this subpart. (2) Post assembly tests and... 46 Shipping 6 2012-10-01 2012-10-01 false Production inspections, tests, quality control, and... Lifeboats (SOLAS) § 160.135-15 Production inspections, tests, quality control, and conformance of lifeboats...

  3. 46 CFR 160.156-15 - Production inspections, tests, quality control, and conformance of rescue boats and fast rescue...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... materials are as per the plans approved under § 160.156-13(h) of this subpart. (2) Post assembly tests and... 46 Shipping 6 2012-10-01 2012-10-01 false Production inspections, tests, quality control, and... inspections, tests, quality control, and conformance of rescue boats and fast rescue boats. (a) Unless the...

  4. 46 CFR 160.156-15 - Production inspections, tests, quality control, and conformance of rescue boats and fast rescue...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... materials are as per the plans approved under § 160.156-13(h) of this subpart. (2) Post assembly tests and... 46 Shipping 6 2013-10-01 2013-10-01 false Production inspections, tests, quality control, and... inspections, tests, quality control, and conformance of rescue boats and fast rescue boats. (a) Unless the...

  5. An Overview of Controls and Flying Qualities Technology on the F/A-18 High Alpha Research Vehicle

    NASA Technical Reports Server (NTRS)

    Pahle, Joseph W.; Wichman, Keith D.; Foster, John V.; Bundick, W. Thomas

    1996-01-01

    The NASA F/A-18 High Alpha Research Vehicle (HARV) has been the flight test bed of a focused technology effort to significantly increase maneuvering capability at high angles of attack. Development and flight test of control law design methodologies, handling qualities metrics, performance guidelines, and flight evaluation maneuvers are described. The HARV has been modified to include two research control effectors, thrust vectoring, and actuated forebody strakes in order to provide increased control power at high angles of attack. A research flight control system has been used to provide a flexible, easily modified capability for high-angle-of-attack research controls. Different control law design techniques have been implemented and flight-tested, including eigenstructure assignment, variable gain output feedback, pseudo controls, and model-following. Extensive piloted simulation has been used to develop nonlinear performance guide-lines and handling qualities criteria for high angles of attack. This paper reviews the development and evaluation of technologies useful for high-angle-of-attack control. Design, development, and flight test of the research flight control system, control laws, flying qualities specifications, and flight test maneuvers are described. Flight test results are used to illustrate some of the lessons learned during flight test and handling qualities evaluations.

  6. 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

  7. Analytic Methods Used in Quality Control in a Compounding Pharmacy.

    PubMed

    Allen, Loyd V

    2017-01-01

    Analytical testing will no doubt become a more important part of pharmaceutical compounding as the public and regulatory agencies demand increasing documentation of the quality of compounded preparations. Compounding pharmacists must decide what types of testing and what amount of testing to include in their quality-control programs, and whether testing should be done in-house or outsourced. Like pharmaceutical compounding, analytical testing should be performed only by those who are appropriately trained and qualified. This article discusses the analytical methods that are used in quality control in a compounding pharmacy. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

  8. Development and Testing of a Nuclear Quality Assurance/Quality Control Technician Curriculum. Final Report.

    ERIC Educational Resources Information Center

    Espy, John; And Others

    A project was conducted to field test selected first- and second-year courses in a postsecondary nuclear quality assurance/quality control (QA/QC) technician curriculum and to develop the teaching/learning modules for seven technical specialty courses remaining in the QA/QC technician curriculum. The field testing phase of the project involved the…

  9. Quality control of test iodine in urine by spectrophotometry UV-Vis

    NASA Astrophysics Data System (ADS)

    Huda, Thorikul; Nafisah, Durotun; Kumorowulan, Suryati; Lestari, Sri

    2017-12-01

    A quality control of iodine test in with UV-Vis spectrophotometry has been done. The purpose of this research is to find out whether the test results of samples conducted by Clinical Office of Research and Development Of GAKI (BP2GAKI) laboratory are still controlled, feasible and reliable, and still consistent over time, as indicated by the control chart. Quality control parameters are linearity, precision, accuracy, limit of detection, and limit of quantification. Based on the quality control that has been done, obtained linearity (r)= -0.9974, the detection limit and the limit of quantitation are respectively 2.26 µg/L and 7.54 µg/L, while the accuracy is calculated by %recovery and precision with value % RSD are 97.4161% and 1.7136% respectively. The quality control of iodine test in urine using the control chart shows excellent or stable results for 30 days and no variation of the results is very different for each day.

  10. 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...

  11. Development of a quality control test procedure for characterizing fracture properties of asphalt mixtures.

    DOT National Transportation Integrated Search

    2011-06-01

    The main objective of this study is to investigate the use of the semi-circular bend (SCB) : test as a quality assurance/quality control (QA/QC) measure for field construction. : Comparison of fracture properties from the SCB test and fatigue beam te...

  12. Analysis of wind-tunnel stability and control tests in terms of flying qualities of full-scale airplanes

    NASA Technical Reports Server (NTRS)

    Kayten, Gerald G

    1945-01-01

    The analysis of results of wind-tunnel stability and control tests of powered airplane models in terms of the flying qualities of full-scale airplanes is advocated. In order to indicated the topics upon which comments are considered desirable in the report of a wind-tunnel stability and control investigation and to demonstrate the nature of the suggested analysis, the present NACA flying-qualities requirements are discussed in relation to wind-tunnel tests. General procedures for the estimation of flying qualities from wind-tunnel tests are outlined.

  13. 10 CFR 72.164 - Control of measuring and test equipment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., instruments, and other measuring and testing devices used in activities affecting quality are properly... WASTE Quality Assurance § 72.164 Control of measuring and test equipment. The licensee, applicant for a... 10 Energy 2 2010-01-01 2010-01-01 false Control of measuring and test equipment. 72.164 Section 72...

  14. Synthesis and quality control of fluorodeoxyglucose and performance assessment of Siemens MicroFocus 220 small animal PET scanner

    NASA Astrophysics Data System (ADS)

    Phaterpekar, Siddhesh Nitin

    The scope of this article is to cover the synthesis and quality control procedures involved in production of Fludeoxyglucose (18F--FDG). The article also describes the cyclotron production of 18F radioisotope and gives a brief overview on operations and working of a fixed energy medical cyclotron. The quality control procedures for FDG involve radiochemical and radionuclidic purity tests, pH tests, chemical purity tests, sterility tests, endotoxin tests. Each of these procedures were carried out for multiple batches of FDG with a passing rate of 95% among 20 batches. The article also covers the quality assurance steps for the Siemens MicroPET Focus 220 Scanner using a Jaszczak phantom. We have carried out spatial resolution tests on the scanner, with an average transaxial resolution of 1.775mm with 2-3mm offset. Tests involved detector efficiency, blank scan sinograms and transmission sinograms. A series of radioactivity distribution tests are also carried out on a uniform phantom, denoting the variations in radioactivity and uniformity by using cylindrical ROIs in the transverse region of the final image. The purpose of these quality control tests is to make sure the manufactured FDG is biocompatible with the human body. Quality assurance tests are carried on PET scanners for efficient performance, and to make sure the quality of images acquired is according to the radioactivity distribution in the subject of interest.

  15. Bioassay selection, experimental design and quality control/assurance for use in effluent assessment and control.

    PubMed

    Johnson, Ian; Hutchings, Matt; Benstead, Rachel; Thain, John; Whitehouse, Paul

    2004-07-01

    In the UK Direct Toxicity Assessment Programme, carried out in 1998-2000, a series of internationally recognised short-term toxicity test methods for algae, invertebrates and fishes, and rapid methods (ECLOX and Microtox) were used extensively. Abbreviated versions of conventional tests (algal growth inhibition tests, Daphnia magna immobilisation test and the oyster embryo-larval development test) were valuable for toxicity screening of effluent discharges and the identification of causes and sources of toxicity. Rapid methods based on chemiluminescence and bioluminescence were not generally useful in this programme, but may have a role where the rapid test has been shown to be an acceptable surrogate for a standardised test method. A range of quality assurance and control measures were identified. Requirements for quality control/assurance are most stringent when deriving data for characterising the toxic hazards of effluents and monitoring compliance against a toxicity reduction target. Lower quality control/assurance requirements can be applied to discharge screening and the identification of causes and sources of toxicity.

  16. 10 CFR 71.125 - Control of measuring and test equipment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... MATERIAL Quality Assurance § 71.125 Control of measuring and test equipment. The licensee, certificate holder, and applicant for a CoC shall establish measures to assure that tools, gauges, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled...

  17. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 2 2013-07-01 2013-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is calibrated and maintained properly, and that inspection, calibration records, and control charts are...

  18. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 2 2010-07-01 2010-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is calibrated and maintained properly, and that inspection, calibration records, and control charts are...

  19. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 2 2011-07-01 2011-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is calibrated and maintained properly, and that inspection, calibration records, and control charts are...

  20. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 2 2012-07-01 2012-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is calibrated and maintained properly, and that inspection, calibration records, and control charts are...

  1. 24 CFR 200.935 - Administrator qualifications and procedures for HUD building products certification programs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... guidelines in any quality assurance review: (1) ASQC Q9000-1-1994 Quality Management and Quality Assurance... Systems—Model for Quality Assurance in Final Inspection and Test; (5) ASQC Q9004-1-1994 Quality Management... in interpreting testing standards, test methods, evaluating test reports and quality control programs...

  2. 21 CFR 866.5910 - Quality control material for cystic fibrosis nucleic acid assays.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Quality control material for cystic fibrosis... Test Systems § 866.5910 Quality control material for cystic fibrosis nucleic acid assays. (a) Identification. Quality control material for cystic fibrosis nucleic acid assays. A quality control material for...

  3. 21 CFR 866.5910 - Quality control material for cystic fibrosis nucleic acid assays.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Quality control material for cystic fibrosis... Test Systems § 866.5910 Quality control material for cystic fibrosis nucleic acid assays. (a) Identification. Quality control material for cystic fibrosis nucleic acid assays. A quality control material for...

  4. 21 CFR 866.5910 - Quality control material for cystic fibrosis nucleic acid assays.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Quality control material for cystic fibrosis... Test Systems § 866.5910 Quality control material for cystic fibrosis nucleic acid assays. (a) Identification. Quality control material for cystic fibrosis nucleic acid assays. A quality control material for...

  5. 21 CFR 866.5910 - Quality control material for cystic fibrosis nucleic acid assays.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Quality control material for cystic fibrosis... Test Systems § 866.5910 Quality control material for cystic fibrosis nucleic acid assays. (a) Identification. Quality control material for cystic fibrosis nucleic acid assays. A quality control material for...

  6. 21 CFR 862.1660 - Quality control material (assayed and unassayed).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Quality control material (assayed and unassayed... Test Systems § 862.1660 Quality control material (assayed and unassayed). (a) Identification. A quality... that may arise from reagent or analytical instrument variation. A quality control material (assayed and...

  7. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 2 2014-07-01 2014-07-01 false Quality control. 51.359 Section 51.359 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS REQUIREMENTS FOR... to assure test accuracy. Computer control of quality assurance checks and quality control charts...

  8. Residual risk of bacterial contamination of platelets: six years of experience with sterility testing.

    PubMed

    Ramirez-Arcos, Sandra; DiFranco, Caesar; McIntyre, Terri; Goldman, Mindy

    2017-09-01

    Canadian Blood Services screens 100% of platelet concentrates (PCs) for bacterial contamination with the BacT/ALERT system. Quality-control sterility testing of 1% (≥10 units) of outdated PCs is performed monthly. Data from routine screening, quality-control testing, and septic reactions obtained from 2010 to 2016 are presented herein. In total, 601,988 buffy coat PC pools and 186,737 apheresis PCs were routinely screened with aerobic cultures over 6 years. Outdate quality-control testing of 8535 buffy coat and 8498 apheresis PCs was performed using aerobic and anaerobic cultures during the same period. Results were classified as "true-positives" when the same bacterium was isolated in initial and confirmatory cultures or "false-negatives" when bacteria were missed in early screening and were captured during quality-control sterility testing or through investigation of sepsis cases. During routine screening, the true-positive rates between buffy coat (0.94 per 10,000) and apheresis (0.96 per 10,000) PCs were similar (p = 0.9473). Seventy-five bacteria isolated during PC screening included Gram-positive and Gram-negative organisms. Six false-negative septic reactions were reported that implicated coagulase-negative staphylococci (n = 3) and Staphylococcus aureus (n = 3) for approximate rates of 1 per 100,000 transfusion reactions and 1 per 500,000 fatalities. During quality-control testing, the false-negative rates between buffy coat (8 per 10,000) and apheresis (9 per 10,000) PCs were similar (p = 0.7897). All 15 quality-control isolates were Gram-positive bacteria. The current bacterial screening protocol is efficacious for identifying Gram-negative bacteria. However, the high proportion of Gram-positive organisms detected on outdate quality-control testing and septic transfusion events demonstrates a residual safety risk that merits further intervention. © 2017 AABB.

  9. Applications of flight control system methods to an advanced combat rotorcraft

    NASA Technical Reports Server (NTRS)

    Tischler, Mark B.; Fletcher, Jay W.; Morris, Patrick M.; Tucker, George T.

    1989-01-01

    Advanced flight control system design, analysis, and testing methodologies developed at the Ames Research Center are applied in an analytical and flight test evaluation of the Advanced Digital Optical Control System (ADOCS) demonstrator. The primary objectives are to describe the knowledge gained about the implications of digital flight control system design for rotorcraft, and to illustrate the analysis of the resulting handling-qualities in the context of the proposed new handling-qualities specification for rotorcraft. Topics covered in-depth are digital flight control design and analysis methods, flight testing techniques, ADOCS handling-qualities evaluation results, and correlation of flight test results with analytical models and the proposed handling-qualities specification. The evaluation of the ADOCS demonstrator indicates desirable response characteristics based on equivalent damping and frequency, but undersirably large effective time-delays (exceeding 240 m sec in all axes). Piloted handling-qualities are found to be desirable or adequate for all low, medium, and high pilot gain tasks; but handling-qualities are inadequate for ultra-high gain tasks such as slope and running landings.

  10. Quality by control: Towards model predictive control of mammalian cell culture bioprocesses.

    PubMed

    Sommeregger, Wolfgang; Sissolak, Bernhard; Kandra, Kulwant; von Stosch, Moritz; Mayer, Martin; Striedner, Gerald

    2017-07-01

    The industrial production of complex biopharmaceuticals using recombinant mammalian cell lines is still mainly built on a quality by testing approach, which is represented by fixed process conditions and extensive testing of the end-product. In 2004 the FDA launched the process analytical technology initiative, aiming to guide the industry towards advanced process monitoring and better understanding of how critical process parameters affect the critical quality attributes. Implementation of process analytical technology into the bio-production process enables moving from the quality by testing to a more flexible quality by design approach. The application of advanced sensor systems in combination with mathematical modelling techniques offers enhanced process understanding, allows on-line prediction of critical quality attributes and subsequently real-time product quality control. In this review opportunities and unsolved issues on the road to a successful quality by design and dynamic control implementation are discussed. A major focus is directed on the preconditions for the application of model predictive control for mammalian cell culture bioprocesses. Design of experiments providing information about the process dynamics upon parameter change, dynamic process models, on-line process state predictions and powerful software environments seem to be a prerequisite for quality by control realization. © 2017 The Authors. Biotechnology Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  11. Chronic Low Quality Sleep Impairs Postural Control in Healthy Adults.

    PubMed

    Furtado, Fabianne; Gonçalves, Bruno da Silva B; Abranches, Isabela Lopes Laguardia; Abrantes, Ana Flávia; Forner-Cordero, Arturo

    2016-01-01

    The lack of sleep, both in quality and quantity, is an increasing problem in modern society, often related to workload and stress. A number of studies have addressed the effects of acute (total) sleep deprivation on postural control. However, up to date, the effects of chronic sleep deficits, either in quantity or quality, have not been analyzed. Thirty healthy adults participated in the study that consisted of registering activity with a wrist actigraph for more than a week before performing a series of postural control tests. Sleep and circadian rhythm variables were correlated and the sum of activity of the least active 5-h period, L5, a rhythm variable, obtained the greater coefficient value with sleep quality variables (wake after sleep onset WASO and efficiency sleep). Cluster analysis was performed to classify subjects into two groups based on L5 (low and high). The balance tests scores used to asses postural control were measured using Biodex Balance System and were compared between the two groups with different sleep quality. The postural tests were divided into dynamic (platform tilt with eyes open, closed and cursor) and static (clinical test of sensory integration). The results showed that during the tests with eyes closed, the group with worse sleep quality had also worse postural control performance. Lack of vision impairs postural balance more deeply in subjects with chronic sleep inefficiency. Chronic poor sleep quality impairs postural control similarly to total sleep deprivation.

  12. Chronic Low Quality Sleep Impairs Postural Control in Healthy Adults

    PubMed Central

    Gonçalves, Bruno da Silva B.; Abranches, Isabela Lopes Laguardia; Abrantes, Ana Flávia

    2016-01-01

    The lack of sleep, both in quality and quantity, is an increasing problem in modern society, often related to workload and stress. A number of studies have addressed the effects of acute (total) sleep deprivation on postural control. However, up to date, the effects of chronic sleep deficits, either in quantity or quality, have not been analyzed. Thirty healthy adults participated in the study that consisted of registering activity with a wrist actigraph for more than a week before performing a series of postural control tests. Sleep and circadian rhythm variables were correlated and the sum of activity of the least active 5-h period, L5, a rhythm variable, obtained the greater coefficient value with sleep quality variables (wake after sleep onset WASO and efficiency sleep). Cluster analysis was performed to classify subjects into two groups based on L5 (low and high). The balance tests scores used to asses postural control were measured using Biodex Balance System and were compared between the two groups with different sleep quality. The postural tests were divided into dynamic (platform tilt with eyes open, closed and cursor) and static (clinical test of sensory integration). The results showed that during the tests with eyes closed, the group with worse sleep quality had also worse postural control performance. Lack of vision impairs postural balance more deeply in subjects with chronic sleep inefficiency. Chronic poor sleep quality impairs postural control similarly to total sleep deprivation. PMID:27732604

  13. New strategy to improve quality control of Montenegro skin test at the production level.

    PubMed

    Guedes, Deborah Carbonera; Minozzo, João Carlos; Pasquali, Aline Kuhn Sbruzzi; Faulds, Craig; Soccol, Carlos Ricardo; Thomaz-Soccol, Vanete

    2017-01-01

    The production of the Montenegro antigen for skin test poses difficulties regarding quality control. Here, we propose that certain animal models reproducing a similar immune response to humans may be used in the quality control of Montenegro antigen production. Fifteen Cavia porcellus (guinea pigs) were immunized with Leishmania amazonensis or Leishmania braziliensis , and, after 30 days, they were skin tested with standard Montenegro antigen. To validate C. porcellus as an animal model for skin tests, eighteen Mesocricetus auratus (hamsters) were infected with L. amazonensis or L. braziliensis , and, after 45 days, they were skin tested with standard Montenegro antigen. Cavia porcellus immunized with L. amazonensis or L. braziliensis , and hamsters infected with the same species presented induration reactions when skin tested with standard Montenegro antigen 48-72h after the test. The comparison between immunization methods and immune response from the two animal species validated C. porcellus as a good model for Montenegro skin test, and the model showed strong potential as an in vivo model in the quality control of the production of Montenegro antigen.

  14. Predicting health-related quality of life in cancer patients receiving chemotherapy: a structural equation approach using the self-control model.

    PubMed

    Park, Yu-Ri; Park, Eun-Young; Kim, Jung-Hee

    2017-11-09

    According to the self-control model, self-control works as a protective factor and a psychological resource. Although an understanding of the effect(s) of peripheral neuropathy on quality of life is important to healthcare professionals, previous studies do not facilitate broad comprehension in this regard. The purpose of this cross-sectional study was to test the multidimensional assumptions of quality of life of patients with cancer, with focus on their self-control. A structural equation model was tested on patients with cancer at the oncology clinic of a university hospital where patients received chemotherapy. A model was tested using structural equation modeling, which allows the researcher to find the empirical evidence by testing a measurement model and a structural model. The model comprised three variables, self-control, health related quality of life, and chemotherapy-induced peripheral neuropathy. Among the variables, self-control was the endogenous and mediating variable. The proposed models showed good fit indices. Self-control partially mediated chemotherapy-induced peripheral neuropathy and quality of life. It was found that the physical symptoms of peripheral neuropathy influenced health-related quality of life both indirectly and directly. Self-control plays a significant role in the protection and promotion of physical and mental health in various stressful situations, and thus, as a psychological resource, it plays a significant role in quality of life. Our results can be used to develop a quality of life model for patients receiving chemotherapy and as a theoretical foundation for the development of appropriate nursing interventions.

  15. Quality Control for Scoring Tests Administered in Continuous Mode: An NCME Instructional Module

    ERIC Educational Resources Information Center

    Allalouf, Avi; Gutentag, Tony; Baumer, Michal

    2017-01-01

    Quality control (QC) in testing is paramount. QC procedures for tests can be divided into two types. The first type, one that has been well researched, is QC for tests administered to large population groups on few administration dates using a small set of test forms (e.g., large-scale assessment). The second type is QC for tests, usually…

  16. 46 CFR 160.135-15 - Production inspections, tests, quality control, and conformance of lifeboats.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... materials are as per the plans approved under § 160.135-13(h) of this subpart. (2) Post assembly tests and... each design must pass each of the tests described in the IMO Revised recommendation on testing, part 2... 46 Shipping 6 2014-10-01 2014-10-01 false Production inspections, tests, quality control, and...

  17. ITC Guidelines on Quality Control in Scoring, Test Analysis, and Reporting of Test Scores

    ERIC Educational Resources Information Center

    Allalouf, Avi

    2014-01-01

    The Quality Control (QC) Guidelines are intended to increase the efficiency, precision, and accuracy of the scoring, analysis, and reporting process of testing. The QC Guidelines focus on large-scale testing operations where multiple forms of tests are created for use on set dates. However, they may also be used for a wide variety of other testing…

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

    PubMed

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

    2016-03-01

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

  19. 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...

  20. 21 CFR 640.56 - Quality control test for potency.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., Center for Biologics Evaluation and Research, Food and Drug Administration. Such testing shall not be... Evaluation and Research, Food and Drug Administration. (d) If the average potency level of antihemophilic... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Quality control test for potency. 640.56 Section...

  1. KPMG Peat Marwick LLP Corporation of Mercer University Fiscal Year Ended June 30, 1995

    DTIC Science & Technology

    1997-06-11

    The objective of a quality control review is to ensure that the audit was conducted in accordance with applicable standards and meets the auditing...requirements of the OMB Circular A-133. We conducted a quality control review of the audit working papers. We focused our review on the following...qualitative aspects of the audit : due professional care, planning, supervision, independence, quality control, internal controls, substantive testing, general and specific compliance testing, and the Schedule of Federal Awards.

  2. 40 CFR 85.2233 - Steady state test equipment calibrations, adjustments, and quality control-EPA 91.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... compensated for automatically and statistical process control demonstrates equal or better quality control... calibrations, adjustments, and quality control-EPA 91. 85.2233 Section 85.2233 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CONTROL OF AIR POLLUTION FROM MOBILE...

  3. Standardized methods and quality control limits for agar and broth microdilution susceptibility testing of Mycoplasma pneumoniae, Mycoplasma hominis, and Ureaplasma urealyticum.

    PubMed

    Waites, Ken B; Duffy, Lynn B; Bébéar, Cécile M; Matlow, Anne; Talkington, Deborah F; Kenny, George E; Totten, Patricia A; Bade, Donald J; Zheng, Xiaotian; Davidson, Maureen K; Shortridge, Virginia D; Watts, Jeffrey L; Brown, Steven D

    2012-11-01

    An international multilaboratory collaborative study was conducted to develop standard media and consensus methods for the performance and quality control of antimicrobial susceptibility testing of Mycoplasma pneumoniae, Mycoplasma hominis, and Ureaplasma urealyticum using broth microdilution and agar dilution techniques. A reference strain from the American Type Culture Collection was designated for each species, which was to be used for quality control purposes. Repeat testing of replicate samples of each reference strain by participating laboratories utilizing both methods and different lots of media enabled a 3- to 4-dilution MIC range to be established for drugs in several different classes, including tetracyclines, macrolides, ketolides, lincosamides, and fluoroquinolones. This represents the first multilaboratory collaboration to standardize susceptibility testing methods and to designate quality control parameters to ensure accurate and reliable assay results for mycoplasmas and ureaplasmas that infect humans.

  4. Handling Qualities of Model Reference Adaptive Controllers with Varying Complexity for Pitch-Roll Coupled Failures

    NASA Technical Reports Server (NTRS)

    Schaefer, Jacob; Hanson, Curt; Johnson, Marcus A.; Nguyen, Nhan

    2011-01-01

    Three model reference adaptive controllers (MRAC) with varying levels of complexity were evaluated on a high performance jet aircraft and compared along with a baseline nonlinear dynamic inversion controller. The handling qualities and performance of the controllers were examined during failure conditions that induce coupling between the pitch and roll axes. Results from flight tests showed with a roll to pitch input coupling failure, the handling qualities went from Level 2 with the baseline controller to Level 1 with the most complex MRAC tested. A failure scenario with the left stabilator frozen also showed improvement with the MRAC. Improvement in performance and handling qualities was generally seen as complexity was incrementally added; however, added complexity usually corresponds to increased verification and validation effort required for certification. The tradeoff between complexity and performance is thus important to a controls system designer when implementing an adaptive controller on an aircraft. This paper investigates this relation through flight testing of several controllers of vary complexity.

  5. 46 CFR 160.156-15 - Production inspections, tests, quality control, and conformance of rescue boats and fast rescue...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... materials are as per the plans approved under § 160.156-13(h) of this subpart. (2) Post assembly tests and... of each design must pass each of the tests described in the IMO Revised recommendation on testing... 46 Shipping 6 2014-10-01 2014-10-01 false Production inspections, tests, quality control, and...

  6. 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.

  7. 10 CFR 26.137 - Quality assurance and quality control.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

  8. 10 CFR 26.137 - Quality assurance and quality control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

  9. 10 CFR 26.137 - Quality assurance and quality control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

  10. 10 CFR 26.137 - Quality assurance and quality control.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

  11. 10 CFR 26.137 - Quality assurance and quality control.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... validation of analytical procedures. Quality assurance procedures must be designed, implemented, and reviewed... resolving any technical, methodological, or administrative errors in the licensee testing facility's testing...

  12. Validation Tests of a Non-Nuclear Combined Asphalt and Soil Density Gauge

    DTIC Science & Technology

    2014-04-01

    limit if applicable. This approach was considered as if this device was to be used on a construction project for quality control where the material...military contingency construction activities, because they are not sufficiently accurate compared to the NDG for quality control use in permanent...binder. Nominal asphalt content with water included was 5.2. m Average results from producer’s Quality Control (QC) testing. The list of instruments

  13. On quality control procedures for solar radiation and meteorological measures, from subhourly to montly average time periods

    NASA Astrophysics Data System (ADS)

    Espinar, B.; Blanc, P.; Wald, L.; Hoyer-Klick, C.; Schroedter-Homscheidt, M.; Wanderer, T.

    2012-04-01

    Meteorological data measured by ground stations are often a key element in the development and validation of methods exploiting satellite images. These data are considered as a reference against which satellite-derived estimates are compared. Long-term radiation and meteorological measurements are available from a large number of measuring stations. However, close examination of the data often reveals a lack of quality, often for extended periods of time. This lack of quality has been the reason, in many cases, of the rejection of large amount of available data. The quality data must be checked before their use in order to guarantee the inputs for the methods used in modelling, monitoring, forecast, etc. To control their quality, data should be submitted to several conditions or tests. After this checking, data that are not flagged by any of the test is released as a plausible data. In this work, it has been performed a bibliographical research of quality control tests for the common meteorological variables (ambient temperature, relative humidity and wind speed) and for the usual solar radiometrical variables (horizontal global and diffuse components of the solar radiation and the beam normal component). The different tests have been grouped according to the variable and the average time period (sub-hourly, hourly, daily and monthly averages). The quality test may be classified as follows: • Range checks: test that verify values are within a specific range. There are two types of range checks, those based on extrema and those based on rare observations. • Step check: test aimed at detecting unrealistic jumps or stagnation in the time series. • Consistency checks: test that verify the relationship between two or more time series. The gathered quality tests are applicable for all latitudes as they have not been optimized regionally nor seasonably with the aim of being generic. They have been applied to ground measurements in several geographic locations, what result in the detection of some control tests that are no longer adequate, due to different reasons. After the modification of some test, based in our experience, a set of quality control tests is now presented, updated according to technology advances and classified. The presented set of quality tests allows radiation and meteorological data to be tested in order to know their plausibility to be used as inputs in theoretical or empirical methods for scientific research. The research leading to those results has partly receive funding from the European Union's Seventh Framework Programme (FP7/2007-2013) under Grant Agreement no. 262892 (ENDORSE project).

  14. Double-quality control reveals high-level toxicity in gloves used for operator protection in assisted reproductive technology.

    PubMed

    Lierman, Sylvie; De Sutter, Petra; Dhont, Marc; Van der Elst, Josiane

    2007-10-01

    To submit different glove brands to double-quality control tests using mouse embryo assay (MEA) and the human sperm motility assay (HuSMA). Operator protection against infectious body fluid contamination is a safety issue in assisted reproductive technology (ART). When using gloves in the ART laboratory, toxic substances can be transmitted to culture media, even during brief contact. Quality control study of gloves in ART. University hospital-based infertility center. Seven- to 8-week-old female B6D2F1 hybrid mice. We tested two surgical, two cleanroom, and six examination glove brands. Only gloves brands that passed both HuSMA and MEA were submitted to further QC using zona-free and/or cryopreserved MEA. Sperm motility index, two-cell and blastocyst development, blastocyst total cell number. Quality control by MEA and HuSMA identified two glove brands to be nontoxic. Our study shows that gloves used in ART can be toxic and should be tested as part of an ongoing quality control program.

  15. Quality Assurance and Quality Control, Part 2.

    PubMed

    Akers, Michael J

    2015-01-01

    The tragedy surrounding the New England Compounding Center and contaminated steroid syringe preparations clearly points out what can happen if quality-assurance and quality-control procedures are not strictly practiced in the compounding of sterile preparations. This article is part 2 of a two-part article on requirements to comply with United States Pharmacopeia general chapters <797> and <1163> with respect to quality assurance of compounded sterile preparations. Part 1 covered documentation requirements, inspection procedures, compounding accuracy checks, and part of a discussion on bacterial endotoxin testing. Part 2 covers sterility testing, the completion from part 1 on bacterial endotoxin testing, a brief dicussion of United States Pharmacopeia <1163>, and advances in pharmaceutical quality systems.

  16. Approaches to quality management and accreditation in a genetic testing laboratory

    PubMed Central

    Berwouts, Sarah; Morris, Michael A; Dequeker, Elisabeth

    2010-01-01

    Medical laboratories, and specifically genetic testing laboratories, provide vital medical services to different clients: clinicians requesting a test, patients from whom the sample was collected, public health and medical-legal instances, referral laboratories and authoritative bodies. All expect results that are accurate and obtained in an efficient and effective manner, within a suitable time frame and at acceptable cost. There are different ways of achieving the end results, but compliance with International Organization for Standardization (ISO) 15189, the international standard for the accreditation of medical laboratories, is becoming progressively accepted as the optimal approach to assuring quality in medical testing. We present recommendations and strategies designed to aid genetic testing laboratories with the implementation of a quality management system, including key aspects such as document control, external quality assessment, internal quality control, internal audit, management review, validation, as well as managing the human side of change. The focus is on pragmatic approaches to attain the levels of quality management and quality assurance required for accreditation according to ISO 15189, within the context of genetic testing. Attention is also given to implementing efficient and effective quality improvement. PMID:20720559

  17. 42 CFR 493.1495 - Standard; Testing personnel responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... samples are tested in the same manner as patient specimens; (3) Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived...

  18. 30 CFR 74.6 - Quality control.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

  19. 30 CFR 74.6 - Quality control.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

  20. 30 CFR 74.6 - Quality control.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

  1. 30 CFR 28.32 - Proposed quality control plans; approval by MSHA.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... subpart shall be reviewed by MSHA to determine its effectiveness in insuring the quality of short-circuit... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS FUSES FOR USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.32 Proposed quality control...

  2. Study of twenty preparations of human albumin solution which failed in quality control testing due to elevated sodium content, a poor internal quality control at manufacturing unit.

    PubMed

    Prasad, J P; Madhu, Y; Singh, Surinder; Soni, G R; Agnihotri, N; Singh, Varsha; Kumar, Pradeep; Jain, Nidhi; Prakash, Anu; Singh, Varun

    2016-11-01

    Current study is conducted in our laboratory due to failure in quality control testing of twenty batches of Human Albumin solution in which sodium content is higher than the prescribed limit. These batches are received in short duration from indigenous manufacturer and is the first incident of failure of Human albumin preparation in sodium content of manufacturer. On request of manufacturer, study is conducted to rule out the cause. Repeat testing of each out of specification batch is conducted and a trend analysis is drawn between our findings and manufacturer's results, also study of trend analysis of manufacturer for the last one year. Trend analysis data indicated towards poor consistency of batches with major shift at various time intervals in sodium content of human albumin preparation. Further analysis rule out that non-traceable quality of standard used in the internal quality control testing by manufacturer is the root cause of the problem. Copyright © 2016 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

  3. FIELD QUALITY CONTROL STRATEGIES ASSESSING SOLIDIFICATION/STABILIZATION

    EPA Science Inventory

    Existing regulatory mobility reduction (leaching) tests are not amenable to real time quality control because of the time required to perform sample extraction and chemical analysis. This is of conccern because the leaching test is the most important parameter used to relate trea...

  4. Vista/F-16 Multi-Axis Thrust Vectoring (MATV) control law design and evaluation

    NASA Technical Reports Server (NTRS)

    Zwerneman, W. D.; Eller, B. G.

    1994-01-01

    For the Multi-Axis Thrust Vectoring (MATV) program, a new control law was developed using multi-axis thrust vectoring to augment the aircraft's aerodynamic control power to provide maneuverability above the normal F-16 angle of attack limit. The control law architecture was developed using Lockheed Fort Worth's offline and piloted simulation capabilities. The final flight control laws were used in flight test to demonstrate tactical benefits gained by using thrust vectoring in air-to-air combat. Differences between the simulator aerodynamics data base and the actual aircraft aerodynamics led to significantly different lateral-directional flying qualities during the flight test program than those identified during piloted simulation. A 'dial-a-gain' flight test control law update was performed in the middle of the flight test program. This approach allowed for inflight optimization of the aircraft's flying qualities. While this approach is not preferred over updating the simulator aerodynamic data base and then updating the control laws, the final selected gain set did provide adequate lateral-directional flying qualities over the MATV flight envelope. The resulting handling qualities and the departure resistance of the aircraft allowed the 422nd_squadron pilots to focus entirely on evaluating the aircraft's tactical utility.

  5. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  6. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  7. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  8. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  9. 40 CFR 266.103 - Interim status standards for burners.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

  10. Motion-base simulator results of advanced supersonic transport handling qualities with active controls

    NASA Technical Reports Server (NTRS)

    Feather, J. B.; Joshi, D. S.

    1981-01-01

    Handling qualities of the unaugmented advanced supersonic transport (AST) are deficient in the low-speed, landing approach regime. Consequently, improvement in handling with active control augmentation systems has been achieved using implicit model-following techniques. Extensive fixed-based simulator evaluations were used to validate these systems prior to tests with full motion and visual capabilities on a six-axis motion-base simulator (MBS). These tests compared the handling qualities of the unaugmented AST with several augmented configurations to ascertain the effectiveness of these systems. Cooper-Harper ratings, tracking errors, and control activity data from the MBS tests have been analyzed statistically. The results show the fully augmented AST handling qualities have been improved to an acceptable level.

  11. Pharmaceutical quality by design: product and process development, understanding, and control.

    PubMed

    Yu, Lawrence X

    2008-04-01

    The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile; Designing product and manufacturing processes; Identifying critical quality attributes, process parameters, and sources of variability; Controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.

  12. Flight-Test Validation and Flying Qualities Evaluation of a Rotorcraft UAV Flight Control System

    NASA Technical Reports Server (NTRS)

    Mettler, Bernard; Tuschler, Mark B.; Kanade, Takeo

    2000-01-01

    This paper presents a process of design and flight-test validation and flying qualities evaluation of a flight control system for a rotorcraft-based unmanned aerial vehicle (RUAV). The keystone of this process is an accurate flight-dynamic model of the aircraft, derived by using system identification modeling. The model captures the most relevant dynamic features of our unmanned rotorcraft, and explicitly accounts for the presence of a stabilizer bar. Using the identified model we were able to determine the performance margins of our original control system and identify limiting factors. The performance limitations were addressed and the attitude control system was 0ptimize.d for different three performance levels: slow, medium, fast. The optimized control laws will be implemented in our RUAV. We will first determine the validity of our control design approach by flight test validating our optimized controllers. Subsequently, we will fly a series of maneuvers with the three optimized controllers to determine the level of flying qualities that can be attained. The outcome enable us to draw important conclusions on the flying qualities requirements for small-scale RUAVs.

  13. Quality control of fireproof coatings for reinforced concrete structures

    NASA Astrophysics Data System (ADS)

    Gravit, Marina; Dmitriev, Ivan; Ishkov, Alexander

    2017-10-01

    The article analyzes methods of quality inspection of fireproof coatings (work flow, measuring, laboratory, etc.). In modern construction there is a problem of lack of distinct monitoring for the fire protection testing. There is a description of this testing for reinforced concrete structures. The article shows the results of calculation quality control of hatches as an example of fireproof coating for reinforced concrete structures.

  14. Proposed quality control guidelines for antimicrobial susceptibility tests using tilmicosin.

    PubMed Central

    Shryock, T R; White, D W; Werner, C S; Staples, J M

    1995-01-01

    Quality control guidelines for tilmicosin, a novel veterinary-use-only macrolide, were developed in a multi-laboratory study according to established National Committee for Clinical Laboratory Standards (NCCLS) procedures (M23-T2). Tilmicosin was incorporated into Sensititre plates for broth microdilution endpoint testing and into two lots of 15-micrograms disks for Kirby-Bauer agar disk diffusion testing. One common lot and five unique lots of Mueller-Hinton media were used. (Broth was cation adjusted, and agar was supplemented with 5% defibrinated sheep blood.) Bacteria used for reference strains included Pasteurella haemolytica 128K, Pasteurella multocida ATCC 43137, and Staphylococcus aureus ATCC 29213 (microdilution) and ATCC 25923 (disk). Replicate tests were conducted. Disk diffusion and broth microdilution quality control ranges are proposed. PMID:7714188

  15. The Use of Quality Control and Data Mining Techniques for Monitoring Scaled Scores: An Overview. Research Report. ETS RR-12-20

    ERIC Educational Resources Information Center

    von Davier, Alina A.

    2012-01-01

    Maintaining comparability of test scores is a major challenge faced by testing programs that have almost continuous administrations. Among the potential problems are scale drift and rapid accumulation of errors. Many standard quality control techniques for testing programs, which can effectively detect and address scale drift for small numbers of…

  16. [The continuous graphic presentation of interdepartmental results (author's transl)].

    PubMed

    Berger, J; Hirsch, H

    1976-10-01

    The results of interdepartmental determinations can be clearly presented in the laboratory in two ways: 1. Entry on a test card, according to Shewhart, as used in internal quality control. 2. Entry on a test card, constructed on the principle of the Cusum test. By the latter procedure, systematic errors are detected sooner than with the usual test card. A graphic variant of the Cusum test is described; a V-mask is not required; the card superficially resembles the usual control card, and the calculation time is minimal. This method may also be used to advantage in internal quality control.

  17. [Implementation of quality standard UNE-EN ISO/IEC 17043 in the External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology].

    PubMed

    Poveda Gabaldón, Marta; Ovies, María Rosario; Orta Mira, Nieves; Serrano, M del Remedio Guna; Avila, Javier; Giménez, Alicia; Cardona, Concepción Gimeno

    2011-12-01

    The quality standard "UNE-EN-ISO 17043: 2010. Conformity assessment. General requirements for proficiency testing" applies to centers that organize intercomparisons in all areas. In the case of clinical microbiology laboratories, these intercomparisons must meet the management and technical standards required to achieve maximum quality in the performance of microbiological analysis and the preparation of test items (sample, product, data or other information used in the proficiency test) to enable them to be accredited. Once accredited, these laboratories can operate as a tool for quality control laboratories and competency assessment. In Spain, accreditation is granted by the Spanish Accreditation Body [Entidad Nacional de Acreditación (ENAC)]. The objective of this review is to explain how to apply the requirements of the standard to laboratories providing intercomparisons in the field of clinical microbiology (the organization responsible for all the tasks related to the development and operation of a proficiency testing program). This requires defining the scope and specifying the technical requirements (personnel management, control of equipment, facilities and environment, the design of the proficiency testing and data analysis for performance evaluation, communication with participants and confidentiality) and management requirements (document control, purchasing control, monitoring of complaints / claims, non-compliance, internal audits and management reviews). Copyright © 2011 Elsevier España S.L. All rights reserved.

  18. The vaccines consistency approach project: an EPAA initiative.

    PubMed

    De Mattia, F; Hendriksen, C; Buchheit, K H; Chapsal, J M; Halder, M; Lambrigts, D; Redhead, K; Rommel, E; Scharton-Kersten, T; Sesardic, T; Viviani, L; Ragan, I

    2015-01-01

    The consistency approach for release testing of established vaccines promotes the use of in vitro, analytical, non-animal based systems allowing the monitoring of quality parameters during the whole production process. By using highly sensitive non-animal methods, the consistency approach has the potential to improve the quality of testing and to foster the 3Rs (replacement, refinement and reduction of animal use) for quality control of established vaccines. This concept offers an alternative to the current quality control strategy which often requires large numbers of laboratory animals. In order to facilitate the introduction of the consistency approach for established human and veterinary vaccine quality control, the European Partnership for Alternatives to Animal Testing (EPAA) initiated a project, the "Vaccines Consistency Approach Project", aiming at developing and validating the consistency approach with stakeholders from academia, regulators, OMCLs, EDQM, European Commission and industry. This report summarises progress since the project's inception.

  19. 30 CFR 28.31 - Quality control plans; contents.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28.31 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.31 Quality control plans; contents. (a... Specification MIL-F-15160D is available for examination at the U.S. Department of Labor, Mine Safety and Health...

  20. 30 CFR 28.31 - Quality control plans; contents.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28.31 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.31 Quality control plans; contents. (a... Specification MIL-F-15160D is available for examination at the U.S. Department of Labor, Mine Safety and Health...

  1. 30 CFR 28.31 - Quality control plans; contents.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28.31 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.31 Quality control plans; contents. (a... Specification MIL-F-15160D is available for examination at the U.S. Department of Labor, Mine Safety and Health...

  2. 30 CFR 28.31 - Quality control plans; contents.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28.31 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.31 Quality control plans; contents. (a... Specification MIL-F-15160D is available for examination at the U.S. Department of Labor, Mine Safety and Health...

  3. Challenges in Routine Implementation and Quality Control of Rapid Diagnostic Tests for Malaria–Rufiji District, Tanzania

    PubMed Central

    McMorrow, Meredith L.; Masanja, M. Irene; Abdulla, Salim M. K.; Kahigwa, Elizeus; Kachur, S. Patrick

    2018-01-01

    Rapid diagnostic tests (RDTs) represent an alternative to microscopy for malaria diagnosis and have shown high sensitivity and specificity in a variety of study settings. Current World Health Organization (WHO) guidelines for quality control of RDTs provide detailed instructions on pre-field testing, but offer little guidance for quality assurance once RDTs are deployed in health facilities. From September 2006 to April 2007, we introduced a histidine-rich protein II (HRP2)-based RDT (Paracheck) for suspected malaria cases five years of age and older in nine health facilities in Rufiji District, Tanzania, to assess sensitivity and specificity of RDTs in routine use at rural health facilities. Thick blood smears were collected for all patients tested with RDTs and stained and read by laboratory personnel in each facility. Thick smears were subsequently reviewed by a reference microscopist to determine RDT sensitivity and specificity. In all nine health facilities, there were significant problems with the quality of staining and microscopy. Sensitivity and specificity of RDTs were difficult to assess given the poor quality of routine blood smear staining. Mean operational sensitivity of RDTs based on reference microscopy was 64.8%, but varied greatly by health facility, range 18.8–85.9%. Sensitivity of RDTs increased with increasing parasite density. Specificity remained high at 87.8% despite relatively poor slide quality. Institution of quality control of RDTs based on poor quality blood smear staining may impede reliable measurement of sensitivity and specificity and undermine confidence in the new diagnostic. There is an urgent need for the development of alternative quality control procedures for rapid diagnostic tests that can be performed at the facility level. PMID:18784230

  4. Agent-based station for on-line diagnostics by self-adaptive laser Doppler vibrometry

    NASA Astrophysics Data System (ADS)

    Serafini, S.; Paone, N.; Castellini, P.

    2013-12-01

    A self-adaptive diagnostic system based on laser vibrometry is proposed for quality control of mechanical defects by vibration testing; it is developed for appliances at the end of an assembly line, but its characteristics are generally suited for testing most types of electromechanical products. It consists of a laser Doppler vibrometer, equipped with scanning mirrors and a camera, which implements self-adaptive bahaviour for optimizing the measurement. The system is conceived as a Quality Control Agent (QCA) and it is part of a Multi Agent System that supervises all the production line. The QCA behaviour is defined so to minimize measurement uncertainty during the on-line tests and to compensate target mis-positioning under guidance of a vision system. Best measurement conditions are reached by maximizing the amplitude of the optical Doppler beat signal (signal quality) and consequently minimize uncertainty. In this paper, the optimization strategy for measurement enhancement achieved by the down-hill algorithm (Nelder-Mead algorithm) and its effect on signal quality improvement is discussed. Tests on a washing machine in controlled operating conditions allow to evaluate the efficacy of the method; significant reduction of noise on vibration velocity spectra is observed. Results from on-line tests are presented, which demonstrate the potential of the system for industrial quality control.

  5. 40 CFR 75.59 - Certification, quality assurance, and quality control record provisions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...-minute readings and the run average); (B) The raw data and results for all required pre-test, post-test... error tests, and all off-line calibration demonstrations, including any follow-up tests after corrective... tests, a test number and reason for test; (ix) For 7-day calibration tests for certification or...

  6. 40 CFR 75.59 - Certification, quality assurance, and quality control record provisions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...-minute readings and the run average); (B) The raw data and results for all required pre-test, post-test... error tests, and all off-line calibration demonstrations, including any follow-up tests after corrective... tests, a test number and reason for test; (ix) For 7-day calibration tests for certification or...

