国家药监局印发全国医疗器械检测机构基本仪器装备标准(2011-2015年)

<正>为加强医疗器械检测机构检验能力建设,规范医疗器械检测机构仪器装备,提高医疗器械监管水平,国家食品药品监督管理局组织制定了《全国医疗器械检测机构基本仪器装备标准(2011-2015年)》,并于日前印发。该标准是在《全国医疗器械检测机构基本仪器装备标准(试行)》(2005-2010年)基础上,以医疗器械国家标准     

医疗器械能力验证计划的设计

目的能力验证计划的设计是能力验证项目最为重要的一环,规范可行的设计能够保证能力验证活动达到预期的目的和效果。本文针对能力验证计划设计的各个要素进行分析,从而对设计环节进行规范和指导。方法结合中国食品药品检定研究院2006—2015年组织实施的医疗器械能力验证项目,对能力验证项目设计的团队组成及限定条件、被测量的量值或特征信息、样品稳定性和均匀性检验方法等相关要素逐一进行阐述和分析。结果对能力验证计划设计所涉及的检验及评价方法给出了可行性的建议,并对能力验证计划设计的规范化提供了参考方案。结论此能力验证计划的设计思路及方案对指导能力验证计划的设计具有重要意义。     

上海市医疗器械检测所简介

正上海市医疗器械检测所(CMTC)是中国合格评定国家认可委员会、国家食品药品监督管理总局及中国质量认证中心等有关部门分别审查认可的国家级医疗器械质量监督检验机构、医疗器械产品认证检测指定实验室,是上海市食品药品监督管理局的直属单位。本所还是国家标准化管理委员会批准成立、国家食品药品监督管理总局认定的全国医疗器械标准化技术归口单位,承担了全国医用电器、全国医用电子仪器、全国外科器械、全国计划生育器械、全国医用注射     

上海市医疗器械检测所

正简介上海市医疗器械检测所(CMTC)是中国合格评定国家认可委员会、国家食品药品监督管理总局及中国质量认证中心等有关部门分别审查认可的国家级医疗器械质量监督检验机构、医疗器械产品认证检测指定实验室,是上海市食品药品监督管理局的直属单位。本所还是国家标准化管理委员会批准成立、国家食品药品监督管理总局认定的全国医疗器械标准化技术归口单位,承担了全国医用电器、     

上海市医疗器械检测所

正简介上海市医疗器械检测所(CMTC)是中国合格评定国家认可委员会、国家食品药品监督管理总局及中国质量认证中心等有关部门分别审查认可的国家级医疗器械质量监督检验机构、医疗器械产品认证检测指定实验室,是上海市食品药品监督管理局的直属单位。本所还是国家标准化管理委员会批准成立、国家食品药品监督管理总局认定的全国医疗器械标准化技术归口单位,承担了全国医用电器、     

上海市医疗器械检测所

正简介上海市医疗器械检测所(CMTC)是中国合格评定国家认可委员会、国家食品药品监督管理总局及中国质量认证中心等有关部门分别审查认可的国家级医疗器械质量监督检验机构、医疗器械产品认证检测指定实验室,是上海市食品药品监督管理局的直属单位。本所还是国家标准化管理委员会批准成立、国家食品药品监督管理总局认定的全国医疗器械标准化技术归口单位,承担了全国医用电器、     

上海市医疗器械检测所

<正>Introductiom简介上海市医疗器械检测所(CMTC)是中国合格评定国家认可委员会、国家食品药品监督管理总局及中国质量认证中心等有关部门分别审查认可的国家级医疗器械质量监督检验机构、医疗器械产品认证检测指定实验室,是上海市食品药品监督管理局的直属单位。本所还是国家标准化管理委员会批准成立、国家食品药品监督管理总局认定的全国医疗器械标准化技术归口单位,承担了全国医用电器、全国医用电子仪器、全国外科器械、全国计划生育器械、全国医用注射     

