Sample records for internal quality controls

  1. CTEPP STANDARD OPERATING PROCEDURE FOR CONDUCTING INTERNAL FIELD AUDITS AND QUALITY CONTROL (SOP-2.25)

    EPA Science Inventory

    This SOP describes the method for conducting internal field audits and quality control procedures. Internal field audits will be conducted to ensure the collection of high quality data. Internal field audits will be conducted by Field Auditors (the Field QA Officer and the Field...

  2. 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

  3. [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.

  4. Assessments of the quality of randomized controlled trials published in International Journal of Urology from 1994 to 2011.

    PubMed

    Cho, Hee Ju; Chung, Jae Hoon; Jo, Jung Ki; Kang, Dong Hyuk; Cho, Jeong Man; Yoo, Tag Keun; Lee, Seung Wook

    2013-12-01

    Randomized controlled trials are one of the most reliable resources for assessing the effectiveness and safety of medical treatments. Low quality randomized controlled trials carry a large bias that can ultimately impair the reliability of their conclusions. The present study aimed to evaluate the quality of randomized controlled trials published in International Journal of Urology by using multiple quality assessment tools. Randomized controlled trials articles published in International Journal of Urology were found using the PubMed MEDLINE database, and qualitative analysis was carried out with three distinct assessment tools: the Jadad scale, the van Tulder scale and the Cochrane Collaboration Risk of Bias Tool. The quality of randomized controlled trials was analyzed by publication year, type of subjects, intervention, presence of funding and whether an institutional review board reviewed the study. A total of 68 randomized controlled trial articles were published among a total of 1399 original articles in International Journal of Urology. Among these randomized controlled trials, 10 (2.70%) were from 1994 to 1999, 23 (4.10%) were from 2000 to 2005 and 35 (4.00%) were from 2006 to 2011 (P = 0.494). On the assessment with the Jadad and van Tulder scale, the numbers and percentage of high quality randomized controlled trials increased over time. The studies that had institutional review board reviews, funding resources or that were carried out in multiple institutions had an increased percentage of high quality articles. The numbers and percentage of high-quality randomized controlled trials published in International Journal of Urology have increased over time. Furthermore, randomized controlled trials with funding resources, institutional review board reviews or carried out in multiple institutions have been found to be of higher quality compared with others not presenting these features. © 2013 The Japanese Urological Association.

  5. Factors of quality of financial report of local government in Indonesia

    NASA Astrophysics Data System (ADS)

    Muda, Iskandar; Haris Harahap, Abdul; Erlina; Ginting, Syafruddin; Maksum, Azhar; Abubakar, Erwin

    2018-03-01

    The purpose of this research is to find out whether the Accounting Information System and Internal Control in Local Revenue Office to the affect the Quality of Financial Report of Local Government. The sampling was conducted by using simple random sampling method in which the sample was determined without considering strata. The data research was conducted by distributing the questionnaires. The results showed that the degree of Accounting Information System and Internal Control simultaneously affect the Quality of Financial Report of Local Government. However, partially, Partially, accounting information system influence to the quality of financial report of local government and the internal control does not affect the quality of financial report.

  6. Report: Utah Department of Environmental Quality Water Quality State Revolving Fund Fiscal Year 2004 Financial Statements

    EPA Pesticide Factsheets

    Report #2005-1-00144, August 8, 2005. We noted weaknesses in internal controls. DEQ internal controls failed to prevent the SRF disbursement, recording and reporting of $479,961 in ineligible assistance.

  7. Headache-specific locus of control and migraine-related quality of life: understanding the role of anxiety

    PubMed Central

    Grinberg, Amy S.; Seng, Elizabeth K.

    2017-01-01

    Purpose This study examined the relationship between headache-specific locus of control (HSLC) and migraine-related quality of life, and anxiety as a mediator of this relationship. Methods Two hundred and thirty-two people with severe migraine participated in the Treatment of Severe Migraine trial. At baseline, participants completed self-report questionnaires of headache-specific locus of control (HSLC; subscales = Internal, Chance, and Medical Professionals), anxiety, and migraine-related quality of life. Correlations examined relationships between HSLC, anxiety, and migraine-related quality of life; ordinary least squares regression evaluated anxiety as a mediator of the relationship between HSLC and migraine-related quality of life. Results Higher internal HSLC was related to higher overall migraine-related quality of life (ps < .05) and emotion function impairments (p = .012). Anxiety mediated the relationship between internal HSLC and all measures of migraine-specific quality of life (ps < .05). Higher external (medical professionals and chance) HSLC was related to higher migraine-related quality of life impairments (all ps < .001). Conclusions All HSLC beliefs are associated with higher migraine-related quality of life impairments. Anxiety mediates the relationship between internal HSLC and migraine-related quality of life. PMID:27488417

  8. 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

  9. Infertility and Subjective Well-Being: The Mediating Roles of Self-Esteem, Internal Control, and Interpersonal Conflict.

    ERIC Educational Resources Information Center

    Abbey, Antonia; And Others

    1992-01-01

    Examined relationship between self-esteem, perceived control, interpersonal conflict between spouses, global and intimacy life quality, and stress produced by infertility in 185 married infertile couples. Found that fertility problem stress had indirect negative effects on life quality via its mediating effects on self-esteem, internal control,…

  10. Patients suffering from restless legs syndrome have low internal locus of control and poor psychological functioning compared to healthy controls.

    PubMed

    Brand, Serge; Beck, Johannes; Hatzinger, Martin; Holsboer-Trachsler, Edith

    2013-01-01

    Restless legs syndrome (RLS) is a disturbing sensorimotor disorder negatively influencing both sleep and psychological functioning. The aim of the present study was to assess RLS patients with respect to locus of control, sleep-related personality traits, quality of life, and sleep as compared to healthy controls. Thirty-eight patients (18 females and 20 males; mean age: 56.06 years) diagnosed with RLS and an age- and gender-matched control group (n = 42) were recruited. Participants completed a series of questionnaires related to locus of control, personality traits, quality of life, and sleep. Compared to healthy controls, RLS patients had a lower internal locus of control, unfavourable sleep-related personality traits such as low self-confidence and higher mental arousal, poorer quality of life, and more depressive symptoms. Sleep was also affected. Multiple regression analyses showed that a low internal and a high external locus of control were predicted by RLS. The pattern of results suggests that RLS is associated with a low locus of control, negative personality traits, and poor quality of life as compared to healthy controls. Copyright © 2013 S. Karger AG, Basel.

  11. Report of the international workshop on quality control of monthly climate data

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

    Not Available

    1993-12-31

    The National Climatic Data Center (NCDC), the US Department of Energy`s Carbon Dioxide Information Analysis Center, and the World Meteorological Organization (WMO) cosponsored an international quality control workshop for monthly climate data, October 5--6, 1993, at NCDC. About 40 scientists from around the world participated. The purpose of the meeting was to discuss and compare various quality control methods and to draft recommendations concerning the most successful systems. The near-term goal to improve quality control of CLIMAT messages for the NCDC/WMO publication Monthly Climatic Data for the World was sucessfully met. An electronic bulletin board was established to post errorsmore » and corrections. Improved communications among Global Telecommunication System hubs will be implemented. Advanced quality control algorithms were discussed and improvements were suggested. Further data exchanges were arranged.« less

  12. 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

  13. Assessment of the iodine concentration in table salt at the production stage in South Africa.

    PubMed Central

    Jooste, Pieter L.

    2003-01-01

    OBJECTIVE: To determine the iodine content of iodized salt at the production stage, to assess the perceptions and knowledge of salt producers about the prevention and control of iodine deficiency, and to examine the internal quality control procedures used during iodization in South Africa. METHOD: Salt samples were collected for iodine analysis by titration from the 12 producers iodizing salt in South Africa. Information on the producers' knowledge of iodine deficiency disorders and on internal quality control was obtained by means of questionnaires. FINDINGS: The legal requirement of 40-60 ppm iodine was met in 30.9% of salt samples; 57.9% contained more than 30 ppm iodine; 34.8% contained under 20 ppm iodine. There were shortcomings in perceptions and knowledge about iodine deficiency disorders and in the internal quality control procedures of a substantial proportion of the producers. CONCLUSION: In order to encourage and support salt producers to achieve optimal iodization there should be an information, education and communication strategy aimed at improving knowledge of iodine deficiency disorders and at raising the standard of internal quality control procedures. External monitoring should continue. PMID:12973644

  14. 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.

  15. Importance of implementing an analytical quality control system in a core laboratory.

    PubMed

    Marques-Garcia, F; Garcia-Codesal, M F; Caro-Narros, M R; Contreras-SanFeliciano, T

    2015-01-01

    The aim of the clinical laboratory is to provide useful information for screening, diagnosis and monitoring of disease. The laboratory should ensure the quality of extra-analytical and analytical process, based on set criteria. To do this, it develops and implements a system of internal quality control, designed to detect errors, and compare its data with other laboratories, through external quality control. In this way it has a tool to detect the fulfillment of the objectives set, and in case of errors, allowing corrective actions to be made, and ensure the reliability of the results. This article sets out to describe the design and implementation of an internal quality control protocol, as well as its periodical assessment intervals (6 months) to determine compliance with pre-determined specifications (Stockholm Consensus(1)). A total of 40 biochemical and 15 immunochemical methods were evaluated using three different control materials. Next, a standard operation procedure was planned to develop a system of internal quality control that included calculating the error of the analytical process, setting quality specifications, and verifying compliance. The quality control data were then statistically depicted as means, standard deviations, and coefficients of variation, as well as systematic, random, and total errors. The quality specifications were then fixed and the operational rules to apply in the analytical process were calculated. Finally, our data were compared with those of other laboratories through an external quality assurance program. The development of an analytical quality control system is a highly structured process. This should be designed to detect errors that compromise the stability of the analytical process. The laboratory should review its quality indicators, systematic, random and total error at regular intervals, in order to ensure that they are meeting pre-determined specifications, and if not, apply the appropriate corrective actions. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

  16. 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

  17. A Self-Instructional Course in Student Financial Aid Administration. Module 15: Internal Aid Office Management and Institutional Quality Control. Second Edition.

    ERIC Educational Resources Information Center

    Washington Consulting Group, Inc., Washington, DC.

    The 15th in a 17-module self-instructional course on student financial aid administration (designed for novice financial aid administrators and other institutional personnel) focuses on internal aid office management and institutional quality control. The course provides a systematic introduction to the management of federal financial aid programs…

  18. 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.

  19. Assuring Quality in Education Evaluation.

    ERIC Educational Resources Information Center

    Trochim, William M. K.; Visco, Ronald J.

    1986-01-01

    A number of quality assurance educational evaluation methods are illustrated. Evaluation data obtained from the Providence, Rhode Island, school district are used. The methods are: (1) from auditing, internal control; (2) from accounting, double bookkeeping; and (3) from industrial quality control, acceptance sampling and cumulative percentage…

  20. Components of the costs of controlling quality: a transaction cost economics approach.

    PubMed

    Stiles, R A; Mick, S S

    1997-01-01

    This article identifies the components that contribute to a healthcare organization's costs in controlling quality. A central tenet of our argument is that at its core, quality is the result of a series of transactions among members of a diverse network. Transaction cost economics is applied internally to analyze intraorganizational transactions that contribute to quality control, and questions for future research are posed.

  1. Locus of control, sources of motivation, and mental boundaries as antecedents of leader-member exchange quality.

    PubMed

    Barbuto, John E; Finch, Weltmer Dayna; Pennisi, Lisa A

    2010-02-01

    In this study were examined leaders' and members' scores on locus of control, sources of motivation, and mental boundaries to predict the quality of leader-member exchanges. 80 elected officials and their 388 direct reports were sampled in a field study. Analysis indicated followers' scores on locus of control, leaders' scores of self-concept internal motivation, leaders' scores on locus of control, and followers' rated goal-internalization motivation were positively related to leader-member exchanges. Implications and directions for research are discussed.

  2. 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.

  3. Introduction to Quality Control in a Compounding Pharmacy.

    PubMed

    Allen, Loyd V

    2016-01-01

    A quality-based program is vital in every compounding pharmacy to ensure that each preparation is compounded properly and is stable for its expected duration of use. This article discusses quality control, quality assurance, continuous quality improvement, and also describes the components of an in-house (in-pharmacy) quality program, as well as the role of outside laboratories. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

  4. [Internal audit--the foundation of healthcare quality management in health care].

    PubMed

    Smiianov, V A

    2014-01-01

    The paper proved the need for internal audit as the basis for quality control of medical care in a health facility, developed the project milestones and explains what needs to be taken into account at every stage during its implementation.

  5. Blood glucose control and quality of health care in non-insulin-treated patients with Type 2 diabetes in Spain: a retrospective and cross-sectional observational study

    PubMed Central

    Rodríguez, A; Calle, A; Vázquez, L; Chacón, F; Polavieja, P; Reviriego, J

    2011-01-01

    Aims To assess blood glucose control and quality of health care provided to non-insulin-treated patients with Type 2 diabetes mellitus in routine clinical practice in Spain. Methods In this observational, retrospective, cross-sectional study, patients were grouped as either having good or suboptimal blood glucose control according to International Diabetes Federation or American Diabetes Association HbA1c goals. Clinical and socio-demographic data and compliance with the main standard level of care recommendations of the International Diabetes Federation were recorded during a routine visit. Correlates of glucose control were analysed by logistic regression. Results Many patients were grouped as having suboptimal control under International Diabetes Federation (61.9%) or American Diabetes Association (45.0%) criteria. The mean number of accomplished International Diabetes Federation recommendations (7.3 out of 11) was higher for endocrinologists (than for internists or primary care physicians), and significantly more patients under their care were in the good glucose control group (than with primary care physicians). More recommendations were associated with blood glucose control using International Diabetes Federation than American Diabetes Association criteria, demanding higher quality of health care for achieving stricter goals. Some recommendations were poorly observed, particularly those concerning patients’ education on diabetes, the prompt prescription of effective treatments and monitoring of complications. Diabetes complications were associated with being in the suboptimal control group. Patients’ education on diabetes and HbA1c monitoring were associated with being in the good control group. Conclusions These results demonstrate the need for improvement in the management of patients with non-insulin-treated Type 2 diabetes in actual clinical practice in Spain. Such improvement would entail a stricter adherence to International Diabetes Federation recommendations. PMID:21294772

  6. Quality Leadership and Quality Control

    PubMed Central

    Badrick, Tony

    2003-01-01

    Different quality control rules detect different analytical errors with varying levels of efficiency depending on the type of error present, its prevalence and the number of observations. The efficiency of a rule can be gauged by inspection of a power function graph. Control rules are only part of a process and not an end in itself; just as important are the trouble-shooting systems employed when a failure occurs. 'Average of patient normals' may develop as a usual adjunct to conventional quality control serum based programmes. Acceptable error can be based on various criteria; biological variation is probably the most sensible. Once determined, acceptable error can be used as limits in quality control rule systems. A key aspect of an organisation is leadership, which links the various components of the quality system. Leadership is difficult to characterise but its key aspects include trust, setting an example, developing staff and critically setting the vision for the organisation. Organisations also have internal characteristics such as the degree of formalisation, centralisation, and complexity. Medical organisations can have internal tensions because of the dichotomy between the bureaucratic and the shadow medical structures. PMID:18568046

  7. Academic Quality Control in Nigerian Universities: Exploring Lecturers' Perceptions

    ERIC Educational Resources Information Center

    Obiekezie, E. O.; Ejemot-Nwadiaro, R. I.; Essien, M. I.; Timothy, A. Essien

    2014-01-01

    The level of job performance, international comparability and competitiveness of Nigerian university graduates are burning issues. Consequently, the academic quality of Nigerian universities has come under severe criticism. Since university lecturers are key players in quality control in universities, this study explored their perceptions of…

  8. Does Internal Quality Management Contribute to More Control or to Improvement of Higher Education?: A Survey on Faculty's Perceptions

    ERIC Educational Resources Information Center

    Kleijnen, Jan; Dolmans, Diana; Willems, Jos; van Hout, Hans

    2011-01-01

    Purpose: The purpose of this paper is to explore faculty's perceptions of quality management activities (QMA) within their departments, attention being paid to relevant quality aspects and whether quality management contributes to control or improvement of higher education. Furthermore, it examines differences between departments and relationships…

  9. DEVELOPMENT OF INTERNATIONAL STANDARDS FOR AIR QUALITY MONITORING AND CONTROL

    EPA Science Inventory

    This report presents a description of the activities and accomplishments of the American Society for Testing and Materials' U. S. Technical Advisory Group (TAG) to the International Standards Organization's Technical Committee 146 on Air Quality. The purpose of the TAG is to re...

  10. I Spy with My Little Eye: Jurors' Detection of Internal Validity Threats in Expert Evidence

    PubMed Central

    McAuliff, Bradley D.; Duckworth, Tejah D.

    2010-01-01

    This experiment examined whether jury-eligible community members (N = 223) were able to detect internally invalid psychological science presented at trial. Participants read a simulated child sexual abuse case in which the defense expert described a study he had conducted on witness memory and suggestibility. We varied the study's internal validity (valid, missing control group, confound, and experimenter bias) and publication status (published, unpublished). Expert evidence quality ratings were higher for the valid versus missing control group version only. Publication increased ratings of defendant guilt when the study was missing a control group. Variations in internal validity did not influence perceptions of child victim credibility or police interview quality. Participants' limited detection of internal validity threats underscores the need to examine the effectiveness of traditional legal safeguards against junk science in court and improve the scientific reasoning ability of lay people and legal professionals. PMID:20162342

  11. Measuring Software Product Quality: The ISO 25000 Series and CMMI

    DTIC Science & Technology

    2004-06-14

    performance objectives” covers objectives and requirements for product quality, service quality , and process performance. Process performance objectives...such that product quality, service quality , and process performance attributes are measurable and controlled throughout the project (internal and

  12. Construction of Genetically Engineered Streptococcus gordonii Strains to Provide Control in QPCR Assays for Assessing Microbiological Quality in Recreational Water.

    EPA Science Inventory

    Quantitative PCR (QPCR) methods for beach monitoring by estimating abundance of Enterococcus spp. in recreational waters use internal, positive controls which address only the amplification of target DNA. In this study two internal, positive controls were developed to control for...

  13. [Pharmaceutical product quality control and good manufacturing practices].

    PubMed

    Hiyama, Yukio

    2010-01-01

    This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

  14. Assuring fish safety and quality in international fish trade.

    PubMed

    Ababouch, Lahsen

    2006-01-01

    International trade in fishery commodities reached US 58.2 billion dollars in 2002, a 5% improvement relative to 2000 and a 45% increase over 1992 levels. Within this global trade, developing countries registered a net trade surplus of US 17.4 billion dollars in 2002 and accounted for almost 50% by value and 55% of fish exports by volume. This globalization of fish trade, coupled with technological developments in food production, handling, processing and distribution, and the increasing awareness and demand of consumers for safe and high quality food have put food safety and quality assurance high in public awareness and a priority for many governments. Consequently, many countries have tightened food safety controls, imposing additional costs and requirements on imports. As early as 1980, there was an international drive towards adopting preventative HACCP-based safety and quality systems. More recently, there has been a growing awareness of the importance of an integrated, multidisciplinary approach to food safety and quality throughout the entire food chain. Implementation of this approach requires an enabling policy and regulatory environment at national and international levels with clearly defined rules and standards, establishment of appropriate food control systems and programmes at national and local levels, and provision of appropriate training and capacity building. This paper discusses the international framework for fish safety and quality, with particular emphasis on the United Nation's Food and Agricultural Organization's (FAO) strategy to promote international harmonization and capacity building.

  15. Internal quality control indicators of cervical cytopathology exams performed in laboratories monitored by the External Quality Control Laboratory.

    PubMed

    Ázara, Cinara Zago Silveira; Manrique, Edna Joana Cláudio; Tavares, Suelene Brito do Nascimento; de Souza, Nadja Lindany Alves; Amaral, Rita Goreti

    2014-09-01

    To evaluate the impact of continued education provided by an external quality control laboratory on the indicators of internal quality control of cytopathology exams. The internal quality assurance indicators for cytopathology exams from 12 laboratories monitored by the External Quality Control Laboratory were evaluated. Overall, 185,194 exams were included, 98,133 of which referred to the period preceding implementation of a continued education program, while 87,061 referred to the period following this intervention. Data were obtained from the Cervical Cancer Database of the Brazilian National Health Service. Following implementation of the continued education program, the positivity index (PI) remained within recommended limits in four laboratories. In another four laboratories, the PI progressed from below the limits to within the recommended standards. In one laboratory, the PI remained low, in two laboratories, it remained very low, and in one, it increased from very low to low. The percentage of exams compatible with a high-grade squamous intraepithelial lesion (HSIL) remained within the recommended limits in five laboratories, while in three laboratories it progressed from below the recommended levels to >0.4% of the total number of satisfactory exams, and in four laboratories it remained below the standard limit. Both the percentage of atypical squamous cells of undetermined significance (ASC-US) in relation to abnormal exams, and the ratio between ASC-US and intraepithelial lesions remained within recommended levels in all the laboratories investigated. An improvement was found in the indicators represented by the positivity index and the percentage of exams compatible with a high-grade squamous intraepithelial lesion, showing that the role played by the external quality control laboratory in providing continued education contributed towards improving laboratory staff skills in detecting cervical cancer precursor lesions.

  16. Shaping Performance: Do International Accreditations and Quality Management Really Help?

    ERIC Educational Resources Information Center

    Nigsch, Stefano; Schenker-Wicki, Andrea

    2013-01-01

    In recent years, international accreditations have become an important form of quality management for business schools all over the world. However, given their high costs and the risk of increasing bureaucratisation and control, accreditations remain highly disputed in academia. This paper uses quantitative data to assess whether accreditations…

  17. Quantity and Quality of Computer Use and Academic Achievement: Evidence from a Large-Scale International Test Program

    ERIC Educational Resources Information Center

    Cheema, Jehanzeb R.; Zhang, Bo

    2013-01-01

    This study looked at the effect of both quantity and quality of computer use on achievement. The Program for International Student Assessment (PISA) 2003 student survey comprising of 4,356 students (boys, n = 2,129; girls, n = 2,227) was used to predict academic achievement from quantity and quality of computer use while controlling for…

  18. Does Public Sector Control Reduce Variance in School Quality?

    ERIC Educational Resources Information Center

    Pritchett, Lant; Viarengo, Martina

    2015-01-01

    Does the government control of school systems facilitate equality in school quality? Whether centralized or localized control produces more equality depends not only on what "could" happen in principle, but also on what does happen in practice. We use the Programme for International Student Assessment (PISA) database to examine the…

  19. Quality Assurance in the German School System

    ERIC Educational Resources Information Center

    Huber, Stephan Gerhard; Gordel, Bettina

    2006-01-01

    Whereas internationally the shift towards quality control of school systems started in the early 1980s, mainly promoted by transnational agencies, this development only began in Germany in the mid 1990s. However, a clear-cut change from an input-controlled and centralised to a more output-controlled, decentralised and deregulated supervision…

  20. 48 CFR 2146.201 - General.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality... acquired under the FEGLI Program contract conform to the contract's quality requirements. (b) OPM will make an initial evaluation of the Contractor's system of internal controls under the quality assurance...

  1. 48 CFR 2146.201 - General.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality... acquired under the FEGLI Program contract conform to the contract's quality requirements. (b) OPM will make an initial evaluation of the Contractor's system of internal controls under the quality assurance...

  2. 48 CFR 2146.201 - General.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality... acquired under the FEGLI Program contract conform to the contract's quality requirements. (b) OPM will make an initial evaluation of the Contractor's system of internal controls under the quality assurance...

  3. 48 CFR 2146.201 - General.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality... acquired under the FEGLI Program contract conform to the contract's quality requirements. (b) OPM will make an initial evaluation of the Contractor's system of internal controls under the quality assurance...

  4. 48 CFR 2146.201 - General.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality... acquired under the FEGLI Program contract conform to the contract's quality requirements. (b) OPM will make an initial evaluation of the Contractor's system of internal controls under the quality assurance...

  5. Can jurors recognize missing control groups, confounds, and experimenter bias in psychological science?

    PubMed

    McAuliff, Bradley D; Kovera, Margaret Bull; Nunez, Gabriel

    2009-06-01

    This study examined the ability of jury-eligible community members (N = 248) to detect internal validity threats in psychological science presented during a trial. Participants read a case summary in which an expert testified about a study that varied in internal validity (valid, missing control group, confound, and experimenter bias) and ecological validity (high, low). Ratings of expert evidence quality and expert credibility were higher for the valid versus missing control group versions only. Internal validity did not influence verdict or ratings of plaintiff credibility and no differences emerged as a function of ecological validity. Expert evidence quality, expert credibility, and plaintiff credibility were positively correlated with verdict. Implications for the scientific reasoning literature and for trials containing psychological science are discussed.

  6. A Quality Assurance Initiative for Commercial-Scale Production in High-Throughput Cryopreservation of Blue Catfish Sperm

    PubMed Central

    Hu, E; Liao, T. W.; Tiersch, T. R.

    2013-01-01

    Cryopreservation of fish sperm has been studied for decades at a laboratory (research) scale. However, high-throughput cryopreservation of fish sperm has recently been developed to enable industrial-scale production. This study treated blue catfish (Ictalurus furcatus) sperm high-throughput cryopreservation as a manufacturing production line and initiated quality assurance plan development. The main objectives were to identify: 1) the main production quality characteristics; 2) the process features for quality assurance; 3) the internal quality characteristics and their specification designs; 4) the quality control and process capability evaluation methods, and 5) the directions for further improvements and applications. The essential product quality characteristics were identified as fertility-related characteristics. Specification design which established the tolerance levels according to demand and process constraints was performed based on these quality characteristics. Meanwhile, to ensure integrity throughout the process, internal quality characteristics (characteristics at each quality control point within process) that could affect fertility-related quality characteristics were defined with specifications. Due to the process feature of 100% inspection (quality inspection of every fish), a specific calculation method, use of cumulative sum (CUSUM) control charts, was applied to monitor each quality characteristic. An index of overall process evaluation, process capacity, was analyzed based on in-control process and the designed specifications, which further integrates the quality assurance plan. With the established quality assurance plan, the process could operate stably and quality of products would be reliable. PMID:23872356

  7. Cabin Air Quality On Board Mir and the International Space Station: A Comparison

    NASA Technical Reports Server (NTRS)

    Macatangay, Ariel; Perry, Jay L.

    2007-01-01

    The maintenance of the cabin atmosphere aboard spacecraft is critical not only to its habitability but also to its function. Ideally, air quality can be maintained by striking a proper balance between the generation and removal of contaminants. Both very dynamic processes, the balance between generation and removal can be difficult to maintain and control because the state of the cabin atmosphere is in constant evolution responding to different perturbations. Typically, maintaining a clean cabin environment on board crewed spacecraft and space habitats is the central function of the environmental control and life support (ECLS) system. While active air quality control equipment is deployed on board every vehicle to remove carbon dioxide, water vapor, and trace chemical components from the cabin atmosphere, perturbations associated with logistics, vehicle construction and maintenance, and ECLS system configuration influence the resulting cabin atmospheric quality. The air-quality data obtained from the International Space Station (ISS) and NASA-Mir programs provides a wealth of information regarding the maintenance of the cabin atmosphere aboard long-lived space habitats. A comparison of the composition of the trace chemical contaminant load is presented. Correlations between ground-based and in-flight operations that influence cabin atmospheric quality are identified and discussed, and observations on cabin atmospheric quality during the NASA-Mir expeditions and the International Space Station are explored.

  8. World Environmental Quality, A Challenge to the International Community.

    ERIC Educational Resources Information Center

    Department of State, Washington, DC.

    The quality of the world environment cannot be dependent upon the efforts of a single nation. This fact is now recognized by most nations. Only through cooperative international actions can effective pollution control and natural resource conservation be realized. The purpose of this booklet is to publicize the work that the United States and…

  9. The Usefulness of Quality Assurance for University Management and Academic Staff: A Case Study of Finland and Iceland

    ERIC Educational Resources Information Center

    Haapakorpi, Arja; Geirsdóttir, Guðrún; Jóhannsdóttir, Gyða

    2013-01-01

    With quality assurance related to the Bologna goals, universities are required to fulfil internationally accepted standardized criteria of quality. This tends to reinforce control in assessment. However, control-oriented evaluations seem to lack meaning for academic staff. The article explored the possibilities and space for improvement-oriented…

  10. ISO 9002 as Literacy Practice: Coping with Quality-Control Documents in a High-Tech Company

    ERIC Educational Resources Information Center

    Kleifgen, Jo Anne

    2005-01-01

    This study describes the process by which a circuit board manufacturing company became certified in an international quality control program known as ISO 9002. Particular attention is paid to how quality documents were made and used in actual practice and to the relationship between these standardized procedures (official literacies) and…

  11. Interactions among catechol-O-methyltransferase genotype, parenting, and sex predict children’s internalizing symptoms and inhibitory control: Evidence for differential susceptibility

    PubMed Central

    SULIK, MICHAEL J.; EISENBERG, NANCY; SPINRAD, TRACY L.; LEMERY-CHALFANT, KATHRYN; SWANN, GREGORY; SILVA, KASSONDRA M.; REISER, MARK; STOVER, DARYN A.; VERRELLI, BRIAN C.

    2015-01-01

    We used sex, observed parenting quality at 18 months, and three variants of the catechol-O-methyltransferase gene (Val158Met [rs4680], intron1 [rs737865], and 3′-untranslated region [rs165599]) to predict mothers’ reports of inhibitory and attentional control (assessed at 42, 54, 72, and 84 months) and internalizing symptoms (assessed at 24, 30, 42, 48, and 54 months) in a sample of 146 children (79 male). Although the pattern for all three variants was very similar, Val158Met explained more variance in both outcomes than did intron1, the 3′-untranslated region, or a haplotype that combined all three catechol-O-methyltransferase variants. In separate models, there were significant three-way interactions among each of the variants, parenting, and sex, predicting the intercepts of inhibitory control and internalizing symptoms. Results suggested that Val158Met indexes plasticity, although this effect was moderated by sex. Parenting was positively associated with inhibitory control for methionine–methionine boys and for valine–valine/valine–methionine girls, and was negatively associated with internalizing symptoms for methionine–methionine boys. Using the “regions of significance” technique, genetic differences in inhibitory control were found for children exposed to high-quality parenting, whereas genetic differences in internalizing were found for children exposed to low-quality parenting. These findings provide evidence in support of testing for differential susceptibility across multiple outcomes. PMID:25159270

  12. [Coronary artery bypass surgery: methods of performance monitoring and quality control].

    PubMed

    Albert, A; Sergeant, P; Ennker, J

    2009-10-01

    The strength of coronary bypass operations depends on the preservation of their benefits regarding freedom of symptoms, quality of life and survival, over decades. Significant variability of the results of an operative intervention according to the hospital or the operating surgeon is considered a weakness in the procedure. The external quality insurance tries to reach a transparent service providing market through hospital ranking comparability. Widely available information and competition will promote the improvement of the whole quality. The structured dialog acts as a control instrument for the BQS (Federal Quality Insurance). It is launched in case of deviations from the standard references or statistically significant differences between the results of the operations in any hospital and the average notational results. In comparison to the external control the hospital internal control has greater ability to reach a medically useful statement regarding the results of the treatment and to correct the mistakes in time. An online information portal based on a departmental databank (DataWarehouse, DataMart) is an attractive solution for the physician in order to get transparently and timely informed about the variability in the performance.The individual surgeon significantly influences the short- and long-term treatment results. Accordingly, selection, targeted training and performance measurements are necessary.Strict risk management and failure analysis of individual cases are included in the methods of internal quality control aiming to identify and correct the inadequacies in the system and the course of treatment. According to the international as well as our own experience, at least 30% of the mortalities after bypass operations are avoidable. A functioning quality control is especially important in minimally invasive interventions because they are often technically more demanding in comparison to the conventional procedures. In the field of OPCAB surgery, the special advantages of the procedure can be utilised to reach a nearly complete avoidance of postoperative stroke through combining the procedure with aorta no-touch technique. The long-term success of the bypass operation depends on the type of bypass material in additions to many other factors. Both internal mammary arteries are considered the most durable.Using an operation preparation check contributes to the operative success.

  13. [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.

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

    PubMed

    Iqbal, Sahar; Mustansar, Tazeen

    2017-03-01

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

  15. Halogenated peptides as internal standards (H-PINS): introduction of an MS-based internal standard set for liquid chromatography-mass spectrometry.

    PubMed

    Mirzaei, Hamid; Brusniak, Mi-Youn; Mueller, Lukas N; Letarte, Simon; Watts, Julian D; Aebersold, Ruedi

    2009-08-01

    As the application for quantitative proteomics in the life sciences has grown in recent years, so has the need for more robust and generally applicable methods for quality control and calibration. The reliability of quantitative proteomics is tightly linked to the reproducibility and stability of the analytical platforms, which are typically multicomponent (e.g. sample preparation, multistep separations, and mass spectrometry) with individual components contributing unequally to the overall system reproducibility. Variations in quantitative accuracy are thus inevitable, and quality control and calibration become essential for the assessment of the quality of the analyses themselves. Toward this end, the use of internal standards cannot only assist in the detection and removal of outlier data acquired by an irreproducible system (quality control) but can also be used for detection of changes in instruments for their subsequent performance and calibration. Here we introduce a set of halogenated peptides as internal standards. The peptides are custom designed to have properties suitable for various quality control assessments, data calibration, and normalization processes. The unique isotope distribution of halogenated peptides makes their mass spectral detection easy and unambiguous when spiked into complex peptide mixtures. In addition, they were designed to elute sequentially over an entire aqueous to organic LC gradient and to have m/z values within the commonly scanned mass range (300-1800 Da). In a series of experiments in which these peptides were spiked into an enriched N-glycosite peptide fraction (i.e. from formerly N-glycosylated intact proteins in their deglycosylated form) isolated from human plasma, we show the utility and performance of these halogenated peptides for sample preparation and LC injection quality control as well as for retention time and mass calibration. Further use of the peptides for signal intensity normalization and retention time synchronization for selected reaction monitoring experiments is also demonstrated.

  16. Evaluation of medical record quality and communication skills among pediatric interns after standardized parent training history-taking in China.

    PubMed

    Yu, Mu Xue; Jiang, Xiao Yun; Li, Yi Juan; Shen, Zhen Yu; Zhuang, Si Qi; Gu, Yu Fen

    2018-02-01

    The effect of using standardized parent training history-taking on the quality of medical records and communication skills among pediatric interns was determined. Fifth-year interns who were undertaking a pediatric clinical practice rotation were randomized to intervention and control groups. All of the pediatric interns received history-taking training by lecture and bedside teaching. The pediatric interns in the intervention group also received standardized parent history-taking training. The following two outcome measures were used: the scores of medical records, which were written by the pediatric interns after history-taking from real parents of pediatric patients; and the communication assessment tool (CAT) assessed by real parents. The general information, history of present illness (HPI), past medical history, personal history, family history, diagnosis, diagnostic analysis, and differential diagnosis scores in the intervention group were significantly higher than the control group (p < 0.05). Assessment of the CAT indicated that the real parents were more satisfied with the pediatric interns in the intervention group. Standardized parent training history-taking is effective in improving the quality of medical records by pediatric interns. Standardized parent training history-taking is a superior teaching tool for clinical reasoning ability, as well as communication skills in clinical pediatric practice.

  17. 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.

  18. [Quality control at the Istituto di Anatomia e Istologia patologica at the Università di Bologna].

    PubMed

    Alampi, G; Baroni, R; Berti, E; Ceccarelli, C; Dina, R; Eusebi, V; Giangaspero, F; Grigioni, F W; Lecce, S; Losi, L

    1994-04-01

    The growing importance in medical practice of a standardized diagnosis in cyto- and histopathology and the recent recommendations for the adoption of standardized schemes for quality control in anatomic pathology by International Committees stimulated the medical staff of the Institute of Anatomic Pathology of the University of Bologna to adopt a pertinent method. The method used by the Department of Pathology of the Yale University (New Haven, Connecticut, USA) was chosen. A Committee for the quality control was appointed and two kinds of controls were set up: an External Quality Assessment (review of the difficult cases by external experts, slide seminars) and an Internal Quality Assessment performed by the members of the Committee on the diagnostic and laboratory routine of the Institute. Such a survey is periodically monitored during the monthly meetings of the Committee and described in the monthly reports. The present paper illustrates the method adopted and the preliminary results obtained in order to stimulate the discussion of such a critical theme in contemporary Anatomic Pathology at a national level.

  19. Improved quality monitoring of multi-center acupuncture clinical trials in China

    PubMed Central

    2009-01-01

    Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

  20. Locus of control, quality of life, anxiety, and depression among Malaysian breast cancer patients: The mediating role of uncertainty.

    PubMed

    Pahlevan Sharif, Saeed

    2017-04-01

    The main objective of this study was to investigate the mediating role of uncertainty in the relationship between locus of control with quality of life, anxiety, and depression. A descriptive and correlational survey was conducted in a private hospital in Kuala Lumpur, Malaysia. A convenience sample of 118 Malaysian breast cancer patients voluntarily participated in the study and responded to a set of questionnaires including: socio-demographic questionnaire, the short form of Locus of Control Scale, the Functional Assessment of Cancer Therapy-Breast (FACT-B), the Hospital Anxiety and Depression Scale (HADS), and the Short-Form Mishel Uncertainty in Illness Scale (SF-MUIS). The results revealed that breast cancer patients with higher internal locus of control and lower external locus of control experience a higher quality of life, lower anxiety, and lower depression. Also, uncertainty mediated the relationship between locus of control with quality of life and depression (quasi-significant). The findings indicated the need for early, targeted psychological interventions seeking to gradually shift cancer patients' locus of control from external to internal in order to improve their quality of life and reduce their depression and anxiety. Moreover, health care providers by providing relevant information to cancer patients, especially for externally oriented patients, can reduce their uncertainty which in turn would improve their quality of life. Copyright © 2017 Elsevier Ltd. All rights reserved.

  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. Can a combination of average of normals and "real time" External Quality Assurance replace Internal Quality Control?

    PubMed

    Badrick, Tony; Graham, Peter

    2018-03-28

    Internal Quality Control and External Quality Assurance are separate but related processes that have developed independently in laboratory medicine over many years. They have different sample frequencies, statistical interpretations and immediacy. Both processes have evolved absorbing new understandings of the concept of laboratory error, sample material matrix and assay capability. However, we do not believe at the coalface that either process has led to much improvement in patient outcomes recently. It is the increasing reliability and automation of analytical platforms along with improved stability of reagents that has reduced systematic and random error, which in turn has minimised the risk of running less frequent IQC. We suggest that it is time to rethink the role of both these processes and unite them into a single approach using an Average of Normals model supported by more frequent External Quality Assurance samples. This new paradigm may lead to less confusion for laboratory staff and quicker responses to and identification of out of control situations.

  3. 48 CFR 1646.201 - Contract Quality Policy.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ensure that services acquired under the FEHB contract conform to the contract's quality and audit requirements. (b) OPM will periodically evaluate the contractor's system of internal controls under the quality... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Contract Quality Policy...

  4. 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.

  5. Guidelines for the detection of Trichinella larvae at the slaughterhouse in a quality assurance system.

    PubMed

    Rossi, Patrizia; Pozio, Edoardo

    2008-01-01

    The European Community Regulation (EC) No. 2075/2005 lays down specific rules on official controls for the detection of Trichinella in fresh meat for human consumption, recommending the pooled-sample digestion method as the reference method. The aim of this document is to provide specific guidance to implement an appropriate Trichinella digestion method by a laboratory accredited according to the ISO/IEC 17025:2005 international standard, and performing microbiological testing following the EA-04/10:2002 international guideline. Technical requirements for the correct implementation of the method, such as the personnel competence, specific equipments and reagents, validation of the method, reference materials, sampling, quality assurance of results and quality control of performance are provided, pointing out the critical control points for the correct implementation of the digestion method.

  6. Japanese Quality Control Circles.

    ERIC Educational Resources Information Center

    Nishiyama, Kazuo

    In recent years, United States scholars with an interest in international business and organizational communication have begun to notice the success of Japanese "quality control circles." These are small groups, usually composed of seven to ten workers, who are organized at the production levels within most large Japanese factories. A…

  7. Developing and implementing a computerized nursing quality control system in a tertiary general medical center in Israel.

    PubMed

    Kagan, Ilya; Cohen, Rachel; Fish, Miri; Mezare, Henia Perry

    2014-01-01

    This article describes the development and implementation of the Nursing Quality Indicators Scale and a quality control system for hospital nursing care, which allows universal access to all external and internal audit results, thus ensuring complete data transparency. Standardized indicators make departments' performance comparable. Key to the new system is nurses' self-audit and responsibility for making quality improvements at the ward level.

  8. A case study: application of statistical process control tool for determining process capability and sigma level.

    PubMed

    Chopra, Vikram; Bairagi, Mukesh; Trivedi, P; Nagar, Mona

    2012-01-01

    Statistical process control is the application of statistical methods to the measurement and analysis of variation process. Various regulatory authorities such as Validation Guidance for Industry (2011), International Conference on Harmonisation ICH Q10 (2009), the Health Canada guidelines (2009), Health Science Authority, Singapore: Guidance for Product Quality Review (2008), and International Organization for Standardization ISO-9000:2005 provide regulatory support for the application of statistical process control for better process control and understanding. In this study risk assessments, normal probability distributions, control charts, and capability charts are employed for selection of critical quality attributes, determination of normal probability distribution, statistical stability, and capability of production processes, respectively. The objective of this study is to determine tablet production process quality in the form of sigma process capability. By interpreting data and graph trends, forecasting of critical quality attributes, sigma process capability, and stability of process were studied. The overall study contributes to an assessment of process at the sigma level with respect to out-of-specification attributes produced. Finally, the study will point to an area where the application of quality improvement and quality risk assessment principles for achievement of six sigma-capable processes is possible. Statistical process control is the most advantageous tool for determination of the quality of any production process. This tool is new for the pharmaceutical tablet production process. In the case of pharmaceutical tablet production processes, the quality control parameters act as quality assessment parameters. Application of risk assessment provides selection of critical quality attributes among quality control parameters. Sequential application of normality distributions, control charts, and capability analyses provides a valid statistical process control study on process. Interpretation of such a study provides information about stability, process variability, changing of trends, and quantification of process ability against defective production. Comparative evaluation of critical quality attributes by Pareto charts provides the least capable and most variable process that is liable for improvement. Statistical process control thus proves to be an important tool for six sigma-capable process development and continuous quality improvement.

  9. KPMG Peat Marwick LLP GreatLakes Composites Consortium, Inc. Fiscal Year Ended December 31, 1995

    DTIC Science & Technology

    1997-06-25

    The objective of a quality control review is to assure that the audit was conducted in accordance with applicable standards and meets the auditing...requirements of the OMB Circular A-133. As the cognizant agency for the Institute, we conducted a quality control review of the audit working papers. We...focused our review on the qualitative aspects of the audit : due professional care, planning, supervision, independence, quality control, internal

  10. Trading Quality across Borders: Colonial Discourse and International Quality Assurance Policies in Higher Education

    ERIC Educational Resources Information Center

    Blanco Ramírez, Gerardo

    2014-01-01

    Accountability and quality assurance have become central discourses in higher education policy throughout the world. However, accountability and quality assurance involve power and control. Practices and ideas about quality developed in the Global North are spreading rapidly across the Global South, leading to increased uniformity in the…

  11. A Randomized Cohort Controlled Trial to Compare Intern Sign-Out Training Interventions.

    PubMed

    Lee, Soo-Hoon; Terndrup, Christopher; Phan, Phillip H; Zaeh, Sandra E; Atsina, Kwame; Minkove, Nicole; Billioux, Alexander; Chatterjee, Souvik; Montague, Idoreyin; Clark, Bennett; Hughes, Andrew; Desai, Sanjay V

    2017-12-01

    Although previous studies have investigated the efficacy of specific sign-out protocols (such as the illness severity, patient summary, action list, situation awareness and contingency planning, and synthesis by reviewer [I-PASS] bundle), the implementation of a bundle can be time consuming and costly. We compared 4 sign-out training pedagogies on sign-out quality. To evaluate training interventions that best enhance multidimensional sign-out quality measured by information exchange, task accountability, and personal responsibility. Four general internal medicine firms were randomly assigned into 1 of the following 4 training interventions: didactics (control), I-PASS, policy mandate on task accountability, and Plan-Do-Study-Act (PDSA). First-year interns at a large, Mid-Atlantic internal medicine residency program. Eight trained observers examined 10 days each in the pre- and postintervention periods for each firm using a standardized sign-out checklist. Pre- and postintervention differences showed significant improvements in the transfer of patient information, task accountability, and personal responsibility for the I-PASS, policy mandate, and PDSA groups, respectively, in line with their respective training foci. Compared to the control, I-PASS reported the best improvements in sign-out quality, although there was room to improve in task accountability and responsibility. Different training emphases improved different dimensions of sign-out quality. A combination of training pedagogies is likely to yield optimal results. © 2017 Society of Hospital Medicine

  12. Outsourcing University Degrees: Implications for Quality Control

    ERIC Educational Resources Information Center

    Edwards, Julie; Crosling, Glenda; Edwards, Ron

    2010-01-01

    Education institutions worldwide have and continue to seek opportunities to spread their offerings abroad. While the provision of courses to students located overseas through partner institutions has many advantages, it raises questions about quality control that are not as applicable to other forms of international education. This paper uses a…

  13. [Study of continuous quality improvement for clinical laboratory processes via the platform of Hospital Group].

    PubMed

    Song, Wenqi; Shen, Ying; Peng, Xiaoxia; Tian, Jian; Wang, Hui; Xu, Lili; Nie, Xiaolu; Ni, Xin

    2015-05-26

    The program of continuous quality improvement in clinical laboratory processes for complete blood count (CBC) was launched via the platform of Beijing Children's Hospital Group in order to improve the quality of pediatric clinical laboratories. Fifteen children's hospitals of Beijing Children's Hospital group were investigated using the method of Chinese adapted continuous quality improvement with PDCA (Plan-Do-Check-Action). The questionnaire survey and inter-laboratory comparison was conducted to find the existing problems, to analyze reasons, to set forth quality targets and to put them into practice. Then, targeted training was conducted to 15 children's hospitals and the second questionnaire survey, self examinations by the clinical laboratories was performed. At the same time, the Group's online internal quality control platform was established. Overall effects of the program were evaluated so that lay a foundation for the next stage of PDCA. Both quality of control system documents and CBC internal quality control scheme for all of clinical laboratories were improved through this program. In addition, standardization of performance verification was also improved, especially with the comparable verification rate of precision and internal laboratory results up to 100%. In terms of instrument calibration and mandatory diagnostic rates, only three out of the 15 hospitals (20%) failed to pass muster in 2014 from 46.67% (seven out of the 15 hospitals) in 2013. The abnormal data of intraday precision variance coefficients of the five CBC indicator parameters (WBC, RBC, Hb, Plt and Hct) of all the 15 laboratories accounted for 1.2% (2/165) in 2014, a marked decrease from 9.6% (14/145) in 2013. While the number of the hospitals using only one horizontal quality control object for daily quality control has dropped to three from five. The 15 hospitals organized a total of 263 times of training in 2014 from 101 times in 2013, up 160%. The quality improvement program for the clinical laboratories launched via the Hospital Group platform can promote the joint development of the pediatric clinical laboratory discipline of all the member hospitals with remarkable improvement results, and the experience is recommendable for further rollout.

  14. Evaluation of information technology impact on effective internal control in the University system

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

    Sanusi Fasilat, A., E-mail: Fasilat17@gmail.com; Hassan, Haslinda, E-mail: lynn@uum.edu.my

    Information Technology (IT) plays a key role in internal control system in various organizations in terms of maintaining records and other internal services. Internal control system is defined as an efficient control procedures set up by firm to safeguard resources and to assure the reliability and accuracy of both financial and non-financial records in line with applicable governance and procedure to acquire the established goal and objectives. This paper focuses on the impact of IT on internal control system in the Nigerian universities. Data are collected from three different universities via questionnaire. Descriptive statistics is used to analyze the data;more » Chi-square is performed to test the hypothesis. The results of the hypothesis showed that IT has a positive relationship with the effective internal control activities in the University system. It is concluded that the adoption of IT will significantly improve the effectiveness of the internal control system operations in the University in terms of quality service delivery.« less

  15. Evaluation of information technology impact on effective internal control in the University system

    NASA Astrophysics Data System (ADS)

    Sanusi Fasilat, A.; Hassan, Haslinda

    2015-12-01

    Information Technology (IT) plays a key role in internal control system in various organizations in terms of maintaining records and other internal services. Internal control system is defined as an efficient control procedures set up by firm to safeguard resources and to assure the reliability and accuracy of both financial and non-financial records in line with applicable governance and procedure to acquire the established goal and objectives. This paper focuses on the impact of IT on internal control system in the Nigerian universities. Data are collected from three different universities via questionnaire. Descriptive statistics is used to analyze the data; Chi-square is performed to test the hypothesis. The results of the hypothesis showed that IT has a positive relationship with the effective internal control activities in the University system. It is concluded that the adoption of IT will significantly improve the effectiveness of the internal control system operations in the University in terms of quality service delivery.

  16. WHO Expert Committee on Biological Standardization.

    PubMed

    2002-01-01

    This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and quality control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on issues relevant to international guidelines, recommendations and other matters related to the manufacture and quality control of biologicals. This is followed by information on the status and development of reference materials for bovine spongiform encephalopathy, various antigens, blood products, cytokines, growth factors and endocrinological substances. The second part of the report, of particular interest to manufacturers and national control authorities, contains sets of recommendations for the production and control of poliomyelitis vaccine (oral) and poliomyelitis vaccine (inactivated) and guidelines for the production and control of live attenuated Japanese encephalitis vaccine. Also included are lists of recommendations and guidelines for biological substances used in medicine, and other relevant documents.

  17. External and semi-internal controls for PCR amplification of homologous sequences in mixed templates.

    PubMed

    Kalle, Elena; Gulevich, Alexander; Rensing, Christopher

    2013-11-01

    In a mixed template, the presence of homologous target DNA sequences creates environments that almost inevitably give rise to artifacts and biases during PCR. Heteroduplexes, chimeras, and skewed template-to-product ratios are the exclusive attributes of mixed template PCR and never occur in a single template assay. Yet, multi-template PCR has been used without appropriate attention to quality control and assay validation, in spite of the fact that such practice diminishes the reliability of results. External and internal amplification controls became obligatory elements of good laboratory practice in different PCR assays. We propose the inclusion of an analogous approach as a quality control system for multi-template PCR applications. The amplification controls must take into account the characteristics of multi-template PCR and be able to effectively monitor particular assay performance. This study demonstrated the efficiency of a model mixed template as an adequate external amplification control for a particular PCR application. The conditions of multi-template PCR do not allow implementation of a classic internal control; therefore we developed a convenient semi-internal control as an acceptable alternative. In order to evaluate the effects of inhibitors, a model multi-template mix was amplified in a mixture with DNAse-treated sample. Semi-internal control allowed establishment of intervals for robust PCR performance for different samples, thus enabling correct comparison of the samples. The complexity of the external and semi-internal amplification controls must be comparable with the assumed complexity of the samples. We also emphasize that amplification controls should be applied in multi-template PCR regardless of the post-assay method used to analyze products. © 2013 Elsevier B.V. All rights reserved.

  18. [Development of pseudoviral competitive internal controls for RT-PCR detection of dengue virus].

    PubMed

    Hang, Xiao-Tong; Li, Jian-Dong; Zhang, Quan-Fu; Li, Chuan; Zhang, Shuo; Liang, Mi-Fang; Li, De-Xin

    2010-02-01

    Development of pseudoviral competitive internal controls for RT-PCR laboratory detection of dengue virus. The internal controls target gene were obtained by insertion of a 180 bp non-related DNA fragment into RT-PCR detection target of dengue virus between the forward and reverse PCR primer binding regions. A yellow florescence protein reporter gene was induced at downstream of internal controls target gene via internal ribosome entry site gene. HEK 293T cells were transfected with plasmid containing this whole cassette and lentiviral packaging support plasmid. Pseudoviral particle was recovered from the supernatant and analyzed quantitatively and qualitatively in simulated samples at the same tube under different experimental conditions. The established pseudoviral competitive internal controls can be used in the RT-PCR detection of different serotype dengue virus and the whole detection process can be monitored. The obtained fragment is easy to be differentiated in agarose electrophoresis. The pseudoviral competitive internal controls could be used for the quality control of the laboratory diagnosis process, simple to prepare, stable for storage, easy to be transformed into internal controls for other RNA virus.

  19. Laws of the United States Relating to Water Pollution Control and Environmental Quality.

    ERIC Educational Resources Information Center

    Congress of the U.S., Washington, DC. House Committee on Public Works.

    This compilation of Federal legislation contains copies of twelve Public Laws, four Executive Orders, and five International Conventions relevant to water pollution control. It also contains two Public Laws and two Executive Orders pertaining to environmental quality. There is a brief introduction summarizing the provisions of each Act. (AL)

  20. Quality control and assurance in hematopoietic stem cell transplantation data registries in Japan and other countries.

    PubMed

    Kuwatsuka, Yachiyo

    2016-01-01

    Observational studies from national and international registries with large volumes of patients are commonly performed to identify superior strategies for hematopoietic stem cell transplantation. Major international and national stem cell transplant registries collect outcome data using electronic data capture systems, and a systematic study support process has been developed. Statistical support for studies is available from some major international registries, and international and national registries also mutually collaborate to promote stem cell transplant outcome studies and transplant-related activities. Transplant registries additionally take measures to improve data quality to further improve the quality of outcome studies by utilizing data capture systems and manual data management. Data auditing can potentially even further improve data quality; however, human and budgetary resources can be limiting factors in system construction and audits of the Japanese transplant registry are not currently performed.

  1. National Survey on Internal Quality Control for HbA(1c) Analytical Instruments in 331 Hospital Laboratories of China.

    PubMed

    Zeng, Rong; Wang, Wei; Zhao, Haijian; Fei, Yang; Wang, Zhiguo

    2015-01-01

    The narrow gap of HbA1 value of mass fraction between "normal" (< 6.0%) and "diabetes" (≥ 6.5%) necessitates tight control of inter-assay standardization, assay precision, and trueness. This survey was initiated to obtain knowledge of the current situation of internal quality control (IQC) practice for HbA(1c) in China and find out the most appropriate quality specifications. Data of IQC for HbA(1c) in 331 institutions participating in the national proficiency testing (PT) programs in China were evaluated using four levels of quality specifications, and the percentages of laboratories meeting the quality requirement were calculated to find out the most appropriate quality specifications for control materials of HbA(1c) in China. The IQC data varied vastly among 331 clinical laboratories in China. The measurement of control materials covered a wide range from 4.52% to 12.24% (inter-quartile range) and there were significant differences among the CVs of different methods, including LPLC, CE-HPLC, AC-HPLC, immunoturbidimetry, and others. Among the four main methods, CE-HPLC and AC-HPLC achieved a better precision. As we can see, the performance of laboratories for HbA(1c) has yet to be improved. Clinical laboratories in China should improve their performance with a stricter imprecision criteria.

  2. 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.

  3. [Internal quality control on HER2 status determination in breast cancers: Experience of a cancer center].

    PubMed

    Ngo, Carine; Laé, Marick; Ratour, Julia; Hamel, Frédérique; Taris, Corinne; Caly, Martial; Le Cunff, Annie; Reyal, Fabien; Kirova, Youlia; Pierga, Jean-Yves; Vincent-Salomon, Anne

    The implementation of an internal quality control is mandatory to guarantee the accuracy of HER2 status in invasive breast cancers. To evaluate the impact of our quality control assurance on HER2 status results in invasive breast carcinomas from 2008 to 2014. HER2 status was determined by immunohistochemistry as the first-line indication, completed by fluorescence in situ hybridization (FISH) for scores 2+ by immunohistochemistry. Internal quality control of HER2 status relied on the standardization of pre-analytical phases, the use of external controls with a known number of HER2 gene copies determined by FISH and continued monitoring of concordance between immunohistochemistry and FISH. The proportion of HER2-positive cases corresponding to scores 3+ by immunohistochemistry and 2+ amplified by FISH varied from 10.6% to 13.8% (median of 11.3%). The proportion of scores 2+ amplified by FISH varied from 13.3% to 32.7% during period of study. The rate of concordance between FISH and immunohistochemistry for score 0/1+ and 3+ cases were≥97%. Eight among 12 discordant cases were false positive resulting from errors in interpretation of immunohistochemistry (score 2+ instead of 3+). Calibration of immunohistochemistry on FISH for HER2 status contributes to limit variability of immunohistochemistry results due to technical issues or interpretation. The implementation of an external control of score 3+ on each slide enables accurate interpretation of score 2+ and 3+ by immunohistochemistry. Copyright © 2017 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

  4. Effect of the 2011 vs 2003 duty hour regulation-compliant models on sleep duration, trainee education, and continuity of patient care among internal medicine house staff: a randomized trial.

    PubMed

    Desai, Sanjay V; Feldman, Leonard; Brown, Lorrel; Dezube, Rebecca; Yeh, Hsin-Chieh; Punjabi, Naresh; Afshar, Kia; Grunwald, Michael R; Harrington, Colleen; Naik, Rakhi; Cofrancesco, Joseph

    2013-04-22

    On July 1, 2011, the Accreditation Council for Graduate Medical Education implemented further restrictions of its 2003 regulations on duty hours and supervision. It remains unclear if the 2003 regulations improved trainee well-being or patient safety. To determine the effects of the 2011 Accreditation Council for Graduate Medical Education duty hour regulations compared with the 2003 regulations concerning sleep duration, trainee education, continuity of patient care, and perceived quality of care among internal medicine trainees. Crossover study design in an academic research setting. Medical house staff. General medical teams were randomly assigned using a sealed-envelope draw to an experimental model or a control model. We randomly assigned 4 medical house staff teams (43 interns) using a 3-month crossover design to a 2003-compliant model of every fourth night overnight call (control) with 30-hour duty limits or to one of two 2011-compliant models of every fifth night overnight call (Q5) or a night float schedule (NF), both with 16-hour duty limits. We measured sleep duration using actigraphy and used admission volumes, educational opportunities, the number of handoffs, and satisfaction surveys to assess trainee education, continuity of patient care, and perceived quality of care. RESULTS The study included 560 control, 420 Q5, and 140 NF days that interns worked and 834 hospital admissions. Compared with controls, interns on NF slept longer during the on call period (mean, 5.1 vs 8.3 hours; P = .003), and interns on Q5 slept longer during the postcall period (mean, 7.5 vs 10.2 hours; P = .05). However, both the Q5 and NF models increased handoffs, decreased availability for teaching conferences, and reduced intern presence during daytime work hours. Residents and nurses in both experimental models perceived reduced quality of care, so much so with NF that it was terminated early. Compared with a 2003-compliant model, two 2011 duty hour regulation-compliant models were associated with increased sleep duration during the on-call period and with deteriorations in educational opportunities, continuity of patient care, and perceived quality of care.

  5. Plant Habitat (PH)

    NASA Technical Reports Server (NTRS)

    Onate, Bryan

    2016-01-01

    The International Space Station (ISS) will soon have a platform for conducting fundamental research of Large Plants. Plant Habitat (PH) is designed to be a fully controllable environment for high-quality plant physiological research. PH will control light quality, level, and timing, temperature, CO2, relative humidity, and irrigation, while scrubbing ethylene. Additional capabilities include leaf temperature and root zone moisture and oxygen sensing. The light cap will have red (630 nm), blue (450 nm), green (525 nm), far red (730 nm) and broad spectrum white LEDs. There will be several internal cameras (visible and IR) to monitor and record plant growth and operations.

  6. Engineering Quality Software: 10 Recommendations for Improved Software Quality Management

    DTIC Science & Technology

    2010-04-27

    lack of user involvement • Inadequate Software Process Management & Control By Contractors • No “Team” of Vendors and users; little SME participation...1990 Quality Perspectives • Process Quality ( CMMI ) • Product Quality (ISO/IEC 2500x) – Internal Quality Attributes – External Quality Attributes... CMMI /ISO 9000 Assessments – Capture organizational knowledge • Identify best practices, lessons learned Know where you are, and where you need to be

  7. Magnetic field dependence of the internal quality factor and noise performance of lumped-element kinetic inductance detectors

    NASA Astrophysics Data System (ADS)

    Flanigan, D.; Johnson, B. R.; Abitbol, M. H.; Bryan, S.; Cantor, R.; Day, P.; Jones, G.; Mauskopf, P.; McCarrick, H.; Miller, A.; Zmuidzinas, J.

    2016-10-01

    We present a technique for increasing the internal quality factor of kinetic inductance detectors (KIDs) by nulling ambient magnetic fields with a properly applied magnetic field. The KIDs used in this study are made from thin-film aluminum, they are mounted inside a light-tight package made from bulk aluminum, and they are operated near 150 mK. Since the thin-film aluminum has a slightly elevated critical temperature (Tc = 1.4 K), it therefore transitions before the package (Tc = 1.2 K), which also serves as a magnetic shield. On cooldown, ambient magnetic fields as small as approximately 30 µT can produce vortices in the thin-film aluminum as it transitions because the bulk aluminum package has not yet transitioned and therefore is not yet shielding. These vortices become trapped inside the aluminum package below 1.2 K and ultimately produce low internal quality factors in the thin-film superconducting resonators. We show that by controlling the strength of the magnetic field present when the thin film transitions, we can control the internal quality factor of the resonators. We also compare the noise performance with and without vortices present, and find no evidence for excess noise beyond the increase in amplifier noise, which is expected with increasing loss.

  8. 10 CFR Appendix I to Part 110 - Illustrative List of Reprocessing Plant Components Under NRC Export Licensing Authority

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... assurance and quality control techniques) out of low carbon stainless steels, titanium, zirconium or other... materials such as low carbon stainless steels, titanium or zirconium, or other high quality materials... features for control of nuclear criticality: (i) Walls or internal structures with a boron equivalent of at...

  9. The internal audit of clinical areas: a pilot of the internal audit methodology in a health service emergency department.