  7. 40 CFR 75.59 - Certification, quality assurance, and quality control record provisions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...-minute readings and the run average); (B) The raw data and results for all required pre-test, post-test... error tests, and all off-line calibration demonstrations, including any follow-up tests after corrective... tests, a test number and reason for test; (ix) For 7-day calibration tests for certification or...

  8. 40 CFR 75.59 - Certification, quality assurance, and quality control record provisions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...-minute readings and the run average); (B) The raw data and results for all required pre-test, post-test... error tests, and all off-line calibration demonstrations, including any follow-up tests after corrective... tests, a test number and reason for test; (ix) For 7-day calibration tests for certification or...

  9. 21 CFR 866.5910 - Quality control material for cystic fibrosis nucleic acid assays.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological Test Systems § 866.5910 Quality control material for cystic fibrosis nucleic acid assays. (a... cystic fibrosis nucleic acid assays is a device intended to help monitor reliability of a test system by...

  10. Development of models to estimate the subgrade and subbase layers' resilient modulus from in situ devices test results for construction control.

    DOT National Transportation Integrated Search

    2008-04-01

    The objective of this study was to develop resilient modulus prediction models for possible application in the quality control/quality assurance (QC/QA) procedures during and after the construction of pavement layers. Field and laboratory testing pro...

  11. Commercial jet fuel quality control

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

    Strauss, K.H.

    1995-05-01

    The paper discusses the purpose of jet fuel quality control between the refinery and the aircraft. It describes fixed equipment, including various types of filters, and the usefulness and limitations of this equipment. Test equipment is reviewed as are various surveillance procedures. These include the Air Transport Association specification ATA 103, the FAA Advisory Circular 150/5230-4, the International Air Transport Association Guidance Material for Fuel Quality Control and Fuelling Service and the Guidelines for Quality Control at Jointly Operated Fuel Systems. Some past and current quality control problems are briefly mentioned.

  12. Assessment of non-destructive testing technologies for quality control/quality assurance of asphalt mixtures : [tech transfer summary].

    DOT National Transportation Integrated Search

    2015-02-01

    Evaluation of the actual performance (quality) of pavements requires : in situ nondestructive testing (NDT) techniques that can accurately : measure the most critical, objective, and sensitive properties of : pavement systems.

  13. 29 CFR 1910.7 - Definition and requirements for a nationally recognized testing laboratory.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., written testing procedures, and calibration and quality control programs) to perform: (i) Testing and... test standards; or (ii) Experimental testing and examining of equipment and materials for workplace..., labeled, or accepted, the following controls or services: (i) Implements control procedures for...

  14. Implementation of basic quality control tests for malaria medicines in Amazon Basin countries: results for the 2005–2010 period

    PubMed Central

    2012-01-01

    Background Ensuring the quality of malaria medicines is crucial in working toward malaria control and eventual elimination. Unlike other validated tests that can assess all critical quality attributes, which is the standard for determining the quality of medicines, basic tests are significantly less expensive, faster, and require less skilled labour; yet, these tests provide reproducible data and information on several critical quality attributes, such as identity, purity, content, and disintegration. Visual and physical inspection also provides valuable information about the manufacturing and the labelling of medicines, and in many cases this inspection is sufficient to detect counterfeit medicines. The Promoting the Quality of Medicines (PQM) programme has provided technical assistance to Amazon Malaria Initiative (AMI) countries to implement the use of basic tests as a key screening mechanism to assess the quality of malaria medicines available to patients in decentralized regions. Methods Trained personnel from the National Malaria Control Programmes (NMCPs), often in collaboration with country’s Official Medicine Control Laboratory (OMCL), developed country- specific protocols that encompassed sampling methods, sample analysis, and data reporting. Sampling sites were selected based on malaria burden, accessibility, and geographical location. Convenience sampling was performed and countries were recommended to store the sampled medicines under conditions that did not compromise their quality. Basic analytical tests, such as disintegration and thin layer chromatography (TLC), were performed utilizing a portable mini-laboratory. Results Results were originally presented at regional meetings in a non-standardized format that lacked relevant medicines information. However, since 2008 information has been submitted utilizing a template specifically developed by PQM for that purpose. From 2005 to 2010, the quality of 1,663 malaria medicines from seven AMI countries was evaluated, mostly collected from the public sector, 1,445/1,663 (86.9%). Results indicate that 193/1,663 (11.6%) were found not to meet quality specifications. Most failures were reported during visual and physical inspection, 142/1663 (8.5%), and most of these were due to expired medicines, 118/142 (83.1%). Samples failing TLC accounted for 27/1,663 (1.6%) and those failing disintegration accounted for 24/1,663 (1.4%). Medicines quality failures decreased significantly during the last two years. Conclusions Basic tests revealed that the quality of medicines in the public sector improved over the years, since the implementation of this type of quality monitoring programme in 2005. However, the lack of consistent confirmatory tests in the quality control (QC) laboratory, utilizing methods that can also evaluate additional quality attributes, could still mask quality issues. In the future, AMI countries should improve coordination with their health authorities and their QC lab consistently, to provide a more complete picture of malaria medicines quality and support the implementation of corrective actions. Facilities in the private and informal sectors also should be included when these sectors constitute an important source of medicines used by malaria patients. PMID:22704680

  15. Implementation of basic quality control tests for malaria medicines in Amazon Basin countries: results for the 2005-2010 period.

    PubMed

    Pribluda, Victor S; Barojas, Adrian; Añez, Arletta; López, Cecilia G; Figueroa, Ruth; Herrera, Roxana; Nakao, Gladys; Nogueira, Fernando Ha; Pianetti, Gerson A; Povoa, Marinete M; Viana, Giselle Mr; Gomes, Margarete S Mendonça; Escobar, Jose P; Sierra, Olga L Muñoz; Norena, Susana P Rendon; Veloz, Raúl; Bravo, Marcy Silva; Aldás, Martha R; Hindssemple, Alison; Collins, Marilyn; Ceron, Nicolas; Krishnalall, Karanchand; Adhin, Malti; Bretas, Gustavo; Hernandez, Nelly; Mendoza, Marjorie; Smine, Abdelkrim; Chibwe, Kennedy; Lukulay, Patrick; Evans, Lawrence

    2012-06-15

    Ensuring the quality of malaria medicines is crucial in working toward malaria control and eventual elimination. Unlike other validated tests that can assess all critical quality attributes, which is the standard for determining the quality of medicines, basic tests are significantly less expensive, faster, and require less skilled labour; yet, these tests provide reproducible data and information on several critical quality attributes, such as identity, purity, content, and disintegration. Visual and physical inspection also provides valuable information about the manufacturing and the labelling of medicines, and in many cases this inspection is sufficient to detect counterfeit medicines. The Promoting the Quality of Medicines (PQM) programme has provided technical assistance to Amazon Malaria Initiative (AMI) countries to implement the use of basic tests as a key screening mechanism to assess the quality of malaria medicines available to patients in decentralized regions. Trained personnel from the National Malaria Control Programmes (NMCPs), often in collaboration with country's Official Medicine Control Laboratory (OMCL), developed country- specific protocols that encompassed sampling methods, sample analysis, and data reporting. Sampling sites were selected based on malaria burden, accessibility, and geographical location. Convenience sampling was performed and countries were recommended to store the sampled medicines under conditions that did not compromise their quality. Basic analytical tests, such as disintegration and thin layer chromatography (TLC), were performed utilizing a portable mini-laboratory. Results were originally presented at regional meetings in a non-standardized format that lacked relevant medicines information. However, since 2008 information has been submitted utilizing a template specifically developed by PQM for that purpose. From 2005 to 2010, the quality of 1,663 malaria medicines from seven AMI countries was evaluated, mostly collected from the public sector, 1,445/1,663 (86.9%). Results indicate that 193/1,663 (11.6%) were found not to meet quality specifications. Most failures were reported during visual and physical inspection, 142/1663 (8.5%), and most of these were due to expired medicines, 118/142 (83.1%). Samples failing TLC accounted for 27/1,663 (1.6%) and those failing disintegration accounted for 24/1,663 (1.4%). Medicines quality failures decreased significantly during the last two years. Basic tests revealed that the quality of medicines in the public sector improved over the years, since the implementation of this type of quality monitoring programme in 2005. However, the lack of consistent confirmatory tests in the quality control (QC) laboratory, utilizing methods that can also evaluate additional quality attributes, could still mask quality issues. In the future, AMI countries should improve coordination with their health authorities and their QC lab consistently, to provide a more complete picture of malaria medicines quality and support the implementation of corrective actions. Facilities in the private and informal sectors also should be included when these sectors constitute an important source of medicines used by malaria patients.

  16. HPLC for quality control of polyimides

    NASA Technical Reports Server (NTRS)

    Young, P. R.; Sykes, G. F.

    1979-01-01

    High Pressure Liquid Chromatography (HPLC) as a quality control tool for polyimide resins and prepregs are presented. A data base to help establish accept/reject criteria for these materials was developed. This work is intended to supplement, not replace, standard quality control tests normally conducted on incoming resins and prepregs. To help achieve these objectives, the HPLC separation of LARC-160 polyimide precursor resin was characterized. Room temperature resin aging effects were studied. Graphite reinforced composites made from fresh and aged resin were fabricated and tested to determine if changes observed by HPLC were significant.

  17. Effectiveness of gratitude disposition promotion program on depression and quality of life of chronic schizophrenic patients.

    PubMed

    Jung, Miran; Han, Kuemsun

    2017-01-01

    Gratitude intervention is expectedly an effective intervention to reduce depression and improve the quality of life in schizophrenic patients, but there is a lack of literature on it. We attempted to develop and test the effectiveness of the gratitude disposition promotion program for chronic schizophrenic patients in Korea. Nonequivalent control group pre- and post-test design was used in two mental health centers located at Gyeonggi-do in South Korea. This paper was a quasi-experimental study and the participants who took part in the gratitude disposition promotion program were 17 of experimental group and 15 of control group. Gratitude disposition (the short gratitude, resentment, and appreciation test), depression (Beck Depression Inventory), and quality of life (developed by Kook) of chronic schizophrenic patients were measured before and after an intervention, as compared to the control. Chi-square test, Fisher's exact test, and t -test were performed for prehomogeneity testing for variables related to the general characteristics. Testing for the effectiveness of gratitude disposition promotion program and hypothesis testing for its effect on depression and quality of life were by ANCOVA and t -test, as verified to significance level of P < 0.05. The participants who received the gratitude disposition promotion program showed significant improvements in gratitude disposition ( F = 18.740, P < 0.0001) and in quality of life ( F = 9.800, P = 0.004), but no significant difference in depression ( F = 3.870, P = 0.059). The gratitude disposition promotion program was an effective clinical intervention program for enhancing gratitude disposition and quality of life of chronic schizophrenic patients in community.

  18. Quality Assurance and Quality Control Practices for Rehabilitation of Sewer and Water Mains

    EPA Science Inventory

    As part of the US Environmental Protection Agency (EPA)’s Aging Water Infrastructure Research Program, several areas of research are being pursued, including a review of quality assurance and quality control (QA/QC) practices and acceptance testing during the installation of reha...

  19. Quality Assurance and Quality Control Practices For Rehabilitation of Sewer and Water Mains

    EPA Science Inventory

    As part of the US Environmental Protection Agency (EPA)’s Aging Water Infrastructure Research Program, several areas of research are being pursued including a review of quality assurance and quality control (QA/QC) practices and acceptance testing during the installation of rehab...

  20. Flight Measurements of the Flying Qualities of a Lockheed P-80A Airplane (Army No. 44-85099): Lateral- and Directional-Stability and Control Characteristics

    NASA Technical Reports Server (NTRS)

    Anderson, Seth B.; Cooper, George E.

    1947-01-01

    This report contains the flight-test results of the lateral and directional-stability and control phase (including tests with wing-tip tanks) of a general flying-qualities investigation of the Lockheed P-80A airplane (Army No. 44-85099). These tests were conducted at indicated airspeeds up to 494 miles per hour (0.691 Mach number) at low altitude and up to 378 miles per hour (0.816 Mach number) at high altitude. These tests showed that the flying qualities of the airplane were for the most part in accordance with the requirements of the Army Air Forces Stability and Control Specifications. The only major deficiency noted was the negative lateral stability with the wing-tip tanks installed.

  1. USAF Test Pilot School. Flying Qualities Textbook, Volume 2, Part 1

    DTIC Science & Technology

    1986-04-01

    Qualities Flight Testing, Performance and Flying Qaulities Branch, Flight Test Engneerd ision, 6510th Test Wing, Air Force Flight Mayst Ce1ter, Edwards...For these aircraft, the program manager may re*uire a mil spec written specifically for the aircraft and control system involwd. 5.20.2 _EL k,Tt...OR MANAGED IN CONTEXT OF MISSION, WITH AVAILABLE PILOT ATTENTION. S UNCONTROLLABLE CONTROL WILL BE LOST DURING SOME PORTION OF MISSION. ACCEPTABLE

  2. Stochastic Models of Quality Control on Test Misgrading.

    ERIC Educational Resources Information Center

    Wang, Jianjun

    Stochastic models are developed in this article to examine the rate of test misgrading in educational and psychological measurement. The estimation of inadvertent grading errors can serve as a basis for quality control in measurement. Limitations of traditional Poisson models have been reviewed to highlight the need to introduce new models using…

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

    PubMed Central

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

    1995-01-01

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

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

    PubMed

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

    2014-04-30

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

  5. Development and flight test results of an autothrottle control system at Mach 3 cruise

    NASA Technical Reports Server (NTRS)

    Gilyard, G. B.; Burken, J. J.

    1980-01-01

    Flight test results obtained with the original Mach hold autopilot designed the YF-12C airplane which uses elevator control and a newly developed Mach hold system having an autothrottle integrated with an altitude hold autopilot system are presented. The autothrottle tests demonstrate good speed control at high Mach numbers and high altitudes while simultaneously maintaining control over altitude and good ride qualities. The autothrottle system was designed to control either Mach number or knots equivalent airspeed (KEAS). Excellent control of Mach number or KEAS was obtained with the autothrottle system when combined with altitude hold. Ride qualities were significantly better than with the conventional Mach hold system.

  6. 10 CFR 71.123 - Test control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Test control. 71.123 Section 71.123 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71.123 Test control. The licensee, certificate holder, and applicant for a CoC shall establish a test...

  7. 10 CFR 71.123 - Test control.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Test control. 71.123 Section 71.123 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71.123 Test control. The licensee, certificate holder, and applicant for a CoC shall establish a test...

  8. 10 CFR 71.123 - Test control.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Test control. 71.123 Section 71.123 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71.123 Test control. The licensee, certificate holder, and applicant for a CoC shall establish a test...

  9. Droplet digital PCR-based EGFR mutation detection with an internal quality control index to determine the quality of DNA.

    PubMed

    Kim, Sung-Su; Choi, Hyun-Jeung; Kim, Jin Ju; Kim, M Sun; Lee, In-Seon; Byun, Bohyun; Jia, Lina; Oh, Myung Ryurl; Moon, Youngho; Park, Sarah; Choi, Joon-Seok; Chae, Seoung Wan; Nam, Byung-Ho; Kim, Jin-Soo; Kim, Jihun; Min, Byung Soh; Lee, Jae Seok; Won, Jae-Kyung; Cho, Soo Youn; Choi, Yoon-La; Shin, Young Kee

    2018-01-11

    In clinical translational research and molecular in vitro diagnostics, a major challenge in the detection of genetic mutations is overcoming artefactual results caused by the low-quality of formalin-fixed paraffin-embedded tissue (FFPET)-derived DNA (FFPET-DNA). Here, we propose the use of an 'internal quality control (iQC) index' as a criterion for judging the minimum quality of DNA for PCR-based analyses. In a pre-clinical study comparing the results from droplet digital PCR-based EGFR mutation test (ddEGFR test) and qPCR-based EGFR mutation test (cobas EGFR test), iQC index ≥ 0.5 (iQC copies ≥ 500, using 3.3 ng of FFPET-DNA [1,000 genome equivalents]) was established, indicating that more than half of the input DNA was amplifiable. Using this criterion, we conducted a retrospective comparative clinical study of the ddEGFR and cobas EGFR tests for the detection of EGFR mutations in non-small cell lung cancer (NSCLC) FFPET-DNA samples. Compared with the cobas EGFR test, the ddEGFR test exhibited superior analytical performance and equivalent or higher clinical performance. Furthermore, iQC index is a reliable indicator of the quality of FFPET-DNA and could be used to prevent incorrect diagnoses arising from low-quality samples.

  10. Measuring management's perspective of data quality in Pakistan's Tuberculosis control programme: a test-based approach to identify data quality dimensions.

    PubMed

    Ali, Syed Mustafa; Anjum, Naveed; Kamel Boulos, Maged N; Ishaq, Muhammad; Aamir, Javariya; Haider, Ghulam Rasool

    2018-01-16

    Data quality is core theme of programme's performance assessment and many organizations do not have any data quality improvement strategy, wherein data quality dimensions and data quality assessment framework are important constituents. As there is limited published research about the data quality specifics that are relevant to the context of Pakistan's Tuberculosis control programme, this study aims at identifying the applicable data quality dimensions by using the 'fitness-for-purpose' perspective. Forty-two respondents pooled a total of 473 years of professional experience, out of which 223 years (47%) were in TB control related programmes. Based on the responses against 11 practical cases, adopted from the routine recording and reporting system of Pakistan's TB control programme (real identities of patient were masked), completeness, accuracy, consistency, vagueness, uniqueness and timeliness are the applicable data quality dimensions relevant to the programme's context, i.e. work settings and field of practice. Based on a 'fitness-for-purpose' approach to data quality, this study used a test-based approach to measure management's perspective and identified data quality dimensions pertinent to the programme and country specific requirements. Implementation of a data quality improvement strategy and achieving enhanced data quality would greatly help organizations in promoting data use for informed decision making.

  11. Quality control of recycled asphaltic concrete : final report.

    DOT National Transportation Integrated Search

    1982-07-01

    This study examined the variations found in recycled asphaltic concrete mix based upon plant quality control data and verification testing. The data was collected from four recycled hot-mix projects constructed in 1981. All plant control and acceptan...

  12. Effectiveness of gratitude disposition promotion program on depression and quality of life of chronic schizophrenic patients

    PubMed Central

    Jung, Miran; Han, Kuemsun

    2017-01-01

    Context: Gratitude intervention is expectedly an effective intervention to reduce depression and improve the quality of life in schizophrenic patients, but there is a lack of literature on it. Aims: We attempted to develop and test the effectiveness of the gratitude disposition promotion program for chronic schizophrenic patients in Korea. Settings and Design: Nonequivalent control group pre- and post-test design was used in two mental health centers located at Gyeonggi-do in South Korea. Materials and Methods: This paper was a quasi-experimental study and the participants who took part in the gratitude disposition promotion program were 17 of experimental group and 15 of control group. Gratitude disposition (the short gratitude, resentment, and appreciation test), depression (Beck Depression Inventory), and quality of life (developed by Kook) of chronic schizophrenic patients were measured before and after an intervention, as compared to the control. Statistical Analysis: Chi-square test, Fisher's exact test, and t-test were performed for prehomogeneity testing for variables related to the general characteristics. Testing for the effectiveness of gratitude disposition promotion program and hypothesis testing for its effect on depression and quality of life were by ANCOVA and t-test, as verified to significance level of P < 0.05. Results: The participants who received the gratitude disposition promotion program showed significant improvements in gratitude disposition (F = 18.740, P < 0.0001) and in quality of life (F = 9.800, P = 0.004), but no significant difference in depression (F = 3.870, P = 0.059). Conclusions: The gratitude disposition promotion program was an effective clinical intervention program for enhancing gratitude disposition and quality of life of chronic schizophrenic patients in community. PMID:28827866

  13. [The Scope, Quality and Safety Requirements of Drug Abuse Testing].

    PubMed

    Küme, Tuncay; Karakükcü, Çiğdem; Pınar, Aslı; Coşkunol, Hakan

    2017-01-01

    The aim of this review is to inform about the scopes and requirements of drug abuse testing. Drug abuse testing is one of the tools for determination of drug use. It must fulfill the quality and safety requirements in judgmental legal and administrative decisions. Drug abuse testing must fulfill some requirements like selection of the appropriate test matrix, appropriate screening test panel, sampling in detection window, patient consent, identification of the donor, appropriate collection site, sample collection with observation, identification and control of the sample, specimen custody chain in preanalytical phase; analysis in authorized laboratories, specimen validity tests, reliable testing METHODS, strict quality control, two-step analysis in analytical phase; storage of the split specimen, confirmation of the split specimen in the objection, result custody chain, appropriate cut-off concentration, the appropriate interpretation of the result in postanalytical phase. The workflow and analytical processes of drug abuse testing are explained in last regulation of the Department of Medical Laboratory Services, Ministry of Health in Turkey. The clinical physicians have to know and apply the quality and safety requirements in drug abuse testing according to last regulations in Turkey.

  14. Flight Tests of a Ministick Controller in an F/A-18 Airplane

    NASA Technical Reports Server (NTRS)

    Stoliker, Patrick C.; Carter, John

    2003-01-01

    In March of 1999, five pilots performed flight tests to evaluate the handling qualities of an F/A-18 research airplane equipped with a small-displacement center stick (ministick) controller that had been developed for the JAS 39 Gripen airplane (a fighter/attack/ reconnaissance airplane used by the Swedish air force). For these tests, the ministick was installed in the aft cockpit (see figure) and production support flight control computers (PSFCCs) were used as interfaces between the controller hardware and the standard F/A-18 flight-control laws. The primary objective of the flight tests was to assess any changes in handling qualities of the F/A-18 airplane attributable to the mechanical characteristics of the ministick. The secondary objective was to demonstrate the capability of the PSFCCs to support flight-test experiments.

  15. Quality control/quality assurance testing for joint density and segregation of asphalt mixtures.

    DOT National Transportation Integrated Search

    2013-04-01

    Longitudinal joint quality control/assurance is essential to the successful performance of asphalt pavements and it has received considerable amount of attention in recent years. The purpose of the study is to evaluate the level of compaction at the ...

  16. Interrater Reliability in Large-Scale Assessments--Can Teachers Score National Tests Reliably without External Controls?

    ERIC Educational Resources Information Center

    Pantzare, Anna Lind

    2015-01-01

    In most large-scale assessment systems a set of rather expensive external quality controls are implemented in order to guarantee the quality of interrater reliability. This study empirically examines if teachers' ratings of national tests in mathematics can be reliable without using monitoring, training, or other methods of external quality…

  17. Materials Testing and Quality Control Soils, 3-28. Military Curriculum Materials for Vocational and Technical Education.

    ERIC Educational Resources Information Center

    Ohio State Univ., Columbus. National Center for Research in Vocational Education.

    This instructional package on material testing and quality control of soils has been adapted from military curriculum materials for use in technical and vocational education programs. This short course presents basic information on soils as well as exploration, field identification, and laboratory procedures that will enable students completing…

  18. Electronic nose for quality control of Colombian coffee through the detection of defects in "Cup Tests".

    PubMed

    Rodríguez, Juan; Durán, Cristhian; Reyes, Adriana

    2010-01-01

    Electronic noses (ENs), are used for many applications, but we must emphasize the importance of their application to foodstuffs like coffee. This paper presents a research study about the analysis of Colombian coffee samples for the detection and classification of defects (i.e., using "Cup Tests"), which was conducted at the Almacafé quality control laboratory in Cúcuta, Colombia. The results obtained show that the application of an electronic nose called "A-NOSE", may be used in the coffee industry for the cupping tests. The results show that e-nose technology can be a useful tool for quality control to evaluate the excellence of the Colombian coffee produced by National Federation of Coffee Growers.

  19. Importance of good manufacturing practices in microbiological monitoring in processing human tissues for transplant.

    PubMed

    Pianigiani, Elisa; Ierardi, Francesca; Fimiani, Michele

    2013-12-01

    Skin allografts represent an important therapeutic resource in the treatment of severe skin loss. The risk associated with application of processed tissues in humans is very low, however, human material always carries the risk of disease transmission. To minimise the risk of contamination of grafts, processing is carried out in clean rooms where air quality is monitored. Procedures and quality control tests are performed to standardise the production process and to guarantee the final product for human use. Since we only validate and distribute aseptic tissues, we conducted a study to determine what type of quality controls for skin processing are the most suitable for detecting processing errors and intercurrent contamination, and for faithfully mapping the process without unduly increasing production costs. Two different methods for quality control were statistically compared using the Fisher exact test. On the basis of the current study we selected our quality control procedure based on pre- and post-processing tissue controls, operator and environmental controls. Evaluation of the predictability of our control methods showed that tissue control was the most reliable method of revealing microbial contamination of grafts. We obtained 100 % sensitivity by doubling tissue controls, while maintaining high specificity (77 %).

  20. Method and system for automated on-chip material and structural certification of MEMS devices

    DOEpatents

    Sinclair, Michael B.; DeBoer, Maarten P.; Smith, Norman F.; Jensen, Brian D.; Miller, Samuel L.

    2003-05-20

    A new approach toward MEMS quality control and materials characterization is provided by a combined test structure measurement and mechanical response modeling approach. Simple test structures are cofabricated with the MEMS devices being produced. These test structures are designed to isolate certain types of physical response, so that measurement of their behavior under applied stress can be easily interpreted as quality control and material properties information.

  1. Profile of a cell test database and a corresponding reliability database

    NASA Technical Reports Server (NTRS)

    Brearley, George R.; Klein, Glenn C.

    1992-01-01

    The development of computerized control, and data retrieval for aerospace cell testing affords an excellent opportunity to incorporate three specific concepts to both manage the test area and to track product performance on a real-time basis. The adoption and incorporation of precepts fostered by this total quality management (TQM) initiative are critical to us for retaining control of our business while substantially reducing the separate quality control inspection activity. Test discrepancies are all 'equally bad' in cell acceptance testing because, for example, we presently do not discriminate between 1 or 25 mV for an overvoltage condition. We must take leadership in classifying such discrepancies in order to expedite their clearance and redirect our resources for prevention activities. The development and use of engineering alerts (or guardbanding) which more closely match our product capabilities and are toleranced tighter than the required customer specification are paramount to managing the test unit in order to remain both quality and cost effective.

  2. Recent National Transonic Facility Test Process Improvements (Invited)

    NASA Technical Reports Server (NTRS)

    Kilgore, W. A.; Balakrishna, S.; Bobbitt, C. W., Jr.; Adcock, J. B.

    2001-01-01

    This paper describes the results of two recent process improvements; drag feed-forward Mach number control and simultaneous force/moment and pressure testing, at the National Transonic Facility. These improvements have reduced the duration and cost of testing. The drag feed-forward Mach number control reduces the Mach number settling time by using measured model drag in the Mach number control algorithm. Simultaneous force/moment and pressure testing allows simultaneous collection of force/moment and pressure data without sacrificing data quality thereby reducing the overall testing time. Both improvements can be implemented at any wind tunnel. Additionally the NTF is working to develop and implement continuous pitch as a testing option as an additional method to reduce costs and maintain data quality.

  3. Recent National Transonic Facility Test Process Improvements (Invited)

    NASA Technical Reports Server (NTRS)

    Kilgore, W. A.; Balakrishna, S.; Bobbitt, C. W., Jr.; Adcock, J. B.

    2001-01-01

    This paper describes the results of two recent process improvements; drag feed-forward Mach number control and simultaneous force/moment and pressure testing, at the National Transonic Facility. These improvements have reduced the duration and cost of testing. The drag feedforward Mach number control reduces the Mach number settling time by using measured model drag in the Mach number control algorithm. Simultaneous force/moment and pressure testing allows simultaneous collection of force/moment and pressure data without sacrificing data quality thereby reducing the overall testing time. Both improvements can be implemented at any wind tunnel. Additionally the NTF is working to develop and implement continuous pitch as a testing option as an additional method to reduce costs and maintain data quality.

  4. Accreditation of Individualized Quality Control Plans by the College of American Pathologists.

    PubMed

    Hoeltge, Gerald A

    2017-03-01

    The Laboratory Accreditation Program of the College of American Pathologists (CAP) began in 2015 to allow accredited laboratories to devise their own strategies for quality control of laboratory testing. Participants now have the option to implement individualized quality control plans (IQCPs). Only nonwaived testing that features an internal control (built-in, electronic, or procedural) is eligible for IQCP accreditation. The accreditation checklists that detail the requirements have been peer-reviewed by content experts on CAP's scientific resource committees and by a panel of accreditation participants. Training and communication have been key to the successful introduction of the new IQCP requirements. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Anticipated Effectiveness of Active Noise Control in Propeller Aircraft Interiors as Determined by Sound Quality Tests

    NASA Technical Reports Server (NTRS)

    Powell, Clemans A.; Sullivan, Brenda M.

    2004-01-01

    Two experiments were conducted, using sound quality engineering practices, to determine the subjective effectiveness of hypothetical active noise control systems in a range of propeller aircraft. The two tests differed by the type of judgments made by the subjects: pair comparisons in the first test and numerical category scaling in the second. Although the results of the two tests were in general agreement that the hypothetical active control measures improved the interior noise environments, the pair comparison method appears to be more sensitive to subtle changes in the characteristics of the sounds which are related to passenger preference.

  6. Sci-Fri AM: Quality, Safety, and Professional Issues 01: CPQR Technical Quality Control Suite Development including Quality Control Workload Results

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

    Malkoske, Kyle; Nielsen, Michelle; Brown, Erika

    A close partnership between the Canadian Partnership for Quality Radiotherapy (CPQR) and the Canadian Organization of Medical Physicist’s (COMP) Quality Assurance and Radiation Safety Advisory Committee (QARSAC) has resulted in the development of a suite of Technical Quality Control (TQC) Guidelines for radiation treatment equipment, that outline specific performance objectives and criteria that equipment should meet in order to assure an acceptable level of radiation treatment quality. The framework includes consolidation of existing guidelines and/or literature by expert reviewers, structured stages of public review, external field-testing and ratification by COMP. The adopted framework for the development and maintenance of themore » TQCs ensures the guidelines incorporate input from the medical physics community during development, measures the workload required to perform the QC tests outlined in each TQC, and remain relevant (i.e. “living documents”) through subsequent planned reviews and updates. This presentation will show the Multi-Leaf Linear Accelerator document as an example of how feedback and cross-national work to achieve a robust guidance document. During field-testing, each technology was tested at multiple centres in a variety of clinic environments. As part of the defined feedback, workload data was captured. This lead to average time associated with testing as defined in each TQC document. As a result, for a medium-sized centre comprising 6 linear accelerators and a comprehensive brachytherapy program, we evaluate the physics workload to 1.5 full-time equivalent physicist per year to complete all QC tests listed in this suite.« less

  7. 30 CFR 74.6 - Quality control.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... DUST SAMPLING DEVICES Approval Requirements for Coal Mine Dust Personal Sampler Unit § 74.6 Quality... equipment procedures and records and to interview the employees who conduct the control tests. Two copies of...

  8. A brief review of aircraft controls research opportunities in the general aviation field

    NASA Technical Reports Server (NTRS)

    Kendall, E. R.

    1984-01-01

    A review of aircraft controls research in the general aviation field is given. Among the topics included are: controls technology benefits, military and commercial test programs, flight tests, ride quality control, and wind loading.

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

    PubMed

    Teka, Abaynesh; Kibatu, Girma

    2012-03-01

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

  10. [The Effects of Mobile Social Networking Service-Based Cognitive Behavior Therapy on Insomnia in Nurses].

    PubMed

    Kim, Ji Eun; Kim, Suk Sun

    2017-08-01

    This study aimed to examine the effects of cognitive behavior therapy for insomnia (CBT-I) based on the mobile social networking service (SNS) on dysfunctional beliefs and attitudes about sleep, sleep quality, daytime sleepiness, depression, and quality of life among rotating-shift nurses in a hospital in Korea. A nonequivalent control group pre-post test design was used. The participants included 55 nurses with rotating three-shift work (25 in the experimental group and 30 in the control group). For the experimental group, CBT-I using mobile SNS was provided once a week for 60 minutes over six weeks. Data were analyzed using descriptive statistics, χ²-test, independent samples t-test, and Mann-whitney U test with the SPSS 21.0 program. In the homogeneity test of the general characteristics and study variables, there were no significant differences between the two groups. Nurses in the experimental group had significantly lower scores on dysfunctional beliefs and attitudes regarding sleep and sleepiness than nurses in the control group. Nurses in the experimental group had significantly higher scores on sleep quality and quality of life than nurses in the control group. These findings indicate that using the mobile SNS-based CBT-I is feasible and has significant and positive treatment-related effects on rotating-shift nurses' irrational thoughts and beliefs in association with sleep, sleep quality, daytime sleepiness, and quality of life. These contribute to expanding our knowledge of rotating-shift nurses' sleep issues and their preferences for intervention. © 2017 Korean Society of Nursing Science

  11. SB certification for mixture-based specification for flexible base.

    DOT National Transportation Integrated Search

    2012-10-01

    Presentation topics: : Establish List of Qualified Producers; : Producers Responsible for Process Control/Quality Control; : Reduce TxDOT Sampling and Testing; : Expedite Aggregate Base Acceptance; : Share Responsibility (Producer/TxDOT) for Quality ...

  12. 40 CFR 1051.345 - What production-line testing records must I send to EPA?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

  13. 40 CFR 1051.345 - What production-line testing records must I send to EPA?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

  14. 40 CFR 1051.345 - What production-line testing records must I send to EPA?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

  15. 40 CFR 1051.345 - What production-line testing records must I send to EPA?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

  16. 40 CFR 1051.345 - What production-line testing records must I send to EPA?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

  17. 23 CFR 637.207 - Quality assurance program.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... independent assurance (IA) program consisting of the following: (1) Acceptance program. (i) Each STD's... quality control samples. (C) The quality control sampling and testing is evaluated by an IA program. (iii... appropriate. See 23 CFR 635.413(e) for specific requirements. (2) The IA program shall evaluate the qualified...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. Rocky Mountain Arsenal, Sanitary Sewer Interim Response Action, Construction Documents for New Sanitary Sewer Construction. Volume 2

    DTIC Science & Technology

    1990-05-01

    curves ; test reports; test cylinders: samples, O&M manuals including parts lists; certifications; warranties and other such required submittals...purpose. 14.4.3. Authority and responsibilities of all quality control personnel. 14.4.4. Schedule of Use of inspection personnel by types and phase of...quality control program shall include four phases of inspection and tests. The Contracting Officer’s representative shall be notified at least 24

  3. Interlaboratory Study of Quality Control Isolates for a Broth Microdilution Method (Modified CLSI M38-A) for Testing Susceptibilities of Dermatophytes to Antifungals▿

    PubMed Central

    Ghannoum, M. A.; Arthington-Skaggs, B.; Chaturvedi, V.; Espinel-Ingroff, A.; Pfaller, M. A.; Rennie, R.; Rinaldi, M. G.; Walsh, T. J.

    2006-01-01

    The Clinical and Laboratory Standards Institute (CLSI; formerly National Committee for Clinical Laboratory Standards, or NCCLS) M38-A standard for the susceptibility testing of filamentous fungi does not specifically address the testing of dermatophytes. In 2003, a multicenter study investigated the reproducibility of the microdilution method developed at the Center for Medical Mycology, Cleveland, Ohio, for testing the susceptibility of dermatophytes. Data from that study supported the introduction of this method for testing dermatophytes in the future version of the CLSI M38-A standard. In order for the method to be accepted by CLSI, appropriate quality control isolates needed to be identified. To that end, an interlaboratory study, involving the original six laboratories plus two additional sites, was conducted to evaluate potential candidates for quality control isolates. These candidate strains included five Trichophyton rubrum strains known to have elevated MICs to terbinafine and five Trichophyton mentagrophytes strains. Antifungal agents tested included ciclopirox, fluconazole, griseofulvin, itraconazole, posaconazole, terbinafine, and voriconazole. Based on the data generated, two quality control isolates, one T. rubrum isolate and one T. mentagrophytes isolate, were identified and submitted to the American Type Culture Collection (ATCC) for inclusion as reference strains. Ranges encompassing 95.2 to 97.9% of all data points for all seven drugs were established. PMID:17050812

  4. [Testing of medicinal products produced from pooled plasma].

    PubMed

    Unkelbach, U; Hunfeld, A; Breitner-Ruddock, S

    2014-10-01

    Medicinal products produced from human plasma fall under the administrative batch release procedure of the competent authority. In Germany, this has been carried out since 1995 by the Paul Ehrlich Institute (PEI), the responsible state control agency for blood products. Medicinal products released for the European and national market are tested for quality, efficacy and safety. Experimental testing of the final product and the starting materials, the plasma pools, as well as control of the production documentation guarantee a constantly high product safety. In the 28,000 batches tested since the beginning of the state controlled batch release testing of these blood products at the PEI, there has been no transmission of infectious viruses (HIV, HBV and HCV) to any patient. The batch release has made a contribution to the improvement of product quality. This procedure is still an important tool to ensure safety of blood products. The PEI is integrated in the batch release network of the European Directorate for the Quality of Medicines & Health Care (EDQM) in Strasbourg. Regulations and guidelines for official control authority batch release (OCABR) ensure harmonized procedures for mutual recognition of batch release on the European level. The EU certificates and German national certificates are requested and accepted in over 70 countries worldwide. Experimental testing in the EU and the requisite certificates have developed into a seal of quality for the world market.

  5. 40 CFR 75.59 - Certification, quality assurance, and quality control record provisions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... and the run average); (B) The raw data and results for all required pre-test, post-test, pre-run and...-day calibration error tests, all daily system integrity checks (Hg monitors, only), and all off-line calibration demonstrations, including any follow-up tests after corrective action: (i) Component-system...

  6. The effect of low and moderate intensity aerobic exercises on sleep quality in men older adults.

    PubMed

    Akbari Kamrani, Ahmad Ali; Shams, Amir; Shamsipour Dehkordi, Parvaneh; Mohajeri, Robabeh

    2014-03-01

    Sleep is an active and complex rhythmic state that may be affected by the aging process. The purpose of present research was to investigate the effect of low and moderate intensity aerobic exercises on sleep quality in older adults. The research method is quasi-experimental with pre-test and post-test design. The statistical sample included 45 volunteer elderly men with age range of 60-70 years-old that divided randomly in two experimental groups (aerobic exercise with low and moderate intensity) and one control group. In each group selected 15 older adults based on inclusion and exclusion criteria (such as, without sleep apnea, not smoking, and no taking hypnotic drugs). First, all subjects were evaluated by a doctor to confirm their physical and mental health. Also, the maximum heart rate (MaxHR) of subjects was obtained by subtracting one's age from 220. Furthermore, based on aerobic exercise type (40-50% MaxHR for low intensity group and 60-70% MaxHR for moderate intensity group) the target MaxHR was calculated for each subject. The exercise protocol consisted of 8 weeks aerobic exercises (2 sessions in per-week) based on Rockport one-mile walking/running test and the control group continued their daily activities. All subjects in per-test and post-test stages completed the Petersburg Sleep Quality Index (PSQI). In pre-test stage, results showed that there were no significant differences between control and experimental groups in sleep quality and its components (P>0.05). On the other hand, results in post-test stage showed that there were significant differences between control and experimental groups in these variables (P<0.05). Also, the Tukey Post Hoc showed that the moderate intensity group scores in total sleep quality and its components were better than other groups (P<0.05). Finally, the low intensity group scores in total sleep quality and its components were better than control group (P<0.05). Generally, the present research showed that the aerobic exercises with moderate intensity (60-70% MaxHR) have a positive and significant effect on sleep quality and its components. Thus, based on these findings, the aerobic exercises with moderate intensity is a useful to improve the sleep quality and its components among community older adults were recommended.

  7. Effect of home care service on the quality of life in patients with gynecological cancer.

    PubMed

    Aktas, Demet; Terzioglu, Fusun

    2015-01-01

    The purpose of the research was to determine the effect of home care service on the quality of life in patients with gynecological cancer. This randomized case control study was carried out in a womans hospital between September 2011 and February 2012. Women undergoing gynecological cancer treatment were separated into intervention and control groups, of 35 patients each. The intervention group was provided with nursing care service through hospital and home visits (1st, 12th weeks) within the framework of a specifically developed nursing care plan. The control group was monitored without any intervention through the hospital routine protocols (1st, 12th weeks). Data were collected using An Interview Form, Home Visit Monitoring Form and Quality of Life Scale/Cancer Survivors. Effects of home care service on the quality of life in gynecological cancer patients were investigated using chi-square tests, McNemar's test, independent t-test and ANOVA. This study found that the intervention group receiving home care service had a moderately high quality of life (average mean: 6.01±0.64), while the control group had comparatively lower quality (average mean: 4.35±0.79) within the 12 week post- discharge period (p<0.05). This study found home care services to be efficient in improving the quality of life in patients with gynecological cancer.

  8. Effect of motivational interviewing on quality of life in patients with epilepsy.

    PubMed

    Hosseini, Nazafarin; Mokhtari, Somaye; Momeni, Ebrahim; Vossoughi, Mehrdad; Barekatian, Majid

    2016-02-01

    In this study, the effect of motivational interviewing on quality of life was evaluated in patients with epilepsy. Fifty-six patients with epilepsy in a clinical trial were randomly assigned to intervention and control groups. Motivational interviewing during 5 sessions was applied for the intervention group, and the control group received health-care services. Quality-of-life questionnaire in epilepsy (QOLIE-89) was applied as pre- and posttest for both groups. Before and two months after intervention, both groups were assessed. Data were analyzed by independent t-test, Chi-square test, and paired t-test. The data analysis showed that mean score of the QOLIE-89 was 38.94±8.55 and 70.90±7.99 in the intervention group before and after the intervention, respectfully, and 44.59±12.27 and 36.52±7.16 in the control group sequentially. The intervention group showed a significant score increase in their quality of life (p<0.001), whereas the control group had a score decrease (p<0.001). Motivational interviewing approach could be used as an effective intervention method for improving patients' quality of life. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. [Investigation on the homogeneity and stability of quality controlling cosmetic samples containing arsenic].

    PubMed

    Dong, Bing; Song, Yu; Fan, Wenjia; Zhu, Ying

    2010-11-01

    To study the homogeneity and stability of arsenic in quality controlling cosmetic samples. Arsenic was determined by atomic fluorescence spectrophotometric method. The t-test and F-test were used to evaluate the significant difference of the within-bottle and between-bottle results with three batches. The RSDs of arsenic obtained in different time were compared with the relative expanding uncertainties to evaluate the stability. Average and variance of within-bottle and between-bottle results of arsenic were not different significantly. The RSDs of Arsenic were less than the relative expanding uncertainties. Quality controlling cosmetic samples containing arsenic were considered homogeneous and stable.

  10. Liver phantom for quality control and training in nuclear medicine

    NASA Astrophysics Data System (ADS)

    Lima Ferreira, Fernanda Carla; Souza, Divanizia do Nascimento

    2011-10-01

    In nuclear medicine, liver scintigraphy aims to verify organ function based on the radionuclide concentration in the liver and bile flow and is also used to detect tumors. Therefore it is necessary to perform quality control tests in the gamma camera before running the exam to prevent false results. Quality control tests of the gamma camera should thus be performed before running the exam to prevent false results. Such tests generally use radioactive material inside phantoms for evaluation of gamma camera parameters in quality control procedures. Phantoms can also be useful for training doctors and technicians in nuclear medicine procedures. The phantom proposed here has artifacts that simulate nodules; it may take on different quantities, locations and sizes and it may also be mounted without the introduction of nodules. Thus, its images may show hot or cold nodules or no nodules. The phantom consists of acrylic plates hollowed out in the centre, with the geometry of an adult liver. Images for analyses of simulated liver scintigraphy were obtained with the detector device at 5 cm from the anterior surface of the phantom. These simulations showed that this object is suitable for quality control in nuclear medicine because it was possible to visualize artifacts larger than 7.9 mm using a 256×256 matrix and 1000 kcpm. The phantom constructed in this work will also be useful for training practitioners and technicians in order to prevent patients from repeat testing caused by error during examinations.

  11. A novel Python program for implementation of quality control in the ELISA.

    PubMed

    Wetzel, Hanna N; Cohen, Cinder; Norman, Andrew B; Webster, Rose P

    2017-09-01

    The use of semi-quantitative assays such as the enzyme-linked immunosorbent assay (ELISA) requires stringent quality control of the data. However, such quality control is often lacking in academic settings due to unavailability of software and knowledge. Therefore, our aim was to develop methods to easily implement Levey-Jennings quality control methods. For this purpose, we created a program written in Python (a programming language with an open-source license) and tested it using a training set of ELISA standard curves quantifying the Fab fragment of an anti-cocaine monoclonal antibody in mouse blood. A colorimetric ELISA was developed using a goat anti-human anti-Fab capture method. Mouse blood samples spiked with the Fab fragment were tested against a standard curve of known concentrations of Fab fragment in buffer over a period of 133days stored at 4°C to assess stability of the Fab fragment and to generate a test dataset to assess the program. All standard curves were analyzed using our program to batch process the data and to generate Levey-Jennings control charts and statistics regarding the datasets. The program was able to identify values outside of two standard deviations, and this identification of outliers was consistent with the results of a two-way ANOVA. This program is freely available, which will help laboratories implement quality control methods, thus improving reproducibility within and between labs. We report here successful testing of the program with our training set and development of a method for quantification of the Fab fragment in mouse blood. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. Flying Quality Analysis of a JAS 39 Gripen Ministick Controller in an F/A-18 Aircraft

    NASA Technical Reports Server (NTRS)

    Carter, John F.; Stoliker, P. C.

    2000-01-01

    NASA Dryden conducted a handling qualities experiment using a small displacement centerstick controller that Saab-Scania developed for the JAS 39 Gripen aircraft. The centerstick, or ministick, was mounted in the rear cockpit of an F/A-18 aircraft. Production support flight control computers (PSFCC) provided a pilot-selectable research control system. The objectives for this experiment included determining whether the mechanical characteristics of the centerstick controller had any significant effect on the handling qualities of the F/A-18, and determining the usefulness of the PSFCCs for this kind of experiment. Five pilots evaluated closed-loop tracking tasks, including echelon and column formation flight and target following. Cooper-Harper ratings and pilot comments were collected for each maneuver. This paper describes the test system, including the PSFCCs, the Gripen centerstick, and the flight test experiment. The paper presents results of longitudinal handling qualities maneuvers, including low order equivalent systems, Neal-Smith, and controls anticipation parameter analyses. The experiment showed that, while the centerstick controller provided a different aircraft feel, few handling qualities deficiencies resulted. It also demonstrated that the PSFCCs were useful for this kind of investigation.