上海市医疗器械检测所

正简介上海市医疗器械检测所(CMTC)是中国合格评定国家认可委员会、国家食品药品监督管理总局及中国质量认证中心等有关部门分别审查认可的国家级医疗器械质量监督检验机构、医疗器械产品认证检测指定实验室,是上海市食品药品监督管理局的直属单位。本所还是国家标准化管理委员会批准成立、国家食品药品监督管理总局认定的全国医疗器械标准化技术归口单位,承担了全国医用电器、全国医用电子仪器、全国外科器械、全国计划生育器械、全国医用注射     

上海市医疗器械检测所

<正>简介Introduction上海市医疗器械检测所(CMTC)是中国合格评定国家认可委员会、国家食品药品监督管理总局及中国质量认证中心等有关部门分别审查认可的国家级医疗器械质量监督检验机构、医疗器械产品认证检测指定实验室,是上海市食品药品监督管理局的直属单位。本所还是国家标准化管理委员会批准成立、国家食品药品监督管理总局认定的全国医疗器械标准化技术归口单位,承担了全国医用电器、     

上海市医疗器械检测所简介

<正>上海市医疗器械检测所(CMTC)是中国合格评定国家认可委员会、国家食品药品监督管理总局及中国质量认证中心等有关部门分别审查认可的国家级医疗器械质量监督检验机构、医疗器械产品认证检测指定实验室,是上海市食品药品监督管理局的直属单位。本所还是国家标准化管理委员会批准成立、国家食品药品监督管理总局认定的全国医疗器械标准化技术归口单位,承担了全国医用电器、     

Evolution of an external quality assessment program in Canadian Mycobacteriology Laboratories: three years of proficiency testing data

In 2000, the Canadian mycobacteriology proficiency testing program was updated and expanded to improve proficiency and standardize the main activities and testing performed in Canadian clinical mycobacteriology laboratories. The program was divided into 2 phases and included samples for acid-fast microscopy, species identification, susceptibility testing for Mycobacterium tuberculosis and nontuberculous mycobacteria, nucleic acid amplification for the detection of M. tuberculosis complex in clinical samples, and restriction fragment length polymorphism (RFLP) typing of M. tuberculosis. Results of participating laboratories are given for a 3-year period (2000-2002). Canadian laboratories exhibited a high level of proficiency in both phases of the program. Improvements were demonstrated in susceptibility testing of M. tuberculosis, and standardization was achieved with Mycobacterium avium complex susceptibility testing. Laboratories demonstrated proficiency in determining unique and identical strains of M. tuberculosis using RFLP; however, difficulties occurred with interlaboratory reproducibility.     

Do proficiency testing participants learn from their mistakes? Experience from the EXCEL throat culture module

CONTEXT: Participation in proficiency testing is required under the Clinical Laboratory Improvement Amendments of 1988. Although the primary purpose of this testing is evaluation of current laboratory performance, a major secondary benefit of such testing is postulated to be progressive improvement in laboratory performance over time as laboratories learn from their previous experiences and feedback. OBJECTIVE: To test the hypothesis that a secondary result of proficiency testing is improvement over time of laboratory performance. DESIGN: The performance of participants in a large proficiency testing program (EXCEL), designed for clinic and office laboratories, on a specific problematic competence, the ability to differentiate group A streptococcus from group C streptococci, was monitored during a 6-year period (1996-2001) for changes in participant performance. INTERVENTIONS: With each testing cycle, feedback on performance relative to peers and an educational discussion analyzing performance and suggesting best practices was submitted to participants. RESULTS: Despite consistent feedback, there was no significant change in participant performance throughout the period studied. CONCLUSIONS: In a large, stable proficiency testing program, a significant throat culture competence, which demonstrated less than optimal performance, did not improve over time, suggesting that current utilization of proficiency testing results in laboratory improvement programs is suboptimal.     