    PubMed

    Brown, Alison; Santilli, Mario; Scott, Belinda

    2015-12-01

    Governing bodies of health services need assurance that major risks to achieving the health service objectives are being controlled. Currently, the main assurance mechanisms generated within the organization are through the review of implementation of policies and procedures and review of clinical audits and quality data. The governing bodies of health services need more robust, objective data to inform their understanding of the control of clinical risks. Internal audit provides a methodological framework that provides independent and objective assurance to the governing body on the control of significant risks. The article describes the pilot of the internal audit methodology in an emergency unit in a health service. An internal auditor was partnered with a clinical expert to assess the application of clinical criteria based on best practice guidelines. The pilot of the internal audit of a clinical area was successful in identifying significant clinical risks that required further management. The application of an internal audit methodology to a clinical area is a promising mechanism to gain robust assurance at the governance level regarding the management of significant clinical risks. This approach needs further exploration and trial in a range of health care settings. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  10. An Annotated Reading List for Concurrent Engineering

    DTIC Science & Technology

    1989-07-01

    The seven tools are sometimes referred to as the seven old tools.) -9- Ishikawa , Kaoru , What is Total Quality Control? The Japanese Way, Prentice-Hall...some solutions. * Ishikawa (1982) presents a practical guide (with easy to use tools) for implementing qual- ity control at the working level...study of, :-, ieering for the last two years. Is..ikawa, Kaoru , Guide to Quality Control, Kraus International Publications, White Plains, NY, 1982. The

  11. Development of Internalization from Age 2 to 6: Longitudinal Stability and Links with Temperament.

    ERIC Educational Resources Information Center

    Coy, Katherine C.; Parrot, Tracie A.

    This study examined relations between internalization of conduct rules and the temperamental quality of inhibitory control in 103 children followed from toddlerhood to early school age; and used recent methodological suggestions to obtain better estimates of stability to examine longitudinal continuity of internalization. Maternal reports of…

  12. Halogenated Peptides as Internal Standards (H-PINS)

    PubMed Central

    Mirzaei, Hamid; Brusniak, Mi-Youn; Mueller, Lukas N.; Letarte, Simon; Watts, Julian D.; Aebersold, Ruedi

    2009-01-01

    As the application for quantitative proteomics in the life sciences has grown in recent years, so has the need for more robust and generally applicable methods for quality control and calibration. The reliability of quantitative proteomics is tightly linked to the reproducibility and stability of the analytical platforms, which are typically multicomponent (e.g. sample preparation, multistep separations, and mass spectrometry) with individual components contributing unequally to the overall system reproducibility. Variations in quantitative accuracy are thus inevitable, and quality control and calibration become essential for the assessment of the quality of the analyses themselves. Toward this end, the use of internal standards cannot only assist in the detection and removal of outlier data acquired by an irreproducible system (quality control) but can also be used for detection of changes in instruments for their subsequent performance and calibration. Here we introduce a set of halogenated peptides as internal standards. The peptides are custom designed to have properties suitable for various quality control assessments, data calibration, and normalization processes. The unique isotope distribution of halogenated peptides makes their mass spectral detection easy and unambiguous when spiked into complex peptide mixtures. In addition, they were designed to elute sequentially over an entire aqueous to organic LC gradient and to have m/z values within the commonly scanned mass range (300–1800 Da). In a series of experiments in which these peptides were spiked into an enriched N-glycosite peptide fraction (i.e. from formerly N-glycosylated intact proteins in their deglycosylated form) isolated from human plasma, we show the utility and performance of these halogenated peptides for sample preparation and LC injection quality control as well as for retention time and mass calibration. Further use of the peptides for signal intensity normalization and retention time synchronization for selected reaction monitoring experiments is also demonstrated. PMID:19411281

  13. [Internal and external quality controls for Elisa techniques of aspergillosis serodiagnosis: proposals of the group "sérodiagnostic fongique" of the Société française de mycologie médicale].

    PubMed

    Persat, F; Lachaud, L; Rabérin, H; Poggi, B; Roques, C; Gangneux, J P

    2013-03-01

    In the end of May 2012, a meeting of the group "sérodiagnostic fongique" of the "Société française de mycologie médicale" had concerned quality controls to use, in particular, in the follow-up of Elisa techniques. A preliminary investigation showed that the internal quality controls (CIQ), according to the terms defined by the accreditation, were not systematically used. In June, was published the new guide of the COFRAC SH-GTA-06 on quality controls, this text being applicable on July 1st, 2012. It incited the working group to formulate proposals on the choice of the CIQ for antigen and antibody Elisa in the aspergillosis serodiagnosis. Informations on the external evaluations of the quality (EEQ) have also been given to better define for what we can expect from it. All these controls will allow every laboratory to better master the used techniques and their conditions of realization. A strengthened dialogue between the users and the manufacturers should incite these last actors to improve the supplied kits. It will drive later to an improvement of the reliability of the results obtained by these techniques and their interest in the aspergillosis diagnosis. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

  14. Meeting the requirements of importing countries: practice and policy for on-farm approaches to food safety.

    PubMed

    Dagg, P J; Butler, R J; Murray, J G; Biddle, R R

    2006-08-01

    In light of the increasing consumer demand for safe, high-quality food and recent public health concerns about food-borne illness, governments and agricultural industries are under pressure to provide comprehensive food safety policies and programmes consistent with international best practice. Countries that export food commodities derived from livestock must meet both the requirements of the importing country and domestic standards. It is internationally accepted that end-product quality control, and similar methods aimed at ensuring food safety, cannot adequately ensure the safety of the final product. To achieve an acceptable level of food safety, governments and the agricultural industry must work collaboratively to provide quality assurance systems, based on sound risk management principles, throughout the food supply chain. Quality assurance systems on livestock farms, as in other parts of the food supply chain, should address food safety using hazard analysis critical control point principles. These systems should target areas including biosecurity, disease monitoring and reporting, feedstuff safety, the safe use of agricultural and veterinary chemicals, the control of potential food-borne pathogens and traceability. They should also be supported by accredited training programmes, which award certification on completion, and auditing programmes to ensure that both local and internationally recognised guidelines and standards continue to be met. This paper discusses the development of policies for on-farm food safety measures and their practical implementation in the context of quality assurance programmes, using the Australian beef industry as a case study.

  15. Stepfamily Relationship Quality and Children's Internalizing and Externalizing Problems.

    PubMed

    Jensen, Todd M; Lippold, Melissa A; Mills-Koonce, Roger; Fosco, Gregory M

    2017-03-07

    The stepfamily literature is replete with between-group analyses by which youth residing in stepfamilies are compared to youth in other family structures across indicators of adjustment and well-being. Few longitudinal studies examine variation in stepfamily functioning to identify factors that promote the positive adjustment of stepchildren over time. Using a longitudinal sample of 191 stepchildren (56% female, mean age = 11.3 years), the current study examines the association between the relationship quality of three central stepfamily dyads (stepparent-child, parent-child, and stepcouple) and children's internalizing and externalizing problems concurrently and over time. Results from path analyses indicate that higher levels of parent-child affective quality are associated with lower levels of children's concurrent internalizing and externalizing problems at Wave 1. Higher levels of stepparent-child affective quality are associated with decreases in children's internalizing and externalizing problems at Wave 2 (6 months beyond baseline), even after controlling for children's internalizing and externalizing problems at Wave 1 and other covariates. The stepcouple relationship was not directly linked to youth outcomes. Our findings provide implications for future research and practice. © 2017 Family Process Institute.

  16. 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.

  17. 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

  18. 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.

  19. The Clinical Nurse Leader--new nursing role with global implications.

    PubMed

    Baernholdt, M; Cottingham, S

    2011-03-01

    This paper describes the development of the Clinical Nurse Leader (CNL ©) role and education, the CNL's impact and potential to improve quality globally. The need for clinical nurse leadership to improve the quality of health care systems while controlling costs is recognized in reports internationally. In the USA, a new nursing role, the CNL, was developed in response to such reports. CNLs are master's level nurse graduates (although not necessarily recruited from a nursing background) with the skills and knowledge to create change within complex systems and improve outcomes while they remain direct care providers. This innovative role can be adapted worldwide to improve the quality of health care systems. © 2010 The Authors. International Nursing Review © 2010 International Council of Nurses.

  20. [New idea of traditional Chinese medicine quality control based on "composition structure" theory].

    PubMed

    Liu, Dan; Jia, Xiaobin; Yu, Danhong

    2012-03-01

    On the road of the modern Chinese medicine developing internationally, there is a key issues that setting up a reasonable, accurate and be quantified quality evaluation system which is comply with the basic theory of Chinese medicine. Based on the overall understanding of the role of traditional Chinese medicine components, author suggested that the idea of "structural components" theory should be embedded into the system and thought the Chinese medicine play a multi-target, multi-channel pharmacodynamic effects founded on the specific microcosmic structural relationship between the components and the components within the group. At present, the way of Chinese pharmacopoeia checking the quality of Chinese medicine is mainly depends on controlling the single or multiple targets of ingredients. In fact, this way is out of the overall effectiveness of the Chinese medicine, so we can not thoroughly controlling the quality of Chinese medicine from the essence of the Chinese medicine. Secondly, it's only macro-structural quantity that the Chinese pharmacopoeia just controlling the less effective ingredients, this is not enough to reflect the internal microstructure of the integrity and systematic. In other words, this cannot reflect the structural components of the Chinese medicine (the essence of traditional Chinese medicine). In view of above mentioned reasons, the author propose the new idea on the quality control in the medicine that quantify the ratio structural relationship in component and the ingredients of the components, set the optimal controlling proportion between the components and ingredients. At the same time, author thought we should conduct the depth study in the micro-quantified the multi-component and multi-ingredient, in the process of studying the material basis of Chinese medicine. Therefore, it could establish a more rational basis for the Chinese medicine quality controlling system.

  1. Deriving proper measurement uncertainty from Internal Quality Control data: An impossible mission?

    PubMed

    Ceriotti, Ferruccio

    2018-03-30

    Measurement uncertainty (MU) is a "non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand, based on the information used". In the clinical laboratory the most convenient way to calculate MU is the "top down" approach based on the use of Internal Quality Control data. As indicated in the definition, MU depends on the information used for its calculation and so different estimates of MU can be obtained. The most problematic aspect is how to deal with bias. In fact bias is difficult to detect and quantify and it should be corrected including only the uncertainty derived from this correction. Several approaches to calculate MU starting from Internal Quality Control data are presented. The minimum requirement is to use only the intermediate precision data, provided to include 6 months of results obtained with a commutable quality control material at a concentration close to the clinical decision limit. This approach is the minimal requirement and it is convenient for all those measurands that are especially used for monitoring or where a reference measurement system does not exist and so a reference for calculating the bias is lacking. Other formulas including the uncertainty of the value of the calibrator, including the bias from a commutable certified reference material or from a material specifically prepared for trueness verification, including the bias derived from External Quality Assessment schemes or from historical mean of the laboratory are presented and commented. MU is an important parameter, but a single, agreed upon way to calculate it in a clinical laboratory is not yet available. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  2. 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.

  3. [The influence of the organizational structure on the internal controls of a foundation for cancer research, prevention and care in the interior of the state of São Paulo, Brazil].

    PubMed

    Bonacim, Carlos Alberto Grespam; Salgado, André Luís; Girioli, Lumila Souza; de Araujo, Adriana Maria Procópio

    2011-05-01

    This work focuses on a discussion about the extent to which the level of organizational structure interferes in the internal control practices of non-governmental organizations (NGOs), especially those related to health. The objective of this work was to observe the efficiency of the internal control tests applied within the organizational structure of the Foundation for Cancer Research, Prevention and Care, checking the reliability of the accounting records and operational controls. A case study in a third sector health organization was the chosen methodology. The case study involved company interviews and the analysis of confidential reports. After an evaluation of the organizational structure (of the relations between officials and volunteers) and the application of evaluation proceedings on the quality of the internal controls, the extent to which the organizational structure interferes with the internal control practices of the hospital was assessed. It was revealed that there are structured mechanisms of control in the institution, however the implementation of these controls is inadequately performed. It was further detected that the level of the organizational structure does indeed interfere in internal control practices at the entity.

  4. 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.

  5. Formaldehyde Concentration Dynamics of the International Space Station Cabin Atmosphere

    NASA Technical Reports Server (NTRS)

    Perry, J. L.

    2005-01-01

    Formaldehyde presents a significant challenge to maintaining cabin air quality on board crewed spacecraft. Generation sources include offgassing from a variety of non-metallic materials as well as human metabolism. Because generation sources are pervasive and human health can be affected by continual exposure to low concentrations, toxicology and air quality control engineering experts jointly identified formaldehyde as a key compound to be monitored as part the International Space Station's (ISS) environmental health monitoring and maintenance program. Data acquired from in-flight air quality monitoring methods are the basis for assessing the cabin environment's suitability for long-term habitation and monitoring the performance of passive and active controls that are in place to minimize crew exposure. Formaldehyde concentration trends and dynamics served in the ISS cabin atmosphere are reviewed implications to present and future flight operations discussed.

  6. Octafluoropropane Concentration Dynamics on Board the International Space Station

    NASA Technical Reports Server (NTRS)

    Perry, J. L.

    2003-01-01

    Since activating the International Space Station s (IS9 Service Module in November 2000, archival air quality samples have shown highly variable concentrations of octafluoropropane in the cabin. This variability has been directly linked to leakage from air conditioning systems on board the Service Module, Zvezda. While octafluoro- propane is not highly toxic, it presents a significant chal- lenge to the trace contaminant control systems. A discussion of octafluoropropane concentration dynamics is presented and the ability of on board trace contami- nant control systems to effectively remove octafluoropro- pane from the cabin atmosphere is assessed. Consideration is given to operational and logistics issues that may arise from octafluoropropane and other halo- carbon challenges to the contamination control systems as well as the potential for effecting cabin air quality.

  7. Trade transport and environment linkages at the U.S.-Mexico border: which policies matter?

    PubMed

    Fernandez, Linda; Das, Monica

    2011-03-01

    We apply a fixed-effects model to examine the impact of trade and environmental policies on air quality at ports along the U.S.-Mexico border. We control for other factors influencing air quality, such as air quality of cities near the border, volume of traffic flows and congestion. Results show the air quality improved after 2004, when the diesel engine policy was applied. We see mixed results for the trade policy, whose implementation time varies across ports along the international border. Controlling for air quality in cities near the border is essential for assessing the policy contributions to air quality. Copyright © 2010. Published by Elsevier Ltd.

  8. Perceptions of friendship among youth with distressed friends.

    PubMed

    Hill, Erin N; Swenson, Lance P

    2014-02-01

    This cross-sectional study examined the relationship between a friend's level of internalizing distress and the focal child's perceptions of friendship amongst 5th, 8th, and 11th grade youth. Participants completed the Youth Self-Report to assess internalizing distress and measures assessing perceptions of friendship quality, social support, and self-disclosure within reciprocal, same-sex friendship dyads. Results indicated that youth with friends experiencing low levels of internalizing distress reported poorer friendship quality and decreased levels of social support and self-disclosure within the friendship compared to youth with friends experiencing average or high internalizing distress. In a second set of analyses controlling for the focal child's own internalizing symptoms, gender, and age, friend's level of internalizing distress remained a significant, unique predictor of target participants' self-disclosure about their own problems within the friendship. The findings suggest that a mild degree of internalizing distress may enhance, rather than harm, friendships amongst youth.

  9. Expediting the Quest for Quality: The Role of IQAC in Academic Audit

    ERIC Educational Resources Information Center

    Nitonde, Rohidas

    2016-01-01

    Academic Audit is an important tool to control and maintain standards in academic sector. It has been found highly relevant by the experts across the world. Academic audit helps institutions to introspect and improve their quality. The present paper intends to probe into the possible role of Internal Quality Assurance Cell (IQAC) in Academic Audit…

  10. Effect of Sahaja yoga meditation on quality of life, anxiety, and blood pressure control.

    PubMed

    Chung, Sheng-Chia; Brooks, Maria M; Rai, Madhur; Balk, Judith L; Rai, Sandeep

    2012-06-01

    The present study investigates the effect of Sahaja yoga meditation on quality of life, anxiety, and blood pressure control. The prospective observational cohort study enrolled two study groups: those receiving treatment from the International Sahaja Yoga Research and Health Center (meditation group) and those receiving treatment from the Mahatma Gandhi Mission Hospital (control group). Researchers measured quality of life, anxiety, and blood pressure before and after treatment. Sixty-seven (67) participants in the meditation group and 62 participants in the control group completed the study. The two groups were comparable in demographic and clinical characteristics. At baseline, the meditation group had higher quality of life (p<0.001) than controls but similar anxiety level (p=0.74) to controls. Within-group pre- versus post-treatment comparisons showed significant improvement in quality of life, anxiety, and blood pressure in the meditation group (p<0.001), while in controls, quality of life deteriorated and there was no improvement in blood pressure. The improvement in quality of life, anxiety reduction, and blood pressure control was greater in the meditation group. The beneficial effect of meditation remained significant after adjusting for confounders. Meditation treatment was associated with significant improvements in quality of life, anxiety reduction, and blood pressure control.

  11. Quality specification and status of internal quality control of cardiac biomarkers in China from 2011 to 2016.

    PubMed

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

    2017-09-07

    This study aimed to investigate the status of internal quality control (IQC) for cardiac biomarkers from 2011 to 2016 so that we can have overall knowledge of the precision level of measurements in China and set appropriate precision specifications. Internal quality control data of cardiac biomarkers, including creatinine kinase MB (CK-MB) (μg/L), CK-MB(U/L), myoglobin (Mb), cardiac troponin I (cTnI), cardiac troponin T (cTnT), and homocysteines (HCY), were collected by a web-based external quality assessment (EQA) system. Percentages of laboratories meeting five precision quality specifications for current coefficient of variations (CVs) were calculated. Then, appropriate precision specifications were chosen for these six analytes. Finally, the CVs and IQC practice were further analyzed with different grouping methods. The current CVs remained nearly constant for 6 years. cTnT had the highest pass rates every year against five specifications, whereas HCY had the lowest pass rates. Overall, most analytes had a satisfactory performance (pass rates >80%), except for HCY, if one-third TEa or the minimum specification were employed. When the optimal specification was applied, the performance of most analytes was frustrating (pass rates < 60%) except for cTnT. The appropriate precision specifications of Mb, cTnI, cTnT and HCY were set as current CVs less than 9.20%, 9.90%, 7.50%, 10.54%, 7.63%, and 6.67%, respectively. The data of IQC practices indicated wide variation and substantial progress. The precision performance of cTnT was already satisfying, while the other five analytes, especially HCY, were still frustrating; thus, ongoing investigation and continuous improvement for IQC are still needed. © 2017 Wiley Periodicals, Inc.

  12. A network architecture for International Business Satellite communications

    NASA Astrophysics Data System (ADS)

    Takahata, Fumio; Nohara, Mitsuo; Takeuchi, Yoshio

    Demand Assignment (DA) control is expected to be introduced in the International Business Satellte communications (IBS) network in order to cope with a growing international business traffic. The paper discusses the DA/IBS network from the viewpoints of network configuration, satellite channel configuration and DA control. The network configuration proposed here consists of one Central Station with network management function and several Network Coordination Stations with user management function. A satellite channel configuration is also presented along with a tradeoff study on transmission bit rate, high power amplifier output power requirement, and service quality. The DA control flow and protocol based on CCITT Signalling System No. 7 are also proposed.

  13. Control of infection in an international airline.

    PubMed

    Kelly, M

    1993-05-01

    The paper examines the possible sources of infection on an international aircraft, including the provision of food, the supply of drinking water, and the removal of waste. It considers aspects of control, and explains some of the steps which have to be taken by a major international carrier to ensure that the high quality expected by the customer is provided in all areas of the world, even those where natural resources and expertise may be limited. The emphasis is on providing a safe product, and removing any possible risk of infection of the passengers.

  14. Narcissism and relational representations among psychiatric outpatients.

    PubMed

    Kealy, David; Ogrodniczuk, John S; Joyce, Anthony S; Steinberg, Paul I; Piper, William E

    2015-06-01

    Pathological narcissism is associated with maladaptive interpersonal behavior, although less is known regarding the internal relational representations of narcissistic patients. The authors examined the relationship between pathological narcissism and two constructs that reflect internal representations of relational patterns: quality of object relations and attachment style. Patients attending a psychiatric day treatment program (N = 218) completed measures of narcissism, general psychiatric distress, and attachment style in terms of attachment avoidance and anxiety. A semistructured interview was used to assess quality of object relations. Multiple regression analysis was conducted, controlling for general psychiatric distress. Pathological narcissism was associated with anxious attachment, but not with avoidant attachment. Narcissism was also associated with lower levels of quality of object relations. The implications of these results are discussed in terms of internal representations of self-other relations.

  15. [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.

  16. Criteria for internal auditing.

    PubMed

    Holder, W W; Clay, R J

    1979-01-01

    An effective, inclusive internal auditing endeavor should help assure hospital managements that (1) an adequate system of internal control exists to assure the safeguarding of assets and the reliability of data produced by the financial information system, (2) uneconomic operating practices are detected promptly so they can be remedied, and (3) program results and effectiveness levels are of sufficiently high quality to demonstrate managerial competence.

  17. Inhibitory control in young children and its role in emerging internalization.

    PubMed

    Kochanska, G; Murray, K; Jacques, T Y; Koenig, A L; Vandegeest, K A

    1996-04-01

    We examined inhibitory control as a quality of temperament that contributes to internalization. Children were assessed twice, at 26-41 months (N = 103) and at 43-56 months (N = 99), on repeated occasions, in multiple observational contexts and using parental reports. Comprehensive behavioral batteries incorporating multiple tasks were designed to measure inhibitory control at toddler and preschool age. They had good internal consistencies, corresponded with maternal ratings, and were developmentally sensitive. Individual children's performance was significantly correlated across both assessments, indicating stable individual differences. Girls surpassed boys at both ages. Children's internalization was observed while they were alone with prohibited objects, with a mundane chore, playing games that occasioned cheating, being induced to violate standards of conduct, and assessed using maternal reports. Inhibitory control was significantly associated with internalization, both contemporaneously and as a predictor in the longitudinal sense. The implications for considering children's temperament as a significant, yet often neglected contributor to developing internalization are discussed.

  18. 12 CFR 652.60 - Corporation board guidelines.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... (a) Your board of directors is responsible for ensuring that you maintain total capital at a level... developing the capital adequacy plan: (1) Capability of management; (2) Strategies and objectives in your business plan; (3) Quality of operating policies, procedures, and internal controls; (4) Quality and...

  19. 12 CFR 652.60 - Corporation board guidelines.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... (a) Your board of directors is responsible for ensuring that you maintain total capital at a level... developing the capital adequacy plan: (1) Capability of management; (2) Strategies and objectives in your business plan; (3) Quality of operating policies, procedures, and internal controls; (4) Quality and...

  20. Quality Assurance through ISO 9000.

    ERIC Educational Resources Information Center

    Zuckerman, Amy

    2000-01-01

    Created in 1987 by the International Organization for Standardization, in Geneva, Switzerland, ISO 9000 is attempting to develop a world standard to help companies and other institutions measure and monitor their quality-control efforts. This article describes four school districts' successful efforts to secure ISO 9000 certification. (MLH)

  1. Quality inspection of anisotropic scintillating lead tungstate (PbWO 4) crystals through measurement of interferometric fringe pattern parameters

    NASA Astrophysics Data System (ADS)

    Cocozzella, N.; Lebeau, M.; Majni, G.; Paone, N.; Rinaldi, D.

    2001-08-01

    Scintillating crystals are widely used as detectors in radiographic systems, computerized axial tomography devices and in calorimeters employed in high-energy physics. This paper results from a project motivated by the development of the CMS calorimeter at CERN, which will make use of a large number of scintillating crystals. In order to prevent crystals from breaking because of internal residual stress, a quality control system based on optic inspection of interference fringe patterns was developed. The principle of measurement procedures was theoretically modelled, and then a dedicated polariscope was designed and built, in order to observe the crystals under induced stresses or to evaluate the residual internal stresses. The results are innovative and open a new perspective for scintillating crystals quality control: the photoelastic constant normal to the optic axis of the lead tungstate crystals (PbWO 4) was measured, and the inspection procedure developed is applicable to mass production, not only to optimize the crystal processing, but also to establish a quality inspection procedure.

  2. Information systems as a quality management tool in clinical laboratories

    NASA Astrophysics Data System (ADS)

    Schmitz, Vanessa; Rosecler Bez el Boukhari, Marta

    2007-11-01

    This article describes information systems as a quality management tool in clinical laboratories. The quality of laboratory analyses is of fundamental importance for health professionals in aiding appropriate diagnosis and treatment. Information systems allow the automation of internal quality management processes, using standard sample tests, Levey-Jennings charts and Westgard multirule analysis. This simplifies evaluation and interpretation of quality tests and reduces the possibility of human error. This study proposes the development of an information system with appropriate functions and costs for the automation of internal quality control in small and medium-sized clinical laboratories. To this end, it evaluates the functions and usability of two commercial software products designed for this purpose, identifying the positive features of each, so that these can be taken into account during the development of the proposed system.

  3. 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.

  4. ISO 9000: The Librarian's Role.

    ERIC Educational Resources Information Center

    Dobson, Chris; Ernst, Carolyn

    1999-01-01

    Describes the special library's role in implementing ISO 9000 (i.e., a series of international quality-assurance standards developed by the International Organization of Standards). Topics discussed include document and data control, keeping the standards current, documentation of procedures, the ISO 9000 audit, and benefits for the library. (MES)

  5. Objective Quality Control of Artillery Computer Meteorological Messages.

    DTIC Science & Technology

    1980-04-01

    Veazey , 1977, Proposed AMS-A for Corps TACFIRE (PACT) System Description, ASL Internal Report, White Sands Missile Range, NM 6 1nclosure 1, "Software...R. Veazey , 1977, Proposed AMS-A for Corps TACFIRE (PACT) System Description, ASL Internal Report, Atmospheric Sciences Laboratory, White Sands Missile

  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. The internalization of posterior subcapsular cataracts (PSCs) in Royal College of Surgeons (RCS) rats. II. The inter-relationship of optical quality and structure as a function of age.

    PubMed

    Kuszak, J R; Al-Ghoul, K J; Novak, L A; Peterson, K L; Herbert, K L; Sivak, J G

    1999-05-06

    The Royal College of Surgeons (RCS) rat is an animal model for human retinal degenerative disease and posterior subcapsular cataracts (PSCs). The purpose of this study was to correlate the structure and optical quality of RCS lenses with PSCs as a function of their internalization, with normal, non-cataractous, age-matched control lenses. Correlative light (LM), scanning electron microscopic (SEM), three-dimensional computer assisted drawings (3D-CADs) and low power helium-neon laser scan analysis were used to examine the structure and function of lenses. The optical properties (average focal length variability; sharpness of focus) of RCS rat lenses are quantitatively compromised by PSCs. Correlative LM and SEM analysis of RCS lenses at various stages of PSC internalization (1.5, 3, 6, 9, 12 and 15 months of age), revealed that the sutures formed by additional fiber growth were progressively more abnormal. During PSC internalization, two to nine small suture branches were formed and arranged in modified line to multiple y configurations rather than the normal three branch y sutures. These temporal changes were also chronicled in animated 3D-CAD videos derived from lens reconstructions based on LM and SEM micrographs from the selected time points stated above. However, laser scan analysis also revealed that as the PSCs of RCS rat lenses were progressively internalized, there was a steady improvement in total sharpness of focus that reached normal levels by 12 months of age. The correlation of laser scan and structural data from specific regions of lenses revealed the following: 1. The abnormal posterior sutures of RCS rats with internalized PSCs effect a greater reduction in optical quality than normal posterior sutures of age-matched controls; 2. However, the resulting abnormal suture plane area was cumulatively similar to that of age-matched controls; 3. Thus, total optical quality was similar between RCS lenses with internalized PSCs and age-matched controls by 12 months of age. The results of this study show that RCS lenses with internalized PSCs can appear grossly, and indeed optically perform, at levels comparable to aged lenses. These findings are consistent with clinical observations of spontaneous recovery from PSC. The results suggest that human PSCs that occur as a consequence of retinal degenerative disease could also be the result of abnormal posterior suture growth. If this is proven to be the case, such PSCs may have some capacity for repair or recovery thereby obviating their surgical removal.

  10. [Quality process control system of Chinese medicine preparation based on "holistic view"].

    PubMed

    Wang, Ya-Qi; Jiao, Jiao-Jiao; Wu, Zhen-Feng; Zheng, Qin; Yang, Ming

    2018-01-01

    "High quality, safety and effectiveness" are the primary principles for the pharmaceutical research and development process in China. The quality of products relies not only on the inspection method, but also on the design and development, process control and standardized management. The quality depends on the process control level. In this paper, the history and current development of quality control of traditional Chinese medicine (TCM) preparations are reviewed systematically. Based on the development model of international drug quality control and the misunderstanding of quality control of TCM preparations, the reasons for impacting the homogeneity of TCM preparations are analyzed and summarized. According to TCM characteristics, efforts were made to control the diversity of TCM, make "unstable" TCM into "stable" Chinese patent medicines, put forward the concepts of "holistic view" and "QbD (quality by design)", so as to create the "holistic, modular, data, standardized" model as the core of TCM preparation quality process control model. Scientific studies shall conform to the actual production of TCM preparations, and be conducive to supporting advanced equipment and technology upgrade, thoroughly applying the scientific research achievements in Chinese patent medicines, and promoting the cluster application and transformation application of TCM pharmaceutical technology, so as to improve the quality and effectiveness of the TCM industry and realize the green development. Copyright© by the Chinese Pharmaceutical Association.

  11. [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.

  12. Many roads may lead to Rome: Selected features of quality control within environmental assessment systems in the US, NL, CA, and UK

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

    Günther, Markus, E-mail: markus.guenther@tu-berlin.de; Geißler, Gesa; Köppel, Johann

    As there is no one-and-only concept on how to precisely define and establish quality control (QC) or quality assurance (QA) in the making of environmental assessments (EA), this paper presents selected features of international approaches that address quality in EA systems in the USA, the Netherlands, Canada, and the United Kingdom. Based on explanative case studies, we highlight the embedding of specific quality control features within the EA systems, the objectives and processes, and relevant transparency challenges. Such features of QC/QA approaches can be considered in cases where substantial quality control and assurance efforts are still missing. Yet further researchmore » needs to be conducted on the efficacy of these approaches, which remains beyond the scope of this study. - Highlights: • We present four tools for quality control and assurance from different EA systems. • Approaches vary in institutional setting, objectives, procedures, and transparency. • Highlighted features might provide guidance in cases where QC/QA is still lacking.« less

  13. An empirical evaluation of software quality assurance practices and challenges in a developing country: a comparison of Nigeria and Turkey.

    PubMed

    Sowunmi, Olaperi Yeside; Misra, Sanjay; Fernandez-Sanz, Luis; Crawford, Broderick; Soto, Ricardo

    2016-01-01

    The importance of quality assurance in the software development process cannot be overemphasized because its adoption results in high reliability and easy maintenance of the software system and other software products. Software quality assurance includes different activities such as quality control, quality management, quality standards, quality planning, process standardization and improvement amongst others. The aim of this work is to further investigate the software quality assurance practices of practitioners in Nigeria. While our previous work covered areas on quality planning, adherence to standardized processes and the inherent challenges, this work has been extended to include quality control, software process improvement and international quality standard organization membership. It also makes comparison based on a similar study carried out in Turkey. The goal is to generate more robust findings that can properly support decision making by the software community. The qualitative research approach, specifically, the use of questionnaire research instruments was applied to acquire data from software practitioners. In addition to the previous results, it was observed that quality assurance practices are quite neglected and this can be the cause of low patronage. Moreover, software practitioners are neither aware of international standards organizations or the required process improvement techniques; as such their claimed standards are not aligned to those of accredited bodies, and are only limited to their local experience and knowledge, which makes it questionable. The comparison with Turkey also yielded similar findings, making the results typical of developing countries. The research instrument used was tested for internal consistency using the Cronbach's alpha, and it was proved reliable. For the software industry in developing countries to grow strong and be a viable source of external revenue, software assurance practices have to be taken seriously because its effect is evident in the final product. Moreover, quality frameworks and tools which require minimum time and cost are highly needed in these countries.

  14. Evaluation of droplet digital PCR for quantification of residual leucocytes in red blood cell concentrates.

    PubMed

    Doescher, A; Loges, U; Petershofen, E K; Müller, T H

    2017-11-01

    Enumeration of residual white blood cells in leucoreduced blood components is essential part of quality control. Digital PCR has substantially facilitated quantitative PCR and was thus evaluated for measurements of leucocytes. Target for quantification of leucocytes by digital droplet PCR was the blood group gene RHCE. The SPEF1 gene was added as internal control for the entire assay starting with automated DNA extraction. The sensitivity of the method was determined by serial dilutions of standard samples. Quality control samples were analysed within 24 h, 7 days and 6 months after collection. Routine samples from leucodepleted red blood cell concentrates (n = 150) were evaluated in parallel by flow-cytometry (LeucoCount) and by digital PCR. Digital PCR reliably detected at least 0·4 leucocytes per assay. The mean difference between PCR and flow-cytometric results from 150 units was -0·01 (±1·0). DNA samples were stable for up to at least six months. PCR measurement of leucocytes in samples from plasma and platelet concentrates also provided valid results in a pilot study. Droplet digital PCR to enumerate leucocytes offers an alternative for quality control of leucoreduced blood products. Sensitivity, specificity and reproducibility are comparable to flow-cytometry. The option to collect samples over an extended period of time and the automatization introduce attractive features for routine quality control. © 2017 International Society of Blood Transfusion.

  15. [Basic considerations during outsourcing of clinical data management services].

    PubMed

    Shen, Tong; Liu, Yan

    2015-11-01

    With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.

  16. Quality management for the international transport of laboratory animals.

    PubMed

    Leary, Steven L

    2008-01-01

    Increased collaboration between investigators at different institutions has increased the number of laboratory animals being transported. The current system of laws and regulations governing animal shipments is inconsistent and government agencies often have areas of overlapping regulatory management. Furthermore, the lack of industry-wide shipping standards and good practices contributes to confusion among those responsible for shipment. One answer to these quality control issues would be the establishment of independent, industry-regulated 'good practices' for animal transport, similar to those used in laboratories for experimental design. These good practices could be based on the existing International Air Transport Association Live Animals Regulations, with contributions from representatives of the specialties involved. Additionally, quality control under the current system of patchwork regulations could be improved if each institution, both academic and commercial, would designate a single point of contact to follow each shipment from start to finish.

  17. Median of patient results as a tool for assessment of analytical stability.

    PubMed

    Jørgensen, Lars Mønster; Hansen, Steen Ingemann; Petersen, Per Hyltoft; Sölétormos, György

    2015-06-15

    In spite of the well-established external quality assessment and proficiency testing surveys of analytical quality performance in laboratory medicine, a simple tool to monitor the long-term analytical stability as a supplement to the internal control procedures is often needed. Patient data from daily internal control schemes was used for monthly appraisal of the analytical stability. This was accomplished by using the monthly medians of patient results to disclose deviations from analytical stability, and by comparing divergences with the quality specifications for allowable analytical bias based on biological variation. Seventy five percent of the twenty analytes achieved on two COBASs INTEGRA 800 instruments performed in accordance with the optimum and with the desirable specifications for bias. Patient results applied in analytical quality performance control procedures are the most reliable sources of material as they represent the genuine substance of the measurements and therefore circumvent the problems associated with non-commutable materials in external assessment. Patient medians in the monthly monitoring of analytical stability in laboratory medicine are an inexpensive, simple and reliable tool to monitor the steadiness of the analytical practice. Copyright © 2015 Elsevier B.V. All rights reserved.

  18. 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.

  19. Producing a Climate-Quality Database of Global Upper Ocean Profile Temperatures - The IQuOD (International Quality-controlled Ocean Database) Project.

    NASA Astrophysics Data System (ADS)

    Sprintall, J.; Cowley, R.; Palmer, M. D.; Domingues, C. M.; Suzuki, T.; Ishii, M.; Boyer, T.; Goni, G. J.; Gouretski, V. V.; Macdonald, A. M.; Thresher, A.; Good, S. A.; Diggs, S. C.

    2016-02-01

    Historical ocean temperature profile observations provide a critical element for a host of ocean and climate research activities. These include providing initial conditions for seasonal-to-decadal prediction systems, evaluating past variations in sea level and Earth's energy imbalance, ocean state estimation for studying variability and change, and climate model evaluation and development. The International Quality controlled Ocean Database (IQuOD) initiative represents a community effort to create the most globally complete temperature profile dataset, with (intelligent) metadata and assigned uncertainties. With an internationally coordinated effort organized by oceanographers, with data and ocean instrumentation expertise, and in close consultation with end users (e.g., climate modelers), the IQuOD initiative will assess and maximize the potential of an irreplaceable collection of ocean temperature observations (tens of millions of profiles collected at a cost of tens of billions of dollars, since 1772) to fulfil the demand for a climate-quality global database that can be used with greater confidence in a vast range of climate change related research and services of societal benefit. Progress towards version 1 of the IQuOD database, ongoing and future work will be presented. More information on IQuOD is available at www.iquod.org.

  20. Enhancement of the Automated Quality Control Procedures for the International Soil Moisture Network

    NASA Astrophysics Data System (ADS)

    Heer, Elsa; Xaver, Angelika; Dorigo, Wouter; Messner, Romina

    2017-04-01

    In-situ soil moisture observations are still trusted to be the most reliable data to validate remotely sensed soil moisture products. Thus, the quality of in-situ soil moisture observations is of high importance. The International Soil Moisture Network (ISMN; http://ismn.geo.tuwien.ac.at/) provides in-situ soil moisture data from all around the world. The data is collected from individual networks and data providers, measured by different sensors in various depths. The data sets which are delivered in different units, time zones and data formats are then transformed into homogeneous data sets. An erroneous behavior of soil moisture data is very difficult to detect, due to annual and daily changes and most significantly the high influence of precipitation and snow melting processes. Only few of the network providers have a quality assessment for their data sets. Therefore, advanced quality control procedures have been developed for the ISMN (Dorigo et al. 2013). Three categories of quality checks were introduced: exceeding boundary values, geophysical consistency checks and a spectrum based approach. The spectrum based quality control algorithms aim to detect erroneous measurements which occur within plausible geophysical ranges, e.g. a sudden drop in soil moisture caused by a sensor malfunction. By defining several conditions which have to be met by the original soil moisture time series and their first and second derivative, such error types can be detected. Since the development of these sophisticated methods many more data providers shared their data with the ISMN and new types of erroneous measurements were identified. Thus, an enhancement of the automated quality control procedures became necessary. In the present work, we introduce enhancements of the existing quality control algorithms. Additionally, six completely new quality checks have been developed, e.g. detection of suspicious values before or after NAN-values, constant values and values that lie in a spectrum where a high majority of values before and after is flagged and therefore a sensor malfunction is certain. For the evaluation of the enhanced automated quality control system many test data sets were chosen, and manually validated to be compared to the existing quality control procedures and the new algorithms. Improvements will be shown that assure an appropriate assessment of the ISMN data sets, which are used for validations of soil moisture data retrieved by satellite data and are the foundation many other scientific publications.

  1. Teaching Evaluation Is Very Necessary at Institutions of Higher Education

    ERIC Educational Resources Information Center

    Daren, Huang

    2009-01-01

    Government supervision over the quality of higher education by means of evaluations, examinations and verifications, or accreditations is a common international practice in terms of monitoring and controlling the quality of higher education. Many countries stipulate by law that institutions of higher education must submit to evaluation by the…

  2. Quality Control Specialist | Center for Cancer Research

    Cancer.gov

    Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID),

  3. A Review of International Space Station Habitable Element Equipment Offgassing Characteristics

    NASA Technical Reports Server (NTRS)

    Perry, Jay L.

    2010-01-01

    Crewed spacecraft trace contaminant control employs both passive and active methods to achieve acceptable cabin atmospheric quality. Passive methods include carefully selecting materials of construction, employing clean manufacturing practices, and minimizing systems and payload operational impacts to the cabin environment. Materials selection and manufacturing processes constitute the first level of equipment offgassing control. An element-level equipment offgassing test provides preflight verification that passive controls have been successful. Offgassing test results from multiple International Space Station (ISS) habitable elements and cargo vehicles are summarized and implications for active contamination control equipment design are discussed

  4. [Standardization in laboratory hematology by participating in external quality assurance programs].

    PubMed

    Nazor, Aida; Siftar, Zoran; Flegar-Mestrić, Zlata

    2011-09-01

    Since 1985, Department of Clinical Chemistry and Laboratory Medicine, Merkur University Hospital, Zagreb, has been participating in the International External Quality Assessment Scheme for Hematology (IEQAS-H) organized by the World Health Organization (WHO). Owing to very good results, in 1987 the Department received a certificate of participation in this control scheme. Department has been cooperating in the external quality assessment program in laboratory hematology which has been continuously performed in Croatia since 1986 by the Committee for External Quality Assessment Schemes under the auspices of the Croatian Society of Medical Biochemists and School of Pharmacy and Biochemistry, University of Zagreb. Nowadays, 186 medical biochemical laboratories are included in the National External Quality Assessment program, which is performed three times per year. Our Department has participated in the international projects of the European Committee for External Quality Assurance Programs in Laboratory Medicine (EQALM).

  5. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation.

    PubMed

    Shah, Shimoli V; Gage, Brian F

    2011-06-07

    Recent studies have investigated alternatives to warfarin for stroke prophylaxis in patients with atrial fibrillation (AF), but whether these alternatives are cost-effective is unknown. On the basis of the results from Randomized Evaluation of Long Term Anticoagulation Therapy (RE-LY) and other trials, we developed a decision-analysis model to compare the cost and quality-adjusted survival of various antithrombotic therapies. We ran our Markov model in a hypothetical cohort of 70-year-old patients with AF using a cost-effectiveness threshold of $50 000/quality-adjusted life-year. We estimated the cost of dabigatran as US $9 a day. For a patient with an average risk of major hemorrhage (≈3%/y), the most cost-effective therapy depended on stroke risk. For patients with the lowest stroke rate (CHADS2 stroke score of 0), only aspirin was cost-effective. For patients with a moderate stroke rate (CHADS2 score of 1 or 2), warfarin was cost-effective unless the risk of hemorrhage was high or quality of international normalized ratio control was poor (time in the therapeutic range <57.1%). For patients with a high stroke risk (CHADS(2) stroke score ≥3), dabigatran 150 mg (twice daily) was cost-effective unless international normalized ratio control was excellent (time in the therapeutic range >72.6%). Neither dabigatran 110 mg nor dual therapy (aspirin and clopidogrel) was cost-effective. Dabigatran 150 mg (twice daily) was cost-effective in AF populations at high risk of hemorrhage or high risk of stroke unless international normalized ratio control with warfarin was excellent. Warfarin was cost-effective in moderate-risk AF populations unless international normalized ratio control was poor.

  6. 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.

  7. The UK Stem Cell Bank: a UK government-funded, international resource center for stem cell research.

    PubMed

    Stacey, Glyn; Hunt, Charles J

    2006-01-01

    The UK Stem Cell Bank is a UK Research Council-funded initiative that aims to provide ethically sourced and quality controlled stocks of cells for researchers and also establish seed stocks of cell lines for clinical trials. Whilst the Bank is prohibited from carrying out basic stem cell research (to avoid conflicts of interest) it is working to improve stem cell banking procedures including cryopreservation, characterization and quality control. The Bank also supports training activities and has provided the hub for the International Stem Cell Initiative, which includes 17 expert stem cell centers aiming to characterize a large number of human embryonic stem cell lines in a standardized way to improve our understanding of the characteristics of these cells.

  8. Modeling the internal dynamics of energy and mass transfer in an imperfectly mixed ventilated airspace.

    PubMed

    Janssens, K; Van Brecht, A; Zerihun Desta, T; Boonen, C; Berckmans, D

    2004-06-01

    The present paper outlines a modeling approach, which has been developed to model the internal dynamics of heat and moisture transfer in an imperfectly mixed ventilated airspace. The modeling approach, which combines the classical heat and moisture balance differential equations with the use of experimental time-series data, provides a physically meaningful description of the process and is very useful for model-based control purposes. The paper illustrates how the modeling approach has been applied to a ventilated laboratory test room with internal heat and moisture production. The results are evaluated and some valuable suggestions for future research are forwarded. The modeling approach outlined in this study provides an ideal form for advanced model-based control system design. The relatively low number of parameters makes it well suited for model-based control purposes, as a limited number of identification experiments is sufficient to determine these parameters. The model concept provides information about the air quality and airflow pattern in an arbitrary building. By using this model as a simulation tool, the indoor air quality and airflow pattern can be optimized.

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

    PubMed

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

    2017-09-01

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

  10. Effective Process Design for the Production of HIC-Resistant Linepipe Steels

    NASA Astrophysics Data System (ADS)

    Nieto, J.; Elías, T.; López, G.; Campos, G.; López, F.; Garcia, R.; De, Amar K.

    2013-09-01

    Production of slabs for sour service applications requires stringent control in slab internal quality and secondary processing so as to guarantee resistance against hydrogen-induced cracking (HIC). ArcelorMittal Steelmaking facility at Lazaro Cardenas, Mexico had recently implemented key steelmaking and casting processing technologies for production of sound, centerline free slabs for catering to the growing API Linepipe and off-shore market for sour service applications. State-of-the-art steelmaking with use of residual-free Direct-reduced Iron and continuous casting facilities with dynamic soft reduction were introduced for the production of slabs with ultra clean centerline. Introduction of controlled cooling of slabs for atomic hydrogen control well below 2 ppm has enabled production of slabs suitable for excellent HIC-resistant plate processing. Substantial tonnages of slabs were produced for production of API X52-X65 grade plates and pipes for sour service. Stringent quality control at each stage of steelmaking, casting, and slab inspection ensured slabs with excellent internal quality suitable for HIC resistance to be guaranteed in final product (Plates & Pipes). Details of production steps which resulted in successful HIC-resistant slab production have been described in this article.

  11. Psychological predictors for health-related quality of life and disability in persons with chronic obstructive pulmonary disease (COPD).

    PubMed

    Mewes, Ricarda; Rief, Winfried; Kenn, Klaus; Ried, Jens; Stenzel, Nikola

    2016-01-01

    Individuals with chronic obstructive pulmonary disease (COPD) exhibit low physical and mental health-related quality of life (HRQL) and high susceptibility to disability. We investigated the influence of psychological factors on HRQL and disability in COPD individuals recruited from the general population. In line with Leventhal's common sense model, we expected psychological factors to be associated with HRQL and disability even after controlling for medical status. Individuals with COPD (n = 502; 59.7 years old; GOLD grades were I: 3%, II: 17%, III: 34%, IV: 46%) were assessed through an online survey administered via COPD patient organisations in Germany. Individuals filled in the Short Form Health Survey (SF-12), COPD Assessment Test, Patient Health Questionnaire (modules: GAD-2, PHQ-15, PHQ-9), Brief Illness Perception Questionnaire, a questionnaire that assesses causal illness attributions, and the internal illness-related locus of control scale of the 'KKG questionnaire for the assessment of control beliefs about illness and health'. Multiple linear regressions were calculated. The investigated factors explained high variances (disability = 56%, physical HRQL = 28%, mental HRQL = 63%, p ≤ .001). Better mental health, more optimistic illness perceptions, attribution to psychological causes, and stronger internal locus of control were associated with lower disability and better HRQL. Comorbid somatic symptoms contributed to high disability and low quality of life. Psychological factors, such as illness perception, attribution and internal locus of control, were associated with disability and HRQL. These factors should be considered when designing treatments for individuals with COPD, and adequate interventions should be provided to enhance illness understanding and self-management skills.

  12. A demand assignment control in international business satellite communications network

    NASA Astrophysics Data System (ADS)

    Nohara, Mitsuo; Takeuchi, Yoshio; Takahata, Fumio; Hirata, Yasuo

    An experimental system is being developed for use in an international business satellite (IBS) communications network based on demand-assignment (DA) and TDMA techniques. This paper discusses its system design, in particular from the viewpoints of a network configuration, a DA control, and a satellite channel-assignment algorithm. A satellite channel configuration is also presented along with a tradeoff study on transmission rate, HPA output power, satellite resource efficiency, service quality, and so on.

  13. 48 CFR 970.0370-1 - Policy.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... management and quality control to discourage waste, fraud and abuse; and to ensure that components, products, and services that are provided to the Department of Energy (DOE) satisfy the contractor's obligations... for effective management systems and internal controls within their areas of assigned responsibility...

  14. Hemiarthroplasty compared to internal fixation with percutaneous cannulated screws as treatment of displaced femoral neck fractures in the elderly: cost-utility analysis performed alongside a randomized, controlled trial.

    PubMed

    Waaler Bjørnelv, G M; Frihagen, F; Madsen, J E; Nordsletten, L; Aas, E

    2012-06-01

    We estimated the cost-effectiveness of hemiarthroplasty compared to internal fixation for elderly patients with displaced femoral neck fractures. Over 2 years, patients treated with hemiarthroplasty gained more quality-adjusted life years than patients treated with internal fixation. In addition, costs for hemiarthroplasty were lower. Hemiarthroplasty was thus cost effective. Estimating the cost utility of hemiarthroplasty compared to internal fixation in the treatment of displaced femoral neck fractures in the elderly. A cost-utility analysis (CUA) was conducted alongside a clinical randomized controlled trial at a university hospital in Norway; 166 patients, 124 (75%) women with a mean age of 82 years were randomized to either internal fixation (n = 86) or hemiarthroplasty (n = 80). Patients were followed up at 4, 12, and 24 months. Health-related quality of life was assessed with the EQ-5D, and in combination with time used to calculate patients' quality-adjusted life years (QALYs). Resource use was identified, quantified, and valued for direct and indirect hospital costs and for societal costs. Results were expressed in incremental cost-effectiveness ratios. Over the 2-year period, patients treated with hemiarthroplasty gained 0.15-0.20 more QALYs than patients treated with internal fixation. For the hemiarthroplasty group, the direct hospital costs, total hospital costs, and total costs were non-significantly less costly compared with the internal fixation group, with an incremental cost of €2,731 (p = 0.81), €2,474 (p = 0.80), and €14,160 (p = 0.07), respectively. Thus, hemiarthroplasty was the dominant treatment. Sensitivity analyses by bootstrapping supported these findings. Hemiarthroplasty was a cost-effective treatment. Trial registration, NCT00464230.

  15. Hanford Internal Dosimetry Project manual. Revision 1

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

    Carbaugh, E.H.; Bihl, D.E.; MacLellan, J.A.

    1994-07-01

    This document describes the Hanford Internal Dosimetry Project, as it is administered by Pacific Northwest Laboratory (PNL) in support of the US Department of Energy and its Hanford contractors. Project services include administrating the bioassay monitoring program, evaluating and documenting assessment of potential intakes and internal dose, ensuring that analytical laboratories conform to requirements, selecting and applying appropriate models and procedures for evaluating radionuclide deposition and the resulting dose, and technically guiding and supporting Hanford contractors in matters regarding internal dosimetry. Specific chapters deal with the following subjects: practices of the project, including interpretation of applicable DOE Orders, regulations, andmore » guidance into criteria for assessment, documentation, and reporting of doses; assessment of internal dose, including summary explanations of when and how assessments are performed; recording and reporting practices for internal dose; selection of workers for bioassay monitoring and establishment of type and frequency of bioassay measurements; capability and scheduling of bioassay monitoring services; recommended dosimetry response to potential internal exposure incidents; quality control and quality assurance provisions of the program.« less

  16. Region-Urbanicity Differences in Locus of Control: Social Disadvantage, Structure, or Cultural Exceptionalism?

    PubMed

    Shifrer, Dara; Sutton, April

    2014-11-01

    People with internal rather than external locus of control experience better outcomes in multiple domains. Previous studies on spatial differences in control within America only focused on the South, relied on aggregate level data or historical evidence, or did not account for other confounding regional distinctions (such as variation in urbanicity). Using data from the National Education Longitudinal Study, we find differences in adolescents' loci of control depending on their region and urbanicity are largely attributable to differences in their social background, and only minimally to structural differences (i.e., differences in the qualities of adolescents' schools). Differences that persist net of differences across adolescents and their schools suggest the less internal control of rural Southern adolescents, and the more internal control of rural and urban Northeastern adolescents, may be due to cultural distinctions in those areas. Results indicate region is more closely associated than urbanicity with differences in locus of control, with Western and Northeastern cultures seemingly fostering more internal control than Midwestern and Southern cultures. These findings contribute to research on spatial variation in a variety of psychological traits.

  17. Region-Urbanicity Differences in Locus of Control: Social Disadvantage, Structure, or Cultural Exceptionalism?

    PubMed Central

    Shifrer, Dara; Sutton, April

    2014-01-01

    People with internal rather than external locus of control experience better outcomes in multiple domains. Previous studies on spatial differences in control within America only focused on the South, relied on aggregate level data or historical evidence, or did not account for other confounding regional distinctions (such as variation in urbanicity). Using data from the National Education Longitudinal Study, we find differences in adolescents' loci of control depending on their region and urbanicity are largely attributable to differences in their social background, and only minimally to structural differences (i.e., differences in the qualities of adolescents' schools). Differences that persist net of differences across adolescents and their schools suggest the less internal control of rural Southern adolescents, and the more internal control of rural and urban Northeastern adolescents, may be due to cultural distinctions in those areas. Results indicate region is more closely associated than urbanicity with differences in locus of control, with Western and Northeastern cultures seemingly fostering more internal control than Midwestern and Southern cultures. These findings contribute to research on spatial variation in a variety of psychological traits. PMID:25382875

  18. Data Management and Data Quality in PERCH, a Large International Case-Control Study of Severe Childhood Pneumonia.

    PubMed

    Watson, Nora L; Prosperi, Christine; Driscoll, Amanda J; Higdon, Melissa M; Park, Daniel E; Sanza, Megan; DeLuca, Andrea N; Awori, Juliet O; Goswami, Doli; Hammond, Emily; Hossain, Lokman; Johnson, Catherine; Kamau, Alice; Kuwanda, Locadiah; Moore, David P; Neyzari, Omid; Onwuchekwa, Uma; Parker, David; Sapchookul, Patranuch; Seidenberg, Phil; Shamsul, Arifin; Siazeele, Kazungu; Srisaengchai, Prasong; Sylla, Mamadou; Levine, Orin S; Murdoch, David R; O'Brien, Katherine L; Wolff, Mark; Deloria Knoll, Maria

    2017-06-15

    The Pneumonia Etiology Research for Child Health (PERCH) study is the largest multicountry etiology study of pediatric pneumonia undertaken in the past 3 decades. The study enrolled 4232 hospitalized cases and 5325 controls over 2 years across 9 research sites in 7 countries in Africa and Asia. The volume and complexity of data collection in PERCH presented considerable logistical and technical challenges. The project chose an internet-based data entry system to allow real-time access to the data, enabling the project to monitor and clean incoming data and perform preliminary analyses throughout the study. To ensure high-quality data, the project developed comprehensive quality indicator, data query, and monitoring reports. Among the approximately 9000 cases and controls, analyzable laboratory results were available for ≥96% of core specimens collected. Selected approaches to data management in PERCH may be extended to the planning and organization of international studies of similar scope and complexity. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

  19. Perceived quality of management information and the influence of overspending penalties in the NHS.

    PubMed

    Marriott, N; Mellett, H

    1996-11-01

    The information needs of managers have changed considerably since the introduction of the internal market and many NHS units have invested in new management information systems to enhance the organization's performance. The characteristics of good quality information include accuracy, timeliness and comprehension. Information for management control also benefits from participation between the provider and the user. There are behavioural implications of using information as a control device and managers must internalize the financial objectives of the organization, usually expressed in budget reports. Failure to meet targets must attract penalties that will influence the managers' behaviour. They must respond to the information provided if control is to be exercised. This paper gives the results of a study into managers' perceptions of the adequacy and usefulness of financial information and the impact of penalties for overspending. It concludes that the financial information currently provided fails to meet many of the criteria of good quality information. Any perceived penalty for failing to attain budget-related goals is better than none, and there is little distinction between an overt reprimand and the ultimate sanction of dismissal.

  20. A New Dual-purpose Quality Control Dosimetry Protocol for Diagnostic Reference-level Determination in Computed Tomography.

    PubMed

    Sohrabi, Mehdi; Parsi, Masoumeh; Sina, Sedigheh

    2018-05-17

    A diagnostic reference level is an advisory dose level set by a regulatory authority in a country as an efficient criterion for protection of patients from unwanted medical exposure. In computed tomography, the direct dose measurement and data collection methods are commonly applied for determination of diagnostic reference levels. Recently, a new quality-control-based dose survey method was proposed by the authors to simplify the diagnostic reference-level determination using a retrospective quality control database usually available at a regulatory authority in a country. In line with such a development, a prospective dual-purpose quality control dosimetry protocol is proposed for determination of diagnostic reference levels in a country, which can be simply applied by quality control service providers. This new proposed method was applied to five computed tomography scanners in Shiraz, Iran, and diagnostic reference levels for head, abdomen/pelvis, sinus, chest, and lumbar spine examinations were determined. The results were compared to those obtained by the data collection and quality-control-based dose survey methods, carried out in parallel in this study, and were found to agree well within approximately 6%. This is highly acceptable for quality-control-based methods according to International Atomic Energy Agency tolerance levels (±20%).

  1. Atlantic Ocean CARINA data: overview and salinity adjustments

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

    Tanhua, T.; Steinfeldt, R.; Key, Robert

    2010-01-01

    Water column data of carbon and carbon-relevant hydrographic and hydrochemical parameters from 188 previously non-publicly available cruise data sets in the Arctic Mediterranean Seas, Atlantic and Southern Ocean have been retrieved and merged into a new database: CARINA (CARbon dioxide IN the Atlantic Ocean). The data have gone through rigorous quality control procedures to assure the highest possible quality and consistency. The data for the pertinent parameters in the CARINA database were objectively examined in order to quantify systematic differences in the reported values, i.e. secondary quality control. Systematic biases found in the data have been corrected in the threemore » data products: merged data files with measured, calculated and interpolated data for each of the three CARINA regions, i.e. the Arctic Mediterranean Seas, the Atlantic and the Southern Ocean. These products have been corrected to be internally consistent. Ninety-eight of the cruises in the CARINA database were conducted in the Atlantic Ocean, defined here as the region south of the Greenland-Iceland-Scotland Ridge and north of about 30 S. Here we present an overview of the Atlantic Ocean synthesis of the CARINA data and the adjustments that were applied to the data product. We also report the details of the secondary QC (Quality Control) for salinity for this data set. Procedures of quality control including crossover analysis between stations and inversion analysis of all crossover data are briefly described. Adjustments to salinity measurements were applied to the data from 10 cruises in the Atlantic Ocean region. Based on our analysis we estimate the internal consistency of the CARINA-ATL salinity data to be 4.1 ppm. With these adjustments the CARINA data products are consistent both internally was well as with GLODAP data, an oceanographic data set based on the World Hydrographic Program in the 1990s, and is now suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation.« less

  2. The advanced qualtiy control techniques planned for the Internation Soil Moisture Network

    NASA Astrophysics Data System (ADS)

    Xaver, A.; Gruber, A.; Hegiova, A.; Sanchis-Dufau, A. D.; Dorigo, W. A.

    2012-04-01

    In situ soil moisture observations are essential to evaluate and calibrate modeled and remotely sensed soil moisture products. Although a number of meteorological networks and field campaigns measuring soil moisture exist on a global and long-term scale, their observations are not easily accessible and lack standardization of both technique and protocol. Thus, handling and especially comparing these datasets with satellite products or land surface models is a demanding issue. To overcome these limitations the International Soil Moisture Network (ISMN; http://www.ipf.tuwien.ac.at/insitu/) has been initiated to act as a centralized data hosting facility. One advantage of the ISMN is that users are able to access the harmonized datasets easily through a web portal. Another advantage is the fully automated processing chain including the data harmonization in terms of units and sampling interval, but even more important is the advanced quality control system each measurement has to run through. The quality of in situ soil moisture measurements is crucial for the validation of satellite- and model-based soil moisture retrievals; therefore a sophisticated quality control system was developed. After a check for plausibility and geophysical limits a quality flag is added to each measurement. An enhanced flagging mechanism was recently defined using a spectrum based approach to detect spurious spikes, jumps and plateaus. The International Soil Moisture Network has already evolved to one of the most important distribution platforms for in situ soil moisture observations and is still growing. Currently, data from 27 networks in total covering more than 800 stations in Europe, North America, Australia, Asia and Africa is hosted by the ISMN. Available datasets also include historical datasets as well as near real-time measurements. The improved quality control system will provide important information for satellite-based as well as land surface model-based validation studies.

  3. Atlantic Ocean CARINA data: overview and salinity adjustments

    NASA Astrophysics Data System (ADS)

    Tanhua, T.; Steinfeldt, R.; Key, R. M.; Brown, P.; Gruber, N.; Wanninkhof, R.; Perez, F.; Körtzinger, A.; Velo, A.; Schuster, U.; van Heuven, S.; Bullister, J. L.; Stendardo, I.; Hoppema, M.; Olsen, A.; Kozyr, A.; Pierrot, D.; Schirnick, C.; Wallace, D. W. R.

    2010-02-01

    Water column data of carbon and carbon-relevant hydrographic and hydrochemical parameters from 188 previously non-publicly available cruise data sets in the Arctic Mediterranean Seas, Atlantic and Southern Ocean have been retrieved and merged into a new database: CARINA (CARbon dioxide IN the Atlantic Ocean). The data have gone through rigorous quality control procedures to assure the highest possible quality and consistency. The data for the pertinent parameters in the CARINA database were objectively examined in order to quantify systematic differences in the reported values, i.e. secondary quality control. Systematic biases found in the data have been corrected in the three data products: merged data files with measured, calculated and interpolated data for each of the three CARINA regions, i.e. the Arctic Mediterranean Seas, the Atlantic and the Southern Ocean. These products have been corrected to be internally consistent. Ninety-eight of the cruises in the CARINA database were conducted in the Atlantic Ocean, defined here as the region south of the Greenland-Iceland-Scotland Ridge and north of about 30° S. Here we present an overview of the Atlantic Ocean synthesis of the CARINA data and the adjustments that were applied to the data product. We also report the details of the secondary QC (Quality Control) for salinity for this data set. Procedures of quality control - including crossover analysis between stations and inversion analysis of all crossover data - are briefly described. Adjustments to salinity measurements were applied to the data from 10 cruises in the Atlantic Ocean region. Based on our analysis we estimate the internal consistency of the CARINA-ATL salinity data to be 4.1 ppm. With these adjustments the CARINA data products are consistent both internally as well as with GLODAP data, an oceanographic data set based on the World Hydrographic Program in the 1990s, and is now suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation.

  4. [Hyaluronate sodium treatment for internal derangement of temporomandibular joint: a systematic review based on randomized controlled trials].