  13. Diagnostics in a digital age: an opportunity to strengthen health systems and improve health outcomes.

    PubMed

    Peeling, Rosanna W

    2015-11-01

    Diagnostics play a critical role in clinical decision making, and in disease control and prevention. Rapid point-of-care (POC) tests for infectious diseases can improve access to diagnosis and patient management, but the quality of these tests vary, quality of testing is often not assured and there are few mechanisms to capture test results for surveillance when the testing is so decentralised. A new generation of POC molecular tests that are highly sensitive and specific, robust and easy to use are now available for deployment in low resource settings. Decentralisation of testing outside of the laboratory can put tremendous stress on the healthcare system and presents challenges for training and quality assurance. A feature of many of these POC molecular devices is that they are equipped with data transmission capacities. In a digital age, it is possible to link data from diagnostic laboratories and POC test readers and devices to provide data on testing coverage, disease trends and timely information for early warning of infectious disease outbreaks to inform design or optimisation of disease control and elimination programmes. Data connectivity also allows control programmes to monitor the quality of tests and testing, and optimise supply chain management; thus, increasing the efficiency of healthcare systems and improving patient outcomes. © The Author 2015. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  14. Can endurance training improve physical capacity and quality of life in young Fontan patients?

    PubMed

    Hedlund, Eva R; Lundell, Bo; Söderström, Liselott; Sjöberg, Gunnar

    2018-03-01

    Children after Fontan palliation have reduced exercise capacity and quality of life. Our aim was to study whether endurance training could improve physical capacity and quality of life in Fontan patients. Fontan patients (n=30) and healthy age- and gender-matched control subjects (n=25) performed a 6-minute walk test at submaximal capacity and a maximal cycle ergometer test. Quality of life was assessed with Pediatric Quality of Life Inventory Version 4.0 questionnaires for children and parents. All tests were repeated after a 12-week endurance training programme and after 1 year. Patients had decreased submaximal and maximal exercise capacity (maximal oxygen uptake 35.0±5.1 ml/minute per·kg versus 43.7±8.4 ml/minute·per·kg, p<0.001) and reported a lower quality of life score (70.9±9.9 versus 85.7±8.0, p<0.001) than controls. After training, patients improved their submaximal exercise capacity in a 6-minute walk test (from 590.7±65.5 m to 611.8±70.9 m, p<0.05) and reported a higher quality of life (p<0.01), but did not improve maximal exercise capacity. At follow-up, submaximal exercise capacity had increased further and improved quality of life was sustained. The controls improved their maximal exercise capacity (p<0.05), but not submaximal exercise capacity or quality of life after training. At follow-up, improvement of maximal exercise capacity was sustained. We believe that an individualised endurance training programme for Fontan patients improves submaximal exercise capacity and quality of life in Fontan patients and the effect on quality of life appears to be long-lasting.

  15. 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.

  16. Defining the best quality-control systems by design and inspection.

    PubMed

    Hinckley, C M

    1997-05-01

    Not all of the many approaches to quality control are equally effective. Nonconformities in laboratory testing are caused basically by excessive process variation and mistakes. Statistical quality control can effectively control process variation, but it cannot detect or prevent most mistakes. Because mistakes or blunders are frequently the dominant source of nonconformities, we conclude that statistical quality control by itself is not effective. I explore the 100% inspection methods essential for controlling mistakes. Unlike the inspection techniques that Deming described as ineffective, the new "source" inspection methods can detect mistakes and enable corrections before nonconformities are generated, achieving the highest degree of quality at a fraction of the cost of traditional methods. Key relationships between task complexity and nonconformity rates are also described, along with cultural changes that are essential for implementing the best quality-control practices.

  17. Examining the Impact of Covariates on Anchor Tests to Ascertain Quality over Time in a College Admissions Test

    ERIC Educational Resources Information Center

    Wiberg, Marie; von Davier, Alina A.

    2017-01-01

    We propose a comprehensive procedure for the implementation of a quality control process of anchor tests for a college admissions test with multiple consecutive administrations. We propose to examine the anchor tests and their items in connection with covariates to investigate if there was any unusual behavior in the anchor test results over time…

  18. The Effects of Quality Books for Children and the Metacognitive Strategy on Students' Self-Esteem Levels

    ERIC Educational Resources Information Center

    Cer, Erkan; Sahin, Ertugrul

    2017-01-01

    Using a quasi-experimental design with pre-test and post-test control groups, 93 eighth grade students were randomly assigned either to the experimental or to the control group and responded to the Rosenberg Self-Esteem Scale two weeks before and after the intervention. While the students in the experimental group were instructed in quality books…

  19. Performance-based quality assurance/quality control (QA/QC) acceptance procedures for in-place soil testing phase 3.

    DOT National Transportation Integrated Search

    2015-01-01

    One of the objectives of this study was to evaluate soil testing equipment based on its capability of measuring in-place stiffness or modulus values. : As design criteria transition from empirical to mechanistic-empirical, soil test methods and equip...

  20. Software quality assurance | News

    Science.gov Websites

    Measure was removed: "Sufficient level of detail in the requirements to develop test cases." ; This control measure was removed since the sufficient level of detail needed to develop test cases is recorded for all test cases. (Note: This is mandatory for applications graded with a High Quality Assurance

  1. [Fitness and quality of life in kidney transplant recipients: case-control study].

    PubMed

    Hernández Sánchez, Sonsoles; Carrero, Juan J; García López, David; Herrero Alonso, Juan Azael; Menéndez Alegre, Héctor; Ruiz, Jonatan R

    2016-04-15

    We analyzed the levels of fitness, muscle structure and quality of life of adults after kidney transplant and healthy adults. A total of 16 kidney transplant patients and 21 healthy controls performed several fitness test, isokinetic evaluation of knee flexion and extension and ultrasonography muscle thickness assessment. They also completed the quality of life questionnaire SF-36. Physical fitness, muscle structure and quality of life of the kidney transplant recipients were significantly poorer than the controls. The transplant patients performed less well in the "get up and go" and "sit to stand" test (p<.001) as well as in assessments of muscle structure, strength and power. The patients had a poorer score in their quality of life assessments, differing from the controls in domains of physical function, physical role, general health and social function (p<.001). Fitness, strength and muscle mass are diminished in kidney transplant patients, resulting in a poorer quality of life which might entail an increased risk to their health. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  2. The use of Minilabs to improve the testing capacity of regulatory authorities in resource limited settings: Tanzanian experience.

    PubMed

    Risha, Peter Gasper; Msuya, Zera; Clark, Malcolm; Johnson, Keith; Ndomondo-Sigonda, Margareth; Layloff, Thomas

    2008-08-01

    The Tanzania Food and Drugs Authority piloted the use of Minilab kits, a thin-layer-chromatographic based drug quality testing technique, in a two-tier quality assurance program. The program is intended to improve testing capacity with timely screening of the quality of medicines as they enter the market. After 1 week training of inspectors on Minilab screening techniques, they were stationed at key Ports-of-Entry (POE) to screen the quality of imported medicines. In addition, three non-Ports-of-Entry centres were established to screen samples collected during Post-Marketing-Surveillance. Standard operating procedures (SOPs) were developed to structure and standardize the implementation process. Over 1200 samples were tested using the Minilab outside the central quality control laboratory (QCL), almost doubling the previous testing capacity. The program contributed to increased regulatory reach and visibility of the Authority throughout the country, serving as a deterrent against entry of substandard medicines into market. The use of Minilab for quality screening was inexpensive and provided a high sample throughput. However, it suffers from the limitation that it can reliably detect only grossly substandard or wrong drug samples and therefore, it should not be used as an independent testing resource but in conjunction with a full-service quality control laboratory capable of auditing reported substandard results.

  3. Flight-Time Identification of a UH-60A Helicopter and Slung Load

    NASA Technical Reports Server (NTRS)

    Cicolani, Luigi S.; McCoy, Allen H.; Tischler, Mark B.; Tucker, George E.; Gatenio, Pinhas; Marmar, Dani

    1998-01-01

    This paper describes a flight test demonstration of a system for identification of the stability and handling qualities parameters of a helicopter-slung load configuration simultaneously with flight testing, and the results obtained.Tests were conducted with a UH-60A Black Hawk at speeds from hover to 80 kts. The principal test load was an instrumented 8 x 6 x 6 ft cargo container. The identification used frequency domain analysis in the frequency range to 2 Hz, and focussed on the longitudinal and lateral control axes since these are the axes most affected by the load pendulum modes in the frequency range of interest for handling qualities. Results were computed for stability margins, handling qualities parameters and load pendulum stability. The computations took an average of 4 minutes before clearing the aircraft to the next test point. Important reductions in handling qualities were computed in some cases, depending, on control axis and load-slung combination. A database, including load dynamics measurements, was accumulated for subsequent simulation development and validation.

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

    PubMed

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

    2015-12-01

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

  5. 75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-05

    ... European Protocol for the Quality Control of the Physical and Technical Aspects of Mammography Screening... entitled ``Physical Laboratory Testing, Breast Compression System'' to follow the Mammography Quality...] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...

  6. [Analysis and countermeasure for quality risk in process of traditional Chinese medicine preparations].

    PubMed

    Yang, Ming; Yang, Yuan-Zhen; Wang, Ya-Qi; Wu, Zhen-Feng; Wang, Xue-Cheng; Luo, Jing

    2017-03-01

    Product quality relies on not only testing methods,but also the design and development, production control and product manufacturing all aspects of logistics management. Quality comes from the process control level.Therefore, it is very important to accurately identify the factors that may induce quality risk in the production process and quality control measures correspondingly.This article systematically analyzes the source of the quality risk of all aspects of the production process in traditional Chinese medicine preparation. Discussing ways and methods of quality risk identification of traditional Chinese medicine preparation and providing references for perfecting the whole process quality management of traditional Chinese medicine preparation. Copyright© by the Chinese Pharmaceutical Association.

  7. 49 CFR 179.7 - Quality assurance program.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... means to detect any nonconformity in the manufacturing, repair, inspection, testing, and qualification... quality control personnel. (3) Procedures to ensure that the latest applicable drawings, design calculations, specifications, and instructions are used in manufacture, inspection, testing, and repair. (4...

  8. Results of an Innovative Education, Training and Quality Assurance Program for Point-of-Care HbA1c Testing using the Bayer DCA 2000 in Australian Aboriginal Community Controlled Health Services

    PubMed Central

    Shephard, Mark D; Gill, Janice P

    2003-01-01

    This study describes the development, implementation and management of a multi-faceted quality assurance program called Quality Assurance for Aboriginal Medical Services (QAAMS) to support point-of-care HbA1c testing on the Bayer DCA 2000 in Aboriginal people with diabetes from 45 Australian Aboriginal Community Controlled Health Services. The quality assurance program comprised four elements: production of culturally appropriate education resources, formal training for Aboriginal Health Workers conducting HbA1c testing, an external quality assurance program and on-going quality management support services including a help hotline and an annual workshop. Aboriginal Health Workers were required to test two quality assurance (QAAMS) samples in a blind sense every month since July 1999. Samples were linearly related and comprised six paired levels of HbA1c. The short and long term performance of each service’s DCA 2000 was reviewed monthly and at the end of each six month testing cycle. The average participation rate over 7 six-monthly QAAMS testing cycles was 88%. 84% of 3100 quality assurance tests performed were within preset limits of acceptability. The median precision (CV%) for HbA1c testing has averaged 3.8% across the past 5 cycles (range 3.4 to 4.0%) and is continuing to improve. The introduction of a medical rebate for HbA1c testing has ensured the program’s sustainability. Through continuing education and training, Aboriginal Health Workers have achieved consistent analytical performance for HbA1c testing on the DCA 2000, equivalent to that of laboratory scientists using the same instrument. This unique quality assurance model can be readily adapted to other Indigenous health settings and other point-of-care tests and instruments. PMID:18568052

  9. The Method of Manufacturing Nonmetallic Test-Blocks on Different Sensitivity Classes

    NASA Astrophysics Data System (ADS)

    Kalinichenko, N. P.; Kalinichenko, A. N.; Lobanova, I. S.; Zaitseva, A. A.; Loboda, E. L.

    2016-01-01

    Nowadays in our modern world there is a vital question of quality control of details made from nonmetallic materials due to their wide spreading. Nondestructive penetrant testing is effective, and in some cases it is the only possible method of accidents prevention at high- risk sites. A brief review of check sample necessary for quality evaluation of penetrant materials is considered. There was offered a way of making agents for quality of penetrant materials testing according to different liquid penetrant testing sensibility classes.

  10. The effects of perceived quality on the behavioural economics of alcohol, amphetamine, cannabis, cocaine, and ecstasy purchases.

    PubMed

    Cole, Jon C; Goudie, Andrew J; Field, Matt; Loverseed, Anne-Claire; Charlton, Sarah; Sumnall, Harry R

    2008-04-01

    Previous research has indicated that non-dependent polydrug users are willing to pay more money to buy good quality drugs as their income increased. This study sought to examine whether altering the perceived quality of controlled drugs would affect drug purchases if the monetary price remained fixed. A random sample of 80 polydrug users were recruited. All participants were administered an anonymous questionnaire consisting of the Drug Abuse Screening Test for Adolescents (DAST-A), the Severity of Dependence Scale for cannabis (SDS), the Alcohol Use Disorders Identification Test (AUDIT), the Hospital Anxiety and Depression Scale (HADS), and questions about their drug use. Participants then completed a simulation of controlled drug purchases where the price of alcohol, amphetamine, cannabis, cocaine, and ecstasy remained the same but their perceived quality changed (i.e. unit price increased as the perceived quality decreased). The demand for alcohol was quality inelastic and alcohol quality had no effects on the purchase of any other controlled drug. Demand for cannabis was quality elastic and alcohol substituted for cannabis as its unit price increased. Demand for cocaine was quality elastic and alcohol, cannabis, and ecstasy substituted for cocaine as its unit price increased. Demand for ecstasy was quality elastic and alcohol and cocaine both substituted for ecstasy as its unit price increased. These results suggest that perceived quality influences the demand for controlled drugs and that monitoring the perceived quality of controlled drugs may provide a warning of potential public health problems in the near future.

  11. Testing and analysis of LWT and SCB properties of asphalt concrete mixtures.

    DOT National Transportation Integrated Search

    2016-04-01

    Currently, Louisianas Quality Control and Quality Assurance (QC/QA) practice for asphalt mixtures in : pavement construction is mainly based on controlling properties of plant produced mixtures that include : gradation and asphalt content, voids f...

  12. VERIFICATION TESTING OF AIR POLLUTION CONTROL TECHNOLOGY QUALITY MANAGEMENT PLAN

    EPA Science Inventory

    This document is the basis for quality assurance for the Air Pollution Control Technology Verification Center (APCT Center) operated under the U.S. Environmental Protection Agency (EPA). It describes the policies, organizational structure, responsibilities, procedures, and qualit...

  13. Real-time control of combined surface water quantity and quality: polder flushing.

    PubMed

    Xu, M; van Overloop, P J; van de Giesen, N C; Stelling, G S

    2010-01-01

    In open water systems, keeping both water depths and water quality at specified values is critical for maintaining a 'healthy' water system. Many systems still require manual operation, at least for water quality management. When applying real-time control, both quantity and quality standards need to be met. In this paper, an artificial polder flushing case is studied. Model Predictive Control (MPC) is developed to control the system. In addition to MPC, a 'forward estimation' procedure is used to acquire water quality predictions for the simplified model used in MPC optimization. In order to illustrate the advantages of MPC, classical control [Proportional-Integral control (PI)] has been developed for comparison in the test case. The results show that both algorithms are able to control the polder flushing process, but MPC is more efficient in functionality and control flexibility.

  14. Effect on Longitudinal Stability and Control Characteristics of a Boeing B-29 Airplane of Variations in Stick-Force and Control-Rate Characteristics Obtained Through Use of a Booster in the Elevator-Control System

    NASA Technical Reports Server (NTRS)

    Mathews, Charles W; Talmage, Donald B; Whitten, James B

    1952-01-01

    A longitudinal stability and control characteristics of a Boeing B-29 airplane have been measured with a booster incorporated in the elevator-control system. Tests were made to determine the effects on the handling qualities of the test airplane of variations in the pilot's control-force gradients as well as the effects of variations in the maximum rate of control motion supplied by the booster. The results of the control-rate investigation indicate that large airplanes may have satisfactory handling qualities with the booster adjusted to give much lower rates of control motion than those normally used by pilots.

  15. Automated Data Quality Assurance using OGC Sensor Web Enablement Frameworks for Marine Observatories

    NASA Astrophysics Data System (ADS)

    Toma, Daniel; Bghiel, Ikram; del Rio, Joaquin; Hidalgo, Alberto; Carreras, Normandino; Manuel, Antoni

    2014-05-01

    Over the past years, environmental sensors have continuously improved by becoming smaller, cheaper, and more intelligent. Therefore, many sensor networks are increasingly deployed to monitor our environment. But due to the large number of sensor manufacturers, accompanying protocols and data encoding, automated integration and data quality assurance of diverse sensors in an observing systems is not straightforward, requiring development of data management code and manual tedious configuration. However, over the past few years it has been demonstrated that Open-Geospatial Consortium (OGC) frameworks can enable web services with fully-described sensor systems, including data processing, sensor characteristics and quality control tests and results. So far, the SWE framework does not describe how to integrate sensors on-the-fly with minimal human intervention. The data management software which enables access to sensors, data processing and quality control tests has to be implemented and the results have to be manually mapped to the SWE models. In this contribution, we describe a Sensor Plug & Play infrastructure for the Sensor Web by combining (1) OGC PUCK protocol - a simple standard embedded instrument protocol to store and retrieve directly from the devices the declarative description of sensor characteristics and quality control tests, (2) an automatic mechanism for data processing and quality control tests underlying the Sensor Web - the Sensor Interface Descriptor (SID) concept, as well as (3) a model for the declarative description of sensor which serves as a generic data management mechanism - designed as a profile and extension of OGC SWE's SensorML standard. We implement and evaluate our approach by applying it to the OBSEA Observatory, and can be used to demonstrate the ability to assess data quality for temperature, salinity, air pressure and wind speed and direction observations off the coast of Garraf, in the north-eastern Spain.

  16. Modernized build and test infrastructure for control software at ESO: highly flexible building, testing, and automatic quality practices for telescope control software

    NASA Astrophysics Data System (ADS)

    Pellegrin, F.; Jeram, B.; Haucke, J.; Feyrin, S.

    2016-07-01

    The paper describes the introduction of a new automatized build and test infrastructure, based on the open-source software Jenkins1, into the ESO Very Large Telescope control software to replace the preexisting in-house solution. A brief introduction to software quality practices is given, a description of the previous solution, the limitations of it and new upcoming requirements. Modifications required to adapt the new system are described, how these were implemented to current software and the results obtained. An overview on how the new system may be used in future projects is also presented.

  17. Quality Assurance of RNA Expression Profiling in Clinical Laboratories

    PubMed Central

    Tang, Weihua; Hu, Zhiyuan; Muallem, Hind; Gulley, Margaret L.

    2012-01-01

    RNA expression profiles are increasingly used to diagnose and classify disease, based on expression patterns of as many as several thousand RNAs. To ensure quality of expression profiling services in clinical settings, a standard operating procedure incorporates multiple quality indicators and controls, beginning with preanalytic specimen preparation and proceeding thorough analysis, interpretation, and reporting. Before testing, histopathological examination of each cellular specimen, along with optional cell enrichment procedures, ensures adequacy of the input tissue. Other tactics include endogenous controls to evaluate adequacy of RNA and exogenous or spiked controls to evaluate run- and patient-specific performance of the test system, respectively. Unique aspects of quality assurance for array-based tests include controls for the pertinent outcome signatures that often supersede controls for each individual analyte, built-in redundancy for critical analytes or biochemical pathways, and software-supported scrutiny of abundant data by a laboratory physician who interprets the findings in a manner facilitating appropriate medical intervention. Access to high-quality reagents, instruments, and software from commercial sources promotes standardization and adoption in clinical settings, once an assay is vetted in validation studies as being analytically sound and clinically useful. Careful attention to the well-honed principles of laboratory medicine, along with guidance from government and professional groups on strategies to preserve RNA and manage large data sets, promotes clinical-grade assay performance. PMID:22020152

  18. Impact of the use of plasma rich in growth factors (PRGF) on the quality of life of patients treated with endodontic surgery when a perforation of sinus membrane occurred. A comparative study.

    PubMed

    Taschieri, S; Corbella, S; Tsesis, I; Del Fabbro, M

    2014-03-01

    The aim of this retrospective investigation was to evaluate the postoperative quality of life after endodontic surgery in maxillary molars when a sinus membrane perforation occurred and platelet concentrates were used. Included patients were treated by microsurgical endodontic treatment in molar and premolar maxillary regions between 2007 and 2010. Patients who fulfilled the inclusion criteria were screened. Data from the quality of life questionnaire were analyzed. The use of plasma rich in growth factors (PRGF) (test group) was compared with a control group when a Schneiderian membrane perforation occurred during endodontic surgery performed with a modern technique in maxillary molars and premolars. A total of 20 patients (12 in the control group and eight in the test group) fulfilled the inclusion criteria. No differences were evaluated at baseline for clinical parameters. Significantly improved patients' quality of life was observed in the test group considering symptoms as swelling, bad breath or taste, and pain. Functional activities were less impaired in the test group and swelling was significantly higher in the control group. In the test group, pain was significantly lower than the control group during the first 6 days after surgery and also, the consumption of painkillers was lower for patients belonging to the test group even if it was not statistically significant. In general, a small sinus membrane perforation (less than 6 mm) during endodontic surgery did not cause severe complications. The use of platelet concentrates could be effective in reducing the impact on patients' quality of life, decreasing pain and surgery side effects as well as swelling.

  19. [Evaluation of quality of HIV diagnostic procedures in Poland].

    PubMed

    Parczewski, Miłosz; Madaliński, Kazimierz; Leszczyszyn-Pynka, Magdalena; Boroń-Kaczmarska, Anna

    2010-01-01

    The aim of this work was quality assessment of HIV diagnostic procedures in Poland, including human and technical resources as well as laboratory practice. Sixty questionnaires were distributed among diagnostic centers to obtain qualitative data. Basing on the survey data serological control using coded panels of HIV-1/2 samples was performed. Thirty-one filled questionnaires were received (50.8%). Surveyed laboratories perform from 350 to 5500 serological screening tests per year. In most of laboratories fourth generation assays are available, while Blood Donation Centers screen the blood both with serological assays and by HIV-RNA detection. Sanitary and Epidemiological Stations and academic laboratories hold the ISO/IEC 17025 or IS0 9001:2001 accreditation, five of the surveyed centers participate in Labquality assurance and two in Quality Control in Molecular Diagnostics programs. Data of control serological testing were received from 21 centers. In the quality control assessment 194 analyses were performed with 91 true negative, 2 false negative, 96 true positive and 5 false positive results. False negative rate of % and false positive rate of 5.2% was noted for this study. Currently, virtually no guidelines related to the HIV-diagnostics quality assurance and control in Poland are in delineated. Development of the national unified quality control system, basing on the central institution is highly desirable. National certification within the frames of the quality control and assurance program should be mandatory for all the diagnostic labs, and aim at improvement of reliability of the result distributed among clinicians and patients.

  20. 40 CFR Appendix B to Part 75 - Quality Assurance and Quality Control Procedures

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Systems 1.2.1Calibration Error Test and Linearity Check Procedures Keep a written record of the procedures used for daily calibration error tests and linearity checks (e.g., how gases are to be injected..., and when calibration adjustments should be made). Identify any calibration error test and linearity...

  1. 40 CFR Appendix B to Part 75 - Quality Assurance and Quality Control Procedures

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Systems 1.2.1Calibration Error Test and Linearity Check Procedures Keep a written record of the procedures used for daily calibration error tests and linearity checks (e.g., how gases are to be injected..., and when calibration adjustments should be made). Identify any calibration error test and linearity...

  2. Automation of testing modules of controller ELSY-ТМК

    NASA Astrophysics Data System (ADS)

    Dolotov, A. E.; Dolotova, R. G.; Petuhov, D. V.; Potapova, A. P.

    2017-01-01

    In modern life, there are means for automation of various processes which allow one to provide high quality standards of released products and to raise labour efficiency. In the given paper, the data on the automation of the test process of the ELSY-TMK controller [1] is presented. The ELSY-TMK programmed logic controller is an effective modular platform for construction of automation systems for small and average branches of industrial production. The modern and functional standard of communication and open environment of the logic controller give a powerful tool of wide spectrum applications for industrial automation. The algorithm allows one to test controller modules by operating the switching system and external devices faster and at a higher level of quality than a human without such means does.

  3. The effect of massage therapy on the quality of sleep in breast cancer patients.

    PubMed

    Kashani, Fahimeh; Kashani, Parisa

    2014-03-01

    Annually, about 6000 new cases are diagnosed with breast cancer in Iran. In Iran, more women are affected with breast cancer than a decade earlier in comparison with other countries, and 70% of them are diagnosed at an advanced phase. Insomnia is the most common disorder following breast cancer, and interference in sleep quality and rest causes changes in physiological functions and reduces the body's daily performance. The objective of this study was to determine the effect of massage therapy on the quality of sleep in patients with breast cancer. This clinical trial was conducted for about 1 month in a referral chemotherapy clinic of a teaching hospital in Isfahan, Iran. The participants consisted of 57 women with breast cancer who were selected by simple random sampling. They were randomly assigned to two groups of control and experimental. The control group was treated only by usual medical therapy, whereas the case group was treated by combined medical-massage therapy. Data collection tools were the validated Pittsburgh Sleep Quality Index and a demographic questionnaire. Data were analyzed by SPSS using descriptive statistics, Chi-square test, paired t-test, and Student's t-test. The results showed significant differences in the mean scores of quality of sleep before and after the intervention in the case group, while no significant differences were observed in the mean scores of quality of sleep before and after the intervention in the control group. In addition, no significant differences were observed in the mean scores of quality of sleep before the intervention between case and control groups. However, significant differences were observed in the mean scores of quality of sleep after the intervention between case and control groups. According to the results of this study, learning and applying massage techniques by medical staff causes health promotion and improves the quality of sleep in cancer patients. Furthermore, massage therapy is suggested as a non-pharmacologic method to improve sleep quality in these patients.

  4. The Neuropsychological Profile of Comorbid Post-Traumatic Stress Disorder in Adult ADHD.

    PubMed

    Antshel, Kevin M; Biederman, Joseph; Spencer, Thomas J; Faraone, Stephen V

    2016-12-01

    ADHD and post-traumatic stress disorder (PTSD) are often comorbid yet despite the increased comorbidity between the two disorders, to our knowledge, no data have been published regarding the neuropsychological profile of adults with comorbid ADHD and PTSD. Likewise, previous empirical studies of the neuropsychology of PTSD did not control for ADHD status. We sought to fill this gap in the literature and to assess the extent to which neuropsychological test performance predicted psychosocial functioning, and perceived quality of life. Participants were 201 adults with ADHD attending an outpatient mental health clinic between 1998 and 2003 and 123 controls without ADHD. Participants completed a large battery of self-report measures and psychological tests. Diagnoses were made using data obtained from structured psychiatric interviews (i.e., Structured Clinical Interview for DSM-IV, Schedule for Affective Disorders and Schizophrenia for School-Age Children Epidemiologic Version). Differences emerged between control participants and participants with ADHD on multiple neuropsychological tests. Across all tests, control participants outperformed participants with ADHD. Differences between the two ADHD groups emerged on seven psychological subtests including multiple Wechsler Adult Intelligence Scale-Third edition and Rey-Osterrieth Complex Figure Test measures. These test differences did not account for self-reported quality of life differences between groups. The comorbidity with PTSD in adults with ADHD is associated with weaker cognitive performance on several tasks that appear related to spatial/perceptual abilities and fluency. Neuropsychological test performances may share variance with the quality of life variables yet are not mediators of the quality of life ratings. © The Author(s) 2014.

  5. 21 CFR 211.165 - Testing and release for distribution.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. The statistical quality control criteria shall include appropriate acceptance levels and/or appropriate rejection levels. (e) The accuracy, sensitivity, specificity, and...

  6. Complete Genome Sequence of the Quality Control Strain Staphylococcus aureus subsp. aureus ATCC 25923

    PubMed Central

    Treangen, Todd J.; Maybank, Rosslyn A.; Enke, Sana; Friss, Mary Beth; Diviak, Lynn F.; Karaolis, David K. R.; Koren, Sergey; Ondov, Brian; Phillippy, Adam M.; Bergman, Nicholas H.

    2014-01-01

    Staphylococcus aureus subsp. aureus ATCC 25923 is commonly used as a control strain for susceptibility testing to antibiotics and as a quality control strain for commercial products. We present the completed genome sequence for the strain, consisting of the chromosome and a 27.5-kb plasmid. PMID:25377701

  7. Amelogenin test: From forensics to quality control in clinical and biochemical genomics.

    PubMed

    Francès, F; Portolés, O; González, J I; Coltell, O; Verdú, F; Castelló, A; Corella, D

    2007-01-01

    The increasing number of samples from the biomedical genetic studies and the number of centers participating in the same involves increasing risk of mistakes in the different sample handling stages. We have evaluated the usefulness of the amelogenin test for quality control in sample identification. Amelogenin test (frequently used in forensics) was undertaken on 1224 individuals participating in a biomedical study. Concordance between referred sex in the database and amelogenin test was estimated. Additional sex-error genetic detecting systems were developed. The overall concordance rate was 99.84% (1222/1224). Two samples showed a female amelogenin test outcome, being codified as males in the database. The first, after checking sex-specific biochemical and clinical profile data was found to be due to a codification error in the database. In the second, after checking the database, no apparent error was discovered because a correct male profile was found. False negatives in amelogenin male sex determination were discarded by additional tests, and feminine sex was confirmed. A sample labeling error was revealed after a new DNA extraction. The amelogenin test is a useful quality control tool for detecting sex-identification errors in large genomic studies, and can contribute to increase its validity.

  8. Aircraft flight test trajectory control

    NASA Technical Reports Server (NTRS)

    Menon, P. K. A.; Walker, R. A.

    1988-01-01

    Two control law design techniques are compared and the performance of the resulting controllers evaluated. The design requirement is for a flight test trajectory controller (FTTC) capable of closed-loop, outer-loop control of an F-15 aircraft performing high-quality research flight test maneuvers. The maneuver modeling, linearization, and design methodologies utilized in this research, are detailed. The results of applying these FTTCs to a nonlinear F-15 simulation are presented.

  9. Effect on Bone Architecture of Marginal Grooves in Dental Implants Under Occlusal Loaded Conditions in Beagle Dogs.

    PubMed

    Kato, Hatsumi; Kuroshima, Shinichiro; Inaba, Nao; Uto, Yusuke; Sawase, Takashi

    2018-02-01

    The aim of this study was to clarify whether marginal grooves on dental implants affect osseointegration, bone structure, and the alignment of collagen fibers to determine bone quality under loaded conditions. Anodized Ti-6Al-4V alloy dental implants, with and without marginal grooves (test and control implants, respectively), were used (3.7 × 8.0 mm). Fourth premolars and first molars of 6 beagle mandibles were extracted. Two control and test implants were placed in randomly selected healed sites at 12 weeks after tooth extraction. Screw-retained single crowns for first molars were fabricated. Euthanasia was performed at 8 weeks after the application of occlusal forces. Implant marginal bone level, bone to implant contact (BIC), bone structure around dental implants, and the alignment of collagen fibers determining bone quality were analyzed. The marginal bone level in test implants was significantly higher than that in control implants. Occlusal forces significantly increased BIC in test implants ( P = .007), whereas BIC did not change in control implants, irrespective of occlusal forces ( P = .303). Moreover, occlusal forces significantly increased BIC in test implants compared with control implants ( P = .032). Additionally, occlusal forces preferentially aligned collagen fibers in test implants, but not control implants. Hence, marginal grooves on dental implants have positive effects on increased osseointegration and adapted bone quality based on the preferential alignment of collagen fibers around dental implants under loaded conditions.

  10. Quality control system preparation for photogrammetric and laser scanning missions of Spanish national plan of aerial orthophotogpaphy (PNOA). (Polish Title: Opracowanie systemu kontroli jakości realizacji nalotów fotogrametrycznych i skaningowych dla hiszpańskiego narodowego planu ortofotomapy lotniczej (PNOA))

    NASA Astrophysics Data System (ADS)

    Rzonca, A.

    2013-12-01

    The paper presents the state of the art of quality control of photogrammetric and laser scanning data captured by airborne sensors. The described subject is very important for photogrammetric and LiDAR project execution, because the data quality a prior decides about the final product quality. On the other hand, precise and effective quality control process allows to execute the missions without wide margin of safety, especially in case of the mountain areas projects. For introduction, the author presents theoretical background of the quality control, basing on his own experience, instructions and technical documentation. He describes several variants of organization solutions. Basically, there are two main approaches: quality control of the captured data and the control of discrepancies of the flight plan and its results of its execution. Both of them are able to use test of control and analysis of the data. The test is an automatic algorithm controlling the data and generating the control report. Analysis is a less complicated process, that is based on documentation, data and metadata manual check. The example of quality control system for large area project was presented. The project is being realized periodically for the territory of all Spain and named National Plan of Aerial Orthophotography (Plan Nacional de Ortofotografía Aérea, PNOA). The system of the internal control guarantees its results soon after the flight and informs the flight team of the company. It allows to correct all the errors shortly after the flight and it might stop transferring the data to another team or company, for further data processing. The described system of data quality control contains geometrical and radiometrical control of photogrammetric data and geometrical control of LiDAR data. According to all specified parameters, it checks all of them and generates the reports. They are very helpful in case of some errors or low quality data. The paper includes the author experience in the field of data quality control, presents the conclusions and suggestions of the organization and technical aspects, with a short definition of the necessary control software.

  11. Quality control for the first large areas of triple-GEM chambers for the CMS endcaps

    NASA Astrophysics Data System (ADS)

    Abbaneo, D.; Abbas, M.; Abbrescia, M.; Abi Akl, M.; Aboamer, O.; Acosta, D.; Ahmad, A.; Ahmed, W.; Aleksandrov, A.; Altieri, P.; Asawatangtrakuldee, C.; Aspell, P.; Assran, Y.; Awan, I.; Bally, S.; Ban, Y.; Banerjee, S.; Barashko, V.; Barria, P.; Bencze, G.; Beni, N.; Benussi, L.; Bhopatkar, V.; Bianco, S.; Bos, J.; Bouhali, O.; Braghieri, A.; Braibant, S.; Buontempo, S.; Calabria, C.; Caponero, M.; Caputo, C.; Cassese, F.; Castaneda, A.; Cauwenbergh, S.; Cavallo, F. R.; Celik, A.; Choi, M.; Choi, S.; Christiansen, J.; Cimmino, A.; Colafranceschi, S.; Colaleo, A.; Conde Garcia, A.; Czellar, S.; Dabrowski, M. M.; De Lentdecker, G.; De Oliveira, R.; de Robertis, G.; Dildick, S.; Dorney, B.; Endroczi, G.; Errico, F.; Fenyvesi, A.; Ferry, S.; Furic, I.; Giacomelli, P.; Gilmore, J.; Golovtsov, V.; Guiducci, L.; Guilloux, F.; Gutierrez, A.; Hadjiiska, R. M.; Hauser, J.; Hoepfner, K.; Hohlmann, M.; Hoorani, H.; Iaydjiev, P.; Jeng, Y. G.; Kamon, T.; Karchin, P.; Korytov, A.; Krutelyov, S.; Kumar, A.; Kim, H.; Lee, J.; Lenzi, T.; Litov, L.; Loddo, F.; Madorsky, A.; Maerschalk, T.; Maggi, M.; Magnani, A.; Mal, P. K.; Mandal, K.; Marchioro, A.; Marinov, A.; Majumdar, N.; Merlin, J. A.; Mitselmakher, G.; Mohanty, A. K.; Mohapatra, A.; Molnar, J.; Muhammad, S.; Mukhopadhyay, S.; Naimuddin, M.; Nuzzo, S.; Oliveri, E.; Pant, L. M.; Paolucci, P.; Park, I.; Passeggio, G.; Pavlov, B.; Philipps, B.; Piccolo, D.; Postema, H.; Puig Baranac, A.; Radi, A.; Radogna, R.; Raffone, G.; Ranieri, A.; Rashevski, G.; Riccardi, C.; Rodozov, M.; Rodrigues, A.; Ropelewski, L.; RoyChowdhury, S.; Ryu, G.; Ryu, M. S.; Safonov, A.; Salva, S.; Saviano, G.; Sharma, A.; Sharma, A.; Sharma, R.; Shah, A. H.; Shopova, M.; Sturdy, J.; Sultanov, G.; Swain, S. K.; Szillasi, Z.; Talvitie, J.; Tatarinov, A.; Tuuva, T.; Tytgat, M.; Vai, I.; Van Stenis, M.; Venditti, R.; Verhagen, E.; Verwilligen, P.; Vitulo, P.; Volkov, S.; Vorobyev, A.; Wang, D.; Wang, M.; Yang, U.; Yang, Y.; Yonamine, R.; Zaganidis, N.; Zenoni, F.; Zhang, A.

    2018-02-01

    The CMS Collaboration plans to equip the very forward muon system with triple-GEM detectors that can withstand the environment of the High-Luminosity LHC. This project is at the final stages of R&D and moving to production. An unprecedented large area of several 100 m2 are to be instrumented with GEM detectors which will be produced in six different sites around the world. A common construction and quality control procedure is required to ensure the performance of each detector. The quality control steps will include optical inspection, cleaning and baking of all materials and parts used to build the detector, leakage current tests of the GEM foils, high voltage tests, gas leak tests of the chambers and monitoring pressure drop vs. time, gain calibration to know the optimal operation region of the detector, gain uniformity tests, and studying the efficiency, noise and tracking performance of the detectors in a cosmic stand using scintillators.

  12. Investigation of the Asphalt Pavement Analyzer (APA) testing program in Nebraska.

    DOT National Transportation Integrated Search

    2008-03-01

    The asphalt pavement analyzer (APA) has been widely used to evaluate hot-mix asphalt (HMA) rutting potential in mix : design and quality control-quality assurance (QC-QA) applications, because the APA testing and its data analyses are : relatively si...

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

    PubMed

    Aidoo, Michael

    2013-09-01

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

  14. CHALLENGES IN SETTING UP QUALITY CONTROL IN DIAGNOSTIC RADIOLOGY FACILITIES IN NIGERIA.

    PubMed

    Inyang, S O; Egbe, N O; Ekpo, E

    2015-01-01

    The Nigerian Nuclear Regulatory Authority (NNRA) was established to regulate and control the use of radioactive and radiation emitting sources in Nigeria. Quality control (QC) on diagnostic radiology equipment form part of the fundamental requirements for the authorization of diagnostic radiology facilities in the Country. Some quality control tests (output, exposure linearity and reproducibility) were measured on the x-ray machines in the facilities that took part in the study. Questionnaire was developed to evaluate the frequencies at which QC tests were conducted in the facilities and the challenges in setting up QC. Results show great variation in the values of the QC parameters measured. Inadequate cooperation by facilities management, lack of QC equipment and insufficient staff form the major challenges in setting up QC in the facilities under study. The responses on the frequencies at which QC tests should be conducted did not correspond to the recommended standards; indicating that personnel were not familiar with QC implementation and may require further training on QC.

  15. 40 CFR 1054.345 - What production-line testing records must I send to EPA?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

  16. 40 CFR 1054.345 - What production-line testing records must I send to EPA?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

  17. 40 CFR 1054.345 - What production-line testing records must I send to EPA?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

  18. 40 CFR 1054.345 - What production-line testing records must I send to EPA?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

  19. 40 CFR 1054.345 - What production-line testing records must I send to EPA?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

  20. Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods

    PubMed Central

    Dozier, Samantha; Brown, Jeffrey; Currie, Alistair

    2011-01-01

    Simple Summary Many vaccines are tested for quality in experiments that require the use of large numbers of animals in procedures that often cause significant pain and distress. Newer technologies have fostered the development of vaccine quality control tests that reduce or eliminate the use of animals, but the availability of these newer methods has not guaranteed their acceptance by regulators or use by manufacturers. We discuss a strategic approach that has been used to assess and ultimately increase the use of non-animal vaccine quality tests in the U.S. and U.K. Abstract In recent years, technologically advanced high-throughput techniques have been developed that replace, reduce or refine animal use in vaccine quality control tests. Following validation, these tests are slowly being accepted for use by international regulatory authorities. Because regulatory acceptance itself has not guaranteed that approved humane methods are adopted by manufacturers, various organizations have sought to foster the preferential use of validated non-animal methods by interfacing with industry and regulatory authorities. After noticing this gap between regulation and uptake by industry, we began developing a paradigm that seeks to narrow the gap and quicken implementation of new replacement, refinement or reduction guidance. A systematic analysis of our experience in promoting the transparent implementation of validated non-animal vaccine potency assays has led to the refinement of our paradigmatic process, presented here, by which interested parties can assess the local regulatory acceptance of methods that reduce animal use and integrate them into quality control testing protocols, or ensure the elimination of peripheral barriers to their use, particularly for potency and other tests carried out on production batches. PMID:26486625

  1. An adaptive toolkit for image quality evaluation in system performance test of digital breast tomosynthesis

    NASA Astrophysics Data System (ADS)

    Zhang, Guozhi; Petrov, Dimitar; Marshall, Nicholas; Bosmans, Hilde

    2017-03-01

    Digital breast tomosynthesis (DBT) is a relatively new diagnostic imaging modality for women. Currently, various models of DBT systems are available on the market and the number of installations is rapidly increasing. EUREF, the European Reference Organization for Quality Assured Breast Screening and Diagnostic Services, has proposed a preliminary Guideline - protocol for the quality control of the physical and technical aspects of digital breast tomosynthesis systems, with an ultimate aim of providing limiting values guaranteeing proper performance for different applications of DBT. In this work, we introduce an adaptive toolkit developed in accordance with this guideline to facilitate the process of image quality evaluation in DBT performance test. This toolkit implements robust algorithms to quantify various technical parameters of DBT images and provides a convenient user interface in practice. Each test is built into a separate module with configurations set corresponding to the European guideline, which can be easily adapted to different settings and extended with additional tests. This toolkit largely improves the efficiency for image quality evaluation of DBT. It is also going to evolve with the development of protocols in quality control of DBT systems.

  2. Analyses and tests of the B-1 aircraft structural mode control system

    NASA Technical Reports Server (NTRS)

    Wykes, J. H.; Byar, T. R.; Macmiller, C. J.; Greek, D. C.

    1980-01-01

    Analyses and flight tests of the B-1 structural mode control system (SMCS) are presented. Improvements in the total dynamic response of a flexible aircraft and the benefits to ride qualities, handling qualities, crew efficiency, and reduced dynamic loads on the primary structures, were investigated. The effectiveness and the performance of the SMCS, which uses small aerodynamic surfaces at the vehicle nose to provide damping to the structural modes, were evaluated.

  3. Preliminary enquiry into the availability, price and quality of malaria rapid diagnostic tests in the private health sector of six malaria-endemic countries.

    PubMed

    Albertini, A; Djalle, D; Faye, B; Gamboa, D; Luchavez, J; Mationg, M L; Mwangoka, G; Oyibo, W; Bennett, J; Incardona, S; Lee, E

    2012-02-01

    This enquiry aimed to provide a snap-shot of availability, price and quality of malaria rapid diagnostic tests (RDTs) in private health facilities at selected sites in six malaria-endemic countries in Africa, South East Asia and South America. In each study site, data collectors surveyed private healthcare facilities which were selected based on accessibility from their home institution. Using a questionnaire, information was recorded about the facility itself and the malaria RDT(s) available. Where possible, a small number of RDTs were procured and quality control tested using a standardized procedure. Of the 324 private healthcare facilities visited, 35 outlets (mainly private clinics and hospitals) were found to supply 10 different types of RDTs products. RDT prices across the six countries ranged from US$1.00 to $16.81. Five of the 14 malaria RDTs collected failed quality control testing. In the private outlets sampled, the availability of RDTs was limited. Some of the RDTs whose quality we tested demonstrated inadequate sensitivity. This presents a number of risks. Given the more widespread distribution of antimalarials currently planned for private sector facilities, parasite-based diagnosis in this sector will be essential to adhere to the WHO guidelines for effective case management of malaria. Considerable regulation and quality control are also necessary to assure the availability of accurate and reliable RDTs, as well as adequate case management and provider adherence to RDT results. Public sector engagement is likely to be essential in this process. © 2011 Blackwell Publishing Ltd.

  4. 78 FR 13835 - Harmonization of Airworthiness Standards-Miscellaneous Structures Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-01

    ... requirements for critical and non-critical castings; add control system requirements that consider structural... of critical casting and Quality control, inspection, and testing requirements for critical and non... control, inspection, and testing requirements for critical and non-critical castings. The proposed rule...

  5. Internal quality control: planning and implementation strategies.

    PubMed

    Westgard, James O

    2003-11-01

    The first essential in setting up internal quality control (IQC) of a test procedure in the clinical laboratory is to select the proper IQC procedure to implement, i.e. choosing the statistical criteria or control rules, and the number of control measurements, according to the quality required for the test and the observed performance of the method. Then the right IQC procedure must be properly implemented. This review focuses on strategies for planning and implementing IQC procedures in order to improve the quality of the IQC. A quantitative planning process is described that can be implemented with graphical tools such as power function or critical-error graphs and charts of operating specifications. Finally, a total QC strategy is formulated to minimize cost and maximize quality. A general strategy for IQC implementation is recommended that employs a three-stage design in which the first stage provides high error detection, the second stage low false rejection and the third stage prescribes the length of the analytical run, making use of an algorithm involving the average of normal patients' data.

  6. Assessment of breadmaking performance of wheat flour dough by means of frequency dependent ultrasound

    NASA Astrophysics Data System (ADS)

    Braunstein, D.; Page, J. H.; Strybulevych, A.; Peressini, D.; Scanlon, M. G.

    2012-12-01

    Technological performance of wheat flour varies among different wheat varieties. Gluten plays a key role within the solid phase of dough in the formation and the retention of gas bubbles during breadmaking. Rheological tests are usually performed to predict breadmaking potential. The aim here was to investigate the ability of ultrasound to discriminate wheat doughs based on breadmaking qualities. The ultimate goal is the development of an online quality control system currently unavailable in the baked goods industry, rendering this work innovative. Samples were prepared from a strong wheat flour, with one control sample and one added with inulin and distilled monoglycerides, producing doughs of distinct breadmaking quality. Doughs were subjected to density determination, elongation tests, and ultrasound analysis. The ultrasound tests were performed in the frequency range of 300 kHz - 6 MHz. Ultrasonic phase velocity increased with increasing frequency to about 2 MHz, becoming constant and then decreasing from 3 MHz for the control sample. Distinct differences in attenuation coefficient between the fibre-enriched and control doughs were observed. Ultrasound can potentially add to a better understanding of dough quality and can discriminate between doughs of contrasting properties.