Status of the clinical laboratory in the mandatory postgraduate medical training system: introduction

To understand the role of the clinical laboratory in the era of mandatory postgraduate medical training, I carried out a questionnaire survey in April 2005 among both university hospitals and clinical teaching hospitals located in the Kinki area. As a result, eleven (84.6%) of the 13 responding laboratories participated in clinical laboratory medical education with an obligatory training program (5 laboratories), with an elective program (3 labs) or both (3 labs). Among the 8 laboratories with an obligatory program, educational lecture subjects included reversed clinicopathological conference (7 labs), blood transfusion (4 labs), laboratory microbiology (4 labs), and blood gas analysis (BGA) (3 labs). On the other hand, in the elective training programs among 6 laboratories, laboratory microbiology including infection control was most frequently held (4 labs) followed by blood transfusion, laboratory hematology and urinalysis (3 labs respectively). Concerning 4 areas, namely, blood transfusion, 12-lead electrocardiography at rest, BGA and ultrasonography, which have been defined as obligatory laboratory techniques for all trainees in mandatory postgraduate medical training, the majority (84.6%) of the responders in this survey replied that they were not sufficient, whereas, Gram's staining was most frequently (69.2%) recommended as an additional obligatory technique in mandatory postgraduate medical training.     

Performance of the Kodak DT-60 physician's office analyzer as measured by CLIA-88 proposed evaluation criteria. Assessment of demographic and quality assurance factors influencing performance.

The 1988 Clinical Laboratories Improvement Act (CLIA-88) proposes to mandate universal proficiency testing and internal quality assurance practices for all laboratories, including those in physician offices. For 3 years, we have provided an independent voluntary proficiency testing program to more than 400 physician office laboratories using Kodak DT-60 analyzers (Eastman Kodak, Rochester, NY). This unique data set enables us to evaluate, using the CLIA-88 proposed grading criteria, the ability of these laboratories to meet the proposed regulatory standards. Using the equivalent of a year's participation under the CLIA proficiency testing format (20 challenges per analyte), at least 88% would "pass," ie, achieve acceptable performance. We investigated the relationship between proficiency testing performance and several internal quality assurance practices as well as other factors commonly associated with quality performance, including analyst's professional background, monthly test volume, number of physicians served, and source of training on the instrument. The best indicator of successful performance in proficiency testing was on-site training provided by the manufacturer, as opposed to training provided by distributor personnel. We conclude that with proper on-site training and retraining, physician office laboratories will be able to meet the mandatory CLIA-88 proficiency testing requirements.     

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

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

Proficiency testing for HLA-DRB high-resolution typing: a 4-year experience in Italy.

Twenty-one Italian laboratories participated for four consecutive years in the collaborative Italian proficiency testing of HLA class II (DRB1, DRB3, DRB4 and DRB5) high-resolution typing. In this paper the results are analysed. Seven different kinds of errors are described and discussed. The errors were divided into technical errors and errors of allele reporting. Each year, a list of errors made was prepared by our laboratory and discussed collegially with all laboratories. The allele reporting errors diminished over time, as a result of the common discussions. The technical performance of the laboratories did not improve overall for the 21 laboratories participating: for 16 of them results were good or improved in quality, but for the remaining five results deteriorated over time. From this experience, some recommendations for the future emerged. A relevant conclusion was that, to improve the performance of a group of laboratories, the proficiency test is not effective alone, but should be integrated within a framework of continuous collaboration and mutual technical help.     

Proficiency testing for HLA‐DRB high‐resolution typing: a 4‐year experience in Italy

Twenty‐one Italian laboratories participated for four consecutive years in the collaborative Italian proficiency testing of HLA class II (DRB1, DRB3, DRB4 and DRB5) high‐resolution typing. In this paper the results are analysed. Seven different kinds of errors are described and discussed. The errors were divided into technical errors and errors of allele reporting. Each year, a list of errors made was prepared by our laboratory and discussed collegially with all laboratories. The allele reporting errors diminished over time, as a result of the common discussions. The technical performance of the laboratories did not improve overall for the 21 laboratories participating: for 16 of them results were good or improved in quality, but for the remaining five results deteriorated over time. From this experience, some recommendations for the future emerged. A relevant conclusion was that, to improve the performance of a group of laboratories, the proficiency test is not effective alone, but should be integrated within a framework of continuous collaboration and mutual technical help.     