    PubMed

    Li, Chunjie; Zhang, Yifan; Jia, Yuanyuan; Lü, Jun; Li, Longjiang; Shi, Zong-Dao

    2011-10-01

    To assess the efficacy and safety of hyaluronate sodium (HS) for internal derangement of temporomandibular joint by means of systematic review on relevant randomized controlled trials. After identifing the study question of the efficacy and safety of HS for internal derangement of temporomandibular joint, Medline, Cochrane Controlled Trials Register, EMBASE, OPEN SIGLE and CBM were searched electronically till October 3rd 2010. Hand-searching covering 19 dental journals in Chinese were also performed. Risk of bias assessment, with Cochrane Collaboration's tool, and data extraction of included studies were conducted by two reviewers in duplicate. Meta analysis was done with Revman 5.0.23 and the quality of evidence was evaluated by GRADE. 10 randomized controlled trials met the eligibility criteria and were included. All these studies had unclear risk of bias. When compared with negative control, HS showed a significant advantage on maximal mouth opening in short and long-term (P < 0.05), and clinical overall assessment in short-term (P < 0.05), but its effect on pain control and long-term effect on clinical overall assessment had no extra benefit (P > 0.05). Additionally, when compared with glucocorticoids, the participants who received HS injection would get a better clinical overall assessment in short-term and less adverse drug reactions (P < 0.05), but presented a similar temporomandibular joint pain relief and maximal mouth opening (P > 0.05). To a certain extent, HS had good efficacy and better safety than controls when treating internal derangement of temporomandibular joint. However, as the quality of some included studies were limited, more randomized controlled trials are needed to reinforce the conclusion.

  5. Human Connectome Project Informatics: quality control, database services, and data visualization

    PubMed Central

    Marcus, Daniel S.; Harms, Michael P.; Snyder, Abraham Z.; Jenkinson, Mark; Wilson, J Anthony; Glasser, Matthew F.; Barch, Deanna M.; Archie, Kevin A.; Burgess, Gregory C.; Ramaratnam, Mohana; Hodge, Michael; Horton, William; Herrick, Rick; Olsen, Timothy; McKay, Michael; House, Matthew; Hileman, Michael; Reid, Erin; Harwell, John; Coalson, Timothy; Schindler, Jon; Elam, Jennifer S.; Curtiss, Sandra W.; Van Essen, David C.

    2013-01-01

    The Human Connectome Project (HCP) has developed protocols, standard operating and quality control procedures, and a suite of informatics tools to enable high throughput data collection, data sharing, automated data processing and analysis, and data mining and visualization. Quality control procedures include methods to maintain data collection consistency over time, to measure head motion, and to establish quantitative modality-specific overall quality assessments. Database services developed as customizations of the XNAT imaging informatics platform support both internal daily operations and open access data sharing. The Connectome Workbench visualization environment enables user interaction with HCP data and is increasingly integrated with the HCP's database services. Here we describe the current state of these procedures and tools and their application in the ongoing HCP study. PMID:23707591

  6. Water quality management library. 2. edition

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

    Eckenfelder, W.W.; Malina, J.F.; Patterson, J.W.

    1998-12-31

    A series of ten books offered in conjunction with Water Quality International, the Biennial Conference and Exposition of the International Association on Water Pollution Research and Control (IAWPRC). Volume 1, Activated Sludge Process, Design and Control, 2nd edition, 1998: Volume 2, Upgrading Wastewater Treatment Plants, 2nd edition, 1998: Volume 3, Toxicity Reduction, 2nd edition, 1998: Volume 4, Municipal Sewage Sludge Management, 2nd edition, 1998: Volume 5, Design and Retrofit of Wastewater Treatment Plants for Biological Nutrient Removal, 1st edition, 1992: Volume 6, Dynamics and Control of the Activated Sludge Process, 2nd edition, 1998: Volume 7: Design of Anaerobic Processes formore » the Treatment of Industrial and Municipal Wastes, 1st edition, 1992: Volume 8, Groundwater Remediation, 1st edition, 1992: Volume 9, Nonpoint Pollution and Urban Stormwater Management, 1st edition, 1995: Volume 10, Wastewater Reclamation and Reuse, 1st edition, 1998.« less

  7. Effect of Tooling Material on the Internal Surface Quality of Ti6Al4V Parts Fabricated by Hot Isostatic Pressing

    NASA Astrophysics Data System (ADS)

    Cai, Chao; Song, Bo; Wei, Qingsong; Yan, Wu; Xue, Pengju; Shi, Yusheng

    2017-01-01

    For the net-shape hot isostatic pressing (HIP) process, control of the internal surface roughness of as-HIPped parts remains a challenge for practical engineering. To reveal the evolution mechanism of the internal surface of the parts during the HIP process, the effect of different tooling materials (H13, T8, Cr12 steel, and graphite) as internal cores on the interfacial diffusion and surface roughness was systematically studied.

  8. Anthropometric standardisation and quality control protocols for the construction of new, international, fetal and newborn growth standards: the INTERGROWTH-21st Project.

    PubMed

    Cheikh Ismail, L; Knight, H E; Ohuma, E O; Hoch, L; Chumlea, W C

    2013-09-01

    The primary aim of the INTERGROWTH-21(st) Project is to construct new, prescriptive standards describing optimal fetal and preterm postnatal growth. The anthropometric measurements include the head circumference, recumbent length and weight of the infants, and the stature and weight of the parents. In such a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes in detail the anthropometric training, standardisation and quality control procedures used to collect data for these new standards. The initial standardisation session was in Nairobi, Kenya, using newborns, which was followed by similar sessions in the eight participating study sites in Brazil, China, India, Italy, Kenya, Oman, UK and USA. The intraobserver and inter-observer technical error of measurement values for head circumference range from 0.3 to 0.4 cm, and for recumbent length from 0.3 to 0.5 cm. These standardisation protocols implemented at each study site worldwide ensure that the anthropometric data collected are of the highest quality to construct international growth standards. © 2013 Royal College of Obstetricians and Gynaecologists.

  9. Implementation of a clinical quality control program in a mammography screening service of Brazil.

    PubMed

    DE Souza Sabino, Silvia Maria Prioli; Silva, Thiago Buosi; Watanabe, Anapaula Hidemi Uema; Syrjänen, Kari; Carvalho, André Lopes; Mauad, Edmundo Carvalho

    2014-09-01

    To evaluate the effect of a clinical quality control program on the final quality of a mammography screening service. We conducted retrospective assessment of the clinical quality of 5,000 mammograms taken in a Mammography Screening Program between November 2010 and September 2011, following the implementation of a Clinical Quality Control Program based on the European Guidelines. Among the 105,000 evaluated quality items, there were 8,588 failures (8.2%) - 1.7 failures per examination. Altogether, 89% of the failures were associated with positioning. The recall rate due to a technical error reached a maximum of 0.5% in the early phase of the observation period and subsequently stabilized (0.09%). The ongoing education and monitoring combined with personalized training increased the critical thinking of the involved professionals, reducing the technical failures and unnecessary exposure of patients to radiation, with substantial improvement in the final quality of mammography. Copyright© 2014 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  10. Improving labeling efficiency in automatic quality control of MRSI data.

    PubMed

    Pedrosa de Barros, Nuno; McKinley, Richard; Wiest, Roland; Slotboom, Johannes

    2017-12-01

    To improve the efficiency of the labeling task in automatic quality control of MR spectroscopy imaging data. 28'432 short and long echo time (TE) spectra (1.5 tesla; point resolved spectroscopy (PRESS); repetition time (TR)= 1,500 ms) from 18 different brain tumor patients were labeled by two experts as either accept or reject, depending on their quality. For each spectrum, 47 signal features were extracted. The data was then used to run several simulations and test an active learning approach using uncertainty sampling. The performance of the classifiers was evaluated as a function of the number of patients in the training set, number of spectra in the training set, and a parameter α used to control the level of classification uncertainty required for a new spectrum to be selected for labeling. The results showed that the proposed strategy allows reductions of up to 72.97% for short TE and 62.09% for long TE in the amount of data that needs to be labeled, without significant impact in classification accuracy. Further reductions are possible with significant but minimal impact in performance. Active learning using uncertainty sampling is an effective way to increase the labeling efficiency for training automatic quality control classifiers. Magn Reson Med 78:2399-2405, 2017. © 2017 International Society for Magnetic Resonance in Medicine. © 2017 International Society for Magnetic Resonance in Medicine.

  11. Higher Education Quality Assurance Organisations in Central and Eastern Europe

    ERIC Educational Resources Information Center

    Temple, Paul; Billing, David

    2003-01-01

    This paper considers the development of intermediary, or buffer, bodies dealing with quality assurance in higher education in Central and Eastern Europe over the past 10 years. It relates these developments to the context of communist-era centralisation and control, and to more recent interventions by international aid agencies. The lessons that…

  12. Quality Control in the Administration of Sport Management Internships

    ERIC Educational Resources Information Center

    Kelley, Dennie Ruth

    2004-01-01

    The quality of an intern's learning experience is the joint responsibility of the academic internship coordinator, the administrator of the sport management program, and the agency supervisor. The purpose of this article is to identify the areas of administrative concern in the three major components of an internship: the institution granting…

  13. [Implementation of the technical requirements of the UNE-EN-ISO 15189 quality standard in a mycobacterial laboratory].

    PubMed

    Guna Serrano, M del Remedio; Ocete Mochón, M Dolores; Lahiguera, M José; Bresó, M Carmen; Gimeno Cardona, Concepción

    2013-02-01

    The UNE-EN-ISO 15189:2007 standard defines the requirements for quality and competence that must be met by medical laboratories. These laboratories should use this international standard to develop their own quality management systems and to evaluate their own competencies; in turn, this standard will be used by accreditation bodies to confirm or recognize the laboratories' competence. In clinical microbiology laboratories, application of the standard implies the implementation of the technical and specific management requirements that must be met to achieve optimal quality when carrying out microbiological tests. In Spain, accreditation is granted by the Spanish Accreditation Body (Entidad Nacional de Acreditación). This review aims to discuss the practical application of the standard's technical requirements in mycobacterial laboratory. Firstly, we define the scope of accreditation. Secondly, we specify how the items of the standard on personnel management, control of equipment, environmental facilities, method validation, internal controls and customer satisfaction surveys were developed and implemented in our laboratory. Copyright © 2013 Elsevier España, S.L. All rights reserved.

  14. National Survey on Internal Quality Control Practice for Lipid Parameters in Laboratories of China from 2014 to 2016.

    PubMed

    Ye, Yuanyuan; Wang, Wei; Zhao, Haijian; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

    2017-09-01

    To investigate the situation of Internal Quality Control (IQC) practice for total cholesterol, triglycerides, HDL-cholesterol and LDL-cholesterol from 2014 to 2016 in laboratories in China and provide improvement measurements. A web-based External Quality Assessment (EQA) system was used to collect IQC data of lipid parameters in laboratories which continuously participated in the national EQA programs in China from 2014 to 2016. Pass rate of the coefficients of variation (CVs) of two level quality controls in four lipid parameters were calculated according to six quality specifications for precision to evaluate the current status of precision level of the four lipid parameters and their change over time in China. 533, 512, 504, and 466 laboratories continuously reported the data of level one for total cholesterol, triglyceride, HDL-cholesterol and LDL-cholesterol, and 212, 210, 208 and 198 laboratories reported the level two, respectively. The percentage of laboratories meeting the quality specification varied based on different criteria. Non-significant change can be found in the pass rate of CVs over time. The number of laboratories using a closed system increased over time, but still only accounted for a small proportion. There is no significant difference in the pass rate of CVs between closed and open systems. Triglycerides currently have a fairly good performance in China. While the performance of laboratories on total cholesterol, HDL-cholesterol and LDL-cholesterol has yet to be improved.

  15. 32 CFR Appendix A to Part 290 - DCAA's Organization and Mission

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... established audit quality control standards, policies, and procedures and other internal control requirements... Information Service, 5285 Port Royal Road, Springfield, VA 22161. (c) Objective. Assist in achieving the... provides accounting and financial advisory service regarding contracts to all DoD components responsible...

  16. 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.

  17. Immobilization in External Rotation Versus Internal Rotation After Primary Anterior Shoulder Dislocation: A Meta-analysis of Randomized Controlled Trials.

    PubMed

    Whelan, Daniel B; Kletke, Stephanie N; Schemitsch, Geoffrey; Chahal, Jaskarndip

    2016-02-01

    The recurrence rate after primary anterior shoulder dislocation is high, especially in young, active individuals. Recent studies have suggested external rotation immobilization as a method to reduce the rate of recurrent shoulder dislocation in comparison to traditional sling immobilization. To assess and summarize evidence from randomized controlled trials on the effect of internal rotation versus external rotation immobilization on the rate of recurrence after primary anterior shoulder dislocation. Meta-analysis. PubMed, MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and abstracts from recent proceedings were searched for eligible studies. Two reviewers selected studies for inclusion, assessed methodological quality, and extracted data. Six randomized controlled trials (632 patients) were included in this review. Demographic and prognostic variables measured at baseline were similar in the pooled groups. The average age was 30.1 years in the pooled external rotation group and 30.3 years in the pooled internal rotation group. Two studies found that external rotation immobilization reduced the rate of recurrence after initial anterior shoulder dislocation compared with conventional internal rotation immobilization, whereas 4 studies failed to find a significant difference between the 2 groups. This meta-analysis suggested no overall significant difference in the rate of recurrence among patients treated with internal rotation versus external rotation immobilization (risk ratio, 0.69; 95% CI, 0.42-1.14; P = .15). There was no significant difference in the rate of compliance between internal and external rotation immobilization (P = .43). The Western Ontario Shoulder Instability Index scores were pooled across 3 studies, and there was no significant difference between the 2 groups (P = .54). Immobilization in external rotation is not significantly more effective in reducing the recurrence rate after primary anterior shoulder dislocation than immobilization in internal rotation. Additionally, this review suggests that there is minimal difference in patients' perceptions of their health-related quality of life after immobilization in internal versus external rotation. © 2015 The Author(s).

  18. Internal quality control of blood products: An experience from a tertiary care hospital blood bank from Southern Pakistan.

    PubMed

    Sultan, Sadia; Zaheer, Hasan Abbas; Waheed, Usman; Baig, Mohammad Amjad; Rehan, Asma; Irfan, Syed Mohammed

    2018-01-01

    Internal quality control (IQC) is the backbone of quality assurance program. In blood banking, the quality control of blood products ensures the timely availability of a blood component of high quality with maximum efficacy and minimal risk to potential recipients. The main objective of this study is to analyze the IQC of blood products as an indicator of our blood bank performance. An observational cross-sectional study was conducted at the blood bank of Liaquat National Hospital and Medical College, from January 2014 to December 2015. A total of 100 units of each blood components were arbitrarily chosen during the study. Packed red cell units were evaluated for hematocrit (HCT); random platelet concentrates were evaluated for pH, yield, and culture; fresh frozen plasma (FFP) and cryoprecipitate (CP) were evaluated for unit volume, factor VIII, and fibrinogen concentrations. A total of 400 units were tested for IQC. The mean HCT of packed red cells was 69.5 ± 7.24, and in 98% units, it met the standard (<80% of HCT). The mean platelet yield was 8.8 ± 3.40 × 10 9 /L and pH was ≥6.2 in 98% bags; cultures were negative in 97% of units tested. Mean factor VIII and fibrinogen levels were found to be 84.24 ± 15.01 and 247.17 ± 49.69 for FFP, respectively. For CP, mean factor VIII and fibrinogen level were found to be 178.75 ± 86.30 and 420.7 ± 75.32, respectively. The IQC of blood products at our blood bank is in overall compliance and met recommended international standards. Implementation of standard operating procedures, accomplishment of standard guidelines, proper documentation with regular audit, and staff competencies can improve the quality performance of the transfusion services.

  19. [Analysis of the results of the SEIMC External Quality Control Program. Year 2011].

    PubMed

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

    2013-02-01

    The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica [SEIMC]) includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology, and molecular microbiology. This article presents the most relevant conclusions and lessons from the 2011 controls. Overall, the results obtained in 2011 confirm the excellent skill and good technical standards found in previous years. Nevertheless, 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, such as those offered by the SEIMC program, in order to ensure maximal quality of microbiological tests. Copyright © 2013 Elsevier España, S.L. All rights reserved.

  20. Chinese vaccine products go global: vaccine development and quality control.

    PubMed

    Xu, Miao; Liang, Zhenglun; Xu, Yinghua; Wang, Junzhi

    2015-05-01

    Through the continuous efforts of several generations, China has become one of the few countries in the world that is capable of independently addressing all the requirements by the Expanded Program on Immunization. Regulatory science is applied to continuously improve the vaccine regulatory system. Passing the prequalification by WHO has allowed Chinese vaccine products to go global. Chinese vaccine products not only secure disease prevention and control domestically but also serve the needs for international public health. This article describes the history of Chinese vaccine development, the current situation of Chinese vaccine industry and its contribution to the prevention and control of infectious diseases. We also share our experience of national quality control and vaccine regulation during the past decades. China's experience in vaccine development and quality control can benefit other countries and regions worldwide, including the developing countries.

  1. Reporting quality of randomised controlled trials published in prosthodontic and implantology journals.

    PubMed

    Kloukos, D; Papageorgiou, S N; Doulis, I; Petridis, H; Pandis, N

    2015-12-01

    The purpose of this study was to examine the reporting quality of randomised controlled trials (RCTs) published in prosthodontic and implantology journals. Thirty issues of nine journals in prosthodontics and implant dentistry were searched for RCTs, covering the years 2005-2012: The Journal of Prosthetic Dentistry, Journal of Oral Rehabilitation, The International Journal of Prosthodontics, The International Journal of Periodontics & Restorative Dentistry, Clinical Oral Implants Research, Clinical Implant Dentistry & Related Research, The International Journal of Oral & Maxillofacial Implants, Implant Dentistry and Journal of Dentistry. The reporting quality was assessed using a modified Consolidated Standards of Reporting Trials (CONSORT) statement checklist. Data were analysed using descriptive statistics followed by univariable and multivariable examination of statistical associations (α = 0·05). A total of 147 RCTs were identified with a mean CONSORT score of 69·4 (s.d. = 9·7). Significant differences were found among journals with the Journal of Oral Rehabilitation achieving the highest score (80·6, s.d. = 5·5) followed by Clinical Oral Implants Research (73·7, s.d. = 8·3). Involvement of a statistician/methodologist was significantly associated with increased CONSORT scores. Overall, the reporting quality of RCTs in major prosthodontic and implantology journals requires improvement. This is of paramount importance considering that optimal reporting of RCTs is an important prerequisite for clinical decision-making. © 2015 John Wiley & Sons Ltd.

  2. School Self-Evaluation and Student Achievement

    ERIC Educational Resources Information Center

    Hofman, Roelande H.; Dijkstra, Nynke J.; Hofman, W. H. Adriaan

    2009-01-01

    In the last 2 decades, educational systems have developed accountability policies in which schools maintain autonomy for their pedagogical, instructional, and organizational practices (internal control). At the same time, they are held accountable to public authorities (external control) for the quality of their education. It is not clear whether…

  3. Industrial-scale radio frequency treatments for insect control in lentils

    USDA-ARS?s Scientific Manuscript database

    Radio frequency (RF) treatments are considered to be a potential postharvest technology for disinfesting legumes of internal seed pests such as the cowpea weevil. After treatment protocols are shown to control postharvest insects without significant quality degradation, it is important to scale-up l...

  4. A Comprehensive Review of Spirit Drink Safety Standards and Regulations from an International Perspective.

    PubMed

    Pang, Xiao-Na; Li, Zhao-Jie; Chen, Jing-Yu; Gao, Li-Juan; Han, Bei-Zhong

    2017-03-01

    Standards and regulations related to spirit drinks have been established by different countries and international organizations to ensure the safety and quality of spirits. Here, we introduce the principles of food safety and quality standards for alcoholic beverages and then compare the key indicators used in the distinct standards of the Codex Alimentarius Commission, the European Union, the People's Republic of China, the United States, Canada, and Australia. We also discuss in detail the "maximum level" of the following main contaminants of spirit drinks: methanol, higher alcohols, ethyl carbamate, hydrocyanic acid, heavy metals, mycotoxins, phthalates, and aldehydes. Furthermore, the control measures used for potential hazards are introduced. Harmonization of the current requirements based on comprehensive scope analysis and the risk assessment approach will enhance both the trade and quality of distilled spirits. This review article provides valuable information that will enable producers, traders, governments, and researchers to increase their knowledge of spirit drink safety requirements, control measures, and research trends.

  5. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2003-01-01

    This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, the report discusses activities related to the development of The International Pharmacopoeia and basic tests for pharmaceutical substances and dosage forms, as well as quality control of reference materials, good manufacturing practices (GMP), stability studies, inspection, hazard analysis, procurement, storage and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including recommendations on the risk of transmitting animal spongiform encephalopathy agents via medicinal products, guidelines on GMP for pharmaceutical products, a model certificate for GMP and guidance on a GMP inspection report. The final annexes provide guidance on the application of Hazard Analysis and Critical Control Point (HACCP) method to pharmaceuticals, good storage practices and a procedure for assessing acceptability of pharmaceutical products for purchase by United Nations agencies.

  6. Interrelations of stress, optimism and control in older people's psychological adjustment.

    PubMed

    Bretherton, Susan Jane; McLean, Louise Anne

    2015-06-01

    To investigate the influence of perceived stress, optimism and perceived control of internal states on the psychological adjustment of older adults. The sample consisted of 212 older adults, aged between 58 and 103 (M = 80.42 years, SD = 7.31 years), living primarily in retirement villages in Melbourne, Victoria. Participants completed the Perceived Stress Scale, Life Orientation Test-Revised, Perceived Control of Internal States Scale and the World Health Organisation Quality of Life-Bref. Optimism significantly mediated the relationship between older people's perceived stress and psychological health, and perceived control of internal states mediated the relationships among stress, optimism and psychological health. The variables explained 49% of the variance in older people's psychological adjustment. It is suggested that strategies to improve optimism and perceived control may improve the psychological adjustment of older people struggling to adapt to life's stressors. © 2014 ACOTA.

  7. 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.

  8. The Effects of Education Quality on Income Growth and Mortality Decline

    ERIC Educational Resources Information Center

    Jamison, Eliot A.; Jamison, Dean T.; Hanushek, Eric A.

    2007-01-01

    Previous work shows that higher levels of education quality (as measured by international student achievement tests) increase growth rates of national income. This paper begins by confirming those findings in an analysis involving more countries over more time with additional controls. We then use the panel structure of our data to assess whether…

  9. Biobanking of CSF: international standardization to optimize biomarker development.

    PubMed

    Teunissen, Charlotte E; Tumani, Hayrettin; Engelborghs, Sebastiaan; Mollenhauer, Brit

    2014-03-01

    Cerebrospinal fluid (CSF) reflects pathophysiological aspects of neurological diseases, where neuroprotective strategies and biomarkers are urgently needed. Therefore, biobanking is very relevant for biomarker discovery and evaluation of neurological diseases. Important and unique features of CSF biobanking are intensive collaboration in international networks and the tight application of standardized protocols. The current adoption of standardized protocols for CSF and blood collection as presented in this review enables biomarker studies in large cohorts of patients and controls. Another topic of this review is the selection of control groups, which influences the outcome of biomarker investigations. Control groups in CSF biobanks mainly consist of different disease controls. This is in part due to the fact that lumbar punctures are mostly performed for clinical indications and rarely for research purposes only, as it is a relatively invasive procedure. Moreover, there is a lack of homogenous criteria and definition of control groups. We therefore propose uniform consensus definitions for such control groups in biomarker research, i.e. Healthy controls (HC), Spinal anesthesia subjects (SAS), Symptomatic controls (SC), Inflammatory Neurological Disease Controls (CINDC), Peripheral Inflammatory Neurological Disease Controls (PINDC) and Non-inflammatory Neurological Disease Controls (NINDC). Another important aspect of CSF biobanking is quality control. Systematic studies to address effects of pre-analytical and storage variation on a broad range of CSF proteins are needed. In conclusion, biomarker research in neurodegenerative diseases has entered a new era due to the collaborative and multicenter efforts of many groups. The streamlining of biobanking procedures, including quality control, and the selection of optimal control groups for investigating biomarkers are important improvements to perform high quality biomarker studies. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  10. Quality of 99mTcO4- from 99Mo Produced by 100Mo(n,2n)99Mo

    NASA Astrophysics Data System (ADS)

    Nagai, Yasuki; Nakahara, Yuto; Kawabata, Masako; Hatsukawa, Yuichi; Hashimoto, Kazuyuki; Saeki, Hideya; Motoishi, Shoji; Ohta, Akio; Shiina, Takayuki; Kawauchi, Yukimasa

    2017-05-01

    The pharmaceutical quality of 99mTc pertechnetate solution obtained from 99Mo, the 100Mo(n,2n) reaction product, was investigated for the first time with an emphasis on the nonradioactive Mo content and endotoxin concentration. They were less than the tolerance dose given in international guidelines and the established upper limit in an international pharmacopoeia, respectively. Four other quality control tests commonly used for a commercially available 99mTc pertechnetate solution also demonstrated to meet the United States Pharmacopeia requirements. The results strongly support that the thermochromatographic separation method used to separate 99mTc from 99Mo can be a promising substitute for the fission product 99Mo.

  11. Vaccine to fibroblast growth factor 23 peptides increases eggshell strength.

    PubMed

    Ren, Z Z; Piepenburg, A J; Bütz, D E; Claus, J R; Cook, M E

    2018-03-01

    Strategies that would increase eggshell quality could be of considerable value to egg producers. This research demonstrated the effective use of fibroblast growth factor 23 (FGF-23) peptide vaccines to increase eggshell quality of Single Comb White Leghorn laying hens (from 69 to 72 wk of age). Hens, fed a standard diet (containing 900 IU/kg vitamin D3), were intramuscularly injected (and boosted) with either a control vaccine (n = 14 hens) or one of 2 FGF-23 peptide vaccines (peptides NP1, GMNPPPYS; and NP7, YTSTERNSFH; n = 15 hens for each peptide). During peak antibody titer, eggs were collected for shell and internal quality analysis, hens were artificially inseminated, and the hatchability of fertilized eggs was determined. Laying hens vaccinated with either FGF-23 peptide NP1 or NP7 had increased (P < 0.05) plasma phosphate level (mmol/L; NP1 = 1.74, NP7 = 1.76, control = 1.47), egg specific gravity (NP1 = 1.083, NP7 = 1.083, control = 1.079), and eggshell strength (g of force; NP1 = 4002, NP7 = 4157, control = 3102) when compared to control vaccinated hens. FGF-23 peptide NP1 vaccinated hens also had increased eggshell thickness (mm, P < 0.001), shell weight (g, P = 0.032), and shell index (% of whole egg, P = 0.023) when compared to control vaccinated hens. FGF-23 peptide NP7 vaccinated hens tended to have decreased eggshell weight (P = 0.064) when compared to control vaccinated hens. Hatchability of fertilized eggs was not affected in incubations 1 and 3, but tended to be decreased (P = 0.097) by FGF-23 peptide NP1 vaccination in incubation 2. In conclusion, vaccines to FGF-23 peptides increased eggshell quality of laying hens with minimal adverse effects on egg internal quality. The effect of FGF-23 peptide vaccination on hatchability remains to be clarified.

  12. 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

  13. 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.

  14. [Discussion on research thinking of traditional Chinese medicine standardization system based on whole process quality control].

    PubMed

    Dong, Ling; Sun, Yu; Pei, Wen-Xuan; Dai, Jun-Dong; Wang, Zi-Yu; Pan, Meng; Chen, Jiang-Peng; Wang, Yun

    2017-12-01

    The concept of "Quality by design" indicates that good design for the whole life cycle of pharmaceutical production enables the drug to meet the expected quality requirements. Aiming at the existing problems of the traditional Chinese medicine (TCM) industry, the TCM standardization system was put forward in this paper from the national strategic level, under the guidance by the idea of quality control in international manufacturing industry and with considerations of TCM industry's own characteristics and development status. The connotation of this strategy was to establish five interrelated systems: multi-indicators system based on tri-indicators system, quality standard and specification system of TCM herbal materials and decoction pieces, quality traceability system, data monitoring system based on whole-process quality control, and whole-process quality management system of TCM, and achieve the whole process systematic and scientific study in TCM industry through "top-level design-implement in steps-system integration" workflow. This article analyzed the correlation between the quality standards of all links, established standard operating procedures of each link and whole process, and constructed a high standard overall quality management system for TCM industry chains, in order to provide a demonstration for the establishment of TCM whole-process quality control system and provide systematic reference and basis for standardization strategy in TCM industry. Copyright© by the Chinese Pharmaceutical Association.

  15. [ISO 15189 accreditation in clinical microbiology laboratory: general concepts and the status in our laboratory].

    PubMed

    Akyar, Işin

    2009-10-01

    One important trend in the laboratory profession and quality management is the global convergence of laboratory operations. The goal of an accredited medical laboratory is to continue "offering useful laboratory service for diagnosis and treatment of the patients and also aid to the health of the nation". An accredited clinical laboratory is managed by a quality control system, it is competent technically and the laboratory service meets the needs of all its patients and physicians by taking the responsibility of all the medical tests and therapies. For this purpose, ISO 15189 international standard has been prepared by 2003. ISO 15189 standard is originated from the arrangement of ISO 17025 and ISO 9001:2000 standards. Many countries such as England, Germany, France, Canada and Australia have preferred ISO 15189 as their own laboratory accreditation programme, meeting all the requirements of their medical laboratories. The accreditation performance of a clinical microbiology laboratory is mainly based on five essential points; preanalytical, analytical, postanalytical, quality control programmes (internal, external, interlaboratory) and audits (internal, external). In this review article, general concepts on ISO 15189 accreditation standards for the clinical microbiology laboratories have been summarized and the status of a private laboratory (Acibadem LabMed, Istanbul) in Turkey has been discussed.

  16. Strengthening radiopharmacy practice in IAEA Member States.

    PubMed

    Duatti, Adriano; Bhonsle, Uday

    2013-05-01

    Radiopharmaceuticals are essential components of nuclear medicine procedures. Without radiopharmaceuticals nuclear medicine procedures cannot be performed. Therefore it could be said that 'No radiopharmaceutical-no nuclear medicine.' A good radiopharmacy practice supports nuclear medicine activities by producing radiopharmaceuticals that are safe and are of the required quality in a consistent way. As with any medicinal product, radiopharmaceuticals are required to be produced under carefully controlled conditions and are tested for their quality, prior to the administration to patients, using validated standard operating procedures. These procedures are based on the principles of Good Manufacturing Practice (GMP). The GMP principles are based on scientific knowledge and applicable regulatory requirements and guidance related to radiopharmaceutical productions and use. The International Atomic Energy Agency (IAEA) is committed to promote, in the Member States (MS), a rational and practical approach for the implementation of GMP for compounding or manufacturing of diagnostic or therapeutic radiopharmaceuticals. To pursue this goal the IAEA has developed various mechanisms and collaborations with individual experts in the field and with relevant national and international institutions or organizations. IAEA's activities in promoting radiopharmaceutical science include commissioning expert advice in the form of publications on radiopharmaceutical production, quality control and usage, producing technical guidance on production and regulatory aspects related to new radiopharmaceuticals, creating guidance documentation for self or internal audits of radiopharmaceutical production facilities, producing guidance on implementation of Quality Management System and GMP in radiopharmacy, assisting in creation of specific radiopharmaceutical monographs for the International Pharmacopoeia, and developing radiopharmacy-related human resource capabilities in MS through individual and regional training courses and education programs. IAEA strongly supports development of clinical nuclear medicine services by assisting MS in setting up reliable Radiopharmaceutical production facilities for single photon emission computed tomography, positron emission tomography, and for therapeutic applications. Copyright © 2013 Elsevier Inc. All rights reserved.

  17. Sharing AIS Related Anomalies (SARA)

    DTIC Science & Technology

    2016-03-01

    Maritime Integrated Command, Control and Communications IMO International Maritime Organization IQ Information Quality ISI Information Sharing...way to summarize level 1 anomalies, an Information Quality ( IQ ) approach was selected. One of the reasons to favour this approach is the option to...Ray [31], but with slightly different IQ dimensions. Six dimensions of IQ have been selected to describe level 2 anomalies (described in Table 3.1

  18. George M. Low Trophy: NASA's quality and excellence award

    NASA Technical Reports Server (NTRS)

    1991-01-01

    NASA's major goal is the preservation of America's position as a leader in the aerospace industry. To maintain that status, it is crucial that the products and services we depend upon from NASA contractors, subcontractors, and suppliers meet the highest quality standards to ensure the space program's success. The George M. Low Trophy: NASA's Quality and Excellence Award is the result of NASA's desire to encourage continuous improvement and Total Quality Management (TQM) in the aerospace industry and is awarded to members of NASA's contractor community that have demonstrated sustained excellence, customer orientation, and outstanding achievements in a Total Quality Management (TQM) environment. The purpose in presenting this award is to increase public awareness of the importance of quality and productivity to the nation's aerospace industry and the nation's leadership position overall; encourage domestic business to continuously pursue efforts that enhance quality and increase productivity which will strengthen the nation's competitiveness in the international arena; and provide a forum for sharing the successful techniques and strategies used by applicants with other American organizations. Awards to Rockwell International and Marotta Scientific Controls, Inc. are announced and discussed.

  19. Thermoelastic Damping in FGM Nano-Electromechanical System in Axial Vibration Based on Eringen Nonlocal Theory

    NASA Astrophysics Data System (ADS)

    Rahimi, Z.; Rashahmadi, S.

    2017-11-01

    The thermo-elastic damping is a dominant source of internal damping in micro-electromechanical systems (MEMS) and nano-electromechanical systems (NEMS). The internal damping cannot neither be controlled nor minimized unless either mechanical or geometrical properties are changed. Therefore, a novel FGMNEM system with a controllable thermo-elastic damping of axial vibration based on Eringen nonlocal theory is considered. The effects of different parameter like the gradient index, nonlocal parameter, length of nanobeam and ambient temperature on the thermo-elastic damping quality factor are presented. It is shown that the thermo-elastic damping can be controlled by changing different parameter.

  20. Validation of a method for the determination of zolpidem in human plasma using LC with fluorescence detection.

    PubMed

    Ring, P R; Bostick, J M

    2000-04-01

    A sensitive and selective high-performance liquid chromatography (HPLC) method was developed for the determination of zolpidem in human plasma. Zolpidem and the internal standard (trazodone) were extracted from human plasma that had been made basic. The basic sample was loaded onto a conditioned Bond Elut C18 cartridge, rinsed with water and eluted with methanol. Forty microliters were then injected onto the LC system. Separation was achieved on a C18 column (150 x 4.6 mm, 5 microm) with a mobile phase composed of acetonitrile:50 mM potassium phosphate monobasic at pH 6.0 (4:6, v/v). Detection was by fluorescence, with excitation at 254 nm and emission at 400 nm. The retention times of zolpidem and internal standard were approximately 4.7 and 5.3 min, respectively. The LC run time was 8 min. The assay was linear in concentration range 1-400 ng/ml for zolpidem in human plasma. The analysis of quality control samples for zolpidem (3, 30, and 300 ng/ml) demonstrated excellent precision with relative standard deviations (RSD) of 3.7, 4.6, and 3.0%, respectively (n = 18). The method was accurate with all intraday (n = 6) and overall (n = 18) mean concentrations within 5.8% from nominal at all quality control sample concentrations. This method was also performed using a Gilson Aspec XL automated sample processor and autoinjector. The samples were manually fortified with internal standard and made basic. The aspec then performed the solid phase extraction and made injections of the samples onto the LC system. Using the automated procedure for analysis, quality control samples for zolpidem (3, 30, and 300 ng/ml) demonstrated acceptable precision with RSD values of 9.0, 4.9, and 5.1%, respectively (n = 12). The method was accurate with all intracurve (n = 4) and overall (n = 12) mean values being less than 10.8% from nominal at all quality control sample concentrations.

  1. International Organization for Standardization (ISO) 15189

    PubMed Central

    Schneider, Frank; Friedberg, Richard C.

    2017-01-01

    The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189. PMID:28643484

  2. An Improved Power Quality BIBRED Converter-Based VSI-Fed BLDC Motor Drive

    NASA Astrophysics Data System (ADS)

    Singh, Bhim; Bist, Vashist

    2014-01-01

    This paper presents an IHQRR (integrated high-quality rectifier regulator) BIBRED (boost integrated buck rectifier energy storage DC-DC) converter-based VSI (voltage source inverter)-fed BLDC (brushless DC) motor drive. The speed control of BLDC motor is achieved by controlling the DC link voltage of the VSI using a single voltage sensor. This allows VSI to operate in fundamental frequency switching mode for electronic commutation of BLDC motor which reduces the switching losses due to high-frequency switching used in conventional approach of PWM (pulse width modulation)-based VSI-fed BLDC motor drive. A BIBRED converter is operated in a dual-DCM (discontinuous conduction mode) thus using a voltage follower approach for PFC (power factor correction) and DC link voltage control. The performance of the proposed drive is evaluated for improved power quality over a wide range of speed control and supply voltage variation for demonstrating the behavior of proposed drive. The power quality indices thus obtained are within the recommended limits by international PQ (power quality) standards such as IEC 61000-3-2.

  3. Quality of Life, Sleep, and Health of Air Traffic Controllers With Rapid Counterclockwise Shift Rotation.

    PubMed

    Sonati, Jaqueline Girnos; De Martino, Milva Maria Figueiredo; Vilarta, Roberto; da Silva Maciel, Érika; Sonati, Renato José Ferreira; Paduan, Paulo Cézar

    2016-08-01

    Rotating shiftwork is common for air traffic controllers and usually causes sleep deprivation, biological adaptations, and life changes for these workers. This study assessed quality of life, the sleep, and the health of 30 air traffic controllers employed at an international airport in Brazil. The objective was to identify health and quality of life concerns of these professionals. The results identified physical inactivity, overweight, excess body fat, low scores for physical and social relationships, and sleep deprivation for workers in all four workshifts. In conclusion, these workers are at risk for chronic non-transmittable diseases and compromised work performance, suggesting the need for more rest time before working nightshifts and work environments that stimulate physical activity and healthy diets. © 2016 The Author(s).

  4. Evaluation of the quality of sandalwood essential oils by gas chromatography-mass spectrometry.

    PubMed

    Howes, Melanie-Jayne R; Simmonds, Monique S J; Kite, Geoffrey C

    2004-03-05

    Trade and historic oils from 'sandalwoods', labelled as Amyris balsamifera, Eremophila mitchelli, Fusanus acuminatus (= Santalum acuminatum), Santalum album, S. austrocaledonicum, S. latifolium, S. spicatum and S. yasi, were assessed using gas chromatography-mass spectrometry (GC-MS). Using GC-MS, none of the oils assessed complied with the internationally recognised standard of a 90% santalol content, and only about half of the trade sandalwood oils met with recent International Organisation for Standardisation standards. The majority of trade oils, reportedly from S. album, contained approximately 50-70% santalols (Z-alpha and Z-beta). Thus, the internationally recognised specification (90% santalols) for S. album requires re-evaluation by more efficient analysis methods. In view of the issues associated with the quality of sandalwood oils being traded, specifications of > or = 43% Z-alpha-santalol and > or = 18% Z-beta-santalol for S. album oil estimated by GC-MS are suggested. GC-MS are recommended as it assists with authentication and quality control issues associated with sandalwood oils.

  5. Use of Six Sigma Worksheets for assessment of internal and external failure costs associated with candidate quality control rules for an ADVIA 120 hematology analyzer.

    PubMed

    Cian, Francesco; Villiers, Elisabeth; Archer, Joy; Pitorri, Francesca; Freeman, Kathleen

    2014-06-01

    Quality control (QC) validation is an essential tool in total quality management of a veterinary clinical pathology laboratory. Cost-analysis can be a valuable technique to help identify an appropriate QC procedure for the laboratory, although this has never been reported in veterinary medicine. The aim of this study was to determine the applicability of the Six Sigma Quality Cost Worksheets in the evaluation of possible candidate QC rules identified by QC validation. Three months of internal QC records were analyzed. EZ Rules 3 software was used to evaluate candidate QC procedures, and the costs associated with the application of different QC rules were calculated using the Six Sigma Quality Cost Worksheets. The costs associated with the current and the candidate QC rules were compared, and the amount of cost savings was calculated. There was a significant saving when the candidate 1-2.5s, n = 3 rule was applied instead of the currently utilized 1-2s, n = 3 rule. The savings were 75% per year (£ 8232.5) based on re-evaluating all of the patient samples in addition to the controls, and 72% per year (£ 822.4) based on re-analyzing only the control materials. The savings were also shown to change accordingly with the number of samples analyzed and with the number of daily QC procedures performed. These calculations demonstrated the importance of the selection of an appropriate QC procedure, and the usefulness of the Six Sigma Costs Worksheet in determining the most cost-effective rule(s) when several candidate rules are identified by QC validation. © 2014 American Society for Veterinary Clinical Pathology and European Society for Veterinary Clinical Pathology.

  6. Selected Aspects Of The Risk In The Supply Chain In Context Of The Supplier Quality Management

    NASA Astrophysics Data System (ADS)

    Koblen, Ivan; Lestyánszka Škůrková, Katarína

    2015-06-01

    The introductory part of the paper underlines the importance of "Risk-based thinking" in the Quality Management System (QMS) and risk in the supply chain, as a principle part of the QMS. After introducing the key terms, the authors focused on the principle part of the article - explanation of the external and internal supply chain risks and the main factors concerning the supply risks, demand risks and environmental risks (as cardinal types of external supply chain risks) as well as the manufacturing and process risks, network/planning and control risks (as most important types of internal supply chain risks). The authors inform on the selected supply chain risk management tools, especially on those which are linked to the appropriate utilization of quality management tools.

  7. Managing quality of teaching and learning in the ophthalmic nursing course.

    PubMed

    Law, M L

    2000-02-01

    With auditing of teaching and learning in earnest by the Quality Assurance Agency for the Higher Education Funding Council, the nature of quality in education is top on the agenda for educational stakeholders. However, the nature of quality is difficult to define and measure. This is because quality is essentially a subjective perception and can mean different things to different individuals. Therefore, attempt to quantify and measure quality is difficult and problematic but is necessary for personal, professional, bureaucratic, political and stakeholder demands for accountability, and demonstration of efficiency, effectiveness and value for money. Using a total quality management framework, the internal controls of quality in the ophthalmic nursing course and at the faculty level are considered. The wider contexts of quality control from the institutional, political and at the customer's levels are explored. This paper concludes that the various methods used to control and measure quality may provide useful information for service clarity and a basis for service development. However, such information needs to be treated with caution and interpreted in the context and environment in which this information is generated. Ultimately, the issues of quality in teaching and learning may be addressed by the teacher's commitment to be developed as a reflective practitioner.

  8. Determinants and impact of suboptimal asthma control in Europe: The INTERNATIONAL CROSS-SECTIONAL AND LONGITUDINAL ASSESSMENT ON ASTHMA CONTROL (LIAISON) study.

    PubMed

    Braido, Fulvio; Brusselle, Guy; Guastalla, Daniele; Ingrassia, Eleonora; Nicolini, Gabriele; Price, David; Roche, Nicolas; Soriano, Joan B; Worth, Heinrich

    2016-05-14

    According to the Global Initiative of Asthma, the aim of asthma treatment is to gain and maintain control. In the INTERNATIONAL CROSS-SECTIONAL AND LONGITUDINAL ASSESSMENT ON ASTHMA CONTROL (LIAISON) study, we evaluated the level of asthma control and quality of life (QoL), as well as their determinants and impact in a population consulting specialist settings. LIAISON is a prospective, multicentre, observational study with a cross-sectional and a 12-month longitudinal phase. Adults with an asthma diagnosis since at least 6 months, receiving the same asthma treatment in the 4 weeks before enrolment were included. Asthma control was assessed with the 6-item Asthma Control Questionnaire (ACQ) and QoL with the MiniAsthma Quality of Life Questionnaire (MiniAQLQ). Overall, 8111 asthmatic patients were enrolled in 12 European countries. Asthma control was suboptimal in 56.5 % of patients and it was associated with poorer asthma-related QoL, higher risk of exacerbations and greater consumption of healthcare resources. Variables associated with suboptimal control were age, gender, obesity, smoking and comorbidities. Major determinants of poor asthma control were seasonal worsening and persisting exposure to allergens/irritants/triggers, followed by treatment-related issues. The cross-sectional phase results confirm that suboptimal control is frequent and has a high individual and economic impact. The clinicaltrials.gov identifier is NCT01567280 .

  9. The "Diagnostic Guideline for Anxiety and Challenging Behaviour" for Persons with Intellectual Disabilities: Preliminary Outcomes on Internalizing Problems, Challenging Behaviours, Quality of Life and Clients' Satisfaction

    ERIC Educational Resources Information Center

    Pruijssers, Addy; Meijel, Berno; Maaskant, Marian; Teerenstra, Steven; van Achterberg, Theo

    2017-01-01

    Background: People with intellectual disabilities are vulnerable to develop psychopathology (in particular anxiety) and related challenging behaviour. Method: A comparative multiple case study with an experimental and a control condition. Results: The application of the guideline showed a trend of decreases of internalizing problems (P = 0.07) and…

  10. Evaluation program for secondary spacecraft cells: Initial evaluation tests of General Electric Company 6.0 ampere-hour nickel-cadmium spacecraft cells for the Improved Tiros Operational Satellite (ITOS)

    NASA Technical Reports Server (NTRS)

    Harkness, J. D.

    1975-01-01

    Quality control measures for Ni-Cd spacecraft cells were analyzed. Cells were examined for electrolyte leakage, internal shorts, low capacity, or inability of any cell to recover its open circuit voltage above 1.50 volts during the internal short test. Test results are given in tabular form.

  11. Quality DOTS management and empowering tuberculosis patients.

    PubMed

    Chugh, Satish

    2009-03-01

    Central Tuberculosis Division (CTD) has covered whole of India under DOTS. IMA is a proud partner of RNTCP which is managed by CTD. International Standards for Tuberculosis Care is expected from all healthcare providers. The basic principles of care is same worldwide. IMA GFATM RNTCP PPM is completing 2 years of its inception. Sensitisation programme and district training programmes has yielded DOTS/DMC centres in the target states. IMA is having 100% commitment for containing tuberculosis in India. There are International Standards for quality management in tuberculosis control, some of the Standards are elaborated in this write-up. In the Indian context, DOTS needs some innovations that is discussed in this article.

  12. Internationalization of traditional Chinese medicine: current international market, internationalization challenges and prospective suggestions.

    PubMed

    Lin, Annie Xianghong; Chan, Ging; Hu, Yuanjia; Ouyang, Defang; Ung, Carolina Oi Lam; Shi, Luwen; Hu, Hao

    2018-01-01

    Through reviewing the current international market for traditional Chinese medicine (TCM), this paper identified the internationalization challenges for TCM, including unclear therapeutic material basis and mechanism, difficulty of quality control, low preparation level, registration/policy barriers, and shortage of intellectual property. To deal with these challenges, suggestions were given including: (1) product innovation of TCM (study the TCM by using the methods and means of western medicine; innovate the basic theory of TCM; develop TCM health product); (2) standard innovation of TCM; (3) building big data platform of Chinese medicine (big data platform of TCM preparation; big data platform on the quality of TCM).

  13. Music-based interventions to reduce internalizing symptoms in children and adolescents: A meta-analysis.

    PubMed

    Geipel, Josephine; Koenig, Julian; Hillecke, Thomas K; Resch, Franz; Kaess, Michael

    2018-01-01

    Existing systematic reviews provide evidence that music therapy is an effective intervention in the treatment of children and adolescents with psychopathology. The objective of the present review was to systematically review and quantify the effects of music-based interventions in reducing internalizing symptoms (i.e., depression and anxiety) in children and adolescents using a meta-analytical approach. Databases and journals were systematically screened for studies eligible for inclusion in meta-analysis on the effects of music-based interventions in reducing internalizing symptoms. A random-effect meta-analysis using standardized mean differences (SMD) was conducted. Five studies were included. Analysis of data from (randomized) controlled trials, yielded a significant main effect (Hedge's g = -0.73; 95%CI [-1.42;-0.04], Z = 2.08, p = 0.04, k = 5), indicating a greater reduction of internalizing symptoms in youth receiving music-based interventions (n = 100) compared to different control group interventions (n = 95). The existing evidence is limited to studies of low power and methodological quality. Included studies were highly heterogeneous with respect to the nature of the intervention, the measurements applied, the samples studied, and the study design. Findings indicate that music-based interventions may be efficient in reducing the severity of internalizing symptoms in children and adolescents. While these results are encouraging with respect to the application of music-based intervention, rigorous research is necessary to replicate existing findings and provide a broader base of evidence. More research adopting well controlled study designs of high methodological quality is needed. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. Recommendations for accreditation of laboratories in molecular biology of hematologic malignancies.

    PubMed

    Flandrin-Gresta, Pascale; Cornillet, Pascale; Hayette, Sandrine; Gachard, Nathalie; Tondeur, Sylvie; Mauté, Carole; Cayuela, Jean-Michel

    2015-01-01

    Over recent years, the development of molecular biology techniques has improved the hematological diseases diagnostic and follow-up. Consequently, these techniques are largely used in the biological screening of these diseases; therefore the Hemato-oncology molecular diagnostics laboratories must be actively involved in the accreditation process according the ISO 15189 standard. The French group of molecular biologists (GBMHM) provides requirements for the implementation of quality assurance for the medical molecular laboratories. This guideline states the recommendations for the pre-analytical, analytical (methods validation procedures, quality controls, reagents), and post-analytical conditions. In addition, herein we state a strategy for the internal quality control management. These recommendations will be regularly updated.

  15. 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.

  16. An Improved Power Quality Based Sheppard-Taylor Converter Fed BLDC Motor Drive

    NASA Astrophysics Data System (ADS)

    Singh, Bhim; Bist, Vashist

    2015-12-01

    This paper deals with the design and analysis of a power factor correction based Sheppard-Taylor converter fed brushless dc motor (BLDCM) drive. The speed of the BLDCM is controlled by adjusting the dc link voltage of the voltage source inverter (VSI) feeding BLDCM. Moreover, a low frequency switching of the VSI is used for electronically commutating the BLDCM for reduced switching losses. The Sheppard-Taylor converter is designed to operate in continuous conduction mode to achieve an improved power quality at the ac mains for a wide range of speed control and supply voltage variation. The BLDCM drive is designed and its performance is simulated in a MATLAB/Simulink environment to achieve the power quality indices within the limits of the international power quality standard IEC-61000-3-2.

  17. Introduction to ISO 15189: a blueprint for quality systems in veterinary laboratories.

    PubMed

    Freeman, Kathleen P; Bauer, Natali; Jensen, Asger L; Thoresen, Stein

    2006-06-01

    A trend in human and veterinary medical laboratory management is to achieve accreditation based on international standards. The International Organization for Standardization (ISO) 15189 standard is the first developed especially for accreditation of medical laboratories, and emphasizes the laboratory-client interface. European veterinary laboratories seeking to train candidates for the certification examination of the European College of Veterinary Clinical Pathology (ECVCP) require approval by the ECVCP Laboratory Standards Committee, which bases its evaluation in part on adherence to quality systems described in the ISO 15189 standards. The purpose of this article was to introduce the latest ISO quality standard and describe its application to veterinary laboratories in Europe, specifically as pertains to accreditation of laboratories involved in training veterinary clinical pathologists. Between 2003 and 2006, the Laboratory Standards Committee reviewed 12 applications from laboratories (3 commercial and 9 university) involved in training veterinary clinical pathologists. Applicants were asked to provide a description of the facilities for training and testing, current methodology and technology, health and safety policy, quality assurance policy (including internal quality control and participation in an external quality assurance program), written standard operating procedures (SOPs) and policies, a description of the laboratory information system, and personnel and training. Also during this time period multiple informal and formal discussions among ECVCP diplomates took place as to current practices and perceived areas of concern with regard to laboratory accreditation requirements. Areas in which improvement most often was needed in veterinary laboratories applying for ECVCP accreditation were the written quality plan, defined quality requirements for the tests performed, written SOPs and policies, training records, ongoing audits and competency assessments, and processes for identifying and addressing opportunities for improvement. Recommendations were developed for a stepwise approach towards achieving ISO 15189 standards, including 3 levels of quality components. The ISO 15189 standard provides a sound framework for veterinary laboratories aspiring to meet international quality standards.

  18. Can current analytical quality performance of UK clinical laboratories support evidence-based guidelines for diabetes and ischaemic heart disease?--A pilot study and a proposal.

    PubMed

    Jassam, Nuthar; Yundt-Pacheco, John; Jansen, Rob; Thomas, Annette; Barth, Julian H

    2013-08-01

    The implementation of national and international guidelines is beginning to standardise clinical practice. However, since many guidelines have decision limits based on laboratory tests, there is an urgent need to ensure that different laboratories obtain the same analytical result on any sample. A scientifically-based quality control process will be a pre-requisite to provide this level of analytical performance which will support evidence-based guidelines and movement of patients across boundaries while maintaining standardised outcomes. We discuss the finding of a pilot study performed to assess UK clinical laboratories readiness to work to a higher grade quality specifications such as biological variation-based quality specifications. Internal quality control (IQC) data for HbA1c, glucose, creatinine, cholesterol and high density lipoprotein (HDL)-cholesterol were collected from UK laboratories participating in the Bio-Rad Unity QC programme. The median of the coefficient of variation (CV%) of the participating laboratories was evaluated against the CV% based on biological variation. Except creatinine, the other four analytes had a variable degree of compliance with the biological variation-based quality specifications. More than 75% of the laboratories met the biological variation-based quality specifications for glucose, cholesterol and HDL-cholesterol. Slightly over 50% of the laboratories met the analytical goal for HBA1c. Only one analyte (cholesterol) had a performance achieving the higher quality specifications consistent with 5σ. Our data from IQC do not consistently demonstrate that the results from clinical laboratories meet evidence-based quality specifications. Therefore, we propose that a graded scale of quality specifications may be needed at this stage.

  19. Quality of randomized controlled trials published in the International Urogynecology Journal 2007-2016.

    PubMed

    Kim, Kyu Shik; Chung, Jae Hoon; Jo, Jung Ki; Kim, Jae Heon; Kim, Seungjun; Cho, Jeoung Man; Cho, Hee Ju; Choi, Hong Yong; Lee, Seung Wook

    2018-07-01

    Randomized controlled trials (RCTs) provide the best quality clinical evidence. The aim of this study was to assess the quality of RCTs published by the International Urogynecology Journal (IUJ) in 2007-2016. RCTs in original articles were extracted from PubMed and IUJ homepage. Change in RCT quality over time was assessed with Jadad and van Tulder scales and Cochrane Collaboration's risk of bias tool (CCRBT). Jadad scores of 3-5 or van Tulder scores of >5 indicated high-quality RCTs. The effect on RCT quality of including funding source and institutional review board (IRB) approval statements and describing the intervention was assessed. In addition, changes in RCT topics over time were assessed. Annual RCT frequencies did not change significantly (6.7-15.7%): 36.1% and 25.7% described blinding and allocation concealment, respectively. Both tended to increase between 2013 and 2016, particularly 2013 and 2014. Funding statement inclusion (39.1% overall) and intervention description (78.2% overall) tended to increase steadily. IRB statement inclusion (60.4% overall) increased significantly (p < 0.01). Jadad scores and van Tulder rose significantly until 2014 (p < 0.01). Frequencies of high-quality RCTs tended to rise. CCRBT indicated that RCTs with a low risk of bias tended to increase until 2014. However, from 2015, Jadad scores, van Tulder, and CCRBT the low risk tended to decreased. RCTs with funding and IRB approval statements had higher Jadad and van Tulder scores than unfunded RCTs (p < 0.01 and p < 0.01, respectively). Intervention description did not associate with better quality. RCT quality improved over time, but a dip in quality was observed in 2015-2016 because of decreased blinding and allocation concealment.

  20. [Application of fingerprint chromatogram in quality control of Shen-Mai injection].

    PubMed

    Shi, Xian-zhe; Yang, Jun; Zhao, Chun-xia; Xiong, Jian-hui; Xu, Guo-wang

    2002-07-01

    The theory and practice of traditional Chinese medicine require some comprehensive methods to assess quality of the Chinese herbal medication. Fingerprint chromatogram is one of the feasible approaches to evaluate the quality of Chinese herbal medication. So the fingerprint chromatogram of Shen-Mai injection was established by using reversed-phase high performance liquid chromatography. The chromatographic conditions were as follows: a Hypersil C18 column was used; the mobile phase was composed of water (A) and acetontrile (B) with linear gradient elution (0-50 min, 5%-95% B, volume fraction); the flow rate was 1.0 mL/min and the UV absorbance detection was set at 202 nm. The peak-area ratios of twenty-three fingerprint peaks and internal standard (diphenyl) were taken as the criteria for quality control. The quality differences in various batches and various manufacturers of Shen-Mai injections were investigated by projection discriminance based on principal component analysis. The results show the method developed is convenient, reliable and applicable for the quality control analysis of Shen-Mai injection.

  1. Analysis of the Parameters Required for Performance Monitoring and Assessment of Military Communications Systems by Military Technical Controller

    DTIC Science & Technology

    1975-12-01

    139 APPENDIX A* BASIC CONCEPT OF MILITARY TECHNICAL CONTROL.142 6 APIENDIX Es TEST EQUIPMENI REQUIRED FOR lEASURF.4ENr OF 1AF’AMETE RS...Control ( SATEC ) Automatic Facilities heport Army Automated Quality Monitoring Reporting System (AQMPS) Army Autcmated Technical Control-Semi (ATC-Semi...technical control then beco.. es equipment status monitoring. All the major equipment in a system wculd have internal sensors with properly selected parameters

  2. Interest and limits of the six sigma methodology in medical laboratory.

    PubMed

    Scherrer, Florian; Bouilloux, Jean-Pierre; Calendini, Ors'Anton; Chamard, Didier; Cornu, François

    2017-02-01

    The mandatory accreditation of clinical laboratories in France provides an incentive to develop real tools to measure performance management methods and to optimize the management of internal quality controls. Six sigma methodology is an approach commonly applied to software quality management and discussed in numerous publications. This paper discusses the primary factors that influence the sigma index (the choice of the total allowable error, the approach used to address bias) and compares the performance of different analyzers on the basis of the sigma index. Six sigma strategy can be applied to the policy management of internal quality control in a laboratory and demonstrates through a comparison of four analyzers that there is no single superior analyzer in clinical chemistry. Similar sigma results are obtained using approaches toward bias based on the EQAS or the IQC. The main difficulty in using the six sigma methodology lies in the absence of official guidelines for the definition of the total error acceptable. Despite this drawback, our comparison study suggests that difficulties with defined analytes do not vary with the analyzer used.

  3. Ensuring the Quality of Stem Cell-Derived In Vitro Models for Toxicity Testing.

    PubMed

    Stacey, Glyn N; Coecke, Sandra; Price, Anna-Bal; Healy, Lyn; Jennings, Paul; Wilmes, Anja; Pinset, Christian; Ingelman-Sundberg, Magnus; Louisse, Jochem; Haupt, Simone; Kidd, Darren; Robitski, Andrea; Jahnke, Heinz-Georg; Lemaitre, Gilles; Myatt, Glenn

    Quality control of cell cultures used in new in vitro toxicology assays is crucial to the provision of reliable, reproducible and accurate toxicity data on new drugs or constituents of new consumer products. This chapter explores the key scientific and ethical criteria that must be addressed at the earliest stages of developing toxicology assays based on human pluripotent stem cell (hPSC) lines. It also identifies key considerations for such assays to be acceptable for regulatory, laboratory safety and commercial purposes. Also addressed is the development of hPSC-based assays for the tissue and cell types of greatest interest in drug toxicology. The chapter draws on a range of expert opinion within the European Commission/Cosmetics Europe-funded alternative testing cluster SEURAT-1 and consensus from international groups delivering this guidance such as the International Stem Cell Banking Initiative. Accordingly, the chapter summarizes the most up-date best practices in the use and quality control of human Pluripotent Stem Cell lines in the development of in vitro toxicity assays from leading experts in the field.

  4. Towards Sustainable Water Quality In Estuarine Impoundments: The Current State.

    NASA Astrophysics Data System (ADS)

    Wright, J.; Worrall, F.

    Several estuarine impoundment schemes have been built or are proposed in the UK and worldwide. The impounding of estuaries is currently a popular approach to urban regeneration in the UK. By creation of an aesthetically pleasing amenity impound- ment, including the drowning of "unsightly" tidal mud flats, it is hoped that prestige development will be encouraged in the estuarine area. Impounding fundamentally alters the dynamics of estuaries, with consequences in terms of sedimentation patterns and rates, and water quality. The SIMBA Project at- tempts to understand the controls on water quality in impoundments, with a view to- wards long term and sustainable high water quality through good barrage design and management practice. Detailed water quality surveys have been carried out on a total of 79 dates on the Tees, Tawe, Wansbeck and Blyth estuaries. Water quality parameters which have been determined are pH, Eh, dissolved oxygen (DO), biochemical oxygen demand (BOD), conductivity, transparency, suspended solids, alkalinity, temperature, nutri- ents (nitrate+nitrite, ammonium and orthophosphate), and a large range of dissolved metals. Statistical analyses are used to demonstrate the major controls on water qual- ity in impoundments. A distinction is made between total tidal exclusion (freshwater) systems, in which water quality is primarily influenced by external/catchment factors, and partial tidal exclusion systems, in which water quality is processed internally. This internal processing is due to density stratification creating compartments of saline wa- ter in contact with oxygen demanding sediments and isolated from the atmosphere, which leads to conditions of low DO and changes in redox conditions which may lead to release of metals and phosphate from the sediment.

  5. Quality assurance in forensic odontology

    PubMed

    Solheim, T

    2018-05-30

    Quality assurance or quality control is a term and concept coming from the industry. Here it is most important. All products must have a minimum quality and variation in size, for example, must be kept within certain strict limits. There must be a system to control this. May be not every single product is controlled, but spot tests must be taken. Measures must be taken to improve the quality if it is not good enough. This concept has been transferred to medicine, odontology, and consequently also to forensic odontology. These areas have in common with industry the production of that certain products. However, they are usually handmade and not produced in an industrial process. In addition, dentistry is a great deal of art and judgement and quality control of these factors may be difficult. In this paper, I will focus on forensic odontology. What are the problems? What can we do and cannot do? In addition, how can we assure the quality of the work, the assessment and conclusion, and the report? I have some personal opinions on that and I will give some suggestions. Quality assurance on an international level is difficult. Conditions and juridical systems are different in different countries. Especially forensic odontologists are different and have different opinions. This presentation will be relevant to the ongoing discussion and attempts at revising the IOFOS' guidelines for quality assurance.