  7. Effect of baby oil on pruritus, sleep quality, and quality of life in hemodialysis patients: pretest-post-test model with control groups.

    PubMed

    Karadag, Ezgi; Kilic, Serap Parlar; Karatay, Gülnaz; Metin, Ozgur

    2014-07-01

    To assess the effect of baby oil on pruritus, sleep quality, and quality of life in hemodialysis (HD) patients. This pretest-post-test model with control groups study was conducted in HD units in two different provinces in eastern Turkey. The study group consisted of a total of 70 patients receiving HD treatment who met the inclusion criteria, 35 being in the intervention group and 35 in the control group. After the patients in both groups were informed about the study, they were administered a questionnaire, the Severity Scale, Visual Analog Scale, the Pittsburgh Sleep Quality Index, and the SF-36 Quality of Life Scale. Following the administration of baby oil to the patients in the intervention group three times a week for a period of 1 month, the same scales were repeated to explore their pruritic status, sleep quality, and quality of life. The same scales were repeated also for the patients in the control group 1 month later but without administering any baby oil. When the Itch Severity Scale, Visual Analog Scale, Pittsburgh Sleep Quality Index, and SF-36 Quality of Life Physical and Mental Component scores of the patients in the control and intervention groups before and after the intervention were compared, the differences in the change were found to be statistically significant in favor of the intervention group (P < 0.05). It was found in this study that administration of baby oil had positive effects on itching, quality of life, and sleep quality in HD patients who had itching complaints. © 2013 The Authors. Japan Journal of Nursing Science © 2013 Japan Academy of Nursing Science.

  8. The importance of quality assurance/quality control of diagnostics to increase the confidence in global foot-and-mouth disease control.

    PubMed

    De Clercq, K; Goris, N; Barnett, P V; MacKay, D K

    2008-01-01

    The last decade international trade in animals and animal products was liberated and confidence in this global trade can increase only if appropriate control measures are applied. As foot-and-mouth disease (FMD) diagnostics will play an essential role in this respect, the Food and Agriculture Organization European Commission for the Control of Foot-and-Mouth Disease (EUFMD) co-ordinates, in collaboration with the European Commission, several programmes to increase the quality of FMD diagnostics. A quality assurance (QA) system is deemed essential for laboratories involved in certifying absence of FMDV or antibodies against the virus. Therefore, laboratories are encouraged to validate their diagnostic tests fully and to install a continuous quality control (QC) monitoring system. Knowledge of performance characteristics of diagnostics is essential to interpret results correctly and to calculate sample rates in regional surveillance campaigns. Different aspects of QA/QC of classical and new FMD virological and serological diagnostics are discussed in respect to the EU FMD directive (2003/85/EC). We recommended accepting trade certificates only from laboratories participating in international proficiency testing on a regular basis.

  9. Design and development of a structural mode control system

    NASA Technical Reports Server (NTRS)

    1977-01-01

    A program was conducted to compile and document some of the existing information about the conceptual design, development, and tests of the B-1 structural mode control system (SMCS) and its impact on ride quality. This report covers the following topics: (1) Rationale of selection of SMCS to meet ride quality criteria versus basic aircraft stiffening. (2) Key considerations in designing an SMCS, including vane geometry, rate and deflection requirements, power required, compensation network design, and fail-safe requirements. (3) Summary of key results of SMCS vane wind tunnel tests. (4) SMCS performance. (5) SMCS design details, including materials, bearings, and actuators. (6) Results of qualification testing of SMCS on the "Iron Bird" flight control simulator, and lab qualification testing of the actuators. (7) Impact of SMCS vanes on engine inlet characteristics from wind tunnel tests.

  10. The consistency approach for quality control of vaccines - a strategy to improve quality control and implement 3Rs.

    PubMed

    De Mattia, Fabrizio; Chapsal, Jean-Michel; Descamps, Johan; Halder, Marlies; Jarrett, Nicholas; Kross, Imke; Mortiaux, Frederic; Ponsar, Cecile; Redhead, Keith; McKelvie, Jo; Hendriksen, Coenraad

    2011-01-01

    Current batch release testing of established vaccines emphasizes quality control of the final product and is often characterized by extensive use of animals. This report summarises the discussions of a joint ECVAM/EPAA workshop on the applicability of the consistency approach for routine release of human and veterinary vaccines and its potential to reduce animal use. The consistency approach is based upon thorough characterization of the vaccine during development and the principle that the quality of subsequent batches is the consequence of the strict application of a quality system and of a consistent production of batches. The concept of consistency of production is state-of-the-art for new-generation vaccines, where batch release is mainly based on non-animal methods. There is now the opportunity to introduce the approach into established vaccine production, where it has the potential to replace in vivo tests with non-animal tests designed to demonstrate batch quality while maintaining the highest quality standards. The report indicates how this approach may be further developed for application to established human and veterinary vaccines and emphasizes the continuing need for co-ordination and harmonization. It also gives recommendations for work to be undertaken in order to encourage acceptance and implementation of the consistency approach. Copyright © 2011. Published by Elsevier Ltd.. All rights reserved.

  11. Sediment toxicity test results for the Urban Waters Study 2010, Bellingham Bay, Washington

    USGS Publications Warehouse

    Biedenbach, James M.

    2011-01-01

    The Washington Department of Ecology annually determines the quality of recently deposited sediments in Puget Sound as a part of Ecology's Urban Waters Initiative. The annual sediment quality studies use the Sediment Quality Triad (SQT) approach, thus relying on measures of chemical contamination, toxicity, and benthic in-faunal effects (Chapman, 1990). Since 2002, the studies followed a rotating sampling scheme, each year sampling a different region of the greater Puget Sound Basin. During the annual studies, samples are collected in locations selected with a stratified-random design, patterned after the designs previously used in baseline surveys completed during 1997-1999 (Long and others, 2003; Wilson and Partridge, 2007). Sediment samples were collected by personnel from the Washington Department of Ecology, in June of 2010 and shipped to the U. S. Geological Survey (USGS) laboratory in Corpus Christi, Texas (not shown), where the tests were performed. Sediment pore water was extracted with a pneumatic apparatus and was stored frozen. Just before testing, water-quality measurements were made and salinity adjusted, if necessary. Tests were performed on a dilution series of each sample consisting of 100-, 50-, and 25-percent pore-water concentrations. The specific objectives of this study were to: * Extract sediment pore water from a total of 30 sediment samples from the Bellingham Bay, Washington area within a day of receipt of the samples. * Measure water-quality parameters (salinity, dissolved oxygen, pH, sulfide, and ammonia) of thawed pore-water samples before testing and adjust salinity, temperature and dissolved oxygen, if necessary, to obtain optimal ranges for the test species. * Conduct the fertilization toxicity test with pore water using sea urchin (Stronylocentrotus purpuratus) (S. purpuratus) gametes. * Perform quality control assays with reference pore water, dilution blanks and a positive control dilution series with sodium dodecyl sulfate (SDS) in conjunction with each test. * Determine which samples caused a significant decrease in percent fertilization success relative to the negative control.

  12. Assessment of in-situ test technology for construction control of base courses and embankments.

    DOT National Transportation Integrated Search

    2004-05-01

    With the coming move from an empirical to mechanistic-empirical pavement design, it is essential to improve the quality control/quality assurance (QC/QA) procedures of compacted materials from a density-based criterion to a stiffness/strength-based c...

  13. Complete Genome Sequence of the Quality Control Strain Staphylococcus aureus subsp. aureus ATCC 25923.

    PubMed

    Treangen, Todd J; Maybank, Rosslyn A; Enke, Sana; Friss, Mary Beth; Diviak, Lynn F; Karaolis, David K R; Koren, Sergey; Ondov, Brian; Phillippy, Adam M; Bergman, Nicholas H; Rosovitz, M J

    2014-11-06

    Staphylococcus aureus subsp. aureus ATCC 25923 is commonly used as a control strain for susceptibility testing to antibiotics and as a quality control strain for commercial products. We present the completed genome sequence for the strain, consisting of the chromosome and a 27.5-kb plasmid. Copyright © 2014 Treangen et al.

  14. Toward Higher QA: From Parametric Release of Sterile Parenteral Products to PAT for Other Pharmaceutical Dosage Forms.

    PubMed

    Hock, Sia Chong; Constance, Neo Xue Rui; Wah, Chan Lai

    2012-01-01

    Pharmaceutical products are generally subjected to end-product batch testing as a means of quality control. Due to the inherent limitations of conventional batch testing, this is not the most ideal approach for determining the pharmaceutical quality of the finished dosage form. In the case of terminally sterilized parenteral products, the limitations of conventional batch testing have been successfully addressed with the application of parametric release (the release of a product based on control of process parameters instead of batch sterility testing at the end of the manufacturing process). Consequently, there has been an increasing interest in applying parametric release to other pharmaceutical dosage forms, beyond terminally sterilized parenteral products. For parametric release to be possible, manufacturers must be capable of designing quality into the product, monitoring the manufacturing processes, and controlling the quality of intermediates and finished products in real-time. Process analytical technology (PAT) has been thought to be capable of contributing to these prerequisites. It is believed that the appropriate use of PAT tools can eventually lead to the possibility of real-time release of other pharmaceutical dosage forms, by-passing the need for end-product batch testing. Hence, this literature review attempts to present the basic principles of PAT, introduce the various PAT tools that are currently available, present their recent applications to pharmaceutical processing, and explain the potential benefits that PAT can bring to conventional ways of processing and quality assurance of pharmaceutical products. Last but not least, current regulations governing the use of PAT and the manufacturing challenges associated with PAT implementation are also discussed. Pharmaceutical products are generally subjected to end-product batch testing as a means of quality control. Due to the inherent limitations of conventional batch testing, this is not the most ideal approach. In the case of terminally sterilized parenteral products, these limitations have been successfully addressed with the application of parametric release (the release of a product based on control of process parameters instead of batch sterility testing at the end of the manufacturing process). Consequently, there has been an increasing interest in applying parametric release to other pharmaceutical dosage forms. With the advancement of process analytical technology (PAT), it is possible to monitor the manufacturing processes closely. This will eventually enable quality control of the intermediates and finished products, and thus their release in real-time. Hence, this literature review attempts to present the basic principles of PAT, introduce the various PAT tools that are currently available, present their recent applications to pharmaceutical processing, and explain the potential benefits that PAT can bring to conventional ways of processing and quality assurance of pharmaceutical products. It will also discuss the current regulations governing the use of PAT and the manufacturing challenges associated with the implementation of PAT.

  15. Manufacture and quality control of interconnecting wire hardnesses, Volume 1

    NASA Technical Reports Server (NTRS)

    1972-01-01

    A standard is presented for manufacture, installation, and quality control of eight types of interconnecting wire harnesses. The processes, process controls, and inspection and test requirements reflected are based on acknowledgment of harness design requirements, acknowledgment of harness installation requirements, identification of the various parts, materials, etc., utilized in harness manufacture, and formulation of a typical manufacturing flow diagram for identification of each manufacturing and quality control process, operation, inspection, and test. The document covers interconnecting wire harnesses defined in the design standard, including type 1, enclosed in fluorocarbon elastomer convolute, tubing; type 2, enclosed in TFE convolute tubing lines with fiberglass braid; type 3, enclosed in TFE convolute tubing; and type 5, combination of types 3 and 4. Knowledge gained through experience on the Saturn 5 program coupled with recent advances in techniques, materials, and processes was incorporated.

  16. Comparison of Piezosurgery and Conventional Rotary Instruments for Removal of Impacted Mandibular Third Molars: A Randomized Controlled Clinical and Radiographic Trial

    PubMed Central

    Shokry, Mohamed; Aboelsaad, Nayer

    2016-01-01

    The purpose of this study was to test the effect of the surgical removal of impacted mandibular third molars using piezosurgery versus the conventional surgical technique on postoperative sequelae and bone healing. Material and Methods. This study was carried out as a randomized controlled clinical trial: split mouth design. Twenty patients with bilateral mandibular third molar mesioangular impaction class II position B indicated for surgical extraction were treated randomly using either the piezosurgery or the conventional bur technique on each site. Duration of the procedure, postoperative edema, trismus, pain, healing, and bone density and quantity were evaluated up to 6 months postoperatively. Results. Test and control sites were compared using paired t-test. There was statistical significance in reduction of pain and swelling in test sites, where the time of the procedure was statistically increased in test site. For bone quantity and quality, statistical difference was found where test site showed better results. Conclusion. Piezosurgery technique improves quality of patient's life in form of decrease of postoperative pain, trismus, and swelling. Furthermore, it enhances bone quality within the extraction socket and bone quantity along the distal aspect of the mandibular second molar. PMID:27597866

  17. Effect of e-learning and repeated performance feedback on spirometry test quality in family practice: a cluster trial.

    PubMed

    Schermer, Tjard R; Akkermans, Reinier P; Crockett, Alan J; van Montfort, Marian; Grootens-Stekelenburg, Joke; Stout, Jim W; Pieters, Willem

    2011-01-01

    Spirometry has become an indispensable tool in primary care to exclude, diagnose, and monitor chronic respiratory conditions, but the quality of spirometry tests in family practices is a reason for concern. Aim of this study was to investigate whether a combination of e-learning and bimonthly performance feedback would improve spirometry test quality in family practices in the course of 1 year. Our study was a cluster trial with 19 family practices allocated to intervention or control conditions through minimization. Intervention consisted of e-learning and bimonthly feedback reports to practice nurses. Control practices received only the joint baseline workshop. Spirometry quality was assessed by independent lung function technicians. Two outcomes were defined, with the difference between rates of tests with 2 acceptable and repeatable blows being the primary outcome and the difference between rates of tests with 2 acceptable blows being the secondary outcome. We used multilevel logistic regression analysis to calculate odds ratios (ORs) for an adequate test in intervention group practices. We analyzed 1,135 tests. Rate of adequate tests was 33% in intervention and 30% in control group practices (OR = 1.3; P=.605). Adequacy of tests did not differ between groups but tended to increase with time: OR = 2.2 (P = .057) after 3 and OR = 2.0 (P = .086) in intervention group practices after 4 feedback reports. When ignoring test repeatability, these differences between the groups were slightly more pronounced: OR = 2.4 (P = .033) after 3 and OR=2.2 (P = .051) after 4 feedback reports. In the course of 1 year, we observed a small and late effect of e-learning and repeated feedback on the quality of spirometry as performed by family practice nurses. This intervention does not seem to compensate the lack of rigorous training and experience in performing spirometry tests in most practices.

  18. Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial

    PubMed Central

    Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

    2016-01-01

    [Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists. PMID:27134355

  19. Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial.

    PubMed

    Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

    2016-03-01

    [Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists.

  20. Quality Control and Nondestructive Evaluation Techniques for Composites. Part 1. Overview of Characterization Techniques for Composite Reliability

    DTIC Science & Technology

    1982-05-01

    MONITORING AND MANAGEMENT , 34 7.0 NONDESTRUCTIVE EVALUATION ( NDE ) 37 8. 0 SURFACE NDE 44 9.0 PERFORMANCE AND PROOF TESTING 46 10.0 SUMMARY AND...Chemical Quality Assurance Testing 2. Processability Testing 3. Cure Monitoring and Management 4. Nondestructive Evaluation ( NDE ) 5. Performance and...the management concept for implementing the specific tests. Chemical analysis, nondestructive evaluation ( NDE ) and environmental fatigue testing of

  1. Application of QC_DR software for acceptance testing and routine quality control of direct digital radiography systems: initial experiences using the Italian Association of Physicist in Medicine quality control protocol.

    PubMed

    Nitrosi, Andrea; Bertolini, Marco; Borasi, Giovanni; Botti, Andrea; Barani, Adriana; Rivetti, Stefano; Pierotti, Luisa

    2009-12-01

    Ideally, medical x-ray imaging systems should be designed to deliver maximum image quality at an acceptable radiation risk to the patient. Quality assurance procedures are employed to ensure that these standards are maintained. A quality control protocol for direct digital radiography (DDR) systems is described and discussed. Software to automatically process and analyze the required images was developed. In this paper, the initial results obtained on equipment of different DDR manufacturers were reported. The protocol was developed to highlight even small discrepancies in standard operating performance.

  2. Dynamic stability and handling qualities tests on a highly augmented, statically unstable airplane

    NASA Technical Reports Server (NTRS)

    Gera, Joseph; Bosworth, John T.

    1987-01-01

    Initial envelope clearance and subsequent flight testing of a new, fully augmented airplane with an extremely high degree of static instability can place unusual demands on the flight test approach. Previous flight test experience with these kinds of airplanes is very limited or nonexistent. The safe and efficient flight testing may be further complicated by a multiplicity of control effectors that may be present on this class of airplanes. This paper describes some novel flight test and analysis techniques in the flight dynamics and handling qualities area. These techniques were utilized during the initial flight envelope clearance of the X-29A aircraft and were largely responsible for the completion of the flight controls clearance program without any incidents or significant delays.

  3. F-8C digital CCV flight control laws

    NASA Technical Reports Server (NTRS)

    Hartmann, G. L.; Hauge, J. A.; Hendrick, R. C.

    1976-01-01

    A set of digital flight control laws were designed for the NASA F-8C digital fly-by-wire aircraft. The control laws emphasize Control Configured Vehicle (CCV) benefits. Specific pitch axis objectives were improved handling qualities, angle-of-attack limiting, gust alleviation, drag reduction in steady and maneuvering flight, and a capability to fly with reduced static stability. The lateral-directional design objectives were improved Dutch roll damping and turn coordination over a wide range in angle-of-attack. An overall program objective was to explore the use of modern control design methodilogy to achieve these specific CCV benefits. Tests for verifying system integrity, an experimental design for handling qualities evaluation, and recommended flight test investigations were specified.

  4. The effect of strength training on quality of prolonged basic cardiopulmonary resuscitation.

    PubMed

    Abelairas-Gómez, Cristian; Barcala-Furelos, Roberto; Szarpak, Łukasz; García-García, Óscar; Paz-Domínguez, Álvaro; López-García, Sergio; Rodríguez-Núñez, Antonio

    2017-01-01

    Providing high-quality chest compressions and rescue breaths are key elements in the effectiveness of cardio-pulmonary resuscitation. To investigate the effects of a strength training programme on the quality of prolonged basic cardiopulmonary resuscitation on a manikin. This was a quasi-experimental trial. Thirty-nine participants with prior basic life support knowledge were randomised to an experimental or control group. They then performed a test of 10 min of chest compressions and mouth-to-mouth ventilation on manikins equipped with a skill reporter tool (baseline or test 1). The experimental group participated in a four-week strength training programme focused on the muscles involved in chest compressions. Both groups were subsequently tested again (test 2). After training, the experimental group significantly increased the mean depth of compression (53.7 ± 2.3 mm vs. 49.9 ± 5.9 mm; p = 0.003) and the correct compression fraction (68.2 ± 21.0% vs. 46.4 ± 29.1%; p = 0.004). Trained subjects maintained chest compression quality over time better than the control group. The mean tidal volume delivered was higher in the experimental than in the control group (701.5 ± 187.0 mL vs. 584.8 ± 113.6 mL; p = 0.040) and above the current resuscitation guidelines. In test 2, the percentage of rescue breaths with excessive volume was higher in the experi-mental group than in the controls (31.5 ± 19.6% vs. 15.6 ± 13.0%; p = 0.007). A simple strength training programme has a significant impact on the quality of chest compressions and its maintenance over time. Additional training is needed to avoid over-ventilation of potential patients.

  5. Stability evaluation of quality parameters for palm oil products at low temperature storage.

    PubMed

    Ramli, Nur Aainaa Syahirah; Mohd Noor, Mohd Azmil; Musa, Hajar; Ghazali, Razmah

    2018-07-01

    Palm oil is one of the major oils and fats produced and traded worldwide. The value of palm oil products is mainly influenced by their quality. According to ISO 17025:2005, accredited laboratories require a quality control procedure with respect to monitoring the validity of tests for determination of quality parameters. This includes the regular use of internal quality control using secondary reference materials. Unfortunately, palm oil reference materials are not currently available. To establish internal quality control samples, the stability of quality parameters needs to be evaluated. In the present study, the stability of quality parameters for palm oil products was examined over 10 months at low temperature storage (6 ± 2 °C). The palm oil products tested included crude palm oil (CPO); refined, bleached and deodorized (RBD) palm oil (RBDPO); RBD palm olein (RBDPOo); and RBD palm stearin (RBDPS). The quality parameters of the oils [i.e. moisture content, free fatty acid content (FFA), iodine value (IV), fatty acids composition (FAC) and slip melting point (SMP)] were determined prior to and throughout the storage period. The moisture, FFA, IV, FAC and SMP for palm oil products changed significantly (P < 0.05), whereas the moisture content for CPO, IV for RBDPO and RBDPOo, stearic acid composition for CPO and linolenic acid composition for CPO, RBDPO, RBDPOo and RBDPS did not (P > 0.05). The stability study indicated that the quality of the palm oil products was stable within the specified limits throughout the storage period at low temperature. The storage conditions preserved the quality of palm oil products throughout the storage period. These findings qualify the use of the palm oil products CPO, RBDPO, RBDPOo and RBDPS as control samples in the validation of test results. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

  6. SU-G-TeP4-15: The Roucoulette: A Set of Quality Control Tests for Dynamic Trajectory (4Pi) Treatment Delivery Techniques

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

    Teke, T

    Purpose: To present and validate a set of quality control tests for trajectory treatment delivery using synchronized dynamic couch (translation and rotation), MLC and collimator motion. Methods: The quality control tests are based on the Picket fence test, which consist of 5 narrow band 2mm width spaced at 2.5cm intervals, and adds progressively synchronized dynamic motions. The tests were exposed on GafChromic EBT3 films. The first test is a regular (no motion and MLC static while beam is on) Picket Fence test used as baseline. The second test includes simultaneous collimator and couch rotation, each stripe corresponding to a differentmore » rotation speed. Errors in these tests were introduced (0.5 degree and 1 degree error in rotation synchronization) to assess the error sensitivity of this test. The second test is similar to the regular Picket Fence but now including dynamic MLC motion and couch translation (including acceleration during delivery) while the beam is on. Finally in the third test, which is a combination of the first and second test, the Picket Fence pattern is delivered using synchronized collimator and couch rotation and synchronized dynamic MLC and couch translation including acceleration. Films were analyzed with FilmQA Pro. Results: The distance between the peaks in the dose profile where measured (18.5cm away from the isocentre in the inplane direction where non synchronized rotation would have the largest effect) and compared to the regular Picket Fence tests. For well synchronized motions distances between peaks where between 24.9–25.4 mm identical to the regular Picket Fence test. This range increased to 24.4–26.4mm and 23.4–26.4mm for 0.5 degree and 1 degree error respectively. The amplitude also decreased up to 15% when errors are introduced. Conclusion: We demonstrated that the Roucoulette tests can be used as a quality control tests for trajectory treatment delivery using synchronized dynamic motion.« less

  7. 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...

  8. Design and development of polyphenylene oxide foam as a reusable internal insulation for LH2 tanks

    NASA Technical Reports Server (NTRS)

    1975-01-01

    Material specification and fabrication process procedures for foam production are presented. The properties of mechanical strength, modulus of elasticity, density and thermal conductivity were measured and related to foam quality. Properties unique to the foam such as a gas layer insulation, density gradient parallel to the fiber direction, and gas flow conductance in both directions were correlated with foam quality. Inspection and quality control tests procedures are outlined and photographs of test equipment and test specimens are shown.

  9. Performance-based quality assurance/quality control (QA/QC) acceptance procedures for in-place soil testing phase 3 : [summary].

    DOT National Transportation Integrated Search

    2015-01-01

    Acceptance of earthwork construction by the Florida Department of Transportation (FDOT) : requires in-place testing conducted with a nuclear density gauge (NDG) to determine : dry density, which must obtain a required percent compaction based upon a ...

  10. Discussion of the quality control and performance testing of ultrasound diagnostic equipment

    NASA Astrophysics Data System (ADS)

    Jiang, Junjie

    2018-03-01

    In recent years, with the rapid development of ultrasonography, the application and popularization of new technology used in ultrasound equipment, the level of providing diagnostic information for doctors enhances unceasingly, which has become the indispensable diagnostic tool for medical institutions. The performance of equipment is directly related to the doctor’s diagnosis and the patient’s health, therefore, it is very important to choose a good method for quality control and performance testing.

  11. Relationship between antigravity control and postural control in young children.

    PubMed

    Sellers, J S

    1988-04-01

    The purposes of this study were 1) to determine the relationship between antigravity control (supine flexion and prone extension) and postural control (static and dynamic balance), 2) to determine the quality of antigravity and postural control, and 3) to determine whether sex and ethnic group differences correlate with differences in antigravity control and postural control in young children. I tested 107 black, Hispanic, and Caucasian children in a Head Start program, with a mean age of 61 months. The study results showed significant relationships between antigravity control and postural control. Subjects' supine flexion performance was significantly related to the quantity and quality of their static and dynamic balance performance, whereas prone extension performance was related only to the quality of dynamic balance performance. Quality scale measurements (r = .90) indicated that the children in this study had not yet developed full antigravity or postural control. The study results revealed differences between sexes in the quality of static balance and prone extension performance and ethnic differences in static balance, dynamic balance, and prone extension performance.

  12. 10 CFR 74.59 - Quality assurance and accounting requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... analyses and evaluations of the design, installation, preoperational tests, calibration, and operation of... performed at a pre-determined frequency, indicate a need for recalibration. Calibrations and tests must be... necessary for performance of the material control tests required by § 74.53(b). (e) Measurement control. The...

  13. 10 CFR 74.59 - Quality assurance and accounting requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... analyses and evaluations of the design, installation, preoperational tests, calibration, and operation of... performed at a pre-determined frequency, indicate a need for recalibration. Calibrations and tests must be... necessary for performance of the material control tests required by § 74.53(b). (e) Measurement control. The...

  14. 10 CFR 26.125 - Licensee testing facility personnel.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., medical technology, or equivalent. He or she shall also have training and experience in the theory and... control practices and procedures, the review, interpretation, and reporting of test results, and proper remedial actions to be taken in response to detection of abnormal test or quality control results. (b...

  15. 10 CFR 26.125 - Licensee testing facility personnel.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., medical technology, or equivalent. He or she shall also have training and experience in the theory and... control practices and procedures, the review, interpretation, and reporting of test results, and proper remedial actions to be taken in response to detection of abnormal test or quality control results. (b...

  16. 10 CFR 26.125 - Licensee testing facility personnel.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., medical technology, or equivalent. He or she shall also have training and experience in the theory and... control practices and procedures, the review, interpretation, and reporting of test results, and proper remedial actions to be taken in response to detection of abnormal test or quality control results. (b...

  17. 10 CFR 26.125 - Licensee testing facility personnel.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., medical technology, or equivalent. He or she shall also have training and experience in the theory and... control practices and procedures, the review, interpretation, and reporting of test results, and proper remedial actions to be taken in response to detection of abnormal test or quality control results. (b...

  18. 10 CFR 26.125 - Licensee testing facility personnel.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., medical technology, or equivalent. He or she shall also have training and experience in the theory and... control practices and procedures, the review, interpretation, and reporting of test results, and proper remedial actions to be taken in response to detection of abnormal test or quality control results. (b...

  19. A real time quality control application for animal production by image processing.

    PubMed

    Sungur, Cemil; Özkan, Halil

    2015-11-01

    Standards of hygiene and health are of major importance in food production, and quality control has become obligatory in this field. Thanks to rapidly developing technologies, it is now possible for automatic and safe quality control of food production. For this purpose, image-processing-based quality control systems used in industrial applications are being employed to analyze the quality of food products. In this study, quality control of chicken (Gallus domesticus) eggs was achieved using a real time image-processing technique. In order to execute the quality control processes, a conveying mechanism was used. Eggs passing on a conveyor belt were continuously photographed in real time by cameras located above the belt. The images obtained were processed by various methods and techniques. Using digital instrumentation, the volume of the eggs was measured, broken/cracked eggs were separated and dirty eggs were determined. In accordance with international standards for classifying the quality of eggs, the class of separated eggs was determined through a fuzzy implication model. According to tests carried out on thousands of eggs, a quality control process with an accuracy of 98% was possible. © 2014 Society of Chemical Industry.

  20. Flight test of the X-29A at high angle of attack: Flight dynamics and controls

    NASA Technical Reports Server (NTRS)

    Bauer, Jeffrey E.; Clarke, Robert; Burken, John J.

    1995-01-01

    The NASA Dryden Flight Research Center has flight tested two X-29A aircraft at low and high angles of attack. The high-angle-of-attack tests evaluate the feasibility of integrated X-29A technologies. More specific objectives focus on evaluating the high-angle-of-attack flying qualities, defining multiaxis controllability limits, and determining the maximum pitch-pointing capability. A pilot-selectable gain system allows examination of tradeoffs in airplane stability and maneuverability. Basic fighter maneuvers provide qualitative evaluation. Bank angle captures permit qualitative data analysis. This paper discusses the design goals and approach for high-angle-of-attack control laws and provides results from the envelope expansion and handling qualities testing at intermediate angles of attack. Comparisons of the flight test results to the predictions are made where appropriate. The pitch rate command structure of the longitudinal control system is shown to be a valid design for high-angle-of-attack control laws. Flight test results show that wing rock amplitude was overpredicted and aileron and rudder effectiveness were underpredicted. Flight tests show the X-29A airplane to be a good aircraft up to 40 deg angle of attack.

  1. 40 CFR Appendix B to Part 75 - Quality Assurance and Quality Control Procedures

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... in section 2.3 of this appendix and the Hg emission tests described in §§ 75.81(c) and 75.81(d)(4). 1.2Specific Requirements for Continuous Emissions Monitoring Systems 1.2.1Calibration Error Test and Linearity Check Procedures Keep a written record of the procedures used for daily calibration error tests and...

  2. Nutritional equivalency evaluation of transgenic maize grain from event DP-O9814O-6 and transgenic soybeans containing event DP-356O43-5: laying hen performance and egg quality measures.

    PubMed

    McNaughton, J; Roberts, M; Rice, D; Smith, B; Hinds, M; Delaney, B; Iiams, C; Sauber, T

    2011-02-01

    The objective of this study was to compare the nutritional performance of laying hens fed maize grain from event DP-Ø9814Ø-6 (98140; gat4621 and zm-hra genes) and processed soybean meal from soybeans containing event DP-356Ø43-5 (356043; gat4601 and gm-hra genes), individually or in combination, with the performance of hens fed diets containing nontransgenic maize and soybean meal. Healthy pullets (n = 216) placed in cages (3 hens/cage) were randomly assigned to 9 dietary treatments (8 cages/treatment): nontransgenic controls 1, 2, and 3 (comparable genetic background controls for 98140, 356043, and 98140 + 356043, respectively); reference 1, reference 2, and reference 3 (commercially available nontransgenic maize-soybean meal sources); and 98140 (test 1), 356043 (test 2), and 98140 + 356043 (test 3). The experiment was divided into three 4-wk phases (24 to 28 wk, 28 to 32 wk, and 32 to 36 wk of age), during which time hens were fed mash diets. Performance (BW, feed intake, and egg production) and egg quality data were collected. Data were analyzed using a mixed model ANOVA; differences between the control and respective test group means were considered significant at P < 0.05. Data generated from the reference groups were used only in the estimation of experimental variability and in generating the tolerance interval. Body weight and BW gain, egg production, and production efficiency for hens fed the test diets were similar to the respective values for hens fed the corresponding control diets. Haugh unit measures and egg component weights were similar between the respective test and control groups, and no differences were observed in quality grades or crack measures. All observed values of the control and test groups were within the calculated tolerance intervals. This research indicates that the performance and egg quality of hens fed diets containing 98140 maize grain, 356043 soybean meal, or a combination of the 2 was comparable with that of hens fed diets formulated with nontransgenic maize grain or soybean meal control diets with comparable genetic backgrounds.

  3. Quality-control issues on high-resolution diagnostic monitors.

    PubMed

    Parr, L F; Anderson, A L; Glennon, B K; Fetherston, P

    2001-06-01

    Previous literature indicates a need for more data collection in the area of quality control of high-resolution diagnostic monitors. Throughout acceptance testing, which began in June 2000, stability of monitor calibration was analyzed. Although image quality on all monitors was found to be acceptable upon initial acceptance testing using VeriLUM software by Image Smiths, Inc (Germantown, MD), it was determined to be unacceptable during the clinical phase of acceptance testing. High-resolution monitors were evaluated for quality assurance on a weekly basis from installation through acceptance testing and beyond. During clinical utilization determination (CUD), monitor calibration was identified as a problem and the manufacturer returned and recalibrated all workstations. From that time through final acceptance testing, high-resolution monitor calibration and monitor failure rate remained a problem. The monitor vendor then returned to the site to address these areas. Monitor defocus was still noticeable and calibration checks were increased to three times per week. White and black level drift on medium-resolution monitors had been attributed to raster size settings. Measurements of white and black level at several different size settings were taken to determine the effect of size on white and black level settings. Black level remained steady with size change. White level appeared to increase by 2.0 cd/m2 for every 0.1 inches decrease in horizontal raster size. This was determined not to be the cause of the observed brightness drift. Frequency of calibration/testing is an issue in a clinical environment. The increased frequency required at our site cannot be sustained. The medical physics division cannot provide dedicated personnel to conduct the quality-assurance testing on all monitors at this interval due to other physics commitments throughout the hospital. Monitor access is also an issue due to radiologists' need to read images. Some workstations are in use 7 AM to 11 PM daily. An appropriate monitor calibration frequency must be established during acceptance testing to ensure unacceptable drift is not masked by excessive calibration frequency. Standards for acceptable black level and white level drift also need to be determined. The monitor vendor and hospital staff agree that currently, very small printed text is an acceptable method of determining monitor blur, however, a better method of determining monitor blur is being pursued. Although monitors may show acceptable quality during initial acceptance testing, they need to show sustained quality during the clinical acceptance-testing phase. Defocus, black level, and white level are image quality concerns, which need to be evaluated during the clinical phase of acceptance testing. Image quality deficiencies can have a negative impact on patient care and raise serious medical-legal concerns. The attention to quality control required of the hospital staff needs to be realistic and not have a significant impact on radiology workflow.

  4. Taking advantage of ground data systems attributes to achieve quality results in testing software

    NASA Technical Reports Server (NTRS)

    Sigman, Clayton B.; Koslosky, John T.; Hageman, Barbara H.

    1994-01-01

    During the software development life cycle process, basic testing starts with the development team. At the end of the development process, an acceptance test is performed for the user to ensure that the deliverable is acceptable. Ideally, the delivery is an operational product with zero defects. However, the goal of zero defects is normally not achieved but is successful to various degrees. With the emphasis on building low cost ground support systems while maintaining a quality product, a key element in the test process is simulator capability. This paper reviews the Transportable Payload Operations Control Center (TPOCC) Advanced Spacecraft Simulator (TASS) test tool that is used in the acceptance test process for unmanned satellite operations control centers. The TASS is designed to support the development, test and operational environments of the Goddard Space Flight Center (GSFC) operations control centers. The TASS uses the same basic architecture as the operations control center. This architecture is characterized by its use of distributed processing, industry standards, commercial off-the-shelf (COTS) hardware and software components, and reusable software. The TASS uses much of the same TPOCC architecture and reusable software that the operations control center developer uses. The TASS also makes use of reusable simulator software in the mission specific versions of the TASS. Very little new software needs to be developed, mainly mission specific telemetry communication and command processing software. By taking advantage of the ground data system attributes, successful software reuse for operational systems provides the opportunity to extend the reuse concept into the test area. Consistency in test approach is a major step in achieving quality results.

  5. VERIFYING THE VOC CONTROL PERFORMANCE OF BIOREACTORS

    EPA Science Inventory

    The paper describes the verification testing approach used to collect high-quality, peer-reviewed data on the performance of bioreaction-based technologies for the control of volatile organic compounds (VOCs). The verification protocol that describes the approach for these tests ...

  6. 46 CFR 160.049-5 - Inspections and tests. 1

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-5... maintain quality control of the materials used, manufacturing methods and the finished product so as to... samples and components produced to maintain the quality of the finished product. Records of tests...

  7. 46 CFR 160.049-5 - Inspections and tests. 1

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-5... maintain quality control of the materials used, manufacturing methods and the finished product so as to... samples and components produced to maintain the quality of the finished product. Records of tests...

  8. 46 CFR 160.049-5 - Inspections and tests. 1

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-5... maintain quality control of the materials used, manufacturing methods and the finished product so as to... samples and components produced to maintain the quality of the finished product. Records of tests...

  9. Design, fabrication and test of graphite/polyimide composite joints and attachments for advanced aerospace vehicles

    NASA Technical Reports Server (NTRS)

    1980-01-01

    Principal program activities dealt with the literature survey, design of joint concepts, assessment of GR/PI material quality, fabrication of test panels and specimens, and small specimen testing. Bonded and bolted designs are presented for each of the four major attachment types. Quality control data are presented for prepreg Lots 2W4651 and 3W2020. Preliminary design allowables test results for tension tests and compression tests of laminates are also presented.

  10. External quality assurance for HIV point-of-care testing in Africa: A collaborative country-partner approach to strengthen diagnostic services

    PubMed Central

    2016-01-01

    It is important to consider the role of diagnostics and the critical need for quality diagnostics services in resource-limited settings. Accurate diagnostic tests play a key role in patient management and the prevention and control of most infectious diseases. As countries plan for implementation of HIV early infant diagnosis and viral load point-of-care testing, the London School of Hygiene & Tropical Medicine has worked with countries and partners with an interest in external quality assurance to support quality point-of-care testing on the continent. Through a series of collaborative consultations and workshops, the London School of Hygiene & Tropical Medicine has gathered lessons learned, tools, and resources and developed quality assurance models that will support point-of-care testing. The London School of Hygiene & Tropical Medicine is committed to the continued advancement of laboratory diagnostics in Africa and quality laboratory services and point-of-care testing. PMID:28879132

  11. Low dynamic muscle strength and its associations with fatigue, functional performance, and quality of life in premenopausal patients with systemic lupus erythematosus and low disease activity: a case–control study

    PubMed Central

    2013-01-01

    Background The purpose of the present study was to compare dynamic muscle strength, functional performance, fatigue, and quality of life in premenopausal systemic lupus erythematosus (SLE) patients with low disease activity versus matched-healthy controls and to determine the association of dynamic muscle strength with fatigue, functional performance, and quality of life in SLE patients. Methods We evaluated premenopausal (18–45 years) SLE patients with low disease activity (Systemic lupus erythematosus disease activity index [SLEDAI]: mean 1.5 ± 1.2). The control (n = 25) and patient (n = 25) groups were matched by age, physical characteristics, and the level of physical activities in daily life (International Physical Activity Questionnaire IPAQ). Both groups had not participated in regular exercise programs for at least six months prior to the study. Dynamic muscle strength was assessed by one-repetition maximum (1-RM) tests. Functional performance was assessed by the Timed Up and Go (TUG), in 30-s test a chair stand and arm curl using a 2-kg dumbbell and balance test, handgrip strength and a sit-and-reach flexibility test. Quality of life (SF-36) and fatigue were also measured. Results The SLE patients showed significantly lower dynamic muscle strength in all exercises (leg press 25.63%, leg extension 11.19%, leg curl 15.71%, chest press 18.33%, lat pulldown 13.56%, 1-RM total load 18.12%, P < 0.001-0.02) compared to the controls. The SLE patients also had lower functional performance, greater fatigue and poorer quality of life. In addition, fatigue, SF-36 and functional performance accounted for 52% of the variance in dynamic muscle strength in the SLE patients. Conclusions Premenopausal SLE patients with low disease activity showed lower dynamic muscle strength, along with increased fatigue, reduced functional performance, and poorer quality of life when compared to matched controls. PMID:24011222

  12. Cognition, depression, fatigue, and quality of life in primary Sjögren's syndrome: correlations.

    PubMed

    Koçer, Belgin; Tezcan, Mehmet Engin; Batur, Hale Zeynep; Haznedaroğlu, Şeminur; Göker, Berna; İrkeç, Ceyla; Çetinkaya, Rümeysa

    2016-12-01

    The aim of the present study was to investigate the prevalence and pattern of cognitive dysfunction observed in primary Sjögren's syndrome (PSS) and to examine the relationships between cognitive abilities, depression, fatigue, and quality of life. Thirty-two subjects with PSS were compared with 19 healthy controls on comprehensive neuropsychological, depression, fatigue, health state, and daily-life activities tests. There was low performance in Clock Drawing, COWAT, Paced Auditory Serial Addition Test (PASAT), Colorless Word Reading (Stroop1) and Recognizing Colors (Stroop2) Patterns of STROOP test, SDLT, Auditory-Verbal Learning Test (AVLT), immediate and long-term verbal memory, Benton Judgment of Line Orientation Test (BJLOT), and in all the patterns of RCFT in PSS patients compared to the healthy control group ( p  < .05). It was observed an increased depression frequency and fatigue severity, impairment in health condition, and a decreased quality of life in PSS cases compared to the healthy controls ( p  < .05). All the depression, fatigue severity, and quality of life tests showed a significant positive correlation with each other ( p  < .05). A significant negative correlation between Clock Drawing and SF-36-BP ( p  = .031, r  = -.382) and SF-36-GH ( p  = .027, r  = -.392) was observed. Clock Drawing, PASAT, and AVLT are very useful tests to determine the subclinical and clinical cognitive dysfunction to evaluate attention, information processing speed, executive functions, and short-term and long-term verbal memory in PSS patients. Depression and fatigue may not affect the neuropsychological tests performance.

  13. Characterization of a whole, inactivated influenza (H5N1) vaccine.

    PubMed

    Tada, Yoshikazu

    2008-11-01

    Effective vaccines against the highly pathogenic influenza A/H5N1 virus are being developed worldwide. In Japan, two adjuvanted, inactivated, whole-virion influenza vaccines were recently developed and licensed as mock-up, pre-pandemic vaccine formulations by the Ministry of Health and Labor Welfare of Japan. During the vaccine design and development process, various obstacles were overcome and, in this report, we introduce the non clinical production, immunogenicity data in human and development process that was associated with egg-derived adjuvanted, inactivated, whole-virion influenza A (H5N1) vaccine. Pilot lots of H5N1 vaccine were produced using the avirulent H5N1 reference strain A/Vietnam/1194/2004 (H5N1) NIBRG-14 and administered following adsorption with aluminum hydroxide as an adjuvant. Quality control and formulation stability tests were performed before clinical trials were initiated (phase I-III). The research foundation for microbial diseases of Osaka University (BIKEN) carried out vaccine production, quality control, stability testing and the phase I clinical trial in addition to overseeing the licensing of this vaccine. Mitsubishi Chemical Safety Institute Ltd. carried out the non clinical pharmacological toxicity and safety studies and the Japanese medical association carried out the phase II/III trials. Phase I-III trials took place in 2006. The production processes were well controlled by established tests and validations. Vaccine quality was confirmed by quality control, stability and pre-clinical tests, and the vaccine was approved as a mock-up, pre-pandemic vaccine by the Ministry of Health and Labor Welfare of Japan. Numerous safety and efficacy procedures were carried out prior to the approval of the described vaccine formulation. Some of these procedures were of particular importance e.g., vaccine development, validation, and quality control tests that included strict monitoring of the hemagglutinin (HA) content of the vaccine formulations. Improving vaccine productivity, shortening the production period and improving antigen yield of the avirulent vaccine strains were also considered important vaccine development criteria.

  14. Assessment of non-destructive testing technologies for quality control/quality assurance of asphalt mixtures.

    DOT National Transportation Integrated Search

    2015-03-01

    Asphalt pavements suffer various failures due to insufficient quality within their design lives. The American Association of State : Highway and Transportation Officials (AASHTO) Mechanistic-Empirical Pavement Design Guide (MEPDG) has been proposed :...

  15. Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial

    PubMed Central

    Manfredini, Fabio; Mallamaci, Francesca; D’Arrigo, Graziella; Baggetta, Rossella; Bolignano, Davide; Torino, Claudia; Lamberti, Nicola; Bertoli, Silvio; Ciurlino, Daniele; Rocca-Rey, Lisa; Barillà, Antonio; Battaglia, Yuri; Rapanà, Renato Mario; Zuccalà, Alessandro; Bonanno, Graziella; Fatuzzo, Pasquale; Rapisarda, Francesco; Rastelli, Stefania; Fabrizi, Fabrizio; Messa, Piergiorgio; De Paola, Luciano; Lombardi, Luigi; Cupisti, Adamasco; Fuiano, Giorgio; Lucisano, Gaetano; Summaria, Chiara; Felisatti, Michele; Pozzato, Enrico; Malagoni, Anna Maria; Castellino, Pietro; Aucella, Filippo; Abd ElHafeez, Samar; Provenzano, Pasquale Fabio; Tripepi, Giovanni; Catizone, Luigi

    2017-01-01

    Previous studies have suggested the benefits of physical exercise for patients on dialysis. We conducted the Exercise Introduction to Enhance Performance in Dialysis trial, a 6-month randomized, multicenter trial to test whether a simple, personalized walking exercise program at home, managed by dialysis staff, improves functional status in adult patients on dialysis. The main study outcomes included change in physical performance at 6 months, assessed by the 6-minute walking test and the five times sit-to-stand test, and in quality of life, assessed by the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire. We randomized 296 patients to normal physical activity (control; n=145) or walking exercise (n=151); 227 patients (exercise n=104; control n=123) repeated the 6-month evaluations. The distance covered during the 6-minute walking test improved in the exercise group (mean distance±SD: baseline, 328±96 m; 6 months, 367±113 m) but not in the control group (baseline, 321±107 m; 6 months, 324±116 m; P<0.001 between groups). Similarly, the five times sit-to-stand test time improved in the exercise group (mean time±SD: baseline, 20.5±6.0 seconds; 6 months, 18.2±5.7 seconds) but not in the control group (baseline, 20.9±5.8 seconds; 6 months, 20.2±6.4 seconds; P=0.001 between groups). The cognitive function score (P=0.04) and quality of social interaction score (P=0.01) in the kidney disease component of the KDQOL-SF improved significantly in the exercise arm compared with the control arm. Hence, a simple, personalized, home-based, low-intensity exercise program managed by dialysis staff may improve physical performance and quality of life in patients on dialysis. PMID:27909047

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

    PubMed

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

    2011-09-01

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

  17. Fingerprint test data report: FM 5064J (Kaiser) lots No. 1 (K) - No. 4 (K). [resin matrix composites

    NASA Technical Reports Server (NTRS)

    1986-01-01

    Quality control tests are presented for resin matrix and carbon-carbon composites. Tests performed are filler test, resin test, prepregs test, and fabric test. The test results are presented in chart form.

  18. Effects of an intervention with drinking chamomile tea on sleep quality and depression in sleep disturbed postnatal women: a randomized controlled trial.

