肺结核病人痰涂片镜检不同质控方式效果评价

目的 探讨适合我国各级实验室开展的痰涂片室间质量控制模式。方法 设计了在不同地理条件下应用不同督导方式进行痰涂片镜检室间质控。结果及结论 经培训后直接督导和间接督导之间、山区和平原之间复检痰片的各项符合率均无统计学差异。直接督导费用明显高于间接督导；山区督导费用明显高于平原（Ｐ〈０．０５）。结合二种督导方式在各自实施中的特点，认为培训和室间质控是提高痰检质量的必要手段，在我国现阶段可根据各地区的疫     

肺结核病人痰涂片镜检不同质控方式效果评价

在不同地理条件设计了应用不同督导方式进行痰涂片镜检室间的质控。结果表明经培训后直接督导和间接督导之间、山区和平原之间复检痰片的各项符合率均无统计学差异。但结合二种督导方式在各自实施中的特点，认为，培训和室间质控是提高痰检质量的必要手段，在我国现阶段可根据各地区的疫情、结防力量、痰检水平和经费等实际情况，采取两种督导方式相结合而偏重其一的模式进行痰涂片镜检质量控制。     

肺结核病人痰涂片镜检不同质控方式效果评价

在不同地理条件设计了应用不同督导方式进行痰涂片镜检室间的质控。结果表明经培养后直接督导和间接督导之间，山区和平原之间复检痰片的各项符合率均无统计学差异。但结合二种督导方式在各自实施中的特点，认为，培训和室间质控是提高痰检质量的必要手段，在我国现阶段可根据各地区的疫情，结防力量，痰检水平和经费等实际情况，采取两种督导方式相结合而偏重的模式进行痰涂片镜检质量控制。     

双盲法痰栓室间质控三年效果评价

目的：探讨在结核病控制规程中痰涂片室间质控的新模式。方法：以新登记肺结核病人痰涂片为质控重点，在区县级实验室之间，开展双盲初级室间质控，省级参比室进行终级质控考核。结果：在不增加经费投入情况下，地区质控覆盖率可达100％，每年约50％新登记肺结核病人痰涂片置于质量监控之下。镜下阳性符合率从本课题实施前99．0％－100％下降至97．1％－98．3％，阴性符合率由99．4％－99．9％下降至98．5％－99．1％。结论：采用双盲法开展同级间室间质控，是经济可行的一种间接督导方式，可有效地扩大质控范围和质控频率；两组双重室间质控使质量控制程度更趋严格，可切实发挥痰检质控在结核病控制规划中的作用。     

双盲法痰检室间质控三年效果评价

目的　探讨在结核病控制规程中痰涂片室间质控的新模式。方法 以新登记肺结核病人痰涂片为质控重点,在区县级实验室之间,开展双盲初级室间质控,省级参比室进行终级质控考核。结果 在不增加经费投入情况下,地区质控覆盖率可达100%,每年约50%新登记肺结核病人痰涂片置于质量监控之下。镜下阳性符合率从本课题实施前99.0%～100%下降至97.1%～98.3%,阴性符合率由99.4%～99.9%下降至98.5%～99.1%。结论 采用双盲法开展同级间室间质控,是经济可行的一种间接督导方式,可有效地扩大质控范围和质控频率;两级双重室间质控使质量控制程序更趋严格,可切实发挥痰检质控在结核病控制规划中的作用。     

痰涂片制片质量对镜检工作效率影响的研究

痰涂片镜检作为发现传染源、选择化疗方案、考核评价疗效的重要手段,在现代结核病控制中占有不可或缺的地位。加强痰涂片的质量控制,提高各级实验室的痰检工作效率已成为当前国家结核病控制规程实施中的重要内容。本文通过对一次痰涂片镜检室间质控数据的分析,阐明痰涂片制片质量因素对镜检工作效率的影响。     

白银市2002-2008年结核病痰涂片检查质量控制分析

加强痰涂片镜检质量控制,提高各级实验室痰检质量和肺结核病人涂阳检出率已成为当前国家结核病控制规划实施中的重要内容[1]。白银市自2002年7月以来,实施“市级-县级”督导模式,建立了自上而下的质控体系,痰检工作逐步规范,病人发现取得明显成效。现就白银市2002-2008年结核病痰检质量控制结果进行总结分析。     