  6. Development of internal amplification controls for DNA profiling with the AmpFℓSTR(®) SGM Plus(®) kit.

    PubMed

    Zahra, Nathalie; Hadi, Sibte; Smith, Judith A; Iyengar, Arati; Goodwin, William

    2011-06-01

    DNA extracted from forensic samples can be degraded and also contain co-extracted contaminants that inhibit PCR. The effects of DNA degradation and PCR inhibition are often indistinguishable when examining a DNA profile. Two internal amplification controls (IACs) were developed to improve quality control of PCR using the AmpFℓSTR® SGM Plus® kit. The co-amplification of these controls with DNA samples was used to monitor amplification efficiency and detect PCR inhibitors. IAC fragments of 90 and 410 bp (IAC₉₀ and IAC₄₁₀) were generated from the plasmid pBR322 using tailed primers and then amplified with ROX-labelled primers. Co-amplification of IAC₉₀ and IAC₄₁₀ was performed with varying amounts of template DNA, degraded DNA and DNA contaminated with humic acid, heme and indigo dye. Both IAC₉₀ and IAC₄₁₀ were successfully amplified with human DNA without significantly affecting the quality of the DNA profile, even with DNA amounts lower than 0.5 ng. In the presence of inhibitors, the IAC₉₀ signal was still present after all human DNA loci fail to amplify; in contrast, the IAC₄₁₀ signal was reduced or absent at low levels of inhibition. Amplification of the two IACs provided an internal PCR control and allowed partial profiles caused by inhibition to be distinguished from degraded DNA profiles. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  7. Environmental Law and the Export of Pollution.

    ERIC Educational Resources Information Center

    Davis, John F.

    1984-01-01

    Environmental problems do not stop at state boundaries; they reach beyond local or national jurisdictions and require international control. Problems concerning air quality, water pollution, and indirect pollution are discussed. Environmental legislation can have a significant impact. (RM)

  8. Methodological quality of the injury surveillance system used in international athletics championships.

    PubMed

    Edouard, Pascal; Branco, Pedro; Alonso, Juan Manuel; Junge, Astrid

    2016-12-01

    Incidence and prevalence data obtained from injury surveillance studies could be biased by the response rate as well as by the completeness and quality of the reports. It therefore appears crucial to analyse the quality of the injury surveillance system itself and thereby validate the quality of the data. This study aimed to analyse the quality of and compliance with the injury surveillance system implemented during international athletics championships. Prospective, epidemiological study. The national medical teams and the local organising committee physicians daily reported all injuries on a standardised injury report form during 14 international athletics championships from 2007 to 2015. The quality of the injury surveillance system was analysed following the guidelines laid down by the Centre for Disease Control and Prevention. On average 41.7±17.4% (mean±standard deviation) of all registered countries participated in the injury surveillance project, accounting for a coverage of athletes of 79.5±10.2% of all registered athletes. Their medical staff returned 89.2±8.4% of the expected injury report forms (information is missing for one championship). The completeness of injury data provided by medical teams and local organising committee physicians averaged 95.8±6.5%. National medical teams reported 60.6±16.6% of all injuries, and local organising committee physicians 28.7±15.0% whereas 10.6±6.5% of injuries were reported by both. The injury surveillance system used during international athletics championships provided good national medical team participation, coverage of athletes, response rate, and completeness of reports. These parameters should be systematically reported for injury surveillance studies to show the quality of the study. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  9. Educational interventions to improve knowledge and skills of interns towards prevention and control of hospital-associated infections.

    PubMed

    Dogra, Sandeep; Mahajan, Ruchita; Jad, Beena; Mahajan, Bella

    2015-08-01

    We believe that there is significant educational deficit amongst interns regarding up-to-date formal knowledge and skills on healthcare-associated infections (HAIs) which might compromise patient safety. This urgently requires curriculum innovations to ensure their formal training on HAIs prevention and control. Education of interns to improve their knowledge and skills toward HAIs prevention and control. This pilot study was conducted in interns using a multimodal approach consisting of a combination of videos, PowerPoint presentation, and hands-on demonstration to provide applied and practical teaching on prevention and control of HAIs. Pre- and post-test assessment of knowledge, attitude, and skills was carried out by multiple choice questions, 5-point Likert scale, and Objective Structured Practical Examination respectively. Paired t-test. A statistically significant improvement in the overall score rates between pre- and post-test of intern's was seen, suggesting that educational programs have a positive effect. Intern's felt benefitted from interventions focused on HAIs prevention and control and hoped that such sessions are integrated in the regular undergraduate curriculum. A majority of the students felt that their learning style assessment matched well with their own perception of learning preference. Assessment drives learning; hence strengthening the contribution of health-care workers to HAIs prevention programs should include measures that enhance knowledge, improve skills and develop appropriate attitudes, resulting in safety and quality of patient care.

  10. Motivation as a Method of Controlling the Social Subject Self-Learning

    ERIC Educational Resources Information Center

    Isaev, Andrey V.; Kravets, Alla G.; Isaeva, Ludmila A.

    2014-01-01

    The paper substantiates inertial nature of the motivation system impact on the individual. Such exposure is a major shift from the level of motivational signs of external perception on the level of the individual internal motivation system. This approach justifies the ability to control the quality of the individual education as in the process of…

  11. Social but safe? Quality and safety of diabetes-related online social networks.

    PubMed

    Weitzman, Elissa R; Cole, Emily; Kaci, Liljana; Mandl, Kenneth D

    2011-05-01

    To foster informed decision-making about health social networking (SN) by patients and clinicians, the authors evaluated the quality/safety of SN sites' policies and practices. Multisite structured observation of diabetes-focused SN sites. Measurements 28 indicators of quality and safety covering: (1) alignment of content with diabetes science and clinical practice recommendations; (2) safety practices for auditing content, supporting transparency and moderation; (3) accessibility of privacy policies and the communication and control of privacy risks; and (4) centralized sharing of member data and member control over sharing. Quality was variable across n=10 sites: 50% were aligned with diabetes science/clinical practice recommendations with gaps in medical disclaimer use (30% have) and specification of relevant glycosylated hemoglobin levels (0% have). Safety was mixed with gaps in external review approaches (20% used audits and association links) and internal review approaches (70% use moderation). Internal safety review offers limited protection: misinformation about a diabetes 'cure' was found on four moderated sites. Of nine sites with advertising, transparency was missing on five; ads for unfounded 'cures' were present on three. Technological safety was poor with almost no use of procedures for secure data storage and transmission; only three sites support member controls over personal information. Privacy policies' poor readability impedes risk communication. Only three sites (30%) demonstrated better practice. Limitations English-language diabetes sites only. The quality/safety of diabetes SN is variable. Observed better practice suggests improvement is feasible. Mechanisms for improvement are recommended that engage key stakeholders to balance autonomy, community ownership, conditions for innovation, and consumer protection.

  12. Quantifying the effect of air quality control measures during the 2010 Commonwealth Games at Delhi, India

    NASA Astrophysics Data System (ADS)

    Beig, Gufran; Chate, Dilip M.; Ghude, Sachin. D.; Mahajan, A. S.; Srinivas, R.; Ali, K.; Sahu, S. K.; Parkhi, N.; Surendran, D.; Trimbake, H. R.

    2013-12-01

    In 2010, the XIX Commonwealth Games (CWG-2010) were held in India for the first time at Delhi and involved 71 commonwealth nations and dependencies with more than 6000 athletes participating in 272 events. This was the largest international multi-sport event to be staged in India and strict emission controls were imposed during the games in order to ensure improved air quality for the participating athletes as a significant portion of the population in Delhi is regularly exposed to elevated levels of pollution. The air quality control measures ranged from vehicular and traffic controls to relocation of factories and reduction of power plant emissions. In order to understand the effects of these policy induced control measures, a network of air quality and weather monitoring stations was set-up across different areas in Delhi under the Government of India's System of Air quality Forecasting And Research (SAFAR) project. Simultaneous measurements of aerosols, reactive trace gases (e.g. NOx, O3, CO) and meteorological parameters were made before, during and after CWG-2010. Contrary to expectations, the emission controls implemented were not sufficient to reduce the pollutants, instead in some cases, causing an increase. The measured pollutants regularly exceeded the National Ambient Air Quality limits over the games period. The reasons for this increase are attributed to an underestimation of the required control measures, which resulted in inadequate planning. The results indicate that any future air quality control measures need to be well planned and strictly imposed in order to improve the air quality in Delhi, which affects a large population and is deteriorating rapidly. Thus, the presence of systematic high resolution data and realistic emission inventories through networks such as SAFAR will be directly useful for the future.

  13. The Wellbeing of Italian Peacekeeper Military: Psychological Resources, Quality of Life and Internalizing Symptoms

    PubMed Central

    Loscalzo, Yura; Giannini, Marco; Gori, Alessio; Fabio, Annamaria Di

    2018-01-01

    Working as a peacekeeper is associated with the exposure to acute and/or catastrophic events and chronic stressors. Hence, the meager literature about peacekeepers’ wellbeing has mainly analyzed Post-Traumatic Stress Disorder (PTSD). This study aims to deep the analysis of the wellbeing of peacekeepers military. Based on the few studies on this population, we hypothesized that Italian peacekeeper military officers and enlisted men (n = 167; 103 males, 6 females, 58 missing) exhibit lower levels of internalizing symptoms (i.e., PTSD, depression, general anxiety, obsessions, and somatization) as compared to a control group (n = 60; 32 males, 28 females). Moreover, we hypothesized that peacekeepers have higher levels of psychological resources (i.e., self-efficacy, self-esteem, social support) and quality of life (i.e., higher life satisfaction and lower general stress). We compared the groups by means of MANOVAs on the subscales of the Psychological Treatment Inventory (PTI; Gori et al., 2015). We found that Italian peacekeepers have lower internalizing symptoms and higher levels of self-efficacy and self-esteem than the control group; however, no statistically significant differences were observed on perceived social support. Finally, peacekeepers have a higher quality of life: scores reflect higher life satisfaction and lower distress than the control group. This study is in line with previous literature supporting the claim that Italian peacekeeper military officers have sufficient psychological resources for coping with the stressful situations implied in peacekeeping missions. Future studies should deepen the analysis of the military’s psychological characteristics by comparing war veterans and peacekeeper military. PMID:29487552

  14. Diagnostic equipment outside the laboratory.

    PubMed Central

    Burrin, J M; Fyffe, J A

    1988-01-01

    A questionnaire was circulated to clinical biochemistry laboratories in the North West Thames region of the United Kingdom requesting information on extralaboratory equipment. Data on the types and numbers of instruments in use, their relationship with the laboratory, and quality assurance procedures were obtained. Laboratories were prepared to maintain equipment over which they had no responsibility for purchase, training of users, or use. The quality assurance of these instruments gave even greater cause for concern. Although internal quality control procedures were performed on many of the instruments, laboratories were involved in only a minority of these procedures. Quality control procedures and training of users were undertaken on site in less than 50% of blood gas analysers and bilirubin meters and in less than 25% of glucose meters. External quality assessment procedures were non-existent for all of the instruments in use with the exception of glucose stick meters in two laboratories. PMID:3192750

  15. RELATIONSHIP OF ASSESS SELF-ESTEEM AND LOCUS OF CONTROL WITH QUALITY OF LIFE DURING TREATMENT STAGES IN PATIENTS REFERRING TO DRUG ADDICTION REHABILITATION CENTERS

    PubMed Central

    Heidari, Mohammad; Ghodusi, Mansureh

    2016-01-01

    Objective: Thus, the present research was carried out aimed at determining the relationship between self-esteem and locus of control and quality of life during treatment stages in the patients referring to drug addiction rehabilitation centers of Borujen city, Iran. Methods: The current study was a sectional research of descriptive correlation type. The research sample was 150 individuals of patients referring to addiction rehabilitation centers of Borujen city. For data gathering, Rosenberg Self-esteem Scale, Rotter’s Locus of Control Scale, and SF36 Quality of Life Questionnaire were used. Following collection of questionnaires, the data were analyzed using SPSS/16 software. Results: According to the results, in the 12th day of treatment, 96 patients exhibited moderate self-esteem, 102 patients had internal locus of control, and the score of their overall quality of life was 40.43±12.71. Furthermore, Pearson’s correlation coefficient indicated that a significant and positive relationship was observed between locus of control and quality of life during different treatment stages. Conclusion: It seems that quality of life improves during addiction treatment stages due to improvement of personality traits including locus of control and self-esteem. Therefore, consultation methods as a very crucial priority in addiction rehabilitation centers shall be taken into account by the health sector authorities and managers and can play an essential role in enhancing quality of life. PMID:27698598

  16. Progressing quality control in environmental impact assessment beyond legislative compliance: An evaluation of the IEMA EIA Quality Mark certification scheme

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

    Bond, Alan, E-mail: alan.bond@uea.ac.uk; Research Unit for Environmental Sciences and Management, North-West University; Fischer, Thomas B, E-mail: fischer@liverpool.ac.uk

    The effectiveness of Environmental Impact Assessment (EIA) systems is contingent on a number of control mechanisms: procedural; judicial; evaluative; public and government agency; professional; and development aid agency. If we assume that procedural and judicial controls are guaranteed in developed EIA systems, then progressing effectiveness towards an acceptable level depends on improving the performance of other control mechanisms over time. These other control mechanisms are either absent, or are typically centrally controlled, requiring public finances; this we argue is an unpopular model in times of greater Government austerity. Here we evaluate a market-based mechanism for improving the performance of evaluativemore » and professional control mechanisms, the UK Institute of Environmental Management and Assessments' EIA Quality Mark. We do this by defining dimensions of effectiveness for the purposes of our evaluation, and by identifying international examples of the approaches taken to delivering the other control measures to validate the approach taken in the EIA Quality Mark. We then evaluate the EIA Quality Mark, when used in combination with legal procedures and an active judiciary, against the effectiveness dimensions and use time-series analysis of registrant data to examine its ability to progress practice. We conclude that the EIA Quality Mark has merit as a model for a market-based mechanism, and may prove a more financially palatable approach for delivering effective EIA in mature systems in countries that lack centralised agency oversight. It may, therefore, be of particular interest to some Member States of the European Union for ensuring forthcoming certification requirements stemming from recent amendments to the EIA Directive. - Highlights: • Quality control mechanisms in EIA are identified. • Effectiveness of EIA is conceptualised for evaluation purposes. • The UK IEMA EIA Quality Mark is introduced as a market-based mechanism. • The EIA Quality Mark is found to progress quality in many, but not all, areas.« less

  17. Collaborative study for the validation of alternative in vitro potency assays for human tetanus immunoglobulins.

    PubMed

    Gross, S; Janssen, S W J; de Vries, B; Terao, E; Daas, A; Buchheit, K-H

    2010-07-01

    An international collaborative study to validate 2 alternative in vitro methods for the potency testing of human tetanus immunoglobulin products was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM). The study, run in the framework of the Biological Standardisation Programme (BSP) under the aegis of the European Commission and the Council of Europe, involved 21 official medicines control and industry laboratories from 15 countries. Both methods, an enzyme-linked immunoassay (EIA) and a toxoid inhibition assay (TIA), showed good reproducibility, repeatability and precision. EIA and TIA discriminated between low, medium and high potency samples. Potency estimates correlated well and both values were in close agreement with those obtained by in vivo methods. Moreover, these alternative methods allowed to resolve discrepant results between laboratories that were due to product potency loss and reporting errors. The study demonstrated that EIA and TIA are suitable quality control methods for tetanus immunoglobulin, which can be standardised in a control laboratory using a quality assurance system. Consequently, the Group of Experts on Human Blood and Blood Products of the European Pharmacopoeia revised the monograph on human tetanus immunoglobulins to include both the methods as compendial alternatives to the in vivo mouse challenge assay. 2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

  18. Quality in the molecular microbiology laboratory.

    PubMed

    Wallace, Paul S; MacKay, William G

    2013-01-01

    In the clinical microbiology laboratory advances in nucleic acid detection, quantification, and sequence analysis have led to considerable improvements in the diagnosis, management, and monitoring of infectious diseases. Molecular diagnostic methods are routinely used to make clinical decisions based on when and how to treat a patient as well as monitor the effectiveness of a therapeutic regime and identify any potential drug resistant strains that may impact on the long term patient treatment program. Therefore, confidence in the reliability of the result provided by the laboratory service to the clinician is essential for patient treatment. Hence, suitable quality assurance and quality control measures are important to ensure that the laboratory methods and service meet the necessary regulatory requirements both at the national and international level. In essence, the modern clinical microbiology laboratory ensures the appropriateness of its services through a quality management system that monitors all aspects of the laboratory service pre- and post-analytical-from patient sample receipt to reporting of results, from checking and upholding staff competency within the laboratory to identifying areas for quality improvements within the service offered. For most European based clinical microbiology laboratories this means following the common International Standard Organization (ISO9001) framework and ISO15189 which sets out the quality management requirements for the medical laboratory (BS EN ISO 15189 (2003) Medical laboratories-particular requirements for quality and competence. British Standards Institute, Bristol, UK). In the United States clinical laboratories performing human diagnostic tests are regulated by the Centers for Medicare and Medicaid Services (CMS) following the requirements within the Clinical Laboratory Improvement Amendments document 1988 (CLIA-88). This chapter focuses on the key quality assurance and quality control requirements within the modern microbiology laboratory providing molecular diagnostics.

  19. Framework for establishing records control in hospitals as an ISO 9001 requirement.

    PubMed

    Al-Qatawneh, Lina

    2017-02-13

    Purpose The purpose of this paper is to present the process followed to control records in a Jordanian private community hospital as an ISO 9001:2008 standard requirement. Design/methodology/approach Under the hospital quality council's supervision, the quality management and development office staff were responsible for designing, planning and implementing the quality management system (QMS) using the ISO 9001:2008 standard. A policy for records control was established. An action plan for establishing the records control was developed and implemented. On completion, a coding system for records was specified to be used by hospital staff. Finally, an internal audit was performed to verify conformity to the ISO 9001:2008 standard requirements. Findings Successful certification by a neutral body ascertained that the hospital's QMS conformed to the ISO 9001:2008 requirements. A framework was developed that describes the records controlling process, which can be used by staff in any healthcare organization wanting to achieve ISO 9001:2008 accreditation. Originality/value Given the increased interest among healthcare organizations to achieve the ISO 9001 certification, the proposed framework for establishing records control is developed and is expected to be a valuable management tool to improve and sustain healthcare quality.

  20. Role of the international organisation for animal health (Office International des Epizooties: OIE) in the control of foot and mouth disease.

    PubMed

    Vallat, B

    2002-10-01

    The author describes activities conducted by the International Organisation for Animal Health (OIE: Office International des Epizooties) to control foot and mouth disease (FMD) world-wide. These activities fall within the framework of the principal missions of the OIE. The first of these missions is the collection and dissemination of epidemiological information and of scientific knowledge on animal diseases, the socio-economic or disease implications of which can be particularly serious. The implementation of the measures required to control the disease and to protect countries threatened by FMD depends on the quality and rapidity of the transmission of this information. The co-ordination of studies, research and control programmes against FMD is equally important for the OIE. This work is based, in particular, on work conducted by the OlE foot and mouth disease and other epizootics Commission. OIE Member Countries not only have access to the most recent data on the diagnosis, surveillance and control of FMD but also have recourse to the official recognition procedure for disease-free status provided by this Commission. Finally, through the standardisation of health recommendations, diagnostic tests, manufacture protocols and the control of biological products, made available by the OIE International Animal Health Code Commission in regard to the former and by the OIE Standards Commission in regard to the latter, the OIE provides the reference for international trade in animals and animal products, and is recognised in this role by the World Trade Organization.

  1. National survey on internal quality control for tumour markers in clinical laboratories in China.

    PubMed

    Wang, Wei; Zhong, Kun; Yuan, Shuai; He, Falin; Du, Yuxuan; Hu, Zhehui; Wang, Zhiguo

    2018-06-15

    This survey was initiated to obtain knowledge on the current situation of internal quality control (IQC) practice for tumour markers (TMs) in China. Additionally, we tried to acquire the most appropriate quality specifications. This survey was a current status survey. The IQC information had been collected via online questionnaires. All of 1821 clinical laboratories which participated in the 2016 TMs external quality assessment (EQA) programme had been enrolled. The imprecision evaluation criteria were the minimal, desirable, and optimal allowable imprecisions based on biological variations, and 1/3 total allowable error (TEa) and 1/4 TEa. A total of 1628 laboratories answered the questionnaires (89%). The coefficients of variation (CVs) of the IQC of participant laboratories varied greatly from 1% (5 th percentile) to 13% (95 th percentile). More than 82% (82 - 91%) of participant laboratories two types of CVs met 1/3 TEa except for CA 19-9. The percentiles of current CVs were smaller than cumulative CVs. A number of 1240 laboratories (76%) reported their principles and systems used. The electrochemiluminescence was the most used principle (45%) and had the smallest CVs. The performance of laboratories for TMs IQC has yet to be improved. On the basis of the obtained results, 1/3 TEa would be realistic and attainable quality specification for TMs IQC for clinical laboratories in China.

  2. Preanalytical errors in medical laboratories: a review of the available methodologies of data collection and analysis.

    PubMed

    West, Jamie; Atherton, Jennifer; Costelloe, Seán J; Pourmahram, Ghazaleh; Stretton, Adam; Cornes, Michael

    2017-01-01

    Preanalytical errors have previously been shown to contribute a significant proportion of errors in laboratory processes and contribute to a number of patient safety risks. Accreditation against ISO 15189:2012 requires that laboratory Quality Management Systems consider the impact of preanalytical processes in areas such as the identification and control of non-conformances, continual improvement, internal audit and quality indicators. Previous studies have shown that there is a wide variation in the definition, repertoire and collection methods for preanalytical quality indicators. The International Federation of Clinical Chemistry Working Group on Laboratory Errors and Patient Safety has defined a number of quality indicators for the preanalytical stage, and the adoption of harmonized definitions will support interlaboratory comparisons and continual improvement. There are a variety of data collection methods, including audit, manual recording processes, incident reporting mechanisms and laboratory information systems. Quality management processes such as benchmarking, statistical process control, Pareto analysis and failure mode and effect analysis can be used to review data and should be incorporated into clinical governance mechanisms. In this paper, The Association for Clinical Biochemistry and Laboratory Medicine PreAnalytical Specialist Interest Group review the various data collection methods available. Our recommendation is the use of the laboratory information management systems as a recording mechanism for preanalytical errors as this provides the easiest and most standardized mechanism of data capture.

  3. Modern science for better quality control of medicinal products "Towards global harmonization of 3Rs in biologicals": The report of an EPAA workshop.

    PubMed

    Schutte, Katrin; Szczepanska, Anna; Halder, Marlies; Cussler, Klaus; Sauer, Ursula G; Stirling, Catrina; Uhlrich, Sylvie; Wilk-Zasadna, Iwona; John, David; Bopst, Martin; Garbe, Joerg; Glansbeek, Harrie L; Levis, Robin; Serreyn, Pieter-Jan; Smith, Dean; Stickings, Paul

    2017-07-01

    This article summarizes the outcome of an international workshop organized by the European Partnership for Alternative Approaches to Animal Testing (EPAA) on Modern science for better quality control of medicinal products: Towards global harmonization of 3Rs in biologicals. As regards the safety testing of biologicals, the workshop participants agreed to actively encourage the deletion of abnormal toxicity tests and target animal batch safety tests from all relevant legal requirements and guidance documents (country-specific guidelines, pharmacopoeia monographs, WHO recommendations). To facilitate the global regulatory acceptance of non-animal methods for the potency testing of, e.g., human diphtheria and tetanus vaccines and veterinary swine erysipelas vaccines, international convergence on the scientific principles of the use of appropriately validated in vitro assays for replacing in vivo methods was identified as an overarching goal. The establishment of scientific requirements for new assays was recognized as a further means to unify regulatory approaches in different jurisdictions. It was recommended to include key regulators and manufacturers early in the corresponding discussions. Manufacturers and responsible expert groups, e.g. at the European Directorate for the Quality of Medicines and Health Care of the Council of Europe or the European Medicines Agency, were invited to consider leadership for international collaboration. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  4. Power-Quality Improvement in PFC Bridgeless SEPIC-Fed BLDC Motor Drive

    NASA Astrophysics Data System (ADS)

    Singh, Bhim; Bist, Vashist

    2013-06-01

    This article presents a design of a power factor correction (PFC)-based brushless DC (BLDC) motor drive. The speed control of BLDC motor is achieved by controlling the DC link voltage of the voltage source inverter (VSI) feeding BLDC motor using a single voltage sensor. A front-end bridgeless single-ended primary inductance converter (SEPIC) is used for DC link voltage control and PFC operation. A bridgeless SEPIC is designed to operate in discontinuous inductor current mode (DICM) thus utilizing a simple control scheme of voltage follower. An electronic commutation of BLDC motor is used for VSI to operate in a low-frequency operation for reduced switching losses in the VSI. Moreover, a bridgeless topology offers less conduction losses due to absence of diode bridge rectifier for further increasing the efficiency. The proposed BLDC motor drive is designed to operate over a wide range of speed control with an improved power-quality at the AC mains under the recommended international power-quality standards such as IEC 61000-3-2.

  5. Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal

    PubMed Central

    Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M. Juliana; Hural, John

    2014-01-01

    The HIV Vaccine Trials Network (HVTN) is a global network of 28 clinical trial sites dedicated to identifying an effective HIV vaccine. Cryopreservation of high-quality peripheral blood mononuclear cells (PBMC) is critical for the assessment of vaccine-induced cellular immune functions. The HVTN PBMC Quality Management Program is designed to ensure viable PBMC are processed, stored and shipped for clinical trial assays from all HVTN clinical trial sites. The program has evolved by developing and incorporating best practices for laboratory and specimen quality and implementing automated, web-based tools. These tools allow the site-affiliated processing laboratories and the central Laboratory Operations Unit to rapidly collect, analyze and report PBMC quality data. The HVTN PBMC Quality Management Program includes five key components: 1) Laboratory Assessment, 2) PBMC Training and Certification, 3) Internal Quality Control, 4) External Quality Control (EQC), and 5) Assay Specimen Quality Control. Fresh PBMC processing data is uploaded from each clinical site processing laboratory to a central HVTN Statistical and Data Management Center database for access and analysis on a web portal. Samples are thawed at a central laboratory for assay or specimen quality control and sample quality data is uploaded directly to the database by the central laboratory. Four year cumulative data covering 23,477 blood draws reveals an average fresh PBMC yield of 1.45×106 ±0.48 cells per milliliter of useable whole blood. 95% of samples were within the acceptable range for fresh cell yield of 0.8–3.2×106 cells/ml of usable blood. Prior to full implementation of the HVTN PBMC Quality Management Program, the 2007 EQC evaluations from 10 international sites showed a mean day 2 thawed viability of 83.1% and recovery of 67.5%. Since then, four year cumulative data covering 3338 specimens used in immunologic assays shows that 99.88% had acceptable viabilities (>66%) for use in cellular assays (mean, 91.46% ±4.5%), and 96.2% had acceptable recoveries (50%–130%) with a mean of recovery of 85.8% ±19.12% of the originally cryopreserved cells. EQC testing revealed that since August 2009, failed recoveries dropped from 4.1% to 1.6% and failed viabilities dropped from 1.0% to 0.3%. The HVTN PBMC quality program provides for laboratory assessment, training and tools for identifying problems, implementing corrective action and monitoring for improvements. These data support the benefits of implementing a comprehensive, web-based PBMC quality program for large clinical trials networks. PMID:24709391

  6. Recommendations of the DNA Commission of the International Society for Forensic Genetics (ISFG) on quality control of autosomal Short Tandem Repeat allele frequency databasing (STRidER).

    PubMed

    Bodner, Martin; Bastisch, Ingo; Butler, John M; Fimmers, Rolf; Gill, Peter; Gusmão, Leonor; Morling, Niels; Phillips, Christopher; Prinz, Mechthild; Schneider, Peter M; Parson, Walther

    2016-09-01

    The statistical evaluation of autosomal Short Tandem Repeat (STR) genotypes is based on allele frequencies. These are empirically determined from sets of randomly selected human samples, compiled into STR databases that have been established in the course of population genetic studies. There is currently no agreed procedure of performing quality control of STR allele frequency databases, and the reliability and accuracy of the data are largely based on the responsibility of the individual contributing research groups. It has been demonstrated with databases of haploid markers (EMPOP for mitochondrial mtDNA, and YHRD for Y-chromosomal loci) that centralized quality control and data curation is essential to minimize error. The concepts employed for quality control involve software-aided likelihood-of-genotype, phylogenetic, and population genetic checks that allow the researchers to compare novel data to established datasets and, thus, maintain the high quality required in forensic genetics. Here, we present STRidER (http://strider.online), a publicly available, centrally curated online allele frequency database and quality control platform for autosomal STRs. STRidER expands on the previously established ENFSI DNA WG STRbASE and applies standard concepts established for haploid and autosomal markers as well as novel tools to reduce error and increase the quality of autosomal STR data. The platform constitutes a significant improvement and innovation for the scientific community, offering autosomal STR data quality control and reliable STR genotype estimates. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  7. International Organization for Standardization (ISO) 15189.

    PubMed

    Schneider, Frank; Maurer, Caroline; Friedberg, Richard C

    2017-09-01

    The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189. © The Korean Society for Laboratory Medicine.

  8. Quality assurance of the international computerised 24 h dietary recall method (EPIC-Soft).

    PubMed

    Crispim, Sandra P; Nicolas, Genevieve; Casagrande, Corinne; Knaze, Viktoria; Illner, Anne-Kathrin; Huybrechts, Inge; Slimani, Nadia

    2014-02-01

    The interview-administered 24 h dietary recall (24-HDR) EPIC-Soft® has a series of controls to guarantee the quality of dietary data across countries. These comprise all steps that are part of fieldwork preparation, data collection and data management; however, a complete characterisation of these quality controls is still lacking. The present paper describes in detail the quality controls applied in EPIC-Soft, which are, to a large extent, built on the basis of the EPIC-Soft error model and are present in three phases: (1) before, (2) during and (3) after the 24-HDR interviews. Quality controls for consistency and harmonisation are implemented before the interviews while preparing the seventy databases constituting an EPIC-Soft version (e.g. pre-defined and coded foods and recipes). During the interviews, EPIC-Soft uses a cognitive approach by helping the respondent to recall the dietary intake information in a stepwise manner and includes controls for consistency (e.g. probing questions) as well as for completeness of the collected data (e.g. system calculation for some unknown amounts). After the interviews, a series of controls can be applied by dietitians and data managers to further guarantee data quality. For example, the interview-specific 'note files' that were created to track any problems or missing information during the interviews can be checked to clarify the information initially provided. Overall, the quality controls employed in the EPIC-Soft methodology are not always perceivable, but prove to be of assistance for its overall standardisation and possibly for the accuracy of the collected data.

  9. Internal quality control: best practice.

    PubMed

    Kinns, Helen; Pitkin, Sarah; Housley, David; Freedman, Danielle B

    2013-12-01

    There is a wide variation in laboratory practice with regard to implementation and review of internal quality control (IQC). A poor approach can lead to a spectrum of scenarios from validation of incorrect patient results to over investigation of falsely rejected analytical runs. This article will provide a practical approach for the routine clinical biochemistry laboratory to introduce an efficient quality control system that will optimise error detection and reduce the rate of false rejection. Each stage of the IQC system is considered, from selection of IQC material to selection of IQC rules, and finally the appropriate action to follow when a rejection signal has been obtained. The main objective of IQC is to ensure day-to-day consistency of an analytical process and thus help to determine whether patient results are reliable enough to be released. The required quality and assay performance varies between analytes as does the definition of a clinically significant error. Unfortunately many laboratories currently decide what is clinically significant at the troubleshooting stage. Assay-specific IQC systems will reduce the number of inappropriate sample-run rejections compared with the blanket use of one IQC rule. In practice, only three or four different IQC rules are required for the whole of the routine biochemistry repertoire as assays are assigned into groups based on performance. The tools to categorise performance and assign IQC rules based on that performance are presented. Although significant investment of time and education is required prior to implementation, laboratories have shown that such systems achieve considerable reductions in cost and labour.

  10. Advances in edible coatings for fresh fruits and vegetables: a review.

    PubMed

    Dhall, R K

    2013-01-01

    Edible coatings are an environmentally friendly technology that is applied on many products to control moisture transfer, gas exchange or oxidation processes. Edible coatings can provide an additional protective coating to produce and can also give the same effect as modified atmosphere storage in modifying internal gas composition. One major advantage of using edible films and coatings is that several active ingredients can be incorporated into the polymer matrix and consumed with the food, thus enhancing safety or even nutritional and sensory attributes. But, in some cases, edible coatings were not successful. The success of edible coatings for fresh products totally depends on the control of internal gas composition. Quality criteria for fruits and vegetables coated with edible films must be determined carefully and the quality parameters must be monitored throughout the storage period. Color change, firmness loss, ethanol fermentation, decay ratio and weight loss of edible film coated fruits need to be monitored. This review discusses the use of different edible coatings (polysaccharides, proteins, lipids and composite) as carriers of functional ingredients on fresh fruits and vegetables to maximize their quality and shelf life. This also includes the recent advances in the incorporation of antimicrobials, texture enhancers and nutraceuticals to improve quality and functionality of fresh-cut fruits. Sensory implications, regulatory status and future trends are also reviewed.

  11. 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.

  12. Towards practical implementation of biophotonics-based solutions for cost-effective monitoring of food quality control (Conference Presentation)

    NASA Astrophysics Data System (ADS)

    Meglinski, Igor; Popov, Alexey; Bykov, Alexander

    2017-03-01

    Biophotonics-based diagnostic and imaging modalities have been widely used in various applications associated with the non-invasive imaging of the internal structure of a range biological media from a range of cells cultures to biological tissues. With the fast growing interest in food securities there remains strong demand to apply reliable and cost effective biophotonics-based technologies for rapid screening of freshness, internal defects and quality of major agricultural products. In current presentation the results of application of optical coherence tomography (OCT) and encapsulated optical bio-sensors for quantitative assessment of freshness of agricultural products, such as meat and sea foods, are presented, and their further perspectives are discussed.

  13. The CIQG International Quality Principles: Toward a Shared Understanding of Quality. CIQG Publication Series

    ERIC Educational Resources Information Center

    Uvalic-Trumbic, Stamenka

    2016-01-01

    The idea of developing International Quality Principles emerged from a dialogue and debate among colleagues from many countries at the Council for Higher Education Accreditation (CHEA) International Quality Group (CIQG) 2014 Annual Meeting. The discussion focused on whether a single set of international standards for academic quality in higher…

  14. Environmental, political, and economic determinants of water quality monitoring in Europe

    NASA Astrophysics Data System (ADS)

    Beck, Lucas; Bernauer, Thomas; Kalbhenn, Anna

    2010-11-01

    Effective monitoring is essential for effective pollution control in national and international water systems. To what extent are countries' monitoring choices driven by environmental criteria, as they should be? And to what extent are they also influenced by other factors, such as political and economic conditions? To address these questions, we describe and explain the evolution of one of the most important international environmental monitoring networks in Europe, the one for water quality, in the time period 1965-2004. We develop a geographic information system that contains information on the location of several thousand active monitoring stations in Europe. Using multivariate statistics, we then examine whether and to what extent the spatial and temporal clustering of monitoring intensity is driven by environmental, political, and economic factors. The results show that monitoring intensity is higher in river basins exposed to greater environmental pressure. However, political and economic factors also play a strong role in monitoring decisions: democracy, income, and peer pressure are conducive to monitoring intensity, and monitoring intensity generally increases over time. Moreover, even though monitoring is more intense in international upstream-downstream settings, we observe only a weak bias toward more monitoring downstream of international borders. In contrast, negative effects of European Union (EU) membership and runup to the EU's Water Framework Directive are potential reasons for concern. Our results strongly suggest that international coordination and standardization of water quality monitoring should be intensified. It will be interesting to apply our analytical approach also to other national and international monitoring networks, for instance, the U.S. National Water-Quality Assessment Program or the European Monitoring and Evaluation Program for air pollution.

  15. Tadalafil once daily and extracorporeal shock wave therapy in the management of patients with Peyronie's disease and erectile dysfunction: results from a prospective randomized trial.

    PubMed

    Palmieri, A; Imbimbo, C; Creta, M; Verze, P; Fusco, F; Mirone, V

    2012-04-01

    Extracorporeal shock wave therapy improves erectile function in patients with Peyronie's disease. However, erectile dysfunction still persists in many cases. We aimed to investigate the effects of extracorporeal shock wave therapy plus tadalafil 5 mg once daily in the management of patients with Peyronie's disease and erectile dysfunction not previously treated. One hundred patients were enrolled in a prospective, randomized, controlled study. Patients were randomly allocated to receive either extracorporeal shock wave therapy alone for 4 weeks (n = 50) or extracorporeal shock wave therapy plus tadalafil 5 mg once daily for 4 weeks (n = 50). Main outcome measures were: erectile function (evaluated through the shortened version of the International Index of Erectile Function), pain during erection (evaluated through a Visual Analog Scale), plaque size, penile curvature and quality of life (evaluated through an internal questionnaire). Follow-up evaluations were performed after 12 and 24 weeks. In both groups, at 12 weeks follow-up, mean Visual Analog Scale score, mean International Index of Erectile Function score and mean quality of life score ameliorated significantly while mean plaque size and mean curvature degree were unchanged. Intergroup analysis revealed a significantly higher mean International Index of Erectile Function score and quality of life score in patients receiving the combination. After 24 weeks, intergroup analysis revealed a significantly higher mean International Index of Erectile Function score and mean quality of life score in patients that received extracorporeal shock wave therapy plus tadalafil. In conclusion extracorporeal shock wave therapy plus tadalafil 5 mg once daily may represent a valid conservative strategy for the management of patients with Peyronie's disease and erectile dysfunction. © 2011 The Authors. International Journal of Andrology © 2011 European Academy of Andrology.

  16. Dynamic controlled atmosphere and ultralow oxygen storage on 'Gala' mutants quality maintenance.

    PubMed

    Thewes, Fabio Rodrigo; Both, Vanderlei; Brackmann, Auri; Weber, Anderson; de Oliveira Anese, Rogerio

    2015-12-01

    The aim of the present work was to compare the effect of ultralow oxygen (ULO) with dynamic controlled atmosphere (DCA) and controlled atmosphere (CA) on the post storage quality of 'Royal Gala' and 'Galaxy' apples after long-term storage. Two experiments were carried out with 'Royal Gala' and 'Galaxy' apples, in the years 2012 and 2013, respectively. A higher internal ethylene concentration was observed in fruits stored under CA; intermediate concentration in fruits under ULO; and the lowest by fruits stored under DCA-CF (DCA based on chlorophyll fluorescence). Flesh firmness was higher in fruits stored under DCA-CF and ULO differing from CA, in the year 2012, but in 2013 fruits stored under ULO showed the highest flesh firmness, differing from CA fruits. DCA-CF is efficient in quality maintenance of 'Royal Gala' and 'Galaxy' apples. Both 'Gala' mutants stored under ULO show a similar quality maintenance to those stored under DCA-CF. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. 40 CFR Table 10 to Subpart Ddddd... - Applicability of General Provisions to Subpart DDDDD

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... requirements; and internal and external QA procedures for testing Yes. § 63.7(d) Testing Facilities... must keep quality control plan on record for the life of the affected source. Keep old versions for 5...

  18. 40 CFR Table 3 to Subpart Cccccc... - Applicability of General Provisions

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... procedures; performance audit requirements; internal and external QA procedures for testing Yes. § 63.7(d... quality control plan on record for 5 years; keep old versions for 5 years after revisions No. § 63.8(e...

  19. 40 CFR Table 7 to Subpart Ppppp of... - Applicability of General Provisions to Subpart PPPPP

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Yes. 3. Performance audit requirements Yes. 4. Internal and external QA procedures for testing Yes... keep quality control plan on record for 5 years. Keep old versions for 5 years after revisions Yes...

  20. Assessment of symptoms of urinary incontinence in women with polycystic ovary syndrome.

    PubMed

    Montezuma, Thais; Antônio, Flávia Ignácio; Rosa e Silva, Ana Carolina Japur de Sá; Sá, Marcos Felipe Silva de; Ferriani, Rui Alberto; Ferreira, Cristine Homsi Jorge

    2011-01-01

    The pelvic floor muscles are sensitive to androgens, and due to hyperandrogenism, women with polycystic ovary syndrome can have increased mass in these muscles compared to controls. The aim of this study is to compare reports of urine leakage and quality of life between women with and without polycystic ovary syndrome. One hundred thirteen 18-to 40-year-old nulliparous women with polycystic ovary syndrome or without the disease (controls) were recruited at the University Hospital of School Medicine of São Paulo University at Ribeirão Preto City, Brazil. The subjects were not taking any hormonal medication, had not undergone previous pelvic surgery and did not exercise their pelvic floor muscles. The women were divided into the following four groups: I-polycystic ovary syndrome with normal body mass index (n = 18), II-polycystic ovary syndrome with body mass index >25 (n = 32), III-controls with normal body mass index (n = 29), and IV-controls with Body Mass Index >25 (n = 34). Quality of life was evaluated using the SF-36 questionnaire, and the subjects with urinary complaints also completed the International Consultation on Incontinence Questionnaire Short Form to evaluate the severity of their urinary incontinence. The replies to the International Consultation on Incontinence Questionnaire Short Form revealed a significant difference in urinary function between groups, with 24% of the subjects in group IV reporting urinary incontinence. The mean scores for the SF-36 questionnaire revealed that group II had the lowest quality of life. The control obese group (IV) reported a higher prevalence of urinary incontinence. There was no difference in the reported frequency of urine loss between the polycystic ovary syndrome and control groups with normal body mass index or between the polycystic ovary syndrome and control groups with body mass index >25.

  1. Trichinella diagnostics and control: mandatory and best practices for ensuring food safety.

    PubMed

    Gajadhar, Alvin A; Pozio, Edoardo; Gamble, H Ray; Nöckler, Karsten; Maddox-Hyttel, Charlotte; Forbes, Lorry B; Vallée, Isabelle; Rossi, Patrizia; Marinculić, Albert; Boireau, Pascal

    2009-02-23

    Because of its role in human disease, there are increasing global requirements for reliable diagnostic and control methods for Trichinella in food animals to ensure meat safety and to facilitate trade. Consequently, there is a need for standardization of methods, programs, and best practices used in the control of Trichinella and trichinellosis. This review article describes the biology and epidemiology of Trichinella, and describes recommended test methods as well as modified and optimized procedures that are used in meat inspection programs. The use of ELISA for monitoring animals for infection in various porcine and equine pre- and post-slaughter programs, including farm or herd certification programs is also discussed. A brief review of the effectiveness of meat processing methods, such as freezing, cooking and preserving is provided. The importance of proper quality assurance and its application in all aspects of a Trichinella diagnostic system is emphasized. It includes the use of international quality standards, test validation and standardization, critical control points, laboratory accreditation, certification of analysts and proficiency testing. Also described, are the roles and locations of international and regional reference laboratories for trichinellosis where expert advice and support on research and diagnostics are available.

  2. Increased hepatitis E virus prevalence on Dutch pig farms from 33 to 55% by using appropriate internal quality controls for RT-PCR.

    PubMed

    Rutjes, Saskia A; Lodder, Willemijn J; Bouwknegt, Martijn; de Roda Husman, Ana Maria

    2007-07-01

    Pigs have been suggested to be a potential reservoir for locally acquired human hepatitis E virus (HEV) infections in the Netherlands. To study possible trends in HEV prevalence in the Dutch pig population, 97 pig farms have been screened for the presence of HEV in stools. The prevalence rate of HEV was estimated at 55% (53/97) in 2005, indicating a significant increase as compared to the prevalence rate of 22% (25/115) as was reported in 1999. The current data suggest that this increase is due to the inclusion of appropriate quality assurance controls such as internal amplification controls for RT-PCR. The abundant presence of pigs excreting HEV raises concerns on potential zoonotic transmission of the virus, either by exposure through the environment or by consumption of contaminated pork products. Moreover, one of the detected strains belonged to a European cluster which was not detected in the Netherlands before, suggesting that HEV strains spread through European countries. These data demonstrate the need to include appropriate controls in diagnostic assays, especially in complex matrices such as feces which are known to contain PCR inhibitory substances.

  3. CALL FOR PAPERS: 13th International Conference on Force and Mass Measurement

    NASA Astrophysics Data System (ADS)

    1992-01-01

    10 14 May 1993, Helsinki Fair Centre, Finland Scope of the Conference The Conference reports and reviews the state of the art and future trends in force and mass measurements in science and industry. Emphasis is on the applications of new methods, current problems in calibration and quality control, as well as on advancements in new sensor technologies and industrial application of force and mass measurements. Main Themes and Topics 1. The state of the art and development trends in force and mass measurements Development and stability of high level mass standards Mass comparators and force standard machine New research topics in mass and force 2. Calibration and quality control Calibration methods Estimation of uncertainties and classification of accuracies Relations between calibration, testing and quality control Requirements for quality control Verification of weighing instruments and their main devices 3. Application of force and mass measurements Automatic weighing Mass flow measurements Quality control in process industry Sensor technologies Practical applications Special applications in industry, trade, etc. Deadline for submission of abstracts: 30 June 1992. For further information please contact: Finnish Society of Automation, Asemapäällikönkatu 12C, SF-00520 HELSINKI, Finland Phone: Int. +3580 1461 644, Fax: Int. +3580 1461 650

  4. Assessing the influence of component processing and donor characteristics on quality of red cell concentrates using quality control data.

    PubMed

    Jordan, A; Chen, D; Yi, Q-L; Kanias, T; Gladwin, M T; Acker, J P

    2016-07-01

    Quality control (QC) data collected by blood services are used to monitor production and to ensure compliance with regulatory standards. We demonstrate how analysis of quality control data can be used to highlight the sources of variability within red cell concentrates (RCCs). We merged Canadian Blood Services QC data with manufacturing and donor records for 28 227 RCC between June 2011 and October 2014. Units were categorized based on processing method, bag manufacturer, donor age and donor sex, then assessed based on product characteristics: haemolysis and haemoglobin levels, unit volume, leucocyte count and haematocrit. Buffy-coat method (top/bottom)-processed units exhibited lower haemolysis than units processed using the whole-blood filtration method (top/top). Units from female donors exhibited lower haemolysis than male donations. Processing method influenced unit volume and the ratio of additive solution to residual plasma. Stored red blood cell characteristics are influenced by prestorage processing and donor factors. Understanding the relationship between processing, donors and RCC quality will help blood services to ensure the safety of transfused products. © 2016 International Society of Blood Transfusion.

  5. Read Code Quality Assurance

    PubMed Central

    Schulz, Erich; Barrett, James W.; Price, Colin

    1998-01-01

    As controlled clinical vocabularies assume an increasing role in modern clinical information systems, so the issue of their quality demands greater attention. In order to meet the resulting stringent criteria for completeness and correctness, a quality assurance system comprising a database of more than 500 rules is being developed and applied to the Read Thesaurus. The authors discuss the requirement to apply quality assurance processes to their dynamic editing database in order to ensure the quality of exported products. Sources of errors include human, hardware, and software factors as well as new rules and transactions. The overall quality strategy includes prevention, detection, and correction of errors. The quality assurance process encompasses simple data specification, internal consistency, inspection procedures and, eventually, field testing. The quality assurance system is driven by a small number of tables and UNIX scripts, with “business rules” declared explicitly as Structured Query Language (SQL) statements. Concurrent authorship, client-server technology, and an initial failure to implement robust transaction control have all provided valuable lessons. The feedback loop for error management needs to be short. PMID:9670131

  6. Read Code quality assurance: from simple syntax to semantic stability.

    PubMed

    Schulz, E B; Barrett, J W; Price, C

    1998-01-01

    As controlled clinical vocabularies assume an increasing role in modern clinical information systems, so the issue of their quality demands greater attention. In order to meet the resulting stringent criteria for completeness and correctness, a quality assurance system comprising a database of more than 500 rules is being developed and applied to the Read Thesaurus. The authors discuss the requirement to apply quality assurance processes to their dynamic editing database in order to ensure the quality of exported products. Sources of errors include human, hardware, and software factors as well as new rules and transactions. The overall quality strategy includes prevention, detection, and correction of errors. The quality assurance process encompasses simple data specification, internal consistency, inspection procedures and, eventually, field testing. The quality assurance system is driven by a small number of tables and UNIX scripts, with "business rules" declared explicitly as Structured Query Language (SQL) statements. Concurrent authorship, client-server technology, and an initial failure to implement robust transaction control have all provided valuable lessons. The feedback loop for error management needs to be short.

  7. [Damage Control Surgery in Polytrauma Patients with Pelvic Fractures. Is It Possible to Use Internal Fixation?

    PubMed

    Havlůj, L; Džupa, V; Gürlich, R

    2017-01-01

    Current polytrauma management is multidisciplinary, with Damage Control Surgery (DCS), Damage Control Orthopaedics (DCO) and Damage Control Resuscitation (DCR) being applied in the first few hours after injury. The most severe group of polytrauma patients are those with circulatory instability and massive blood loss as a consequence of unstable pelvic fractures. In treating these patients, of crucial importance is the speed and quality of stabilisation of pelvic fracture fragments. The authors present two case reports of polytrauma patients with unstable pelvic fractures, in whom open reduction and internal fixation was performed on the anterior fracture segment through extended laparotomy in order to stop bleeding into the abdominopelvic cavity as part of the DCS approach. Key words: exsanguination, polytrauma, unstable pelvic fracture, plate fixation.

  8. Control Techtronics International

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

    West, J.

    1995-12-31

    Polish graded coal can be burned in existing stoker boilers and meet the 1998 Air Quality standard. This is accomplished with the Control Techtronics microprocessor-based combustion controller accurately and repeatedly: (a) matching the combustion air to the coal firing rate, with continuous stack sensor feedback; (b) continuously varying the boiler`s firing rate based on output water temperature or steam pressure; (c) continuously varying the exhaust fan`s speed to maintain minimum negative pressure in the boiler`s combustion chamber; and recirculating a portion of the flue gas, at varying amounts throughout the boiler`s firing rate. Systems for five boilers have been installedmore » and are operating on MPEC`s Balicka plant in Krakow. Control Techtronics International has $10 million of U.S. Export-Import Bank funds available for similar projects throughout Poland.« less

  9. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2005-01-01

    This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, this report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices (GMP), inspection, distribution and trade and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including an amendment to good manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products and related materials and draft guidelines for registration of fixed-dose combination medicinal products.

  10. Self-reported quality of life and self-esteem in sad and anxious school children.

    PubMed

    Martinsen, Kristin D; Neumer, Simon-Peter; Holen, Solveig; Waaktaar, Trine; Sund, Anne Mari; Kendall, Philip C

    2016-09-13

    Anxiety and depressive symptoms are common in childhood, however problems in need of intervention may not be identified. Children at risk for developing more severe problems can be identified based on elevated symptom levels. Quality of life and self-esteem are important functional domains and may provide additional valuable information. Schoolchildren (n = 915), aged 9-13, who considered themselves to be more anxious or sad than their peers, completed self-reports of anxiety (Multidimensional Anxiety Scale for children (MASC-C), depression (The Short Mood and Feelings Questionnaire; SMFQ), quality of life (Kinder Lebensqualität Fragebogen; KINDL) and self-esteem (Beck self-concept inventory for youth (BSCI-Y) at baseline of a randomized controlled indicative study. Using multivariate analyses, we examined the relationships between internalizing symptoms, quality of life and self-esteem in three at-risk symptom groups. We also examined gender and age differences. 52.1 % of the screened children scored above the defined at-risk level reporting elevated symptoms of either Anxiety and Depression (Combined group) (26.6 %), Depression only (15.4 %) or Anxiety only (10.2 %). One-way ANOVA analysis showed significant mean differences between the symptom groups on self-reported quality of life and self-esteem. Regression analysis predicting quality of life and self-esteem showed that in the Depression only group and the Combined group, symptom levels were significantly associated with lower self-reported scores on both functional domains. In the Combined group, older children reported lower quality of life and self-esteem than younger children. Internalizing symptoms explained more of the variance in quality of life than in self-esteem. Symptoms of depression explained more of the variance than anxious symptoms. Female gender was associated with higher levels of internalizing symptoms, but there was no gender difference in quality of life and self-esteem. Internalizing symptoms were associated with lower self-reported quality of life and self-esteem in children in the at-risk groups reporting depressive or depressive and anxious symptoms. A transdiagnostic approach targeting children with internalizing symptoms may be important as an early intervention to change a possible negative trajectory. Tailoring the strategies to the specific symptom pattern of the child will be important to improve self-esteem. Trial registration in Clinical trials: NCT02340637 , June 12, 2014.

  11. Implementation of quality systems by Mexican exporters of processed meat.

    PubMed

    Maldonado-Siman, E; Bernal-Alcántara, R; Cadena-Meneses, J A; Altamirano-Cárdenas, J R; Martinez-Hernández, P A

    2014-12-01

    Requirements of hazard analysis and critical control points (HACCP) are becoming essential for international trade in food commodities as a safety assurance component. This research reports the level of the adoption of ISO 9000 and the HACCP system by Federal Inspection Type (TIF) pork-exporting enterprises. Implementation and operating costs are reported as well as the benefits involved in this food industry process. In Mexico, there are 97 companies classified as TIF enterprises, and 22 are registered as exporters of processed pork with the National Services for Safety and Quality and Animal Health of the Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food. Surveys were administered to 22 companies, with a 95.2% response rate. Enterprise characteristics were evaluated, as well as their operating activities. Fieldwork consisted of administering structured questionnaires to TIF exporters. All the surveyed enterprises had implemented HACCP, whereas the ISO 9000 regulation was applied in only 30%. Of total production, 75% is exported to 13 countries, and 25% goes to the Mexican market niche. Results indicate that the main factors for adopting HACCP are related to accessibility to international markets, improving quality, and reducing product quality audits by customers. The results also indicated that staff training was the most important issue. Microbiological testing was the highest cost of the operation. The main benefits reported were related to better access to international markets and a considerable reduction in microbial counts. This study shows the willingness of Mexican pork processors to implement food safety protocols for producing safe and quality products to compete in the international food trade.

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

    PubMed Central

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

    2018-01-01

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

  13. 2015 International PV Quality Assurance Task Force (PVQAT) Workshop |

    Science.gov Websites

    Photovoltaic Research | NREL International PV Quality Assurance Task Force (PVQAT) Workshop 2015 International PV Quality Assurance Task Force (PVQAT) Workshop Wednesday, February 25, 2015 Chairs : Tony Sample and Masaaki Yamamichi The 2015 International PV Quality Assurance Task Force (PVQAT

  14. Role of re-screening of cervical smears in internal quality control.

    PubMed Central

    Baker, A; Melcher, D; Smith, R

    1995-01-01

    AIMS--To investigate the use of rapid re-screening as a quality control method for previously screened cervical slides; to compare this method with 10% random re-screening and clinically indicated double screening. METHODS--Between June 1990 and December 1994, 117,890 negative smears were subjected to rapid re-screening. RESULTS--This study shows that rapid re-screening detects far greater numbers of false negative cases when compared with both 10% random re-screening and clinically indicated double screening, with no additional demand on human resources. The technique also identifies variation in the performance of screening personnel as an additional benefit. CONCLUSION--Rapid re-screening is an effective method of quality control. Although less sensitive, rapid re-screening should replace 10% random re-screening and selected re-screening as greater numbers of false negative results are detected while consuming less resources. PMID:8543619

  15. A Design Basis for Spacecraft Cabin Trace Contaminant Control

    NASA Technical Reports Server (NTRS)

    Perry, Jay L.

    2009-01-01

    Successful trace chemical contamination control is one of the components necessary for achieving good cabin atmospheric quality. While employing seemingly simple process technologies, sizing the active contamination control equipment must employ a reliable design basis for the trace chemical load in the cabin atmosphere. A simplified design basis that draws on experience gained from the International Space Station program is presented. The trace chemical contamination control design load refines generation source magnitudes and includes key chemical functional groups representing both engineering and toxicology challenges.

  16. International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab.

    PubMed

    Prior, Sandra; Hufton, Simon E; Fox, Bernard; Dougall, Thomas; Rigsby, Peter; Bristow, Adrian

    2018-01-01

    The intrinsic complexity and heterogeneity of therapeutic monoclonal antibodies is built into the biosimilarity paradigm where critical quality attributes are controlled in exhaustive comparability studies with the reference medicinal product. The long-term success of biosimilars will depend on reassuring healthcare professionals and patients of consistent product quality, safety and efficacy. With this aim, the World Health Organization has endorsed the need for public bioactivity standards for therapeutic monoclonal antibodies in support of current controls. We have developed a candidate international potency standard for rituximab that was evaluated in a multi-center collaborative study using participants' own qualified Fc-effector function and cell-based binding bioassays. Dose-response curve model parameters were shown to reflect similar behavior amongst rituximab preparations, albeit with some differences in potency. In the absence of a common reference standard, potency estimates were in poor agreement amongst laboratories, but the use of the candidate preparation significantly reduced this variability. Our results suggest that the candidate rituximab standard can support bioassay performance and improve data harmonization, which when implemented will promote consistency of rituximab products over their life-cycles. This data provides the first scientific evidence that a classical standardization exercise allowing traceability of bioassay data to an international standard is also applicable to rituximab. However, we submit that this new type of international standard needs to be used appropriately and its role not to be mistaken with that of the reference medicinal product.

  17. 40 CFR Table 10 to Subpart Uuuu of... - Applicability of General Provisions to Subpart UUUU

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... requirements; internal and external QA procedures for testing No. § 63.7(d) Testing Facilities Requirements for....; must keep quality control plan on record for 5 years; keep old versions for 5 years after revisions No...

  18. Food toxin detection with atomic force microscope

    USDA-ARS?s Scientific Manuscript database

    Externally introduced toxins or internal spoilage correlated pathogens and their metabolites are all potential sources of food toxins. To prevent and protect unsafe food, many food toxin detection techniques have been developed to detect various toxins for quality control. Although several routine m...

  19. Enhancing Technology Education Students' Understanding of ISO 9000.

    ERIC Educational Resources Information Center

    Harding, Kerry A.; Tesolowski, Dennis G.; Simmons, J. Bryan

    2000-01-01

    Defines ISO 9000, the quality control standard of the International Organization for Standardization (ISO), and looks at the benefits of ISO certification. Looks at the four levels of ISO 9000 and discusses the construction of training courses to prepare ISO documentation. (JOW)

  20. Sibling Relationships among Children with ADHD

    ERIC Educational Resources Information Center

    Mikami, Amori Yee; Pfiffner, Linda J.

    2008-01-01

    Objective: This study investigated the quality of sibling relationships among children with ADHD relative to those without ADHD. Additional analyses examined whether externalizing and internalizing problems comorbid with ADHD affected sibling relationships. Method: Participants were 77 children with ADHD and 14 nonproblem control children. Sibling…

  1. Effect of thermal stress on fertility and egg quality of Japanese quail.

    PubMed

    El-Tarabany, Mahmoud S

    2016-10-01

    Heat stress is one of the major causes of a decreased performance of laying quail in tropical and subtropical countries. The aim of this study was to investigate the impact of temperature humidity index (THI) on fertility aspects, external and internal egg quality parameters in Japanese quail. One hundred and forty four (144) Japanese quail, 12 of weeks age, were used. Birds were divided randomly into three equal groups, control (at low THI, lower than 70), H 1 (at moderate THI, 70-75) and H 2 (at high THI, 76-80). Quail in the control and H 1 groups had significant greater fertility (p=0.021) and hatchability % (p=0.037), compared with H 2 group. Quail in the control group (at low THI) laid heavier egg weight with a higher external (egg weight (p=0.03), shell thickness, shell weight, eggshell ratio and eggshell density (p=0.001)) and internal egg quality score (albumin weight (p=0.026), yolk height (p=0.003), yolk index (p=0.039) and Haugh unit (p=0.001)). Otherwise, such quality traits were compromised in heat-stressed quail. At the high THI level, egg weight had a significant positive correlation with albumin weight (r=0.58, p<0.01), yolk weight (r=0.22, p<0.05), albumen ratio (r=0.17, p<0.05), yolk height (r=0.14, p<0.05) and yolk index (r=0.18, p<0.05), but was negatively correlated with yolk ratio (r=-0.15, p<0.05). Japanese quail exposed to heat stress (THI over 75) revealed drop in fertility indices and egg quality traits, indicating a detrimental policy of economic income. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Efficacy of antimicrobial pullulan-based coating to improve internal quality and shelf-life of chicken eggs during storage.

    PubMed

    Morsy, Mohamed K; Sharoba, Ashraf M; Khalaf, Hassan H; El-Tanahy, Hassan H; Cutter, Catherine N

    2015-05-01

    There has been a growing interest in the use of natural materials as a delivery mechanism for antimicrobials and coatings in foods. The aim of the present study was to evaluate the effectiveness of pullulan coatings to improve internal quality and shelf-life of fresh eggs during 10 wk of storage at 25 and 4 °C. Three treatments of eggs were evaluated as follows; non-coated (control; C), coated with pullulan (P), and coated with pullulan containing nisin (N). The effects of the pullulan coatings on microbiological qualities, physical properties, and freshness parameters were investigated and compared with non-coated eggs. For non-coated eggs, as storage time increased, yolk index, albumen index, and Haugh unit value decreased and weight loss increased. However, pullulan coatings (P or N) minimized weight loss (<1.5%) and preserved the albumen and yolk quality of eggs (with a final B grade) 3 wk longer than non-coated eggs at 25 °C. At 4 °C, both P- and N-coated eggs went from AA to A grade after 9 wk and maintained the grade for 10 wk (4 wk longer than that of non-coated eggs). This study is the first to demonstrate that pullulan coatings can preserve the internal quality, prolong the shelf-life, and minimize weight loss of fresh eggs. © 2015 Institute of Food Technologists®

  3. 7 CFR 51.485 - Good internal quality.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Good internal quality. 51.485 Section 51.485... STANDARDS) United States Standards for Grades of Cantaloups 1 Definitions § 51.485 Good internal quality. Good internal quality means that the combined juice from the edible portion of a sample of cantaloups...

  4. The impact of an integrated hospital-community medical information system on quality and service utilization in hospital departments.