    PubMed

    Chang, Shao-Min; Chen, Chung-Hey

    2016-02-01

    The purpose of this study was to evaluate the effects of chamomile tea on sleep quality, fatigue and depression in postpartum women. Sleep quality is a significant issue for postnatal women. Chamomile is widely used as a folk remedy for its presumed sedative-hypnotic effects. A pretest-post-test randomized controlled trial was used. A total of 80 Taiwanese postnatal women with poor sleep quality (Postpartum Sleep Quality Scale; PSQS score ≧16) were recruited from November 2012-August 2013. They were systematically assigned, with a random start, to either the experimental group (n = 40) or the control group (n = 40). The participants in the experimental group were instructed to drink chamomile tea for a period of 2 weeks. The participants in the control group received regular postpartum care only. The PSQS, Edinburgh Postnatal Depression Scale, and Postpartum Fatigue Scale were used to assess outcomes. Two-sample t-tests were used to examine the mean differences in outcome variables between the two groups. Compared with the control group, the experimental group demonstrated significantly lower scores of physical-symptoms-related sleep inefficiency (t = -2·482, P = 0·015) and the symptoms of depression (t = -2·372, P = 0·020). However, the scores for all three instruments were similar for both groups at 4-week post-test, suggesting that the positive effects of chamomile tea were limited to the immediate term. Chamomile tea may be recommended to postpartum women as a supplementary approach to alleviating depression and sleep quality problems. © 2015 John Wiley & Sons Ltd.

  19. [A strategy of constructing the technological system for quality control of Chinese medicine based on process control and management].

    PubMed

    Cheng, Yi-Yu; Qian, Zhong-Zhi; Zhang, Bo-Li

    2017-01-01

    The current situation, bottleneck problems and severe challenges in quality control technology of Chinese Medicine (CM) are briefly described. It is presented to change the phenomenon related to the post-test as the main means and contempt for process control in drug regulation, reverse the situation of neglecting the development of process control and management technology for pharmaceutical manufacture and reconstruct the technological system for quality control of CM products. The regulation and technology system based on process control and management for controlling CM quality should be established to solve weighty realistic problems of CM industry from the root causes, including backwardness of quality control technology, weakness of quality risk control measures, poor reputation of product quality and so on. By this way, the obstacles from poor controllability of CM product quality could be broken. Concentrating on those difficult problems and weak links in the technical field of CM quality control, it is proposed to build CMC (Chemistry, Manufacturing and Controls) regulation for CM products with Chinese characteristics and promote the regulation international recognition as soon as possible. The CMC technical framework, which is clinical efficacy-oriented, manufacturing manner-centered and process control-focused, was designed. To address the clinical characteristics of traditional Chinese medicine (TCM) and the production feature of CM manufacture, it is suggested to establish quality control engineering for CM manufacturing by integrating pharmaceutical analysis, TCM chemistry, TCM pharmacology, pharmaceutical engineering, control engineering, management engineering and other disciplines. Further, a theoretical model of quality control engineering for CM manufacturing and the methodology of digital pharmaceutical engineering are proposed. A technology pathway for promoting CM standard and realizing the strategic goal of CM internationalization is elaborated. Copyright© by the Chinese Pharmaceutical Association.

  20. Telecommunications Systems Career Ladder, AFSC 307XO.

    DTIC Science & Technology

    1981-01-01

    standard test tone levels perform impulse noise tests make in-service or out-of- service quality check.s on composite signal transmission levels Even...service or out-of- service quality control (QC) reports maintain trouble and restoration record forms (DD Form 1443) direct circuit or system checks...include: perform fault isolation on analog circuits make in-service or out-of- service quality checks on voice frequency carrier telegraph (VFCT) terminals

  1. 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...

  2. Randomised controlled trial of the effectiveness of using foot reflexology to improve quality of sleep amongst Taiwanese postpartum women.

    PubMed

    Li, Chia-Yen; Chen, Su-Chiu; Li, Chung-Yi; Gau, Meei-Ling; Huang, Chiu-Mieh

    2011-04-01

    to examine the effectiveness of using foot reflexology to improve sleep quality in postpartum women. randomised controlled trial, conducted at two postpartum centres in northern Taiwan. 65 postpartum women reporting poor quality of sleep were recruited from July 2007 to December 2007. participants were assigned randomly to either an intervention or a control group. Participants in both groups received the same care except for reflexology therapy. The intervention group received a single 30-minute foot reflexology session at the same time each evening for five consecutive days. Sessions were administered by a certified nurse reflexologist. MEASURES AND FINDINGS: the outcome measure was the Pittsburgh sleep quality index (PSQI), and this was performed at baseline and post test. Mean PQSI scores for both groups declined over time between baseline and post test. Using a generalised estimation equation to control several confounding variables, the changes in mean PSQI were found to be significantly lower in the intervention group (β=-2.24, standard error=0.38, p<0.001) than in the control group. an intervention involving foot reflexology in the postnatal period significantly improved the quality of sleep. midwives should evaluate maternal sleep quality and design early intervention programmes to improve quality of sleep in order to increase maternal biopsychosocial well-being. Midwives interested in complementary therapies should be encouraged to obtain training in reflexology and to apply it in clinical settings if it is allowed. Copyright © 2009 Elsevier Ltd. All rights reserved.

  3. Development of an advanced pitch active control system for a wide body jet aircraft

    NASA Technical Reports Server (NTRS)

    Guinn, Wiley A.; Rising, Jerry J.; Davis, Walt J.

    1984-01-01

    An advanced PACS control law was developed for a commercial wide-body transport (Lockheed L-1011) by using modern control theory. Validity of the control law was demonstrated by piloted flight simulation tests on the NASA Langley visual motion simulator. The PACS design objective was to develop a PACS that would provide good flying qualities to negative 10 percent static stability margins that were equivalent to those of the baseline aircraft at a 15 percent static stability margin which is normal for the L-1011. Also, the PACS was to compensate for high-Mach/high-g instabilities that degrade flying qualities during upset recoveries and maneuvers. The piloted flight simulation tests showed that the PACS met the design objectives. The simulation demonstrated good flying qualities to negative 20 percent static stability margins for hold, cruise and high-speed flight conditions. Analysis and wind tunnel tests performed on other Lockheed programs indicate that the PACS could be used on an advanced transport configuration to provide a 4 percent fuel savings which results from reduced trim drag by flying at negative static stability margins.

  4. Quality, and not just quantity, of education accounts for differences in psychometric performance between african americans and white non-hispanics with Alzheimer's disease.

    PubMed

    Chin, Alexander L; Negash, Selam; Xie, Sharon; Arnold, Steven E; Hamilton, Roy

    2012-03-01

    The effect of race on cognitive test performance in the evaluation of Alzheimer's disease (AD) remains controversial. One factor that may contribute substantially to differences in cognitive test performance in diverse populations is education. The current study examined the extent to which quality of education, even after controlling for formal years of education, accounts for differences in cognitive performance between African Americans and White Non-Hispanics (WNHs). The retrospective cohort included 244 patients diagnosed with AD who self-identified as African Americans (n = 51) or WNHs (n = 193). The Wechsler Test of Adult Reading (WTAR) was used as an estimate of quality of education. In an analysis that controlled for traditional demographics, including age, sex, and years of formal education, African Americans scored significantly lower than WNHs on the Mini-Mental State Examination, as well as on neuropsychological tests of memory, attention, and language. However, after also adjusting for reading level, all previously observed differences were significantly attenuated. The attenuating effect remained even after controlling for disease severity, indicating that reading scores are not confounded by severity of dementia. These findings suggest that quality, and not just quantity, of education needs to be taken into account when assessing cognitive performance in African Americans with AD.

  5. Flight test experience with high-alpha control system techniques on the F-14 airplane

    NASA Technical Reports Server (NTRS)

    Gera, J.; Wilson, R. J.; Enevoldson, E. K.; Nguyen, L. T.

    1981-01-01

    Improved handling qualities of fighter aircraft at high angles of attack can be provided by various stability and control augmentation techniques. NASA and the U.S. Navy are conducting a joint flight demonstration of these techniques on an F-14 airplane. This paper reports on the flight test experience with a newly designed lateral-directional control system which suppresses such high angle of attack handling qualities problems as roll reversal, wing rock, and directional divergence while simultaneously improving departure/spin resistance. The technique of integrating a piloted simulation into the flight program was used extensively in this program. This technique had not been applied previously to high angle of attack testing and required the development of a valid model to simulate the test airplane at extremely high angles of attack.

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

    PubMed

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

    2013-01-01

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

  7. Radiation protection program for early detection of breast cancer in a mammography facility

    NASA Astrophysics Data System (ADS)

    Villagomez Casimiro, Mariana; Ruiz Trejo, Cesar; Espejo Fonseca, Ruby

    2014-11-01

    Mammography is the best tool for early detection of Breast Cancer. In this diagnostic radiology modality it is necessary to establish the criteria to ensure the proper use and operation of the equipment used to obtain mammographic images in order to contribute to the safe use of ionizing radiation. The aim of the work was to implement at FUCAM-AC the radiation protection program which must be established for patients and radiation workers according to Mexican standards [1-4]. To achieve this goal, radiation protection and quality control manuals were elaborated [5]. Furthermore, a quality control program (QCP) in the mammography systems (analog/digital), darkroom included, has been implemented. Daily sensitometry, non-variability of the image quality, visualizing artifacts, revision of the equipment mechanical stability, compression force and analysis of repetition studies are some of the QCP routine tests that must be performed by radiological technicians of this institution as a set of actions to ensure the protection of patients. Image quality and patients dose assessment were performed on 4 analog equipment installed in 2 mobile units. In relation to dose assessment, all equipment passed the acceptance criteria (<3 mGy per projection). The image quality test showed that most images (70%)- presented artifacts. A brief summary of the results of quality control tests applied to the equipment and film processor are presented. To maintain an adequate level of quality and safety at FUCAM-AC is necessary that the proposed radiation protection program in this work is applied.

  8. 7 CFR 58.336 - Frequency of sampling for quality control of cream, butter and related products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... or modified Kohman test may be used. (c) Chemical—(1) Acid degree value. This test should be made on... lipase activity. (2) Free fatty acid. This test should be made on churnings or batches from samples taken... temperature of 72 °F. to establish and maintain a satisfactory keeping quality history. Optionally 98 °F. for...

  9. 7 CFR 58.336 - Frequency of sampling for quality control of cream, butter and related products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... or modified Kohman test may be used. (c) Chemical—(1) Acid degree value. This test should be made on... lipase activity. (2) Free fatty acid. This test should be made on churnings or batches from samples taken... temperature of 72 °F. to establish and maintain a satisfactory keeping quality history. Optionally 98 °F. for...

  10. 7 CFR 58.336 - Frequency of sampling for quality control of cream, butter and related products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... or modified Kohman test may be used. (c) Chemical—(1) Acid degree value. This test should be made on... lipase activity. (2) Free fatty acid. This test should be made on churnings or batches from samples taken... temperature of 72 °F. to establish and maintain a satisfactory keeping quality history. Optionally 98 °F. for...

  11. 7 CFR 58.336 - Frequency of sampling for quality control of cream, butter and related products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... or modified Kohman test may be used. (c) Chemical—(1) Acid degree value. This test should be made on... lipase activity. (2) Free fatty acid. This test should be made on churnings or batches from samples taken... temperature of 72 °F. to establish and maintain a satisfactory keeping quality history. Optionally 98 °F. for...

  12. Assessment of average of normals (AON) procedure for outlier-free datasets including qualitative values below limit of detection (LoD): an application within tumor markers such as CA 15-3, CA 125, and CA 19-9.

    PubMed

    Usta, Murat; Aral, Hale; Mete Çilingirtürk, Ahmet; Kural, Alev; Topaç, Ibrahim; Semerci, Tuna; Hicri Köseoğlu, Mehmet

    2016-11-01

    Average of normals (AON) is a quality control procedure that is sensitive only to systematic errors that can occur in an analytical process in which patient test results are used. The aim of this study was to develop an alternative model in order to apply the AON quality control procedure to datasets that include qualitative values below limit of detection (LoD). The reported patient test results for tumor markers, such as CA 15-3, CA 125, and CA 19-9, analyzed by two instruments, were retrieved from the information system over a period of 5 months, using the calibrator and control materials with the same lot numbers. The median as a measure of central tendency and the median absolute deviation (MAD) as a measure of dispersion were used for the complementary model of AON quality control procedure. The u bias values, which were determined for the bias component of the measurement uncertainty, were partially linked to the percentages of the daily median values of the test results that fall within the control limits. The results for these tumor markers, in which lower limits of reference intervals are not medically important for clinical diagnosis and management, showed that the AON quality control procedure, using the MAD around the median, can be applied for datasets including qualitative values below LoD.

  13. Child oral health-related quality of life and early childhood caries: a non-inferiority randomized control trial.

    PubMed

    Arrow, P; Klobas, E

    2016-06-01

    The aim of this study was to compare changes in child oral health-related quality of life (COHRQoL) after treatment for early childhood caries (ECC) using two alternative treatment approaches. A randomized control trial with random allocation of parent/child dyads with ECC to test (minimum intervention) or control (standard care). Participating parents completed the Early Childhood Oral Health Impact Scale (ECOHIS) at baseline and follow-up. Changes in ECOHIS scores and extent of COHRQoL impacts between and within groups were tested using the chi-squared statistic for groups, Wilcoxon's rank-sum test, and matched-pairs signed-rank test. Two hundred and fifty-four children were randomized (test = 127; control = 127). At baseline, mean ECOHIS score 11.1, sd 8.2; mean age = 3.8 years, sd 0.90; mean dmft = 4.9, sd 4.0; and 59% male. After a mean interval of 11.4 months, 210 children were followed-up and returned a completed questionnaire (test = 111; control = 99). There was no significant difference in COHRQoL changes between test and control. For all the children combined, there were significantly fewer impacts at follow-up in the child and family domains and the total ECOHIS, Wilcoxon signed-rank test, p < 0.05. COHRQoL improved with primary dental care for ECC, and there was no statistically significant difference between test and control in the extent of the improvement. © 2016 Australian Dental Association.

  14. [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.

  15. Audit and internal quality control in immunohistochemistry

    PubMed Central

    Maxwell, P; McCluggage, W

    2000-01-01

    Aims—Although positive and negative controls are performed and checked in surgical pathology cases undergoing immunohistochemistry, internal quality control procedures for immunohistochemistry are not well described. This study, comprising a retrospective audit, aims to describe a method of internal quality control for immunohistochemistry. A scoring system that allows comparison between cases is described. Methods—Two positive tissue controls for each month over a three year period (1996–1998) of the 10 antibodies used most frequently were evaluated. All test cases undergoing immunohistochemistry in the months of April in this three year period were also studied. When the test case was completely negative for a given antibody, the corresponding positive tissue control from that day was examined. A marking system was devised whereby each immunohistochemical slide was assessed out of a possible score of 8 to take account of staining intensity, uniformity, specificity, background, and counterstaining. Using this scoring system, cases were classified as showing optimal (7–8), borderline (5–6), or unacceptable (0–4) staining. Results—Most positive tissue controls showed either optimal or borderline staining with the exception of neurone specific enolase (NSE), where most slides were unacceptable or borderline as a result of a combination of low intensity, poor specificity, and excessive background staining. All test cases showed either optimal or borderline staining with the exception of a single case stained for NSE, which was unacceptable. Conclusions—This retrospective audit shows that immunohistochemically stained slides can be assessed using this scoring system. With most antibodies, acceptable staining was achieved in most cases. However, there were problems with staining for NSE, which needs to be reviewed. Laboratories should use a system such as this to evaluate which antibodies regularly result in poor staining so that they can be excluded from panels. Routine evaluation of immunohistochemical staining should become part of everyday internal quality control procedures. Key Words: immunohistochemistry • audit • internal quality control PMID:11265178

  16. Effect of yoga therapy on anxiety and depressive symptoms and quality-of-life among caregivers of in-patients with neurological disorders at a tertiary care center in India: A randomized controlled trial.

    PubMed

    Umadevi, P; Ramachandra; Varambally, S; Philip, M; Gangadhar, B N

    2013-07-01

    The concerns of caregivers of patients with neurological disorders have been a felt need for a long time, with many of them experiencing significant psychiatric morbidity. This study aimed to find the effect of yoga in reducing anxiety and depression, as well as improving quality-of-life in caregivers of patients with neurological disorders. The study was conducted using a randomized controlled design, with yoga intervention and waitlisted controls. SIXTY CONSENTING CAREGIVERS OF INPATIENTS IN NEUROLOGY WARDS WERE RANDOMIZED INTO TWO GROUPS: Yoga and control. Demographic variables except years of education and length of caretaking were comparable in the two groups, as also baseline scores of anxiety, depression and quality-of-life. A specific yoga module comprising yogāsanas, prāṇāyāma, and chanting was taught to the participants in the yoga group by the researcher. At follow-up 43 patients (yoga n=20 and control group n=23) were available. Two-way repeated measures analysis of variance was used to test the change from pre-test to post-test scores within and between groups. Analysis of covariance was performed to compare the post-test scores between the groups adjusting for education and length of caretaking. Following one month intervention of yoga therapy, there was a significant (P<0.001) decrease in anxiety and depression scores, as well as improved quality-of-life among the participants in the yoga group as compared with the control group. This study highlights the usefulness of a yoga intervention for caregivers of inpatients with neurological problems. The small sample size and lack of blinding were some of the limitations of this study.

  17. Effect of Group Positive Psychotherapy on Improvement of Life Satisfaction and The Quality of Life in Infertile Woman.

    PubMed

    Seyedi Asl, Seyed Teymur; Sadeghi, Kheirollah; Bakhtiari, Mitra; Ahmadi, Seyed Mojtaba; Nazari Anamagh, Alireza; Khayatan, Tayebeh

    2016-01-01

    Positive psychotherapy is one of the new approaches in psychology which is innovated for treating psychological disorders and enhancing positive emotions. The aim of this study is to investigate the effectiveness of the group positive psychotherapy on elevation of life satisfaction and quality of life in infertile women. In a randomized trial study, Beck Depression Inventory II (BDI-II) and clinical interview were used in a pre-test post-test control group design. After analyzing the result of the questionnaire, 36 infertile women who showed signs of mild to moderate depression were randomly placed into two following groups: control (n=18) and intervention (n=18). Before the treatment, the members of both groups answered BDI-II, Satisfaction With Life Scale (SWLS) and 12 item Short Form Health Survey (SF-12). The intervention group received six sessions of group positive psychotherapy, but the treatment of the control group began six weeks after the intervention group. The results showed that the life satisfaction scores of the intervention group were significantly elevated from 22.66 in pre-test to 26.13 in post-test (P<0.001), while this improvement was not significant in the control group (P=0.405). The difference between life satisfaction scores of the intervention and the control groups was also significant (F=8.92, P=0.006). However, no significant change in the quality of life level of the intervention and control groups was observed (P=0.136). Thus it can be deduced from the findings that this treatment method could be introduced as solution to increase the life satisfaction in infertile women, but not as a treatment for elevating their quality of life (Registration Number: IRCT2013042810063N3).

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

    Malkoske, Kyle; Nielsen, Michelle; Brown, Erika

    The Canadian Partnership for Quality Radiotherapy (CPQR) and the Canadian Organization of Medical Physicist’s (COMP) Quality Assurance and Radiation Safety Advisory Committee (QARSAC) have worked together in the development of a suite of Technical Quality Control (TQC) Guidelines for radiation treatment equipment and technologies, that outline specific performance objectives and criteria that equipment should meet in order to assure an acceptable level of radiation treatment quality. Early community engagement and uptake survey data showed 70% of Canadian centers are part of this process and that the data in the guideline documents reflect, and are influencing the way Canadian radiation treatmentmore » centres run their technical quality control programs. As the TQC development framework matured as a cross-country initiative, guidance documents have been developed in many clinical technologies. Recently, there have been new TQC documents initiated for Gamma Knife and Cyberknife technologies where the entire communities within Canada are involved in the review process. At the same time, QARSAC reviewed the suite as a whole for the first time and it was found that some tests and tolerances overlapped across multiple documents as single tests could pertain to multiple quality control areas. The work to streamline the entire suite has allowed for improved usability of the suite while keeping the integrity of single quality control areas. The suite will be published by the JACMP, in the coming year.« less

  19. Quality control of FWC during assembly and commissioning in SST-1 Tokamak

    NASA Astrophysics Data System (ADS)

    Patel, Hitesh; Santra, Prosenjit; Parekh, Tejas; Biswas, Prabal; Jayswal, Snehal; Chauhan, Pradeep; Paravastu, Yuvakiran; George, Siju; Semwal, Pratibha; Thankey, Prashant; Ramesh, Gattu; Prakash, Arun; Dhanani, Kalpesh; Raval, D. C.; Khan, Ziauddin; Pradhan, Subrata

    2017-04-01

    First Wall Components (FWC) of SST-1 tokamak, which are in the immediate vicinity of plasma, comprises of limiters, divertors, baffles, passive stabilizers designed to operate long duration (∼1000 s) discharges of elongated plasma. All FWC consist of copper alloy heat sink modules with SS cooling tubes brazed onto it, graphite tiles acting as armour material facing the plasma, and are mounted to the vacuum vessels with suitable Inconel support structures at inter-connected ring & port locations. The FWC are very recently assembled and commissioned successfully inside the vacuum vessel of SST-1 undergoing a rigorous quality control and checks at every stage of the assembly process. This paper will present the quality control aspects and checks of FWC from commencement of assembly procedure, namely material test reports, leak testing of high temperature baked components, assembled dimensional tolerances, leak testing of all welded joints, graphite tile tightening torques, electrical continuity and electrical isolation of passive stabilizers from vacuum vessel, baking and cooling hydraulic connections inside vacuum vessel.

  20. Sigma metrics used to assess analytical quality of clinical chemistry assays: importance of the allowable total error (TEa) target.

    PubMed

    Hens, Koen; Berth, Mario; Armbruster, Dave; Westgard, Sten

    2014-07-01

    Six Sigma metrics were used to assess the analytical quality of automated clinical chemistry and immunoassay tests in a large Belgian clinical laboratory and to explore the importance of the source used for estimation of the allowable total error. Clinical laboratories are continually challenged to maintain analytical quality. However, it is difficult to measure assay quality objectively and quantitatively. The Sigma metric is a single number that estimates quality based on the traditional parameters used in the clinical laboratory: allowable total error (TEa), precision and bias. In this study, Sigma metrics were calculated for 41 clinical chemistry assays for serum and urine on five ARCHITECT c16000 chemistry analyzers. Controls at two analyte concentrations were tested and Sigma metrics were calculated using three different TEa targets (Ricos biological variability, CLIA, and RiliBÄK). Sigma metrics varied with analyte concentration, the TEa target, and between/among analyzers. Sigma values identified those assays that are analytically robust and require minimal quality control rules and those that exhibit more variability and require more complex rules. The analyzer to analyzer variability was assessed on the basis of Sigma metrics. Six Sigma is a more efficient way to control quality, but the lack of TEa targets for many analytes and the sometimes inconsistent TEa targets from different sources are important variables for the interpretation and the application of Sigma metrics in a routine clinical laboratory. Sigma metrics are a valuable means of comparing the analytical quality of two or more analyzers to ensure the comparability of patient test results.

  1. Effect of Connective Tissue Manipulation on Symptoms and Quality of Life in Patients With Chronic Constipation: A Randomized Controlled Trial.

    PubMed

    Gürsen, Ceren; Kerem Günel, Mintaze; Kaya, Serap; Kav, Taylan; Akbayrak, Türkan

    2015-06-01

    The purpose of this study was to examine the effects of connective tissue manipulation (CTM) on the severity of constipation and health-related quality of life in individuals diagnosed with chronic constipation. Fifty patients with a diagnosis of chronic constipation according to Rome III criteria were recruited and randomized to an intervention (n = 25) or control group (n = 25). The intervention group received CTM in addition to the lifestyle advice, whereas the control group was given only lifestyle advice for constipation. All assessments were performed at baseline and at the end of 4 weeks. The primary outcome measure was the Constipation Severity Instrument. Secondary outcomes included Patient Assessment of Constipation Quality of Life Questionnaire, Bristol Stool Scale, and 7-day bowel diary. Differences between groups were analyzed with t tests, Mann-Whitney U test and χ(2) test. Compared with the control group, subjects in the intervention group reported significantly greater improvement in total and subscale scores of the Constipation Severity Instrument and Patient Assessment of Constipation Quality of Life Questionnaire (P < .05). Based on the results from bowel diaries, the improvements in the number of bowel movements, duration of defecation, stool consistency, and the feeling of incomplete evacuation in the intervention group were also significantly more than the control group (P < .05). This study showed that CTM and lifestyle advice were superior to reducing symptoms of constipation and quality of life compared with lifestyle advice alone for patients with chronic constipation. Copyright © 2015 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

  2. Quality control algorithms for rainfall measurements

    NASA Astrophysics Data System (ADS)

    Golz, Claudia; Einfalt, Thomas; Gabella, Marco; Germann, Urs

    2005-09-01

    One of the basic requirements for a scientific use of rain data from raingauges, ground and space radars is data quality control. Rain data could be used more intensively in many fields of activity (meteorology, hydrology, etc.), if the achievable data quality could be improved. This depends on the available data quality delivered by the measuring devices and the data quality enhancement procedures. To get an overview of the existing algorithms a literature review and literature pool have been produced. The diverse algorithms have been evaluated to meet VOLTAIRE objectives and sorted in different groups. To test the chosen algorithms an algorithm pool has been established, where the software is collected. A large part of this work presented here is implemented in the scope of the EU-project VOLTAIRE ( Validati on of mu ltisensors precipit ation fields and numerical modeling in Mediter ran ean test sites).

  3. Development of concrete QC/QA specifications for highway construction in Kentucky.

    DOT National Transportation Integrated Search

    2001-08-01

    There is a growing trend toward quality-based specifications in highway construction. A large number of quality control/quality assurance (QC/QA) specifications shift the responsibility of day-to-day testing from the state DOH to the contractor. This...

  4. 75 FR 6597 - Determination to Approve Alternative Final Cover Request for the Lake County, MT Landfill...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-10

    ... layer, a 24-inch native sand layer, an 18-inch imported silt evapotranspiration layer, and a 6-inch... Quality Assurance & Control Plan'' for the closure project that specifies that testing will be performed... described in detail in the ``Construction Quality Assurance & Control Plan.'' II. EPA's Action A...

  5. Automated quality control in a file-based broadcasting workflow

    NASA Astrophysics Data System (ADS)

    Zhang, Lina

    2014-04-01

    Benefit from the development of information and internet technologies, television broadcasting is transforming from inefficient tape-based production and distribution to integrated file-based workflows. However, no matter how many changes have took place, successful broadcasting still depends on the ability to deliver a consistent high quality signal to the audiences. After the transition from tape to file, traditional methods of manual quality control (QC) become inadequate, subjective, and inefficient. Based on China Central Television's full file-based workflow in the new site, this paper introduces an automated quality control test system for accurate detection of hidden troubles in media contents. It discusses the system framework and workflow control when the automated QC is added. It puts forward a QC criterion and brings forth a QC software followed this criterion. It also does some experiments on QC speed by adopting parallel processing and distributed computing. The performance of the test system shows that the adoption of automated QC can make the production effective and efficient, and help the station to achieve a competitive advantage in the media market.

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

    PubMed

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

    2007-05-01

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

  7. Applying Sigma Metrics to Reduce Outliers.

    PubMed

    Litten, Joseph

    2017-03-01

    Sigma metrics can be used to predict assay quality, allowing easy comparison of instrument quality and predicting which tests will require minimal quality control (QC) rules to monitor the performance of the method. A Six Sigma QC program can result in fewer controls and fewer QC failures for methods with a sigma metric of 5 or better. The higher the number of methods with a sigma metric of 5 or better, the lower the costs for reagents, supplies, and control material required to monitor the performance of the methods. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Mirror therapy for patients with severe arm paresis after stroke--a randomized controlled trial.

    PubMed

    Thieme, Holm; Bayn, Maria; Wurg, Marco; Zange, Christian; Pohl, Marcus; Behrens, Johann

    2013-04-01

    To evaluate the effects of individual or group mirror therapy on sensorimotor function, activities of daily living, quality of life and visuospatial neglect in patients with a severe arm paresis after stroke. Randomized controlled trial. Inpatient rehabilitation centre. Sixty patients with a severe paresis of the arm within three months after stroke. Three groups: (1) individual mirror therapy, (2) group mirror therapy and (3) control intervention with restricted view on the affected arm. Motor function on impairment (Fugl-Meyer Test) and activity level (Action Research Arm Test), independence in activities of daily living (Barthel Index), quality of life (Stroke Impact Scale) and visuospatial neglect (Star Cancellation Test). After five weeks, no significant group differences for motor function were found (P > 0.05). Pre-post differences for the Action Research Arm Test and Fugl-Meyer Test: individual mirror therapy: 3.4 (7.1) and 3.2 (3.8), group mirror therapy: 1.1 (3.1) and 5.1 (10.0) and control therapy: 2.8 (6.7) and 5.2 (8.7). However, a significant effect on visuospatial neglect for patients in the individual mirror therapy compared to control group could be shown (P < 0.01). Furthermore, it was possible to integrate a mirror therapy group intervention for severely affected patients after stroke. This study showed no effect on sensorimotor function of the arm, activities of daily living and quality of life of mirror therapy compared to a control intervention after stroke. However, a positive effect on visuospatial neglect was indicated.

  9. Results from 15years of quality surveillance for a National Indigenous Point-of-Care Testing Program for diabetes.

    PubMed

    Shephard, Mark; Shephard, Anne; McAteer, Bridgit; Regnier, Tamika; Barancek, Kristina

    2017-12-01

    Diabetes is a major health problem for Australia's Aboriginal and Torres Strait Islander peoples. Point-of-care testing for haemoglobin A1c (HbA1c) has been the cornerstone of a long-standing program (QAAMS) to manage glycaemic control in Indigenous people with diabetes and recently, to diagnose diabetes. The QAAMS quality management framework includes monthly testing of quality control (QC) and external quality assurance (EQA) samples. Key performance indicators of quality include imprecision (coefficient of variation [CV%]) and percentage acceptable results. This paper reports on the past 15years of quality testing in QAAMS and examines the performance of HbA1c POC testing at the 6.5% cut-off recommended for diagnosis. The total number of HbA1c EQA results submitted from 2002 to 2016 was 29,093. The median imprecision for EQA testing by QAAMS device operators averaged 2.81% (SD 0.50; range 2.2 to 3.9%) from 2002 to 2016 and 2.44% (SD 0.22; range 2.2 to 2.9%) from 2009 to 2016. No significant difference was observed between the median imprecision achieved in QAAMS and by Australasian laboratories from 2002 to 2016 (p=0.05; two-tailed paired t-test) and from 2009 to 2016 (p=0.17; two-tailed paired t-test). For QC testing from 2009 to 2016, imprecision averaged 2.5% and 3.0% for the two levels of QC tested. Percentage acceptable results averaged 90% for QA testing from 2002 to 2016 and 96% for QC testing from 2009 to 2016. The DCA Vantage was able to measure a patient and an EQA sample with an HbA1c value close to 6.5% both accurately and precisely. HbA1c POC testing in QAAMS has remained analytically sound, matched the quality achieved by Australasian laboratories and met profession-derived analytical goals for 15years. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  10. [Strategies and development of quality assurance and control in the ELSA-Brasil].

    PubMed

    Schmidt, Maria Inês; Griep, Rosane Härter; Passos, Valéria Maria; Luft, Vivian Cristine; Goulart, Alessandra Carvalho; Menezes, Greice Maria de Souza; Molina, Maria del Carmen Bisi; Vigo, Alvaro; Nunes, Maria Angélica

    2013-06-01

    The ELSA-Brasil (Estudo Longitudinal de Saúde do Adulto - Brazilian Longitudinal Study for Adult Health) is a cohort study composed of 15,105 adults followed up in order to assess the development of chronic diseases, especially diabetes and cardiovascular disease. Its size, multicenter nature and the diversity of measurements required effective and efficient mechanisms of quality assurance and control. The main quality assurance activities (those developed before data collection) were: careful selection of research instruments, centralized training and certification, pretesting and pilot studies, and preparation of operation manuals for the procedures. Quality control activities (developed during data collection and processing) were performed more intensively at the beginning, when routines had not been established yet. The main quality control activities were: periodic observation of technicians, test-retest studies, data monitoring, network of supervisors, and cross visits. Data that estimate the reliability of the obtained information attest that the quality goals have been achieved.

  11. Benchmarking to the world's best in mathematics. Quality control in curriculum and instruction among the top performers in the TIMSS.

    PubMed

    Phelps, R P

    2001-08-01

    This article describes the education quality control systems (for mathematics) used by those countries that performed best on the Third International Mathematics and Science Study (TIMSS). Enforced quality control measures are defined as "decision points"--where adherence to the curriculum and instruction system can be reinforced. Most decision points involve stakes for the student, teacher, or school. They involve potential consequences for failure to adhere to the system and to follow the program at a reasonable pace. Generally, countries with more decision points perform better on the TIMSS. When the number of decision points and TIMSS test scores are adjusted for country wealth, the relationship between the degree of (enforced) quality control and student achievement appears to be positive and exponential. The more (enforced) quality control measures employed in an education system, the greater is students' academic achievement.

  12. An embedded barcode for "connected" malaria rapid diagnostic tests.

    PubMed

    Scherr, Thomas F; Gupta, Sparsh; Wright, David W; Haselton, Frederick R

    2017-03-29

    Many countries are shifting their efforts from malaria control to disease elimination. New technologies will be necessary to meet the more stringent demands of elimination campaigns, including improved quality control of malaria diagnostic tests, as well as an improved means for communicating test results among field healthcare workers, test manufacturers, and national ministries of health. In this report, we describe and evaluate an embedded barcode within standard rapid diagnostic tests as one potential solution. This information-augmented diagnostic test operates on the familiar principles of traditional lateral flow assays and simply replaces the control line with a control grid patterned in the shape of a QR (quick response) code. After the test is processed, the QR code appears on both positive or negative tests. In this report we demonstrate how this multipurpose code can be used not only to fulfill the control line role of test validation, but also to embed test manufacturing details, serve as a trigger for image capture, enable registration for image analysis, and correct for lighting effects. An accompanying mobile phone application automatically captures an image of the test when the QR code is recognized, decodes the QR code, performs image processing to determine the concentration of the malarial biomarker histidine-rich protein 2 at the test line, and transmits the test results and QR code payload to a secure web portal. This approach blends automated, sub-nanomolar biomarker detection, with near real-time reporting to provide quality assurance data that will help to achieve malaria elimination.

  13. A cost-constrained model of strategic service quality emphasis in nursing homes.

    PubMed

    Davis, M A; Provan, K G

    1996-02-01

    This study employed structural equation modeling to test the relationship between three aspects of the environmental context of nursing homes; Medicaid dependence, ownership status, and market demand, and two basic strategic orientations: low cost and differentiation based on service quality emphasis. Hypotheses were proposed and tested against data collected from a sample of nursing homes operating in a single state. Because of the overwhelming importance of cost control in the nursing home industry, a cost constrained strategy perspective was supported. Specifically, while the three contextual variables had no direct effect on service quality emphasis, the entire model was supported when cost control orientation was introduced as a mediating variable.

  14. Fingerprint test data report: FM 5834 test lots No. 1, 3, 4, and 5. [resin matrix composites

    NASA Technical Reports Server (NTRS)

    1986-01-01

    Quality control testing is presented for various lots of resin matrix composites. The tests conducted were filler test, resin test, fabric test, and prepreg test for lots 1, 3, 4, and 5. The results of the tests are presented in chart forms.

  15. Interaction of feel system and flight control system dynamics on lateral flying qualities

    NASA Technical Reports Server (NTRS)

    Bailey, Randall E.; Powers, Bruce G.; Shafer, Mary F.

    1988-01-01

    An investigation of feel system and flight control system dynamics on lateral flying qualities was conducted using the variable stability USAF NT-33 aircraft. Experimental variations in feel system natural frequency, force-deflection gradient, control system command architecture type, flight control system filter frequency, and control system delay were made. The experiment data include pilot ratings using the Cooper-Harper (1969) rating scale, pilot comments, and tracking performance statistic. Three test pilots served as evaluators. The data indicate that as the feel system natural frequency is reduced lateral flying qualities degrade. At the slowest feel system frequency, the closed-loop response becomes nonlinear with a 'bobweight' effect apparent in the feel system. Feel system influences were essentially independent of the control system architecture. The flying qualities influence due to the feel system was different than when the identical dynamic systenm was used as a flight control system element.

  16. Spatial regression test for ensuring temperature data quality in southern Spain

    NASA Astrophysics Data System (ADS)

    Estévez, J.; Gavilán, P.; García-Marín, A. P.

    2018-01-01

    Quality assurance of meteorological data is crucial for ensuring the reliability of applications and models that use such data as input variables, especially in the field of environmental sciences. Spatial validation of meteorological data is based on the application of quality control procedures using data from neighbouring stations to assess the validity of data from a candidate station (the station of interest). These kinds of tests, which are referred to in the literature as spatial consistency tests, take data from neighbouring stations in order to estimate the corresponding measurement at the candidate station. These estimations can be made by weighting values according to the distance between the stations or to the coefficient of correlation, among other methods. The test applied in this study relies on statistical decision-making and uses a weighting based on the standard error of the estimate. This paper summarizes the results of the application of this test to maximum, minimum and mean temperature data from the Agroclimatic Information Network of Andalusia (southern Spain). This quality control procedure includes a decision based on a factor f, the fraction of potential outliers for each station across the region. Using GIS techniques, the geographic distribution of the errors detected has been also analysed. Finally, the performance of the test was assessed by evaluating its effectiveness in detecting known errors.

  17. 21 CFR 862.1660 - Quality control material (assayed and unassayed).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry... control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations...

  18. 21 CFR 862.1660 - Quality control material (assayed and unassayed).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry... control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations...

  19. 21 CFR 862.1660 - Quality control material (assayed and unassayed).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry... control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations...

  20. Impact of Mother-Daughter Relationship on Hypertension Self-management and Quality of Life: Testing Dyadic Dynamics Using the Actor-Partner Interdependence Model.

    PubMed

    Shawler, Celeste; Edward, Jean; Ling, Jiying; Crawford, Tim N; Rayens, Mary Kay

    Although hypertension (HTN) treatment rates are similar across age groups of women, effective control is significantly worse among older women. Only 20% of hypertensive women aged 70 to 79 years have controlled blood pressure. The purpose of this longitudinal study was to test the effects of the quality of mother-daughter relationship, inner strength, and control on HTN self-management and health-related quality of life (HRQOL) for both members of the dyad at 6 months. The Actor-Partner Interdependence Model was used to examine the direct ("actor") and indirect ("partner") effects of 46 dyads. The mothers' perceived relationship quality with daughters directly impacted their own self-management of HTN and HRQOL while also indirectly affecting their daughters' self-management. Similarly, the daughters' perceived strength of their relationship with their mothers directly influenced their self-management and HRQOL and indirectly affected their mothers' self-management and HRQOL.

  1. Influence of quality control variables on failure of graphite/epoxy under extreme moisture conditions

    NASA Technical Reports Server (NTRS)

    Clements, L. L.; Lee, P. R.

    1980-01-01

    Tension tests on graphite/epoxy composites were performed to determine the influence of various quality control variables on failure strength as a function of moisture and moderate temperatures. The extremely high and low moisture contents investigated were found to have less effect upon properties than did temperature or the quality control variables of specimen flaws and prepreg batch to batch variations. In particular, specimen flaws were found to drastically reduce the predicted strength of the composite, whereas specimens from different batches of prepreg displayed differences in strength as a function of temperature and extreme moisture exposure. The findings illustrate the need for careful specimen preparation, studies of flaw sensitivity, and careful quality control in any study of composite materials.

  2. Researcher responsibilities and genetic counseling for pure-bred dog populations.

    PubMed

    Bell, Jerold S

    2011-08-01

    Breeders of dogs have ethical responsibilities regarding the testing and management of genetic disease. Molecular genetics researchers have their own responsibilities, highlighted in this article. Laboratories offering commercial genetic testing should have proper sample identification and quality control, official test result certificates, clear explanations of test results and reasonably priced testing fees. Providing test results to a publicly-accessible genetic health registry allows breeders and the public to search for health-tested parents to reduce the risk of producing or purchasing affected offspring. Counseling on the testing and elimination of defective genes must consider the effects of genetic selection on the population. Recommendations to breed quality carriers to normal-testing dogs and replacing them with quality normal-testing offspring will help to preserve breeding lines and breed genetic diversity. Copyright © 2011 Elsevier Ltd. All rights reserved.

  3. Instrumental Surveillance of Water Quality.

    ERIC Educational Resources Information Center

    Miller, J. A.; And Others

    The role analytical instrumentation performs in the surveillance and control of the quality of water resources is reviewed. Commonly performed analyses may range from simple tests for physical parameters to more highly sophisticated radiological or spectrophotometric methods. This publication explores many of these types of water quality analyses…

  4. Six Sigma Quality Management System and Design of Risk-based Statistical Quality Control.

    PubMed

    Westgard, James O; Westgard, Sten A

    2017-03-01

    Six sigma concepts provide a quality management system (QMS) with many useful tools for managing quality in medical laboratories. This Six Sigma QMS is driven by the quality required for the intended use of a test. The most useful form for this quality requirement is the allowable total error. Calculation of a sigma-metric provides the best predictor of risk for an analytical examination process, as well as a design parameter for selecting the statistical quality control (SQC) procedure necessary to detect medically important errors. Simple point estimates of sigma at medical decision concentrations are sufficient for laboratory applications. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Critical outlook and trends for environmental reference materials at the Measurements & Testing Generic Activity (European Commission).

    PubMed

    Quevauviller, P; Bennink, D; Bøwadt, S

    2001-05-01

    It is now well recognised that the quality control (QC) of all types of analyses, including environmental analyses depends on the appropriate use of reference materials. One of the ways to check the accuracy of methods is based on the use of Certified Reference Materials (CRMs), whereas other types of (not certified) Reference Materials (RMs) are used for routine quality control (establishment of control charts) and interlaboratory testing (e.g. proficiency testing). The perception of these materials, in particular with respect to their production and use, differs widely according to various perspectives (e.g. RM producers, routine laboratories, researchers). This review discusses some critical aspects of RM use and production for the QC of environmental analyses and describes the new approach followed by the Measurements & Testing Generic Activity (European Commission) to tackle new research and production needs.

  6. A quality improvement plan for hypertension control: the INCOTECA Project (INterventions for COntrol of hyperTEnsion in CAtalonia)

    PubMed Central

    Vallès-Fernandez, Roser; Rosell-Murphy, Magdalena; Correcher-Aventin, Olga; Mengual-Martínez, Lucas; Aznar-Martínez, Núria; Prieto-De Lamo, Gemma; Franzi-Sisó, Alícia; Puig-Manresa, Jordi; Ma Bonet-Simó, Josep

    2009-01-01

    Background Different studies have shown insufficient blood pressure (BP) control in hypertensive patients. Multiple factors influence hypertension management, and the quality of primary care is one of them. We decided therefore to evaluate the effectiveness of a quality improvement plan directed at professionals of Primary Health Care Teams (PHCT) with the aim to achieve a better control of hypertension. The hypothesis of the study is that the implementation of a quality improvement plan will improve the control of hypertension. The primary aim of this study will be to evaluate the effectiveness of this plan. Methods and design Design: multicentric study quasi-experimental before – after with control group. The non-randomised allocation of the intervention will be done at PHCT level. Setting: 18 PHCT in the Barcelona province (Spain). Sample: all patients with a diagnosis of hypertension (population based study). Exclusion criteria: patients with a diagnosis of hypertension made later than 01/01/2006 and patients younger than 18 years. Intervention: a quality improvement plan, which targets primary health care professionals and includes educational sessions, feedback to health professionals, audit and implementation of recommended clinical practice guidelines for the management of hypertensive patients. Measurements: age, sex, associated co-morbidity (diabetes mellitus type I and II, heart failure and renal failure). The following variables will be recorded: BP measurement, cardiovascular risk and antihypertensive drugs used. Results will be measured before the start of the intervention and twelve months after the start of the study. Dependent variable: prevalence of hypertensive patients with poor BP control. Analysis: Chi-square test and Student's t-test will be used to measure the association between independent qualitative and quantitative variables, respectively. Non-parametric tests will be used for the analysis of non-normally distributed variables. Significance level (α) will be set at < 0.05. Outcomes will be analysed on an intention-to-treat basis. Discussion The implementation of a quality improvement plan might benefit the coordination of different professionals of PHCTs and may also improve blood pressure control. Trial Registration This protocol has been registered at clinicaltrials.gov with the ID number MS: 1998275938244441. PMID:19321009

  7. Honeywell Technical Order Transfer Tests.

    DTIC Science & Technology

    1987-06-12

    of simple corrections, a reasonable reproduction of the original could be generated. The quality was not good enough for a production environment. Lack of automated quality control (AQC) tools could account for the errors.

  8. Modeling of liquid flow in surface discontinuities

    NASA Astrophysics Data System (ADS)

    Lobanova, I. S.; Meshcheryakov, V. A.; Kalinichenko, A. N.

    2018-01-01

    Polymer composite and metallic materials have found wide application in various industries such as aviation, rocket, car manufacturing, ship manufacturing, etc. Many design elements need permanent quality control. Ensuring high quality and reliability of products is impossible without effective nondestructive testing methods. One of these methods is penetrant testing using penetrating substances based on liquid penetration into defect cavities. In this paper, we propose a model of liquid flow to determine the rates of filling the defect cavities with various materials and, based on this, to choose optimal control modes.

  9. Working on the Work Framework for Engagement: Impacting Students' Perceived Learning, Attitudes toward School, and Achievement

    ERIC Educational Resources Information Center

    Forehand, Michael Joshua

    2014-01-01

    A quasi-experimental, pre-test post-test nonequivalent control group study was utilized to determine the difference in students' perceived learning, attitudes toward school, and achievement when participating in classes utilizing engagement design qualities as compared to students in classes not utilizing engagement design qualities. To inform the…

  10. Nonlinear Dynamic Inversion Baseline Control Law: Flight-Test Results for the Full-scale Advanced Systems Testbed F/A-18 Airplane

    NASA Technical Reports Server (NTRS)

    Miller, Christopher J.

    2011-01-01

    A model reference nonlinear dynamic inversion control law has been developed to provide a baseline controller for research into simple adaptive elements for advanced flight control laws. This controller has been implemented and tested in a hardware-in-the-loop simulation and in flight. The flight results agree well with the simulation predictions and show good handling qualities throughout the tested flight envelope with some noteworthy deficiencies highlighted both by handling qualities metrics and pilot comments. Many design choices and implementation details reflect the requirements placed on the system by the nonlinear flight environment and the desire to keep the system as simple as possible to easily allow the addition of the adaptive elements. The flight-test results and how they compare to the simulation predictions are discussed, along with a discussion about how each element affected pilot opinions. Additionally, aspects of the design that performed better than expected are presented, as well as some simple improvements that will be suggested for follow-on work.