Proficiency testing program for clinical laboratories performing antifungal susceptibility testing of pathogenic yeast species

Antifungal susceptibility testing is expected to facilitate the selection of adequate therapy for fungal infections. The general availability of antifungal susceptibility testing in clinical laboratories is low, even though a number of standard methods are now available. The objective of the present study was to develop and evaluate a proficiency testing program (PTP) for the antifungal susceptibility testing of pathogenic yeasts in laboratories licensed by the New York State Department of Health. A number of quality control standards, and methods for documenting laboratory performance, were developed in consultation with the laboratory directors. The participating laboratories were provided with five American Type Culture Collection strains of pathogenic yeasts for which the minimum inhibitory concentrations (MICs) of amphotericin B and fluconazole were well defined. A majority of laboratories (14 of 17) used broth microdilution, and these were evenly split between the NCCLS M-27A protocol and the Sensititre YeastOne method. The other three laboratories performed susceptibility testing with Etest. Overall, the levels of agreement between MIC reference ranges and the reported MICs were 85 and 74% for amphotericin B and for fluconazole, respectively. All laboratories except one successfully detected fluconazole resistance in a Candida krusei strain. However, amphotericin B resistance in a Candida lusitaniae strain was not detected by any of the participating labs. It is concluded that a suitably designed PTP could adequately monitor the competence of clinical laboratories performing antifungal susceptibility testing.     

Need for an external proficiency testing program for cytokines, chemokines, and plasma markers of immune activation

An external evaluation program for measuring the performance of laboratories testing for cytokines and immune activation markers in biological fluids was developed. Cytokines, chemokines, soluble cytokine receptors, and other soluble markers of immune activation (CSM) were measured in plasma from a healthy human immunodeficiency virus (HIV)-seronegative reference population and from HIV-seropositive individuals as well as in supernatant fluids from in vitro-stimulated human immune cells. The 14 components measured were tumor necrosis factor (TNF) alpha, gamma interferon, interleukin-1 (IL-1), IL-2, IL-4, IL-6, IL-10, Rantes, MIP-Ia, MIP-Ibeta, soluble TNF receptor II, soluble IL-2 receptor alpha, beta(2)-microglobulin, and neopterin. Twelve laboratories associated with the Adult and Pediatric AIDS Clinical Trial Groups participated in the study. The performance features that were evaluated included intralaboratory variability, interlaboratory variability, comparison of reagent sources, and ability to detect CSM in the plasma of normal subjects as well as the changes occurring in disease. The principal findings were as follows: (i) on initial testing, i.e., before participating in the program, laboratories frequently differed markedly in their analytic results; (ii) the quality of testing of a CSM in individual participating laboratories could be assessed; (iii) most commercial kits allowed distinction between normal and abnormal plasma CSM levels and between supernatants of stimulated and unstimulated cells; (iv) different sources of reagents and reference standards frequently provided different absolute values; (v) inexperienced laboratories can benefit from participating in the program; (vi) laboratory performance improved during active participation in the program; and (vii) comparability between analyses conducted at different sites can be ensured by an external proficiency testing program.     

Five years of experience with a national external quality control program for the culture and identification of Neisseria gonorrhoeae.

In response to a need for monitoring the proficiency of public health laboratories in isolating and identifying Neisseria gonorrhoeae, a national external quality control program was developed. Essentially, three types of freeze-dried samples, representing different levels of challenge for identification, were sent to laboratories for testing. The quality of the samples was confirmed by external reference laboratories, and stability of the samples was confirmed by thermal degradation tests before the samples were sent to laboratories enrolled in the program. By analyzing laboratory results, we identified common errors and chronic problems in testing samples. As a group, laboratories testing small numbers of actual patient specimens did not perform as well in the program as did laboratories testing large numbers of specimens; however, the performance of laboratories testing small numbers of specimens improved over time. Overall, laboratories experienced the most difficulty with samples containing N. gonorrhoeae mixed with other microbial species. Laboratories that performed confirmatory tests committed fewer errors than did laboratories that performed presumptive tests only, but the failure to use pure cultures of gonococci for inoculation of cystine tryptic digest agar appeared to be a chronic problem in confirmatory carbohydrate testing. A review of the use of different plating media and confirmatory tests showed that the use of certain media and tests changed over time.