    PubMed

    Nirel, Nurit; Rosen, Bruce; Sharon, Assaf; Blondheim, Orna; Sherf, Michael; Samuel, Hadar; Cohen, Arnon D

    2010-09-01

    In 2005, an innovative system of hospital-community on-line medical records (OFEK) was implemented at Clalit Health Services (CHS). The goals of the study were to examine the extent of OFEK's use and its impact on quality indicators and medical-service utilization in Internal Medicine and General Surgery wards of CHS hospitals. Examining the frequency of OFEK's use with its own track-log data; comparing, "before" and "after", quality indicators and service utilization data in experimental (CHS patients) versus control groups (other patients). OFEK's use increased by tens of percentages each year, Internal Medicine wards showed a significant decrease in the number of laboratory tests and 3 CT tests performed compared with the control group. Wards using OFEK extensively showed a greater decrease in CT tests, in one imaging test, and in the average number of ambulatory hospitalizations. No similar changes were found in General Surgery wards. The study helps evaluate the extent to which OFEK's targets were achieved and contributes to the development of measures to examine the impact of such systems, which can be used to assess a broad range of Health Information Technology (HIT) systems. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

  5. Pocket change: a simple educational intervention increases hospitalist documentation of comorbidities and improves hospital quality performance measures.

    PubMed

    Sparks, Rachel; Salskov, Alex H; Chang, Anita S; Wentworth, Kelly L; Gupta, Pritha P; Staiger, Thomas O; Anawalt, Bradley D

    2015-01-01

    Complete documentation of patient comorbidities in the medical record is important for clinical care, hospital reimbursement, and quality performance measures. We designed a pocket card reminder and brief educational intervention aimed at hospitalists with the goal of improving documentation of 6 common comorbidities present on admission: coagulation abnormalities, metastatic cancer, anemia, fluid and electrolyte abnormalities, malnutrition, and obesity. Two internal medicine inpatient teams led by 10 hospitalist physicians at an academic medical center received the educational intervention and pocket card reminder (n = 520 admissions). Two internal medicine teams led by nonhospitalist physicians served as a control group (n = 590 admissions). Levels of documentation of 6 common comorbidities, expected length of stay, and expected mortality were measured at baseline and during the 9-month study period. The intervention was associated with increased documentation of anemia, fluid and electrolyte abnormalities, malnutrition, and obesity in the intervention group, both compared to baseline and compared to the control group during the study period. The expected length of stay increased in the intervention group during the study period. A simple educational intervention and pocket card reminder were associated with improved documentation and hospital quality measures at an academic medical center.

  6. Daily peer review of abnormal cervical smears in the assessment of individual practice as an additional method of internal quality control.

    PubMed

    Confortini, M; Di Stefano, C; Biggeri, A; Bulgaresi, P; Di Claudio, G; Grisotto, L; Maddau, C; Matucci, M; Petreschi, C; Troni, G M; Turco, P; Foxi, P

    2016-02-01

    An important internal quality control system used in the Cancer Prevention and Research Institute cytopathology laboratory in Florence is the peer review procedure, based on the review of all abnormal cytological smears which routinely emerge. Peer review is an important training opportunity for all cytologists, especially for those with less experience. This article shows the results of the peer review procedure. Of the 63 754 Papanicolaou (Pap) smears screened in 2011, 1086 were considered to be abnormal [at least atypical squamous cells of undetermined significance (ASC-US+)] on primary screening (selected by a single cytologist) and were subjected to the peer review procedure. The overall performance of the laboratory's cytologists was evaluated using a multiple rater analysis and the comparison of each cytologist with the final diagnosis. Further, the agreement was assessed by means of Cohen's kappa and weighted kappa statistics. In general, a moderate/substantial level of agreement between the ten cytologists and the final diagnoses was evident. Kappa values for each reader compared with the final diagnosis ranged from 0.54 to 0.69. The overall kappa value was 0.62 [95% confidence interval (CI), 0.58-0.66] and overall weighted kappa value was 0.76 (95% CI, 0.74-0.79). The category-specific agreement showed the lowest values for atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion (ASC-H). In summary, peer review represents an important internal quality control in the evaluation and improvement of inter-observer agreement and of the functioning of the laboratory as a whole. Multi-head microscope sessions may improve particularly the reproducibility of borderline diagnoses and, above all, can be an important training contribution for cytologists. © 2014 John Wiley & Sons Ltd.

  7. Different top-down approaches to estimate measurement uncertainty of whole blood tacrolimus mass concentration values.

    PubMed

    Rigo-Bonnin, Raül; Blanco-Font, Aurora; Canalias, Francesca

    2018-05-08

    Values of mass concentration of tacrolimus in whole blood are commonly used by the clinicians for monitoring the status of a transplant patient and for checking whether the administered dose of tacrolimus is effective. So, clinical laboratories must provide results as accurately as possible. Measurement uncertainty can allow ensuring reliability of these results. The aim of this study was to estimate measurement uncertainty of whole blood mass concentration tacrolimus values obtained by UHPLC-MS/MS using two top-down approaches: the single laboratory validation approach and the proficiency testing approach. For the single laboratory validation approach, we estimated the uncertainties associated to the intermediate imprecision (using long-term internal quality control data) and the bias (utilizing a certified reference material). Next, we combined them together with the uncertainties related to the calibrators-assigned values to obtain a combined uncertainty for, finally, to calculate the expanded uncertainty. For the proficiency testing approach, the uncertainty was estimated in a similar way that the single laboratory validation approach but considering data from internal and external quality control schemes to estimate the uncertainty related to the bias. The estimated expanded uncertainty for single laboratory validation, proficiency testing using internal and external quality control schemes were 11.8%, 13.2%, and 13.0%, respectively. After performing the two top-down approaches, we observed that their uncertainty results were quite similar. This fact would confirm that either two approaches could be used to estimate the measurement uncertainty of whole blood mass concentration tacrolimus values in clinical laboratories. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  8. Traceability from a US perspective.

    PubMed

    Smith, G C; Tatum, J D; Belk, K E; Scanga, J A; Grandin, T; Sofos, J N

    2005-09-01

    Traceability of a food consists of development of "an information trail that follows the food product's physical trail". Internationally, the US is lagging behind many countries in developing traceability systems for food in general and especially for livestock, poultry and their products. The US food industry is developing, implementing and maintaining traceability systems designed to improve food supply management, facilitate traceback for food safety and quality, and differentiate and market foods with subtle or undetectable quality attributes. Traceability, for livestock, poultry and meat, in its broadest context, can, could, or will eventually be used: (1) to ascertain origin and ownership, and to deter theft and misrepresentation, of animals and meat; (2) for surveillance, control and eradication of foreign animal diseases; (3) for biosecurity protection of the national livestock population; (4) for compliance with requirements of international customers; (5) for compliance with country-of-origin labeling requirements; (6) for improvement of supply-side management, distribution/delivery systems and inventory controls; (7) to facilitate value-based marketing; (8) to facilitate value-added marketing; (9) to isolate the source and extent of quality-control and food-safety problems; and (10) to minimize product recalls and make crisis management protocols more effective. Domestically and internationally, it has now become essential that producers, packers, processors, wholesalers, exporters and retailers assure that livestock, poultry and meat are identified, that record-keeping assures traceability through all or parts of the complete life-cycle, and that, in some cases, the source, the production-practices and/or the process of generating final products, can be verified. At issue, as the US develops traceback capabilities, will be the breadth, depth and precision of its specific traceability systems.

  9. Volume and methodological quality of randomized controlled trials in laparoscopic surgery: assessment over a 10-year period.

    PubMed

    Antoniou, Stavros A; Andreou, Alexandros; Antoniou, George A; Koch, Oliver O; Köhler, Gernot; Luketina, Ruzica-R; Bertsias, Antonios; Pointner, Rudolph; Granderath, Frank-Alexander

    2015-11-01

    Measures have been taken to improve methodological quality of randomized controlled trials (RCTs). This review systematically assessed the trends in volume and methodological quality of RCTs on minimally invasive surgery within a 10-year period. RCTs on minimally invasive surgery were searched in the 10 most cited general surgical journals and the 5 most cited journals of laparoscopic interest for the years 2002 and 2012. Bibliometric and methodological quality components were abstracted using the Scottish Intercollegiate Guidelines Network. The pooled number of RCTs from low-contribution regions demonstrated an increasing proportion of the total published RCTs, compensating for a concomitant decrease of the respective contributions from Europe and North America. International collaborations were more frequent in 2012. Acceptable or high quality RCTs accounted for 37.9% and 54.4% of RCTs published in 2002 and 2012, respectively. Components of external validity were poorly reported. Both the volume and the reporting quality of laparoscopic RCTs have increased from 2002 to 2012, but there seems to be ample room for improvement of methodological quality. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol in European adult patients - the LIAISON study protocol

    PubMed Central

    2013-01-01

    Background According to international guidelines, the goal of asthma management is to achieve and maintain control of the disease, which can be assessed using composite measures. Prospective studies are required to determine how these measures are associated with asthma outcomes and/or future risk. The ‘InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol (LIAISON)’ observational study has been designed to evaluate asthma control and its determinants, including components of asthma management. Methods/design The LIAISON study will be conducted in 12 European countries and comprises a cross-sectional phase and a 12-month prospective phase. Both phases will aim at assessing asthma control (six-item Asthma Control Questionnaire, ACQ), asthma-related quality of life (Mini Asthma Quality of Life Questionnaire, Mini-AQLQ), risk of non-adherence to treatment (four-item Morisky Medication Adherence Scale, MMAS-4), potential reasons for poor control, treatment strategies and associated healthcare costs. The cross-sectional phase will recruit > 8,000 adult patients diagnosed with asthma for at least 6 months and receiving the same asthma treatment in the 4 weeks before enrolment. The prospective phase will include all patients with uncontrolled/poorly controlled asthma at the initial visit to assess the proportion reaching control during follow-up and to examine predictors of future risk. Visits will take place after 3, 6 and 12 months. Discussion The LIAISON study will provide important information on the prevalence of asthma control and on the quality of life in a broad spectrum of real-life patient populations from different European countries and will also contribute to evaluate differences in management strategies and their impact on healthcare costs over 12 months of observation. Trial registration ClinicalTrials.gov identifier, NCT01567280. PMID:23530817

  11. Linked Analysis of East Asia Emission Reduction Pathways

    NASA Astrophysics Data System (ADS)

    Kim, Y.; Woo, J. H.; Bu, C.; Lee, Y.; Kim, J.; Jang, Y.; Park, M.

    2017-12-01

    Air pollution and its impacts over the Northeast Asia are very severe because of the massive pollutant emissions and high population. Korea has been trying to improve air quality with the enhanced environmental legislation. The air quality over Korea, however, does not entirely dependent on its local emissions. Transboundary air pollution from China highly affects Korean atmosphere. The purpose of this research is to understand role of local and transbounday efforts to improve air quality changes over Korea. In this research, we have tried to set up the multiple emission scenario pathways for Korea and China using IIASA's GAINS (Greenhouse gas - Air pollution Interactions aNd Synergies) modeling framework. More up-to-date growth factors and control policy packets were made using regional socio-economic data and control policy information from local governments and international statistics. Four major scenario pathways, 1) Base (Baseline: current legislation), 2) OTB/OTB(On the book/On the way : existing control measure/planed control measure), 3) BOTW_GHG(Beyond on the way : OTW with GHG reduction plan), 4) BOTW_NH3 (OTW with additional NH3 reduction measure) were developed to represent air quality improvement pathways in consideration of both Korean and Chinese efforts. Strict ambient PM2.5 standards from Seoul metropolitan Air quality Improvement Plan(SAIP) seems too enthusiastic without linking air quality control efforts of China. Step-by-step emission controls and following air quality, control cost, health impact from each scenario will be presented at the conference. This subject is supported by Korea Ministry of Environment as "Climate Change Correspondence Program". And This work was supported under the framework of national strategy project on fine particulate matters by Ministry of Science, ICT and Future Planning.

  12. Associations between chronotype, sleep quality, suicidality, and depressive symptoms in patients with major depression and healthy controls.

    PubMed

    Selvi, Yavuz; Aydin, Adem; Boysan, Murat; Atli, Abdullah; Agargun, Mehmed Yucel; Besiroglu, Lutfullah

    2010-10-01

    Research interest concerning associations between sleep characteristics and suicidality in psychopathology has been growing. However, possible linkages of suicidality to sleep characteristics in terms of sleep quality and chronotypes among depressive patients have not been well documented. In the current study, the authors investigated the possible effects of sleep quality and chronotype on the severity of depressive symptoms and suicide risk in patients with depressive disorder and healthy controls. The study was conducted on 80 patients clinically diagnosed with major depression and 80 healthy subjects who were demographically matched with the patient group. All participants completed a questionnaire package containing self-report measures, including the Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), Morningness-Eveningness Questionnaire (MEQ), and Suicide Ideation Scale (SIS), and subjects were interviewed with the suicidality section of the Mini-International Neuropsychiatric Interview (MINI). Results are as follows: (a) logistic regression analyses revealed that poor sleep quality and depression symptom severity significantly predicted onset of major depression; (b) morningness-type circadian rhythm may play as a significant relief factor after onset of major depression; (c) sleep variables of chronotype and sleep quality did not significantly predict suicide ideation after controlling for depressive symptoms in the major depression group; and (d) suicide ideation and poor sleep quality were antecedents of depression symptom severity in patients with major depression, and in healthy controls. Findings are discussed under the theoretical assumptions concerning possible relations between chronotype, sleep quality, depression, and suicidality.

  13. Ambient air quality programmes for health impact assessment in the WHO European region.

    PubMed

    Mücke, H G

    2000-06-01

    An important aim of air quality assessment is to provide information about population exposure and health impact assessment. Numerous epidemiological studies have already shown that exposure to excessive levels of ambient air pollutants are associated with either acute or chronic health effects. Until recently, the adequacy of monitoring population exposure in relation to quantitative assessment of health effects of air pollution was rarely considered in ambient air monitoring strategies. This made the formulation of health-related recommendations to risk management difficult and weakens preventive and other measures to reduce adverse health effects of air pollution. To improve local and national capacities for health impact assessment, the European Centre for Environment and Health of the World Health Organization has prepared methodology guidelines concerning selected aspects of air monitoring. The WHO Collaborating Centre for Air Quality Management and Air Pollution Control support efforts in line with international programmes on quality assurance and control for Europe.

  14. Ensuring Quality in AFRINEST and SATT

    PubMed Central

    2013-01-01

    Background: Three randomized open-label clinical trials [Simplified Antibiotic Therapy Trial (SATT) Bangladesh, SATT Pakistan and African Neonatal Sepsis Trial (AFRINEST)] were developed to test the equivalence of simplified antibiotic regimens compared with the standard regimen of 7 days of parenteral antibiotics. These trials were originally conceived and designed separately; subsequently, significant efforts were made to develop and implement a common protocol and approach. Previous articles in this supplement briefly describe the specific quality control methods used in the individual trials; this article presents additional information about the systematic approaches used to minimize threats to validity and ensure quality across the trials. Methods: A critical component of quality control for AFRINEST and SATT was striving to eliminate variation in clinical assessments and decisions regarding eligibility, enrollment and treatment outcomes. Ensuring appropriate and consistent clinical judgment was accomplished through standardized approaches applied across the trials, including training, assessment of clinical skills and refresher training. Standardized monitoring procedures were also applied across the trials, including routine (day-to-day) internal monitoring of performance and adherence to protocols, systematic external monitoring by funding agencies and external monitoring by experienced, independent trial monitors. A group of independent experts (Technical Steering Committee/Technical Advisory Group) provided regular monitoring and technical oversight for the trials. Conclusions: Harmonization of AFRINEST and SATT have helped to ensure consistency and quality of implementation, both internally and across the trials as a whole, thereby minimizing potential threats to the validity of the trials’ results. PMID:23945575

  15. Treatment of Internet gaming disorder: An international systematic review and CONSORT evaluation.

    PubMed

    King, Daniel L; Delfabbro, Paul H; Wu, Anise M S; Doh, Young Yim; Kuss, Daria J; Pallesen, Ståle; Mentzoni, Rune; Carragher, Natacha; Sakuma, Hiroshi

    2017-06-01

    Treatment services for Internet gaming disorder are becoming increasingly prevalent worldwide, particularly in East Asia. This international systematic review was designed to appraise the quality standards of the gaming disorder treatment literature, a task previously undertaken by King et al. (2011) prior to the inclusion of Internet gaming disorder in Section III of the DSM-5 and 'Gaming disorder' in the draft ICD-11. The reporting quality of 30 treatment studies conducted from 2007 to 2016 was assessed. Reporting quality was defined according to the 2010 Consolidating Standards of Reporting Trials (CONSORT) statement. The results reaffirmed previous criticisms of these trials, namely: (a) inconsistencies in the definition, diagnosis, and measurement of disordered use; (b) lack of randomization and blinding; (c) lack of controls; and (d) insufficient information on recruitment dates, sample characteristics, and effect sizes. Although cognitive-behavioral therapy has a larger evidence base than other therapies, it remains difficult to make definitive statements on its benefits. Study design quality has not improved over the last decade, indicating a need for greater consistency and standardization in this area. Continuing international efforts to understand the core psychopathology of gaming disorder are vital to developing a model of best practice in treatment. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. Sleep and chronobiology in cluster headache.

    PubMed

    Barloese, M; Lund, N; Petersen, A; Rasmussen, M; Jennum, P; Jensen, R

    2015-10-01

    Cluster headache (CH) is the headache disorder with the strongest chronobiological traits. The severe attacks of pain occur with diurnal and annual rhythmicity but the precise rhythm and involvement of potential zeitgebers is unknown. Patients complain of poor sleep quality yet this has never been studied. We investigated triggers, rhythms, sleep quality and chronotypes in CH. Patients and controls completed questionnaires and structured interviews composed of new and previously validated parts including the Pittsburgh Sleep Quality Index (PSQI) and Morningness-Eveningness Questionnaire (MEQ). Patients were characterized by a CH index, a unified measure of headache burden. A total of 275 CH patients and 145 matched controls were included. The most common trigger was sleep (80%) and a relationship between clusters and daylight was identified. Of the patients, 82.2% reported diurnal and 56% annual rhythmicity. Patients reported impaired sleep quality (PSQI) (p < 0.0001) and an inverse relationship between time passed since last attack and sleep quality was identified (p < 0.0001). The CH index was positively related to the PSQI (p < 0.0001). Diurnally, CH exhibits a relationship with night-time and annually with daylight hours. Patients' sleep quality is reduced compared with controls. Results suggest a complex relationship as sleep quality improves between clusters, but remains pathological. © International Headache Society 2015.

  17. Moving beyond perceptions: internalized stigma in the irritable bowel syndrome.

    PubMed

    Taft, T H; Riehl, M E; Dowjotas, K L; Keefer, L

    2014-07-01

    Internalized stigma (IS) is an important construct in the chronic illness literature with implications for several patient reported outcomes. To date, no study exists evaluating IS in patients with the irritable bowel syndrome (IBS). Two hundred and forty three online and clinical participants completed the following questionnaires: the IS scale for mental illness (ISMI; modified for IBS), perceived stigma scale for IBS, NIH-PROMIS Anxiety and Depression Scales, IBS quality of life scale, and the Perceived Health Competence Scale. Demographical and clinical data were also collected. The modified ISMI was reliable and valid in this population. Participants reported both perceived and IS. Alienation was most reported, followed by social withdrawal and discrimination experiences. IS predicted 25-40% of the variance in psychological functioning, quality of life, healthcare utilization, and health competence when controlling for stigma perception and disease variables. IBS patients perceived more stigma from personal relations than healthcare providers. Hispanic participants reported more perceived stigma, indicating there may be cultural differences in IBS-related stigma experience. Symptom severity, disruptiveness, and treatment choices are also implicated in stigma perception and internalization. Patients with IBS report both perceived and IS with alienation most reported. However, IS significantly predicts several patient outcomes when controlling for PS. Cultural and illness traits may influence how stigma is perceived and internalized. Future research is warranted. © 2014 John Wiley & Sons Ltd.

  18. Is Your Biobank Up to Standards? A Review of the National Canadian Tissue Repository Network Required Operational Practice Standards and the Controlled Documents of a Certified Biobank.

    PubMed

    Hartman, Victoria; Castillo-Pelayo, Tania; Babinszky, Sindy; Dee, Simon; Leblanc, Jodi; Matzke, Lise; O'Donoghue, Sheila; Carpenter, Jane; Carter, Candace; Rush, Amanda; Byrne, Jennifer; Barnes, Rebecca; Mes-Messons, Anne-Marie; Watson, Peter

    2018-02-01

    Ongoing quality management is an essential part of biobank operations and the creation of high quality biospecimen resources. Adhering to the standards of a national biobanking network is a way to reduce variability between individual biobank processes, resulting in cross biobank compatibility and more consistent support for health researchers. The Canadian Tissue Repository Network (CTRNet) implemented a set of required operational practices (ROPs) in 2011 and these serve as the standards and basis for the CTRNet biobank certification program. A review of these 13 ROPs covering 314 directives was conducted after 5 years to identify areas for revision and update, leading to changes to 7/314 directives (2.3%). A review of all internal controlled documents (including policies, standard operating procedures and guides, and forms for actions and processes) used by the BC Cancer Agency's Tumor Tissue Repository (BCCA-TTR) to conform to these ROPs was then conducted. Changes were made to 20/106 (19%) of BCCA-TTR documents. We conclude that a substantial fraction of internal controlled documents require updates at regular intervals to accommodate changes in best practices. Reviewing documentation is an essential aspect of keeping up to date with best practices and ensuring the quality of biospecimens and data managed by biobanks.

  19. Self-stigma and quality of life in patients with depressive disorder: a cross-sectional study.

    PubMed

    Holubova, Michaela; Prasko, Jan; Ociskova, Marie; Marackova, Marketa; Grambal, Ales; Slepecky, Milos

    2016-01-01

    Self-stigma is a maladaptive psychosocial phenomenon that can affect many areas of patients' lives and have a negative impact on their quality of life (QoL). This study explored the association between self-stigma, QoL, demographic data, and the severity of symptoms in patients with depressive disorder. Patients who met the International Classification of Diseases, 10th revision, research criteria for depressive disorder were enrolled in this cross-sectional study. All outpatients completed the following measurements: the Quality of Life Enjoyment and Satisfaction Questionnaire, the Internalized Stigma of Mental Illness Scale, demographic questionnaire, and the objective and subjective Clinical Global Impression-Severity scales that measure the severity of disorder. A total of 81 depressive disorder patients (with persistent affective disorder - dysthymia, major depressive disorder, or recurrent depressive disorder) and 43 healthy controls participated in this study. Compared with the healthy control group, a lower QoL was observed in patients with depressive disorder. The level of self-stigma correlated positively with total symptom severity score and negatively with QoL. Multiple regression analysis revealed that the overall rating of objective symptom severity and score of self-stigma were significantly associated with QoL. This study suggests a lower QoL in patients with depressive disorder in comparison with healthy controls and a negative impact of self-stigma level on QoL in patients suffering from depressive disorders.

  20. A systematic review of the quality of statistical methods employed for analysing quality of life data in cancer randomised controlled trials.

    PubMed

    Hamel, Jean-Francois; Saulnier, Patrick; Pe, Madeline; Zikos, Efstathios; Musoro, Jammbe; Coens, Corneel; Bottomley, Andrew

    2017-09-01

    Over the last decades, Health-related Quality of Life (HRQoL) end-points have become an important outcome of the randomised controlled trials (RCTs). HRQoL methodology in RCTs has improved following international consensus recommendations. However, no international recommendations exist concerning the statistical analysis of such data. The aim of our study was to identify and characterise the quality of the statistical methods commonly used for analysing HRQoL data in cancer RCTs. Building on our recently published systematic review, we analysed a total of 33 published RCTs studying the HRQoL methods reported in RCTs since 1991. We focussed on the ability of the methods to deal with the three major problems commonly encountered when analysing HRQoL data: their multidimensional and longitudinal structure and the commonly high rate of missing data. All studies reported HRQoL being assessed repeatedly over time for a period ranging from 2 to 36 months. Missing data were common, with compliance rates ranging from 45% to 90%. From the 33 studies considered, 12 different statistical methods were identified. Twenty-nine studies analysed each of the questionnaire sub-dimensions without type I error adjustment. Thirteen studies repeated the HRQoL analysis at each assessment time again without type I error adjustment. Only 8 studies used methods suitable for repeated measurements. Our findings show a lack of consistency in statistical methods for analysing HRQoL data. Problems related to multiple comparisons were rarely considered leading to a high risk of false positive results. It is therefore critical that international recommendations for improving such statistical practices are developed. Copyright © 2017. Published by Elsevier Ltd.

  1. 13 CFR 130.330 - Operating requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... assessment and evaluation, and internal quality control. (c) The Lead Center shall be open to the public... provide administrative services and coordination for the SBDC network, including program development... Project Officer as soon as is feasible. Other SBDC service providers shall be open during the normal...

  2. 7 CFR 1767.70 - Record storage media.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF... retention period provided for in the master index of records, unless there is a quality transfer from one... for accuracy and documented. (b) Each borrower shall implement internal control procedures that assure...

  3. 75 FR 22412 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-28

    ... relationships and supply chain control, as well as expectations from global regulators. Pharmaceutical companies...; Quality Agreement Development throughout the product and process lifecycle; Supply Chain Transparency and Pedigree; How to Audit the Supply Chain; Rx-360 and International Pharmaceutical Excipients Council...

  4. 78 FR 38983 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

    ... specialties: clinical nurse specialist, nurse practitioner, certified nurse anesthetist, certified nurse... a decision aid for dialysis facility selection; (2) aid facilities with their internal quality... a new OMB control number); Title of Information Collection: Evaluation of the Graduate Nurse...

  5. HIV Interventions to Reduce HIV/AIDS Stigma: A Systematic Review

    PubMed Central

    Banks, Bahby; Jonas, Dan; Miles, Margaret Shandor; Smith, Giselle Corbie

    2011-01-01

    We reviewed the literature to determine the effectiveness of HIV-related interventions in reducing HIV/AIDS stigma. Studies selected had randomized controlled trial (RCT), pretest–posttest with a non-randomized control group, or pretest–posttest one group study designs in which HIV-related interventions were being evaluated, and in which HIV/AIDS stigma was one of the outcomes being measured. A checklist was used to extract data from accepted studies, assess their internal validity, and overall quality. Data were extracted from 19 studies, and 14 of these studies demonstrated effectiveness in reducing HIV/ AIDS stigma. Only 2 of these 14 effective studies were considered good studies, based on quality, the extent to which the intervention focused on reducing HIV/AIDS stigma, and the statistics reported to demonstrate effectiveness. Future studies to reduce HIV/AIDS stigma could improve by designing interventions that pay greater attention to internal validity, use validated HIV/AIDS stigma instruments, and achieve both statistical and public health significance. PMID:21088989

  6. Analysis of the Ability of United States and Russian Trace Contaminant Control Systems to Meet U.S. 180-Day and Russian 360-Day Spacecraft Maximum Allowable Concentrations

    NASA Technical Reports Server (NTRS)

    Perry, J. L.

    2016-01-01

    As the Space Station Freedom program transitioned to become the International Space Station (ISS), uncertainty existed concerning the performance capabilities for U.S.- and Russian-provided trace contaminant control (TCC) equipment. In preparation for the first dialogue between NASA and Russian Space Agency personnel in Moscow, Russia, in late April 1994, an engineering analysis was conducted to serve as a basis for discussing TCC equipment engineering assumptions as well as relevant assumptions on equipment offgassing and cabin air quality standards. The analysis presented was conducted as part of the efforts to integrate Russia into the ISS program via the early ISS Multilateral Medical Operations Panel's Air Quality Subgroup deliberations. This analysis, served as a basis for technical deliberations that established a framework for TCC system design and operations among the ISS program's international partners that has been instrumental in successfully managing the ISS common cabin environment.

  7. HIV interventions to reduce HIV/AIDS stigma: a systematic review.

    PubMed

    Sengupta, Sohini; Banks, Bahby; Jonas, Dan; Miles, Margaret Shandor; Smith, Giselle Corbie

    2011-08-01

    We reviewed the literature to determine the effectiveness of HIV-related interventions in reducing HIV/AIDS stigma. Studies selected had randomized controlled trial (RCT), pretest-posttest with a non-randomized control group, or pretest-posttest one group study designs in which HIV-related interventions were being evaluated, and in which HIV/AIDS stigma was one of the outcomes being measured. A checklist was used to extract data from accepted studies, assess their internal validity, and overall quality. Data were extracted from 19 studies, and 14 of these studies demonstrated effectiveness in reducing HIV/AIDS stigma. Only 2 of these 14 effective studies were considered good studies, based on quality, the extent to which the intervention focused on reducing HIV/AIDS stigma, and the statistics reported to demonstrate effectiveness. Future studies to reduce HIV/AIDS stigma could improve by designing interventions that pay greater attention to internal validity, use validated HIV/AIDS stigma instruments, and achieve both statistical and public health significance.

  8. Using internal marketing to improve organizational commitment and service quality.

    PubMed

    Tsai, Yafang; Wu, Shih-Wang

    2011-12-01

    The purpose of this article was to explore the structural relationships among internal marketing, organizational commitment and service quality and to practically apply the findings. Internal marketing is a way to assist hospitals in improving the quality of the services that they provide while executing highly labour-intensive tasks. Through internal marketing, a hospital can enhance the organizational commitment of its employees to attain higher service quality. This research uses a cross-sectional study to survey nursing staff perceptions about internal marketing, organizational commitment and service quality. The results of the survey are evaluated using equation models. The sample includes three regional hospitals in Taiwan. Three hundred and fifty questionnaires were distributed and 288 valid questionnaires were returned, yielding a response rate of 82.3%. The survey process lasted from 1 February to 9 March 2007. The data were analysed with SPSS 12.0, including descriptive statistics based on demographics. In addition, the influence of demographics on internal marketing, organizational commitment and service quality is examined using one-way anova. The findings reveal that internal marketing plays a critical role in explaining employee perceptions of organizational commitment and service quality. Organizational commitment is the mediator between internal marketing and service quality. The results indicate that internal marketing has an impact on both organizational commitment and service quality. Internal marketing should be emphasized to influence frontline nursing staff, thereby helping to create better organizational commitment and service quality. © 2011 The Authors. Journal of Advanced Nursing © 2011 Blackwell Publishing Ltd.

  9. Optimization-based controller design for rotorcraft

    NASA Technical Reports Server (NTRS)

    Tsing, N.-K.; Fan, M. K. H.; Barlow, J.; Tits, A. L.; Tischler, M. B.

    1993-01-01

    An optimization-based methodology for linear control system design is outlined by considering the design of a controller for a UH-60 rotorcraft in hover. A wide range of design specifications is taken into account: internal stability, decoupling between longitudinal and lateral motions, handling qualities, and rejection of windgusts. These specifications are investigated while taking into account physical limitations in the swashplate displacements and rates of displacement. The methodology crucially relies on user-machine interaction for tradeoff exploration.

  10. Correlates of Nocturia and Relationships of Nocturia With Sleep Quality and Glycemic Control in Women With Type 2 Diabetes.

    PubMed

    Chang, Chun-Jen; Pei, Dee; Wu, Chien-Chih; Palmer, Mary H; Su, Ching-Chieh; Kuo, Shu-Fen; Liao, Yuan-Mei

    2017-07-01

    To explore correlates of nocturia, compare sleep quality and glycemic control for women with and without nocturia, and examine relationships of nocturia with sleep quality and glycemic control in women with diabetes. This study was a cross-sectional, correlational study with data collected from 275 women with type 2 diabetes. Data were collected using a structured questionnaire. Multivariate logistic regression analyses were used to identify correlates. Chi-squared tests were used to identify candidate variables for the first logistic regression model. A one-way analysis of variance was used to compare sleep quality and glycemic control for women with and those without nocturia. Pearson correlations were used to examine the relationships of nocturia with sleep quality and glycemic control. Of the 275 participants, 124 (45.1%) had experienced nocturia (at least two voids per night). Waist circumference, parity, time since diagnosis of diabetes, sleep quality, and increased daytime urinary frequency were correlated with nocturia after adjusting for age. Compared to women without nocturia, women who had nocturia reported poorer sleep quality. A significant correlation was found between the number of nocturnal episodes and sleep quality. Nocturia and poor sleep are common among women with diabetes. The multifactorial nature of nocturia supports the delivered management and treatments being targeted to underlying etiologies in order to optimize women's symptom management. Interventions aimed at modifiable correlates may include maintaining a normal body weight and regular physical exercise for maintaining a normal waist circumference, and decreasing caffeine consumption, implementing feasible modifications in sleeping environments and maintaining sleep hygiene to improve sleep quality. Healthcare professionals should screen for nocturia and poor sleep and offer appropriate nonpharmacological lifestyle management, behavioral interventions, or pharmacotherapy for women with diabetes. © 2017 Sigma Theta Tau International.

  11. Quality control in mutation analysis: the European Molecular Genetics Quality Network (EMQN).

    PubMed

    Müller, C R

    2001-08-01

    The demand for clinical molecular genetics testing has steadily grown since its introduction in the 1980s. In order to reach and maintain the agreed quality standards of laboratory medicine, the same internal and external quality assurance (IQA/EQA) criteria have to be applied as for "conventional" clinical chemistry or pathology. In 1996 the European Molecular Genetics Quality Network (EMQN) was established in order to spread QA standards across Europe and to harmonise the existing national activities. EMQN is operated by a central co-ordinator and 17 national partners from 15 EU countries; since 1998 it is being funded by the EU commission for a 3-year period. EMQN promotes QA by two tools: by providing disease-specific best practice meetings (BPM) and EQA schemes. A typical BPM is focussed on one disease or group of related disorders. International experts report on the latest news of gene characterisation and function and the state-of-the-art techniques for mutation detection. Disease-specific EQA schemes are provided by experts in the field. DNA samples are sent out together with mock clinical referrals and a diagnostic question is asked. Written reports must be returned which are marked for genotyping and interpretation. So far, three BPMs have been held and six EQA schemes are in operation at various stages. Although mutation types and diagnostic techniques varied considerably between schemes, the overall technical performance showed a high diagnostic standard. Nevertheless, serious genotyping errors have been occurred in some schemes which underline the necessity of quality assurance efforts. The European Molecular Genetics Quality Network provides a necessary platform for the internal and external quality assurance of molecular genetic testing.

  12. Quantitative monitoring of HCMV DNAlactia in human milk by real time PCR assay: Implementation of internal control contributes to standardization and quality control.

    PubMed

    Hartleif, Steffen; Göhring, Katharina; Goelz, Rangmar; Jahn, Gerhard; Hamprecht, Klaus

    2016-11-01

    For cytomegalovirus screening of breastfeeding mothers of preterm infants under risk, we present a rapid, quantitative real-time PCR protocol using the hybridization format of the viral gB target region. For quantification, we used an external gB fragment cloned into a vector system. For standardization, we created an internal control-plasmid by site-directed mutagenesis with an exchange of 9 nucleotides. Spiked with internal control, patient wildtype amplicons could be discriminated from internal controls by hybridization probes using two-channel fluorescence detection. Potential bias of formerly reported false nucleotide sequence data of gB-hybridization probes was excluded. Using this approach, we could demonstrate excellent analytical performance and high reproducibility of HCMV detection during lactation. This assay shows very good correlation with a commercial quantitative HCMV DNA PCR and may help to identify rapidly HCMV shedding mothers of very low birth weight preterm infants to prevent HCMV transmission. On the other hand, negative DNA amplification results allow feeding of milk samples of seropositive mothers to their preterm infants under risk (<30 weeks of gestational age, <1000g birth weight) during the onset and late stage of HCMV shedding during lactation. Copyright © 2016 Elsevier B.V. All rights reserved.

  13. Implementation of buffy-coat-derived pooled platelet concentrates for internal quality control of light transmission aggregometry: a proof of concept study.

    PubMed

    Prüller, F; Rosskopf, K; Mangge, H; Mahla, E; von Lewinski, D; Weiss, E C; Riegler, A; Enko, D

    2017-12-01

    Essentials In platelet function testing, standardized internal controls (IQC) are not commercially provided. Platelet function testing was performed daily on aliquoted pooled platelet concentrates. Pooled platelet concentrates showed stability for control purposes from Monday to Friday. Pooled platelet concentrates provide the necessary steadiness to serve as IQC material. Background Standardized commercially available control material for internal quality control (IQC) of light transmission aggregometry (LTA) is still lacking. Moreover, the availability of normal blood donors to provide fresh platelets is difficult in small laboratories, where 'volunteers' may be in short supply. Objectives To evaluate the implementation of buffy-coat-derived pooled platelet concentrates (PCs) for IQC material for LTA. Methods We used buffy-coat-derived pooled PCs from the blood bank as IQC material for LTA. On each weekend one PC was prepared (> 200 mL) and aliquoted from the original storage bag on a daily basis in four baby bags (40-50 mL), which were delivered from Monday to Friday to our laboratory. The IQC measurements of at least 85 work-weeks (from Monday to Friday) were evaluated with this new IQC material. LTA was performed on a four-channel Chronolog 700 Aggregometer (Chronolog Corporation, Havertown, PA, USA) (agonists: collagen, adenosine diphosphate [ADP], arachidonic acid [AA] and thrombin receptor activator peptide-6 [TRAP-6]). Results The medians of platelet aggregation from IQC measurements with collagen, ADP and AA from Monday to Friday were 68.0-59.5, 3.0-2.0 and 51.0-50.0%, respectively, and the mean of platelet aggregation with TRAP-6 was 71.2-66.4%. Conclusions Buffy-coat-derived pooled PCs serve as a reliable and robust IQC material for LTA measurements and would be beneficial for the whole laboratory procedure and employees' safety. © 2017 International Society on Thrombosis and Haemostasis.

  14. [IMPLEMENTATION OF A QUALITY MANAGEMENT SYSTEM IN A NUTRITION UNIT ACCORDING TO ISO 9001:2008].

    PubMed

    Velasco Gimeno, Cristina; Cuerda Compés, Cristina; Alonso Puerta, Alba; Frías Soriano, Laura; Camblor Álvarez, Miguel; Bretón Lesmes, Irene; Plá Mestre, Rosa; Izquierdo Membrilla, Isabel; García-Peris, Pilar

    2015-09-01

    the implementation of quality management systems (QMS) in the health sector has made great progress in recent years, remains a key tool for the management and improvement of services provides to patients. to describe the process of implementing a quality management system (QMS) according to the standard ISO 9001:2008 in a Nutrition Unit. the implementation began in October 2012. Nutrition Unit was supported by Hospital Preventive Medicine and Quality Management Service (PMQM). Initially training sessions on QMS and ISO standards for staff were held. Quality Committee (QC) was established with representation of the medical and nursing staff. Every week, meeting took place among members of the QC and PMQM to define processes, procedures and quality indicators. We carry on a 2 months follow-up of these documents after their validation. a total of 4 processes were identified and documented (Nutritional status assessment, Nutritional treatment, Monitoring of nutritional treatment and Planning and control of oral feeding) and 13 operating procedures in which all the activity of the Unit were described. The interactions among them were defined in the processes map. Each process has associated specific quality indicators for measuring the state of the QMS, and identifying opportunities for improvement. All the documents associated with requirements of ISO 9001:2008 were developed: quality policy, quality objectives, quality manual, documents and records control, internal audit, nonconformities and corrective and preventive actions. The unit was certified by AENOR in April 2013. the implementation of a QMS causes a reorganization of the activities of the Unit in order to meet customer's expectations. Documenting these activities ensures a better understanding of the organization, defines the responsibilities of all staff and brings a better management of time and resources. QMS also improves the internal communication and is a motivational element. Explore the satisfaction and expectations of patients can include their view in the design of care processes. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  15. Assessing relationship quality in mandated community treatment: blending care with control.

    PubMed

    Skeem, Jennifer L; Louden, Jennifer Eno; Polaschek, Devon; Camp, Jacqueline

    2007-12-01

    Traditional measures of the therapeutic alliance do not capture the dual roles inherent in relationships with involuntary clients. Providers not only care for, but also have control over, involuntary clients. In 2 studies of probationers mandated to psychiatric treatment (n=90; n=322), the authors developed and validated the revised Dual-Role Relationships Inventory (DRI-R). The authors found that (a) relationship quality in mandated treatment involves caring and fairness, trust, and an authoritative (not authoritarian) style, (b) the DRI-R assesses these domains of relationship quality, is internally consistent, and relates in a theoretically coherent pattern with ratings of within-session behavior and with measures of the therapeutic alliance, relationship satisfaction, symptoms, and treatment motivation, and (c) the quality of dual-role relationships predicts future compliance with the rules, as assessed by probation violations and revocation. The DRI-R covaries with multiple domains more strongly than a leading measure of the therapeutic alliance, suggesting that it better captures the nature and effect of relationship quality in mandated treatment.

  16. Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal.

    PubMed

    Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M Juliana; Hural, John

    2014-07-01

    The HIV Vaccine Trials Network (HVTN) is a global network of 28 clinical trial sites dedicated to identifying an effective HIV vaccine. Cryopreservation of high-quality peripheral blood mononuclear cells (PBMC) is critical for the assessment of vaccine-induced cellular immune functions. The HVTN PBMC Quality Management Program is designed to ensure that viable PBMC are processed, stored and shipped for clinical trial assays from all HVTN clinical trial sites. The program has evolved by developing and incorporating best practices for laboratory and specimen quality and implementing automated, web-based tools. These tools allow the site-affiliated processing laboratories and the central Laboratory Operations Unit to rapidly collect, analyze and report PBMC quality data. The HVTN PBMC Quality Management Program includes five key components: 1) Laboratory Assessment, 2) PBMC Training and Certification, 3) Internal Quality Control, 4) External Quality Control (EQC), and 5) Assay Specimen Quality Control. Fresh PBMC processing data is uploaded from each clinical site processing laboratory to a central HVTN Statistical and Data Management Center database for access and analysis on a web portal. Samples are thawed at a central laboratory for assay or specimen quality control and sample quality data is uploaded directly to the database by the central laboratory. Four year cumulative data covering 23,477 blood draws reveals an average fresh PBMC yield of 1.45×10(6)±0.48 cells per milliliter of useable whole blood. 95% of samples were within the acceptable range for fresh cell yield of 0.8-3.2×10(6) cells/ml of usable blood. Prior to full implementation of the HVTN PBMC Quality Management Program, the 2007 EQC evaluations from 10 international sites showed a mean day 2 thawed viability of 83.1% and a recovery of 67.5%. Since then, four year cumulative data covering 3338 specimens used in immunologic assays shows that 99.88% had acceptable viabilities (>66%) for use in cellular assays (mean, 91.46% ±4.5%), and 96.2% had acceptable recoveries (50%-130%) with a mean of recovery of 85.8% ±19.12% of the originally cryopreserved cells. EQC testing revealed that since August 2009, failed recoveries dropped from 4.1% to 1.6% and failed viabilities dropped from 1.0% to 0.3%. The HVTN PBMC quality program provides for laboratory assessment, training and tools for identifying problems, implementing corrective action and monitoring for improvements. These data support the benefits of implementing a comprehensive, web-based PBMC quality program for large clinical trials networks. Copyright © 2014 Elsevier B.V. All rights reserved.

  17. Comprehensive Auditing in Nuclear Medicine Through the International Atomic Energy Agency Quality Management Audits in Nuclear Medicine Program. Part 2: Analysis of Results.

    PubMed

    Dondi, Maurizio; Torres, Leonel; Marengo, Mario; Massardo, Teresa; Mishani, Eyal; Van Zyl Ellmann, Annare; Solanki, Kishor; Bischof Delaloye, Angelika; Lobato, Enrique Estrada; Miller, Rodolfo Nunez; Ordonez, Felix Barajas; Paez, Diana; Pascual, Thomas

    2017-11-01

    The International Atomic Energy Agency has developed a program, named Quality Management Audits in Nuclear Medicine (QUANUM), to help its Member States to check the status of their nuclear medicine practices and their adherence to international reference standards, covering all aspects of nuclear medicine, including quality assurance/quality control of instrumentation, radiopharmacy (further subdivided into levels 1, 2, and 3, according to complexity of work), radiation safety, clinical applications, as well as managerial aspects. The QUANUM program is based on both internal and external audits and, with specifically developed Excel spreadsheets, it helps assess the level of conformance (LoC) to those previously defined quality standards. According to their level of implementation, the level of conformance to requested standards; 0 (absent) up to 4 (full conformance). Items scored 0, 1, and 2 are considered non-conformance; items scored 3 and 4 are considered conformance. To assess results of the audit missions performed worldwide over the last 8 years, a retrospective analysis has been run on reports from a total of 42 audit missions in 39 centers, three of which had been re-audited. The analysis of all audit reports has shown an overall LoC of 73.9 ± 8.3% (mean ± standard deviation), ranging between 56.6% and 87.9%. The highest LoC has been found in the area of clinical services (83.7% for imaging and 87.9% for therapy), whereas the lowest levels have been found for Radiopharmacy Level 2 (56.6%); Computer Systems and Data Handling (66.6%); and Evaluation of the Quality Management System (67.6%). Prioritization of non-conformances produced a total of 1687 recommendations in the final audit report. Depending on the impact on safety and daily clinical activities, they were further classified as critical (requiring immediate action; n = 276; 16% of the total); major (requiring action in relatively short time, typically from 3 to 6 months; n = 604; 36%); whereas the remaining 807 (48%) were classified as minor, that is, to be addressed whenever possible. The greatest proportion of recommendations has been found in the category "Managerial, Organization and Documentation" (26%); "Staff Radiation Protection and Safety" (17.3%); "Radiopharmaceuticals Preparation, Dispensing and Handling" (15.8%); and "Quality Assurance/Quality Control" and "Management of Equipment and Software" (11.4%). The lowest level of recommendations belongs to the item "Human Resources" (4%). The QUANUM program proved applicable to a wide variety of institutions, from small practices to larger centers with PET/CT and cyclotrons. Clinical services rendered to patients showed a good compliance with international standards, whereas issues related to radiation protection of both staff and patients will require a higher degree of attention. This is a relevant feedback for the International Atomic Energy Agency with regard to the effective translation of safety recommendations into routine practice. Training on drafting and application of standard operating procedures should also be considered a priority. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  18. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2011-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

  19. [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.

  20. The quest for quality blood banking program in the new millennium the American way.

    PubMed

    Kim, Dae Un

    2002-08-01

    For an industry to succeed and satisfy its customers, "QUALITY" must be a primary goal. Quality has been central to blood banking from its inception, with the evolution of a Quality Program since the opening of the first blood bank in U.S. at the Cook County Hospital in 1937. Over the ensuing decades, continuous scientific progress in blood preservation, filters, viral and blood group testing, crossmatching, automation, and computerization including bar coding, etc. has contributed to the quality and safety of the blood products and transfusion service. However, with the advent of the AIDS era, an increasingly sensitized and informed public is continuously demanding that the highest level of quality be achieved and maintained in all processes involved in providing all blood products. The Food and Drug Administration (FDA) introduced the concept of a "zero risk blood supply" as the industry goal. Furthermore, the cost containment and resource-constrained environment have changed the complexity of the quality practice. Both regulatory agencies such as the FDA, the Health Care Financing Administration [HCFA, which was recently renamed as the Centers for Medicare and Medicaid Services (CMS) in July, 2001], and the State Department of Health, and accrediting agencies, such as the American Association of Blood Banks (AABB), the College of American Pathologists (CAP), and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), require blood banks and transfusion services to establish and follow a Quality Control and Quality Assurance Program for their licensing, certification and accreditation. Every laboratory has to comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) quality requirements being implemented by the CMS. The FDA guidelines assist facilities in compliance with Current Good Manufacturing Practices (cGMP). The AABB's Quality System Essentials (QSE) are based on these specifications and provide additional guidance in implementing practices that assure quality and compliance with cGMP. AABB and CAP are granted "deemed status" as accrediting organizations under the CLIA '88 program by CMS, as well as JCAHO and some states. The International Standards Organization (ISO) has established international standards in most fields. The U.S. is represented in ISO by the American National Standards Institute (ANSI), and the National Committee for Clinical Laboratory Standards (NCCLS), as a global organization headquartered in the U.S., is a member of ANSI. The FDA and the AABB had begun incorporating many ISO principles into their own regulations and standards. The AABB's 10 QSEs are rooted in the 20 clauses of ISO 9000 series and compatible with their standards. In a Maslow-type model quality hierarchy by Tsiakals, so far the bottom three of the five progressive levels, Quality Control for method control, Quality Assurance for process control, and Quality System for system control have been implemented just to meet the regulatory and accrediting requirements. The next higher level, Quality Management for financial control, and the ultimate highest level, Total Quality Management for strategic control, should be our quest in this new millennium, and with the help of the AABB, ISO, FDA and all other organizations, we will achieve it. We should change our approach to quality issues from detection to prevention. We should improve the quality in transfusion practice itself by effective utilization of blood as a therapeutic resource with clear indication, maximum surgical blood order schedule, alternative transfusion such as autologous transfusion, hemodilution, and intra/post-operative blood salvage, surgical hemostasis, pharmacological hemostasis, and synthetic erythropoietin. Most importantly, implementation of the Quality Program should be something that we want to do rather than simply a burden that we have to do. A well-managed Quality Program is an effective and cost-efficient operation for the blood banks and transfusion services, and will enable us to better serve the patients for whom we exist.

  1. Alining Large Cylinders for Welding

    NASA Technical Reports Server (NTRS)

    Ehl, J. H.

    1985-01-01

    Special tooling alines and holds internally-stiffened large-diameter cylindrical parts for welding. Alinement brackets attached to strengthening fins on insides of cylindrical tank sections. Jackscrews on brackets raised or lowered to eliminate mismatches between adjacent sections. Tooling substantially reduces costs while allowing more precise control and improved quality.

  2. Combining genomic approaches to understand genetic control of aflatoxin contamination in peanut

    USDA-ARS?s Scientific Manuscript database

    Aflatoxin contamination in peanut is more prevalent under rainfed conditions making produce unfit for human and animal consumption, affecting the international trade adversely. Although the losses in yield and quality due to aflatoxin contamination is higher than realized, there are limited resistan...

  3. 42 CFR 422.4 - Types of MA plans.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... availability, service area, and quality. (ii) Coordinated care plans may include mechanisms to control... requirements of sections 138 and 220 of the Internal Revenue Code. (3) MA private fee-for-service plan. An MA... Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

  4. 13 CFR 120.1050 - On-site reviews and examinations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... operations management; (3) Credit administration; and (4) Compliance with Loan Program Requirements. (b) On... reviews. SBA may conduct on-site reviews of the SBA loan operations of SBA Lenders. The on-site review may... losses); (3) Management quality (including internal controls, loan portfolio management, and asset...

  5. Vector and reservoir control for preventing leishmaniasis

    PubMed Central

    González, Urbà; Pinart, Mariona; Sinclair, David; Firooz, Alireza; Enk, Claes; Vélez, Ivan D; Esterhuizen, Tonya M; Tristan, Mario; Alvar, Jorge

    2015-01-01

    Background Leishmaniasis is caused by the Leishmania parasite, and transmitted by infected phlebotomine sandflies. Of the two distinct clinical syndromes, cutaneous leishmaniasis (CL) affects the skin and mucous membranes, and visceral leishmaniasis (VL) affects internal organs. Approaches to prevent transmission include vector control by reducing human contact with infected sandflies, and reservoir control, by reducing the number of infected animals. Objectives To assess the effects of vector and reservoir control interventions for cutaneous and for visceral leishmaniasis. Search methods We searched the following databases to 13 January 2015: Cochrane Infectious Diseases Group Specialized Register, CENTRAL, MEDLINE, EMBASE, LILACS and WHOLIS, Web of Science, and RePORTER. We also searched trials registers for ongoing trials. Selection criteria Randomized controlled trials (RCTs) evaluating the effects of vector and reservoir control interventions in leishmaniasis-endemic regions. Data collection and analysis Two review authors independently searched for trials and extracted data from included RCTs. We resolved any disagreements by discussion with a third review author. We assessed the quality of the evidence using the GRADE approach. Main results We included 14 RCTs that evaluated a range of interventions across different settings. The study methods were generally poorly described, and consequently all included trials were judged to be at high or unclear risk of selection and reporting bias. Only seven trials reported clinical outcome data which limits our ability to make broad generalizations to different epidemiological settings and cultures. Cutaneous leishmaniasis One four-arm RCT from Afghanistan compared indoor residual spraying (IRS), insecticide-treated bednets (ITNs), and insecticide-treated bedsheets, with no intervention. Over 15 months follow-up, all three insecticide-based interventions had a lower incidence of CL than the control area (IRS: risk ratio (RR) 0.61, 95% confidence interval (CI) 0.38 to 0.97, 2892 participants, moderate quality evidence; ITNs: RR 0.32, 95% CI 0.18 to 0.56, 2954 participants, low quality evidence; ITS: RR 0.34, 95% CI 0.20 to 0.57, 2784 participants, low quality evidence). No difference was detected between the three interventions (low quality evidence). One additional trial of ITNs from Iran was underpowered to show a difference. Insecticide treated curtains were compared with no intervention in one RCT from Venezuela, where there were no CL episodes in the intervention areas over 12 months follow-up compared to 142 in control areas (RR 0.00, 95% CI 0.00 to 0.49, one trial, 2938 participants, low quality evidence). Personal protection using insecticide treated clothing was evaluated by two RCTs in soldiers, but the trials were underpowered to reliably detect effects on the incidence of CL (RR 0.40, 95% CI 0.13 to 1.20, two trials, 558 participants, low quality evidence). Visceral leishmaniasis In a single RCT of ITNs versus no intervention from India and Nepal, the incidence of VL was low in both groups and no difference was detected (RR 0.99, 95% CI 0.46 to 2.15, one trial, 19,810 participants, moderate quality evidence). Two trials from Brazil evaluated the effects of culling infected dogs compared to no intervention or IRS. Although they report a reduction in seroconversion over 18 months follow-up, they did not measure or report effects on clinical disease. Authors' conclusions Using insecticides to reduce phlebotomine sandfly numbers may be effective at reducing the incidence of CL, but there is insufficient evidence from trials to know whether it is better to spray the internal walls of houses or to treat bednets, curtains, bedsheets or clothing. PLAIN LANGUAGE SUMMARY Vector and reservoir control for preventing leishmaniasis This review summarises trials evaluating different measures to prevent leishmaniasis. After searching for relevant trials up to January 2015, we included 14 randomized controlled trials. What is vector and reservoir control and how might they prevent leishmaniasis? Leishmaniasis is a group of infectious diseases caused by Leishmania parasites, which are transmitted between humans and animals by the bite of infected phlebotomine sandflies. There are two main clinical diseases: cutaneous leishmaniasis (CL), where parasites infect the skin, and visceral leishmaniasis (VL), where they infect the internal organs. Leishmaniasis could be prevented by reducing human contact with infected phlebotomine sandflies (the vector), or by reducing the number of infected animals (the reservoir). What the research says? Cutaneous leishmaniasis Using insecticides to reduce the number of sandflies may be effective at reducing the number of new cases of cutaneous leishmaniasis (low quality evidence). However, there is not enough evidence to know whether it is better to use insecticides to spray the internal walls of houses, or use insecticide treated bednets, bedsheets, or curtains. Personal protection using insecticide treated clothing was also evaluated in two small trials in soldiers, but the trials were too small to know whether this was effective (low quality evidence). Visceral leishmaniasis Insecticide treated nets may not be effective at preventing visceral leishmaniasis but this has only been tested in a single trial from India and Nepal (low quality evidence). Although culling dogs is sometimes discussed as a potential way to reduce visceral leishmaniasis, this has not been tested in trials measuring clinical disease. PMID:26246011

  6. Internal medicine residency redesign: proposal of the Internal Medicine Working Group.

    PubMed

    Horwitz, Ralph I; Kassirer, Jerome P; Holmboe, Eric S; Humphrey, Holly J; Verghese, Abraham; Croft, Carol; Kwok, Minjung; Loscalzo, Joseph

    2011-09-01

    Concerned with the quality of internal medicine training, many leaders in the field assembled to assess the state of the residency, evaluate the decline in interest in the specialty, and create a framework for invigorating the discipline. Although many external factors are responsible, we also found ourselves culpable: allowing senior role models to opt out of important training activities, ignoring a progressive atrophy of bedside skills, and focusing on lock-step curricula, lectures, and compiled diagnostic and therapeutic strategies. The group affirmed its commitment to a vision of internal medicine rooted in science and learned with mentors at the bedside. Key factors for new emphasis include patient-centered small group teaching, greater incorporation of clinical epidemiology and health services research, and better schedule control for trainees. Because previous proposals were weakened by lack of evidence, we propose to organize the Cooperative Educational Studies Group, a pool of training programs that will collect a common data set describing their programs, design interventions to be tested rigorously in multi-methodological approaches, and at the same time produce knowledge about high-quality practice. Copyright © 2011 Elsevier Inc. All rights reserved.

  7. Associations of Mothers’ Friendship Quality with Adolescents’ Friendship Quality and Emotional Adjustment

    PubMed Central

    Glick, Gary C.; Rose, Amanda J.; Swenson, Lance P.; Waller, Erika M.

    2012-01-01

    Little research has examined the association of parents’ friendships with adolescent’s well-being, perhaps because the association was considered too distal. However, developmental theories suggest that contexts in which parents, but not their children, are situated may be related to child development (Bronfenbrenner, 1979; 1986). The current work examined associations between the quality of mothers’ own friendships and their adolescent children’s friendship quality and emotional adjustment. Fifth-, eighth-, and eleventh-graders (N = 172) whose mothers’ friendships were characterized by conflict and antagonism reported having friendships that were high in negative friendship qualities as well as elevated internalizing symptoms. These associations held after controlling for mother-child relationship quality, suggesting that mothers’ friendships may have a unique association with adolescents’ adjustment. PMID:24348001

  8. MODIS. Volume 1: MODIS level 1A software baseline requirements

    NASA Technical Reports Server (NTRS)

    Masuoka, Edward; Fleig, Albert; Ardanuy, Philip; Goff, Thomas; Carpenter, Lloyd; Solomon, Carl; Storey, James

    1994-01-01

    This document describes the level 1A software requirements for the moderate resolution imaging spectroradiometer (MODIS) instrument. This includes internal and external requirements. Internal requirements include functional, operational, and data processing as well as performance, quality, safety, and security engineering requirements. External requirements include those imposed by data archive and distribution systems (DADS); scheduling, control, monitoring, and accounting (SCMA); product management (PM) system; MODIS log; and product generation system (PGS). Implementation constraints and requirements for adapting the software to the physical environment are also included.

  9. Implementation of Quality Systems in Nuclear Medicine: Why It Matters. An Outcome Analysis (Quality Management Audits in Nuclear Medicine Part III).

    PubMed

    Dondi, Maurizio; Paez, Diana; Torres, Leonel; Marengo, Mario; Delaloye, Angelika Bischof; Solanki, Kishor; Van Zyl Ellmann, Annare; Lobato, Enrique Estrada; Miller, Rodolfo Nunez; Giammarile, Francesco; Pascual, Thomas

    2018-05-01

    The International Atomic Energy Agency (IAEA) developed a comprehensive program-Quality Management Audits in Nuclear Medicine (QUANUM). This program covers all aspects of nuclear medicine practices including, but not limited to, clinical practice, management, operations, and services. The QUANUM program, which includes quality standards detailed in relevant checklists, aims at introducing a culture of comprehensive quality audit processes that are patient oriented, systematic, and outcome based. This paper will focus on the impact of the implementation of QUANUM on daily routine practices in audited centers. Thirty-seven centers, which had been externally audited by experts under IAEA auspices at least 1 year earlier, were invited to run an internal audit using the QUANUM checklists. The external audits also served as training in quality management and the use of QUANUM for the local teams, which were responsible of conducting the internal audits. Twenty-five out of the 37 centers provided their internal audit report, which was compared with the previous external audit. The program requires that auditors score each requirement within the QUANUM checklists on a scale of 0-4, where 0-2 means nonconformance and 3-4 means conformance to international regulations and standards on which QUANUM is based. Our analysis covering both general and clinical areas assessed changes on the conformance status on a binary manner and the level of conformance scores. Statistical analysis was performed using nonparametric statistical tests. The evaluation of the general checklists showed a global improvement on both the status and the levels of conformances (P < 0.01). The evaluation of the requirements by checklist also showed a significant improvement in all, with the exception of Hormones and Tumor marker determinations, where changes were not significant. Of the 25 evaluated institutions, 88% (22 of 25) and 92% (23 of 25) improved their status and levels of conformance, respectively. Fifty-five requirements, on average, increased from nonconformance to conformance status. In 8 key areas, the number of improved requirements was well above the average: Administration & Management (checklist 2); Radiation Protection & Safety (checklist 4); General Quality Assurance system (checklist 6); Imaging Equipment Quality Assurance or Quality Control (checklist 7); General Diagnostic (checklist 9); General Therapeutic (checklist 12); Radiopharmacy Level 1 (checklist 14); and Radiopharmacy Level 2 (checklist 15). Analysis of results related to clinical activities showed an overall positive impact on both the status and the level of conformance to international standards. Similar results were obtained for the most frequently performed clinical imaging and therapeutic procedures. Our study shows that the implementation of a comprehensive quality management system through the IAEA QUANUM program has a positive impact on nuclear medicine practices. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  10. Metrology: Measurement Assurance Program Guidelines

    NASA Technical Reports Server (NTRS)

    Eicke, W. G.; Riley, J. P.; Riley, K. J.

    1995-01-01

    The 5300.4 series of NASA Handbooks for Reliability and Quality Assurance Programs have provisions for the establishment and utilization of a documented metrology system to control measurement processes and to provide objective evidence of quality conformance. The intent of these provisions is to assure consistency and conformance to specifications and tolerances of equipment, systems, materials, and processes procured and/or used by NASA, its international partners, contractors, subcontractors, and suppliers. This Measurement Assurance Program (MAP) guideline has the specific objectives to: (1) ensure the quality of measurements made within NASA programs; (2) establish realistic measurement process uncertainties; (3) maintain continuous control over the measurement processes; and (4) ensure measurement compatibility among NASA facilities. The publication addresses MAP methods as applied within and among NASA installations and serves as a guide to: control measurement processes at the local level (one facility); conduct measurement assurance programs in which a number of field installations are joint participants; and conduct measurement integrity (round robin) experiments in which a number of field installations participate to assess the overall quality of particular measurement processes at a point in time.

  11. Rotorcraft handling-qualities design criteria development

    NASA Technical Reports Server (NTRS)

    Aiken, Edwin W.; Lebacqz, J. Victor; Chen, Robert T. N.; Key, David L.

    1988-01-01

    Joint NASA/Army efforts at the Ames Research Center to develop rotorcraft handling-qualities design criteria began in earnest in 1975. Notable results were the UH-1H VSTOLAND variable stability helicopter, the VFA-2 camera-and-terrain-board simulator visual system, and the generic helicopter real-time mathematical model, ARMCOP. An initial series of handling-qualities studies was conducted to assess the effects of rotor design parameters, interaxis coupling, and various levels of stability and control augmentation. The ability to conduct in-flight handling-qualities research was enhanced by the development of the NASA/Army CH-47 variable-stability helicopter. Research programs conducted using this vehicle include vertical-response investigations, hover augmentation systems, and the effects of control-force characteristics. The handling-qualities data base was judged to be sufficient to allow an update of the military helicopter handling-qualities specification, MIL-H-8501. These efforts, including not only the in-house experimental work but also contracted research and collaborative programs performed under the auspices of various international agreements. The report concludes by reviewing the topics that are currently most in need of work, and the plans for addressing these topics.