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

    PubMed

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

    2016-12-01

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

  12. pcr: an R package for quality assessment, analysis and testing of qPCR data

    PubMed Central

    Ahmed, Mahmoud

    2018-01-01

    Background Real-time quantitative PCR (qPCR) is a broadly used technique in the biomedical research. Currently, few different analysis models are used to determine the quality of data and to quantify the mRNA level across the experimental conditions. Methods We developed an R package to implement methods for quality assessment, analysis and testing qPCR data for statistical significance. Double Delta CT and standard curve models were implemented to quantify the relative expression of target genes from CT in standard qPCR control-group experiments. In addition, calculation of amplification efficiency and curves from serial dilution qPCR experiments are used to assess the quality of the data. Finally, two-group testing and linear models were used to test for significance of the difference in expression control groups and conditions of interest. Results Using two datasets from qPCR experiments, we applied different quality assessment, analysis and statistical testing in the pcr package and compared the results to the original published articles. The final relative expression values from the different models, as well as the intermediary outputs, were checked against the expected results in the original papers and were found to be accurate and reliable. Conclusion The pcr package provides an intuitive and unified interface for its main functions to allow biologist to perform all necessary steps of qPCR analysis and produce graphs in a uniform way. PMID:29576953

  13. Randomised controlled trial of routine individual feedback to improve rationality and reduce numbers of test requests.

    PubMed

    Winkens, R A; Pop, P; Bugter-Maessen, A M; Grol, R P; Kester, A D; Beusmans, G H; Knottnerus, J A

    1995-02-25

    Feedback can be described as a way to provide information on doctors' performance to enable changes in future behaviour. Feedback is used with the aim of changing test-ordering behaviour. It can lead to reductions in test usage and cost savings. It is not sufficiently clear, however, whether feedback leads to more appropriate test use. Since 1985, the Diagnostic Coordinating Center Maastricht has been giving feedback on diagnostic tests as a routine health care activity to all family doctors in its region. Both quantity and quality of requests are discussed. In a randomised, controlled trial over 2.5 years, discussion of tests not included previously was added to the existing routine feedback. One group of family doctors (n = 39) received feedback on test-group A (electrocardiography, endoscopy, cervical smears, and allergy tests), the other (n = 40) on test-group B (radiographic and ultrasonographic tests). Thus, each group of doctors acted as a control group for the other. Changes in volume and rationality of requests were analysed. The number of requests decreased during the trial (p = 0.036). Request numbers decreased particularly for test-group A (p = 0.04). The proportion of requests that were non-rational decreased more in the intervention than in the control groups (p = 0.009). Rationality improved predominantly for test-group B (p = 0.043). Thus, routine feedback can change the quantity and quality of requests.

  14. A Validity-Based Approach to Quality Control and Assurance of Automated Scoring

    ERIC Educational Resources Information Center

    Bejar, Isaac I.

    2011-01-01

    Automated scoring of constructed responses is already operational in several testing programmes. However, as the methodology matures and the demand for the utilisation of constructed responses increases, the volume of automated scoring is likely to increase at a fast pace. Quality assurance and control of the scoring process will likely be more…

  15. Radiation protection program for early detection of breast cancer in a mammography facility

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

    Mariana, Villagomez Casimiro, E-mail: marjim10-66@ciencias.unam.mx, E-mail: cesar@fisica.unam.mx; Cesar, Ruiz Trejo, E-mail: marjim10-66@ciencias.unam.mx, E-mail: cesar@fisica.unam.mx; Ruby, Espejo Fonseca

    Mammography is the best tool for early detection of Breast Cancer. In this diagnostic radiology modality it is necessary to establish the criteria to ensure the proper use and operation of the equipment used to obtain mammographic images in order to contribute to the safe use of ionizing radiation. The aim of the work was to implement at FUCAM-AC the radiation protection program which must be established for patients and radiation workers according to Mexican standards [1–4]. To achieve this goal, radiation protection and quality control manuals were elaborated [5]. Furthermore, a quality control program (QCP) in the mammography systemsmore » (analog/digital), darkroom included, has been implemented. Daily sensitometry, non-variability of the image quality, visualizing artifacts, revision of the equipment mechanical stability, compression force and analysis of repetition studies are some of the QCP routine tests that must be performed by radiological technicians of this institution as a set of actions to ensure the protection of patients. Image quality and patients dose assessment were performed on 4 analog equipment installed in 2 mobile units. In relation to dose assessment, all equipment passed the acceptance criteria (<3 mGy per projection). The image quality test showed that most images (70%)– presented artifacts. A brief summary of the results of quality control tests applied to the equipment and film processor are presented. To maintain an adequate level of quality and safety at FUCAM-AC is necessary that the proposed radiation protection program in this work is applied.« less

  16. Hot mix asphalt voids acceptance review of QC/QA data 2000 through 2004.

    DOT National Transportation Integrated Search

    2006-07-01

    This report analyzes the Quality Control/Quality Assurance (QC/QA) data for hot mix asphalt using voids acceptance as : the testing criteria for the years 2000 through 2004. Analysis of the overall quality of the HMA is accomplished by : reviewing th...

  17. Adapted physical activity is beneficial on balance, functional mobility, quality of life and fall risk in community-dwelling older women: a randomized single-blinded controlled trial.

    PubMed

    Kovács, E; Prókai, L; Mészáros, L; Gondos, T

    2013-06-01

    Exercise programmes have important role in prevention of falls, but to date, we have little knowledge about the effects of Adapted Physical Activity programme on balance of older women. The aim of this study was to investigate the effects of an Adapted Physical Activity programme on balance, risk of falls and quality of life in community-dwelling older women. This was a randomized controlled study. Community, in a local sport centre. Older women aged over 60 years. Seventy-six women were randomised to an exercise group providing Adapted Physical Activity programme for 25 weeks or a control group (in which they did not participate in any exercise programme). The one-leg stance test, Timed Up and Go test, incidence of fall and the quality of life (SF-36V2) were measured at baseline and after 25 weeks. The one-leg stance test and the Timed Up and Go test in the exercise group was significantly better than in the control group after the intervention period (P=0.005; P=0.001, respectively). The Physical Functioning, Vitality and General Health subdomains of quality of life were also significantly better in the exercise group compared to the control group (P=0.004; P=0.005; P=0.038, respectively). Relative risk was 0.40 (90% CI 0.174 to 0.920) and the number needed to treat was 5 (95% CI 2.3 to 23.3). This 25-week Adapted Physical Activity programme improves static balance, functional mobility, as well as Physical Functioning, Vitality and General Health subdomains of quality of life. Based on our results, the Adapted Physical Activity programme may be a promising fall prevention exercise programme improving static balance and functional mobility for community-dwelling older women.

  18. Effect of a multidisciplinary supportive program for family caregivers of patients with heart failure on caregiver burden, quality of life, and depression: A randomized controlled study.

    PubMed

    Hu, Xiaolin; Dolansky, Mary A; Su, Yonglin; Hu, Xiuying; Qu, Moying; Zhou, Lingjuan

    2016-10-01

    Caregivers of patients with heart failure experience burden and negative health outcomes. Adequate support for family caregivers improves their well-being and the quality of care provided to the patients. However, little is known about the benefits of interventions for caregivers of patients with heart failure in China. To test the effects of a multidisciplinary supportive program for family caregivers on caregiver burden, quality of life, and depression. A randomized controlled design with repeated measures was used in this study. A total of 118 participants were randomized into experimental (n=59) and control groups (n=59) from May to December 2014 in one hospital in Chengdu, People's Republic of China. Participants in the experimental group received a 3-month multidisciplinary supportive program, consisting of three 60-min sessions of group classes, three 30-min peer support groups, and regular telephone follow-ups and consultations, while participants in the control group received usual care only. Outcomes were caregiver burden, quality of life, and depression. Data were collected at baseline, post-test (3 months after discharge), and 3 months after post-test (6 months after discharge). The repeated measures analysis of variance was used to examine the effects of groups, changes over time, and time-group interaction on outcome variables. There were significant improvements in caregiver burden, mental health, and depression after post-test and 3 months after post-test in the experimental group. However, there was no significant improvement in caregivers' physical health at either 3 or 6 months following discharge. A multidisciplinary supportive program for caregivers of heart failure patients had positive effects and provides a unique perspective of an intervention considering Chinese culture and customs. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. Multileaf collimator performance monitoring and improvement using semiautomated quality control testing and statistical process control.

    PubMed

    Létourneau, Daniel; Wang, An; Amin, Md Nurul; Pearce, Jim; McNiven, Andrea; Keller, Harald; Norrlinger, Bernhard; Jaffray, David A

    2014-12-01

    High-quality radiation therapy using highly conformal dose distributions and image-guided techniques requires optimum machine delivery performance. In this work, a monitoring system for multileaf collimator (MLC) performance, integrating semiautomated MLC quality control (QC) tests and statistical process control tools, was developed. The MLC performance monitoring system was used for almost a year on two commercially available MLC models. Control charts were used to establish MLC performance and assess test frequency required to achieve a given level of performance. MLC-related interlocks and servicing events were recorded during the monitoring period and were investigated as indicators of MLC performance variations. The QC test developed as part of the MLC performance monitoring system uses 2D megavoltage images (acquired using an electronic portal imaging device) of 23 fields to determine the location of the leaves with respect to the radiation isocenter. The precision of the MLC performance monitoring QC test and the MLC itself was assessed by detecting the MLC leaf positions on 127 megavoltage images of a static field. After initial calibration, the MLC performance monitoring QC test was performed 3-4 times/week over a period of 10-11 months to monitor positional accuracy of individual leaves for two different MLC models. Analysis of test results was performed using individuals control charts per leaf with control limits computed based on the measurements as well as two sets of specifications of ± 0.5 and ± 1 mm. Out-of-specification and out-of-control leaves were automatically flagged by the monitoring system and reviewed monthly by physicists. MLC-related interlocks reported by the linear accelerator and servicing events were recorded to help identify potential causes of nonrandom MLC leaf positioning variations. The precision of the MLC performance monitoring QC test and the MLC itself was within ± 0.22 mm for most MLC leaves and the majority of the apparent leaf motion was attributed to beam spot displacements between irradiations. The MLC QC test was performed 193 and 162 times over the monitoring period for the studied units and recalibration had to be repeated up to three times on one of these units. For both units, rate of MLC interlocks was moderately associated with MLC servicing events. The strongest association with the MLC performance was observed between the MLC servicing events and the total number of out-of-control leaves. The average elapsed time for which the number of out-of-specification or out-of-control leaves was within a given performance threshold was computed and used to assess adequacy of MLC test frequency. A MLC performance monitoring system has been developed and implemented to acquire high-quality QC data at high frequency. This is enabled by the relatively short acquisition time for the images and automatic image analysis. The monitoring system was also used to record and track the rate of MLC-related interlocks and servicing events. MLC performances for two commercially available MLC models have been assessed and the results support monthly test frequency for widely accepted ± 1 mm specifications. Higher QC test frequency is however required to maintain tighter specification and in-control behavior.

  20. Quality, and not just quantity, of education accounts for differences in psychometric performance between African Americans and White Non-Hispanics with Alzheimer’s disease

    PubMed Central

    Chin, Alexander L.; Negash, Selam; Xie, Sharon; Arnold, Steven E.; Hamilton, Roy

    2013-01-01

    The effect of race on cognitive test performance in the evaluation of Alzheimer’s disease (AD) remains controversial. One factor that may contribute substantially to differences in cognitive test performance in diverse populations is education. The current study examined the extent to which quality of education, even after controlling for formal years of education, accounts for differences in cognitive performance between African Americans and White Non-Hispanics (WNHs). The retrospective cohort included 244 patients diagnosed with AD who self-identified as African Americans (n=51) or WNHs (n=193). The Wechsler Test of Adult Reading (WTAR) was used as an estimate of quality of education. In an analysis that controlled for traditional demographics, including age, sex, and years of formal education, African Americans scored significantly lower than WNHs on the Mini-Mental State Examination, as well as on neuropsychological tests of memory, attention, and language. However, after also adjusting for reading level, all previously observed differences were significantly attenuated. The attenuating effect remained even after controlling for disease severity, indicating that reading scores are not confounded by severity of dementia. These findings suggest that quality, and not just quantity, of education needs to be taken into account when assessing cognitive performance in African Americans with AD. PMID:22300593

  1. SU-E-T-103: Development and Implementation of Web Based Quality Control Software

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

    Studinski, R; Taylor, R; Angers, C

    Purpose: Historically many radiation medicine programs have maintained their Quality Control (QC) test results in paper records or Microsoft Excel worksheets. Both these approaches represent significant logistical challenges, and are not predisposed to data review and approval. It has been our group's aim to develop and implement web based software designed not just to record and store QC data in a centralized database, but to provide scheduling and data review tools to help manage a radiation therapy clinics Equipment Quality control program. Methods: The software was written in the Python programming language using the Django web framework. In order tomore » promote collaboration and validation from other centres the code was made open source and is freely available to the public via an online source code repository. The code was written to provide a common user interface for data entry, formalize the review and approval process, and offer automated data trending and process control analysis of test results. Results: As of February 2014, our installation of QAtrack+ has 180 tests defined in its database and has collected ∼22 000 test results, all of which have been reviewed and approved by a physicist via QATrack+'s review tools. These results include records for quality control of Elekta accelerators, CT simulators, our brachytherapy programme, TomoTherapy and Cyberknife units. Currently at least 5 other centres are known to be running QAtrack+ clinically, forming the start of an international user community. Conclusion: QAtrack+ has proven to be an effective tool for collecting radiation therapy QC data, allowing for rapid review and trending of data for a wide variety of treatment units. As free and open source software, all source code, documentation and a bug tracker are available to the public at https://bitbucket.org/tohccmedphys/qatrackplus/.« less

  2. Storming the Molecular Diagnostic IP Fortress

    PubMed Central

    TERRY, MARK

    2006-01-01

    How genes are patented, and how companies control those patents through licensing, raises issues of patient access to medical tests, monopolistic business practices, ethics, lab-test quality, and the future of genetic test development. PMID:23424336

  3. Breadboard Facility

    NASA Technical Reports Server (NTRS)

    1977-01-01

    In the sixties, Chrysler was NASA's prime contractor for the Saturn I and IB test launch vehicles. The company installed and operated at Huntsville what was known as the Saturn I/IB Development Breadboard Facility. "Breadboard," means an array of electrical and electronic equipment for performing a variety of development and test functions. This work gave Chrysler a broad capability in computerized testing to assure quality control in development of solid-state electronic systems. Today that division is manufacturing many products not destined for NASA, most of them being associated with the company's automotive line. A major project is production and quality-control testing of the "lean-burn" engine, one that has a built-in Computer to control emission timing, and allow the engine to run on a leaner mixture of fuel and air. Other environment-related products include vehicle emission analyzers. The newest of the line is an accurate, portable solid state instrument for testing auto exhaust gases. The exhaust analyzers, now being produced for company dealers and for service

  4. Initial Investigation of Reaction Control System Design on Spacecraft Handling Qualities for Earth Orbit Docking

    NASA Technical Reports Server (NTRS)

    Bailey, Randall E.; Jackson, E. Bruce; Goodrich, Kenneth H.; Ragsdale, W. Al; Neuhaus, Jason; Barnes, Jim

    2008-01-01

    A program of research, development, test, and evaluation is planned for the development of Spacecraft Handling Qualities guidelines. In this first experiment, the effects of Reaction Control System design characteristics and rotational control laws were evaluated during simulated proximity operations and docking. Also, the influence of piloting demands resulting from varying closure rates was assessed. The pilot-in-the-loop simulation results showed that significantly different spacecraft handling qualities result from the design of the Reaction Control System. In particular, cross-coupling between translational and rotational motions significantly affected handling qualities as reflected by Cooper-Harper pilot ratings and pilot workload, as reflected by Task-Load Index ratings. This influence is masked but only slightly by the rotational control system mode. While rotational control augmentation using Rate Command Attitude Hold can reduce the workload (principally, physical workload) created by cross-coupling, the handling qualities are not significantly improved. The attitude and rate deadbands of the RCAH introduced significant mental workload and control compensation to evaluate when deadband firings would occur, assess their impact on docking performance, and apply control inputs to mitigate that impact.

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

    PubMed

    Men'shikov, V V

    2013-08-01

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

  6. Tumorigenicity assessment of human cell-processed therapeutic products.

    PubMed

    Yasuda, Satoshi; Sato, Yoji

    2015-09-01

    Human pluripotent stem cells (hPSCs) are expected to be sources of various cell types used for cell therapy, although hPSCs are intrinsically tumorigenic and form teratomas in immunodeficient animals after transplant. Despite the urgent need, no detailed guideline for the assessment of tumorigenicity of human cell-processed therapeutic products (hCTPs) has been issued. Here we describe our consideration on tumorigenicity and related tests of hCTPs. The purposes of those tests for hPSC-based products are classified into three categories: 1) quality control of raw materials; 2) quality control of intermediate/final products; and 3) safety assessment of final products. Appropriate types of tests need to be selected, taking the purpose(s) into consideration. In contrast, human somatic (and somatic stem) cells are believed to have little tumorigenicity. Therefore, GMP-compliant quality control is essential to avoid contamination of somatic cell-derived products with tumorigenic cells. Compared with in vivo tumorigenicity tests, in vitro cell proliferation assays may be more useful and reasonable for detecting immortalized cells that have a growth advantage in somatic cell-based products. The results obtained from tumorigenicity and related tests for hCTPs should meet the criteria for decisions on product development, manufacturing processes, and clinical applications. Copyright © 2015.

  7. [Analysis of the results of the SEIMC External Quality Control Program. Year 2013].

    PubMed

    de Gopegui Bordes, Enrique Ruiz; Orta Mira, Nieves; Del Remedio Guna Serrano, M; Medina González, Rafael; Rosario Ovies, María; Poveda, Marta; Gimeno Cardona, Concepción

    2015-07-01

    The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) include controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology, molecular microbiology and HIV-1, HCV and HBV viral loads. This manuscript presents the analysis of results obtained of the participants from the 2013 SEIMC External Quality Control Programme, except viral loads controls, that they are summarized in a manuscript abroad. As a whole, the results obtained in 2013 confirm the excellent skill and good technical standards found in previous editions. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. Once again, the results of this program highlighted the need to implement both internal and external controls in order to assure the maximal quality of the microbiological tests. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  8. Development of flying qualities criteria for single pilot instrument flight operations

    NASA Technical Reports Server (NTRS)

    Bar-Gill, A.; Nixon, W. B.; Miller, G. E.

    1982-01-01

    Flying qualities criteria for Single Pilot Instrument Flight Rule (SPIFR) operations were investigated. The ARA aircraft was modified and adapted for SPIFR operations. Aircraft configurations to be flight-tested were chosen and matched on the ARA in-flight simulator, implementing modern control theory algorithms. Mission planning and experimental matrix design were completed. Microprocessor software for the onboard data acquisition system was debugged and flight-tested. Flight-path reconstruction procedure and the associated FORTRAN program were developed. Algorithms associated with the statistical analysis of flight test results and the SPIFR flying qualities criteria deduction are discussed.

  9. Longitudinal Stability and Control Characteristics of a B-29 Airplane with a Booster Incorporated in the Elevator Control System to Provide Various Stick-Force and Control-Rate Characteristics

    NASA Technical Reports Server (NTRS)

    Mathews, Charles W.; Talmage, Donald B.; Whitten, James B.

    1948-01-01

    The longitudinal stability and control characteristics of a B-29 airplane have been measured with a booster incorporated in the elevator control system. Tests were made to determine the effects on the handling qualities of the test airplane of variations in pilots control-force gradients as well as the effects of variations in the maximum rate of control motion supplied by the booster system.

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

    PubMed

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

    2012-03-01

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

  11. The Effect of the MassHealth Hospital Pay-for-Performance Program on Quality

    PubMed Central

    Ryan, Andrew M; Blustein, Jan

    2011-01-01

    Objective To test the effect of Massachusetts Medicaid's (MassHealth) hospital-based pay-for-performance (P4P) program, implemented in 2008, on quality of care for pneumonia and surgical infection prevention (SIP). Data Hospital Compare process of care quality data from 2004 to 2009 for acute care hospitals in Massachusetts (N = 62) and other states (N = 3,676) and American Hospital Association data on hospital characteristics from 2005. Study Design Panel data models with hospital fixed effects and hospital-specific trends are estimated to test the effect of P4P on composite quality for pneumonia and SIP. This base model is extended to control for the completeness of measure reporting. Further sensitivity checks include estimation with propensity-score matched control hospitals, excluding hospitals in other P4P programs, varying the time period during which the program was assumed to have an effect, and testing the program effect across hospital characteristics. Principal Findings Estimates from our preferred specification, including hospital fixed effects, trends, and the control for measure completeness, indicate small and nonsignificant program effects for pneumonia (−0.67 percentage points, p>.10) and SIP (−0.12 percentage points, p>.10). Sensitivity checks indicate a similar pattern of findings across specifications. Conclusions Despite offering substantial financial incentives, the MassHealth P4P program did not improve quality in the first years of implementation. PMID:21210796

  12. Quality of anti-malarials collected in the private and informal sectors in Guyana and Suriname

    PubMed Central

    2012-01-01

    Background Despite a significant reduction in the number of malaria cases in Guyana and Suriname, this disease remains a major problem in the interior of both countries, especially in areas with gold mining and logging operations, where malaria is endemic. National malaria control programmes in these countries provide treatment to patients with medicines that are procured and distributed through regulated processes in the public sector. However, availability to medicines in licensed facilities (private sector) and unlicensed facilities (informal sector) is common, posing the risk of access to and use of non-recommended treatments and/or poor quality products. Methods To assess the quality of circulating anti-malarial medicines, samples were purchased in the private and informal sectors of Guyana and Suriname in 2009. The sampling sites were selected based on epidemiological data and/or distance from health facilities. Samples were analysed for identity, content, dissolution or disintegration, impurities, and uniformity of dosage units or weight variation according to manufacturer, pharmacopeial, or other validated method. Results Quality issues were observed in 45 of 77 (58%) anti-malarial medicines sampled in Guyana of which 30 failed visual & physical inspection and 18 failed quality control tests. The proportion of monotherapy and ACT medicines failing quality control tests was 43% (13/30) and 11% (5/47) respectively. A higher proportion of medicines sampled from the private sector 34% (11/32) failed quality control tests versus 16% (7/45) in the informal sector. In Suriname, 58 medicines were sampled, of which 50 (86%) were Artecom®, the fixed-dose combination of piperaquine-dihydroartemisinin-trimethoprim co-blistered with a primaquine phosphate tablet. All Artecom samples were found to lack a label claim for primaquine, thus failing visual and physical inspection. Conclusions The findings of the studies in both countries point to significant problems with the quality of anti-malarial medicines available in private and informal sector facilities as well as the availability of therapy not compliant with national treatment guidelines. They also stress the need to strengthen regulatory control efforts on the availability of anti-malarial medicines in these sectors and in endemic areas. PMID:22704709

  13. Electronic adherence monitoring device performance and patient acceptability: a randomized control trial.

    PubMed

    Chan, Amy Hai Yan; Stewart, Alistair William; Harrison, Jeff; Black, Peter Nigel; Mitchell, Edwin Arthur; Foster, Juliet Michelle

    2017-05-01

    To investigate the performance and patient acceptability of an inhaler electronic monitoring device in a real-world childhood asthma population. Children 6 to 15 years presenting with asthma to the hospital emergency department and prescribed inhaled corticosteroids were included. Participants were randomized to receive a device with reminder features enabled or disabled for use with their preventer. Device quality control tests were conducted. Questionnaires on device acceptability, utility and ergonomics were completed at six months. A total of 1306 quality control tests were conducted; 84% passed pre-issue and 87% return testing. The most common failure reason was actuation under-recording. Acceptability scores were high, with higher scores in the reminder than non-reminder group (median, 5 th -95 th percentile: 4.1, 3.1-5.0 versus 3.7, 2.3-4.8; p < 0.001). Most (>90%) rated the device easy to use. Feedback was positive across five themes: device acceptability, ringtone acceptability, suggestions for improvement, effect on medication use, and effect on asthma control. This study investigates electronic monitoring device performance and acceptability in children using quantitative and qualitative measures. Results indicate satisfactory reliability, although failure rates of 13-16% indicate the importance of quality control. Favorable acceptability ratings support the use of these devices in children.

  14. Summary of the effects of engine throttle response on airplane formation-flying qualities

    NASA Technical Reports Server (NTRS)

    Walsh, Kevin R.

    1992-01-01

    A flight evaluation as conducted to determine the effect of engine throttle response characteristics on precision formation-flying qualities. A variable electronic throttle control system was developed and flight-tested on a TF-104G airplane with a J79-11B engine at the NASA Dryden Flight Research Facility. Ten research flights were flown to evaluate the effects of throttle gain, time delay, and fuel control rate limiting on engine handling qualities during a demanding precision wing formation task. Handling quality effects of lag filters and lead compensation time delays were also evaluated. Data from pilot ratings and comments indicate that throttle control system time delays and rate limits cause significant degradations in handling qualities. Threshold values for satisfactory (level 1) and adequate (level 2) handling qualities of these key variables are presented.

  15. Segments from red blood cell units should not be used for quality testing.

    PubMed

    Kurach, Jayme D R; Hansen, Adele L; Turner, Tracey R; Jenkins, Craig; Acker, Jason P

    2014-02-01

    Nondestructive testing of blood components could permit in-process quality control and reduce discards. Tubing segments, generated during red blood cell (RBC) component production, were tested to determine their suitability as a sample source for quality testing. Leukoreduced RBC components were produced from whole blood (WB) by two different methods: WB filtration and buffy coat (BC). Components and their corresponding segments were tested on Days 5 and 42 of hypothermic storage (HS) for spun hematocrit (Hct), hemoglobin (Hb) content, percentage hemolysis, hematologic indices, and adenosine triphosphate concentration to determine whether segment quality represents unit quality. Segment samples overestimated hemolysis on Days 5 and 42 of HS in both BC- and WB filtration-produced RBCs (p < 0.001 for all). Hct and Hb levels in the segments were also significantly different from the units at both time points for both production methods (p < 0.001 for all). Indeed, for all variables tested different results were obtained from segment and unit samples, and these differences were not consistent across production methods. The quality of samples from tubing segments is not representative of the quality of the corresponding RBC unit. Segments are not suitable surrogates with which to assess RBC quality. © 2013 American Association of Blood Banks.

  16. 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.

  17. Flight testing the digital electronic engine control in the F-15 airplane

    NASA Technical Reports Server (NTRS)

    Myers, L. P.

    1984-01-01

    The digital electronic engine control (DEEC) is a full-authority digital engine control developed for the F100-PW-100 turbofan engine which was flight tested on an F-15 aircraft. The DEEC hardware and software throughout the F-15 flight envelope was evaluated. Real-time data reduction and data display systems were implemented. New test techniques and stronger coordination between the propulsion test engineer and pilot were developed which produced efficient use of test time, reduced pilot work load, and greatly improved quality data. The engine pressure ratio (EPR) control mode is demonstrated. It is found that the nonaugmented throttle transients and engine performance are satisfactory.

  18. Multicriteria Gain Tuning for Rotorcraft Flight Controls (also entitled The Development of the Conduit Advanced Control System Design and Evaluation Interface with a Case Study Application Fly by Wire Helicopter Design)

    NASA Technical Reports Server (NTRS)

    Biezad, Daniel

    1997-01-01

    Handling qualities analysis and control law design would seem to be naturally complimenting components of aircraft flight control system design, however these two closely coupled disciplines are often not well integrated in practice. Handling qualities engineers and control system engineers may work in separate groups within an aircraft company. Flight control system engineers and handling quality specialists may come from different backgrounds and schooling and are often not aware of the other group's research. Thus while the handling qualities specifications represent desired aircraft response characteristics, these are rarely incorporated directly in the control system design process. Instead modem control system design techniques are based on servo-loop robustness specifications, and simple representations of the desired control response. Comprehensive handling qualities analysis is often left until the end of the design cycle and performed as a check of the completed design for satisfactory performance. This can lead to costly redesign or less than satisfactory aircraft handling qualities when the flight testing phase is reached. The desire to integrate the fields of handling qualities and flight,control systems led to the development of the CONDUIT system. This tool facilitates control system designs that achieve desired handling quality requirements and servo-loop specifications in a single design process. With CONDUIT, the control system engineer is now able to directly design and control systems to meet the complete handling specifications. CONDUIT allows the designer to retain a preferred control law structure, but then tunes the system parameters to meet the handling quality requirements.

  19. Monitoring scale scores over time via quality control charts, model-based approaches, and time series techniques.

    PubMed

    Lee, Yi-Hsuan; von Davier, Alina A

    2013-07-01

    Maintaining a stable score scale over time is critical for all standardized educational assessments. Traditional quality control tools and approaches for assessing scale drift either require special equating designs, or may be too time-consuming to be considered on a regular basis with an operational test that has a short time window between an administration and its score reporting. Thus, the traditional methods are not sufficient to catch unusual testing outcomes in a timely manner. This paper presents a new approach for score monitoring and assessment of scale drift. It involves quality control charts, model-based approaches, and time series techniques to accommodate the following needs of monitoring scale scores: continuous monitoring, adjustment of customary variations, identification of abrupt shifts, and assessment of autocorrelation. Performance of the methodologies is evaluated using manipulated data based on real responses from 71 administrations of a large-scale high-stakes language assessment.

  20. 10 CFR 26.167 - Quality assurance and quality control.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... be designed, implemented, and reviewed to monitor the conduct of each step of the testing process. (b... sample and the error is determined to be technical or methodological, the licensee or other entity shall...

  1. 10 CFR 26.167 - Quality assurance and quality control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... be designed, implemented, and reviewed to monitor the conduct of each step of the testing process. (b... sample and the error is determined to be technical or methodological, the licensee or other entity shall...

  2. 10 CFR 26.167 - Quality assurance and quality control.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... be designed, implemented, and reviewed to monitor the conduct of each step of the testing process. (b... sample and the error is determined to be technical or methodological, the licensee or other entity shall...

  3. 10 CFR 26.167 - Quality assurance and quality control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... be designed, implemented, and reviewed to monitor the conduct of each step of the testing process. (b... sample and the error is determined to be technical or methodological, the licensee or other entity shall...

  4. 10 CFR 26.167 - Quality assurance and quality control.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... be designed, implemented, and reviewed to monitor the conduct of each step of the testing process. (b... sample and the error is determined to be technical or methodological, the licensee or other entity shall...

  5. Guidelines for software inspections

    NASA Technical Reports Server (NTRS)

    1983-01-01

    Quality control inspections are software problem finding procedures which provide defect removal as well as improvements in software functionality, maintenance, quality, and development and testing methodology is discussed. The many side benefits include education, documentation, training, and scheduling.

  6. Systematic Review of Plant-Based Homeopathic Basic Research: An Update.

    PubMed

    Ücker, Annekathrin; Baumgartner, Stephan; Sokol, Anezka; Huber, Roman; Doesburg, Paul; Jäger, Tim

    2018-05-01

     Plant-based test systems have been described as a useful tool for investigating possible effects of homeopathic preparations. The last reviews of this research field were published in 2009/2011. Due to recent developments in the field, an update is warranted. Publications on plant-based test systems were analysed with regard to publication quality, reproducibility and potential for further research.  A literature search was conducted in online databases and specific journals, including publications from 2008 to 2017 dealing with plant-based test systems in homeopathic basic research. To be included, they had to contain statistical analysis and fulfil quality criteria according to a pre-defined manuscript information score (MIS). Publications scoring at least 5 points (maximum 10 points) were assumed to be adequate. They were analysed for the use of adequate controls, outcome and reproducibility.  Seventy-four publications on plant-based test systems were found. Thirty-nine publications were either abstracts or proceedings of conferences and were excluded. From the remaining 35 publications, 26 reached a score of 5 or higher in the MIS. Adequate controls were used in 13 of these publications. All of them described specific effects of homeopathic preparations. The publication quality still varied: a substantial number of publications (23%) did not adequately document the methods used. Four reported on replication trials. One replication trial found effects of homeopathic preparations comparable to the original study. Three replication trials failed to confirm the original study but identified possible external influencing factors. Five publications described novel plant-based test systems. Eight trials used systematic negative control experiments to document test system stability.  Regarding research design, future trials should implement adequate controls to identify specific effects of homeopathic preparations and include systematic negative control experiments. Further external and internal replication trials, and control of influencing factors, are needed to verify results. Standardised test systems should be developed. The Faculty of Homeopathy.

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

    PubMed Central

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

    2007-01-01

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

  8. [Critical reflexion on quality improvement and networking].

    PubMed

    Adler, R

    2012-06-06

    Qualitiy-control and networking are two issues of debate in modern medicine. The origin of these terms is not to be found in medicine, but rather in industry. However their naive transfer to the field of medicine causes damage. It is relatively easy to test industrial products for their quality. Dealing with meaningful medical problems is far too complex. Simple data such as blood pressure, HbA1c, etc. may be assessed. The only means of quality-control of complex medical situations and actions are ward rounds by attending physicians, case presentations at staff meetings, etc. Issues of clinical quality-control are discussed on the basis of the history of an aged couple. Furthermore a personal clinical experience illustrates how doctors create a useful network with other physicians and how they eliminate "useless" colleagues from their network. Economists should have no influence or impact whatsoever on the quality-control and networking of physicians.

  9. Development and Characterization of Reference Materials for Genetic Testing: Focus on Public Partnerships.

    PubMed

    Kalman, Lisa V; Datta, Vivekananda; Williams, Mickey; Zook, Justin M; Salit, Marc L; Han, Jin Yeong

    2016-11-01

    Characterized reference materials (RMs) are needed for clinical laboratory test development and validation, quality control procedures, and proficiency testing to assure their quality. In this article, we review the development and characterization of RMs for clinical molecular genetic tests. We describe various types of RMs and how to access and utilize them, especially focusing on the Genetic Testing Reference Materials Coordination Program (Get-RM) and the Genome in a Bottle (GIAB) Consortium. This review also reinforces the need for collaborative efforts in the clinical genetic testing community to develop additional RMs.

  10. 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.

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

    PubMed

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

    2013-01-01

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

  12. 40 CFR 141.719 - Additional filtration toolbox components.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... establish a quality control release value (QCRV) for a non-destructive performance test that demonstrates... test; and Cp = the filtrate concentration measured during the challenge test. Equivalent units must be... or the applicability of the non-destructive performance test and associated QCRV, additional...

  13. 40 CFR 141.719 - Additional filtration toolbox components.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... establish a quality control release value (QCRV) for a non-destructive performance test that demonstrates... test; and Cp = the filtrate concentration measured during the challenge test. Equivalent units must be... or the applicability of the non-destructive performance test and associated QCRV, additional...

  14. 40 CFR 141.719 - Additional filtration toolbox components.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... establish a quality control release value (QCRV) for a non-destructive performance test that demonstrates... test; and Cp = the filtrate concentration measured during the challenge test. Equivalent units must be... or the applicability of the non-destructive performance test and associated QCRV, additional...

  15. Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial.

    PubMed

    Manfredini, Fabio; Mallamaci, Francesca; D'Arrigo, Graziella; Baggetta, Rossella; Bolignano, Davide; Torino, Claudia; Lamberti, Nicola; Bertoli, Silvio; Ciurlino, Daniele; Rocca-Rey, Lisa; Barillà, Antonio; Battaglia, Yuri; Rapanà, Renato Mario; Zuccalà, Alessandro; Bonanno, Graziella; Fatuzzo, Pasquale; Rapisarda, Francesco; Rastelli, Stefania; Fabrizi, Fabrizio; Messa, Piergiorgio; De Paola, Luciano; Lombardi, Luigi; Cupisti, Adamasco; Fuiano, Giorgio; Lucisano, Gaetano; Summaria, Chiara; Felisatti, Michele; Pozzato, Enrico; Malagoni, Anna Maria; Castellino, Pietro; Aucella, Filippo; Abd ElHafeez, Samar; Provenzano, Pasquale Fabio; Tripepi, Giovanni; Catizone, Luigi; Zoccali, Carmine

    2017-04-01

    Previous studies have suggested the benefits of physical exercise for patients on dialysis. We conducted the Exercise Introduction to Enhance Performance in Dialysis trial, a 6-month randomized, multicenter trial to test whether a simple, personalized walking exercise program at home, managed by dialysis staff, improves functional status in adult patients on dialysis. The main study outcomes included change in physical performance at 6 months, assessed by the 6-minute walking test and the five times sit-to-stand test, and in quality of life, assessed by the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire. We randomized 296 patients to normal physical activity (control; n =145) or walking exercise ( n =151); 227 patients (exercise n =104; control n =123) repeated the 6-month evaluations. The distance covered during the 6-minute walking test improved in the exercise group (mean distance±SD: baseline, 328±96 m; 6 months, 367±113 m) but not in the control group (baseline, 321±107 m; 6 months, 324±116 m; P <0.001 between groups). Similarly, the five times sit-to-stand test time improved in the exercise group (mean time±SD: baseline, 20.5±6.0 seconds; 6 months, 18.2±5.7 seconds) but not in the control group (baseline, 20.9±5.8 seconds; 6 months, 20.2±6.4 seconds; P =0.001 between groups). The cognitive function score ( P =0.04) and quality of social interaction score ( P =0.01) in the kidney disease component of the KDQOL-SF improved significantly in the exercise arm compared with the control arm. Hence, a simple, personalized, home-based, low-intensity exercise program managed by dialysis staff may improve physical performance and quality of life in patients on dialysis. Copyright © 2017 by the American Society of Nephrology.

  16. 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.

  17. Application of reiteration of Hankel singular value decomposition in quality control

    NASA Astrophysics Data System (ADS)

    Staniszewski, Michał; Skorupa, Agnieszka; Boguszewicz, Łukasz; Michalczuk, Agnieszka; Wereszczyński, Kamil; Wicher, Magdalena; Konopka, Marek; Sokół, Maria; Polański, Andrzej

    2017-07-01

    Medical centres are obliged to store past medical records, including the results of quality assurance (QA) tests of the medical equipment, which is especially useful in checking reproducibility of medical devices and procedures. Analysis of multivariate time series is an important part of quality control of NMR data. In this work we proposean anomaly detection tool based on Reiteration of Hankel Singular Value Decomposition method. The presented method was compared with external software and authors obtained comparable results.

  18. Rapid toxicity detection in water quality control utilizing automated multispecies biomonitoring for permanent space stations

    NASA Technical Reports Server (NTRS)

    Morgan, E. L.; Young, R. C.; Smith, M. D.; Eagleson, K. W.

    1986-01-01

    The objective of this study was to evaluate proposed design characteristics and applications of automated biomonitoring devices for real-time toxicity detection in water quality control on-board permanent space stations. Simulated tests in downlinking transmissions of automated biomonitoring data to Earth-receiving stations were simulated using satellite data transmissions from remote Earth-based stations.

  19. 40 CFR Appendix B to Part 75 - Quality Assurance and Quality Control Procedures

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... transmitters of an orifice-, nozzle-, or venturi-type fuel flowmeter under section 2.1.6 of appendix D to this... nozzle) of an orifice-, venturi-, or nozzle-type fuel flowmeter. Examples of the types of information to..., but ≤200 ppm). The out-of-control period begins upon failure of the calibration error test and ends...

  20. Testing the quality of images for permanent magnet desktop MRI systems using specially designed phantoms.

    PubMed

    Qiu, Jianfeng; Wang, Guozhu; Min, Jiao; Wang, Xiaoyan; Wang, Pengcheng

    2013-12-21

    Our aim was to measure the performance of desktop magnetic resonance imaging (MRI) systems using specially designed phantoms, by testing imaging parameters and analysing the imaging quality. We designed multifunction phantoms with diameters of 18 and 60 mm for desktop MRI scanners in accordance with the American Association of Physicists in Medicine (AAPM) report no. 28. We scanned the phantoms with three permanent magnet 0.5 T desktop MRI systems, measured the MRI image parameters, and analysed imaging quality by comparing the data with the AAPM criteria and Chinese national standards. Image parameters included: resonance frequency, high contrast spatial resolution, low contrast object detectability, slice thickness, geometrical distortion, signal-to-noise ratio (SNR), and image uniformity. The image parameters of three desktop MRI machines could be measured using our specially designed phantoms, and most parameters were in line with MRI quality control criterion, including: resonance frequency, high contrast spatial resolution, low contrast object detectability, slice thickness, geometrical distortion, image uniformity and slice position accuracy. However, SNR was significantly lower than in some references. The imaging test and quality control are necessary for desktop MRI systems, and should be performed with the applicable phantom and corresponding standards.

  1. New patient-controlled abdominal compression method in radiography: radiation dose and image quality.

    PubMed

    Piippo-Huotari, Oili; Norrman, Eva; Anderzén-Carlsson, Agneta; Geijer, Håkan

    2018-05-01

    The radiation dose for patients can be reduced with many methods and one way is to use abdominal compression. In this study, the radiation dose and image quality for a new patient-controlled compression device were compared with conventional compression and compression in the prone position . To compare radiation dose and image quality of patient-controlled compression compared with conventional and prone compression in general radiography. An experimental design with quantitative approach. After obtaining the approval of the ethics committee, a consecutive sample of 48 patients was examined with the standard clinical urography protocol. The radiation doses were measured as dose-area product and analyzed with a paired t-test. The image quality was evaluated by visual grading analysis. Four radiologists evaluated each image individually by scoring nine criteria modified from the European quality criteria for diagnostic radiographic images. There was no significant difference in radiation dose or image quality between conventional and patient-controlled compression. Prone position resulted in both higher dose and inferior image quality. Patient-controlled compression gave similar dose levels as conventional compression and lower than prone compression. Image quality was similar with both patient-controlled and conventional compression and was judged to be better than in the prone position.

  2. Image quality testing of assembled IR camera modules

    NASA Astrophysics Data System (ADS)

    Winters, Daniel; Erichsen, Patrik

    2013-10-01

    Infrared (IR) camera modules for the LWIR (8-12_m) that combine IR imaging optics with microbolometer focal plane array (FPA) sensors with readout electronics are becoming more and more a mass market product. At the same time, steady improvements in sensor resolution in the higher priced markets raise the requirement for imaging performance of objectives and the proper alignment between objective and FPA. This puts pressure on camera manufacturers and system integrators to assess the image quality of finished camera modules in a cost-efficient and automated way for quality control or during end-of-line testing. In this paper we present recent development work done in the field of image quality testing of IR camera modules. This technology provides a wealth of additional information in contrast to the more traditional test methods like minimum resolvable temperature difference (MRTD) which give only a subjective overall test result. Parameters that can be measured are image quality via the modulation transfer function (MTF) for broadband or with various bandpass filters on- and off-axis and optical parameters like e.g. effective focal length (EFL) and distortion. If the camera module allows for refocusing the optics, additional parameters like best focus plane, image plane tilt, auto-focus quality, chief ray angle etc. can be characterized. Additionally, the homogeneity and response of the sensor with the optics can be characterized in order to calculate the appropriate tables for non-uniformity correction (NUC). The technology can also be used to control active alignment methods during mechanical assembly of optics to high resolution sensors. Other important points that are discussed are the flexibility of the technology to test IR modules with different form factors, electrical interfaces and last but not least the suitability for fully automated measurements in mass production.

  3. Metrologies for quantitative nanomechanical testing and quality control in semiconductor manufacturing

    NASA Astrophysics Data System (ADS)

    Pratt, Jon R.; Kramar, John A.; Newell, David B.; Smith, Douglas T.

    2005-05-01

    If nanomechanical testing is to evolve into a tool for process and quality control in semiconductor fabrication, great advances in throughput, repeatability, and accuracy of the associated instruments and measurements will be required. A recent grant awarded by the NIST Advanced Technology Program seeks to address the throughput issue by developing a high-speed AFM-based platform for quantitative nanomechanical measurements. The following paper speaks to the issue of quantitative accuracy by presenting an overview of various standards and techniques under development at NIST and other national metrology institutes (NMIs) that can provide a metrological basis for nanomechanical testing. The infrastructure we describe places firm emphasis on traceability to the International System of Units, paving the way for truly quantitative, rather than qualitative, physical property testing.

  4. Effects of imparting planned health education on hot flush beliefs and quality of life of climacteric women.

    PubMed

    Sis Çelik, A; Pasinlioğlu, T

    2017-02-01

    The aim of the present study was to determine the effect of imparting planned health education to climacteric women on their beliefs related to hot flushes and on their quality of life. The research was conducted using pretest and post-test semi-experimental models along with a control group. Of 450 women, 255 were randomly selected and invited to participate in the study. Five people did not agree to participate in the study. Three people were also excluded from the study because they did not complete training. The research sample was comprised of 247 climacteric women (121 women in the experimental group and 126 women in the control group) who were <65 years (the average ages of the participants in the experimental group were 50.61 ± 5.54 years and in the control group 50.94 ± 6.03 years), had experienced hot flushes within the past month, were going through the menopause and postmenopause, were not using hormone replacement therapy, and had agreed to participate in the study. Participants were asked to complete a Sociodemographic Questionnaire, the Hot Flush Beliefs Scale, and The Menopause-Specific Quality of Life Questionnaire. Three educational sessions at 2-week intervals were given to the women in the experimental group. The research was supported with an educational booklet prepared by the researchers. Training was not given to the women in the control group. After the education of the experimental group (after about 6 months), women in both groups recompleted the data collection forms, and post-test data were collected. On all the subscales, the total of the Hot Flush Beliefs Scale, and the average post-test score, the women in the experimental group scored lower than the women in the control group (the average post-test total score in the experimental group was 26.22 ± 10.09 and in control group it was 52.25 ± 15.04; p < 0.001). While the women in the experimental group developed positive beliefs about their hot flushes, the beliefs of the women in the control group remained unchanged. The average post-test score on all the subscales of the Menopause-Specific Quality of Life Questionnaire for the women in the experimental group was lower than that for the women in the control group (p < 0.001; the average post-test score in the experimental group for the vasomotor subscale was 1.78 ± 0.88, for the psychosocial subscale 1.50 ± 0.75, for the physical subscale 1.69 ± 0.63, and for the sexual subscale 2.91 ± 2.06; the average post-test score in the control group for the the vasomotor subscale was 3.80 ± 1.88, for the psychosocial subscale 2.79 ± 1.08, for the physical subscale 3.10 ± 1.04, and for the sexual subscale 2.25 ± 2.11). While the quality of life of the women in the experimental group showed an upward trend, that of the women in the control group remained the same. It was found that planned health education about the climacteric period reduced women's negative beliefs about hot flushes and enhanced their quality of life.