我国痰涂片镜检质量控制状况分析与评价

痰涂片镜检质量控制是国家结核病控制规划（ＮＴＰ）的重要内容。自１９９４年卫生部结核病控制中心拟定“痰检质控试行方案”以来,不断扩大质控覆盖面,逐步建立了以结核病细菌学实验室网为基础,以“国家级→省级→地（市）级→县级”实验室逐级督导为基本模式的质控系统。本文对１９９５～１９９９年全国痰检质控状况进行了分析。５年来痰涂片质控面由最初覆盖２０个省９８个县发展到１９９９年的３１个省１３３７个县,痰涂片阳     

甘肃省结核病痰涂片省对县室间质量控制结果分析

目的评价甘肃省各级结核病实验室工作质量,更好为结核病控制工作服务。方法按照《中国结核病防治规划痰涂片镜检质量保证手册》的要求,对各级结核病实验室进行室间质控,并对结果进行分析。结果2004—2007年省对县痰涂片盲法复检阳性符合率89.0%,阴性符合率99.7%,痰涂片的5项质量指标普遍低于国家标准,出现严重错误的实验室占39.4%,现场评价和批量测试结果均良好。结论室间质控的实施提高了甘肃省痰涂片复检符合率,改善了实验室的建设,提高了痰检人员的业务能力,室间质控更具科学性。     

江西省肺结核病痰检质量控制结果分析

目的 分析１９９５年江西省肺结核病痰检质量控制情况，方法 全省共抽查痰涂片９４２张，由省痰检质控人员按肺结核痰检质标准统一进行镜检复验。结果 镜检总符合率平均为９０％，痰涂片大小，厚薄，染色符合要求者分别为８６．０％，６７．１％，８２．８％项目县痰检工作的各项质量指标均高于非项目是。讨论 提高痰检质量，不但要提高镜检技术，更应提高痰片制作质量，并应参照项目县痰检质控措施制度实施。     

Establishment of external quality control program for hs-CRP and three-year follow-up of the performance for precision and accuracy

AIM: We established an external quality control (QC) program for high-sensitivity C-reactive protein (hs-CRP) for a collaborative epidemiological study.METHODS: External QC was performed 3 times in 3 years to follow hs-CRP performance for precision and accuracy.RESULTS: For precision, the mean coefficient of variation (CV) of the internal QC by 9 laboratories was 2.2% and 1.9% in the 1st and 2nd tests, respectively. The mean CV of the external QC by 4 laboratories was 2.7% in the three tests. The CV of both the internal and external QC satisfied the acceptable range specified by the AHA/CDC Scientific Statement, CV < 10%. For accuracy, the mean values of the 1st external QC by 9 laboratories were set as the consensus value and the acceptable range was set to within +/- 10% from it. The mean accuracy by 9 laboratories was 0.51% in the 2nd external QC. The mean accuracy by 4 laboratories was - 0.37% in the 3rd external QC. These findings demonstrated that the initial consensus value was valid in the continued external QC, and hs-CRP was stable for 3 years.CONCLUSION: We demonstrated both the precision and accuracy of hs-CRP by an external QC program applied for 3 years in a collaborative epidemiological study.     

Quality control in urinalysis

Quality control (QC) has been introduced in laboratories, and QC surveys in urinalysis have been performed by College of American Pathologist, by Japanese Association of Medical Technologists, by Osaka Medical Association and by manufacturers. QC survey in urinalysis for synthetic urine by the reagent strip and instrument made in same manufacturer, and by an automated urine cell analyser provided satisfactory results among laboratories. QC survey in urinalysis for synthetic urine by the reagent strips and instruments made by various manufacturers indicated differences in the determination values among manufacturers, and between manual and automated methods because the reagent strips and instruments have different characteristics, respectively. QC photo survey in urinalysis on the microscopic photos of urine sediment constituents indicated differences in the identification of cells among laboratories. From the results, it is necessary to standardize a reagent strip method, manual and automated methods, and synthetic urine.     