  12. Evaluation of a redesign initiative in an internal-medicine residency.

    PubMed

    McMahon, Graham T; Katz, Joel T; Thorndike, Mary E; Levy, Bruce D; Loscalzo, Joseph

    2010-04-08

    Several organizations have advocated for comprehensive redesign of graduate medical training, but the effect that residency redesign will have on measures of patient satisfaction, resident and intern (trainee) satisfaction, and patient care is unknown. We designed an experimental inpatient-medicine service with reduced resident workload comprising two teams, with each team consisting of two attending physicians, two residents, and three interns. Attending physicians, selected for their teaching prowess, supervised the teams throughout the workday and during bedside team-teaching rounds. This experimental model was compared with a control model comprising two teams, with each consisting of one resident and two interns, plus multiple supervising attending physicians who volunteered to participate. Patients were alternately assigned to the experimental teams and the control teams, subject to limits on the number of patients interns are allowed to admit. Over a 12-month period, 1892 patients were assigned to the experimental teams and 2096 to the control teams; the average census per intern was 3.5 and 6.6 patients, respectively. Overall satisfaction was significantly higher among trainees on the experimental teams than among those on the control teams (78% and 55%, respectively; P=0.002). As compared with the control teams, the experimental teams were not associated with a higher average length of patient stay or readmission rate; adherence to standards for quality of inpatient care was similar in both groups of teams. Interns on the experimental teams spent more time in learning and teaching activities than did interns on the control teams (learning: 20% of total time vs. 10%, P=0.01; teaching: 8% of total time vs. 2%, P=0.006). As compared with a traditional inpatient care model, an experimental model characterized by reduced trainee workload and increased participation of attending physicians was associated with higher trainee satisfaction and increased time for educational activities. 2010 Massachusetts Medical Society

  13. Minutes: Accredited Standards Committee on Acoustics, S1 U.S. Tag for ISO/TC43 Acoustics and IEC/TC29 Electroacoustics

    DTIC Science & Technology

    1991-05-02

    international arena with respect to noise control technology and noise environmental quality In order to give you soma background into the work of the...14 a) A new working groug _S1/WG2Q Ground Impedance................ 14 b) Air Movement and Control Association. Inc. (AMCA...the Air Movement and Control Association (AMCA) on their inquiries concerning ANSI S1.11-1986 Specification for octave-band and fractional-octave-band

  14. Control Chart on Semi Analytical Weighting

    NASA Astrophysics Data System (ADS)

    Miranda, G. S.; Oliveira, C. C.; Silva, T. B. S. C.; Stellato, T. B.; Monteiro, L. R.; Marques, J. R.; Faustino, M. G.; Soares, S. M. V.; Ulrich, J. C.; Pires, M. A. F.; Cotrim, M. E. B.

    2018-03-01

    Semi-analytical balance verification intends to assess the balance performance using graphs that illustrate measurement dispersion, trough time, and to demonstrate measurements were performed in a reliable manner. This study presents internal quality control of a semi-analytical balance (GEHAKA BG400) using control charts. From 2013 to 2016, 2 weight standards were monitored before any balance operation. This work intended to evaluate if any significant difference or bias were presented on weighting procedure over time, to check the generated data reliability. This work also exemplifies how control intervals are established.

  15. International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab

    PubMed Central

    Prior, Sandra; Hufton, Simon E.; Dougall, Thomas; Rigsby, Peter; Bristow, Adrian

    2018-01-01

    ABSTRACT The intrinsic complexity and heterogeneity of therapeutic monoclonal antibodies is built into the biosimilarity paradigm where critical quality attributes are controlled in exhaustive comparability studies with the reference medicinal product. The long-term success of biosimilars will depend on reassuring healthcare professionals and patients of consistent product quality, safety and efficacy. With this aim, the World Health Organization has endorsed the need for public bioactivity standards for therapeutic monoclonal antibodies in support of current controls. We have developed a candidate international potency standard for rituximab that was evaluated in a multi-center collaborative study using participants' own qualified Fc-effector function and cell-based binding bioassays. Dose-response curve model parameters were shown to reflect similar behavior amongst rituximab preparations, albeit with some differences in potency. In the absence of a common reference standard, potency estimates were in poor agreement amongst laboratories, but the use of the candidate preparation significantly reduced this variability. Our results suggest that the candidate rituximab standard can support bioassay performance and improve data harmonization, which when implemented will promote consistency of rituximab products over their life-cycles. This data provides the first scientific evidence that a classical standardization exercise allowing traceability of bioassay data to an international standard is also applicable to rituximab. However, we submit that this new type of international standard needs to be used appropriately and its role not to be mistaken with that of the reference medicinal product. PMID:28985159

  16. Finding Silver Linings: A Preliminary Examination of Benefit Finding in Youth With Chronic Pain.

    PubMed

    Soltani, Sabine; Neville, Alex; Hurtubise, Karen; Hildenbrand, Aimee; Noel, Melanie

    2018-04-01

    Chronic pain is a pervasive condition in adolescence and is associated with significant psychological distress, functional disability, social isolation, and decreased quality of life for a subset of affected youth. There is a paucity of research examining potential resilience factors and adaptive processes in pediatric chronic pain. Benefit finding refers to the process of perceiving positive consequences in the face of adversity. Previous research on benefit finding in pediatric samples (e.g., oncology; acute injury) has yielded inconsistent results. This is the first study to examine this construct in youth with chronic pain. The objective of the current investigation was to extend previous research on benefit finding to adolescents with chronic pain and to assess relationships between benefit finding, internalizing mental health symptoms (i.e., anxiety, depression, and posttraumatic stress disorder [PTSD]), pain outcomes (pain intensity and interference), and quality of life. Psychometrically sound self-report measures of benefit finding, anxiety, depressive, and PTSD symptoms, pain intensity, pain interference, and quality of life were completed by 145 youth (67.4% female, Mage = 13.3 years, SD = 2.6), referred to a tertiary-level chronic pain program. Benefit finding was significantly correlated with internalizing mental health symptoms, pain outcomes, and quality of life. Further, benefit finding significantly predicted children's self-reported pain intensity, pain interference, and quality of life when controlling for age and sex. Findings suggest that benefit finding is associated with internalizing mental health symptoms, pain outcomes, and quality of life in youth with chronic pain. Future research examining this construct is warranted.

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

    PubMed

    Fulga, Netta

    2013-06-01

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

  18. Interagency field manual for the collection of water-quality data

    USGS Publications Warehouse

    Lurry, Dee L.; Kolbe, Christine M.

    2000-01-01

    The USEPA, IBWC, USGS, and Texas Natural Resource Conservation Commission (TNRCC) have been working cooperatively to establish a Water-Quality Monitoring Council for the international reach of the Rio Grande (Río Bravo). A similar effort is occurring along the western international boundary with interested partners including the U.S. Bureau of Reclamation (BOR), Arizona Department of Environmental Quality (ADEQ), and the California Regional Water Quality Control Board (CRWQCB). As of February 1997, the partners agreed to work towards greater cooperation, specifically: 1. to revise the 1977 Joint Report of IBWC Engineers as specified in IBWC Minute No. 289; 2. to implement a binational Intergovernmental Task Force for Water-Quality Monitoring (ITFM) workgroup by inviting the participation of cooperators from Mexico; 3. to review and revise each agency’s existing monitoring network to reduce interagency redundancy; 4. to develop a bilingual manual for water-quality monitoring that would describe various field methods used for sampling water, aquatic biology, and sediment, and for assessing stream habitat; and selection of methods on the basis of DQOs, representativeness, and limitations; 5. to establish a common, easily accessible water-quality database; and 6. to hold joint training programs in water-quality monitoring and data management. Part of the fourth goal—to develop a field manual for water-sample-collection methods—will be accomplished with the publication of this manual.

  19. 42 CFR 460.136 - Internal quality assessment and performance improvement activities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Internal quality assessment and performance improvement activities. 460.136 Section 460.136 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES....136 Internal quality assessment and performance improvement activities. (a) Quality assessment and...

  20. A randomized, controlled trial of team-based competition to increase learner participation in quality-improvement education.

    PubMed

    Scales, Charles D; Moin, Tannaz; Fink, Arlene; Berry, Sandra H; Afsar-Manesh, Nasim; Mangione, Carol M; Kerfoot, B Price

    2016-04-01

    Several barriers challenge resident engagement in learning quality improvement (QI). We investigated whether the incorporation of team-based game mechanics into an evidence-based online learning platform could increase resident participation in a QI curriculum. Randomized, controlled trial. Tertiary-care medical center residency training programs. Resident physicians (n = 422) from nine training programs (anesthesia, emergency medicine, family medicine, internal medicine, ophthalmology, orthopedics, pediatrics, psychiatry and general surgery) randomly allocated to a team competition environment (n = 200) or the control group (n = 222). Specialty-based team assignment with leaderboards to foster competition, and alias assignment to de-identify individual participants. Participation in online learning, as measured by percentage of questions attempted (primary outcome) and additional secondary measures of engagement (i.e. response time). Changes in participation measures over time between groups were assessed with a repeated measures ANOVA framework. Residents in the intervention arm demonstrated greater participation than the control group. The percentage of questions attempted at least once was greater in the competition group (79% [SD ± 32] versus control, 68% [SD ± 37], P= 0.03). Median response time was faster in the competition group (P= 0.006). Differences in participation continued to increase over the duration of the intervention, as measured by average response time and cumulative percent of questions attempted (each P< 0.001). Team competition increases resident participation in an online course delivering QI content. Medical educators should consider game mechanics to optimize participation when designing learning experiences. Published by Oxford University Press in association with the International Society for Quality in Health Care 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  1. Multi response optimization of internal grinding process parameters for outer ring using Taguchi method and PCR-TOPSIS

    NASA Astrophysics Data System (ADS)

    Wisnuadi, Alief Regyan; Damayanti, Retno Wulan; Pujiyanto, Eko

    2018-02-01

    Bearing is one of the most widely used parts in automotive industry. One of the leading bearing manufacturing companies in the world is SKF Indonesia. This company must produce bearing with international standard. SKF Indonesia must do continuous improvement in order to face competition. During this time, SKF Indonesia is only performing quality control at its Quality Assurance department. In other words, quality improvement at SKF Indonesia has not been done thoroughly. The purpose of this research is to improve quality of outer ring product at SKF Indonesia by conducting an internal grinding process experiment about setting speed ratio, fine position, and spark out grinding time. The specific purpose of this experiment is to optimize some quality responses such as roughness, roundness, and cycle time. All of the response in this experiment were smaller the better. Taguchi method and PCR-TOPSIS are used for the optimization process. The result of this research shows that by using Taguchi method and PCR-TOPSIS, the optimum condition occurs on speed ratio 36, fine position 18 µm/s and spark out 0.5 s. The optimum conditions result were roughness 0.398 µm, roundness 1.78 µm and cycle time 8.1 s. This results have been better than the previous results and meet the standards. The roughness of 0.523 µm decrease to 0.398 µm and the average cycle time of 8.5 s decrease to 8.1 s.

  2. Cancer control in developing countries: using health data and health services research to measure and improve access, quality and efficiency.

    PubMed

    Hanna, Timothy P; Kangolle, Alfred C T

    2010-10-13

    Cancer is a rapidly increasing problem in developing countries. Access, quality and efficiency of cancer services in developing countries must be understood to advance effective cancer control programs. Health services research can provide insights into these areas. This article provides an overview of oncology health services in developing countries. We use selected examples from peer-reviewed literature in health services research and relevant publicly available documents. In spite of significant limitations in the available data, it is clear there are substantial barriers to access to cancer control in developing countries. This includes prevention, early detection, diagnosis/treatment and palliation. There are also substantial limitations in the quality of cancer control and a great need to improve economic efficiency. We describe how the application of health data may assist in optimizing (1) Structure: strengthening planning, collaboration, transparency, research development, education and capacity building. (2) PROCESS: enabling follow-up, knowledge translation, patient safety and quality assurance. (3) OUTCOME: facilitating evaluation, monitoring and improvement of national cancer control efforts. There is currently limited data and capacity to use this data in developing countries for these purposes. There is an urgent need to improve health services for cancer control in developing countries. Current resources and much-needed investments must be optimally managed. To achieve this, we would recommend investment in four key priorities: (1) Capacity building in oncology health services research, policy and planning relevant to developing countries. (2) Development of high-quality health data sources. (3) More oncology-related economic evaluations in developing countries. (4) Exploration of high-quality models of cancer control in developing countries. Meeting these needs will require national, regional and international collaboration as well as political leadership. Horizontal integration with programs for other diseases will be important.

  3. The business process management software for successful quality management and organization: A case study from the University of Split School of Medicine.

    PubMed

    Sapunar, Damir; Grković, Ivica; Lukšić, Davor; Marušić, Matko

    2016-05-01

    Our aim was to describe a comprehensive model of internal quality management (QM) at a medical school founded on the business process analysis (BPA) software tool. BPA software tool was used as the core element for description of all working processes in our medical school, and subsequently the system served as the comprehensive model of internal QM. The quality management system at the University of Split School of Medicine included the documentation and analysis of all business processes within the School. The analysis revealed 80 weak points related to one or several business processes. A precise analysis of medical school business processes allows identification of unfinished, unclear and inadequate points in these processes, and subsequently the respective improvements and increase of the QM level and ultimately a rationalization of the institution's work. Our approach offers a potential reference model for development of common QM framework allowing a continuous quality control, i.e. the adjustments and adaptation to contemporary educational needs of medical students. Copyright © 2016 by Academy of Sciences and Arts of Bosnia and Herzegovina.

  4. A Scottish Approach to the Challenge of Educational Change.

    ERIC Educational Resources Information Center

    McLachlan, Jeffrey; Wood, Vivienne

    This paper examines the adjustment of Napier Polytechnic of Edinburgh (Scotland, United Kingdom) to educational change. Discussed are: the historical development of the school; Napier's role in today's higher education; the school's shift from external to internal quality control of Council for National Academic Awards courses; the school's…

  5. Technique and interpretation in tree seed radiography

    Treesearch

    Howard B. Kriebel

    1966-01-01

    The study of internal seed structure by radiography requires techniques which will give good definition. To establish the best procedures, we conducted a series of experiments in which we manipulated the principal controllable variables affecting the quality of X-radiographs: namely, focus-to-film distance, film speed (grain), exposure time, kilovoltage, and...

  6. Can I Trust ORE Reports?

    ERIC Educational Resources Information Center

    Feedback, 1984

    1984-01-01

    This issue of FEEDBACK, a newsletter produced by the the Austin Independent School District Office of Research and Evaluation (ORE), illustrates the accuracy, validity, and fairness of ORE reports. The independence of the reports is explained. Internal and external quality controls are used to ensure reliability and accuracy of the reports.…

  7. 78 FR 79465 - International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-30

    ... Essential Medicines and Health Products (EMP): http://www.who.int/medicines/areas/quality_safety/ECDD/en... medicine: --Please mention other, if any, medical use not included in the approved indications (off label...: (Controlled substances act/ Medicines law/Poisons acts/Consumer protection acts/Generic legislation/Analogue...

  8. Satellite Synthetic Aperture Radar Detection of Ocean Internal Waves in the South China Sea

    DTIC Science & Technology

    2006-09-30

    will occur and what effects they will have on the hydrodynamic and acoustic environment. This project focuses on the use of remotely sensed...Therefore, two projects sometimes share the same data resources of field observations. REFERENCES Boyer, T., and S. Levites , Quality control and

  9. The Cost of Fad Treatments in Autism

    ERIC Educational Resources Information Center

    Zane, Thomas; Davis, Cheryl; Rosswurm, Mary

    2008-01-01

    With the increase in the incidence of autism, there has been a corresponding increase in the number of treatments for this disorder. Professionals generally recognize the need for effective treatments. Effectiveness is typically considered to mean the use of quality research with good control over internal and external validity threats. Thus, only…

  10. INTER-SITE COMPARISON OF AMBIENT AEROSOLS IN THE HOUSTON AREA DURING TEXAQS-2000

    EPA Science Inventory

    During the late summer of 2000 (8/15 - 9/15/00), the Texas Air Quality Study - 2000 (TEXAQS-2000) was conducted to improve understanding of the factors that control the formation and transport of air pollutants along the Gulf Coast of southeastern Texas. An international team ...

  11. Design Research as a Mechanism for Consultants to Facilitate and Evaluate Educational Innovations

    ERIC Educational Resources Information Center

    Castillo, Jose M.; Dorman, Clark; Gaunt, Brian; Hardcastle, Beth; Justice, Kelly; March, Amanda L.

    2016-01-01

    Schools across the nation are implementing innovative practices; however, questions remain regarding how to facilitate quality implementation. Research designs that emphasize high degrees of control over independent variables result in findings with internal validity, but that may not generalize to complex, dynamic educational systems. The purpose…

  12. An up-to-date quality-controlled surface mass balance data set for the 90°-180°E Antarctica sector and 1950-2005 period

    NASA Astrophysics Data System (ADS)

    Magand, O.; Genthon, C.; Fily, M.; Krinner, G.; Picard, G.; Frezzotti, M.; Ekaykin, A. A.

    2007-06-01

    On the basis of thousands of surface mass balance (SMB) field measurements over the entire Antarctic ice sheet it is currently estimated that more than 2 Gt of ice accumulate each year at the surface of Antarctica. However, these estimates suffer from large uncertainties. Various problems affect Antarctic SMB measurements, in particular, limited or unwarranted spatial and temporal representativeness, measurement inaccuracy, and lack of quality control. We define quality criteria on the basis of (1) an up-to-date review and quality rating of the various SMB measurement methods and (2) essential information (location, dates of measurements, time period covered by the SMB values, and primary data sources) related to each SMB data. We apply these criteria to available SMB values from Queen Mary to Victoria lands (90°-180°E Antarctic sector) from the early 1950s to present. This results in a new set of observed SMB values for the 1950-2005 time period with strong reduction in density and coverage but also expectedly reduced inaccuracies and uncertainties compared to other compilations. The quality-controlled SMB data set also contains new results from recent field campaigns (International Trans-Antarctic Scientific Expedition (ITASE), Russian Antarctic Expedition (RAE), and Australian National Antarctic Research Expeditions (ANARE) projects) which comply with the defined quality criteria. A comparative evaluation of climate model results against the quality-controlled updated SMB data set and other widely used ones illustrates that such Antarctic SMB studies are significantly affected by the quality of field SMB values used as reference.

  13. [Recommendations for the control of documents and the establishment of a documentary system].

    PubMed

    Vinner, E

    2013-06-01

    The quality management system that must be implemented in a MBL to meet the requirements of the standard NF EN ISO 15189 is based, among other things, on the creation and use by staff of a documentary system approved and updated. This documentary system is constituted by external documents (standards, suppliers' documents...) and internal documents (quality manual, procedures, instructions, technical and quality recordings...). A procedure of the documentary system control must be formalized. The documentary system should be modeled in order to identify the various procedures to be drafted and the incurred risks in the case a document would be missing in this system. Each document must be indexed in a unique way and document management must be carried out rigorously. The use of document management software is a great help to manage the life cycle of documents.

  14. [Proposed recommendations for the practical use of internal quality controls (IQC) in a medical biology laboratory].

    PubMed

    Giannoli, Jean-Marc; Szymanowicz, Anton

    2011-01-01

    We propose a set of recommendations and practices to optimize the use of quality control of medical biology examinations. The fundamentals are reviewed: definition of a series of analysis, IQC at one or more level, Westgard alert rules and rejection, practical remedial actions to take for the technician, corrective and preventive actions to be implemented by the biologist. We have also formalized three flowcharts to guide the technician in their daily practice to ensure analytical quality of investigations carried out. These decision trees are the result of the experience submitted by an accredited and professional laboratory attentive to the ongoing improvement of IQC. This article can provide useful assistance to biologists for accreditation but also aims to foster collaboration reliable medical biology laboratory at the appropriate management of patients.

  15. Medical education in Sweden.

    PubMed

    Lindgren, Stefan; Brännström, Thomas; Hanse, Eric; Ledin, Torbjörn; Nilsson, Gunnar; Sandler, Stellan; Tidefelt, Ulf; Donnér, Jakob

    2011-01-01

    Undergraduate medical education in Sweden has moved from nationally regulated, subject-based courses to programmes integrated either around organ systems or physiological and patho-physiological processes, or organised around basic medical science in conjunction with clinical specialities, with individual profiles at the seven medical schools. The national regulations are restricted to overall academic and professional outcomes. The 5½ year long university undergraduate curriculum is followed by a mandatory 18 months internship, delivered by the County Councils. While quality control and accreditation for the university curriculum is provided by the Swedish National Agency for Higher Education, no such formal control exists for the internship; undergraduate medical education is therefore in conflict with EU directives from 2005. The Government is expected to move towards 6 years long university undergraduate programmes, leading to licence, which will facilitate international mobility of both Swedish and foreign medical students and doctors. Ongoing academic development of undergraduate education is strengthened by the Bologna process. It includes outcome (competence)-based curricula, university Masters level complying with international standards, progression of competence throughout the curriculum, student directed learning, active participation and roles in practical clinical education and a national assessment model to assure professional competence. In the near future, the dimensioning of Swedish undergraduate education is likely to be decided more by international demands and aspects of quality than by national demands for doctors.

  16. Sigma metrics as a tool for evaluating the performance of internal quality control in a clinical chemistry laboratory.

    PubMed

    Kumar, B Vinodh; Mohan, Thuthi

    2018-01-01

    Six Sigma is one of the most popular quality management system tools employed for process improvement. The Six Sigma methods are usually applied when the outcome of the process can be measured. This study was done to assess the performance of individual biochemical parameters on a Sigma Scale by calculating the sigma metrics for individual parameters and to follow the Westgard guidelines for appropriate Westgard rules and levels of internal quality control (IQC) that needs to be processed to improve target analyte performance based on the sigma metrics. This is a retrospective study, and data required for the study were extracted between July 2015 and June 2016 from a Secondary Care Government Hospital, Chennai. The data obtained for the study are IQC - coefficient of variation percentage and External Quality Assurance Scheme (EQAS) - Bias% for 16 biochemical parameters. For the level 1 IQC, four analytes (alkaline phosphatase, magnesium, triglyceride, and high-density lipoprotein-cholesterol) showed an ideal performance of ≥6 sigma level, five analytes (urea, total bilirubin, albumin, cholesterol, and potassium) showed an average performance of <3 sigma level and for level 2 IQCs, same four analytes of level 1 showed a performance of ≥6 sigma level, and four analytes (urea, albumin, cholesterol, and potassium) showed an average performance of <3 sigma level. For all analytes <6 sigma level, the quality goal index (QGI) was <0.8 indicating the area requiring improvement to be imprecision except cholesterol whose QGI >1.2 indicated inaccuracy. This study shows that sigma metrics is a good quality tool to assess the analytical performance of a clinical chemistry laboratory. Thus, sigma metric analysis provides a benchmark for the laboratory to design a protocol for IQC, address poor assay performance, and assess the efficiency of existing laboratory processes.

  17. Therapeutic effects of short-term monochromatic infrared energy therapy on patients with knee osteoarthritis: a double-blind, randomized, placebo-controlled study.

    PubMed

    Hsieh, Ru-Lan; Lo, Min-Tzu; Lee, Wen-Chung; Liao, Wei-Cheng

    2012-11-01

    Randomized, double-blind, placebo-controlled study. To examine the short-term therapeutic effects of monochromatic infrared energy (MIRE) on participants with knee osteoarthritis (OA). Patients were assessed according to the International Classification of Functioning, Disability and Health. MIRE is commonly used in therapy for patients with peripheral neuropathies. However, research has not focused intensively on the therapeutic effects of MIRE in patients with knee OA. This study enrolled 73 participants with knee OA. Participants received six 40-minute sessions of active or placebo MIRE treatment (890-nm wavelength; power, 6.24 W; energy density, 2.08 J/cm2/min; total energy, 83.2 J/cm2) over the knee joints for 2 weeks. International Classification of Functioning, Disability and Health-related outcomes were collected weekly over 4 weeks using the Knee injury and Osteoarthritis Outcome Score, Lysholm Knee Scale, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory, Chronic Pain Grade questionnaire, World Health Organization Quality of Life-brief version, and OA Quality of Life Questionnaire. Data were analyzed by repeated-measures analysis of variance. No statistically significant differences were found for the interaction of group by time for Knee injury and Osteoarthritis Outcome Score scores, including pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Scores on the Lysholm Knee Scale, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory, Chronic Pain Grade questionnaire, World Health Organization Quality of Life-brief version, and OA Quality of Life Questionnaire also showed no significant differences between the 2 groups at any of the 4 follow-up assessments. Short-term MIRE therapy provided no beneficial effects to body functions, activities, participation, and quality of life in patients with knee OA.

  18. International Business Research: Coauthorship Patterns and Quality

    ERIC Educational Resources Information Center

    Chan, Kam C; Fung, Hung-Gay; Leung, Wai K.

    2008-01-01

    The authors investigate published international business research in four international business journals over a 10-year period, 1995-2004: (a) patterns of coauthorship across regions, and (b) the relation between coauthorship patterns and the quality of international business (IB) articles. A cross-region coauthorship enhances the quality of an…

  19. Comprehensive Auditing in Nuclear Medicine Through the International Atomic Energy Agency Quality Management Audits in Nuclear Medicine (QUANUM) Program. Part 1: the QUANUM Program and Methodology.

    PubMed

    Dondi, Maurizio; Torres, Leonel; Marengo, Mario; Massardo, Teresa; Mishani, Eyal; Van Zyl Ellmann, Annare; Solanki, Kishor; Bischof Delaloye, Angelika; Lobato, Enrique Estrada; Miller, Rodolfo Nunez; Paez, Diana; Pascual, Thomas

    2017-11-01

    An effective management system that integrates quality management is essential for a modern nuclear medicine practice. The Nuclear Medicine and Diagnostic Imaging Section of the International Atomic Energy Agency (IAEA) has the mission of supporting nuclear medicine practice in low- and middle-income countries and of helping them introduce it in their health-care system, when not yet present. The experience gathered over several years has shown diversified levels of development and varying degrees of quality of practice, among others because of limited professional networking and limited or no opportunities for exchange of experiences. Those findings triggered the development of a program named Quality Management Audits in Nuclear Medicine (QUANUM), aimed at improving the standards of NM practice in low- and middle-income countries to internationally accepted standards through the introduction of a culture of quality management and systematic auditing programs. QUANUM takes into account the diversity of nuclear medicine services around the world and multidisciplinary contributions to the practice. Those contributions include clinical, technical, radiopharmaceutical, and medical physics procedures. Aspects of radiation safety and patient protection are also integral to the process. Such an approach ensures consistency in providing safe services of superior quality to patients. The level of conformance is assessed using standards based on publications of the IAEA and the International Commission on Radiological Protection, and guidelines from scientific societies such as Society of Nuclear Medicine and Molecular Imaging (SNMMI) and European Association of Nuclear Medicine (EANM). Following QUANUM guidelines and by means of a specific assessment tool developed by the IAEA, auditors, both internal and external, will be able to evaluate the level of conformance. Nonconformances will then be prioritized and recommendations will be provided during an exit briefing. The same tool could then be applied to assess any improvement after corrective actions are taken. This is the first comprehensive audit program in nuclear medicine that helps evaluate managerial aspects, safety of patients and workers, clinical practice, and radiopharmacy, and, above all, keeps them under control all together, with the intention of continuous improvement. Copyright © 2017. Published by Elsevier Inc.

  20. 7 CFR 51.481 - Very good internal quality.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Very good internal quality. 51.481 Section 51.481 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards... quality. Very good internal quality means that the combined juice from the edible portion of a sample of...

  1. Data quality control and tools in passive seismic experiments exemplified on the Czech broadband seismic pool MOBNET in the AlpArray collaborative project

    NASA Astrophysics Data System (ADS)

    Vecsey, Luděk; Plomerová, Jaroslava; Jedlička, Petr; Munzarová, Helena; Babuška, Vladislav; AlpArray Working Group

    2017-12-01

    This paper focuses on major issues related to the data reliability and network performance of 20 broadband (BB) stations of the Czech (CZ) MOBNET (MOBile NETwork) seismic pool within the AlpArray seismic experiments. Currently used high-resolution seismological applications require high-quality data recorded for a sufficiently long time interval at seismological observatories and during the entire time of operation of the temporary stations. In this paper we present new hardware and software tools we have been developing during the last two decades while analysing data from several international passive experiments. The new tools help to assure the high-quality standard of broadband seismic data and eliminate potential errors before supplying data to seismological centres. Special attention is paid to crucial issues like the detection of sensor misorientation, timing problems, interchange of record components and/or their polarity reversal, sensor mass centring, or anomalous channel amplitudes due to, for example, imperfect gain. Thorough data quality control should represent an integral constituent of seismic data recording, preprocessing, and archiving, especially for data from temporary stations in passive seismic experiments. Large international seismic experiments require enormous efforts from scientists from different countries and institutions to gather hundreds of stations to be deployed in the field during a limited time period. In this paper, we demonstrate the beneficial effects of the procedures we have developed for acquiring a reliable large set of high-quality data from each group participating in field experiments. The presented tools can be applied manually or automatically on data from any seismic network.

  2. Missed detection of significant positive and negative shifts in gentamicin assay: implications for routine laboratory quality practices.

    PubMed

    Koerbin, Gus; Liu, Jiakai; Eigenstetter, Alex; Tan, Chin Hon; Badrick, Tony; Loh, Tze Ping

    2018-02-15

    A product recall was issued for the Roche/Hitachi Cobas Gentamicin II assays on 25 th May 2016 in Australia, after a 15 - 20% positive analytical shift was discovered. Laboratories were advised to employ the Thermo Fisher Gentamicin assay as an alternative. Following the reintroduction of the revised assay on 12 th September 2016, a second reagent recall was made on 20 th March 2017 after the discovery of a 20% negative analytical shift due to erroneous instrument adjustment factor. The practices of an index laboratory were examined to determine how the analytical shifts evaded detection by routine internal quality control (IQC) and external quality assurance (EQA) systems. The ability of the patient result-based approaches, including moving average (MovAvg) and moving sum of outliers (MovSO) approaches in detecting these shifts were examined. Internal quality control data of the index laboratory were acceptable prior to the product recall. The practice of adjusting IQC target following a change in assay method resulted in the missed negative shift when the revised Roche assay was reintroduced. While the EQA data of the Roche subgroup showed clear negative bias relative to other laboratory methods, the results were considered as possible 'matrix effect'. The MovAvg method detected the positive shift before the product recall. The MovSO did not detect the negative shift in the index laboratory but did so in another laboratory 5 days before the second product recall. There are gaps in current laboratory quality practices that leave room for analytical errors to evade detection.

  3. Cancer Incidence in Five Continents: Inclusion criteria, highlights from Volume X and the global status of cancer registration.

    PubMed

    Bray, F; Ferlay, J; Laversanne, M; Brewster, D H; Gombe Mbalawa, C; Kohler, B; Piñeros, M; Steliarova-Foucher, E; Swaminathan, R; Antoni, S; Soerjomataram, I; Forman, D

    2015-11-01

    Cancer Incidence in Five Continents (CI5), a longstanding collaboration between the International Agency for Research on Cancer and the International Association of Cancer Registries, serves as a unique source of cancer incidence data from high-quality population-based cancer registries around the world. The recent publication of Volume X comprises cancer incidence data from 290 registries covering 424 populations in 68 countries for the registration period 2003-2007. In this article, we assess the status of population-based cancer registries worldwide, describe the techniques used in CI5 to evaluate their quality and highlight the notable variation in the incidence rates of selected cancers contained within Volume X of CI5. We also discuss the Global Initiative for Cancer Registry Development as an international partnership that aims to reduce the disparities in availability of cancer incidence data for cancer control action, particularly in economically transitioning countries, already experiencing a rapid rise in the number of cancer patients annually. © 2015 UICC.

  4. 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

  5. A survey of coagulation laboratory practices and satisfaction ratings of member laboratories of the Thailand National External Quality Assessment Scheme for blood coagulation.

    PubMed

    Chuntarut, A; Tientadakul, P; Wongkrajang, P

    2016-06-01

    The Thailand National External Quality Assessment Scheme (NEQAS) for blood coagulation was established in 2005. The objective of this study was to collect data of coagulation laboratory practices and satisfaction of NEQAS member. Two hundred seventy-six questionnaires were sent to laboratories that are members of NEQAS to obtain data relating to coagulation laboratory practice and satisfaction in 2014. Data from this survey were compared with data from the survey conducted in 2005 to evaluate levels of improvement. Of 276 questionnaires sent, 212 (76.8%) were returned. Improvements were characterized by the number of laboratories that (i) decreased use of 3.8% sodium citrate as anticoagulant; (ii) implemented use of at least two control levels for internal quality control; and (iii) implemented reporting of reference values with results, as well as establishing their own reference range and using geometric mean as the denominator for international normalized ratio calculation. For overall satisfaction, 179 of 206 (86.9%) participant laboratories reported being satisfied or very satisfied. Improvements in coagulation laboratory practices in Thailand were observed in every step of the total testing process. However, additional improvements are still needed, such as determination and use of a local reference range. © 2016 John Wiley & Sons Ltd.

  6. Energy balance and obesity: what are the main drivers?

    PubMed

    Romieu, Isabelle; Dossus, Laure; Barquera, Simón; Blottière, Hervé M; Franks, Paul W; Gunter, Marc; Hwalla, Nahla; Hursting, Stephen D; Leitzmann, Michael; Margetts, Barrie; Nishida, Chizuru; Potischman, Nancy; Seidell, Jacob; Stepien, Magdalena; Wang, Youfa; Westerterp, Klaas; Winichagoon, Pattanee; Wiseman, Martin; Willett, Walter C

    2017-03-01

    The aim of this paper is to review the evidence of the association between energy balance and obesity. In December 2015, the International Agency for Research on Cancer (IARC), Lyon, France convened a Working Group of international experts to review the evidence regarding energy balance and obesity, with a focus on Low and Middle Income Countries (LMIC). The global epidemic of obesity and the double burden, in LMICs, of malnutrition (coexistence of undernutrition and overnutrition) are both related to poor quality diet and unbalanced energy intake. Dietary patterns consistent with a traditional Mediterranean diet and other measures of diet quality can contribute to long-term weight control. Limiting consumption of sugar-sweetened beverages has a particularly important role in weight control. Genetic factors alone cannot explain the global epidemic of obesity. However, genetic, epigenetic factors and the microbiota could influence individual responses to diet and physical activity. Energy intake that exceeds energy expenditure is the main driver of weight gain. The quality of the diet may exert its effect on energy balance through complex hormonal and neurological pathways that influence satiety and possibly through other mechanisms. The food environment, marketing of unhealthy foods and urbanization, and reduction in sedentary behaviors and physical activity play important roles. Most of the evidence comes from High Income Countries and more research is needed in LMICs.

  7. Design and validation of a comprehensive fecal incontinence questionnaire.

    PubMed

    Macmillan, Alexandra K; Merrie, Arend E H; Marshall, Roger J; Parry, Bryan R

    2008-10-01

    Fecal incontinence can have a profound effect on quality of life. Its prevalence remains uncertain because of stigma, lack of consistent definition, and dearth of validated measures. This study was designed to develop a valid clinical and epidemiologic questionnaire, building on current literature and expertise. Patients and experts undertook face validity testing. Construct validity, criterion validity, and test-retest reliability was undertaken. Construct validity comprised factor analysis and internal consistency of the quality of life scale. The validity of known groups was tested against 77 control subjects by using regression models. Questionnaire results were compared with a stool diary for criterion validity. Test-retest reliability was calculated from repeated questionnaire completion. The questionnaire achieved good face validity. It was completed by 104 patients. The quality of life scale had four underlying traits (factor analysis) and high internal consistency (overall Cronbach alpha = 0.97). Patients and control subjects answered the questionnaire significantly differently (P < 0.01) in known-groups validity testing. Criterion validity assessment found mean differences close to zero. Median reliability for the whole questionnaire was 0.79 (range, 0.35-1). This questionnaire compares favorably with other available instruments, although the interpretation of stool consistency requires further research. Its sensitivity to treatment still needs to be investigated.

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

    USGS Publications Warehouse

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

    2005-01-01

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

  9. Cairo consensus on the IVF laboratory environment and air quality: report of an expert meeting.

    PubMed

    Mortimer, D; Cohen, J; Mortimer, S T; Fawzy, M; McCulloh, D H; Morbeck, D E; Pollet-Villard, X; Mansour, R T; Brison, D R; Doshi, A; Harper, J C; Swain, J E; Gilligan, A V

    2018-03-02

    This proceedings report presents the outcomes from an international Expert Meeting to establish a consensus on the recommended technical and operational requirements for air quality within modern assisted reproduction technology (ART) laboratories. Topics considered included design and construction of the facility, as well as its heating, ventilation and air conditioning system; control of particulates, micro-organisms (bacteria, fungi and viruses) and volatile organic compounds (VOCs) within critical areas; safe cleaning practices; operational practices to optimize air quality while minimizing physicochemical risks to gametes and embryos (temperature control versus air flow); and appropriate infection-control practices that minimize exposure to VOC. More than 50 consensus points were established under the general headings of assessing site suitability, basic design criteria for new construction, and laboratory commissioning and ongoing VOC management. These consensus points should be considered as aspirational benchmarks for existing ART laboratories, and as guidelines for the construction of new ART laboratories. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  10. Orion Handling Qualities During ISS Proximity Operations and Docking

    NASA Technical Reports Server (NTRS)

    Stephens, John-Paul; Vos, Gordon A.; Bilimoria, Karl D.; Mueller, Eric R.; Brazzel, Jack; Spehar, Pete

    2011-01-01

    NASA's Orion spacecraft is designed to autonomously rendezvous and dock with many vehicles including the International Space Station. However, the crew is able to assume manual control of the vehicle s attitude and flight path. In these instances, Orion must meet handling qualities requirements established by NASA. Two handling qualities assessments were conducted at the Johnson Space Center to evaluate preliminary designs of the vehicle using a six degree of freedom, high-fidelity guidance, navigation, and control simulation. The first assessed Orion s handling qualities during the last 20 ft before docking, and included both steady and oscillatory motions of the docking target. The second focused on manual acquisition of the docking axis during the proximity operations phase and subsequent station-keeping. Cooper-Harper handling qualities ratings, workload ratings and comments were provided by 10 evaluation pilots for the docking study and 5 evaluation pilots for the proximity operations study. For the docking task, both cases received 90% Level 1 (satisfactory) handling qualities ratings, exceeding NASA s requirement. All ratings for the ProxOps task were Level 1. These evaluations indicate that Orion is on course to meet NASA's handling quality requirements for ProxOps and docking.

  11. [A preliminary study on the forming quality of titanium alloy removable partial denture frameworks fabricated by selective laser melting].

    PubMed

    Liu, Y F; Yu, H; Wang, W N; Gao, B

    2017-06-09

    Objective: To evaluate the processing accuracy, internal quality and suitability of the titanium alloy frameworks of removable partial denture (RPD) fabricated by selective laser melting (SLM) technique, and to provide reference for clinical application. Methods: The plaster model of one clinical patient was used as the working model, and was scanned and reconstructed into a digital working model. A RPD framework was designed on it. Then, eight corresponding RPD frameworks were fabricated using SLM technique. Three-dimensional (3D) optical scanner was used to scan and obtain the 3D data of the frameworks and the data was compared with the original computer aided design (CAD) model to evaluate their processing precision. The traditional casting pure titanium frameworks was used as the control group, and the internal quality was analyzed by X-ray examination. Finally, the fitness of the frameworks was examined on the plaster model. Results: The overall average deviation of the titanium alloy RPD framework fabricated by SLM technology was (0.089±0.076) mm, the root mean square error was 0.103 mm. No visible pores, cracks and other internal defects was detected in the frameworks. The framework fits on the plaster model completely, and its tissue surface fitted on the plaster model well. There was no obvious movement. Conclusions: The titanium alloy RPD framework fabricated by SLM technology is of good quality.

  12. Longitudinal associations between adolescent perceived degree and style of parental prohibition and internalization and defiance.

    PubMed

    Vansteenkiste, Maarten; Soenens, Bart; Van Petegem, Stijn; Duriez, Bart

    2014-01-01

    This study examined associations between perceived degree and style of parental prohibition and adolescents' internalization of and oppositional defiance against parental rules in the friendship and moral domain. Relations were investigated in 2 longitudinal adolescent samples (total N = 532). Results indicated that perceived style but not degree of prohibition related to overtime changes in internalization and oppositional defiance. Specifically, in line with self-determination theory, autonomy-supportive and controlling styles of prohibiting were found to relate differentially to quality of internalization and oppositional defiance. Cross-lagged analyses indicated that several of these associations were reciprocal. The discussion focuses on the critical role of perceived parental style for communicating prohibitions. PsycINFO Database Record (c) 2014 APA, all rights reserved.

  13. A closer look at co-rumination: gender, coping, peer functioning and internalizing/externalizing problems.

    PubMed

    Tompkins, Tanya L; Hockett, Ashlee R; Abraibesh, Nadia; Witt, Jody L

    2011-10-01

    Co-rumination, defined as repetitive, problem-focused talk explains higher levels of friendship quality in youth (Rose, 2002) and increased levels of anxiety/depression in females. Middle adolescents (N = 146) participated in a study of co-rumination, individual coping, externalizing/internalizing problems, and peer functioning. Consistent with past research, girls reported higher levels of co-rumination and internalizing symptoms. Co-rumination was also positively correlated with self-reports, but not teacher reports, of anxiety/depression and aggressive behavior. Both self-reported number of friends and teacher-rated social acceptance were negatively associated with co-rumination. Co-rumination partially accounted for the significant indirect effect of gender on internalizing symptoms. Additionally, co-rumination was associated with internalizing and externalizing symptoms but not individual coping efforts. Finally, co-rumination accounted for a unique amount of variance in internalizing symptoms, controlling for externalizing problems and secondary control coping. Theoretical implications and the importance of including broad domains of adjustment and peer functioning in future investigations of co-rumination are discussed. Copyright © 2011 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

  14. Quality of Diabetes Care: The Challenges of an Increasing Epidemic in Mexico. Results from Two National Health Surveys (2006 and 2012)

    PubMed Central

    Flores-Hernández, Sergio; Saturno-Hernández, Pedro J.; Reyes-Morales, Hortensia; Barrientos-Gutiérrez, Tonatiuh; Villalpando, Salvador; Hernández-Ávila, Mauricio

    2015-01-01

    Background The quality of diabetes care remains suboptimal according to numerous studies assessing the achievement of quality indicators for diabetes care in various healthcare settings. We report about global and specific quality indicators for diabetes care and their association to glycemic control at the population level in two national health surveys in Mexico. Methods We conducted a cross-sectional analysis of the 2006 and 2012 National Health Surveys in Mexico. We examined quality of care for 2,965 and 4,483 adults (≥ 20 years) with diagnosed type 2 diabetes using fourteen simple and two composite indicators derived from self-reported information. In a subsample for both surveys, glycated hemoglobin (HbA1c) was measured at the time of the interview. We obtained survey weight-adjusted estimators using multiple regression models (logistic and linear) with combined data files, including survey year as covariate to assess change. Results Global quality of care in 2012 was 40.8%, with a relative improvement of 11.7% between 2006 and 2012. Detections of cardiovascular disease risk factors (dyslipidemia and hypertension) were the indicators with the highest improvement, while non-pharmaceutical treatment and diabetic foot exams showed minor changes. We found a significant association between the quality of the process of diabetes care and glycemic control (OR 2.53, 95% CI 1.63-3.94). Age more than 65 years old, the type of health subsystem, gender (males), and high socio-economic status were also significantly associated to glycemic control. Conclusions Quality diabetes care and glycemic control improved and are significantly associated. However, according to international standards, the current situation remains suboptimal. A more holistic approach is needed, with an emphasis on improving quality in outpatient care. PMID:26230991

  15. Quality of Diabetes Care: The Challenges of an Increasing Epidemic in Mexico. Results from Two National Health Surveys (2006 and 2012).

    PubMed

    Flores-Hernández, Sergio; Saturno-Hernández, Pedro J; Reyes-Morales, Hortensia; Barrientos-Gutiérrez, Tonatiuh; Villalpando, Salvador; Hernández-Ávila, Mauricio

    2015-01-01

    The quality of diabetes care remains suboptimal according to numerous studies assessing the achievement of quality indicators for diabetes care in various healthcare settings. We report about global and specific quality indicators for diabetes care and their association to glycemic control at the population level in two national health surveys in Mexico. We conducted a cross-sectional analysis of the 2006 and 2012 National Health Surveys in Mexico. We examined quality of care for 2,965 and 4,483 adults (≥ 20 years) with diagnosed type 2 diabetes using fourteen simple and two composite indicators derived from self-reported information. In a subsample for both surveys, glycated hemoglobin (HbA1c) was measured at the time of the interview. We obtained survey weight-adjusted estimators using multiple regression models (logistic and linear) with combined data files, including survey year as covariate to assess change. Global quality of care in 2012 was 40.8%, with a relative improvement of 11.7% between 2006 and 2012. Detections of cardiovascular disease risk factors (dyslipidemia and hypertension) were the indicators with the highest improvement, while non-pharmaceutical treatment and diabetic foot exams showed minor changes. We found a significant association between the quality of the process of diabetes care and glycemic control (OR 2.53, 95% CI 1.63-3.94). Age more than 65 years old, the type of health subsystem, gender (males), and high socio-economic status were also significantly associated to glycemic control. Quality diabetes care and glycemic control improved and are significantly associated. However, according to international standards, the current situation remains suboptimal. A more holistic approach is needed, with an emphasis on improving quality in outpatient care.

  16. National surveys on internal quality control for blood gas analysis and related electrolytes in clinical laboratories of China.

    PubMed

    Duan, Min; Wang, Wei; Zhao, Haijian; Zhang, Chuanbao; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

    2018-05-01

    Internal quality control (IQC) is essential for precision evaluation and continuous quality improvement. This study aims to investigate the IQC status of blood gas analysis (BGA) in clinical laboratories of China from 2014 to 2017. IQC information on BGA (including pH, pCO2, pO2, Na+, K+, Ca2+, Cl-) was submitted by external quality assessment (EQA) participant laboratories and collected through Clinet-EQA reporting system in March from 2014 to 2017. First, current CVs were compared among different years and measurement systems. Then, percentages of laboratories meeting five allowable imprecision specifications for each analyte were calculated, respectively. Finally, laboratories were divided into different groups based on control rules and frequency to compare their variation trend. The current CVs of BGA were significantly decreasing from 2014 to 2017. pH and pCO2 got the highest pass rates when compared with the minimum imprecision specification, whereas pO2, Na+, K+, Ca2+, Cl- got the highest pass rates when 1/3 TEa imprecision specification applied. The pass rates of pH, pO2, Na+, K+, Ca2+, Cl- were significantly increasing during the 4 years. The comparisons of current CVs among different measurement systems showed that the precision performance of different analytes among different measurement systems had no regular distribution from 2014 to 2017. The analysis of IQC practice indicated great progress and improvement among different years. The imprecision performance of BGA has improved from 2014 to 2017, but the status of imprecision performance in China remains unsatisfying. Therefore, further investigation and continuous improvement measures should be taken.

  17. [Scientific role of German ophthalmology in the European telecommunication project OPHTEL].

    PubMed

    Mertz, M; Mann, G; Zahlmann, G; Obermaier, M

    1997-07-01

    In Denmark, France, Germany, Great Britain and Italy, the OPHTEL project combines clinical centers of ophthalmology and internal medicine, an institute for medical informatics and health services research, a publishing company and different industrial partners in the EDP market. With the aid of visual telecommunication and rapid data transfer, methods and conditions will be developed and proved so that any physician can very easily obtain sufficient information for treating his patient. Thus, the regional differences in the quality of structured health service (e.g., urban/ rural) will be overcome throughout Europe. SCIENTIFIC TASKS: A multilingual diagnostic and therapeutic thesaurus has to be worked out in order to create standards for communication and quality control. Based on literature, images and image analysis in a knowledge-based data bank, a monitoring system (containing watch-dog functions) and the basic aspects of an ophthalmological patient/disease register will be investigated. (In parallel, a technical development of synchronous and asynchronous telecommunication between eye physicians is taking place in close cooperation with the regional Bavarian project Teleopathalmology in Bavaria on-line). State of the art 6 months after starting the project:the knowledge-based image data bank has been founded and also an ophthalmological 8 language thesaurus and definition standard. All data transfer lines are installed. The project is taking place amid diverging sections of medicine: ophthalmology and internal medicine, health politics and data protection, individual treatment and common interest (health care), product management and office organization. Thus, the scientific quality of the transferred ophthalmological content must undergo sophisticated controls. FUTURE STEPS: Intense cooperation with the big German associations for ophthalmology (DOG, BVA) and the European ophthalmological societies concerning EDP, classification and quality control.

  18. Comparison of Three Quality of Life Instruments in Lymphatic Filariasis: DLQI, WHODAS 2.0, and LFSQQ

    PubMed Central

    Thomas, Cristina; Narahari, Saravu R.; Bose, Kuthaje S.; Vivekananda, Kuthaje; Nwe, Steven; West, Dennis P.; Kwasny, Mary; Kundu, Roopal V.

    2014-01-01

    Background The Global Program to Eliminate Lymphatic Filariasis aims to interrupt transmission of lymphatic filariasis and manage morbidity in people currently living with the disease. A component of morbidity management is improving health-related quality of life (HRQoL) in patients. Measurement of HRQoL in current management programs is varied because of the lack of a standard HRQoL tool for use in the lymphatic filariasis population. Methodology/Principal Findings In this study, the psychometric properties of three health status measures were compared when used in a group of lymphatic filariasis patients and healthy controls. The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), the Dermatology Life Quality Index (DLQI), and the Lymphatic Filariasis Quality of Life Questionnaire (LFSQQ) were administered to 36 stage II and stage III lymphatic filariasis subjects and 36 age and sex matched controls in Kerala, India. All three tools yielded missing value rates lower than 10%, suggesting high feasibility. Highest internal consistency was seen in the LFSQQ (α = 0.97). Discriminant validity analysis demonstrated that HRQoL was significantly lower in the LF group than in controls for the WHODAS 2.0, DLQI, and LFSQQ, but total HRQoL scores did not differ between stage II and stage III lymphedema subjects. The LFSQQ total score correlated most strongly with the WHODAS 2.0 (r = 0.91, p<0.001) and DLQI (r = 0.81, p<0.001). Conclusions/Significance The WHODAS 2.0, DLQI, and LFSQQ demonstrate acceptable feasibility, internal consistency, discriminate validity, and construct validity. Based on our psychometric analyses, the LFSQQ performs the best and is recommended for use in the lymphatic filariasis population. PMID:24587467

  19. CARINA data synthesis project: pH data scale unification and cruise adjustments

    NASA Astrophysics Data System (ADS)

    Velo, A.; Pérez, F. F.; Lin, X.; Key, R. M.; Tanhua, T.; de La Paz, M.; van Heuven, S.; Jutterström, S.; Ríos, A. F.

    2009-10-01

    Data on carbon and carbon-relevant hydrographic and hydrochemical parameters from previously non-publicly available cruise data sets in the Artic Mediterranean Seas (AMS), Atlantic and Southern Ocean have been retrieved and merged to a new database: CARINA (CARbon IN the Atlantic). These data have gone through rigorous quality control (QC) procedures to assure the highest possible quality and consistency. The data for most of the measured parameters in the CARINA database were objectively examined in order to quantify systematic differences in the reported values, i.e. secondary quality control. Systematic biases found in the data have been corrected in the data products, i.e. three merged data files with measured, calculated and interpolated data for each of the three CARINA regions; AMS, Atlantic and Southern Ocean. Out of a total of 188 cruise entries in the CARINA database, 59 reported pH measured values. Here we present details of the secondary QC on pH for the CARINA database. Procedures of quality control, including crossover analysis between cruises and inversion analysis of all crossover data are briefly described. Adjustments were applied to the pH values for 21 of the cruises in the CARINA dataset. With these adjustments the CARINA database is consistent both internally as well as with GLODAP data, an oceanographic data set based on the World Hydrographic Program in the 1990s. Based on our analysis we estimate the internal accuracy of the CARINA pH data to be 0.005 pH units. The CARINA data are now suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation.

  20. CARINA alkalinity data in the Atlantic Ocean

    NASA Astrophysics Data System (ADS)

    Velo, A.; Perez, F. F.; Brown, P.; Tanhua, T.; Schuster, U.; Key, R. M.

    2009-08-01

    Data on carbon and carbon-relevant hydrographic and hydrochemical parameters from previously non-publicly available cruise data sets in the Arctic, Atlantic and Southern Ocean have been retrieved and merged to a new database: CARINA (CARbon IN the Atlantic). These data have gone through rigorous quality control (QC) procedures to assure the highest possible quality and consistency. The data for most of the measured parameters in the CARINA data base were objectively examined in order to quantify systematic differences in the reported values, i.e. secondary quality control. Systematic biases found in the data have been corrected in the data products, i.e. three merged data files with measured, calculated and interpolated data for each of the three CARINA regions; Arctic, Atlantic and Southern Ocean. Out of a total of 188 cruise entries in the CARINA database, 98 were conducted in the Atlantic Ocean and of these, 75 cruises report alkalinity values. Here we present details of the secondary QC on alkalinity for the Atlantic Ocean part of CARINA. Procedures of quality control, including crossover analysis between cruises and inversion analysis of all crossover data are briefly described. Adjustments were applied to the alkalinity values for 16 of the cruises in the Atlantic Ocean region. With these adjustments the CARINA database is consistent both internally as well as with GLODAP data, an oceanographic data set based on the World Hydrographic Program in the 1990s. Based on our analysis we estimate the internal accuracy of the CARINA-ATL alkalinity data to be 3.3 μmol kg-1. The CARINA data are now suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation.

  1. CARINA: nutrient data in the Atlantic Ocean

    NASA Astrophysics Data System (ADS)

    Tanhua, T.; Brown, P. J.; Key, R. M.

    2009-11-01

    Data on carbon and carbon-relevant hydrographic and hydrochemical parameters from previously non-publicly available cruise data sets in the Arctic, Atlantic and Southern Ocean have been retrieved and merged to a new database: CARINA (CARbon IN the Atlantic). These data have gone through rigorous quality control (QC) procedures to assure the highest possible quality and consistency. The data for most of the measured parameters in the CARINA data base were objectively examined in order to quantify systematic differences in the reported values, i.e. secondary quality control. Systematic biases found in the data have been corrected in the data products, i.e. three merged data files with measured, calculated and interpolated data for each of the three CARINA regions; Arctic Mediterranean Seas, Atlantic and Southern Ocean. Out of a total of 188 cruise entries in the CARINA database, 98 were conducted in the Atlantic Ocean and of these 84 cruises report nitrate values, 79 silicate, and 78 phosphate. Here we present details of the secondary QC for nutrients for the Atlantic Ocean part of CARINA. Procedures of quality control, including crossover analysis between cruises and inversion analysis of all crossover data are briefly described. Adjustments were applied to the nutrient values for 43 of the cruises in the Atlantic Ocean region. With these adjustments the CARINA database is consistent both internally as well as with GLODAP data, an oceanographic data set based on the World Hydrographic Program in the 1990s (Key et al., 2004). Based on our analysis we estimate the internal accuracy of the CARINA-ATL nutrient data to be: nitrate 1.5%; phosphate 2.6%; silicate 3.1%. The CARINA data are now suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation.

  2. CARINA: nutrient data in the Atlantic Ocean

    NASA Astrophysics Data System (ADS)

    Tanhua, T.; Brown, P. J.; Key, R. M.

    2009-07-01

    Data on carbon and carbon-relevant hydrographic and hydrochemical parameters from previously non-publicly available cruise data sets in the Arctic, Atlantic and Southern Ocean have been retrieved and merged to a new database: CARINA (CARbon IN the Atlantic). These data have gone through rigorous quality control (QC) procedures to assure the highest possible quality and consistency. The data for most of the measured parameters in the CARINA data base were objectively examined in order to quantify systematic differences in the reported values, i.e. secondary quality control. Systematic biases found in the data have been corrected in the data products, i.e. three merged data files with measured, calculated and interpolated data for each of the three CARINA regions; Arctic, Atlantic and Southern Ocean. Out of a total of 188 cruise entries in the CARINA database, 98 were conducted in the Atlantic Ocean and of these 84 cruises report nitrate values, 79 silicate, and 78 phosphate. Here we present details of the secondary QC for nutrients for the Atlantic Ocean part of CARINA. Procedures of quality control, including crossover analysis between cruises and inversion analysis of all crossover data are briefly described. Adjustments were applied to the nutrient values for 43 of the cruises in the Atlantic Ocean region. With these adjustments the CARINA database is consistent both internally as well as with GLODAP data, an oceanographic data set based on the World Hydrographic Program in the 1990s (Key et al., 2004). Based on our analysis we estimate the internal accuracy of the CARINA-ATL nutrient data to be: nitrate 1.5%; phosphate 2.6%; silicate 3.1%. The CARINA data are now suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation.

  3. CARINA alkalinity data in the Atlantic Ocean

    NASA Astrophysics Data System (ADS)

    Velo, A.; Perez, F. F.; Brown, P.; Tanhua, T.; Schuster, U.; Key, R. M.

    2009-11-01

    Data on carbon and carbon-relevant hydrographic and hydrochemical parameters from previously non-publicly available cruise data sets in the Arctic, Atlantic and Southern Ocean have been retrieved and merged to a new database: CARINA (CARbon IN the Atlantic). These data have gone through rigorous quality control (QC) procedures to assure the highest possible quality and consistency. The data for most of the measured parameters in the CARINA data base were objectively examined in order to quantify systematic differences in the reported values, i.e. secondary quality control. Systematic biases found in the data have been corrected in the data products, i.e. three merged data files with measured, calculated and interpolated data for each of the three CARINA regions; Arctic, Atlantic and Southern Ocean. Out of a total of 188 cruise entries in the CARINA database, 98 were conducted in the Atlantic Ocean and of these, 75 cruises report alkalinity values. Here we present details of the secondary QC on alkalinity for the Atlantic Ocean part of CARINA. Procedures of quality control, including crossover analysis between cruises and inversion analysis of all crossover data are briefly described. Adjustments were applied to the alkalinity values for 16 of the cruises in the Atlantic Ocean region. With these adjustments the CARINA database is consistent both internally as well as with GLODAP data, an oceanographic data set based on the World Hydrographic Program in the 1990s. Based on our analysis we estimate the internal accuracy of the CARINA-ATL alkalinity data to be 3.3 μmol kg-1. The CARINA data are now suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation.

  4. Practical Software Measurement: Measuring for Process Management and Improvement,

    DTIC Science & Technology

    1997-04-01

    Ishikawa , Kaoru . Guide to Quality Control, Second Revised Edition. White Plains, N.Y.: UNIPUB-Kraus International Publications, 1986. CMU/SEI-97...begin, you may want to assemble a group of people who work within the process to brainstorm possible reasons for the unusual behavior. Ishikawa charts...control limits and center line. • Cause-and-effect diagrams (also know as Ishikawa charts) allow you to probe for, map, and prioritize a set of factors

  5. Emerging developments in the standardized chemical characterization of indoor air quality.

    PubMed

    Nehr, Sascha; Hösen, Elisabeth; Tanabe, Shin-Ichi

    2017-01-01

    Despite the fact that the special characteristics of indoor air pollution make closed environments quite different from outdoor environments, the conceptual ideas for assessing air quality indoors and outdoors are similar. Therefore, the elaboration of International Standards for air quality characterization in view of controlling indoor air quality should resort to this common basis. In this short review we describe the possibilities of standardization of tools dedicated to indoor air quality characterization with a focus on the tools permitting to study the indoor air chemistry. The link between indoor exposure and health as well as the critical processes driving the indoor air quality are introduced. Available International Standards for the assessment of indoor air quality are depicted. The standards comprise requirements for the sampling on site, the analytical procedures, and the determination of material emissions. To date, these standardized procedures assure that indoor air, settled dust and material samples are analyzed in a comparable manner. However, existing International Standards exclusively specify conventional, event-driven target-screening using discontinuous measurement methods for long-lived pollutants. Therefore, this review draws a parallel between physico-chemical processes in indoor and outdoor environments. The achievements in atmospheric sciences also improve our understanding of indoor environments. The community of atmospheric scientists can be both ideal and supporter for researchers in the area of indoor air quality characterization. This short review concludes with propositions for future standardization activities for the chemical characterization of indoor air quality. Future standardization efforts should focus on: (i) the elaboration of standardized measurement methods and measurement strategies for online monitoring of long-lived and short-lived pollutants, (ii) the assessment of the potential and the limitations of non-target screening, (iii) the paradigm shift from event-driven investigations to systematic approaches to characterize indoor environments, and (iv) the development of tools for policy implementation. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. Quality assurance in pathology in colorectal cancer screening and diagnosis—European recommendations

    PubMed Central

    Quirke, Phil; Risio, Mauro; Lambert, René; von Karsa, Lawrence

    2010-01-01

    In Europe, colorectal cancer is the most common newly diagnosed cancer and the second most common cause of cancer deaths, accounting for approximately 436,000 incident cases and 212,000 deaths in 2008. The potential of high-quality screening to improve control of the disease has been recognized by the Council of the European Union who issued a recommendation on cancer screening in 2003. Multidisciplinary, evidence-based European Guidelines for quality assurance in colorectal cancer screening and diagnosis have recently been developed by experts in a pan-European project coordinated by the International Agency for Research on Cancer. The full guideline document consists of ten chapters and an extensive evidence base. The content of the chapter dealing with pathology in colorectal cancer screening and diagnosis is presented here in order to promote international discussion and collaboration leading to improvements in colorectal cancer screening and diagnosis by making the principles and standards recommended in the new EU Guidelines known to a wider scientific community. PMID:21061133

  7. KSC Center Director Bridges accepts an ISO 9001 certificate from DNV

    NASA Technical Reports Server (NTRS)

    1998-01-01

    Center Director Roy Bridges displays the ISO 9001 certificate he was awarded by Det Norske Veritas (DNV), Inc., an international ISO certification organization, at a ceremony at KSC. Dalton Lyon of DNV made the presentation, which included a 2000th ISO Certificate Plaque. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already world-class team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification.