  5. Expanding HIV testing and counselling into communities: Feasibility, acceptability, and effects of an integrated family planning/HTC service delivery model by Village Health Teams in Uganda.

    PubMed

    Brunie, Aurélie; Wamala-Mucheri, Patricia; Akol, Angela; Mercer, Sarah; Chen, Mario

    2016-10-01

    Improving HIV testing and counselling (HTC) requires a range of strategies. This article reports on HTC service delivery by Village Health Teams (VHTs) in Uganda in the context of a model integrating this new component into pre-existing family planning services. Eight health centres from matched pairs were randomly allocated to intervention or control. After being trained, 36 VHTs reporting to selected facilities in the intervention group started offering HTC along with family planning, while VHTs in the control group provided family planning only. Proficiency testing was conducted as external quality assurance. A survey of all 36 VHTs and 137 family planning clients in the intervention group and 119 clients in the control group and a review of record data were conducted after 10 months. Survey responses by VHTs and their clients in the intervention group demonstrate knowledge of counselling messages and safe testing. External quality assessment results provide additional evidence of competency. Eighty per cent of the family planning clients surveyed in the intervention group received an HIV test during the intervention; 27% of those were first-time testers. More clients had ever tested for HIV in the intervention group compared with the control; clients also retested more often. Findings indicate that this model is feasible and acceptable for expanding quality HTC into communities. This study was registered with ClinicalTrials.gov, number [NCT02244398]. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  6. [Analysis of the results of the SEIMC External Quality Control Program. Year 2012].

    PubMed

    de Gopegui Bordes, Enrique Ruiz; Guna Serrano, M del Remedio; Orta Mira, Nieves; Ovies, María Rosario; Poveda, Marta; Gimeno Cardona, Concepción

    2014-02-01

    The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) include controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. This article presents the most relevant conclusions and lessons from the 2012 controls. As a whole, the results obtained in 2012 confirm the excellent skill and good technical standards found in previous editions. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. Once again, the results of this program highlighted the need to implement both internal and external controls in order to assure the maximal quality of the microbiological tests. Copyright © 2014 Elsevier España, S.L. All rights reserved.

  7. [Analysis of the results of the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology].

    PubMed

    Ruiz de Gopegui Bordes, Enrique; Serrano, M del Remedio Guna; Orta Mira, Nieves; Ovies, María Rosario; Poveda, Marta; Cardona, Concepción Gimeno

    2011-12-01

    The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. This article presents the most important conclusions and lessons of the 2010 controls. As a whole, the results obtained in 2010 confirm the excellent skill and good technical standards found in previous years. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. The results of this program highlight the need to implement both internal and external controls to ensure maximal quality of microbiological tests(1). Copyright © 2011 Elsevier España S.L. All rights reserved.

  8. [Analysis of the results of the SEIMC External Quality Control Program. Year 2014].

    PubMed

    Gopegui Bordes, Enrique Ruiz de; Guna Serrano, M Del Remedio; Orta Mira, Nieves; Medina González, Rafael; Rosario Ovies, María; Poveda, Marta; Gimeno Cardona, Concepción

    2016-07-01

    The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) include controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. This article presents the most relevant conclusions and lessons from the 2014 controls. As a whole, the results obtained in 2014 confirm the excellent skill and good technical standards found in previous editions. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. Once again, the results of the SEIMC program highlighted the need to implement both internal and external controls in order to assure the maximal quality of the microbiological tests. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  9. Long-Term Quality Control Program Plan for Cord Blood Banks in Korea: A Pilot Study for Cryopreservation Stability.

    PubMed

    Seo, Soo Hyun; Shin, Sue; Roh, Eun Youn; Song, Eun Young; Oh, Sohee; Kim, Byoung Jae; Yoon, Jong Hyun

    2017-03-01

    Maintaining the quality of cryopreserved cord blood is crucial. In this pilot study, we describe the results of the internal quality control program for a cord blood bank thus far. Donated cord blood units unsuitable for transplantation were selected for internal quality control once a month. One unit of cord blood, aliquoted into 21 capillaries, was cryopreserved and thawed annually to analyze the total nucleated cell count, CD34⁺ cell count, cell viability test, and colony-forming units assay. No significant differences in the variables (total nucleated cell count, cell viability, CD34⁺ cell count) were observed between samples cryopreserved for one and two years. Upon comparing the variables before cryopreservation and post thawing with the capillaries of one year of storage, cell viability and CD34⁺ cell counts decreased significantly. The use of cord blood samples in capillaries, which can be easily stored for a long period, was similar to the methods used for testing segments attached to the cord blood unit. The results of this study may be useful for determining the period during which the quality of cryopreserved cord blood units used for transplantation is maintained.

  10. Long-Term Quality Control Program Plan for Cord Blood Banks in Korea: A Pilot Study for Cryopreservation Stability

    PubMed Central

    Seo, Soo Hyun; Shin, Sue; Roh, Eun Youn; Song, Eun Young; Oh, Sohee; Kim, Byoung Jae

    2017-01-01

    Background Maintaining the quality of cryopreserved cord blood is crucial. In this pilot study, we describe the results of the internal quality control program for a cord blood bank thus far. Methods Donated cord blood units unsuitable for transplantation were selected for internal quality control once a month. One unit of cord blood, aliquoted into 21 capillaries, was cryopreserved and thawed annually to analyze the total nucleated cell count, CD34+ cell count, cell viability test, and colony-forming units assay. Results No significant differences in the variables (total nucleated cell count, cell viability, CD34+ cell count) were observed between samples cryopreserved for one and two years. Upon comparing the variables before cryopreservation and post thawing with the capillaries of one year of storage, cell viability and CD34+ cell counts decreased significantly. The use of cord blood samples in capillaries, which can be easily stored for a long period, was similar to the methods used for testing segments attached to the cord blood unit. Conclusions The results of this study may be useful for determining the period during which the quality of cryopreserved cord blood units used for transplantation is maintained. PMID:28028998

  11. Effects of a sitting boxing program on upper limb function, balance, gait, and quality of life in stroke patients.

    PubMed

    Park, Junhyuck; Gong, Jihwan; Yim, Jongeun

    2017-01-01

    Boxing training including traditional stretching, muscular strength training, and duration training would be considered to be effective for improved functional stretching, dynamic balance, walking speed, and quality of life. We aimed to investigate upper limb function, balance, gait, and quality of life in stroke patients before and after a sitting boxing program. Twenty-six participants were randomly allocated to a boxing group (n = 13) and control group (n = 13) after the upper limb function, balance, gait, and quality of Life were recorded. The boxing group underwent a sitting boxing program (3 times/week) as well as conventional physical therapy (3 times/week) for 6 weeks. The control group only underwent conventional physical therapy (3 times/week) for 6 weeks. The Manual Functional Test (MFT), non-affected hand grip, Berg Balance Scale (BBS), velocity moment with eye opened, 10-m Walk Test (10 MWT), and Stroke-Specific Quality of Life questionnaire (SS-QOL) were significantly improved in the boxing group (p < 0.05) and showed significantly greater improvements in the boxing group compared to the control group (p < 0.05) after 6 weeks. The sitting boxing program group had positive effects on upper extremity function, balance, gait, and quality of life in stroke patients.

  12. Examining asthma quality of care using a population-based approach

    PubMed Central

    Klomp, Helena; Lawson, Joshua A.; Cockcroft, Donald W.; Chan, Benjamin T.; Cascagnette, Paul; Gander, Laurie; Jorgenson, Derek

    2008-01-01

    Background Asthma accounts for considerable burden on health care, but in most cases, asthma can be controlled. Quality-of-care indicators would aid in monitoring asthma management. We describe the quality of asthma care using a set of proposed quality indicators. Methods We performed a retrospective cross-sectional study using health databases in Saskatchewan, a Canadian province with a population of about 1 million people. We assessed 6 quality-of-care indicators among people with asthma: admission to hospital because of asthma; poor asthma control (high use of short-acting β-agonists, admission to hospital because of asthma or death due to asthma); no inhaled corticosteroid use among patients with poor control; at least moderate inhaled corticosteroid use among patients with poor control; high inhaled corticosteroid use and use of another preventer medication among patients with poor control; and any main preventer use among patients with poor control. We calculated crude and adjusted rates with 95% confidence intervals. We tested for differences using the χ2 test for proportions and generalized linear modelling techniques. Results In 2002/03, there were 24 616 people aged 5–54 years with asthma in Saskatchewan, representing a prevalence of 3.8%. Poor symptom control was observed in 18% of patients with asthma. Among those with poor control, 37% were not dispensed any inhaled corticosteroids, and 40% received potentially inadequate doses. Among those with poor control who were dispensed high doses of inhaled corticosteroids, 26% also used another preventer medication. Hospital admissions because of asthma were highest among those aged 6–9 years and females aged 20–44 years. Males and those in adult age groups (predominantly 20–44 years) had worse quality of care for 4 indicators examined. Interpretation Suboptimal asthma management would be improved through increased use of inhaled corticosteroids and preventer medications, and reduced reliance on short-acting β-agonist medications as recommended by consensus guidelines. PMID:18390944

  13. CONDUIT: A New Multidisciplinary Integration Environment for Flight Control Development

    NASA Technical Reports Server (NTRS)

    Tischler, Mark B.; Colbourne, Jason D.; Morel, Mark R.; Biezad, Daniel J.; Levine, William S.; Moldoveanu, Veronica

    1997-01-01

    A state-of-the-art computational facility for aircraft flight control design, evaluation, and integration called CONDUIT (Control Designer's Unified Interface) has been developed. This paper describes the CONDUIT tool and case study applications to complex rotary- and fixed-wing fly-by-wire flight control problems. Control system analysis and design optimization methods are presented, including definition of design specifications and system models within CONDUIT, and the multi-objective function optimization (CONSOL-OPTCAD) used to tune the selected design parameters. Design examples are based on flight test programs for which extensive data are available for validation. CONDUIT is used to analyze baseline control laws against pertinent military handling qualities and control system specifications. In both case studies, CONDUIT successfully exploits trade-offs between forward loop and feedback dynamics to significantly improve the expected handling, qualities and minimize the required actuator authority. The CONDUIT system provides a new environment for integrated control system analysis and design, and has potential for significantly reducing the time and cost of control system flight test optimization.

  14. Long-term pavement performance indicators for failed materials.

    DOT National Transportation Integrated Search

    2016-04-01

    State Transportation Agencies (STAs) use quality control/quality assurance (QC/QA) specifications to guide the testing and inspection of : road pavement construction. Although failed materials of pavement rarely occur in practice, it is critical to h...

  15. Effects of selection for decreased residual feed intake on composition and quality of fresh pork.

    PubMed

    Smith, R M; Gabler, N K; Young, J M; Cai, W; Boddicker, N J; Anderson, M J; Huff-Lonergan, E; Dekkers, J C M; Lonergan, S M

    2011-01-01

    The objectives of this study were to determine the extent to which selection for decreased residual feed intake (RFI) affects pork composition and quality. Pigs from the fifth generation of selection for decreased RFI (select) and a randomly selected line (control) were utilized. Two experiments were conducted. In Exp. 1, barrows (22.6 ± 3.9 kg) from select and control lines were paired based on age and BW. The test was conducted in 8 replicates of pairs for the test period of 6 wk. Calpastatin activity and myosin isoforms profile were determined on samples from the LM. Control barrows were heavier (59.1 vs. 55.0 kg; P < 0.01) at the end of the test period. Calpastatin activity was greater (P < 0.01) in LM of select barrows than control barrows. In Exp. 2, composition and quality of gilts (114 kg) from control and select lines were determined. The model included fixed effects of line, slaughter date, melanocortin-4 receptor (MC4R) genotype, barn group, line × slaughter date, genotype × line interactions, a covariate of off-test BW, and sire, pen, and litter fitted as random effects. The select line (n = 80) had 0.043 kg less (P < 0.05) RFI per day than the control line (n = 89). Loin quality and composition were determined at 2 d postmortem. Desmin degradation was measured at 2 and 7 d postmortem. Purge, cook loss, sensory traits, and star probe texture were measured at 7 to 10 d postmortem on cooked chops. Residual correlations between RFI and composition and quality traits were calculated. Compared with the control line, carcasses from the select line tended to have less (P = 0.09) backfat, greater (P < 0.05) loin depth, and greater (P < 0.05) fat free lean. Loin chops from the select line had less (P < 0.01) intramuscular lipid content than loin chops from control line. Significant residual correlations between RFI and both tenderness (r = 0.24, P < 0.01) and star probe (r = -0.26, P < 0.01) were identified. Selection for decreased RFI has the potential to improve carcass composition with few effects on pH and water-holding capacity. However, decreased RFI could negatively affect tenderness and texture because of decreased lipid content and decreased postmortem protein degradation.

  16. Oromucosal film preparations: classification and characterization methods.

    PubMed

    Preis, Maren; Woertz, Christina; Kleinebudde, Peter; Breitkreutz, Jörg

    2013-09-01

    Recently, the regulatory authorities have enlarged the variety of 'oromucosal preparations' by buccal films and orodispersible films. Various film preparations have entered the market and pharmacopoeias. Due to the novelty of the official monographs, no standardized characterization methods and quality specifications are included. This review reports the methods of choice to characterize oromucosal film preparations with respect to biorelevant characterization and quality control. Commonly used dissolution tests for other dosage forms are not transferable for films in all cases. Alternatives and guidance on decision, which methods are favorable for film preparations are discussed. Furthermore, issues about requirements for film dosage forms are reflected. Oromucosal film preparations offer a wide spectrum of opportunities. There are a lot of suggestions in the literature on how to control the quality of these innovative products, but no standardized tests are available. Regulatory authorities need to define the standards and quality requirements more precisely.

  17. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  18. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  19. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  20. Langley Wind Tunnel Data Quality Assurance-Check Standard Results

    NASA Technical Reports Server (NTRS)

    Hemsch, Michael J.; Grubb, John P.; Krieger, William B.; Cler, Daniel L.

    2000-01-01

    A framework for statistical evaluation, control and improvement of wind funnel measurement processes is presented The methodology is adapted from elements of the Measurement Assurance Plans developed by the National Bureau of Standards (now the National Institute of Standards and Technology) for standards and calibration laboratories. The present methodology is based on the notions of statistical quality control (SQC) together with check standard testing and a small number of customer repeat-run sets. The results of check standard and customer repeat-run -sets are analyzed using the statistical control chart-methods of Walter A. Shewhart long familiar to the SQC community. Control chart results are presented for. various measurement processes in five facilities at Langley Research Center. The processes include test section calibration, force and moment measurements with a balance, and instrument calibration.

  1. 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.

  2. Deriving criteria to select arthropod species for laboratory tests to assess the ecological risks from cultivating arthropod-resistant genetically engineered crops.

    PubMed

    Romeis, Jörg; Raybould, Alan; Bigler, Franz; Candolfi, Marco P; Hellmich, Richard L; Huesing, Joseph E; Shelton, Anthony M

    2013-01-01

    Arthropods form a major part of the biodiversity in agricultural landscapes. Many species are valued because they provide ecosystem services, including biological control, pollination and decomposition, or because they are of conservation interest. Some arthropods reduce crop yield and quality, and conventional chemical pesticides, biological control agents and genetically engineered (GE) crops are used to control them. A common concern addressed in the ecological risk assessment (ERA) that precedes regulatory approval of these pest control methods is their potential to adversely affect valued non-target arthropods (NTAs). A key concept of ERA is early-tier testing using worst-case exposure conditions in the laboratory and surrogate test species that are most likely to reveal an adverse effect. If no adverse effects are observed in those species at high exposures, confidence of negligible ecological risk from the use of the pest control method is increased. From experience with chemical pesticides and biological control agents, an approach is proposed for selecting test species for early-tier ERA of GE arthropod-resistant crops. Surrogate species should be selected that most closely meet three criteria: (i) Potential sensitivity: species should be the most likely to be sensitive to the arthropod-active compound based on the known spectrum of activity of the active ingredient, its mode of action, and the phylogenetic relatedness of the test and target species; (ii) species should be representative of valued taxa or functional groups that are most likely to be exposed to the arthropod-active compound in the field; and (iii) Availability and reliability: suitable life-stages of the test species must be obtainable in sufficient quantity and quality, and validated test protocols must be available that allow consistent detection of adverse effects on ecologically relevant parameters. Our proposed approach ensures that the most suitable species are selected for testing and that the resulting data provide the most rigorous test of the risk hypothesis of no adverse effect in order to increase the quality and efficiency of ERAs for cultivation of GE crops. Copyright © 2012 Elsevier Ltd. All rights reserved.

  3. Evaluation of repeatability of Kansas test method KT-73, "density, absorption and voids in hardened concrete," boil test.

    DOT National Transportation Integrated Search

    2015-06-01

    For years, the Kansas Department of Transportation (KDOT) and concrete producers in the state have used a : Rapid Chloride Test for concrete cylinders, AASHTO T277. This test has been thought of as an appropriate quality : control test to evaluate pe...

  4. Quality assurance and quality control for thermal/optical analysis of aerosol samples for organic and elemental carbon.

    PubMed

    Chow, Judith C; Watson, John G; Robles, Jerome; Wang, Xiaoliang; Chen, L-W Antony; Trimble, Dana L; Kohl, Steven D; Tropp, Richard J; Fung, Kochy K

    2011-12-01

    Accurate, precise, and valid organic and elemental carbon (OC and EC, respectively) measurements require more effort than the routine analysis of ambient aerosol and source samples. This paper documents the quality assurance (QA) and quality control (QC) procedures that should be implemented to ensure consistency of OC and EC measurements. Prior to field sampling, the appropriate filter substrate must be selected and tested for sampling effectiveness. Unexposed filters are pre-fired to remove contaminants and acceptance tested. After sampling, filters must be stored in the laboratory in clean, labeled containers under refrigeration (<4 °C) to minimize loss of semi-volatile OC. QA activities include participation in laboratory accreditation programs, external system audits, and interlaboratory comparisons. For thermal/optical carbon analyses, periodic QC tests include calibration of the flame ionization detector with different types of carbon standards, thermogram inspection, replicate analyses, quantification of trace oxygen concentrations (<100 ppmv) in the helium atmosphere, and calibration of the sample temperature sensor. These established QA/QC procedures are applicable to aerosol sampling and analysis for carbon and other chemical components.

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

    PubMed

    Ueno, Tamio; Matuda, Junichi; Yamane, Nobuhisa

    2013-03-01

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

  6. [Study thought of pharmaceutical preparations quality standards by dynamic quality control technology].

    PubMed

    Yu, Dan-Hong; Mao, Chen-Mei; Lv, Cheng-Zhe; Jin, Hui-Zhen; Yao, Xin; Jia, Xiao-Bin

    2014-07-01

    Pharmaceutical preparations, particularly as a "secret recipe" of traditional Chinese medicine in medical institutions, are the product of China's medical and health industry, and they are also an important means of competing of different medical institutions. Although pharmaceutical preparations have advantages and characteristics than institutes for drug and pharmaceutical companies, the quality standards of pharmaceutical preparations in medical institutions has not reached the desired level over the years. As we all know, the quality of pharmaceutical preparations is important to ensure the efficacy, especially under the environment of people pay more sttention on drug safety and effectiveness and contry increase emphasis on the stste of pharmaceutical preparations. In view of this, we will improve the grade, stability, and clinical efficacy of pharmaceutical preparations by the advanced equipment, testing instruments and the process dynamic quality control technology. Finally, we hope we can provide new ideas for the quality control of pharmaceutical preparations.

  7. Sleeping with one eye open: loneliness and sleep quality in young adults.

    PubMed

    Matthews, T; Danese, A; Gregory, A M; Caspi, A; Moffitt, T E; Arseneault, L

    2017-09-01

    Feelings of loneliness are common among young adults, and are hypothesized to impair the quality of sleep. In the present study, we tested associations between loneliness and sleep quality in a nationally representative sample of young adults. Further, based on the hypothesis that sleep problems in lonely individuals are driven by increased vigilance for threat, we tested whether past exposure to violence exacerbated this association. Data were drawn from the Environmental Risk (E-Risk) Longitudinal Twin Study, a birth cohort of 2232 twins born in England and Wales in 1994 and 1995. We measured loneliness using items from the UCLA Loneliness Scale, and sleep quality using the Pittsburgh Sleep Quality Index. We controlled for covariates including social isolation, psychopathology, employment status and being a parent of an infant. We examined twin differences to control for unmeasured genetic and family environment factors. Feelings of loneliness were associated with worse overall sleep quality. Loneliness was associated specifically with subjective sleep quality and daytime dysfunction. These associations were robust to controls for covariates. Among monozygotic twins, within-twin pair differences in loneliness were significantly associated with within-pair differences in sleep quality, indicating an association independent of unmeasured familial influences. The association between loneliness and sleep quality was exacerbated among individuals exposed to violence victimization in adolescence or maltreatment in childhood. Loneliness is robustly associated with poorer sleep quality in young people, underscoring the importance of early interventions to mitigate the long-term outcomes of loneliness. Special care should be directed towards individuals who have experienced victimization.

  8. Parenting Behavior, Quality of the Parent-Adolescent Relationship, and Adolescent Functioning in Four Ethnic Groups

    ERIC Educational Resources Information Center

    Wissink, Inge B.; Dekovic, Maja; Meijer, Anne Marie

    2006-01-01

    The cross-ethnic similarity in the pattern of associations among parenting behavior (support and authoritative and restrictive control), the quality of the parent-adolescent relationship (disclosure and positive and negative quality), and several developmental outcomes (aggressive behavior, delinquent behavior, and global self-esteem) was tested.…

  9. A flight cylinder bioassay as a simple, effective quality control test for Cydia pomonella

    USDA-ARS?s Scientific Manuscript database

    Assessment of quality of the sterile male insects that are being mass-reared for release in area-wide integrated pest management programmes that include a sterile insect technique component is crucial for the success of these programmes. Routine monitoring of sterile male quality needs to be carried...

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

    USDA-ARS?s Scientific Manuscript database

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

  11. A novel non-uniform control vector parameterization approach with time grid refinement for flight level tracking optimal control problems.

    PubMed

    Liu, Ping; Li, Guodong; Liu, Xinggao; Xiao, Long; Wang, Yalin; Yang, Chunhua; Gui, Weihua

    2018-02-01

    High quality control method is essential for the implementation of aircraft autopilot system. An optimal control problem model considering the safe aerodynamic envelop is therefore established to improve the control quality of aircraft flight level tracking. A novel non-uniform control vector parameterization (CVP) method with time grid refinement is then proposed for solving the optimal control problem. By introducing the Hilbert-Huang transform (HHT) analysis, an efficient time grid refinement approach is presented and an adaptive time grid is automatically obtained. With this refinement, the proposed method needs fewer optimization parameters to achieve better control quality when compared with uniform refinement CVP method, whereas the computational cost is lower. Two well-known flight level altitude tracking problems and one minimum time cost problem are tested as illustrations and the uniform refinement control vector parameterization method is adopted as the comparative base. Numerical results show that the proposed method achieves better performances in terms of optimization accuracy and computation cost; meanwhile, the control quality is efficiently improved. Copyright © 2017 ISA. Published by Elsevier Ltd. All rights reserved.

  12. Examining System-Wide Impacts of Solar PV Control Systems with a Power Hardware-in-the-Loop Platform

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

    Williams, Tess L.; Fuller, Jason C.; Schneider, Kevin P.

    2014-06-08

    High penetration levels of distributed solar PV power generation can lead to adverse power quality impacts, such as excessive voltage rise, voltage flicker, and reactive power values that result in unacceptable voltage levels. Advanced inverter control schemes have been developed that have the potential to mitigate many power quality concerns. However, local closed-loop control may lead to unintended behavior in deployed systems as complex interactions can occur between numerous operating devices. To enable the study of the performance of advanced control schemes in a detailed distribution system environment, a test platform has been developed that integrates Power Hardware-in-the-Loop (PHIL) withmore » concurrent time-series electric distribution system simulation. In the test platform, GridLAB-D, a distribution system simulation tool, runs a detailed simulation of a distribution feeder in real-time mode at the Pacific Northwest National Laboratory (PNNL) and supplies power system parameters at a point of common coupling. At the National Renewable Energy Laboratory (NREL), a hardware inverter interacts with grid and PV simulators emulating an operational distribution system. Power output from the inverters is measured and sent to PNNL to update the real-time distribution system simulation. The platform is described and initial test cases are presented. The platform is used to study the system-wide impacts and the interactions of inverter control modes—constant power factor and active Volt/VAr control—when integrated into a simulated IEEE 8500-node test feeder. We demonstrate that this platform is well-suited to the study of advanced inverter controls and their impacts on the power quality of a distribution feeder. Additionally, results are used to validate GridLAB-D simulations of advanced inverter controls.« less

  13. The effects of preoperative aromatherapy massage on anxiety and sleep quality of colorectal surgery patients: A randomized controlled study.

    PubMed

    Ayik, Cahide; Özden, Dilek

    2018-02-01

    To examine the effects of aromatherapy massage on anxiety and sleep quality in patients undergoing colorectal surgery in the preoperative period. In recent years, there has been an increase in the number of studies conducted on aromatherapy massage. It is stated that studies conducted on aromatherapy massage for anxiety and sleep quality reveal contradictory results and that more research is required on the issue. A randomized controlled trial. Eighty patients undergoing colorectal surgery were randomly assigned to experimental and control group. To the experimental group (n = 40), aromatherapy massage was applied in accordance with the "Back Massage Guide" using 5% lavender oil (Lavandula Hybrida) for ten minutes before surgery and the morning of surgery. The control group received standard nursing care in compliance with the hospital procedure. Data were obtained by the State Anxiety Inventory (SAI) and Richard-Campbell Sleep Questionnaire (RCSQ). Results were analyzed using the t-test, Chi-square test or Fisher's exact test. There was no baseline difference between the groups. A statistically significant difference was found between the experimental and control group in terms of the SAI and RCSQ mean scores recorded on the morning of surgery. It was determined that the SAI and RCSQ mean score of the experimental group after aromatherapy massage on the morning of surgery decreased when compared to that of the evening before surgery. It was found that aromatherapy massage with lavender oil increased the sleep quality and reduced the level of anxiety in patients with colorectal surgery in the preoperative period. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Clinical trials of homoeopathy.

    PubMed Central

    Kleijnen, J; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

  15. QALMA: A computational toolkit for the analysis of quality protocols for medical linear accelerators in radiation therapy

    NASA Astrophysics Data System (ADS)

    Rahman, Md Mushfiqur; Lei, Yu; Kalantzis, Georgios

    2018-01-01

    Quality Assurance (QA) for medical linear accelerator (linac) is one of the primary concerns in external beam radiation Therapy. Continued advancements in clinical accelerators and computer control technology make the QA procedures more complex and time consuming which often, adequate software accompanied with specific phantoms is required. To ameliorate that matter, we introduce QALMA (Quality Assurance for Linac with MATLAB), a MALAB toolkit which aims to simplify the quantitative analysis of QA for linac which includes Star-Shot analysis, Picket Fence test, Winston-Lutz test, Multileaf Collimator (MLC) log file analysis and verification of light & radiation field coincidence test.

  16. Effect of testing for cancer on cancer- and venous thromboembolism (VTE)-related mortality and morbidity in people with unprovoked VTE.

    PubMed

    Robertson, Lindsay; Yeoh, Su Ern; Stansby, Gerard; Agarwal, Roshan

    2017-08-23

    Venous thromboembolism (VTE) is a collective term for two conditions: deep vein thrombosis (DVT) and pulmonary embolism (PE). A proportion of people with VTE have no underlying or immediately predisposing risk factors and the VTE is referred to as unprovoked. Unprovoked VTE can often be the first clinical manifestation of an underlying malignancy. This has raised the question of whether people with an unprovoked VTE should be investigated for an underlying cancer. Treatment for VTE is different in cancer and non-cancer patients and a correct diagnosis would ensure that people received the optimal treatment for VTE to prevent recurrence and further morbidity. Furthermore, an appropriate cancer diagnosis at an earlier, potentially curative stage could avoid the risk of cancer progression and thus lead to improvements in cancer-related mortality and morbidity. This is an update of a review first published in 2015. To determine whether testing for undiagnosed cancer in people with a first episode of unprovoked VTE (DVT of the lower limb or PE) is effective in reducing cancer and VTE-related mortality and morbidity and to determine which tests for cancer are best at identifying treatable cancers early. For this update, the Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (16 February 2017). In addition, the CIS searched the Cochrane Register of Studies CENTRAL (2017, Issue 1). We searched trials registries (February 2017) and checked the reference lists of relevant articles. Randomised and quasi-randomised trials in which people with an unprovoked VTE were allocated to receive specific tests for cancer or clinically indicated tests only were eligible for inclusion in this review. Primary outcomes included all-cause mortality, cancer-related mortality and VTE-related mortality. Two review authors independently selected studies, assessed quality and extracted data. We resolved any disagreements by discussion. Four studies with 1644 participants met the inclusion criteria (two studies in the original review and two in this update). Two studies assessed the effect of extensive tests versus tests at the physician's discretion) while the other two studies assessed the effect of standard testing plus positron emission tomography (PET)/computed tomography (CT) scanning versus standard testing alone. For extensive tests versus tests at the physician's discretion, the quality of the evidence was low due to risk of bias (early termination of the studies). When comparing standard testing plus PET/CT scanning versus standard testing alone, the quality of evidence was moderate due to a risk of detection bias. The quality of the evidence was downgraded further when detection bias was present in one study with a low number of events.When comparing extensive tests versus tests at the physician's discretion, pooled analysis on two studies showed that testing for cancer was consistent with either a benefit or no benefit on cancer-related mortality (odds ratio (OR) 0.49, 95% confidence interval (CI) 0.15 to 1.67; 396 participants; 2 studies; P = 0.26; low quality evidence). One study (201 participants) showed that, overall, malignancies were less advanced in extensively tested participants than in participants in the control group. In total, 9/13 participants diagnosed with cancer in the extensively tested group had a T1 or T2 stage malignancy compared to 2/10 participants diagnosed with cancer in the control group (OR 5.00, 95% CI 1.05 to 23.76; P = 0.04; low quality evidence). There was no clear difference in detection of advanced stages between extensive tests versus tests at the physician's discretion: one participant in the extensively tested group had stage T3 compared with four participants in the control group (OR 0.25, 95% CI 0.03 to 2.28; P = 0.22; low quality evidence). In addition, extensively tested participants were diagnosed earlier than control group (mean: 1 month with extensive tests versus 11.6 months with tests at physician's discretion to cancer diagnosis from the time of diagnosis of VTE). Extensive testing did not increase the frequency of an underlying cancer diagnosis (OR 1.32, 95% CI 0.59 to 2.93; 396 participants; 2 studies; P = 0.50; low quality evidence). Neither study measured all-cause mortality, VTE-related morbidity and mortality, complications of anticoagulation, adverse effects of cancer tests, participant satisfaction or quality of life.When comparing standard testing plus PET/CT screening versus standard testing alone, standard testing plus PET/CT screening was consistent with either a benefit or no benefit on all-cause mortality (OR 1.22, 95% CI 0.49 to 3.04; 1248 participants; 2 studies; P = 0.66; moderate quality evidence), cancer-related mortality (OR 0.55, 95% CI 0.20 to 1.52; 1248 participants; 2 studies; P = 0.25; moderate quality evidence) or VTE-related morbidity (OR 1.02, 95% CI 0.48 to 2.17; 854 participants; 1 study; P = 0.96; moderate quality evidence). With regards to stage of cancer, there was no clear difference for detection of early (OR 1.78, 95% 0.51 to 6.17; 394 participants; 1 study; P = 0.37; low quality evidence) or advanced (OR 1.00, 95% CI 0.14 to 7.17; 394 participants; 1 study; P = 1.00; low quality evidence) stages of cancer. There was also no clear difference in the frequency of an underlying cancer diagnosis (OR 1.71, 95% CI 0.91 to 3.20; 1248 participants; 2 studies; P = 0.09; moderate quality evidence). Time to cancer diagnosis was 4.2 months in the standard testing group and 4.0 months in the standard testing plus PET/CT group (P = 0.88). Neither study measured VTE-related mortality, complications of anticoagulation, adverse effects of cancer tests, participant satisfaction or quality of life. Testing for cancer in people with unprovoked VTE may lead to earlier diagnosis of cancer at an earlier stage of the disease. However, there is currently insufficient evidence to draw definitive conclusions concerning the effectiveness of testing for undiagnosed cancer in people with a first episode of unprovoked VTE (DVT or PE) in reducing cancer and VTE-related morbidity and mortality. The results could be consistent with either benefit or no benefit. Further good-quality large-scale randomised controlled trials are required before firm conclusions can be made.

  17. High cortisol levels are associated with low quality food choice in type 2 diabetes.

    PubMed

    Duong, Michelle; Cohen, Jessica I; Convit, Antonio

    2012-02-01

    Hypothalamic-pituitary-adrenal (HPA) axis control may be impaired in type 2 diabetes (T2DM). Glucocorticoids increase consumption of low quality foods high in calories, sugar, and fat. We explored the relationship between cortisol levels, poor blood glucose control, and food quality choice in T2DM. Twenty-seven healthy controls were age-, gender- and education-matched to 27 T2DM participants. Standard clinical blood tests and cortisol values were measured from fasting blood samples. Participants recorded all consumed food and drink items in a consecutive 3-day food diary. Diaries were analyzed for "high quality" and "low quality" foods using a standardized method with high reliability (0.97 and 0.86, respectively). Controlling for education, body mass index (BMI) and hemoglobin A1C (HbA1C), log-transformed cortisol (LogC) predicted the percent of low quality foods (R (2) = 0.092, β = 0.360, P < 0.05), but not the percent of high quality foods chosen. Controlling for education, BMI, and LogC, HbA1C significantly predicted both the percent of low quality foods (ΔR (2) = 0.079, β = 0.348, P = 0.024) and high quality foods chosen (ΔR (2) = 0.085, β = -0.362, P = 0.022). The relationship between HbA1C and low quality food choice may be mediated by cortisol, controlling for BMI and education (P < 0.01). HbA1C displayed both an indirect (cortisol-mediated) effect (P < 0.05) and direct effect on low quality food choice (P < 0.05). The relationship between HbA1C and low quality food choice may be partially mediated by cortisol. Poor blood glucose control may cause HPA axis disruption, increased consumption of low quality foods.

  18. The quest for performance-related specifications for hydraulic cement concrete.

    DOT National Transportation Integrated Search

    1982-01-01

    This paper reviews some of the problems associated with quality assurance for hydraulic cement concrete and the difficulties of relating the results of quality control and acceptance testing to the performance of the concrete facility. The importance...

  19. Inhibitory Control Mediates the Association between Perceived Stress and Secure Relationship Quality.

    PubMed

    Herd, Toria; Li, Mengjiao; Maciejewski, Dominique; Lee, Jacob; Deater-Deckard, Kirby; King-Casas, Brooks; Kim-Spoon, Jungmeen

    2018-01-01

    Past research has demonstrated negative associations between exposure to stressors and quality of interpersonal relationships among children and adolescents. Nevertheless, underlying mechanisms of this association remain unclear. Chronic stress has been shown to disrupt prefrontal functioning in the brain, including inhibitory control abilities, and evidence is accumulating that inhibitory control may play an important role in secure interpersonal relationship quality, including peer problems and social competence. In this prospective longitudinal study, we examine whether changes in inhibitory control, measured at both behavioral and neural levels, mediate the association between stress and changes in secure relationship quality with parents and peers. The sample included 167 adolescents (53% males) who were first recruited at age 13 or 14 years and assessed annually three times. Adolescents' inhibitory control was measured by their behavioral performance and brain activities, and adolescents self-reported perceived stress levels and relationship quality with mothers, fathers, and peers. Results suggest that behavioral inhibitory control mediates the association between perceived stress and adolescent's secure relationship quality with their mothers and fathers, but not their peers. In contrast, given that stress was not significantly correlated with neural inhibitory control, we did not further test the mediation path. Our results highlight the role of inhibitory control as a process through which stressful life experiences are related to impaired secure relationship quality between adolescents and their mothers and fathers.

  20. Inhibitory Control Mediates the Association between Perceived Stress and Secure Relationship Quality

    PubMed Central

    Herd, Toria; Li, Mengjiao; Maciejewski, Dominique; Lee, Jacob; Deater-Deckard, Kirby; King-Casas, Brooks; Kim-Spoon, Jungmeen

    2018-01-01

    Past research has demonstrated negative associations between exposure to stressors and quality of interpersonal relationships among children and adolescents. Nevertheless, underlying mechanisms of this association remain unclear. Chronic stress has been shown to disrupt prefrontal functioning in the brain, including inhibitory control abilities, and evidence is accumulating that inhibitory control may play an important role in secure interpersonal relationship quality, including peer problems and social competence. In this prospective longitudinal study, we examine whether changes in inhibitory control, measured at both behavioral and neural levels, mediate the association between stress and changes in secure relationship quality with parents and peers. The sample included 167 adolescents (53% males) who were first recruited at age 13 or 14 years and assessed annually three times. Adolescents’ inhibitory control was measured by their behavioral performance and brain activities, and adolescents self-reported perceived stress levels and relationship quality with mothers, fathers, and peers. Results suggest that behavioral inhibitory control mediates the association between perceived stress and adolescent’s secure relationship quality with their mothers and fathers, but not their peers. In contrast, given that stress was not significantly correlated with neural inhibitory control, we did not further test the mediation path. Our results highlight the role of inhibitory control as a process through which stressful life experiences are related to impaired secure relationship quality between adolescents and their mothers and fathers. PMID:29535664

  1. Multileaf collimator performance monitoring and improvement using semiautomated quality control testing and statistical process control

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

    Létourneau, Daniel, E-mail: daniel.letourneau@rmp.uh.on.ca; McNiven, Andrea; Keller, Harald

    2014-12-15

    Purpose: High-quality radiation therapy using highly conformal dose distributions and image-guided techniques requires optimum machine delivery performance. In this work, a monitoring system for multileaf collimator (MLC) performance, integrating semiautomated MLC quality control (QC) tests and statistical process control tools, was developed. The MLC performance monitoring system was used for almost a year on two commercially available MLC models. Control charts were used to establish MLC performance and assess test frequency required to achieve a given level of performance. MLC-related interlocks and servicing events were recorded during the monitoring period and were investigated as indicators of MLC performance variations. Methods:more » The QC test developed as part of the MLC performance monitoring system uses 2D megavoltage images (acquired using an electronic portal imaging device) of 23 fields to determine the location of the leaves with respect to the radiation isocenter. The precision of the MLC performance monitoring QC test and the MLC itself was assessed by detecting the MLC leaf positions on 127 megavoltage images of a static field. After initial calibration, the MLC performance monitoring QC test was performed 3–4 times/week over a period of 10–11 months to monitor positional accuracy of individual leaves for two different MLC models. Analysis of test results was performed using individuals control charts per leaf with control limits computed based on the measurements as well as two sets of specifications of ±0.5 and ±1 mm. Out-of-specification and out-of-control leaves were automatically flagged by the monitoring system and reviewed monthly by physicists. MLC-related interlocks reported by the linear accelerator and servicing events were recorded to help identify potential causes of nonrandom MLC leaf positioning variations. Results: The precision of the MLC performance monitoring QC test and the MLC itself was within ±0.22 mm for most MLC leaves and the majority of the apparent leaf motion was attributed to beam spot displacements between irradiations. The MLC QC test was performed 193 and 162 times over the monitoring period for the studied units and recalibration had to be repeated up to three times on one of these units. For both units, rate of MLC interlocks was moderately associated with MLC servicing events. The strongest association with the MLC performance was observed between the MLC servicing events and the total number of out-of-control leaves. The average elapsed time for which the number of out-of-specification or out-of-control leaves was within a given performance threshold was computed and used to assess adequacy of MLC test frequency. Conclusions: A MLC performance monitoring system has been developed and implemented to acquire high-quality QC data at high frequency. This is enabled by the relatively short acquisition time for the images and automatic image analysis. The monitoring system was also used to record and track the rate of MLC-related interlocks and servicing events. MLC performances for two commercially available MLC models have been assessed and the results support monthly test frequency for widely accepted ±1 mm specifications. Higher QC test frequency is however required to maintain tighter specification and in-control behavior.« less

  2. 21 CFR 862.1660 - Quality control material (assayed and unassayed).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds...). Except when used in donor screening tests, unassayed material is exempt from the premarket notification...

  3. Quality Audit in the Fastener Industry

    NASA Technical Reports Server (NTRS)

    Reagan, John R.

    1995-01-01

    Both the financial and quality communities rely on audits to verify customers records. The financial community is highly structured around three categories of risk, INHERENT RISK, CONTROL RISK, and DETECTION RISK. Combined, the product of these three categories constitute the AUDIT RISK. The financial community establishes CONTROL RISK based in large part on a systems level understanding of the process flow. This system level understanding is best expressed in a flowchart. The quality community may be able to adopt this structure and thereby reduce cost while maintaining and enhancing quality. The quality community should attempt to flowchart the systems level quality process before beginning substantive testing. This theory needs to be applied in several trial cases to prove or disprove this hypothesis

  4. Quality audit in the fastener industry

    NASA Astrophysics Data System (ADS)

    Reagan, John R.

    1995-09-01

    Both the financial and quality communities rely on audits to verify customers records. The financial community is highly structured around three categories of risk, INHERENT RISK, CONTROL RISK, and DETECTION RISK. Combined, the product of these three categories constitute the AUDIT RISK. The financial community establishes CONTROL RISK based in large part on a systems level understanding of the process flow. This system level understanding is best expressed in a flowchart. The quality community may be able to adopt this structure and thereby reduce cost while maintaining and enhancing quality. The quality community should attempt to flowchart the systems level quality process before beginning substantive testing. This theory needs to be applied in several trial cases to prove or disprove this hypothesis

  5. Large-Scale Operations Management Test of Use of the White Amur for Control of Problem Aquatic Plants. Report 2. First Year Poststocking Results. Volume VI. The Water and Sediment Quality of Lake Conway, Florida.

    DTIC Science & Technology

    1982-02-01

    AD A113 .5. ORANGE COUNTY POLLUTION CONTROL DEPT ORLANDO FL F/S 6/6 LARGE-SCALE OPERATIONS MANAGEMENT TEST OF USE OF THE WHITE AMUR-ETC(U) FEB 82 H D...Large-Scale Operations Management Test of use of the white amur for control of problem aquatic plants in Lake Conway, Fla. Report 1 of the series presents...as follows: Miller, D. 1982. "Large-Scale Operations Management Test of Use of the White Amur for Control of Problem Aquatic Plants; Report 2, First

  6. Large-Scale Operations Management Test of Use of the White Amur for Control of Problem Aquatic Plants. Report 3. Second Year Poststocking Results. Volume VI. The Water and Sediment Quality of Lake Conway, Florida.

    DTIC Science & Technology

    1982-08-01

    AD-A-11 701 ORANGE COUNTY POLLUTION CONTROL DEPT ORLANDO FL F/0 6/6 LARGE-SCALE OPERATIONS MANAGEMENT TEST OF USE OF THE WHITE AMUR--ETC(U) AUG 82 H...8217 OPERATIONS MANAGEMENT TEST OF USE OF THE WHITE AMUR FOR CONTROL -OF PROBLEM AQ.UATIC PLANTS SECOND YEAR POSTSTOCKING RESULTS Volume, Vt The Water...and Subetie) S. TYPE OF REPORT & PERIOD COVERED LARGE-SCALE OPERATIONS MANAGEMENT TEST OF USE OF Report 3 of a series THE WHITE AMUR FOR CONTROL OF

  7. An NCME Instructional Module on Quality Control Procedures in the Scoring, Equating, and Reporting of Test Scores

    ERIC Educational Resources Information Center

    Allalouf, Avi

    2007-01-01

    There is significant potential for error in long production processes that consist of sequential stages, each of which is heavily dependent on the previous stage, such as the SER (Scoring, Equating, and Reporting) process. Quality control procedures are required in order to monitor this process and to reduce the number of mistakes to a minimum. In…

  8. Quality Control (QC) System Development for the Pell Grant Program: A Conceptual Framework.

    ERIC Educational Resources Information Center

    Advanced Technology, Inc., Reston, VA.

    The objectives of the Pell Grant quality control (QC) system and the general definition of QC are considered. Attention is also directed to: the objectives of the Stage II Pell Grant QC system design and testing project, the approach used to develop the QC system, and the interface of the QC system and the Pell Grant delivery system. The…

  9. Quality Control in Clinical Laboratory Samples

    DTIC Science & Technology

    2015-01-01

    is able to find and correct flaws in the analytical processes of a lab before potentially incorrect patient resu lts are released. According to...verifi es that the results produced are accurate and precise . Clinical labs use management of documentation as well as inco rporation of a continuous...improvement process to streamline the overall quality control process . QC samples are expected to be identical and tested identically to patient

  10. The Development of a Technical Conceptual Structure for the Concepts Possessed by Selected Quality Control Specialists. Report of a Research Project.

    ERIC Educational Resources Information Center

    Nee, John G.

    This project had as its specific objective the development and field testing of a procedure for identifying the structure of technical concepts possessed by a group of selected quality control specialists. The associative theory of verbal behavior served as the rationale by which conceptual structures depicted by graphical maps of technical…

  11. Understanding biomaterial-tissue interface quality: combined in vitro evaluation

    NASA Astrophysics Data System (ADS)

    Gasik, Michael

    2017-12-01

    One of the greatest challenges in the development of new medical products and devices remains in providing maximal patient safety, efficacy and suitability for the purpose. A 'good quality' of the tissue-implant interface is one of the most critical factors for the success of the implant integration. In this paper this challenge is being discussed from the point of view of basic stimuli combination to experimental testing. The focus is in particular on bacterial effects on tissue-implant interaction (for different materials). The demonstration of the experimental evaluation of the tissue-implant interface is for dental abutment with mucosal contact. This shows that testing of the interface quality could be the most relevant in controlled conditions, which mimic as possible the clinical applications, but consider variables being under the control of the evaluator.

  12. Failure of Quality Control Measures To Prevent Reporting of False Resistance to Imipenem, Resulting in a Pseudo-Outbreak of Imipenem-Resistant Pseudomonas aeruginosa

    PubMed Central

    Carmeli, Yehuda; Eichelberger, Karen; Soja, Don; Dakos, Joanna; Venkataraman, Lata; DeGirolami, Paola; Samore, Matthew

    1998-01-01

    False results showing an outbreak of Pseudomonas aeruginosa with resistance to imipenem were traced to a defective lot of microdilution MIC testing panels. These panels contained two- to threefold lower concentrations of imipenem than expected and resulted in artifactual two- to fourfold increases in MICs of imipenem. The quality-control MIC results for Pseudomonas aeruginosa ATCC 27853 were 4 μg/ml, the highest value within the range recommended by the National Committee for Clinical Laboratory Standards. We recommend that this value be considered out of the quality-control range. PMID:9466787

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

    PubMed

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

    2018-02-17

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

  14. [Quality assurance of a virtual simulation software: application to IMAgo and SIMAgo (ISOgray)].