Quality control system for mass screening in Japan

Japan was the first country to establish a nationwide quality control system. When the Japanese Federal Government initiated Nationwide Neonatal Screening in 1977, the system officially included a Quality Control (QC) System that should cover all screening laboratories in Japan. This QC system is quite different from that for usual clinical chemistry. The aim of the National QC System for Neonatal Screening is evaluation of the accuracy of the tests and evaluation of the ability to detect suspicious samples with very mild abnormalities. For accomplishing the aim, the QC center established an inter-laboratory QC survey Screening laboratories having weak points can be identified through the inter-laboratory QC survey, and the Center must find a way to improve the ability of these screening laboratories. This requires a nationwide consensus regarding the cut-off levels of tested materials. Based on the cooperation of the Societies For Mass-screening, of Inborn Errors of Metabolism and of Pediatric Endocrinology, we set low cutoff levels for each compound to minimize the number of false negative cases. The system also included the evaluation of the quality of essential screening reagents and the special filter paper for blood collection (in partnership with the production companies). For this purpose, we developed some new methods for evaluating the standard-compounds for the various screening tests exactly, except in the case of TSH screening.     

新生儿全血TSH水平测定外部质量控制分析

目的配合１９９７年全国碘缺乏病监测工作,更好的完成新生儿脐带血ＴＳＨ水平测定,对全国省级实验室进行外部质量评定。方法分为ＥＬＩＳＡ、ＩＲＭＡ两种测定方法,２７个实验室中采用ＥＬＩＳＡ方法的有８个,采用ＩＲＭＡ方法的有１９个,评价指标为准确度和可比性。结果测定结果落在参考值范围内的省份,ＩＲＭＡ方法高、低浓度样品各有１６个、１４个,ＥＬＩＳＡ方法高、低浓度样品各有７个、５个;相对误差＜１０％的省份,ＩＲＭＡ方法高、低浓度样品分别为１５个、１３个,ＥＬＩＳＡ方法高、低浓度样品分别为５个、４个;并且多数省份的结果之间呈现较好的可比性。结论新生儿脐血ＴＳＨ水平测定质量还存在一定问题,我们应尽快建立统一的测定方法,加强技术培训和质量管理工作。     

Multi-laboratory evaluation of a scrub typhus diagnostic kit

Scrub typhus is a major cause of febrile illness throughout the Asia-Pacific region. It is commonly undiagnosed, partly because of the lack of a simple, reliable diagnostic test which can be used in clinical laboratories. The indirect immunoperoxidase technique, configured into a test kit, was provided to technicians who were trained in its use. They used the kit during a 2 year field trial in their respective clinical hospital laboratories throughout Malaysia. In an evaluation using 1,722 consecutive sera tested in those laboratories, the kit was found to have a median sensitivity for IgG detection of 0.85 (range 0.33-0.95), a median specificity of 0.94 (range 0.88-1.00), reproducibility of 0.86, and efficiency of 0.92 when compared to the reference laboratory. In a proficiency survey in which 10 laboratories received 3 coded test samples, all but 2 laboratories had results within 1 dilution of the reference laboratory in quantitating specific IgG, whereas 7 laboratories were within 1 dilution in quantitating IgM. The shelf life of the kit was at least 1 year at 4 degrees C.     

Quality control in a manual and an automated leukocyte differential count

Quality control (QC) has been introduced in laboratories, and QC surveys in leukocyte differential count to enhance quality have been performed by College of American Pathologists, Japanese Association of Medical Technologists, Osaka Medical Association and manufacturers. The results of QC survey in a manual leukocyte differential count indicated problems on the differentiation of segmented neutrophils and band neutrophils and the detection of pathological blood cells on blood smear. While the results of QC survey in an automated leukocyte differential count performed by same manufacturer with an automated blood cell counter were satisfactory, however, there was a difference in leukocyte differential cell counts among laboratories with other manufacturer's instruments because the synthetic blood material used in QC is an exclusive item for an instrument. It is necessary to further reeducate the medical technologists in order to improve morphological performance, and to standardize the synthetic blood material for compatibility with various automated blood cell counters.     