  8. KSC-98pc907

    NASA Image and Video Library

    1998-08-11

    Center Director Roy Bridges displays the ISO 9001 certificate he was awarded by Det Norske Veritas (DNV), Inc., an international ISO certification organization, at a ceremony at KSC. Dalton Lyon of DNV made the presentation, which included a 2000th ISO Certificate Plaque. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already world-class team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification

  9. KSC-98pc908

    NASA Image and Video Library

    1998-08-11

    Center Director Roy Bridges (right) displays the 2000th ISO Certificate Plaque he was given by Dalton Lyon (left) of Det Norske Veritas (DNV), Inc., an international ISO certification organization, at a ceremony at KSC. The plaque is a representation of the ISO 9001 certification awarded to KSC by DNV. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already worldclass team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification

  10. Ethical pharmaceutical promotion and communications worldwide: codes and regulations

    PubMed Central

    2014-01-01

    The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice. Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines. PMID:24679064

  11. Ethical pharmaceutical promotion and communications worldwide: codes and regulations.

    PubMed

    Francer, Jeffrey; Izquierdo, Jose Zamarriego; Music, Tamara; Narsai, Kirti; Nikidis, Chrisoula; Simmonds, Heather; Woods, Paul

    2014-03-29

    The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines.

  12. Longitudinal handling qualities during approach and landing of a powered lift STOL aircraft

    NASA Technical Reports Server (NTRS)

    Franklin, J. A.; Innis, R. C.

    1972-01-01

    Longitudinal handling qualities evaluations were conducted on the Ames Research Center Flight Simulator for Advanced Aircraft (FSAA) for the approach and landing tasks of a powered lift STOL research aircraft. The test vehicle was a C-8A aircraft modified with a new wing incorporating internal blowing over an augmentor flap. The investigation included: (1) use of various flight path and airspeed control techniques for the basic vehicle; (2) assessment of stability and command augmentation schemes for pitch attitude and airspeed control; (3) determination of the influence of longitudinal and vertical force coupling for the power control; (4) determination of the influence of pitch axis coupling with the thrust vector control; and (5) evaluations of the contribution of stability and command augmentation to recovery from a single engine failure. Results are presented in the form of pilot ratings and commentary substantiated by landing approach time histories.

  13. [Internal audit in medical laboratory: what means of control for an effective audit process?].

    PubMed

    Garcia-Hejl, Carine; Chianéa, Denis; Dedome, Emmanuel; Sanmartin, Nancy; Bugier, Sarah; Linard, Cyril; Foissaud, Vincent; Vest, Philippe

    2013-01-01

    To prepare the French Accreditation Committee (COFRAC) visit for initial certification of our medical laboratory, our direction evaluated its quality management system (QMS) and all its technical activities. This evaluation was performed owing an internal audit. This audit was outsourced. Auditors had an expertise in audit, a whole knowledge of biological standards and were independent. Several nonconformities were identified at that time, including a lack of control of several steps of the internal audit process. Hence, necessary corrective actions were taken in order to meet the requirements of standards, in particular, the formalization of all stages, from the audit program, to the implementation, review and follow-up of the corrective actions taken, and also the implementation of the resources needed to carry out audits in a pre-established timing. To ensure an optimum control of each step, the main concepts of risk management were applied: process approach, root cause analysis, effects and criticality analysis (FMECA). After a critical analysis of our practices, this methodology allowed us to define our "internal audit" process, then to formalize it and to follow it up, with a whole documentary system.

  14. Study on Quality Standard of Processed Curcuma Longa Radix

    PubMed Central

    Zhao, Yongfeng; Quan, Liang; Zhou, Haiting; Cao, Dong; Li, Wenbing; Yang, Zhuo

    2017-01-01

    To control the quality of Curcuma Longa Radix by establishing quality standards, this paper increased the contents of extract and volatile oil determination. Meanwhile, the curcumin was selected as the internal marker, and the relative correlation factors (RCFs) of demethoxycurcumin and bisdemethoxycurcumin were established by high performance liquid chromatography (HPLC). The contents of multicomponents were calculated based on their RCFs. The rationality and feasibility of the methods were evaluated by comparison of the quantitative results between external standard method (ESM) and quantitative analysis of multicomponents by single-marker (QAMS). Ethanol extracts ranged from 9.749 to 15.644% and the mean value was 13.473%. The volatile oil ranged from 0.45 to 0.90 mL/100 g and the mean value was 0.66 mL/100 g. This method was accurate and feasible and could provide a reference for further comprehensive and effective control of the quality standard of Curcuma Longa Radix and its processed products. PMID:29375640

  15. Revisiting the Quality of Reporting Randomized Controlled Trials in Nursing Literature.

    PubMed

    Adams, Yenupini Joyce; Kamp, Kendra; Liu, Cheng Ching; Stommel, Manfred; Thana, Kanjana; Broome, Marion E; Smith, Barbara

    2018-03-01

    To examine and update the literature on the quality of randomized controlled trials (RCTs) as reported in top nursing journals, based on manuscripts' adherence to the CONsolidated Standards of Reporting Trials (CONSORT) guidelines. Descriptive review of adherence of RCT manuscript to CONSORT guidelines. Top 40 International Scientific Indexing (ISI) ranked nursing journals that published 20 or more RCTs between 2010 and 2014, were included in the study. Selected articles were randomly assigned to four reviewers who assessed the quality of the articles using the CONSORT checklist. Data were analyzed using descriptive and inferential statistics. A total of 119 articles were included in the review. The mean CONSORT score significantly differed by journal but did not differ based on year of publication. The least consistently reported items included random allocation, who randomly assigned participants and whether those administering the interventions were blinded to group assignment. Although progress has been made, there is still room for improvement in the quality of RCT reporting in nursing journals. Special attention must be paid to how adequately studies adhere to the CONSORT prior to publication in nursing journals. Evidence from (RCTs) are thought to provide the best evidence for evaluating the impact of treatments and interventions by the U.S. Preventive Services Task Force. Since the evidence may be used for the development of clinical practice guidelines, it is critical that RCTs be designed, conducted, and reported appropriately and precisely. © 2017 Sigma Theta Tau International.

  16. The relationship between external and internal validity of randomized controlled trials: A sample of hypertension trials from China.

    PubMed

    Zhang, Xin; Wu, Yuxia; Ren, Pengwei; Liu, Xueting; Kang, Deying

    2015-10-30

    To explore the relationship between the external validity and the internal validity of hypertension RCTs conducted in China. Comprehensive literature searches were performed in Medline, Embase, Cochrane Central Register of Controlled Trials (CCTR), CBMdisc (Chinese biomedical literature database), CNKI (China National Knowledge Infrastructure/China Academic Journals Full-text Database) and VIP (Chinese scientific journals database) as well as advanced search strategies were used to locate hypertension RCTs. The risk of bias in RCTs was assessed by a modified scale, Jadad scale respectively, and then studies with 3 or more grading scores were included for the purpose of evaluating of external validity. A data extract form including 4 domains and 25 items was used to explore relationship of the external validity and the internal validity. Statistic analyses were performed by using SPSS software, version 21.0 (SPSS, Chicago, IL). 226 hypertension RCTs were included for final analysis. RCTs conducted in university affiliated hospitals (P < 0.001) or secondary/tertiary hospitals (P < 0.001) were scored at higher internal validity. Multi-center studies (median = 4.0, IQR = 2.0) were scored higher internal validity score than single-center studies (median = 3.0, IQR = 1.0) (P < 0.001). Funding-supported trials had better methodological quality (P < 0.001). In addition, the reporting of inclusion criteria also leads to better internal validity (P = 0.004). Multivariate regression indicated sample size, industry-funding, quality of life (QOL) taken as measure and the university affiliated hospital as trial setting had statistical significance (P < 0.001, P < 0.001, P = 0.001, P = 0.006 respectively). Several components relate to the external validity of RCTs do associate with the internal validity, that do not stand in an easy relationship to each other. Regarding the poor reporting, other possible links between two variables need to trace in the future methodological researches.

  17. Training and support to improve ICD coding quality: A controlled before-and-after impact evaluation.

    PubMed

    Dyers, Robin; Ward, Grant; Du Plooy, Shane; Fourie, Stephanus; Evans, Juliet; Mahomed, Hassan

    2017-05-24

    The proposed National Health Insurance policy for South Africa (SA) requires hospitals to maintain high-quality International Statistical Classification of Diseases (ICD) codes for patient records. While considerable strides had been made to improve ICD coding coverage by digitising the discharge process in the Western Cape Province, further intervention was required to improve data quality. The aim of this controlled before-and-after study was to evaluate the impact of a clinician training and support initiative to improve ICD coding quality. To compare ICD coding quality between two central hospitals in the Western Cape before and after the implementation of a training and support initiative for clinicians at one of the sites. The difference in differences in data quality between the intervention site and the control site was calculated. Multiple logistic regression was also used to determine the odds of data quality improvement after the intervention and to adjust for potential differences between the groups. The intervention had a positive impact of 38.0% on ICD coding completeness over and above changes that occurred at the control site. Relative to the baseline, patient records at the intervention site had a 6.6 (95% confidence interval 3.5 - 16.2) adjusted odds ratio of having a complete set of ICD codes for an admission episode after the introduction of the training and support package. The findings on impact on ICD coding accuracy were not significant. There is sufficient pragmatic evidence that a training and support package will have a considerable positive impact on ICD coding completeness in the SA setting.

  18. International Students' Perceptions of Service Quality in the UK Banking Sector: An Exploratory Study

    ERIC Educational Resources Information Center

    Bond, Christopher; Hsu, Marc Ting-Chun

    2011-01-01

    This study reviews and evaluates international students' perceptions of UK banks. The specific research objectives were to identify international students' expectations and perceptions of service quality from UK banks and to assess the quality GAP or dissonance between these. A total of 297 international students studying in the UK responded to…

  19. The Effectiveness of Mindfulness-Based Stress Reduction on Perceived Pain Intensity and Quality of Life in Patients With Chronic Headache.

    PubMed

    Bakhshani, Nour Mohammad; Amirani, Ahmadreza; Amirifard, Hamed; Shahrakipoor, Mahnaz

    2015-08-06

    The aim of this study was to determine the effectiveness of Mindfulness-Based Stress reduction (MBSR) on perceived pain intensity and quality of life in patients with chronic headache. Thus, forty patients based on the diagnosis of a neurologist and diagnostic criteria of the International Headache Society (IHS) for migraine and chronic tension-type headache were selected and randomly assigned to the intervention group and control group, respectively. The participants completed the Pain and quality of life (SF-36) questionnaire. The intervention group enrolled in an eight-week MBSR program that incorporated meditation and daily home practice, per week, session of 90-minutes. Results of covariance analysis with the elimination of the pre-test showed significantly improvement of pain and quality of life in the intervention group compared with the control group. The findings from this study revealed that MBSR can be used non-pharmacological intervention for improvement the quality of life and development of strategies to cope with pain in patients with chronic headache. And can be used in combination with other therapies such as pharmacotherapy.

  20. Redesigning the Role of Deputy Heads in Norwegian Schools--Tensions between Control and Autonomy?

    ERIC Educational Resources Information Center

    Abrahamsen, Hedvig

    2018-01-01

    A substantial body of research emphasises school leadership as a major influence on quality improvement in schools. Although numerous studies have identified the importance of the principal, fewer studies have examined the middle management level within schools, the deputy heads and assistant principals. Influenced by international trends, local…

  1. Ensuring Quality in Online Courses: Applying the AACSB International's Distance Learning Quality Issues

    ERIC Educational Resources Information Center

    Gaytan, Jorge

    2013-01-01

    The purpose of this qualitative study was to examine the Distance Learning Quality Issues published by the American Assembly of Collegiate Schools of Business International (AACSB-International) to document the various characteristics that high-quality online courses must possess. A content analysis methodology was employed to examine the seven…

  2. Postharvest Exogenous Application of Abscisic Acid Reduces Internal Browning in Pineapple.

    PubMed

    Zhang, Qin; Liu, Yulong; He, Congcong; Zhu, Shijiang

    2015-06-10

    Internal browning (IB) is a postharvest physiological disorder causing economic losses in pineapple, but there is no effective control measure. In this study, postharvest application of 380 μM abscisic acid (ABA) reduced IB incidence by 23.4-86.3% and maintained quality in pineapple fruit. ABA reduced phenolic contents and polyphenol oxidase and phenylalanine ammonia lyase activities; increased catalase and peroxidase activities; and decreased O2(·-), H2O2, and malondialdehyde levels. This suggests ABA could control IB through inhibiting phenolics biosynthesis and oxidation and enhancing antioxidant capability. Furthermore, the efficacy of IB control by ABA was not obviously affected by tungstate, ABA biosynthesis inhibitor, nor by diphenylene iodonium, NADPH oxidase inhibitor, nor by lanthanum chloride, calcium channel blocker, suggesting that ABA is sufficient for controlling IB. This process might not involve H2O2 generation, but could involve the Ca(2+) channels activation. These results provide potential for developing effective measures for controlling IB in pineapple.

  3. Information system equality for food security--implementation of the food safety control system in Taiwan.

    PubMed

    Chen, Shaun C; Hsu, Guoo-Shyng Wang; Chiu, Chihwei P

    2009-01-01

    Food security plays a central role in governing agricultural policies in Taiwan. In addition to overuse or the illegal use of pesticide, meat leanness promoters, animal drugs and melamine in the food supply; as well as foodborne illness draws the greatest public concern due to incidents that occur every year in Taiwan. The present report demonstrates the implementation of a food safety control system in Taiwan. In order to control foodborne outbreaks effectively, the central government of the Department of Health of Taiwan launched the food safety control system which includes both the good hygienic practice (GHP) and the HACCP plan, in the last decade. From 1998 to the present, 302 food affiliations that implemented the system have been validated and accredited by a well-established audit system. The implementation of a food safety control system in compliance with international standards is of crucial importance to ensure complete safety and the high quality of foods, not only for domestic markets, but also for international trade.

  4. Modification and Evaluation of a Velopharyngeal Insufficiency Quality of Life Instrument

    PubMed Central

    Skirko, Jonathan R.; Weaver, Edward M; Perkins, Jonathan; Kinter, Sara; Sie, Kathleen C.Y.

    2018-01-01

    Objective Modify the existing 45-item velopharyngeal insufficiency (VPI) quality of life (QOL) instrument (VPIQL), assess the modified instrument for reliability and provide further validation. There are patient and parent versions of the instrument. Design Validation convenience sample from a previously conducted pilot study. Setting Two academic tertiary referral medical centers. Participants De-identified data were used from 29 subjects with VPI and 29 control subjects age 5–17 years, and parents. Outcome measures Subjects and parents completed VPIQL and a generic pediatric QOL instrument (PedsQL4-0). Data Analysis Twenty-two items were removed from the VPIQL for ceiling effects, floor effects, and redundancy, to produce the modified instrument, VPI Effects on Life Outcomes (VELO) instrument. VELO was tested for internal consistency (Chronbach’s alpha), discriminant validity (paired t-test with control subjects), and concurrent validity (Pearson correlation with the PedsQL4-0). These analyses were also completed for parents. Results The 45-item VPIQL instrument was reduced to the 23-item VELO instrument. The VELO had excellent internal consistency (Chronbach’s alpha 0.96 for parents and 0.95 for VPI subjects). The VELO discriminated well between VPI and control subjects, with mean score (SD) was significantly lower (worse) for VPI subjects (67.6 [23.9]) than for control subjects (97.0 [5.2]) (p<0.0001). The VELO total score was significantly correlated with the PedsQL4.0 (r=0.73) among subjects with VPI. Similar results were seen in parent responses. Conclusions The VELO is a 23-item QOL instrument that was designed to measure and follow QOL in subjects with VPI, with less burden than the original VPIQL. VELO demonstrates internal consistency, disciminant validty, and concurrent validity with the PedsQL4-0. PMID:23069823

  5. Quality-assurance plan for the analysis of fluvial sediment by the U.S. Geological Survey Kentucky Water Science Center Sediment Laboratory

    USGS Publications Warehouse

    Shreve, Elizabeth A.; Downs, Aimee C.

    2005-01-01

    This report describes laboratory procedures used by the U.S. Geological Survey Kentucky Water Science Center Sediment Laboratory for the processing and analysis of fluvial-sediment samples for concentration of sand and finer material. The report details the processing of a sediment sample through the laboratory from receiving the sediment sample, through the analytical process, to compiling results of the requested analysis. Procedures for preserving sample integrity, calibrating and maintaining of laboratory and field instruments and equipment, analyzing samples, internal quality assurance and quality control, and validity of the sediment-analysis results also are described. The report includes a list of references cited and a glossary of sediment and quality-assurance terms.

  6. Dosimetry and image quality assessment in a direct radiography system

    PubMed Central

    Oliveira, Bruno Beraldo; de Oliveira, Marcio Alves; Paixão, Lucas; Teixeira, Maria Helena Araújo; Nogueira, Maria do Socorro

    2014-01-01

    Objective To evaluate the mean glandular dose with a solid state detector and the image quality in a direct radiography system, utilizing phantoms. Materials and Methods Irradiations were performed with automatic exposure control and polymethyl methacrylate slabs with different thicknesses to calculate glandular dose values. The image quality was evaluated by means of the structures visualized on the images of the phantoms. Results Considering the uncertainty of the measurements, the mean glandular dose results are in agreement with the values provided by the equipment and with internationally adopted reference levels. Results obtained from images of the phantoms were in agreement with the reference values. Conclusion The present study contributes to verify the equipment conformity as regards dose values and image quality. PMID:25741119

  7. Predictive Techniques for Spacecraft Cabin Air Quality Control

    NASA Technical Reports Server (NTRS)

    Perry, J. L.; Cromes, Scott D. (Technical Monitor)

    2001-01-01

    As assembly of the International Space Station (ISS) proceeds, predictive techniques are used to determine the best approach for handling a variety of cabin air quality challenges. These techniques use equipment offgassing data collected from each ISS module before flight to characterize the trace chemical contaminant load. Combined with crew metabolic loads, these data serve as input to a predictive model for assessing the capability of the onboard atmosphere revitalization systems to handle the overall trace contaminant load as station assembly progresses. The techniques for predicting in-flight air quality are summarized along with results from early ISS mission analyses. Results from groundbased analyses of in-flight air quality samples are compared to the predictions to demonstrate the technique's relative conservatism.

  8. Benefits of a Pharmacology Antimalarial Reference Standard and Proficiency Testing Program Provided by the Worldwide Antimalarial Resistance Network (WWARN)

    PubMed Central

    Lourens, Chris; Lindegardh, Niklas; Barnes, Karen I.; Guerin, Philippe J.; Sibley, Carol H.; White, Nicholas J.

    2014-01-01

    Comprehensive assessment of antimalarial drug resistance should include measurements of antimalarial blood or plasma concentrations in clinical trials and in individual assessments of treatment failure so that true resistance can be differentiated from inadequate drug exposure. Pharmacometric modeling is necessary to assess pharmacokinetic-pharmacodynamic relationships in different populations to optimize dosing. To accomplish both effectively and to allow comparison of data from different laboratories, it is essential that drug concentration measurement is accurate. Proficiency testing (PT) of laboratory procedures is necessary for verification of assay results. Within the Worldwide Antimalarial Resistance Network (WWARN), the goal of the quality assurance/quality control (QA/QC) program is to facilitate and sustain high-quality antimalarial assays. The QA/QC program consists of an international PT program for pharmacology laboratories and a reference material (RM) program for the provision of antimalarial drug standards, metabolites, and internal standards for laboratory use. The RM program currently distributes accurately weighed quantities of antimalarial drug standards, metabolites, and internal standards to 44 pharmacology, in vitro, and drug quality testing laboratories. The pharmacology PT program has sent samples to eight laboratories in four rounds of testing. WWARN technical experts have provided advice for correcting identified problems to improve performance of subsequent analysis and ultimately improved the quality of data. Many participants have demonstrated substantial improvements over subsequent rounds of PT. The WWARN QA/QC program has improved the quality and value of antimalarial drug measurement in laboratories globally. It is a model that has potential to be applied to strengthening laboratories more widely and improving the therapeutics of other infectious diseases. PMID:24777099

  9. Sexual Dysfunctions in Men and Women with Inflammatory Bowel Disease: The Influence of IBD-Related Clinical Factors and Depression on Sexual Function.

    PubMed

    Bel, Linda G J; Vollebregt, Anna M; Van der Meulen-de Jong, Andrea E; Fidder, Herma H; Ten Hove, Willem R; Vliet-Vlieland, Cornelia W; Ter Kuile, Moniek M; de Groot, Helena E; Both, Stephanie

    2015-07-01

    Inflammatory bowel disease (IBD) is likely to have an impact on sexual function because of its symptoms, like diarrhea, fatigue, and abdominal pain. Depression is commonly reported in IBD and is also related to impaired sexual function. This study aimed to evaluate sexual function and its association with depression among patients with IBD compared with controls. IBD patients registered at two hospitals participated. The control group consisted of a general practitioner practice population. The web-based questionnaire included the Female Sexual Function Index (FSFI) for women and the International Index of Erectile Function (IIEF) for men. Other variables evaluated were depression, disease activity, IBD-related quality of life, body image, and fatigue. In total, 168 female and 119 male patients were available for analysis (response rate 24%). Overall, patients with IBD did not significantly differ in prevalence of sexual dysfunctions from controls: female patients 52%, female controls 44%, male patients and male controls both 25%. However, men and women with an active disease scored significantly lower than patients in remission and controls, indicating impaired sexual functioning during disease activity. Significant associations were found between active disease, fatigue, depressive mood, quality of life, and sexual function for both male and female patients. The association between disease activity and sexual function was totally mediated by depression. Male and female IBD patients with an active disease show impaired sexual function relative to patients in remission and controls. Depression is the most important determinant for impaired sexual function in IBD. © 2015 International Society for Sexual Medicine.

  10. Design, development, and field demonstration of a remotely deployable water quality monitoring system

    NASA Technical Reports Server (NTRS)

    Wallace, J. W.; Lovelady, R. W.; Ferguson, R. L.

    1981-01-01

    A prototype water quality monitoring system is described which offers almost continuous in situ monitoring. The two-man portable system features: (1) a microprocessor controlled central processing unit which allows preprogrammed sampling schedules and reprogramming in situ; (2) a subsurface unit for multiple depth capability and security from vandalism; (3) an acoustic data link for communications between the subsurface unit and the surface control unit; (4) eight water quality parameter sensors; (5) a nonvolatile magnetic bubble memory which prevents data loss in the event of power interruption; (6) a rechargeable power supply sufficient for 2 weeks of unattended operation; (7) a water sampler which can collect samples for laboratory analysis; (8) data output in direct engineering units on printed tape or through a computer compatible link; (9) internal electronic calibration eliminating external sensor adjustment; and (10) acoustic location and recovery systems. Data obtained in Saginaw Bay, Lake Huron are tabulated.

  11. Restless Legs Syndrome and Poor Sleep Quality in Obese Children and Adolescents

    PubMed

    Baran, Rıza Taner; Atar, Müge; Pirgon, Özgür; Filiz, Serkan; Filiz, Meral

    2018-06-01

    Adult epidemiological studies suggest that the rate of Restless Legs syndrome (RLS) in the general population may range from 5% to 15%. The aim of this study was to investigate the frequency of RLS in a community sample of obese adolescents aged 10-16 years and to assess the association with sleep quality and health-related glucose metabolism markers. The study group comprised 144 obese and overweight children aged 10-16 yearsand the control group consisted of 66 age-matched healthy children. The RLS Questionnaire devised by the International RLS Study and the Pittsburgh Sleep Quality Index (PSQI), where a score >5 indicates poor sleep quality, was used to assess sleep quality. Mean body mass index (BMI) of the overweight/obese and control groups were 30.5±0.5 and 18.7±0.2, respectively. The frequency of RLS was higher in the obese group (21.7%) than the overweight (3.4%) and control (1.5%) (p<0.001) groups. The frequency of a poor PSQI score was significantly higher (p<0.001) in the obese group (37.3%) than the control group (24.2%). The obese with RLS group also had poorer sleep quality scores than the non-RLS obese group. Many symptoms of sleep disruption were more common in obese patients with RLS and RLS was independently correlated with a high PSQI score [odds ratio (OR): 2.25, confidence interval (Cl): 0.96-5.28, p<0.001)] and an increased BMI z-score (OR: 8.87, Cl: 2.04-38.61, p<0.001). RLS is common in obese children and may be associated with altered sleep quality. Obese children with RLS need to be assessed since they may need support to improve their sleep quality.

  12. Restless Legs Syndrome and Poor Sleep Quality in Obese Children and Adolescents

    PubMed Central

    Baran, Rıza Taner; Atar, Müge; Pirgon, Özgür; Filiz, Serkan; Filiz, Meral

    2018-01-01

    Objective: Adult epidemiological studies suggest that the rate of Restless Legs syndrome (RLS) in the general population may range from 5% to 15%. The aim of this study was to investigate the frequency of RLS in a community sample of obese adolescents aged 10-16 years and to assess the association with sleep quality and health-related glucose metabolism markers. Methods: The study group comprised 144 obese and overweight children aged 10-16 yearsand the control group consisted of 66 age-matched healthy children. The RLS Questionnaire devised by the International RLS Study and the Pittsburgh Sleep Quality Index (PSQI), where a score >5 indicates poor sleep quality, was used to assess sleep quality. Results: Mean body mass index (BMI) of the overweight/obese and control groups were 30.5±0.5 and 18.7±0.2, respectively. The frequency of RLS was higher in the obese group (21.7%) than the overweight (3.4%) and control (1.5%) (p<0.001) groups. The frequency of a poor PSQI score was significantly higher (p<0.001) in the obese group (37.3%) than the control group (24.2%). The obese with RLS group also had poorer sleep quality scores than the non-RLS obese group. Many symptoms of sleep disruption were more common in obese patients with RLS and RLS was independently correlated with a high PSQI score [odds ratio (OR): 2.25, confidence interval (Cl): 0.96-5.28, p<0.001)] and an increased BMI z-score (OR: 8.87, Cl: 2.04-38.61, p<0.001). Conclusion: RLS is common in obese children and may be associated with altered sleep quality. Obese children with RLS need to be assessed since they may need support to improve their sleep quality. PMID:29175807

  13. International Society of Human and Animal Mycology (ISHAM)-ITS reference DNA barcoding database--the quality controlled standard tool for routine identification of human and animal pathogenic fungi.

    PubMed

    Irinyi, Laszlo; Serena, Carolina; Garcia-Hermoso, Dea; Arabatzis, Michael; Desnos-Ollivier, Marie; Vu, Duong; Cardinali, Gianluigi; Arthur, Ian; Normand, Anne-Cécile; Giraldo, Alejandra; da Cunha, Keith Cassia; Sandoval-Denis, Marcelo; Hendrickx, Marijke; Nishikaku, Angela Satie; de Azevedo Melo, Analy Salles; Merseguel, Karina Bellinghausen; Khan, Aziza; Parente Rocha, Juliana Alves; Sampaio, Paula; da Silva Briones, Marcelo Ribeiro; e Ferreira, Renata Carmona; de Medeiros Muniz, Mauro; Castañón-Olivares, Laura Rosio; Estrada-Barcenas, Daniel; Cassagne, Carole; Mary, Charles; Duan, Shu Yao; Kong, Fanrong; Sun, Annie Ying; Zeng, Xianyu; Zhao, Zuotao; Gantois, Nausicaa; Botterel, Françoise; Robbertse, Barbara; Schoch, Conrad; Gams, Walter; Ellis, David; Halliday, Catriona; Chen, Sharon; Sorrell, Tania C; Piarroux, Renaud; Colombo, Arnaldo L; Pais, Célia; de Hoog, Sybren; Zancopé-Oliveira, Rosely Maria; Taylor, Maria Lucia; Toriello, Conchita; de Almeida Soares, Célia Maria; Delhaes, Laurence; Stubbe, Dirk; Dromer, Françoise; Ranque, Stéphane; Guarro, Josep; Cano-Lira, Jose F; Robert, Vincent; Velegraki, Aristea; Meyer, Wieland

    2015-05-01

    Human and animal fungal pathogens are a growing threat worldwide leading to emerging infections and creating new risks for established ones. There is a growing need for a rapid and accurate identification of pathogens to enable early diagnosis and targeted antifungal therapy. Morphological and biochemical identification methods are time-consuming and require trained experts. Alternatively, molecular methods, such as DNA barcoding, a powerful and easy tool for rapid monophasic identification, offer a practical approach for species identification and less demanding in terms of taxonomical expertise. However, its wide-spread use is still limited by a lack of quality-controlled reference databases and the evolving recognition and definition of new fungal species/complexes. An international consortium of medical mycology laboratories was formed aiming to establish a quality controlled ITS database under the umbrella of the ISHAM working group on "DNA barcoding of human and animal pathogenic fungi." A new database, containing 2800 ITS sequences representing 421 fungal species, providing the medical community with a freely accessible tool at http://www.isham.org/ and http://its.mycologylab.org/ to rapidly and reliably identify most agents of mycoses, was established. The generated sequences included in the new database were used to evaluate the variation and overall utility of the ITS region for the identification of pathogenic fungi at intra-and interspecies level. The average intraspecies variation ranged from 0 to 2.25%. This highlighted selected pathogenic fungal species, such as the dermatophytes and emerging yeast, for which additional molecular methods/genetic markers are required for their reliable identification from clinical and veterinary specimens. © The Author 2015. Published by Oxford University Press on behalf of The International Society for Human and Animal Mycology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  14. Adaptive Flow Control for Enabling Quality of Service in Tactical Ad Hoc Wireless Networks

    DTIC Science & Technology

    2010-12-01

    environment in wireless networks , we use sensors in the network routers to detect and respond to congestion. We use backpressure techniques... wireless mesh network . In the current approach, we used OLSR as the routing scheme. However, B.A.T.M.A.N. offers the significant advantage of being based...Control and QoS Routing in Multi-Channel Wireless Mesh Networks ,” 68-77. ACM International Symposium on Mobile Ad Hoc Networking &

  15. Quality Control Review of the Defense Finance and Accounting Service Internal Audit Organization

    DTIC Science & Technology

    2014-12-01

    Executive documented a threat to independence because they provided direction in a nonaudit service (IR End-to-End Assessment of DFAS Texarkana Operations...effect the lack of segregation of duties and system management controls has on the DFAS Texarkana Vendor Pay and Payroll functions.” Based on our...Infrastructure Management, February 10, 2014 Performance CO12PRC010TX Columbus Audit of DFAS Texarkana Vendor Pay and Payroll, November 19, 2013

  16. The Relationship between Internal Teacher Profiles and the Quality of Teacher-Child Interactions in Prekindergarten

    ERIC Educational Resources Information Center

    Decker-Woodrow, Lauren

    2018-01-01

    This study investigates the relationship between internal teacher profiles and pre-K teacher-child interaction quality in the pre-K classroom. Two questions were addressed: (1) What internal profiles exist for pre-kindergarten (pre-K) teachers? and (2) Do internal profiles relate to observed structural and process quality in the pre-K classroom?…

  17. The Impact of Stress Urinary Incontinence on Individual Components of Quality of Life in Malaysian Women.

    PubMed

    Lim, Renly; Liong, Men Long; Leong, Wing Seng; Lau, Yong Khee; Khan, Nurzalina Abdul Karim; Yuen, Kah Hay

    2018-02-01

    To assess the impact of stress urinary incontinence (SUI) on individual components of quality of life (QoL) using both condition-specific and generic questionnaires, and to compare the results of the 2 instruments with a control group. Women with or without SUI aged ≥21 years old were recruited. Subjects completed the International Consultation of Incontinence-Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation of Incontinence-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol), and EQ-5D questionnaires. A total of 120 women with SUI and 145 controls participated. The ICIQ-LUTSqol total score (mean ± standard deviation) was significantly higher in the SUI group (38.96 ± 10.28) compared with the control group (20.78 ± 2.73) (P <.001). When adjusted for significant confounders, the SUI group continued to have significantly poorer QoL compared with the control group (P <.001). The negative effect of SUI on "physical activities" and "jobs" were the 2 most frequently reported and burdensome components of the ICIQ-LUTSqol, with approximately 50% of women with SUI affected "moderately" or "a lot." When measured using the EQ-5D questionnaire, there were significantly higher percentages of patients with SUI who had problems with usual activities, pain or discomfort, and anxiety or depression (P <.05). Women suffering from SUI have significantly poorer QoL compared with continent women when measured using both condition-specific and generic QoL measures. Clinicians should pay closer attention to the impact of SUI on individual components of QoL, particularly limitations on physical activities and jobs, which were the 2 most impairing and frequently reported components of QoL. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Quality of life: international and domestic students studying medicine in New Zealand.

    PubMed

    Henning, Marcus A; Krägeloh, Christian; Moir, Fiona; Doherty, Iain; Hawken, Susan J

    2012-08-01

    International students form a significant proportion of students studying within universities in Western countries. The quality of life perceptions of international medical students in comparison with domestic medical students has not been well documented. There is some evidence to suggest that international medical students may have different educational and social experiences in relation to their domestic peers. This study investigates the levels of quality of life experienced by international and domestic students studying medicine. A total of 548 medical students completed the abbreviated version of the World Health Organization Quality of Life questionnaire. The focus of the analysis was to evaluate differences between international and domestic students in their early clinical years. The responses were analysed using multivariate analysis of variance methods. International medical students are experiencing lower social and environmental quality of life compared with domestic peers. International medical students in New Zealand have expressed quality of life concerns, which likely have an impact on their academic achievement, feelings of wellness, acculturation, and social adaptation. The findings reinforce the need for creating stronger social networks and accessible accommodation, as well as developing systems to ensure safety, peer mentorship and student support.

  19. Validation of a proposal for evaluating hospital infection control programs.

    PubMed

    Silva, Cristiane Pavanello Rodrigues; Lacerda, Rúbia Aparecida

    2011-02-01

    To validate the construct and discriminant properties of a hospital infection prevention and control program. The program consisted of four indicators: technical-operational structure; operational prevention and control guidelines; epidemiological surveillance system; and prevention and control activities. These indicators, with previously validated content, were applied to 50 healthcare institutions in the city of São Paulo, Southeastern Brazil, in 2009. Descriptive statistics were used to characterize the hospitals and indicator scores, and Cronbach's α coefficient was used to evaluate the internal consistency. The discriminant validity was analyzed by comparing indicator scores between groups of hospitals: with versus without quality certification. The construct validity analysis was based on exploratory factor analysis with a tetrachoric correlation matrix. The indicators for the technical-operational structure and epidemiological surveillance presented almost 100% conformity in the whole sample. The indicators for the operational prevention and control guidelines and the prevention and control activities presented internal consistency ranging from 0.67 to 0.80. The discriminant validity of these indicators indicated higher and statistically significant mean conformity scores among the group of institutions with healthcare certification or accreditation processes. In the construct validation, two dimensions were identified for the operational prevention and control guidelines: recommendations for preventing hospital infection and recommendations for standardizing prophylaxis procedures, with good correlation between the analysis units that formed the guidelines. The same was found for the prevention and control activities: interfaces with treatment units and support units were identified. Validation of the measurement properties of the hospital infection prevention and control program indicators made it possible to develop a tool for evaluating these programs in an ethical and scientific manner in order to obtain a quality diagnosis in this field.

  20. Quality of life amongst older Brazilians: a cross-cultural validation of the CASP-19 into Brazilian-Portuguese.

    PubMed

    Lima, Fábia M; Hyde, Martin; Chungkham, Holendro Singh; Correia, Clarice; Siqueira Campos, Alexsandra; Campos, Marília; Novaes, Moacir; Laks, Jerson; Petribu, Kátia

    2014-01-01

    As population ageing becomes a global phenomenon the need to understand the quality of life of older people around the world has become increasingly salient. The CASP-19 is a well established measure of quality of later life. The scale is composed of 19 items which map onto the four domains of control (C), Autonomy (A), Self-Realisation (S) and Pleasure (P). It has already been translated to 12 languages and has been used in a number of national and international studies. However use of the scale outside of Europe has been very limited. The objective of this study was to translate and evaluate the use of the CASP-19 amongst older Brazilians. The CASP-19 was translated from English to Portuguese, back-translated and submitted to an analysis of equivalence by a committee of judges. The scale was then administered to a sample of community dwelling older people in Recife, Brazil (n = 87), and tested for psychometric properties. The Control and Pleasure domains exhibited good internal consistency. By removing one item from each of the Autonomy and Self Realisation domains their internal consistency was improved. The mean age of the sample was 75.6±0.7 years, subjects were mainly female (52.9%), white (52.9%), who lived without a partner (54%), and had a monthly income varying from USD 340.00 to USD 850.00. Translation and cross-cultural adaptation permitted good understanding and applicability of final version. Psychometric analyses revealed that the removal of two items improved the internal consistency of the Autonomy and Pleasure domains. Confirmatory factor analyses suggest that a 16 item, four factor, model best fits the data. In this small exploratory study the CASP-19 Brazil demonstrated good psychometric properties. It was easy to use for both participants and researchers. Hopefully future studies in Brazil will employ the scale so that more direct cross national comparisons can be made with older people in Europe and the US.

  1. The European general thoracic surgery database project.

    PubMed

    Falcoz, Pierre Emmanuel; Brunelli, Alessandro

    2014-05-01

    The European Society of Thoracic Surgeons (ESTS) Database is a free registry created by ESTS in 2001. The current online version was launched in 2007. It runs currently on a Dendrite platform with extensive data security and frequent backups. The main features are a specialty-specific, procedure-specific, prospectively maintained, periodically audited and web-based electronic database, designed for quality control and performance monitoring, which allows for the collection of all general thoracic procedures. Data collection is the "backbone" of the ESTS database. It includes many risk factors, processes of care and outcomes, which are specially designed for quality control and performance audit. The user can download and export their own data and use them for internal analyses and quality control audits. The ESTS database represents the gold standard of clinical data collection for European General Thoracic Surgery. Over the past years, the ESTS database has achieved many accomplishments. In particular, the database hit two major milestones: it now includes more than 235 participating centers and 70,000 surgical procedures. The ESTS database is a snapshot of surgical practice that aims at improving patient care. In other words, data capture should become integral to routine patient care, with the final objective of improving quality of care within Europe.

  2. The Benefits of Internalizing Air Quality and Greenhouse Gas Externalities in the US Energy System

    NASA Astrophysics Data System (ADS)

    Brown, Kristen E.

    The emission of pollutants from energy use has effects on both local air quality and the global climate, but the price of energy does not reflect these externalities. This study aims to analyze the effect that internalizing these externalities in the cost of energy would have on the US energy system, emissions, and human health. In this study, we model different policy scenarios in which fees are added to emissions related to generation and use of energy. The fees are based on values of damages estimated in the literature and are applied to upstream and combustion emissions related to electricity generation, industrial energy use, transportation energy use, residential energy use, and commercial energy use. The energy sources and emissions are modeled through 2055 in five-year time steps. The emissions in 2045 are incorporated into a continental-scale atmospheric chemistry and transport model, CMAQ, to determine the change in air quality due to different emissions reduction scenarios. A benefit analysis tool, BenMAP, is used with the air quality results to determine the monetary benefit of emissions reductions related to the improved air quality. We apply fees to emissions associated with health impacts, climate change, and a combination of both. We find that the fees we consider lead to reductions in targeted emissions as well as co-reducing non-targeted emissions. For fees on the electric sector alone, health impacting pollutant (HIP) emissions reductions are achieved mainly through control devices while Greenhouse Gas (GHG) fees are addressed through changes in generation technologies. When sector specific fees are added, reductions come mainly from the industrial and electricity generation sectors, and are achieved through a mix of energy efficiency, increased use of renewables, and control devices. Air quality is improved in almost all areas of the country with fees, including when only GHG fees are applied. Air quality tends to improve more in regions with larger emissions reductions, especially for PM2.5.

  3. How Do the Approaches to Accountability Compare for Charities Working in International Development?

    PubMed Central

    Kirsch, David

    2014-01-01

    Approaches to accountability vary between charities working to reduce under-five mortality in underdeveloped countries, and healthcare workers and facilities in Canada. Comparison reveals key differences, similarities and trade-offs. For example, while health professionals are governed by legislation and healthcare facilities have a de facto obligation to be accredited, charities and other international organizations are not subject to mandatory international laws or guidelines or to de facto international standards. Charities have policy goals similar to those found in the Canadian substudies, including access, quality, cost control, cost-effectiveness and customer satisfaction. However, the relative absence of external policy tools means that these goals may not be realized. Accountability can be beneficial, but too much or the wrong kind of accountability can divert resources and diminish returns. PMID:25305397

  4. A review of the International Atomic Energy Agency (IAEA) international standards for tissue banks.

    PubMed

    Morales Pedraza, Jorge; Lobo Gajiwala, Astrid; Martinez Pardo, María Esther

    2012-03-01

    The IAEA International Standards for Tissue Banks published in 2003 were based on the Standards then currently in use in the USA and the European Union, among others, and reflect the best practices associated with the operation of a tissue bank. They cover legal, ethical and regulatory controls as well as requirements and procedures from donor selection and tissue retrieval to processing and distribution of finished tissue for clinical use. The application of these standards allows tissue banks to operate with the current good tissue practice, thereby providing grafts of high quality that satisfy the national and international demand for safe and biologically useful grafts. The objective of this article is to review the IAEA Standards and recommend new topics that could improve the current version.

  5. Critical Need for Plutonium and Uranium Isotopic Standards with Lower Uncertainties

    DOE PAGES

    Mathew, Kattathu Joseph; Stanley, Floyd E.; Thomas, Mariam R.; ...

    2016-09-23

    Certified reference materials (CRMs) traceable to national and international safeguards database are a critical prerequisite for ensuring that nuclear measurement systems are free of systematic biases. CRMs are used to validate measurement processes associated with nuclear analytical laboratories. Diverse areas related to nuclear safeguards are impacted by the quality of the CRM standards available to analytical laboratories. These include: nuclear forensics, radio-chronometry, national and international safeguards, stockpile stewardship, nuclear weapons infrastructure and nonproliferation, fuel fabrication, waste processing, radiation protection, and environmental monitoring. For the past three decades the nuclear community is confronted with the strange situation that improvements in measurementmore » data quality resulting from the improved accuracy and precision achievable with modern multi-collector mass spectrometers could not be fully exploited due to large uncertainties associated with CRMs available from New Brunswick Laboratory (NBL) that are used for instrument calibration and measurement control. Similar conditions prevail for both plutonium and uranium isotopic standards and for impurity element standards in uranium matrices. Herein, the current status of U and Pu isotopic standards available from NBL is reviewed. Critical areas requiring improvement in the quality of the nuclear standards to enable the U. S. and international safeguards community to utilize the full potential of modern multi-collector mass spectrometer instruments are highlighted.« less

  6. Critical Need for Plutonium and Uranium Isotopic Standards with Lower Uncertainties

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

    Mathew, Kattathu Joseph; Stanley, Floyd E.; Thomas, Mariam R.

    Certified reference materials (CRMs) traceable to national and international safeguards database are a critical prerequisite for ensuring that nuclear measurement systems are free of systematic biases. CRMs are used to validate measurement processes associated with nuclear analytical laboratories. Diverse areas related to nuclear safeguards are impacted by the quality of the CRM standards available to analytical laboratories. These include: nuclear forensics, radio-chronometry, national and international safeguards, stockpile stewardship, nuclear weapons infrastructure and nonproliferation, fuel fabrication, waste processing, radiation protection, and environmental monitoring. For the past three decades the nuclear community is confronted with the strange situation that improvements in measurementmore » data quality resulting from the improved accuracy and precision achievable with modern multi-collector mass spectrometers could not be fully exploited due to large uncertainties associated with CRMs available from New Brunswick Laboratory (NBL) that are used for instrument calibration and measurement control. Similar conditions prevail for both plutonium and uranium isotopic standards and for impurity element standards in uranium matrices. Herein, the current status of U and Pu isotopic standards available from NBL is reviewed. Critical areas requiring improvement in the quality of the nuclear standards to enable the U. S. and international safeguards community to utilize the full potential of modern multi-collector mass spectrometer instruments are highlighted.« less

  7. Quality assurance for antimicrobial susceptibility testing of Neisseria gonorrhoeae in Latin American and Caribbean countries, 2013-2015.

    PubMed

    Sawatzky, Pam; Martin, Irene; Galarza, Patricia; Carvallo, Marıa Elena Trigoso; Araya Rodriguez, Pamela; Cruz, Olga Marina Sanabria; Hernandez, Alina Llop; Martinez, Mario Fabian; Borthagaray, Graciela; Payares, Daisy; Moreno, José E; Chiappe, Marina; Corredor, Aura Helena; Thakur, Sidharath Dev; Dillon, Jo-Anne R

    2018-04-19

    A Neisseria gonorrhoeae antimicrobial susceptibility quality control comparison programme was re-established in Latin America and the Caribbean to ensure antimicrobial susceptibility data produced from the region are comparable nationally and internationally. Three panels, consisting of N. gonorrhoeae isolates comprising reference strains and other characterised isolates were sent to 11 participating laboratories between 2013 and 2015. Antimicrobial susceptibilities for these isolates were determined using agar dilution, Etest or disc diffusion methods. Modal minimum inhibitory concentrations (MICs) for each panel isolate/antibiotic combination were calculated. The guidelines of the Clinical and Laboratory Standards Institute were used for interpretations of antimicrobial susceptibility. The agreement of MICs with the modal MICs was determined for each of the participating laboratories as well as for each of the antibiotics tested. Five of 11 laboratories that participated in at least one panel had an overall average agreement between participants' MIC results and modal MICs of >90%. For other laboratories, agreements ranged from 60.0% to 82.4%. The proportion of agreement between interpretations for all the antibiotics, except penicillin and tetracycline, was >90%. The percentages of agreement between MIC results and their modes for erythromycin, spectinomycin, cefixime and azithromycin were >90%. Tetracycline, ceftriaxone and ciprofloxacin agreement ranged from 84.5% to 89.1%, while penicillin had 78.8% agreement between MICs and modal MICs. The participating laboratories had acceptable results, similar to other international quality assurance programmes. It is important to ensure continuation of the International Gonococcal Antimicrobial Susceptibility Quality Control Comparison Programme to ensure that participants can identify and correct any problems in antimicrobial susceptibility testing for N. gonorrhoeae as they arise and continue to generate reproducible and reliable data. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  8. Economic evaluations of tobacco control mass media campaigns: a systematic review

    PubMed Central

    Atusingwize, Edwinah; Lewis, Sarah; Langley, Tessa

    2015-01-01

    Background International evidence shows that mass media campaigns are effective tobacco control interventions. However, they require substantial investment; a key question is whether their costs are justified by their benefits. The aim of this study was to systematically and comprehensively review economic evaluations of tobacco control mass media campaigns. Methods An electronic search of databases and grey literature was conducted to identify all published economic evaluations of tobacco control mass media campaigns. The authors reviewed studies independently and assessed the quality of studies using the Drummond 10-point checklist. A narrative synthesis was used to summarise the key features and quality of the identified studies. Results 10 studies met the inclusion criteria and were included in the review. All the studies included a cost effectiveness analysis, a cost utility analysis or both. The methods were highly heterogeneous, particularly in terms of the types of costs included. On the whole, studies were well conducted, but the interventions were often poorly described in terms of campaign content and intensity, and cost information was frequently inadequate. All studies concluded that tobacco control mass media campaigns are a cost effective public health intervention. Conclusions The evidence on the cost effectiveness of tobacco control mass media campaigns is limited, but of acceptable quality and consistently suggests that they offer good value for money. PMID:24985730

  9. 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.

  10. Transboundary movement of hazardous wastes into Lebanon: Part 2. Environmental impacts and the need for remedial actions.

    PubMed

    Jurdi, Mey

    2002-01-01

    This paper discusses the transboundary movement of hazardous wastes (the "silent trade") into Lebanon in terms of environmental impacts and remedial actions. It highlights the projected impacts on potable-water quality, the exposure of the groundwater aquifer, and the status of quality control programs. The public responses to these problems are presented and characterized in terms of mistrust and rejection. The constraints developing countries face in handling environmental impacts and undertaking remedial actions are emphasized. The vision derived from the decade covered (1990-2000) emphasizes the need for international collaboration, through Basel Convention efforts, to control the transboundary movement of hazardous wastes and the disposal of such wastes. The need for "global harmonization" should be given serious consideration.

  11. No Association of Coronary Artery Disease with X-Chromosomal Variants in Comprehensive International Meta-Analysis.

    PubMed

    Loley, Christina; Alver, Maris; Assimes, Themistocles L; Bjonnes, Andrew; Goel, Anuj; Gustafsson, Stefan; Hernesniemi, Jussi; Hopewell, Jemma C; Kanoni, Stavroula; Kleber, Marcus E; Lau, King Wai; Lu, Yingchang; Lyytikäinen, Leo-Pekka; Nelson, Christopher P; Nikpay, Majid; Qu, Liming; Salfati, Elias; Scholz, Markus; Tukiainen, Taru; Willenborg, Christina; Won, Hong-Hee; Zeng, Lingyao; Zhang, Weihua; Anand, Sonia S; Beutner, Frank; Bottinger, Erwin P; Clarke, Robert; Dedoussis, George; Do, Ron; Esko, Tõnu; Eskola, Markku; Farrall, Martin; Gauguier, Dominique; Giedraitis, Vilmantas; Granger, Christopher B; Hall, Alistair S; Hamsten, Anders; Hazen, Stanley L; Huang, Jie; Kähönen, Mika; Kyriakou, Theodosios; Laaksonen, Reijo; Lind, Lars; Lindgren, Cecilia; Magnusson, Patrik K E; Marouli, Eirini; Mihailov, Evelin; Morris, Andrew P; Nikus, Kjell; Pedersen, Nancy; Rallidis, Loukianos; Salomaa, Veikko; Shah, Svati H; Stewart, Alexandre F R; Thompson, John R; Zalloua, Pierre A; Chambers, John C; Collins, Rory; Ingelsson, Erik; Iribarren, Carlos; Karhunen, Pekka J; Kooner, Jaspal S; Lehtimäki, Terho; Loos, Ruth J F; März, Winfried; McPherson, Ruth; Metspalu, Andres; Reilly, Muredach P; Ripatti, Samuli; Sanghera, Dharambir K; Thiery, Joachim; Watkins, Hugh; Deloukas, Panos; Kathiresan, Sekar; Samani, Nilesh J; Schunkert, Heribert; Erdmann, Jeanette; König, Inke R

    2016-10-12

    In recent years, genome-wide association studies have identified 58 independent risk loci for coronary artery disease (CAD) on the autosome. However, due to the sex-specific data structure of the X chromosome, it has been excluded from most of these analyses. While females have 2 copies of chromosome X, males have only one. Also, one of the female X chromosomes may be inactivated. Therefore, special test statistics and quality control procedures are required. Thus, little is known about the role of X-chromosomal variants in CAD. To fill this gap, we conducted a comprehensive X-chromosome-wide meta-analysis including more than 43,000 CAD cases and 58,000 controls from 35 international study cohorts. For quality control, sex-specific filters were used to adequately take the special structure of X-chromosomal data into account. For single study analyses, several logistic regression models were calculated allowing for inactivation of one female X-chromosome, adjusting for sex and investigating interactions between sex and genetic variants. Then, meta-analyses including all 35 studies were conducted using random effects models. None of the investigated models revealed genome-wide significant associations for any variant. Although we analyzed the largest-to-date sample, currently available methods were not able to detect any associations of X-chromosomal variants with CAD.

  12. A tobacco industry study of airline cabin air quality: dropping inconvenient findings

    PubMed Central

    Neilsen, K; Glantz, S

    2004-01-01

    Objective: To examine an industry funded and controlled study of in flight air quality (IFAQ). Methods: Systematic search of internal tobacco industry documents available on the internet and at the British American Tobacco Guildford Depository. Results: Individuals from several tobacco industry companies, led by Philip Morris, designed, funded, conducted, and controlled the presentation of results of a study of IFAQ for the Scandinavian airline SAS in 1988 while attempting to minimise the appearance of industry control. Industry lawyers and scientists deleted results unfavourable to the industry's position from the study before delivering it to the airline. The published version of the study further downplayed the results, particularly with regard to respirable suspended particulates. The study ignored the health implications of the results and instead promoted the industry position that ventilation could solve problems posed by secondhand smoke. Conclusions: Sponsoring IFAQ studies was one of several tactics the tobacco industry employed in attempts to reverse or delay implementation of in-flight smoking restrictions. As a result, airline patrons and employees, particularly flight attendants, continued to be exposed to pollution from secondhand smoke, especially particulates, which the industry's own consultants had noted exceeded international standards. This case adds to the growing body of evidence that scientific studies associated with the tobacco industry cannot be taken at face value. PMID:14985613

  13. Impact of a pharmacist-led warfarin self-management program on quality of life and anticoagulation control: a randomized trial.

    PubMed

    Verret, Lucie; Couturier, Justine; Rozon, Andréanne; Saudrais-Janecek, Sarah; St-Onge, Amélie; Nguyen, Angela; Basmadjian, Arsène; Tremblay, Simon; Brouillette, Denis; de Denus, Simon

    2012-10-01

    To evaluate the impact of a pharmacist-led warfarin patient self-management program on quality of life and anticoagulation control compared with management in a physician-led specialized anticoagulation clinic. Prospective, randomized, controlled, open-label trial. Tertiary care academic medical center. A total of 114 patients aged 18-75 years who were followed at a specialized anticoagulation clinic, had received warfarin for at least 6 months, and were expected to continue warfarin for a minimum of 4 months. All patients attended an educational session on anticoagulation provided by a pharmacist. Patients randomized to the self-management group (58 patients) also received practical training to use the CoaguChek XS device and a self-management dosing algorithm. Patients in the control group (56 patients) continued to undergo standard management at the anticoagulation clinic. Patients completed a validated quality-of-life questionnaire and the validated Oral Anticoagulation Knowledge test at the beginning and end of the study. The quality of anticoagulation control was evaluated by using the time spent in therapeutic range. After 4 months of follow-up, a significant improvement in the self-management group was observed compared with the control group in four of the five quality-of-life topics (p<0.05). Improvements in knowledge were observed in both groups after the training session and persisted after 4 months (p<0.05 for all). The time spent in the therapeutic range (80.0% in the self-management group vs 75% in the control group, p=0.79) and in the extended therapeutic range ([target international normalized ratio ± 0.3] 93.2% in the self-management group vs 91.1% in the control group, p=0.30) were similar between groups. A self-management warfarin program led by pharmacists resulted in significant improvement in the quality of life of patients receiving warfarin therapy as well as a reduction in the time required for anticoagulation monitoring, while maintaining a level of anticoagulation control similar to a high-quality specialized anticoagulation clinic. © 2012 Pharmacotherapy Publications, Inc.

  14. [Analytical quality in biological monitoring of workers exposed to chemicals: experience of the Prevention and Safety at the Workplace Service in Modena].

    PubMed

    Alpaca, R I Paredes; Migliore, A; Di Rico, R; Canali, Claudia; Rota, Cristina; Trenti, T; Cariani, Elisabetta

    2010-01-01

    The quality of laboratory data is one of the main factors in guaranteeing efficacy of biological monitoring. To analyze the quality of laboratory data used for biological monitoring of exposed workers. A survey involving 18 companies employing 945 workers in the area of Modena, Italy, was carried out in 2008. Most of the 9 private laboratories receiving biological samples did not perform directly part or all of the laboratory assessments requested, but this was not indicated in the final report. Major problems were observed in the application of internal quality control, and only one laboratory participated in external quality assessment for blood lead measurements. Our results raise major concerns on the traceability and reliability of laboratory assessments performed for biomonitoring of exposed workers. Systematic evaluation of the quality of analytical data would be highly recommendable.

  15. Using a centrifuge for quality control of pre-wetted lightweight aggregate in internally cured concrete

    NASA Astrophysics Data System (ADS)

    Miller, Albert E.

    Early age shrinkage of cementitious systems can result in an increased potential for cracking which can lead to a reduction in service life. Early age shrinkage cracking can be particularly problematic for high strength concretes, which are often specified due to their high strength and low permeability. However, these high strength concretes frequently exhibit a reduction in the internal relative humidity (RH) due to the hydration reaction (chemical shrinkage) and self-desiccation which results in a bulk shrinkage, termed autogenous shrinkage, which is substantial at early ages. Due to the low permeability of these concretes, standard external curing is not always efficient in addressing this reduction in internal RH since the penetration of water can be limited. Internal curing has been developed to reduce autogenous shrinkage. Internally cured mixtures use internal reservoirs filled with fluid (generally water) that release this fluid at appropriate times to counteract the effects of self-desiccation thereby maintaining a high internal RH. Internally cured concrete is frequently produced in North America using pre-wetted lightweight aggregate. One important aspect associated with preparing quality internally cured concrete is being able to determine the absorbed moisture and surface moisture associated with the lightweight aggregate which enables aggregate moisture corrections to be made for the concrete mixture. This thesis represents work performed to develop a test method using a centrifuge to determine the moisture state of pre-wetted fine lightweight aggregate. The results of the test method are then used in a series of worksheets that were developed to assist field technicians when performing the tests and applying the results to a mixture design. Additionally, research was performed on superabsorbent polymers to assess their ability to be used as an internal curing reservoir.

  16. Olive oil authentication: A comparative analysis of regulatory frameworks with especial emphasis on quality and authenticity indices, and recent analytical techniques developed for their assessment. A review.

    PubMed

    Bajoub, Aadil; Bendini, Alessandra; Fernández-Gutiérrez, Alberto; Carrasco-Pancorbo, Alegría

    2018-03-24

    Over the last decades, olive oil quality and authenticity control has become an issue of great importance to consumers, suppliers, retailers, and regulators in both traditional and emerging olive oil producing countries, mainly due to the increasing worldwide popularity and the trade globalization of this product. Thus, in order to ensure olive oil authentication, various national and international laws and regulations have been adopted, although some of them are actually causing an enormous debate about the risk that they can represent for the harmonization of international olive oil trade standards. Within this context, this review was designed to provide a critical overview and comparative analysis of selected regulatory frameworks for olive oil authentication, with special emphasis on the quality and purity criteria considered by these regulation systems, their thresholds and the analytical methods employed for monitoring them. To complete the general overview, recent analytical advances to overcome drawbacks and limitations of the official methods to evaluate olive oil quality and to determine possible adulterations were reviewed. Furthermore, the latest trends on analytical approaches to assess the olive oil geographical and varietal origin traceability were also examined.

  17. A quality improvement project using statistical process control methods for type 2 diabetes control in a resource-limited setting.

    PubMed

    Flood, David; Douglas, Kate; Goldberg, Vera; Martinez, Boris; Garcia, Pablo; Arbour, MaryCatherine; Rohloff, Peter

    2017-08-01

    Quality improvement (QI) is a key strategy for improving diabetes care in low- and middle-income countries (LMICs). This study reports on a diabetes QI project in rural Guatemala whose primary aim was to improve glycemic control of a panel of adult diabetes patients. Formative research suggested multiple areas for programmatic improvement in ambulatory diabetes care. This project utilized the Model for Improvement and Agile Global Health, our organization's complementary healthcare implementation framework. A bundle of improvement activities were implemented at the home, clinic and institutional level. Control charts of mean hemoglobin A1C (HbA1C) and proportion of patients meeting target HbA1C showed improvement as special cause variation was identified 3 months after the intervention began. Control charts for secondary process measures offered insights into the value of different components of the intervention. Intensity of home-based diabetes education emerged as an important driver of panel glycemic control. Diabetes QI work is feasible in resource-limited settings in LMICs and can improve glycemic control. Statistical process control charts are a promising methodology for use with panels or registries of diabetes patients. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  18. Valid internal standard technique for arson detection based on gas chromatography-mass spectrometry.

    PubMed

    Salgueiro, Pedro A S; Borges, Carlos M F; Bettencourt da Silva, Ricardo J N

    2012-09-28

    The most popular procedures for the detection of residues of accelerants in fire debris are the ones published by the American Society for Testing and Materials (ASTM E1412-07 and E1618-10). The most critical stages of these tests are the conservation of fire debris from the sampling to the laboratory, the extraction of residues of accelerants from the debris to the activated charcoal strips (ACS) and from those to the final solvent, as well as the analysis of sample extract by gas chromatography-mass spectrometry (GC-MS) and the interpretation of the instrumental signal. This work proposes a strategy for checking the quality of the sample conservation, the accelerant residues transference to final solvent and GC-MS analysis, using internal standard additions. It is used internal standards ranging from a highly volatile compound for checking debris conservation to low volatile compound for checking GC-MS repeatability. The developed quality control (QC) parameters are not affected by GC-MS sensitivity variation and, specifically, the GC-MS performance control is not affected by ACS adsorption saturation that may mask test performance deviations. The proposed QC procedure proved to be adequate to check GC-MS repeatability, ACS extraction and sample conservation since: (1) standard additions are affected by negligible uncertainty and (2) observed dispersion of QC parameters are fit for its intended use. Copyright © 2012 Elsevier B.V. All rights reserved.

  19. Growth Chambers on the International Space Station for Large Plants

    NASA Technical Reports Server (NTRS)

    Massa, G. D.; Wheeler, R. M.; Morrow, R. C.; Levine, H. G.

    2016-01-01

    The International Space Station (ISS) now has platforms for conducting research on horticultural plant species under LED lighting, and those capabilities continue to expand. The 'Veggie' vegetable production system was deployed to the ISS as an applied research platform for food production in space. Veggie is capable of growing a wide array of horticultural crops. It was designed for low power usage, low launch mass and stowage volume, and minimal crew time requirements. The Veggie flight hardware consists of a light cap containing red (630 nm), blue, (455 nm) and green (530 nm) LEDs. Interfacing with the light cap is an extendable bellows/baseplate for enclosing the plant canopy. A second large plant growth chamber, the Advanced Plant Habitat (APH), is will fly to the ISS in 2017. APH will be a fully controllable environment for high-quality plant physiological research. APH will control light (quality, level, and timing), temperature, CO2, relative humidity, and irrigation, while scrubbing any cabin or plant-derived ethylene and other volatile organic compounds. Additional capabilities include sensing of leaf temperature and root zone moisture, root zone temperature, and oxygen concentration. The light cap will have red (630 nm), blue (450 nm), green (525 nm), far red (730 nm) and broad spectrum white LEDs (4100K). There will be several internal cameras (visible and IR) to monitor and record plant growth and operations. Veggie and APH are available for research proposals.

  20. SPRT Calibration Uncertainties and Internal Quality Control at a Commercial SPRT Calibration Facility

    NASA Astrophysics Data System (ADS)

    Wiandt, T. J.

