重庆市卫生微生物检验室间质量评价

微生物检验为疾病预防控制和卫生监督及时准确地提供检验数据是卫生防疫工作的重要组成部分。室间质评是提高微生物实验室总体水平的重要手段。重庆市卫生防疫站于1997年10月和2000年11月分别进行了全市各级卫生防疫机构微生物检验室间质量评价,现就1997-2000年的室间质评结果总结分析的如下:1 材料与方法1.1材料1.1.1 质控菌株 质控菌株分别为金黄色葡萄球菌、表皮葡萄球菌、鲍志贺菌Ⅰ型、鲍志贺菌Ⅱ型、鼠伤寒沙门菌、肠炎沙门菌、肠出血性大肠埃希菌O157:H7、致病性大肠埃希菌、副溶血性弧菌、非O1;霍乱弧菌共10株菌。质控菌株均为标准菌株。     

水中硫酸盐的室间质量评价结果分析

笔者对江苏省疾病预防控制中心发放的质控水样，采用离子色谱法测定水中硫酸盐，其分析结果报告如下。     

河南省计划生育系统临床实验室室间质量评价资料分析

目的:对2010-2011年两次河南省人口计生系统参评县临床实验室室间质量评价结果进行分析,以提高临床实验室检测质量和技术服务能力。方法:按照全血细胞计数、常规化学、免疫学3个专业每年发放质控标本50份,分两次测定,对汇总结果进行统计分析。结果:2011年各个项目PT成绩和及格率较2010年均有明显提升。结论:经过省级分中心指导和开展室间质评管理,使各参评县检测质量得到有效提升,质量评价活动促进了实验室的检测质量和水平。     

微生物实验室室间质量控制的研究

[目的]开展微生物检测实验室室间质量控制并作评价。[方法]（1）应用估草杆菌黑色变种芽胞污染滤纸片，卫生纸，纱布和棉花等4类物品，作为菌落计数和初始污染菌检测盲样，取金黄色葡萄球菌，大肠埃希菌，志贺菌和沙门菌等6株菌制备混合菌种管，混合菌种管为3株菌，按大肠埃希菌为98.5%-99.0%，其他菌1.0%-0.5%的比例混合，采用两种营养琼脂配方制备干燥培养基盲样。（2）盲样随机组合排列，每个实验室承担3-4项盲样检测。（3）根据检测报告和原始记录等综合考核评分。[结果]微生物实验室盲样报告综合评分，按时报告分值除外，质量检测单位平均为75.41分，医疗单位64.80分。医疗用品企业56.26分。36家实验室盲样检测结果表明；菌落计数符合允许误差范围有16家（44.4%)，初始污染菌符合允许误差范围为14家（38.9%)。26份微生物菌落数高于国家标准的盲样检测，有9份（34.6%)样品被错判为合格产品，混合菌种管鉴定合格率为85.7%。[结论]只有建立或完善规范的微生物实验室室内质量控制体系。才能真正提高微生物检测质量。     

全国新生儿疾病筛查室间质量评价回顾

目的:回顾2008~2011年参加卫生部临床检验中心组织的新生儿疾病筛查项目室间质评结果并分析,以了解该项目质控质量。方法:采用酶标法与时间分辨法进行12批60份TSH、Phe样本检测。结果:定量结果评价:60份质评样本中,59份TSH测定值和60份Phe测定值偏倚在允许范围内,1份TSH测定值偏倚≥30%为失控。定性结果评价:60份质评样本中,59份TSH定性反馈结果和60份Phe定性反馈结果通过,1份TSH反馈结果未通过定性判断,符合率分别为98.3%(TSH)和100%(Phe)。结论:回顾分析4年来参评项目数据,对于整体质控工作及科学管理检测质量的提高具有指导价值。     

卫生微生物实验室间质量评价的探讨

[目的]分析评价广东省2001～2003年疾控机构卫生微生物实验室间比对试验结果,及时发现问题,提出改进意见;并探讨一套较科学、较客观的室间质量评价方法。[方法]广东省疾病预防控制中心于2001-2003年每年组织全省各级疾控机构进行卫生微生物实验室间比对试验,并针对卫生微生物检验的特点及全省各机构的情况,遂年调整试验项目、试验难度、评价方法,对三年情况进行评价分析。[结果]2001-2003年共有245个(次),单位参加比对试验,84.1%(206/245)的单位考核成绩满意(80～100分);比对试验结果显示,80.9%(55/68)的省市单位考核成绩居于全省平均水平之上(SI≥0),与县区(65.0%,115/177)相比,差别有显著性(P<0.01);珠江三角洲地区88.4%(76/86)的市县单位SI≥0,与珠三角以外地区(59.1%,94/159)相比,差别有显著性(P<0.01)。[结论]广东省卫生防病检验机构卫生微生物实验室总体检测能力较高,但分布不均匀,部分检验机构技术质量水平有待提高。评价方法也有待改善,力争摸索出一套科学、客观的卫生微生物实验室间质量评价方法。     