Impact of international laboratory partnerships on the performance of HIV/sexually transmitted infection testing in five resource-constrained countries

To review a quality control and quality assurance (QC/QA) model established to ensure the validity and reliability of collection, storage and analysis of biological outcome data, and to promote good laboratory practices (GLPs) and sustained operational improvements in international clinical laboratories, we conducted a two-arm randomized community-level HIV behavioural intervention trial in five countries: China, India, Peru, Russia and Zimbabwe. The trial was based on diffusion theory utilizing a Community Popular Opinion Leaders (CPOLs) intervention model with behavioural and biological outcomes. The QC/QA model was established by the Biological Outcome Workgroup, which collaborated with the Data Coordinating Center and John Hopkins University Reference Laboratory. Five international laboratories conducted chlamydia/gonorrhoea polymerase chain reaction (PRC)-based assays, herpes simplex virus type 2 enzyme immunoassay (EIA), syphilis serology (rapid plasma regain and Treponema pallidum particle agglutination assay, HIV serology (EIA/Western blot) and Trichomonas vaginalis culture. Data were collected at baseline, 12 and 24 months. Laboratory performance and infrastructure improved throughout the trial. Recommendations for improvement were consistently followed. Quality laboratories in resource-poor settings can be established, operating standards can be improved and certification can be obtained with consistent training, monitoring and technical support. Building collaborative partnership relations can establish a sustainable network for clinical trials, and can lead to accreditation and international laboratory development.     

The application of quality systems in ART programs

A quality control (QC) system is needed in ART units to assure reproducibility of all methods and competence in all duties performed by the personnel. The necessity of a quality control system becomes even clearer when considering the possible risks of ART. It is therefore essential to have a system to assure that everybody knows exactly how everything should be done. Furthermore, a QC system should bring about improvements such as making activities and procedures clearer to the staff and making the working methods more flexible. QC was initially created for the industry, and has later been applied to other types of activities such as management of organizations, services like health care including different types of clinical testing laboratories. To maintain a high standard in our IVF laboratory, and to assure reproducibility of the methods used we decided to apply for accreditation according to the European Norm (EN) 45001 and requirements for the competence of testing laboratories ISO/IEC Guide 25. A process was started where all routines and methods within the laboratory were documented and finally the QC system was described in a quality manual. Application for accreditation was submitted to the Swedish board for accreditation and conformity assessment (SWEDAC). Our ART laboratory finally became accredited according to the EN 45001 and requirements for the competence of testing laboratories ISO/IEC Guide 25. Introducing and fully implementing a quality control system in our laboratory has standardized the methods and the way that the embryologists perform their work in the laboratory. It has also optimized the environment in which the patient's gametes and embryos are handled.     

An international quality control programme for PRISM chemiluminescent immunoassays in blood service and blood product laboratories

Background Laboratories screening for blood‐borne virus infections in blood and blood products are required by international standards and guidelines to ensure that their testing processes remain within control. An effective means of ensuring this aim is through participation in a quality control programme. Analyses of results from a quality control (QC) programme conducted for the Abbott PRISM (PRISM) assays are reported. Materials and methods Laboratories participating in the National Serology Reference Laboratory, Australia's PRISM QC programme were provided with aliquots of a multimarker QC sample which were tested regularly in each PRISM subchannel. Test results were submitted to a single database using an Internet‐based QC monitoring system, EDCNet. The QC test results submitted between 15 October 2001 and 5 March 2006 for each PRISM instrument and each lot of PRISM reagent were analysed to determine the imprecision and bias in each test system. Results A total of 157 404 test results from approximately 47 000 test runs submitted into the EDCNet database were analysed. Six batches of the multimarker QC samples were tested in 454 PRISM reagent lots. The coefficient of variation of QC sample test results ranged from 9·17 to 15·83%, 8·29 to 9·44%, 10·50 to 15·38% and 7·05 to 10·32% when tested in the PRISM anti‐hepatitis C virus, anti‐human immunodeficiency virus, anti‐human T‐cell lymphotrophic virus and hepatitis B surface antigen assays, respectively. Analysis of QC test results reported from testing in the anti‐HTLV assay detected one lot of reagent (10572HN00) which was identified to be an outlier using Tukey's filter. Discussion Analysis of test results of an external QC sample can be used as a statistical process control through ongoing measurement of imprecision. When laboratories test the same QC sample in the same assay and submit test results to a single database, the results can be compared and a measure of bias can be calculated. The resulting QC programme can offer detection of unexpected variation in the testing processes and the source of variation investigated.