    2008-06-01

    The Hart Scientific Division of the Fluke Corporation operates two accredited standard platinum resistance thermometer (SPRT) calibration facilities, one at the Hart Scientific factory in Utah, USA, and the other at a service facility in Norwich, UK. The US facility is accredited through National Voluntary Laboratory Accreditation Program (NVLAP), and the UK facility is accredited through UKAS. Both provide SPRT calibrations using similar equipment and procedures, and at similar levels of uncertainty. These uncertainties are among the lowest available commercially. To achieve and maintain low uncertainties, it is required that the calibration procedures be thorough and optimized. However, to minimize customer downtime, it is also important that the instruments be calibrated in a timely manner and returned to the customer. Consequently, subjecting the instrument to repeated calibrations or extensive repeated measurements is not a viable approach. Additionally, these laboratories provide SPRT calibration services involving a wide variety of SPRT designs. These designs behave differently, yet predictably, when subjected to calibration measurements. To this end, an evaluation strategy involving both statistical process control and internal consistency measures is utilized to provide confidence in both the instrument calibration and the calibration process. This article describes the calibration facilities, procedure, uncertainty analysis, and internal quality assurance measures employed in the calibration of SPRTs. Data will be reviewed and generalities will be presented. Finally, challenges and considerations for future improvements will be discussed.

  1. Service employees give as they get: internal service as a moderator of the service climate-service outcomes link.

    PubMed

    Ehrhart, Karen Holcombe; Witt, L A; Schneider, Benjamin; Perry, Sara Jansen

    2011-03-01

    We lend theoretical insight to the service climate literature by exploring the joint effects of branch service climate and the internal service provided to the branch (the service received from corporate units to support external service delivery) on customer-rated service quality. We hypothesized that service climate is related to service quality most strongly when the internal service quality received is high, providing front-line employees with the capability to deliver what the service climate motivates them to do. We studied 619 employees and 1,973 customers in 36 retail branches of a bank. We aggregated employee perceptions of the internal service quality received from corporate units and the local service climate and external customer perceptions of service quality to the branch level of analysis. Findings were consistent with the hypothesis that high-quality internal service is necessary for branch service climate to yield superior external customer service quality. PsycINFO Database Record (c) 2011 APA, all rights reserved.

  2. Statistical tools for transgene copy number estimation based on real-time PCR.

    PubMed

    Yuan, Joshua S; Burris, Jason; Stewart, Nathan R; Mentewab, Ayalew; Stewart, C Neal

    2007-11-01

    As compared with traditional transgene copy number detection technologies such as Southern blot analysis, real-time PCR provides a fast, inexpensive and high-throughput alternative. However, the real-time PCR based transgene copy number estimation tends to be ambiguous and subjective stemming from the lack of proper statistical analysis and data quality control to render a reliable estimation of copy number with a prediction value. Despite the recent progresses in statistical analysis of real-time PCR, few publications have integrated these advancements in real-time PCR based transgene copy number determination. Three experimental designs and four data quality control integrated statistical models are presented. For the first method, external calibration curves are established for the transgene based on serially-diluted templates. The Ct number from a control transgenic event and putative transgenic event are compared to derive the transgene copy number or zygosity estimation. Simple linear regression and two group T-test procedures were combined to model the data from this design. For the second experimental design, standard curves were generated for both an internal reference gene and the transgene, and the copy number of transgene was compared with that of internal reference gene. Multiple regression models and ANOVA models can be employed to analyze the data and perform quality control for this approach. In the third experimental design, transgene copy number is compared with reference gene without a standard curve, but rather, is based directly on fluorescence data. Two different multiple regression models were proposed to analyze the data based on two different approaches of amplification efficiency integration. Our results highlight the importance of proper statistical treatment and quality control integration in real-time PCR-based transgene copy number determination. These statistical methods allow the real-time PCR-based transgene copy number estimation to be more reliable and precise with a proper statistical estimation. Proper confidence intervals are necessary for unambiguous prediction of trangene copy number. The four different statistical methods are compared for their advantages and disadvantages. Moreover, the statistical methods can also be applied for other real-time PCR-based quantification assays including transfection efficiency analysis and pathogen quantification.

  3. Validation of housekeeping genes as internal controls for studying gene expression during Pacific oyster (Crassostrea gigas) development by quantitative real-time PCR.

    PubMed

    Du, Yishuai; Zhang, Linlin; Xu, Fei; Huang, Baoyu; Zhang, Guofan; Li, Li

    2013-03-01

    Hatchery-reared larvae of the Pacific oyster (Crassostrea gigas) often suffer from massive mortality induced by Ostreid herpesvirus 1 (OsHV-1) infection, indicating the importance of better understanding of oyster immune defense systems. The accuracy of measurements of gene expression levels based on quantitative real-time PCR assays relies on the use of housekeeping genes as internal controls; however, few studies have focused on the selection of such internal controls. In this study, we conducted a comprehensive investigation of internal control genes during oyster development in virus-infected and uninfected samples. Transcriptome data for 38 developmental stages were downloaded and the gene expression patterns were classified into 30 clusters. A total of 317 orthologs of classical housekeeping genes in the oyster genome were annotated. After combining the expression profiles and oyster housekeeping gene dataset, 14 candidate internal controls were selected for further investigation: Elongation factor-1α (EF-1α), 18S rRNA (18S), 28S rRNA (28S), Glyceraldehyde 3-phosphate dehydrogenase (GAPDH), β-actin (ACT), Ribosomal protein L7 (RL7), Ribosomal protein L27 (RL27), Ribosomal protein L36 (RL36), Ribosomal protein S18 (RS18), Heterogeneous nuclear ribonucleoprotein A2/B1 (RO21), Eukaryotic translation elongation factor 2 (EF2), Ubiquitin-conjugating enzyme E2D2 (UBCD1), S-phase kinase-associated protein 1 (SKP1) and Heterogeneous nuclear ribonucleoprotein Q (HNRPQ). RNA was extracted from oyster larvae infected with OsHV-1 (group A; GA), and OsHV-1 free larvae (group B; GB). The expression levels of the 14 candidate internal controls were studied in GA and GB larvae by real-time PCR. Their expression stabilities were further analyzed using the GeNorm program. RL7 and RS18 were the most stable genes in both OsHV-1 infected (GA) and uninfected (GB) larvae. These results suggest that RL7 and RS18 could be used as internal controls for studying gene expression in normal growing oyster larvae and in OsHV-1 infected larvae. These high quality internal controls will be a valuable resource in future studies of oyster larval mortality. Copyright © 2012 Elsevier Ltd. All rights reserved.

  4. Engaging International Students: An Analysis of the Australian Universities Quality Agency (AUQA) Reports

    ERIC Educational Resources Information Center

    Burdett, Jane; Crossman, Joanna

    2012-01-01

    Purpose: Australia has enjoyed two decades of growth in international student enrolments. This phenomenon, combined with the evolution of quality assurance policy frameworks, has stimulated interest in the social and academic experiences of international students and their educational outcomes. The Australian Universities Quality Agency's (AUQA)…

  5. Self-consciousness, friendship quality, and adolescent internalizing problems

    PubMed Central

    Bowker, Julie C.; Rubin, Kenneth H.

    2013-01-01

    The correlates between public and private self-consciousness and internalizing difficulties were examined during early adolescence. Friendship quality was assessed as a possible moderator of the relation between self-consciousness and maladjustment. One hundred and thirty-seven young adolescents (N = 87 girls; M age = 13.98 years) reported on their self-consciousness, internalizing problems, and the quality of their best friendship. Results indicated stronger associations between private self-consciousness and internalizing correlates than between public self-consciousness and internalizing problems, suggesting that private self-consciousness may be a stronger risk factor during adolescence. Contrary to expectations, evidence revealed that positive friendship quality may exacerbate some difficulties associated with self-consciousness. Results pertaining to friendship quality add to the growing literature on the ways in which friendships can contribute to adjustment difficulties. PMID:19998530

  6. The impact of the improvement in internal medicine consultation process on ED length of stay.

    PubMed

    Shin, Sangheon; Lee, Soo Hoon; Kim, Dong Hoon; Kim, Seong Chun; Kim, Tae Yun; Kang, Changwoo; Jeong, Jin Hee; Lim, Daesung; Park, Yong Joo; Lee, Sang Bong

    2018-04-01

    Although consultations are essential for delivering safe, high-quality care to patients in emergency departments, they contribute to emergency department patient flow problems and overcrowding which is associated with several adverse outcomes, such as increases in patient mortality and poor quality care. This study aimed to investigate how time flow metrics including emergency department length of stay is influenced by changes to the internal medicine consultation policy. This study is a pre- and post-controlled interventional study. We attempted to improve the internal medicine consultation process to be more concise. After the intervention, only attending emergency physicians consult internal medicine chief residents, clinical fellows, or junior staff of each internal medicine subspecialty who were on duty when patients required special care or an admission to internal medicine. Emergency department length of stay of patients admitted to the department of internal medicine prior to and after the intervention decreased from 996.94min to 706.62min. The times from consultation order to admission order and admission order to emergency department departure prior to and after the intervention were decreased from 359.59min to 180.38min and from 481.89min to 362.37min, respectively. The inpatient mortality rates and Inpatient bed occupancy rates prior to and after the intervention were similar. The improvements in the internal medicine consultation process affected the flow time metrics. Therefore, more comprehensive and cooperative strategies need to be developed to reduce the time cycle metrics and overcrowding of all patients in the emergency department. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Symptom Severity and Quality of Life Among Long-term Colorectal Cancer Survivors Compared With Matched Control Subjects: A Population-Based Study.

    PubMed

    Hart, Tae L; Charles, Susan T; Gunaratne, Mekhala; Baxter, Nancy N; Cotterchio, Michelle; Cohen, Zane; Gallinger, Steven

    2018-03-01

    Data are lacking regarding physical functioning, psychological well-being, and quality of life among colorectal cancer survivors >10 years postdiagnosis. The purpose of this study was to examine self-reported physical functioning, quality of life, and psychological well-being in long-term colorectal cancer survivors compared with age- and sex-matched unaffected control subjects. Participants completed a cross-sectional survey. The colorectal cancer survivors and unaffected control subjects were recruited from the Ontario Familial Colorectal Cancer Registry. A population-based sample of colorectal cancer survivors (N = 296) and their age- and sex-matched unaffected control subjects (N = 255) were included. Survivors were, on average, 15 years postdiagnosis. Quality of life was measured with the Functional Assessment of Cancer Therapy-General scale, bowel dysfunction with the Memorial Sloan-Kettering Cancer Center scale, urinary dysfunction with the International Consultation on Incontinence Questionnaire-Short Form, fatigue with the Functional Assessment of Chronic Illness Therapy-Fatigue scale, and depression with the Center for Epidemiologic Studies-Depression scale. In linear mixed-model analyses adjusting for income, education, race, and comorbid medical conditions, survivors reported good emotional, functional, physical, and overall quality of life, comparable to control subjects. Fatigue and urinary functioning did not differ significantly between survivors and control subjects. Survivors reported significantly higher social quality of life and lower depression compared with unaffected control subjects. The only area where survivors reported significantly worse deficits was in bowel dysfunction, but the magnitude of differences was relatively small. Generalizability is limited by moderately low participation rates. Findings are likely biased toward healthy participants. No baseline assessment was available to examine change in outcomes over time. Long-term colorectal cancer survivors appear to have comparable quality of life and, in some areas, better well-being than their unaffected peers. Bowel dysfunction may continue to be an ongoing issue even 15 years after colorectal cancer diagnosis. Overall quality of life can be expected to be good in this group of older survivors. See Video Abstract at http://links.lww.com/DCR/A476.

  8. Precursor to the TRICARE Next Generation Program

    DTIC Science & Technology

    2004-06-01

    Precursor to T-NEX 6 Appendix A - Maps of Interest 84 Appendix B - International Classification of Diseases Codes 86...utilization management, and disease management (Lupo, 2003). Health management will be demonstrated by measurable quality improvements, population...National Association of County and City Health Officials and the Center for Disease Control and Prevention that helps key officials review community

  9. A new StaRT-PCR approach to detect and quantify fish viral hemorrhagic septicemia virus (VHSv): enhanced quality control with internal standards

    USDA-ARS?s Scientific Manuscript database

    Viral Hemorrhagic Septicemia virus (VHSv) causes one of the world’s most important finfish diseases, killing >80 species across Eurasia and North America. A new and especially virulent strain (IVb) emerged in the North American Great Lakes in 2003, threatening fisheries, baitfish, and aquaculture in...

  10. Quality of Working Life in the Automobile Industry: A Canada-UK Comparative Study.

    ERIC Educational Resources Information Center

    Lewchuk, Wayne; Stewart, Paul; Yates, Charlotte

    2001-01-01

    Surveys in five automobile plants in Canada and the United Kingdom (n=2,600+) indicated that implementation of lean production methods has been uneven across companies and countries and is not associated with greater employee involvement or control. Variations may reflect company-specific responses to the pressures of international competition.…

  11. External Accountability of Collaborative Arrangements; A Case Study of a Multi Academy Trust in England

    ERIC Educational Resources Information Center

    Ehren, Melanie C. M.; Godfrey, David

    2017-01-01

    This paper explores the impact of external accountability on four mechanisms of network-internal quality control and the properties of (mandated) inter-organizational networks. An explorative case study approach examines the external accountability of a newly established educational network (MAT) and how schools and the Trust are held accountable…

  12. The Relationship between the Training Function and ISO-9000 Registration.

    ERIC Educational Resources Information Center

    Maxwell, Randy C.; Jost, Karen L.

    ISO 9000 is one of a series of international standards providing guidelines and governing quality of products and services. The ISO 9000 certification demonstrates the capability of a supplier to control the processes that determine the acceptability of the product or service being supplied. This paper focuses on the training aspects of ISO 9000…

  13. Onufrienko holds a Grab Sample Container (GSC) in the SM during Expedition Four

    NASA Image and Video Library

    2002-05-23

    ISS004-E-12368 (23 May 2002) --- Cosmonaut Yury I. Onufrienko, Expedition Four mission commander representing Rosaviakosmos, holds a Grab Sample Container (GSC) in the Zvezda Service Module on the International Space Station (ISS). The GSC is used to take air samples in various modules as part of environmental quality control.

  14. Efficacy of an Acceptance-Based Behavior Therapy for Generalized Anxiety Disorder: Evaluation in a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Roemer, Lizabeth; Orsillo, Susan M.; Salters-Pedneault, Kristalyn

    2008-01-01

    Generalized anxiety disorder (GAD) is a chronic anxiety disorder, associated with comorbidity and impairment in quality of life, for which improved psychosocial treatments are needed. GAD is also associated with reactivity to and avoidance of internal experiences. The current study examined the efficacy of an acceptance-based behavioral therapy…

  15. The Troll HSE Risk Management System

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

    Wiig, E.; Berthelsen, I.; Donovan, K.

    1996-12-31

    The Petroleum Act and Internal Control regulations in Norway lay down requirements for how HSE shall be Managed and documented. To comply with the Norwegian legislation the Troll Project has developed an HSE Risk Management System (RMS) structured around Hazards and Effects Management. The resulting quality, technical and operating integrity, and HSE performance are an endorsement of the power of RMS.

  16. Industrial workers' health and environmental pollution under the new international division of labor: the Taiwan experience.

    PubMed Central

    Chen, M S; Huang, C L

    1997-01-01

    Using Taiwan as an example, this paper conducts a historical analysis of the relationship between economic development in the new international division of labor and environmental pollution and industrial workers' health. Three industries-asbestos, plastic, and dye-were chosen for case studies. We trace the emergence of each industry in Taiwan and study each industry's protection of workers' health and environmental quality. Under the new international division of labor, the state's prioritization of economic development leads to lenient regulation. Under such state policies, employers have few incentives to invest in the protection of their workers' health and in the control of environmental pollution. Workers and the public are constrained in their efforts to protect their own health and prevent environmental pollution. This situation is exemplified by the deplorable working conditions and inadequate environmental pollution controls in the asbestos, plastic, and dye industries. Workers' health and the public's health are greatly compromised by economic development in the new international division of labor. Images p1228-a p1228-b PMID:9240119

  17. 78 FR 22269 - International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-15

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.

  18. Self-assessment procedure using fuzzy sets

    NASA Astrophysics Data System (ADS)

    Mimi, Fotini

    2000-10-01

    Self-Assessment processes, initiated by a company itself and carried out by its own people, are considered to be the starting point for a regular strategic or operative planning process to ensure a continuous quality improvement. Their importance has increased by the growing relevance and acceptance of international quality awards such as the Malcolm Baldrige National Quality Award, the European Quality Award and the Deming Prize. Especially award winners use the instrument of a systematic and regular Self-Assessment and not only because they have to verify their quality and business results for at least three years. The Total Quality Model of the European Foundation for Quality Management (EFQM), used for the European Quality Award, is the basis for Self-Assessment in Europe. This paper presents a self-assessment supporting method based on a methodology of fuzzy control systems providing an effective means of converting the linguistic approximation into an automatic control strategy. In particular, the elements of the Quality Model mentioned above are interpreted as linguistic variables. The LR-type of a fuzzy interval is used for their representation. The input data has a qualitative character based on empirical investigation and expert knowledge and therefore the base- variables are ordinal scaled. The aggregation process takes place on the basis of a hierarchical structure. Finally, in order to render the use of the method more practical a software system on PC basis is developed and implemented.

  19. Measuring quality progress

    NASA Astrophysics Data System (ADS)

    Lambert, Larry D.

    The study by the American Productivity & Quality Center (APQC) was commissioned by Loral Space Information Systems, Inc. and the National Aeronautics and Space Administration (NASA) to evaluate internal assessment systems. APQC benchmarked approaches to the internal assessment of quality management systems in three phases. The first phase included work conducted for the International Benchmarking Clearinghouse (IBC) and consisted of an in-depth analysis of the 1991 Malcolm Baldrige National Quality Award criteria. The second phase was also performed for the IBC and compared the 1991 award criteria among the following quality awards: Deming Prize, Malcolm Baldrige National Quality Award, The President's Award for Quality and Productivity Improvement, The NASA Excellence Award (The George M. Lowe Trophy) for Quality and Productivity Improvement and the Shigeo Shingo Award for Excellence in Manufacturing. The third phase compared the internal implementation approaches of 23 companies selected from American industry for their recognized, formal assessment systems.

  20. Measuring quality progress

    NASA Technical Reports Server (NTRS)

    Lambert, Larry D.

    1992-01-01

    The study by the American Productivity & Quality Center (APQC) was commissioned by Loral Space Information Systems, Inc. and the National Aeronautics and Space Administration (NASA) to evaluate internal assessment systems. APQC benchmarked approaches to the internal assessment of quality management systems in three phases. The first phase included work conducted for the International Benchmarking Clearinghouse (IBC) and consisted of an in-depth analysis of the 1991 Malcolm Baldrige National Quality Award criteria. The second phase was also performed for the IBC and compared the 1991 award criteria among the following quality awards: Deming Prize, Malcolm Baldrige National Quality Award, The President's Award for Quality and Productivity Improvement, The NASA Excellence Award (The George M. Lowe Trophy) for Quality and Productivity Improvement and the Shigeo Shingo Award for Excellence in Manufacturing. The third phase compared the internal implementation approaches of 23 companies selected from American industry for their recognized, formal assessment systems.

  1. Internal Quality Assurance--Enhancing Quality Culture. ENQA Workshop Report 16

    ERIC Educational Resources Information Center

    ENQA (European Association for Quality Assurance in Higher Education), 2010

    2010-01-01

    The European Association for Quality Assurance in Higher Education (ENQA), in cooperation with the Quality Assurance Agency (QAA, UK), organised a seminar on theme "Internal Quality Assurance--Enhancing quality culture" which was held on 8-9 June, 2010 in London, United Kingdom. The seminar marked the fourth annual meeting of the ENQA…

  2. Combination of Methoprene and Controlled Aeration to Manage Insects in Stored Wheat.

    PubMed

    Liu, Samuel S; Arthur, Frank H; VanGundy, Douglas; Phillips, Thomas W

    2016-06-17

    A commercial formulation of the insect growth regulator methoprene was applied to wheat stored in small bins either alone or in combination with controlled aeration of the bins, to lower grain temperature for insect pest management of stored wheat. Grain temperatures were monitored and modified by a computer-controlled thermocouple system that also activated the aeration system at programmed set-points to move cool ambient air through the grain mass to lower grain temperature. Results from sampling insect populations in experimental storage bins along with laboratory mortality bioassays of insects placed on wheat taken from the bins over the course of the storage period showed that methoprene was very effective in controlling infestation by the externally-feeding stored grain insects Plodia interpunctella (Hübner), the Indian meal moth Tribolium castaneum (Herbst), the red flour beetle, Cryptolestes ferrugineus (Stephens), the rusty grain beetle, and also for the internal-feeding pest Rhyzopertha dominica( Fauvel), the lesser grain borer. Methoprene did not give good control of the internal-feeding pest Sitophilus oryzae (L.), the rice weevil. Aeration alone was somewhat effective in suppressing insect population development, while methoprene alone or when combined with aeration greatly enhanced insect control. Commercial grain grading for industry quality standards at the end of the storage period confirmed the impact of insect suppression on maintaining high quality of the stored wheat. This field experiment shows that methoprene combined with aeration to cool grain can be effective for pest management of stored wheat in the southern plains of the United States of America.

  3. Aquarium Trade Supply-Chain Losses of Marine Invertebrates Originating from Papua New Guinea.

    PubMed

    Militz, Thane A; Kinch, Jeff; Southgate, Paul C

    2018-04-01

    A major difficulty in managing live organism wildlife trade is often the reliance on trade data to monitor exploitation of wild populations. Harvested organisms that die or are discarded before a point of sale are regularly not reported. For the global marine aquarium trade, identifying supply-chain losses is necessary to more accurately assess exploitation from trade data. We examined quality control rejections and mortality of marine invertebrates (Asteroidea, Gastropoda, Malacostraca, Ophiuroidea) moving through the Papua New Guinea marine aquarium supply-chain, from fisher to importer. Utilizing catch invoices and exporter mortality records we determined that, over a 160 day period, 38.6% of the total invertebrate catch (n = 13,299 individuals) was lost before export. Supply-chain losses were divided among invertebrates rejected in the quality control process (11.5%) and mortality of the accepted catch in transit to, and during holding at, an export facility (30.6%). A further 0.3% died during international transit to importers. We quantified supply-chain losses for the ten most fished species which accounted for 96.4% of the catch. Quality control rejections (n = 1533) were primarily explained by rejections of oversized invertebrates (83.2% of rejections). We suggest that enforceable size limits on species prone to size-based rejections and elimination of village-based holding of invertebrates would reduce losses along the Papua New Guinea supply-chain. This case study underscores that low mortality during international transit may mask large losses along supply-chains prior to export and exemplifies the limitations of trade data to accurately monitor exploitation.

  4. The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial

    PubMed Central

    2010-01-01

    Background Hospital treatment of chronic obstructive pulmonary disease (COPD) frequently does not follow published evidences. This lack of adherence can contribute to the high morbidity, mortality and readmissions rates. The European Quality of Care Pathway (EQCP) study on acute exacerbations of COPD (NTC00962468) is undertaken to determine how care pathways (CP) as complex intervention for hospital treatment of COPD affects care variability, adherence to evidence based key interventions and clinical outcomes. Methods An international cluster Randomized Controlled Trial (cRCT) will be performed in Belgium, Italy, Ireland and Portugal. Based on the power analysis, a sample of 40 hospital teams and 398 patients will be included in the study. In the control arm of the study, usual care will be provided. The experimental teams will implement a CP as complex intervention which will include three active components: a formative evaluation of the quality and organization of care, a set of evidence based key interventions, and support on the development and implementation of the CP. The main outcome will be six-month readmission rate. As a secondary endpoint a set of clinical outcome and performance indicators (including care process evaluation and team functioning indicators) will be measured in both groups. Discussion The EQCP study is the first international cRCT on care pathways. The design of the EQCP project is both a research study and a quality improvement project and will include a realistic evaluation framework including process analysis to further understand why and when CP can really work. Trial Registration number NCT00962468 PMID:21092098

  5. Aquarium Trade Supply-Chain Losses of Marine Invertebrates Originating from Papua New Guinea

    NASA Astrophysics Data System (ADS)

    Militz, Thane A.; Kinch, Jeff; Southgate, Paul C.

    2018-04-01

    A major difficulty in managing live organism wildlife trade is often the reliance on trade data to monitor exploitation of wild populations. Harvested organisms that die or are discarded before a point of sale are regularly not reported. For the global marine aquarium trade, identifying supply-chain losses is necessary to more accurately assess exploitation from trade data. We examined quality control rejections and mortality of marine invertebrates (Asteroidea, Gastropoda, Malacostraca, Ophiuroidea) moving through the Papua New Guinea marine aquarium supply-chain, from fisher to importer. Utilizing catch invoices and exporter mortality records we determined that, over a 160 day period, 38.6% of the total invertebrate catch ( n = 13,299 individuals) was lost before export. Supply-chain losses were divided among invertebrates rejected in the quality control process (11.5%) and mortality of the accepted catch in transit to, and during holding at, an export facility (30.6%). A further 0.3% died during international transit to importers. We quantified supply-chain losses for the ten most fished species which accounted for 96.4% of the catch. Quality control rejections ( n = 1533) were primarily explained by rejections of oversized invertebrates (83.2% of rejections). We suggest that enforceable size limits on species prone to size-based rejections and elimination of village-based holding of invertebrates would reduce losses along the Papua New Guinea supply-chain. This case study underscores that low mortality during international transit may mask large losses along supply-chains prior to export and exemplifies the limitations of trade data to accurately monitor exploitation.

  6. [Development and Effects of a Cognitive-behavioral Therapy Based Program in Reducing Internalized Stigma in Patients with Schizophrenia].

    PubMed

    Kim, Mi Young; Jun, Seong Sook

    2016-06-01

    This study was done to develop a internalized stigma reducing program based on cognitive-behavioral therapy and appropriate for patients with schizophrenia and to evaluate its effectiveness. The study design was a mixed method research. Qualitative study, 13 patients with schizophrenia who had experience in overcoming stigma were purposively chosen for interviews and data were analyzed using Giorgi method. Quantitative study, 64 patients with schizophrenia (experimental group=32, control group=32) were recruited. The cognitive-behavioral therapy-based program for reducing internalized stigma in patients with schizophrenia was provided for 8 weeks (12 sessions). Data were collected from June. 20, 2013 to Feb. 14, 2014. Quantitative data were analyzed using χ²-test, t-test, repeated measures ANOVA with the SPSS program. Qualitative results, from the experience of coping with stigma in patients with schizophrenia seventeen themes and five themes-clusters were drawn up. Quantitative results showed that internalized stigma, self-esteem, mental health recovery and quality of life were significantly better in the experimental group compared to the control group. Study findings indicate that this program for reducing internalized stigma in patients with schizophrenia is effective and can be recommended as a rehabilitation program intervention to help patients with schizophrenia to cope with internalized stigma.

  7. Overview of the Nordic Seas CARINA data and salinity measurements

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

    Olsen, Are; Key, Robert; Jeansson, Emil

    2009-01-01

    Water column data of carbon and carbon relevant hydrographic and hydrochemical parameters from 188 previously non-publicly available cruises in the Arctic, Atlantic, and Southern Ocean have been retrieved and merged into a new database: CARINA (CARbon IN the Atlantic). The data have been subject to rigorous quality control (QC) in order to ensure highest possible quality and consistency. The data for most of the parameters included were examined in order to quantify systematic biases in the reported values, i.e. secondary quality control. Significant biases have been corrected for in the data products, i.e. the three merged files with measured, calculatedmore » and interpolated values for each of the three CARINA regions; the Arctic Mediterranean Seas (AMS), the Atlantic (ATL) and the Southern Ocean (SO).With the adjustments the CARINA database is consistent both internally as well as with GLODAP (Key et al., 2004) and is suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation. The Arctic Mediterranean Seas include the Arctic Ocean and the Nordic Seas, and the quality control was carried out separately in these two areas. This contribution provides an overview of the CARINA data from the Nordic Seas and summaries the findings of the QC of the salinity data. One cruise had salinity data that were of questionable quality, and these have been removed from the data product. An evaluation of the consistency of the quality controlled salinity data suggests that they are consistent to at least 0.005.« less

  8. Recent water quality trends in a typical semi-arid river with a sharp decrease in streamflow and construction of sewage treatment plants

    NASA Astrophysics Data System (ADS)

    Cheng, Peng; Li, Xuyong; Su, Jingjun; Hao, Shaonan

    2018-01-01

    Identification of the interactive responses of water quantity and quality to changes in nature and human stressors is important for the effective management of water resources. Many studies have been conducted to determine the influence of these stressors on river discharge and water quality. However, there is little information about whether sewage treatment plants can improve water quality in a region where river streamflow has decreased sharply. In this study, a seasonal trend decomposition method was used to analyze long-term (1996-2015) and seasonal trends in the streamflow and water quality of the Guanting Reservoir Basin, which is located in a semi-arid region of China. The results showed that the streamflow in the Guanting Reservoir Basin decreased sharply from 1996-2000 due to precipitation change and human activities (human use and reservoir regulation), while the streamflow decline over the longer period of time (1996-2015) could be attributed to human activities. During the same time, the river water quality improved significantly, having a positive relationship with the capacity of wastewater treatment facilities. The water quality in the Guanting Reservoir showed a deferred response to the reduced external loading, due to internal loading from sediments. These results implied that for rivers in which streamflow has declined sharply, the water quality could be improved significantly by actions to control water pollution control. This study not only provides useful information for water resource management in the Guanting Reservoir Basin, but also supports the implementation of water pollution control measures in other rivers with a sharp decline in streamflow.

  9. Multigroup Propensity Score Approach to Evaluating an Effectiveness Trial of the New Beginnings Program.

    PubMed

    Tein, Jenn-Yun; Mazza, Gina L; Gunn, Heather J; Kim, Hanjoe; Stuart, Elizabeth A; Sandler, Irwin N; Wolchik, Sharlene A

    2018-06-01

    We used a multigroup propensity score approach to evaluate a randomized effectiveness trial of the New Beginnings Program (NBP), an intervention targeting divorced or separated families. Two features of effectiveness trials, high nonattendance rates and inclusion of an active control, make program effects harder to detect. To estimate program effects based on actual intervention participation, we created a synthetic inactive control comprised of nonattenders and assessed the impact of attending the NBP or active control relative to no intervention (inactive control). We estimated propensity scores using generalized boosted models and applied inverse probability of treatment weighting for the comparisons. Relative to the inactive control, NBP strengthened parenting quality as well as reduced child exposure to interparental conflict, parent psychological distress, and child internalizing problems. Some effects were moderated by parent gender, parent ethnicity, or child age. On the other hand, the effects of active versus inactive control were minimal for parenting and in the unexpected direction for child internalizing problems. Findings from the propensity score approach complement and enhance the interpretation of findings from the intention-to-treat approach.

  10. Report on Quality Control Review of the Raich Ende Malter & Co. LLP FY 2009 Single Audit of the Riverside Research Institute

    DTIC Science & Technology

    2012-03-07

    compliance was based on a determination that 10 of the 14 compliance requirements were applicable to the Institute. However, the audit working papers...for all 14 of the compliance requirements were not adequate to support conclusions on applicability, internal control, and the audit opinion on...compliance with laws, regulations, and award provisions applicable to the R&D cluster program. In addition, the audit firm did not appropriately report an

  11. Soyuz 7 Return Samples: Assessment of Air Quality Aboard the International Space Station

    NASA Technical Reports Server (NTRS)

    James, John T.

    2004-01-01

    The toxicological assessments of one grab sample canister (GSC), 6 dual sorbent tubes (DSTs), and 20 formaldehyde badges returned aboard Soyuz 7 are reported. Analytical methods have not changed from earlier reports. Surrogate standard recoveries from the GSC were 84-89%. The recoveries of the less volatile surrogates from the DSTs were 87 to 112%; however, 13C-acetone was only recovered at 53-59%. Formaldehyde recoveries from 2 lab controls were 87 and 95%; trip controls were not returned to ground.

  12. Relationship between perception with the quality of life of T2DM patients in Dok II Jayapura Hospital

    NASA Astrophysics Data System (ADS)

    Perwitasari, D. A.; Faridah, I. N.; Kulle, Y.; Yulistika, M.

    2017-11-01

    Diabetes mellitus disease is one of the chronic diseases which can cause a fatal risk if its management is not appropriate. The purpose of this study was to determine the relationship between perception and quality of life in Dok II Jayapura hospital. This study used an observational research design with cross sectional approach with prospective sampling in diabetic patients in internal disease policemen who were underwent outpatient treatment at Dok II Jayapura hospital. Research instruments used EQ-5D (European Quality-5 Dimension) and B-IPQ (Brief Illness Perception Quetionare). Data analysis used was univariate analysis by using percentage or mean value, bivariate using T-test or Mann-Whitney test, and multivariate using multiple linear regression. There were 80 T2DM patients who met the inclusion criteria. Based on patient demographic data, there were 29 people (36.6%) male patients and 51 people (63.8%) female patients, with mean age of patient (55.79±10.52) year. Perception has correlation with quality of life influenced by index value on treatment control (6.73±1.475) and emotional response (3.11±2.199) and by visual analog scale on understanding (5.99±1.587), duration (6.50±2.968), and personal controls (6.20±1.641). Based on the results obtained to improve the quality of life of T2DM patients that is on the index value on the control of treatment and emotional response and on visual analog scale on the understanding, duration and personal control should be changed so that the quality of life of patients increases. The family history, social status and type of treatment factors also affect the quality of life.

  13. Cancer control in developing countries: using health data and health services research to measure and improve access, quality and efficiency

    PubMed Central

    2010-01-01

    Background Cancer is a rapidly increasing problem in developing countries. Access, quality and efficiency of cancer services in developing countries must be understood to advance effective cancer control programs. Health services research can provide insights into these areas. Discussion This article provides an overview of oncology health services in developing countries. We use selected examples from peer-reviewed literature in health services research and relevant publicly available documents. In spite of significant limitations in the available data, it is clear there are substantial barriers to access to cancer control in developing countries. This includes prevention, early detection, diagnosis/treatment and palliation. There are also substantial limitations in the quality of cancer control and a great need to improve economic efficiency. We describe how the application of health data may assist in optimizing (1) Structure: strengthening planning, collaboration, transparency, research development, education and capacity building. (2) Process: enabling follow-up, knowledge translation, patient safety and quality assurance. (3) Outcome: facilitating evaluation, monitoring and improvement of national cancer control efforts. There is currently limited data and capacity to use this data in developing countries for these purposes. Summary There is an urgent need to improve health services for cancer control in developing countries. Current resources and much-needed investments must be optimally managed. To achieve this, we would recommend investment in four key priorities: (1) Capacity building in oncology health services research, policy and planning relevant to developing countries. (2) Development of high-quality health data sources. (3) More oncology-related economic evaluations in developing countries. (4) Exploration of high-quality models of cancer control in developing countries. Meeting these needs will require national, regional and international collaboration as well as political leadership. Horizontal integration with programs for other diseases will be important. PMID:20942937

  14. Union for International Cancer Control International Session: healthcare economics: the significance of the UN Summit non-communicable diseases political declaration in Asia.

    PubMed

    Akaza, Hideyuki; Kawahara, Norie; Masui, Tohru; Takeyama, Kunihiko; Nogimori, Masafumi; Roh, Jae Kyung

    2013-06-01

    The Japan National Committee for the Union for International Cancer Control (UICC) and UICC-Asia Regional Office (ARO) organized an international session as part of the official program of the 71st Annual Meeting of the Japanese Cancer Association to discuss the topic "Healthcare Economics: The Significance of the UN Summit non-communicable diseases (NCDs) Political Declaration in Asia." The presenters and participants discussed the growing cost of cancer in the Asian region and the challenges that are faced by the countries of Asia, all of which face budgetary and other systemic constraints in tackling and controlling cancer in the region. The session benefited from the participation of various stakeholders, including cancer researchers and representatives of the pharmaceutical industry. They discussed the significance of the UN Political Declaration on the prevention and control of NCDs (2011) as a means of boosting awareness of cancer in the Asian region and also addressed the ways in which stakeholders can cooperate to improve cancer control and treatment. Other issues that were covered included challenges relating to pharmaceutical trials in Asia and how to link knowledge and research outcomes. The session concluded with the recognition that with the onset of a super-aged society in most countries in Asia and an increasing focus on quality of life rather than quantity of life, it is more important than ever for all stakeholders to continue to share information and promote policy dialogue on cancer control and treatment. © 2013 Japanese Cancer Association.

  15. [Update on microbiological quality assurance meat and meat products in Morocco].

    PubMed

    Rachidi, H; Latrache, H

    2018-03-01

    Food safety has become an absolute necessity in all countries. As a result, Morocco has taken several measures and actions to develop food safety and food-borne disease control. This study aimed to highlight the level of improvement in the quality assurance of meat and meat products in Morocco. It is based on a non-exhaustive review of the regulatory texts governing food safety in the country, as well as a statistical study on establishments of meat and meat products adopting a self-checking system and approved by the National Office of Sanitary Safety of Food. Morocco has introduced several laws and regulations requiring sanitary control of food products. Also, the number of establishments of meat and meat products adopting a system of self-control and approved by the National Office of Sanitary Safety of Food has improved significantly. It has increased from 58 in 2007 to 273 in 2016. The adoption of self-monitoring systems allows better access to international markets, improved quality of food products and a considerable reduction in microbial contamination. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

  16. International Microgrid Assessment. Governance, INcentives, and Experience (IMAGINE)

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

    Marnay, Chris; Zhou, Nan; Qu, Min

    Microgrids can provide an avenue for increasing the amount of distributed generation and delivery of electricity, where control is more dispersed and quality of service is locally tailored to end-use requirements. Much of this functionality is very different from the predominant utility model to date of centralized power production which is then transmitted and distributed across long distances with a uniform quality of service. This different functionality holds much promise for positive change, in terms of increasing reliability, energy efficiency, and renewable energy while decreasing and carbon emissions. All of these functions should provide direct cost savings for customers andmore » utilities as well as positive externalities for society. As we have seen from the international experience, allowing microgrids to function in parallel with the grid requires some changes in electricity governance and incentives to capture cost savings and actively price in positive externalities. If China can manage to implement these governance changes and create those incentive policies, it will go beyond the establishment of a successful microgrid demonstration program and become an international leader in microgrid deployment.« less

  17. DNA Commission of the International Society for Forensic Genetics: revised and extended guidelines for mitochondrial DNA typing.

    PubMed

    Parson, W; Gusmão, L; Hares, D R; Irwin, J A; Mayr, W R; Morling, N; Pokorak, E; Prinz, M; Salas, A; Schneider, P M; Parsons, T J

    2014-11-01

    The DNA Commission of the International Society of Forensic Genetics (ISFG) regularly publishes guidelines and recommendations concerning the application of DNA polymorphisms to the question of human identification. Previous recommendations published in 2000 addressed the analysis and interpretation of mitochondrial DNA (mtDNA) in forensic casework. While the foundations set forth in the earlier recommendations still apply, new approaches to the quality control, alignment and nomenclature of mitochondrial sequences, as well as the establishment of mtDNA reference population databases, have been developed. Here, we describe these developments and discuss their application to both mtDNA casework and mtDNA reference population databasing applications. While the generation of mtDNA for forensic casework has always been guided by specific standards, it is now well-established that data of the same quality are required for the mtDNA reference population data used to assess the statistical weight of the evidence. As a result, we introduce guidelines regarding sequence generation, as well as quality control measures based on the known worldwide mtDNA phylogeny, that can be applied to ensure the highest quality population data possible. For both casework and reference population databasing applications, the alignment and nomenclature of haplotypes is revised here and the phylogenetic alignment proffered as acceptable standard. In addition, the interpretation of heteroplasmy in the forensic context is updated, and the utility of alignment-free database searches for unbiased probability estimates is highlighted. Finally, we discuss statistical issues and define minimal standards for mtDNA database searches. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  18. [Training evaluation of clinical laboratory excellence for technologists from some county and township hospitals in 31 provinces of China].

    PubMed

    Shang, Hong; Cui, Wei; Zhang, Man; Yang, Hongying; Sun, Ziyong; Duan, Yong; Chen, Ming; Yuan, Hong; Guan, Ming; Zhang, Shufang; Jia, Mei

    2015-09-22

    To improve clinical testing excellence through a large scale training project targeting laboratory operators at China's county and township hospitals. The Chinese Society of Laboratory Medicine launched the "Clinical Laboratory Standards and Training Support Project" from 2010 to 2013. The project innovatively created a model of partnership between government, professional association, individual hospitals and other social forces. A survey before training was conducted in 445 county-hospital laboratories in 31 provinces. Six months after implementation, a sampling survey was conducted among 250 participating county hospitals in 9 provinces to assess the project. From 2010 to 2013, the project had covered 31 provinces of China, and trained technologists from 3 570 hospitals. After training, the average pass rate of assessment examination increased to 83.7% compared with 16.2% before the training. 29.6% hospitals added new biochemistry parameters, and the number of hospital with new hematology, immunology, and microbiology parameters accounted for 24.4%, 21.2% and 16.4%, respectively. The internal quality control and external quality assessment items also increased significantly. Biochemistry increased most, reaching 12.8% and 10.0%, and microbiology also reached 4.4% and 2.8% respectively. Bio-safety management capacities were also enhanced. The number of hospital implementing bio-safety risk assessment increased from 41.2% to 76.4%. This project helpfully fills an important technical gap of clinical testing in China's rural healthcare infrastructure. Through training, clinical laboratory operations has been standardized, and systems of internal quality control and external quality assessment are increasingly improved.

  19. [Nursing service certification. Norm UNE-EN-ISO 9001-2008].

    PubMed

    Salazar de la Guerra, R; Ferrer Arnedo, C; Labrador Domínguez, M J; Sangregorio Matesanz, A

    2014-01-01

    To certify the nursing services using a quality management system, taking an international standard as a reference, and based on a continuous improvement process. The standard was revised, and the Quality Management System documentation was updated, consisting of a Quality Manual and 7 control procedures. All the existing procedures were coded in accordance with the documentation control process. Each operational procedure was associated with a set of indicators which permitted to know the results obtained, analyze the deviations and to implement further improvements. The system was implemented successfully. Twenty-eight care procedures and eleven procedures concerning techniques were incorporated into the management system. Thirty indicators were established that allowed the whole process to be monitored. All patients were assigned to a nurse in their clinical notes and all of them had a personalized Care Plan according to planning methodology using North American Nursing Diagnosis Association (NANDA), Nursing Interventions Classification (NIC) and Nursing Outcomes Classification (NOC) international rankings. The incidence of falls, as well as the incidence of chronic skin wounds, was low, taking into account the characteristics of the patient and the duration of the stay (mean=35.87 days). The safety indicators had a high level of compliance, with 90% of patients clearly identified and 100% with hygiene protocol. The confidence rating given to the nurses was 91%. The certification enabled the quality of the service to be improved using a structured process, analyzing the results, dealing with non-conformities and introducing improvements. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

  20. High-throughput multiplexed T-cell-receptor excision circle quantitative PCR assay with internal controls for detection of severe combined immunodeficiency in population-based newborn screening.

    PubMed

    Gerstel-Thompson, Jacalyn L; Wilkey, Jonathan F; Baptiste, Jennifer C; Navas, Jennifer S; Pai, Sung-Yun; Pass, Kenneth A; Eaton, Roger B; Comeau, Anne Marie

    2010-09-01

    Real-time quantitative PCR (qPCR) targeting a specific marker of functional T cells, the T-cell-receptor excision circle (TREC), detects the absence of functional T cells and has a demonstrated clinical validity for detecting severe combined immunodeficiency (SCID) in infants. There is need for a qPCR TREC assay with an internal control to monitor DNA quality and the relative cellular content of the particular dried blood spot punch sampled in each reaction. The utility of the qPCR TREC assay would also be far improved if more tests could be performed on the same newborn screening sample. We approached the multiplexing of qPCR for TREC by attenuating the reaction for the reference gene, with focus on maintaining tight quality assurance for reproducible slopes and for prevention of sample-to-sample cross contamination. Statewide newborn screening for SCID using the multiplexed assay was implemented, and quality-assurance data were recorded. The multiplex qPCR TREC assay showed nearly 100% amplification efficiency for each of the TREC and reference sequences, clinical validity for multiple forms of SCID, and an analytic limit of detection consistent with prevention of contamination. The eluate and residual ghost from a 3.2-mm dried blood spot could be used as source material for multiplexed immunoassays and multiplexed DNA tests (Multiplex Plus), with no disruption to the multiplex TREC qPCR. Population-based SCID newborn screening programs should consider multiplexing for quality assurance purposes. Potential benefits of using Multiplex Plus include the ability to perform multianalyte profiling.

  1. 26 CFR 1.23-4 - Performance and quality standards. [Reserved

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 26 Internal Revenue 1 2010-04-01 2010-04-01 true Performance and quality standards. [Reserved] 1.23-4 Section 1.23-4 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY INCOME TAX INCOME TAXES Changes in Rates During A Taxable Year § 1.23-4 Performance and quality standards. [Reserved...

  2. Internal Quality Assurance Benchmarking. ENQA Workshop Report 20

    ERIC Educational Resources Information Center

    Blackstock, Douglas; Burquel, Nadine; Comet, Nuria; Kajaste, Matti; dos Santos, Sergio Machado; Marcos, Sandra; Moser, Marion; Ponds, Henri; Scheuthle, Harald; Sixto, Luis Carlos Velon

    2012-01-01

    The Internal Quality Assurance group of ENQA (IQA Group) has been organising a yearly seminar for its members since 2007. The main objective is to share experiences concerning the internal quality assurance of work processes in the participating agencies. The overarching theme of the 2011 seminar was how to use benchmarking as a tool for…

  3. Development and Validation of a Laboratory-Developed Multiplex Real-Time PCR Assay on the BD Max System for Detection of Herpes Simplex Virus and Varicella-Zoster Virus DNA in Various Clinical Specimens.

    PubMed

    Pillet, Sylvie; Verhoeven, Paul O; Epercieux, Amélie; Bourlet, Thomas; Pozzetto, Bruno

    2015-06-01

    A multiplex real-time PCR (quantitative PCR [qPCR]) assay detecting herpes simplex virus (HSV) and varicella-zoster virus (VZV) DNA together with an internal control was developed on the BD Max platform combining automated DNA extraction and an open amplification procedure. Its performance was compared to those of PCR assays routinely used in the laboratory, namely, a laboratory-developed test for HSV DNA on the LightCycler instrument and a test using a commercial master mix for VZV DNA on the ABI7500fast system. Using a pool of negative cerebrospinal fluid (CSF) samples spiked with either calibrated controls for HSV-1 and VZV or dilutions of a clinical strain that was previously quantified for HSV-2, the empirical limit of detection of the BD Max assay was 195.65, 91.80, and 414.07 copies/ml for HSV-1, HSV-2, and VZV, respectively. All the samples from HSV and VZV DNA quality control panels (Quality Control for Molecular Diagnostics [QCMD], 2013, Glasgow, United Kingdom) were correctly identified by the BD Max assay. From 180 clinical specimens of various origins, 2 CSF samples were found invalid by the BD Max assay due to the absence of detection of the internal control; a concordance of 100% was observed between the BD Max assay and the corresponding routine tests. The BD Max assay detected the PCR signal 3 to 4 cycles earlier than did the routine methods. With results available within 2 h on a wide range of specimens, this sensitive and fully automated PCR assay exhibited the qualities required for detecting simultaneously HSV and VZV DNA on a routine basis. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

  4. KSC Center Director Bridges accepts an ISO 9001 certification plaque from DNV

    NASA Technical Reports Server (NTRS)

    1998-01-01

    Center Director Roy Bridges (right) displays the 2000th ISO Certificate Plaque he was given by Dalton Lyon (left) of Det Norske Veritas (DNV), Inc., an international ISO certification organization, at a ceremony at KSC. The plaque is a representation of the ISO 9001 certification awarded to KSC by DNV. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already world- class team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification.

  5. Data quality at the Singapore Cancer Registry: An overview of comparability, completeness, validity and timeliness.

    PubMed

    Fung, Janice Wing Mei; Lim, Sandra Bee Lay; Zheng, Huili; Ho, William Ying Tat; Lee, Bee Guat; Chow, Khuan Yew; Lee, Hin Peng

    2016-08-01

    To provide a comprehensive evaluation of the quality of the data at the Singapore Cancer Registry (SCR). Quantitative and semi-quantitative methods were used to assess the comparability, completeness, accuracy and timeliness of data for the period of 1968-2013, with focus on the period 2008-2012. The SCR coding and classification systems follow international standards. The overall completeness was estimated at 98.1% using the flow method and 97.5% using the capture-recapture method, for the period of 2008-2012. For the same period, 91.9% of the cases were morphologically verified (site-specific range: 40.4-100%) with 1.1% DCO cases. The under-reporting in 2011 and 2012 due to timely publication was estimated at 0.03% and 0.51% respectively. This review shows that the processes in place at the SCR yields data which are internationally comparable, relatively complete, valid, and timely, allowing for greater confidence in the use of quality data in the areas of cancer prevention, treatment and control. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. Research of the Quality of Quarry Dumpers Engine Crankshafts Sliding Bearings of Various Manufacturers

    NASA Astrophysics Data System (ADS)

    Korotkov, Alexander; Korotkova, Lidiya; Vidin, Denis

    2017-11-01

    Sliding bearings are an important part of many large and critical components. They are widely used in power equipment, high-capacity pumps, compressors, electric motors and internal combustion engines (ICE). As a rule, sliding bearings include an antifriction bushing, part of the shaft surface (bearing journal), and a layer of oil between them. These are complex and critical parts in which there may occur dangerous defects, and which directly affect the durability, accuracy and reliability of the entire unit. To ensure high reliability of the equipment with sliding bearings applied in complex equipment, it is necessary to provide the quality control and sufficient level of monitoring of the technical condition, as well as diagnosis of emerging defects. This paper presents a comparative analysis of the internal combustion engines sliding bearings quality of various manufacturing companies. It gives operational properties of bearings depending on the compositional composition. The results of chemical analysis of the base, the cover and intermediate layers of the ICE liners are presented here. We have also made recommendations to increase the operational performance of sliding bearings.

  7. KSC-98pc909

    NASA Image and Video Library

    1998-08-11

    Center Director Roy Bridges speaks to KSC employees at the ISO certification ceremony held at the Training Auditorium. Bridges was presented an ISO 9001 certificate and plaque awarded to KSC by Det Norske Veritas (DNV), Inc., an international ISO certification organization. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already worldclass team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification. Next to Bridges is Heidi Hollingsworth, with the Center for Independent Living, who uses American Sign Language for any hearing-impaired employees in the audience

  8. Long-term outcomes of internet-based self-management support in adults with asthma: randomized controlled trial.

    PubMed

    van Gaalen, Johanna L; Beerthuizen, Thijs; van der Meer, Victor; van Reisen, Patricia; Redelijkheid, Geertje W; Snoeck-Stroband, Jiska B; Sont, Jacob K

    2013-09-12

    Long-term asthma management falls short of the goals set by international guidelines. The Internet is proposed as an attractive medium to support guided self-management in asthma. Recently, in a multicenter, pragmatic randomized controlled parallel trial with a follow-up period of 1 year, patients were allocated Internet-based self-management (IBSM) support (Internet group [IG]) or usual care (UC) alone. IBSM support was automatically terminated after 12 months of follow-up. In this study, IBSM support has been demonstrated to improve asthma-related quality of life, asthma control, lung function, and the number of symptom-free days as compared to UC. IBSM support was based on known key components for effective self-management and included weekly asthma control monitoring and treatment advice, online and group education, and communication (both online and offline) with a respiratory nurse. The objective of the study was to assess the long-term effects of providing patients 1 year of IBSM support as compared to UC alone. Two hundred adults with physician-diagnosed asthma (3 or more months of inhaled corticosteroids prescribed in the past year) from 37 general practices and 1 academic outpatient department who previously participated were invited by letter for additional follow-up at 1.5 years after finishing the study. The Asthma Control Questionnaire (ACQ) and the Asthma Quality of Life Questionnaire (AQLQ) were completed by 107 participants (60 UC participants and 47 IG participants). A minimal clinical important difference in both questionnaires is 0.5 on a 7-point scale. At 30 months after baseline, a sustained and significant difference in terms of asthma-related quality of life of 0.29 (95% CI 0.01-0.57) and asthma control of -0.33 (95% CI -0.61 to -0.05) was found in favor of the IBSM group. No such differences were found for inhaled corticosteroid dosage or for lung function, measured as forced expiratory volume in 1 second. Improvements in asthma-related quality of life and asthma control were sustained in patients who received IBSM support for 1 year, even up to 1.5 years after terminating support. Future research should be focused on implementation of IBSM on a wider scale within routine asthma care. International Standard Randomized Controlled Trial Number (ISRCTN): 79864465; http://www.controlled-trials.com/ISRCTN79864465 (Archived by WebCite at http://www.webcitation.org/6J4VHhPk4).

  9. Effect of antibrowning dips and controlled atmosphere storage on the physico-chemical, visual and nutritional quality of minimally processed "Rojo Brillante" persimmons.

    PubMed

    Sanchís, Elena; Mateos, Milagros; Pérez-Gago, María B

    2017-01-01

    The combined effect of antibrowning dips and controlled atmosphere storage on fresh-cut "Rojo Brillante" persimmon quality was investigated. Persimmon slices were dipped in 10 g L -1 ascorbic acid, 10 g L -1 citric acid or water and were stored in different controlled atmospheres at 5 ℃. Controlled atmosphere conditions were 21 kPa O 2  + 10 kPa CO 2 (Atm-B), 21 kPa O 2  + 20 kPa CO 2 (Atm-C), 5 kPa O 2  + 10 kPa CO 2 (Atm-D) and 5 kPa O 2 in the absence of CO 2 (Atm-E). Air (Atm-A) was used as a control. Atmospheres with high CO 2 concentrations induced darkening, associated with a flesh disorder known as "internal flesh browning". Only the samples placed in Atm-E, and treated with 10 g L -1 ascorbic acid or 10 g L -1 citric acid, controlled enzymatic browning, reduced firmness loss and prevented the "internal flesh browning" disorder. The maximum limit of marketability was achieved in the samples treated with 10 g L -1 citric acid and stored in Atm-E for nine storage days at 5 ℃. The total vitamin C, free radical scavenging activity, total phenolic content and total carotenoids of the fresh-cut "Rojo Brillante" persimmons were affected by maturity stage at harvest, whereas antibrowning dips and controlled atmosphere storage had no clear effect. © The Author(s) 2016.

  10. The genetic control of milling yield, dough rheology and baking quality of wheat.

    PubMed

    Kuchel, H; Langridge, P; Mosionek, L; Williams, K; Jefferies, S P

    2006-05-01

    Improving the end-use quality of wheat is a key target for many breeding programmes. With the exception of the relationship between glutenin alleles and some dough rheological characters, knowledge concerning the genetic control of wheat quality traits is somewhat limited. A doubled haploid population produced from a cross between two Australian cultivars 'Trident' and 'Molineux' has been used to construct a linkage map based largely on microsatellite molecular makers. 'Molineux' is superior to 'Trident' for a number of milling, dough rheology and baking quality characteristics, although by international standards 'Trident' would still be regarded as possessing moderately good end-use quality. This population was therefore deemed useful for investigation of wheat end-use quality. A number of significant QTL identified for dough rheological traits mapped to HMW and LMW glutenin loci on chromosomes 1A and 1B. However, QTL associated with dough strength and loaf volume were also identified on chromosome 2A and a significant QTL associated with loaf volume and crumb quality was identified on chromosome 3A. A QTL for flour protein content and milling yield was identified on chromosome 6A and a QTL associated with flour colour reported previously on chromosome 7B was confirmed in this population. The detection of loci affecting dough strength, loaf volume and flour protein content may provide fresh opportunities for the application of marker-assisted selection to improve bread-making quality.

  11. Glenn's Telescience Support Center Provided Around-the-Clock Operations Support for Space Experiments on the International Space Station

    NASA Technical Reports Server (NTRS)

    Malarik, Diane C.

    2005-01-01

    NASA Glenn Research Center s Telescience Support Center (TSC) allows researchers on Earth to operate experiments onboard the International Space Station (ISS) and the space shuttles. NASA s continuing investment in the required software, systems, and networks provides distributed ISS ground operations that enable payload developers and scientists to monitor and control their experiments from the Glenn TSC. The quality of scientific and engineering data is enhanced while the long-term operational costs of experiments are reduced because principal investigators and engineering teams can operate their payloads from their home institutions.

  12. How do the approaches to accountability compare for charities working in international development?

    PubMed

    Kirsch, David

    2014-09-01

    Approaches to accountability vary between charities working to reduce under-five mortality in underdeveloped countries, and healthcare workers and facilities in Canada. Comparison reveals key differences, similarities and trade-offs. For example, while health professionals are governed by legislation and healthcare facilities have a de facto obligation to be accredited, charities and other international organizations are not subject to mandatory international laws or guidelines or to de facto international standards. Charities have policy goals similar to those found in the Canadian substudies, including access, quality, cost control, cost-effectiveness and customer satisfaction. However, the relative absence of external policy tools means that these goals may not be realized. Accountability can be beneficial, but too much or the wrong kind of accountability can divert resources and diminish returns. Copyright © 2014 Longwoods Publishing.

  13. Quality assurance in military medical research and medical radiation accident management.

    PubMed

    Hotz, Mark E; Meineke, Viktor

    2012-08-01

    The provision of quality radiation-related medical diagnostic and therapeutic treatments cannot occur without the presence of robust quality assurance and standardization programs. Medical laboratory services are essential in patient treatment and must be able to meet the needs of all patients and the clinical personnel responsible for the medical care of these patients. Clinical personnel involved in patient care must embody the quality assurance process in daily work to ensure program sustainability. In conformance with the German Federal Government's concept for modern departmental research, the international standard ISO 9001, one of the relevant standards of the International Organization for Standardization (ISO), is applied in quality assurance in military medical research. By its holistic approach, this internationally accepted standard provides an excellent basis for establishing a modern quality management system in line with international standards. Furthermore, this standard can serve as a sound basis for the further development of an already established quality management system when additional standards shall apply, as for instance in reference laboratories or medical laboratories. Besides quality assurance, a military medical facility must manage additional risk events in the context of early recognition/detection of health risks of military personnel on deployment in order to be able to take appropriate preventive and protective measures; for instance, with medical radiation accident management. The international standard ISO 31000:2009 can serve as a guideline for establishing risk management. Clear organizational structures and defined work processes are required when individual laboratory units seek accreditation according to specific laboratory standards. Furthermore, international efforts to develop health laboratory standards must be reinforced that support sustainable quality assurance, as in the exchange and comparison of test results within the scope of external quality assurance, but also in the exchange of special diagnosis data among international research networks. In summary, the acknowledged standard for a quality management system to ensure quality assurance is the very generic standard ISO 9001.Health Phys. 103(2):221-225; 2012.

  14. Value of HIV patients with regular follow-up as in-house internal controls of flow cytometry measurement of lymphocyte subsets.

    PubMed

    de Carvalho Bittencourt, Marcelo; Kohler, Chantal; Henard, Sandrine; Rabaud, Christian; Béné, Marie C; Faure, Gilbert C

    2013-01-01

    Quality assessment in flow cytometry cannot obey the same rules as those applicable to the measurement of chemical analytes. However, regular follow-up of known patients may provide a robust in-house control of cell subsets evaluation. Sequential blood samples assessed for 32 HIV patients over several years and showing good stability were retrospectively assessed to establish coefficient of variations of the percentages of CD3+, CD4+, CD8+ cells, and CD4+ absolute counts (ACs). Mean relative standard variations for the whole cohort were of 0.04, 0.14, 0.08, and 0.18 for CD3%, CD4%, CD8%, and CD4 ACs, respectively. In-house follow-up of regularly checked compliant patients is a good alternative to traditional and costly repeatability and reproducibility studies for the validation of routine flow cytometry. © 2013 International Clinical Cytometry Society. Copyright © 2013 International Clinical Cytometry Society.

  15. 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.

  16. 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.

  17. Systematic Review of International Colposcopy Quality Improvement Guidelines.

    PubMed

    Mayeaux, Edward J; Novetsky, Akiva P; Chelmow, David; Choma, Kim; Garcia, Francisco; Liu, Angela H; Papasozomenos, Theognosia; Einstein, Mark H

    2017-10-01

    The American Society for Colposcopy and Cervical Pathology Colposcopy Standards Committee organized multiple working groups to draft colposcopy standards for the United States. As part of this project, international quality assurance and improvement measures were examined. The quality improvement working group performed a systematic review of the literature to collate international guidelines related to quality improvement. Source guidelines were collected using searches in Medline, Google Scholar, the International Federation of Cervical Pathology and Colposcopy Web site, other regional colposcopy group's Web sites, and communications with International Federation of Cervical Pathology and Colposcopy board of directors' members and other expert members of various national groups. Once identified, the sources were reviewed by multiple workgroup members for potential guideline materials. Fifty-six unique documents were identified, of which 18 met inclusion criteria and contributed data to the analysis. Information was abstracted and grouped by related subject. Wide variation exists in colposcopy guidance and quality indicators from regional and national colposcopy societies. Abstracted international guidelines are presented.

  18. Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus.

    PubMed

    Nobels, Frank; Debacker, Noëmi; Brotons, Carlos; Elisaf, Moses; Hermans, Michel P; Michel, Georges; Muls, Erik

    2011-09-22

    To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Recruitment was completed in December 2008 with 3994 evaluable patients. This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. NCT00681850.

  19. Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus

    PubMed Central

    2011-01-01

    Background To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Methods Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Results Recruitment was completed in December 2008 with 3994 evaluable patients. Conclusions This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. Trial registration NCT00681850 PMID:21939502

  20. The influence of farmland pollution on the quality and safety of agricultural products

    NASA Astrophysics Data System (ADS)

    Ma, Z. L.; Li, L. Y.; Ye, C.; Lin, X. Y.; B, C.; Wei

    2018-02-01

    The quality and safety of agricultural products is not only a major livelihood issues for people’s health, but also the main barriers to international trade of agricultural products nowadays. The soil is the foundation to the production of agricultural products and the guarantee of agricultural development. The farmland soil quality is directly related to the quality and safety of agricultural products. Our country’s soil has been polluted by a series of pollution, Such as the excessive discharge of industrial wastes, the encroachment of household waste, and the unreasonable use of pesticides and fertilizers. Soil degradation is a serious threat to the quality and safety of agricultural products, so eliminating soil degradation is the fundamental way out for quality and safety of agricultural products. By analyzing problems of the quality and safety of agricultural products in our country, and exploring the farmland soil influence on the quality and safety of agricultural products. This article provides a reference for improving the control level of quality and safety of agricultural products and the farmland soil quality.

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