    PubMed

    Isambert, A; Beaudré, A; Ferreira, I; Lefkopoulos, D

    2007-06-01

    Virtual simulation process is often used to prepare three dimensional conformal radiation therapy treatments. As the quality of the treatment is widely dependent on this step, it is mandatory to perform extensive controls on this software before clinical use. The tests presented in this work have been carried out on the treatment planning system ISOgray (DOSIsoft), including the delineation module IMAgo and the virtual simulation module SIMAgo. According to our experience, the most relevant controls of international protocols have been selected. These tests mainly focused on measuring and delineation tools, virtual simulation functionalities, and have been performed with three phantoms: the Quasar Multi-Purpose Body Phantom, the Quasar MLC Beam Geometry Phantom (Modus Medical Devices Inc.) and a phantom developed at Hospital Tenon. No major issues have been identified while performing the tests. These controls have emphasized the necessity for the user to consider with a critical eye the results displayed by a virtual simulation software. The contrast of visualisation, the slice thickness, the calculation and display mode of 3D structures used by the software are many factors of uncertainties. A virtual simulation software quality assurance procedure has been written and applied on a set of CT images. Similar tests have to be performed periodically and at minimum at each change of major version.

  15. Performance Assessment of Internal Quality Control (IQC) Products in Blood Transfusion Compatibility Testing in China

    PubMed Central

    Li, Jing-Jing; Gao, Qi; Liu, Zhi-Dong; Kang, Qiong-Hua; Hou, Yi-Jun; Zhang, Luo-Chuan; Hu, Xiao-Mei; Li, Jie; Zhang, Juan

    2015-01-01

    Internal quality control (IQC) is a critical component of laboratory quality management, and IQC products can determine the reliability of testing results. In China, given the fact that most blood transfusion compatibility laboratories do not employ IQC products or do so minimally, there is a lack of uniform and standardized IQC methods. To explore the reliability of IQC products and methods, we studied 697 results from IQC samples in our laboratory from 2012 to 2014. The results showed that the sensitivity and specificity of the IQCs in anti-B testing were 100% and 99.7%, respectively. The sensitivity and specificity of the IQCs in forward blood typing, anti-A testing, irregular antibody screening, and cross-matching were all 100%. The reliability analysis indicated that 97% of anti-B testing results were at a 99% confidence level, and 99.9% of forward blood typing, anti-A testing, irregular antibody screening, and cross-matching results were at a 99% confidence level. Therefore, our IQC products and methods are highly sensitive, specific, and reliable. Our study paves the way for the establishment of a uniform and standardized IQC method for pre-transfusion compatibility testing in China and other parts of the world. PMID:26488582

  16. Evaluating quality management systems for HIV rapid testing services in primary healthcare clinics in rural KwaZulu-Natal, South Africa

    PubMed Central

    Jaya, Ziningi; Drain, Paul K.

    2017-01-01

    Introduction Rapid HIV tests have improved access to HIV diagnosis and treatment by providing quick and convenient testing in rural clinics and resource-limited settings. In this study, we evaluated the quality management system for voluntary and provider-initiated point-of-care HIV testing in primary healthcare (PHC) clinics in rural KwaZulu-Natal (KZN), South Africa. Material and methods We conducted a quality assessment audit in eleven PHC clinics that offer voluntary HIV testing and counselling in rural KZN, South Africa from August 2015 to October 2016. All the participating clinics were purposively selected from the province-wide survey of diagnostic services. We completed an on-site monitoring checklist, adopted from the WHO guidelines for assuring accuracy and reliability of HIV rapid tests, to assess the quality management system for HIV rapid testing at each clinic. To determine clinic’s compliance to WHO quality standards for HIV rapid testing the following quality measure was used, a 3-point scale (high, moderate and poor). A high score was defined as a percentage rating of 90 to 100%, moderate was defined as a percentage rating of 70 to 90%, and poor was defined as a percentage rating of less than 70%. Clinic audit scores were summarized and compared. We employed Pearson pair wise correlation coefficient to determine correlations between clinics audit scores and clinic and clinics characteristics. Linear regression model was computed to estimate statistical significance of the correlates. Correlations were reported as significant at p ≤0.05. Results Nine out of 11 audited rural PHC clinics are located outside 20Km of the nearest town and hospital. Majority (18.2%) of the audited rural PHC clinics reported that HIV rapid test was performed by HIV lay counsellors. Overall, ten clinics were rated moderate, in terms of their compliance to the stipulated WHO guidelines. Audit results showed that rural PHC clinics’ average rating score for compliance to the WHO guidelines ranged between 64.4% (CI: 44%– 84%) and 89.2% (CI: 74%– 100%).Ten out of eleven of the clinics were rated as moderate (70–89%). All clinic have scored highest for the following audit component: equipment; process control and specimen management; and facility ad safety, with 100%. Clinics obtained the lowest scores for the assessment audit component followed by process improvement and organisation, with 40.9% (CI: 15.7–66.1%), 45.5% (CI: 10.4–80.5%) and 56.8% (CI: 31.8 81.8%), respectively. A statistically significant correlation was observed between the following: category of staff performing the HIV rapid tests in the audited clinics and service and satisfactory audit component; weekly average number of patients using the audited PHC clinics and service and satisfactory audit component; number of HIV lay counsellors in the audited clinics and quality control audit component with p<0.05. Discussion In the small audit of primary healthcare clinics located within the rural part of KwaZulu-Natal, results revealed an overall moderate rating of the quality management system for rapid HIV testing. Improvements in the organisation, quality control, process improvement and assessment components could enable a higher quality assurance rating for rural HIV testing in KwaZulu-Natal. PMID:28829801

  17. Evaluating quality management systems for HIV rapid testing services in primary healthcare clinics in rural KwaZulu-Natal, South Africa.

    PubMed

    Jaya, Ziningi; Drain, Paul K; Mashamba-Thompson, Tivani P

    2017-01-01

    Rapid HIV tests have improved access to HIV diagnosis and treatment by providing quick and convenient testing in rural clinics and resource-limited settings. In this study, we evaluated the quality management system for voluntary and provider-initiated point-of-care HIV testing in primary healthcare (PHC) clinics in rural KwaZulu-Natal (KZN), South Africa. We conducted a quality assessment audit in eleven PHC clinics that offer voluntary HIV testing and counselling in rural KZN, South Africa from August 2015 to October 2016. All the participating clinics were purposively selected from the province-wide survey of diagnostic services. We completed an on-site monitoring checklist, adopted from the WHO guidelines for assuring accuracy and reliability of HIV rapid tests, to assess the quality management system for HIV rapid testing at each clinic. To determine clinic's compliance to WHO quality standards for HIV rapid testing the following quality measure was used, a 3-point scale (high, moderate and poor). A high score was defined as a percentage rating of 90 to 100%, moderate was defined as a percentage rating of 70 to 90%, and poor was defined as a percentage rating of less than 70%. Clinic audit scores were summarized and compared. We employed Pearson pair wise correlation coefficient to determine correlations between clinics audit scores and clinic and clinics characteristics. Linear regression model was computed to estimate statistical significance of the correlates. Correlations were reported as significant at p ≤0.05. Nine out of 11 audited rural PHC clinics are located outside 20Km of the nearest town and hospital. Majority (18.2%) of the audited rural PHC clinics reported that HIV rapid test was performed by HIV lay counsellors. Overall, ten clinics were rated moderate, in terms of their compliance to the stipulated WHO guidelines. Audit results showed that rural PHC clinics' average rating score for compliance to the WHO guidelines ranged between 64.4% (CI: 44%- 84%) and 89.2% (CI: 74%- 100%).Ten out of eleven of the clinics were rated as moderate (70-89%). All clinic have scored highest for the following audit component: equipment; process control and specimen management; and facility ad safety, with 100%. Clinics obtained the lowest scores for the assessment audit component followed by process improvement and organisation, with 40.9% (CI: 15.7-66.1%), 45.5% (CI: 10.4-80.5%) and 56.8% (CI: 31.8 81.8%), respectively. A statistically significant correlation was observed between the following: category of staff performing the HIV rapid tests in the audited clinics and service and satisfactory audit component; weekly average number of patients using the audited PHC clinics and service and satisfactory audit component; number of HIV lay counsellors in the audited clinics and quality control audit component with p<0.05. In the small audit of primary healthcare clinics located within the rural part of KwaZulu-Natal, results revealed an overall moderate rating of the quality management system for rapid HIV testing. Improvements in the organisation, quality control, process improvement and assessment components could enable a higher quality assurance rating for rural HIV testing in KwaZulu-Natal.

  18. Development of large aperture telescope technology (LATT): test results on a demonstrator bread-board

    NASA Astrophysics Data System (ADS)

    Briguglio, R.; Xompero, M.; Riccardi, A.; Lisi, F.; Duò, F.; Vettore, C.; Gallieni, D.; Tintori, M.; Lazzarini, P.; Patauner, C.; Biasi, R.; D'Amato, F.; Pucci, M.; Pereira do Carmo, João.

    2017-11-01

    The concept of a low areal density primary mirror, actively controlled by actuators, has been investigated through a demonstration prototype. A spherical mirror (400 mm diameter, 2.7 Kg mass) has been manufactured and tested in laboratory and on the optical bench, to verify performance, controllability and optical quality. In the present paper we will describe the prototype and the test results.

  19. ASVCP guidelines: quality assurance for point-of-care testing in veterinary medicine.

    PubMed

    Flatland, Bente; Freeman, Kathleen P; Vap, Linda M; Harr, Kendal E

    2013-12-01

    Point-of-care testing (POCT) refers to any laboratory testing performed outside the conventional reference laboratory and implies close proximity to patients. Instrumental POCT systems consist of small, handheld or benchtop analyzers. These have potential utility in many veterinary settings, including private clinics, academic veterinary medical centers, the community (eg, remote area veterinary medical teams), and for research applications in academia, government, and industry. Concern about the quality of veterinary in-clinic testing has been expressed in published veterinary literature; however, little guidance focusing on POCT is available. Recognizing this void, the ASVCP formed a subcommittee in 2009 charged with developing quality assurance (QA) guidelines for veterinary POCT. Guidelines were developed through literature review and a consensus process. Major recommendations include (1) taking a formalized approach to POCT within the facility, (2) use of written policies, standard operating procedures, forms, and logs, (3) operator training, including periodic assessment of skills, (4) assessment of instrument analytical performance and use of both statistical quality control and external quality assessment programs, (5) use of properly established or validated reference intervals, (6) and ensuring accurate patient results reporting. Where possible, given instrument analytical performance, use of a validated 13s control rule for interpretation of control data is recommended. These guidelines are aimed at veterinarians and veterinary technicians seeking to improve management of POCT in their clinical or research setting, and address QA of small chemistry and hematology instruments. These guidelines are not intended to be all-inclusive; rather, they provide a minimum standard for maintenance of POCT instruments in the veterinary setting. © 2013 American Society for Veterinary Clinical Pathology and European Society for Veterinary Clinical Pathology.

  20. Single-Cycle Versus Multicycle Proof Testing

    NASA Technical Reports Server (NTRS)

    Hudak, S. J., Jr.; Mcclung, R. C.; Bartlett, M. L.; Fitzgerald, J. H.; Russell, D. A.

    1992-01-01

    Report compares single-cycle with multiple-cycle mechanical-stress tests of parts under mechanical stresses. Objective of proof testing: to screen out gross manufacturing or material deficiencies and provide additional assurance of quality. Report concludes that changes in distribution of crack sizes during multicycle proof testing depend on initial distribution, number of cycles, relationship between resistance of material and elastic/plastic fracture-mechanics parameter, relationship between load control and displacement control, and magnitude of applied load or displacement. Whether single-cycle or multicycle testing used depends on shape, material, and technique of fabrication of components tested.

  1. A routine quality assurance test for CT automatic exposure control systems.

    PubMed

    Iball, Gareth R; Moore, Alexis C; Crawford, Elizabeth J

    2016-07-08

    The study purpose was to develop and validate a quality assurance test for CT automatic exposure control (AEC) systems based on a set of nested polymethylmethacrylate CTDI phantoms. The test phantom was created by offsetting the 16 cm head phantom within the 32 cm body annulus, thus creating a three part phantom. This was scanned at all acceptance, routine, and some nonroutine quality assurance visits over a period of 45 months, resulting in 115 separate AEC tests on scanners from four manufacturers. For each scan the longitudinal mA modulation pattern was generated and measurements of image noise were made in two annular regions of interest. The scanner displayed CTDIvol and DLP were also recorded. The impact of a range of AEC configurations on dose and image quality were assessed at acceptance testing. For systems that were tested more than once, the percentage of CTDIvol values exceeding 5%, 10%, and 15% deviation from baseline was 23.4%, 12.6%, and 8.1% respectively. Similarly, for the image noise data, deviations greater than 2%, 5%, and 10% from baseline were 26.5%, 5.9%, and 2%, respectively. The majority of CTDIvol and noise deviations greater than 15% and 5%, respectively, could be explained by incorrect phantom setup or protocol selection. Barring these results, CTDIvol deviations of greater than 15% from baseline were found in 0.9% of tests and noise deviations greater than 5% from baseline were found in 1% of tests. The phantom was shown to be sensitive to changes in AEC setup, including the use of 3D, longitudinal or rotational tube current modulation. This test methodology allows for continuing performance assessment of CT AEC systems, and we recommend that this test should become part of routine CT quality assurance programs. Tolerances of ± 15% for CTDIvol and ± 5% for image noise relative to baseline values should be used. © 2016 The Authors

  2. Improving Elementary School Quality Through the Use of a Social-Emotional and Character Development Program: A Matched-Pair, Cluster-Randomized, Controlled Trial in Hawai’i

    PubMed Central

    Snyder, Frank J.; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac J.; Flay, Brian R.

    2012-01-01

    BACKGROUND School safety and quality affect student learning and success. This study examined the effects of a comprehensive elementary school-wide social-emotional and character education program, Positive Action, on teacher, parent, and student perceptions of school safety and quality utilizing a matched-pair, cluster-randomized, controlled design. The Positive Action Hawai’i trial included 20 racially/ethnically diverse schools and was conducted from 2002–2003 through 2005–2006. METHODS School-level archival data, collected by the Hawai’i Department of Education, were used to examine program effects at 1-year post-trial. Teacher, parent, and student data were analyzed to examine indicators of school quality such as student safety and well-being, involvement, and satisfaction, as well as overall school quality. Matched-paired t-tests were used for the primary analysis, and sensitivity analyses included permutation tests and random-intercept growth curve models. RESULTS Analyses comparing change from baseline to 1-year post-trial revealed that intervention schools demonstrated significantly improved school quality compared to control schools, with 21%, 13%, and 16% better overall school quality scores as reported by teachers, parents, and students, respectively. Teacher, parent, and student reports on individual school-quality indicators showed improvement in student safety and well-being, involvement, satisfaction, quality student support, focused and sustained action, standards-based learning, professionalism and system capacity, and coordinated team work. Teacher reports also showed an improvement in the responsiveness of the system. CONCLUSIONS School quality was substantially improved, providing evidence that a school-wide social-emotional and character education program can enhance school quality and facilitate whole-school change. PMID:22142170

  3. Improving elementary school quality through the use of a social-emotional and character development program: a matched-pair, cluster-randomized, controlled trial in Hawai'i.

    PubMed

    Snyder, Frank J; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac J; Flay, Brian R

    2012-01-01

    School safety and quality affect student learning and success. This study examined the effects of a comprehensive elementary school-wide social-emotional and character education program, Positive Action, on teacher, parent, and student perceptions of school safety and quality utilizing a matched-pair, cluster-randomized, controlled design. The Positive Action Hawai'i trial included 20 racially/ethnically diverse schools and was conducted from 2002-2003 through 2005-2006. School-level archival data, collected by the Hawai'i Department of Education, were used to examine program effects at 1-year post-trial. Teacher, parent, and student data were analyzed to examine indicators of school quality such as student safety and well-being, involvement, and satisfaction, as well as overall school quality. Matched-paired t-tests were used for the primary analysis, and sensitivity analyses included permutation tests and random-intercept growth curve models. Analyses comparing change from baseline to 1-year post-trial revealed that intervention schools demonstrated significantly improved school quality compared to control schools, with 21%, 13%, and 16% better overall school quality scores as reported by teachers, parents, and students, respectively. Teacher, parent, and student reports on individual school-quality indicators showed improvement in student safety and well-being, involvement, satisfaction, quality student support, focused and sustained action, standards-based learning, professionalism and system capacity, and coordinated team work. Teacher reports also showed an improvement in the responsiveness of the system. School quality was substantially improved, providing evidence that a school-wide social-emotional and character education program can enhance school quality and facilitate whole-school change. © 2011, American School Health Association.

  4. Analytical techniques: A compilation

    NASA Technical Reports Server (NTRS)

    1975-01-01

    A compilation, containing articles on a number of analytical techniques for quality control engineers and laboratory workers, is presented. Data cover techniques for testing electronic, mechanical, and optical systems, nondestructive testing techniques, and gas analysis techniques.

  5. 7 CFR 58.733 - Quality control tests.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... cheese products shall have been tested prior to usage to determine its moisture and fat content. (2...: (1) Finish and appearance, (2) flavor, (3) color, (4) body and texture, and (5) slicing or spreading...

  6. 7 CFR 58.733 - Quality control tests.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... cheese products shall have been tested prior to usage to determine its moisture and fat content. (2...: (1) Finish and appearance, (2) flavor, (3) color, (4) body and texture, and (5) slicing or spreading...

  7. 7 CFR 58.733 - Quality control tests.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... cheese products shall have been tested prior to usage to determine its moisture and fat content. (2...: (1) Finish and appearance, (2) flavor, (3) color, (4) body and texture, and (5) slicing or spreading...

  8. Global harmonization of food safety regulations: perspectives from Japan after the Fukushima nuclear accident.

    PubMed

    Yoshida, Mitsuru

    2014-08-01

    Japanese food self-sufficiency was only 39% on the basis of kcal in 2012, so Japan relies heavily on imported food. Hence the necessity of having international rules on the regulation of food contaminants is important especially for countries like Japan that depend on food imports. A One-Stop-Testing system is desired, in which the test result obtained from a single testing laboratory is accepted as valid worldwide. To establish this system, laboratory accreditation under international standards is a necessary step. Furthermore, the importance of supply of reference materials for internal quality control and proficiency testing for external quality control of each laboratory's analytical system is reviewed in connection with the experience of radioactive nuclide contamination resulting from the Fukushima nuclear power plant accident in March 2011. © 2013 Society of Chemical Industry.

  9. Cost Effectiveness of Adopted Quality Requirements in Hospital Laboratories

    PubMed Central

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

    2013-01-01

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

  10. Evaluation of repeatability of Kansas test method KT-73, "density, absorption and voids in hardened concrete," boil test : [technical summary].

    DOT National Transportation Integrated Search

    2015-06-01

    For years, the Kansas Department of Transportation (KDOT) and concrete producers in : the state have used a Rapid Chloride Test for concrete cylinders, AASHTO T277. This : test has been thought of as an appropriate quality control test to evaluate pe...

  11. 46 CFR 160.037-4 - Approval and production tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... signal plus packaging in a sealed plastic waterproof bag, the 24-hour water immersion conditioning will... discontinued production line. (2) Inspections and tests by the manufacturer. The manufacturer's quality control...: (i) Conditioning of test specimens—water resistance. Immerse specimen horizontally with uppermost...

  12. 46 CFR 160.037-4 - Approval and production tests.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... signal plus packaging in a sealed plastic waterproof bag, the 24-hour water immersion conditioning will... discontinued production line. (2) Inspections and tests by the manufacturer. The manufacturer's quality control...: (i) Conditioning of test specimens—water resistance. Immerse specimen horizontally with uppermost...

  13. 46 CFR 160.037-4 - Approval and production tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... signal plus packaging in a sealed plastic waterproof bag, the 24-hour water immersion conditioning will... discontinued production line. (2) Inspections and tests by the manufacturer. The manufacturer's quality control...: (i) Conditioning of test specimens—water resistance. Immerse specimen horizontally with uppermost...

  14. Developing an economical and reliable test for measuring the resilient modulus and Poisson's ratio of subgrade.

    DOT National Transportation Integrated Search

    2010-11-01

    The resilient modulus and Poissons ratio of base and sublayers in highway use are : important parameters in design and quality control process. The currently used techniques : include CBR (California Bearing Ratio) test, resilient modulus test,...

  15. Manager personality, manager service quality orientation, and service climate: test of a model.

    PubMed

    Salvaggio, Amy Nicole; Schneider, Benjamin; Nishii, Lisa H; Mayer, David M; Ramesh, Anuradha; Lyon, Julie S

    2007-11-01

    This article conceptually and empirically explores the relationships among manager personality, manager service quality orientation, and climate for customer service. Data were collected from 1,486 employees and 145 managers in grocery store departments (N = 145) to test the authors' theoretical model. Largely consistent with hypotheses, results revealed that core self-evaluations were positively related to managers' service quality orientation, even after dimensions of the Big Five model of personality were controlled, and that service quality orientation fully mediated the relationship between personality and global service climate. Implications for personality and organizational climate research are discussed. (c) 2007 APA

  16. Rules of thumb to increase the software quality through testing

    NASA Astrophysics Data System (ADS)

    Buttu, M.; Bartolini, M.; Migoni, C.; Orlati, A.; Poppi, S.; Righini, S.

    2016-07-01

    The software maintenance typically requires 40-80% of the overall project costs, and this considerable variability mostly depends on the software internal quality: the more the software is designed and implemented to constantly welcome new changes, the lower will be the maintenance costs. The internal quality is typically enforced through testing, which in turn also affects the development and maintenance costs. This is the reason why testing methodologies have become a major concern for any company that builds - or is involved in building - software. Although there is no testing approach that suits all contexts, we infer some general guidelines learned during the Development of the Italian Single-dish COntrol System (DISCOS), which is a project aimed at producing the control software for the three INAF radio telescopes (the Medicina and Noto dishes, and the newly-built SRT). These guidelines concern both the development and the maintenance phases, and their ultimate goal is to maximize the DISCOS software quality through a Behavior-Driven Development (BDD) workflow beside a continuous delivery pipeline. We consider different topics and patterns; they involve the proper apportion of the tests (from end-to-end to low-level tests), the choice between hardware simulators and mockers, why and how to apply TDD and the dependency injection to increase the test coverage, the emerging technologies available for test isolation, bug fixing, how to protect the system from the external resources changes (firmware updating, hardware substitution, etc.) and, eventually, how to accomplish BDD starting from functional tests and going through integration and unit tests. We discuss pros and cons of each solution and point out the motivations of our choices either as a general rule or narrowed in the context of the DISCOS project.

  17. Modified SPC for short run test and measurement process in multi-stations

    NASA Astrophysics Data System (ADS)

    Koh, C. K.; Chin, J. F.; Kamaruddin, S.

    2018-03-01

    Due to short production runs and measurement error inherent in electronic test and measurement (T&M) processes, continuous quality monitoring through real-time statistical process control (SPC) is challenging. Industry practice allows the installation of guard band using measurement uncertainty to reduce the width of acceptance limit, as an indirect way to compensate the measurement errors. This paper presents a new SPC model combining modified guard band and control charts (\\bar{\\text{Z}} chart and W chart) for short runs in T&M process in multi-stations. The proposed model standardizes the observed value with measurement target (T) and rationed measurement uncertainty (U). S-factor (S f) is introduced to the control limits to improve the sensitivity in detecting small shifts. The model was embedded in automated quality control system and verified with a case study in real industry.

  18. A micro-vibration generated method for testing the imaging quality on ground of space remote sensing

    NASA Astrophysics Data System (ADS)

    Gu, Yingying; Wang, Li; Wu, Qingwen

    2018-03-01

    In this paper, a novel method is proposed, which can simulate satellite platform micro-vibration and test the impact of satellite micro-vibration on imaging quality of space optical remote sensor on ground. The method can generate micro-vibration of satellite platform in orbit from vibrational degrees of freedom, spectrum, magnitude, and coupling path. Experiment results show that the relative error of acceleration control is within 7%, in frequencies from 7Hz to 40Hz. Utilizing this method, the system level test about the micro-vibration impact on imaging quality of space optical remote sensor can be realized. This method will have an important applications in testing micro-vibration tolerance margin of optical remote sensor, verifying vibration isolation and suppression performance of optical remote sensor, exploring the principle of micro-vibration impact on imaging quality of optical remote sensor.

  19. Spaceport Command and Control System Automated Testing

    NASA Technical Reports Server (NTRS)

    Stein, Meriel

    2017-01-01

    The Spaceport Command and Control System (SCCS) is the National Aeronautics and Space Administrations (NASA) launch control system for the Orion capsule and Space Launch System, the next generation manned rocket currently in development. This large system requires high quality testing that will properly measure the capabilities of the system. Automating the test procedures would save the project time and money. Therefore, the Electrical Engineering Division at Kennedy Space Center (KSC) has recruited interns for the past two years to work alongside full-time engineers to develop these automated tests, as well as innovate upon the current automation process.

  20. Spaceport Command and Control System Automation Testing

    NASA Technical Reports Server (NTRS)

    Hwang, Andrew

    2017-01-01

    The Spaceport Command and Control System (SCCS) is the National Aeronautics and Space Administrations (NASA) launch control system for the Orion capsule and Space Launch System, the next generation manned rocket currently in development. This large system requires high quality testing that will properly measure the capabilities of the system. Automating the test procedures would save the project time and money. Therefore, the Electrical Engineering Division at Kennedy Space Center (KSC) has recruited interns for the past two years to work alongside full-time engineers to develop these automated tests, as well as innovate upon the current automation process.

  1. Post-examination interpretation of objective test data: monitoring and improving the quality of high-stakes examinations--a commentary on two AMEE Guides.

    PubMed

    Tavakol, Mohsen; Dennick, Reg

    2012-01-01

    As great emphasis is rightly placed upon the importance of assessment to judge the quality of our future healthcare professionals, it is appropriate not only to choose the most appropriate assessment method, but to continually monitor the quality of the tests themselves, in a hope that we may continually improve the process. This article stresses the importance of quality control mechanisms in the exam cycle and briefly outlines some of the key psychometric concepts including reliability measures, factor analysis, generalisability theory and item response theory. The importance of such analyses for the standard setting procedures is emphasised. This article also accompanies two new AMEE Guides in Medical Education (Tavakol M, Dennick R. Post-examination Analysis of Objective Tests: AMEE Guide No. 54 and Tavakol M, Dennick R. 2012. Post examination analysis of objective test data: Monitoring and improving the quality of high stakes examinations: AMEE Guide No. 66) which provide the reader with practical examples of analysis and interpretation, in order to help develop valid and reliable tests.

  2. Establishing a Quality Control System for Stem Cell-Based Medicinal Products in China

    PubMed Central

    2015-01-01

    Stem cell-based medicinal products (SCMPs) are emerging as novel therapeutic products. The success of its development depends on the existence of an effective quality control system, which is constituted by quality control technologies, standards, reference materials, guidelines, and the associated management system in accordance with regulatory requirements along product lifespan. However, a worldwide, effective quality control system specific for SCMPs is still far from established partially due to the limited understanding of stem cell sciences and lack of quality control technologies for accurately assessing the safety and biological effectiveness of SCMPs before clinical use. Even though, based on the existing regulations and current stem cell sciences and technologies, initial actions toward the goal of establishing such a system have been taken as exemplified by recent development of new “interim guidelines” for governing quality control along development of SCMPs and new development of the associated quality control technologies in China. In this review, we first briefly introduced the major institutions involved in the regulation of cell substrates and therapeutic cell products in China and the existing regulatory documents and technical guidelines used as critical references for developing the new interim guidelines. With focus only on nonhematopoietic stem cells, we then discussed the principal quality attributes of SCMPs as well as our thinking of proper testing approaches to be established with relevant evaluation technologies to ensure all quality requirements of SCMPs along different manufacturing processes and development stages. At the end, some regulatory and technical challenges were also discussed with the conclusion that combined efforts should be taken to promote stem cell regulatory sciences to establish the effective quality control system for SCMPs. PMID:25471126

  3. A flight investigation of the stability, control, and handling qualities of an augmented jet flap STOL airplane

    NASA Technical Reports Server (NTRS)

    Vomaske, R. F.; Innis, R. C.; Swan, B. E.; Grossmith, S. W.

    1978-01-01

    The stability, control, and handling qualities of an augmented jet flap STOL airplane are presented. The airplane is an extensively modified de Havilland Buffalo military transport. The modified airplane has two fan-jet engines which provide vectorable thrust and compressed air for the augmentor jet flap and Boundary-Layer Control (BLC). The augmentor and BLC air is cross ducted to minimize asymmetric moments produced when one engine is inoperative. The modifications incorporated in the airplane include a Stability Augmentation System (SAS), a powered elevator, and a powered lateral control system. The test gross weight of the airplane was between 165,000 and 209,000 N (37,000 and 47,000 lb). Stability, control, and handling qualities are presented for the airspeed range of 40 to 180 knots. The lateral-directional handling qualities are considered satisfactory for the normal operating range of 65 to 160 knots airspeed when the SAS is functioning. With the SAS inoperative, poor turn coordination and spiral instability are primary deficiencies contributing to marginal handling qualities in the landing approach. The powered elevator control system enhanced the controllability in pitch, particularly in the landing flare and stall recovery.

  4. Effect of aromatherapy via inhalation on the sleep quality and fatigue level in people undergoing hemodialysis.

    PubMed

    Muz, Gamze; Taşcı, Sultan

    2017-10-01

    The most common problems in hemodialysis patients are sleep disorders and fatigue. This randomized-controlled experimental study was conducted to determine the effect of aromatherapy applied by inhalation on sleep quality and fatigue level in hemodialysis patients. The study was completed in five hemodialysis centers settled in two provinces with 27 intervention group patients and 35 controls, being totally 62 patients, recruited with simple randomization. Ethical approval, informed consent from the individuals and institutional permission were obtained. Data were collected with a questionnaire form and Visual Analogue Scale (VAS) for fatigue, Piper fatigue scale, Pittsburgh Sleep Quality Index (PSQI), and follow-up forms for the patient and the researcher. Aromatherapy inhalation (sweet orange and lavender oil) was performed before going to bed every day for one month to the intervention group patients. No other application has been made to the control group patients except for standard hemodialysis treatment. All of the forms were performed at baseline and at follow-up at the end of the four weeks (baseline and last follow-up), VAS and Piper fatigue scale were performed during follow-ups at the end of every week (the first, second and third follow-ups). Data were statistically analyzed with Independent Samples t-test, one way analysis of variance, Pearson correlation analysis, chi-square test, Friedman and Mann Whitney U tests and Bonferroni test. p<0.05 was set as statistically significant in comparisons. Mean total and sub-dimension scores of VAS, Piper fatigue scale and PSQI (except for daytime sleepiness dysfunction sub-dimension) of the intervention and control groups at baseline were not significantly different (p>0.05). It was found that mean total and sub-dimension scores of VAS, Piper fatigue scale and PSQI of the intervention group significantly decreased in other follow-ups compared to the control group (p<0.05). Consequently, it was determined that aromatherapy applied by inhalation improved sleep quality, decreased fatigue level and severity in hemodialysis patients. Accordingly, aromatherapy prepared with sweet orange and lavender oil may be recommended to increase sleep quality and to decrease fatigue level of the hemodialysis patients. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Identifying the Gaps in Practice for Combating Lead in Drinking Water in Hong Kong

    PubMed Central

    Lee, Wai Ling; Jia, Jie; Bao, Yani

    2016-01-01

    Excessive lead has been found in drinking water in Hong Kong in tests carried out in 2015. Investigations have identified that the problem in public rental housing estates was caused by the problematic solders used in the plumbing, and recommendations on enhancing the quality control system and strengthening the relevant water quality standards have been proposed. The cause for the same problem happening in other premises where soldering has not been adopted for water pipe connections is left unidentified. Considering the unidentified cause and the recommendations made, this study aims to identify the gaps in practice followed in Hong Kong for safeguarding the water quality of new installations. A holistic review of governing ordinances and regulations, products and materials used and the testing and commissioning requirements adopted in Hong Kong and elsewhere in the world were conducted. Based on international practices and parametric analysis, it was found that there are gaps in practices followed in Hong Kong, which are directly and indirectly leading to the lead-in-water crisis. Recommendations for improvement in the quality control system, and the water quality standards including the allowable lead content and leaching limit for products and materials and the testing and commissioning requirements on plumbing installations have been made. The review and the identified gaps would become useful reference for countries in strengthening their relevant water quality standards. PMID:27706062

  6. Identifying the Gaps in Practice for Combating Lead in Drinking Water in Hong Kong.

    PubMed

    Lee, Wai Ling; Jia, Jie; Bao, Yani

    2016-09-30

    Excessive lead has been found in drinking water in Hong Kong in tests carried out in 2015. Investigations have identified that the problem in public rental housing estates was caused by the problematic solders used in the plumbing, and recommendations on enhancing the quality control system and strengthening the relevant water quality standards have been proposed. The cause for the same problem happening in other premises where soldering has not been adopted for water pipe connections is left unidentified. Considering the unidentified cause and the recommendations made, this study aims to identify the gaps in practice followed in Hong Kong for safeguarding the water quality of new installations. A holistic review of governing ordinances and regulations, products and materials used and the testing and commissioning requirements adopted in Hong Kong and elsewhere in the world were conducted. Based on international practices and parametric analysis, it was found that there are gaps in practices followed in Hong Kong, which are directly and indirectly leading to the lead-in-water crisis. Recommendations for improvement in the quality control system, and the water quality standards including the allowable lead content and leaching limit for products and materials and the testing and commissioning requirements on plumbing installations have been made. The review and the identified gaps would become useful reference for countries in strengthening their relevant water quality standards.

  7. To dance or not to dance? A comparison of balance, physical fitness and quality of life in older Irish set dancers and age-matched controls.

    PubMed

    Shanahan, J; Coman, L; Ryan, F; Saunders, J; O'Sullivan, K; Ni Bhriain, O; Clifford, A M

    2016-12-01

    The objective of this study is to determine if older adults regularly participating in Irish set dancing have superior balance, physical fitness and quality of life compared to age-matched controls. This study used a community-based, observational cross-sectional design. Regular set dancers (n = 39) and age-matched controls (n = 33) were recruited. Participants were assessed using the physical activity scale for the elderly (physical activity levels), mini-BESTest (balance) and senior fitness test (battery of functional fitness tests). Quality of life was also assessed using the EuroQol EQ visual analogue scale. When controlling for between-group differences in levels of physical activity (ANCOVA analysis), the dancers had significantly better balance, functional capacity and quality of life (all P < 0.05) compared to controls. No differences between the groups were observed in other measures of functional fitness. The findings of this study suggest regular participation in set dancing is associated with health benefits for older adults. These results may inform future studies prospectively examining the role of set dancing for falls prevention, emotional well-being and cognitive function in community-dwelling older adults. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

  8. The relevance and use of mouse embryo bioassays for quality control in an assisted reproductive technology program.

    PubMed

    Scott, L F; Sundaram, S G; Smith, S

    1993-09-01

    To define both the limits of a mouse embryo bioassay for quality control in an assisted reproductive technology (ART) program and the areas where it can be effectively used. Embryos at the pronuclear and two-cell stage from three different strains of mice were used to assess the effectiveness of this assay for media quality control using five different media routinely used in ART. Pronuclear and two-cell embryos from CD-1 mice were used to test the ability of a mouse embryo bioassay to control for water quality, contaminants in the culture system, and fluctuations in the environmental conditions using a medium, culture system, and scoring technique that were optimized for this strain. The mouse embryo bioassay is not effective in differentiating media appropriate for supporting human embryo development since the development of mouse embryos in vitro is strain, stage, and media related. However, CD-1 embryos were shown to be sensitive to variations in water quality, pH, temperature, incubator conditions, and contaminants in the system when grown in a protein-free medium optimized for their development. Both total blastocyst number and the cell count in the blastocysts were affected. Pronuclear embryos were more sensitive to perturbations in the culture system than two-cell embryos. A mouse embryo bioassay can be effectively used as a means of quality control of water, chemicals, and contact materials and for technique standardization and training in an assisted reproduction program. All the conditions of the test should be defined, pronuclear embryos should be used, and the end point should be fully expanded blastocysts and/or cell numbers in these blastocysts where appropriate.

  9. The effect of exercise on physical fitness and quality of life in postmenopausal women.

    PubMed

    Teoman, Nursen; Ozcan, Ayşe; Acar, Berrin

    2004-01-20

    This study was designed to determine the effect of exercise on the physical fitness level and quality of life in postmenopausal women. 81 volunteer postmenopausal women who entered the menopause naturally and have been taking hormone replacement treatment (HRT) were divided randomly into two groups: exercise (n=41) and control (n=40). Physical fitness tests and the Nottingham Health Profile (NHP) were used to assess physical fitness and quality of life in both groups, both before and after 6 weeks. The study group participated in an exercise programme, which was composed of sub-maximal aerobic exercises for a 6-week period 3 times a week. The statistical analyses were done by paired samples t-test and independent samples t-test. At the end of 6 weeks exercise period, when the two groups were compared after the exercise period, we found statistically significant differences in strength, endurance, flexibility and balance parameters in the exercise group (P<0.05). There was also a statistically significant change in the exercise group for the NHP indicating an improvement in the quality of life (P<0.05). In this study, it was concluded that the fitness level and quality of life on postmenopausal women could be improved by a regular and controlled exercise programme of 6 weeks.

  10. The Manufacture, Shipping and Receiving and Quality Control of Rodent Bedding Materials

    NASA Technical Reports Server (NTRS)

    Kraft, Lisbeth M.

    1980-01-01

    The criteria for rodent bedding and nesting materials are discussed. The literature is reviewed regarding sources of bedding materials, manufacturing methods, quality control, procedures (microbiological, physical and chemical), storage, methods, shipment, methods of use and disposal, current knowledge concerning bedding effects on animals as related to research and testing and legal aspects. Future needs, especially with respect to the promulgation of standards, also are addressed.

  11. The Effects of an Orientation Program on Quality of Life of Patients with Thalassemia: a Quasi-Experimental Study.

    PubMed

    Rafii, Zahra; Ahmadi, Fazlollah; Nourbakhsh, Sayed Mohamad Kazem; Hajizadeh, Ebrahim

    2016-09-01

    Introduction: Medical advances have improved life expectancy and survival of patients with thalassemia. However, as getting older, patients with thalassemia experience different complications which impair their quality of life. The aim of this study was to examine the effects of a nurse-implemented orientation program on quality of life in patients with thalassemia. Methods: A convenience sample of 55 patients with thalassemia were recruited in this quasi-experimental study. Patients were randomly allocated to control or experimental groups. A demographic questionnaire, Thalassemia quality of life questionnaire, and 36-item short form health survey were used for data collection before and one month after the intervention. In the intervention group, 1.5-month orientation program including of the three steps of inauguration, implementation, and closure was implemented, while the control group received routine care. The Chi-square, independent t-test and paired-samples t-test were used for data analysis by using SPSS ver.13 software. Results: The intervention and control group did not differ significantly from each other regarding demographic characteristics. Moreover, no significant difference was observed between the two groups regarding the quality of life scores after the implementation of orientation program. Conclusion: Implementing a short-term orientation program was not effective in enhancing the quality of life in patients with thalassemia; hence, developing long-term multimodal strategies may result in better improvement.

  12. Mechanical and Acoustic Characteristics of the Weld and the Base Metal Machine Part of Career Transport

    NASA Astrophysics Data System (ADS)

    Smirnov, Alexander N.; Knjaz'kov, Victor L.; Levashova, Elena E.; Ababkov, Nikolay V.; Pimonov, Maksim V.

    2018-01-01

    Currently, many industries use foreign-made machinery. There is no opportunity to purchase quality original spare parts for which machinery. Therefore, enterprises operating this equipment are looking for producers of analogues of various parts and assemblies. Quite often, the metal of such analog components turns out to be substandard, which leads to their breakdown at a much earlier date and the enterprises incur material losses. Due to the fact that the complex of performance characteristics and the resource of products are laid at the stage of their production, it is extremely important to control the quality of the raw materials. The structure, mechanical, acoustic and magnetic characteristics of metal samples of such destroyed details of quarry transport as hydraulic cylinders and detail “axis” of an excavator are investigated. A significant spread of data on the chemical composition of metal, hardness and characteristics of non-destructive testing is established, which gives grounds to recommend to manufacturers and suppliers of parts is more responsible to approach the incoming quality control. The results of the investigation of metal samples by destructive and non-destructive methods of control are compared, which showed that the spectral-acoustic method of nondestructive testing can be used to control the quality of the responsible machine parts under conditions of import substitution.

  13. [Application of microscopic spectroscopy in quality control of Niuhuang Qingxin pills].

    PubMed

    Nie, Li-Xing; Zhang, Ye; Zhang, Nan-Ping; Hu, Xiao-Ru; Kang, Shuai; Hou, Jian-Zhong; Dai, Zhong; Ma, Shuang-Cheng

    2016-10-01

    Application of microscopic spectroscopy in quality control of Niuhuang Qingxin pills was discussed. First, microscopic characteristics specified by the statutory standard of Niuhuang Qingxin pills were summarized. Then new identification method was established for Dioscoreae Rhizoma, Saigae Tataricae Cornu, Cinnamomi Cortex and Saposhnikoviae Radix. Finally, microscopic spectroscopy was used for test of Dioscoreae Rhizoma's adulterant Dioscoreae Fordii Rhizoma.It was the first time for this technology being applied in adulteration test of Chinese patent medicine.The results showed that Saigae Tataricae Cornu was not detected in 2 batches of Niuhuang Qingxin pills from 1 manufacturer while Dioscoreae Fordii Rhizoma was detected in 3 batches of samples from 2 manufacturers. The proposed methods were accurate, simple, rapid, objective and economic, which offered a more comprehensive approach for quality control of Niuhuang Qingxin pills. It was indicated that conventional technology such as microscopic spectroscopy could play an important role in identification of traditional Chinese medicine whose index ingredient was deficient or tiny. Copyright© by the Chinese Pharmaceutical Association.

  14. SMART-DS: Synthetic Models for Advanced, Realistic Testing: Distribution Systems and Scenarios

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

    Hodge, Bri-Mathias; Palmintier, Bryan

    This presentation provides an overview of full-scale, high-quality, synthetic distribution system data set(s) for testing distribution automation algorithms, distributed control approaches, ADMS capabilities, and other emerging distribution technologies.

  15. Develop nondestructive rapid pavement quality assurance/quality control evaluation test methods and supporting technology : project summary.

    DOT National Transportation Integrated Search

    2017-01-01

    The findings from the proof of concept with mechanics-based models for flexible base suggest additional validation work should be performed, draft construction specification frameworks should be developed, and work extending the technology to stabili...

  16. Develop nondestructive rapid pavement quality Assurance/quality control evaluation test methods and supporting technology : project summary.

    DOT National Transportation Integrated Search

    2017-01-01

    The findings from the proof of concept with mechanics-based models for flexible base suggest additional validation work should be performed, draft construction specification frameworks should be developed, and work extending the technology to stabili...

  17. Plastic optical fibre sensor for quality control in food industry

    NASA Astrophysics Data System (ADS)

    Novo, C.; Bilro, L.; Ferreira, R.; Alberto, N.; Antunes, P.; Leitão, C.; Nogueira, R.; Pinto, J. L.

    2013-05-01

    The present work addresses the need for new devices felt in the context of quality control, especially in the food industry. Due to the spectral dependence of the attenuation coefficient, a novel dual-parameter sensor for colour and refractive index was developed and tested. The sensor employs plastic optical fibres to measure the transmitted optical power in three measurement cells each with a different incident wavelength. The performance of the sensor was tested using several dyes at different concentrations and aqueous solutions of glycerine and ethanol. Results show that this technique allows the monitoring of refractive index and colour without cross-sensitivity.

  18. A design procedure for the handling qualities optimization of the X-29A aircraft

    NASA Technical Reports Server (NTRS)

    Bosworth, John T.; Cox, Timothy H.

    1989-01-01

    A design technique for handling qualities improvement was developed for the X-29A aircraft. As with any new aircraft, the X-29A control law designers were presented with a relatively high degree of uncertainty in their mathematical models. The presence of uncertainties, and the high level of static instability of the X-29A caused the control law designers to stress stability and robustness over handling qualities. During flight test, the mathematical models of the vehicle were validated or corrected to match the vehicle dynamic behavior. The updated models were then used to fine tune the control system to provide fighter-like handling characteristics. A design methodology was developed which works within the existing control system architecture to provide improved handling qualities and acceptable stability with a minimum of cost in both implementation as well as software verification and validation.

  19. Housing choice and control, housing quality, and control over professional support as contributors to the subjective quality of life and community adaptation of people with severe mental illness.

    PubMed

    Nelson, Geoffrey; Sylvestre, John; Aubry, Tim; George, Lindsey; Trainor, John

    2007-03-01

    This research examined two premises of supported housing: (a) that consumer choice/control over housing and support and the quality of housing are important contributors to the subjective quality of life and adaptation to community living of people with mental illness, and (b) that apartments provide mental health consumers with more choice/control over housing and support than group living arrangements. To test these two hypotheses, we collected data from participants with mental illness housed through a government initiative in Ontario, Canada. A total of 130 participants completed a baseline interview, and 91 of those participants also completed a follow-up interview 9-months later. Support was found for both hypotheses. The results were discussed in terms of the paradigm of supported housing, previous research, and implications for housing policy and program development in the community mental health sector.

  20. Role of technology in supporting quality control and treatment fidelity in a family caregiver clinical trial.

    PubMed

    Farran, Carol J; Etkin, Caryn D; McCann, Judith J; Paun, Olimpia; Eisenstein, Amy R; Wilbur, Joellen

    2011-11-01

    This article describes how a family caregiver lifestyle physical activity clinical trial uses research technology to enhance quality control and treatment fidelity. This trial uses a range of Internet, Blaise(®) Windows-based software and Echo Server technologies to support quality control issues, such as data collection, data entry, and study management advocated by the clinical trials literature, and to ensure treatment fidelity concerning intervention implementation (i.e., design, training, delivery, receipt, and enactment) as proposed by the National Institutes of Health Behavior Change Consortium. All research staff are trained to use these technologies. Strengths of this technological approach to support quality control and treatment fidelity include the comprehensive plan, involvement of all staff, and ability to maintain accurate and timely data. Limitations include the upfront time and costs for developing and testing these technological methods, and having support staff readily available to address technological issues if they occur.

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