临床化学检验室间质量评价结果分析

目的分析参加卫生部临床化学检验室间质量评价的结果,控制实验的准确度,减少系统误差,提高检验质量。方法根据卫生部临床检验中心室间质量评价活动评价标准:能力比对检验(PT)总平均成绩≥80%为合格,<80%为不合格;变异指数得分(VIS)总平均成绩≤80分为优秀,80150分为不合格;对医院检验科8年参加卫生部临床检验中心室间质量评价活动共100批次的质量控制血清进行统计分析。结果通过参加卫生部临床检验中心室间质量评价活动,生化检验质量成绩逐年提高。结论参加室间质量评价活动对提高检验科的检验质量和管理水平有重大作用。     

2017-2019年全国临床检验中心室间质量评价结果分析

目的 对安康市中心医院2017-2019年参加全国临床检验中心室间质量评价结果进行总结分析,探讨临床实验室检测的准确性和可比性,持续提高临床实验室检测能力和质量管理水平.方法 依据全国临床检验中心室间质量评价活动安排,对各个参评项目使用常规检测方法在规定时间内完成检测工作,并通过网络形式报告检测结果,及时对回报结果进行...     

2005年-2010年浙江省全血细胞计数室间质量评价结果分析

临床实验室检验结果在临床诊断、治疗、观察病情等过程中具有重要作用。临床检验室间质量评价(external quality as-sessment,EQA)通过多家实验室分析同一样本,在实验室间建立可比性,对实验室的检验质量进行评价与监督,提高了实验室识别检测误差的能力,对保证临床检验的准确性和一致性起了积极的作用,同时为实验室间结果的互认提供依据。2006年的《临床实验室管理办法》明确规定实验室必须参加     

临床血液分析室间质量评价五年结果分析

目的通过对五年中血液分析室室间质量评价结果分析,总结多年来此项质量控制的失控的原因和在控的经验。方法按照黑龙江省临床检验中心检测的要求,每年十个质控品分不同时间两次规范测定,然后进行系统分析。结果 2007年血液分析室间质评统计结果,全年总成绩为100%,(注:2007年血液质控品有凝集现象,临检中心取消了部分结果,参与的实验室基本都评为优秀。)2008年总成绩为96%,2009年总成绩为96.5%,2010年为82%,2011年总成绩为94%。结论结果分析表明临床血液学的质量控制准确与否与实验室的全面质量管理的每一个环节都息息相关,这就要求我们要完善实验室的质量管理工作,提高检验人员的业务素质,杜绝一切可能影响质量的不利因素,以提高检验质量的准确度与精密度。     

做好室间质评 提高检测水平

目的 通过参加室间质量评价活动,了解某科室的检测水平,找出存在的问题并加以改进,努力提高实验室的检测水平.方法 对某科室2007～2010年参加全国采供血机构和广西区血液监测中心血液检验室间质量评价结果做回顾性分析.结果 卫生部临床检验中心室间质量评价血型准确率100％,失分最多的是ALT,其次是抗-HIV、HBsAg和抗-HCV.广西区血液监测中心室间质量评价HBsAg、抗-HCV、抗-TP、抗-HIV各有一次失分.结论 提高检测人员的检测水平,加强责任心,使用先进的检测仪器和质量好的试剂,才能在室间质评中取得优异成绩.     

体外诊断产品准确度评估方法的变化

准确度是体外诊断产品的一项重要性能,然而其从历史上以不同含义在使用,产生了模糊与混淆。随着VIM和ISO 18113的发布,准确度的定义进一步清晰,同时准确度的评估方法由传统上的误差方法到当前基于测量结果不确定度的方法,我国体外诊断产品国家标准和行业标准中准确度试验方法的改进也表明行业内逐渐明确该定义。     

Effects of dependent errors in the assessment of diagnostic test performance

Latent class models can be used to assess diagnostic test performance when there is no perfectly accurate gold standard test available for comparison. These models usually assume independent errors between the tests, conditional on the true disease state of the subject. Maximum likelihood estimates of the prevalence of the disease and the error rates of diagnostic tests are then obtained. This paper examines the impact of error dependencies between binary diagnostic tests on the parameter estimates obtained from the latent class models. The independence model often gives parameter estimates having relatively small bias, but in some situations (for example, when disease prevalence is low and the tests have low specificity, such as in population screening) the bias may be more serious. © 1997 John Wiley & Sons, Ltd.     

Use of three-valued logic to enhance the stability of interpretation algorithms in medical diagnostic devices

The procedure proposed for converting the binary production principles to the three-valued form, the relationship found between the well-known three-valued logic networks, and the particular properties of three-valued logic expressions permit introduction of the mechanisms that are responsible for three-valued production principles and the construction of logic conclusions by the results of this variation. The apparatus designed ensures a higher stability of ECG interpretation without lowering its efficiency and makes it possible to estimate the quality of interpretation by the capacities of the apparatus itself.     

Use of diagnostic imaging procedures and fetal monitoring devices in the care of pregnant women

Medical devices and diagnostic imaging procedures such as ultrasound, X-rays, and electronic fetal monitoring devices are used in the medical care of many pregnant women today. The responsibility for the safety and effectiveness of these diagnostic technologies is shared by a number of Public Health Service agencies, one of which is the Center for Devices and Radiological Health (CDRH), a unit within the Food and Drug Administration. The CDRH collaborated with the National Center for Health Statistics (NCHS) in conducting a study of recent trends in the uses of diagnostic ultrasound, medical X-rays, and electronic fetal monitoring devices in the medical care of pregnant women. This study used data from the 1980 National Natality and Fetal Mortality Surveys and the 1987 pretest to the National Maternal and Infant Health Survey. Hospitals and prenatal care providers of the pregnant women contributed information regarding the use of these medical devices. Between 1980 and 1987, ultrasound use more than doubled, increasing from 33.5 percent of pregnancies in 1980 to 78.8 percent in 1987 (P less than 0.001). More ultrasound examinations were performed earlier in gestation in 1987 than in 1980, with 10.1 percent being performed during the first trimester in 1987, compared with 6.9 percent in 1980 (P less than 0.001). Use of external electronic fetal monitoring devices during delivery also increased significantly between 1980 and 1987, from 33.5 percent to 74.6 percent (P less than 0.001). Use of medical X-rays among women with live births remained relatively unchanged, 15.0 percent in 1980 and 15.3 percent in 1987 (P = .282). The implications of these trends are discussed.     

The WHO international external quality assessment scheme for haematology

Quality assurance is essential in laboratory medicine; an important component is external quality assessment in order to ensure that reliable performance is achieved by all laboratories and that between-laboratory comparability is maintained. In a number of countries there are national external quality assessment schemes. WHO has established a programme aimed at encouraging the organization of similar schemes in all countries. Towards this goal an international external quality assessment scheme has been established for each of the specialities of haematology, clinical chemistry, microbiology and parasitology.     

Evaluation of Thailand national external quality assessment on HIV testing

PURPOSE: The Thailand National Institute of Health (NIH) established an external quality assessment (EQA) scheme on HIV serology testing since 1994 for many public health laboratories. For the past six years, the NIH has evaluated the activities of 226 laboratories. DESIGN/METHODOLOGY/APPROACH: Approximately 40,000 tests using 16 trial samples of external quality assessment panel performed at 226 laboratories during 2000-2006. The methods performed were classified into five assays; machine-based enzyme immunoassay (MBA), microplate-based enzyme immunoassay (EIA), simple/rapid test and antigen assay only performed at blood screening laboratory centers. A few laboratories performed confirmation method by western blot (WB). Most participating laboratories performed at least two methods. FINDINGS: The evaluation showed that, during the six-year period, the program had an increasing response rate among all groups of laboratories: government hospital laboratories, private hospital and clinic laboratories and blood screening laboratory centers. Moreover, there were no significantly different errors found between these groups. The highest median percent of overall errors found was in antigen assay. Very minimal errors appeared on other methods. ORIGINALITY/VALUE: National HIV EQA program has played an important role in improving the quality of participating laboratory performance. The participating laboratories gained a better understanding and were able to use good quality anti-HIV approved kits. Furthermore, HIV serology testing selection was varied over the past six years as microplate-based EIA was mostly used in the past but currently MBA and simple/rapid test are more commonly used. The test methods were determined by test volumes and budget. In addition, sensitivity was one critical reason labs chose to use EIA. The most popular method used was simple/rapid testing. Overall errors occurred with all assays but not with WB. Errors could occur with any test techniques if good quality management is not employed.     

体外诊断试剂有效管理与质量安全控制的探讨

体外诊断试剂作为一种特殊的医疗诊断药品已广泛的应用于医学的科学研究和临床检验,由于目前相关法规执行力度不够和监管措施不到位而造成医院在体外诊断试剂的使用管理上存在某些问题,因此只有对体外诊断试剂进行有效管理与质量安全控制,才能够对试剂的规范、安全使用起到监控作用,有效提高体外诊断试剂的质量安全,为临床检测结果的准确性、稳定性提供保障。落实对体外诊断试剂的有效管理和质量安全控制。     

A proposal for harmonising laboratory performance assessment criteria in national asbestos fibre counting schemes

Four European national asbestos fibre counting proficiency testing schemes have been studied in order to compare their criteria for the assessment of laboratory performance. Performance assessment is based on each laboratory's results after counting a certain number of samples. Two methods are currently being applied. To be classified 'satisfactory' laboratories must obtain at least 75% of normalised counts lying within defined performance limits (in three schemes), or the median and coefficient of variation of normalised counts must be within performance limits (in the fourth scheme). Differences in the numbers of test samples mean that the schemes are operating with different selectivity in assessing their laboratories' performances. Differences in the percentage of laboratory results falling within performance limits indicate that the schemes do not operate the same confidence probability in correctly assessing individual counts. It means that some schemes may be more lenient than others. This paper discusses two proposals to move towards harmonisation of the asbestos fibre counting proficiency testing schemes: (i) standardisation of the number of samples used for laboratory assessment and (ii) changes to the criteria to establish the limits of satisfactory performance.