《江西省医疗机构临床实验室管理办法实施细则》的说明

为了全面贯彻落实卫生部《医疗机构临床实验室管理办法》等文件精神,省卫生厅于2006年10月制定下发了《江西省医疗机构临床实验室管理办法实施细则》。     

实施《医疗机构临床实验室管理办法》探讨临床实验室管理的模式

目的全面贯彻执行落实《医疗机构临床实验室管理办法》，加强临床实验室建设和管理，探讨临床实验室管理的模式。方法按照《临床实验室管理办法》和“临床实验室资格认可制度》的管理要求，落实全面质量管理体系和ISO15189。结果（1）建立全面质量管理体系，提高检验质量的管理；（2）建立资格认可制度，规范临床实验室的管理；（3）临床实验室生物安全防护管理；（4）开展社会化服务，实行监督管理；（5）坚持以人为本和人性化管理；（6）临床实验室经济效益与社会效益的管理。结论落实《医疗机构临床实验室管理办法》，加强临床实验室建设和管理，规范临床实验室执业行为，保证临床实验室按照安全、准确、及时、有效、经济、便民和保护患者隐私的原则开展临床检验工作。检验医学应向《五化》发展，即标准化、自动化、信息化、人性化和临床化。     

浙江省临床实验室工作质量考核概况分析

浙江省医院检验科工作质量考核自1996年起已进入第4个周期（3年为1个周期），并从第2周期起开始分级管理。为落实《医疗机构临床实验室管理办法》，加强对浙江省医疗机构临床实验室的管理，切实提高临床检验水平，保证医疗质量和医疗安全，浙江省临床检验中心结合第3个周期的考核内容，参照《医疗机构临床实验室管理办法》的部分要求，重新修改和制定了《浙江省医院检验科工作质量考核细则》，并于2006对浙江省医院检验科的工作质量进行实地考核。     

临床生物化学检验的实验操作与能力量化考核方法

目前全国医疗机构临床实验室正在进一步贯彻卫生部2006年颁布的《医疗机构临床实验室管理办法》,将国际标准化组织指定的实验室标准化管理文件《医学实验室质量和能力的专用要求》(ISO15189)正式转化为中国的国家标准(GB/     

学习《医疗机构临床实验室管理办法》的几点体会

《医疗机构临床实验室管理办法》已于2006年6月1日起实施，这是半个世纪以来，国家针对临床实验室管理而制定的国家级的第一部规章，该管理办法的实施，标志着我国临床检验医学实验室的管理从科学化、标准化、规范化的管理方向发展，必将在检验医学界产生重大的有历史意义的影响。     

福建省《医疗机构临床实验室管理办法》执行情况的考核结果及分析

<正>《医疗机构临床实验室管理办法》(以下简称"办法")于2006年2月由卫生部颁发并要求从6月1日起实施,是临床实验室管理的基本依据和临床实验室准人的法规性文件。     

100所临床实验室工作质量考核概况分析

为了进一步落实卫医发[2006]73号文件关于《医疗机构临床实验室管理办法》文件精神,加强我省医疗机构临床实验室管理,切实提高临床检验水平,保证医疗质量和医疗安全,省临检中心按年度工作计划对全省95家公立医院检验科和5家民营医学独立实验室进行了实地工作质量考核。考核内容:主要按照《浙江省医院检验科工作质量考核细则》《医疗机构临床实验室管理办法》及其配套文件的要求制订的新考核标准。考核方法:通过查各类规章制度、质控记录、归档病历中的检验报告单,看实验室工作现场和现场质控物测试考核,并按工作任务、管理制度、检验质量保…     

依法加强院内医疗废物管理

医疗废物是指医疗卫生机构在医疗、预防、保健以及其他相关活动中产生的具有直接或间接感染性、毒性以及其他危害性的废物。医疗废物中含有大量的致病微生物，不仅污染环境，而且传播疾病。长期以来由于缺乏法律依据，使得一些医疗机构对医疗废物管理重视不够，处理不当。造成环境、空气的污染及噪音、实验室的污染。历经SARS后，国家对此予以高度重视，国务院和卫生部先后颁布了《医疗废物管理条例》和《医疗机构医疗废物管理办法》。使医疗废物管理纳入法制轨道。为了做到医疗废物规范化和制度化管理，我院相继制定和采取了一系列管理措施。现将其介绍如下。     

以医院管理年活动为契机,全面推动科室管理进程

2005年卫生部《关于开展“以病人为中心，以提高医疗服务质量为主题”的医院管理年活动方案》，拉开了医院管理年活动的帷幕。2006年6月1日《医疗机构临床实验室管理办法》开始实施；2007年2月，广西卫生厅下发了《广西壮族自治区医疗机构临床实验室考核评价标准》，下称《考核评价标准》。从2006年开始，广西卫生厅组织专家对全区2级以上医院的管理年活动进行了3次检查和督导，临床实验室作为重点之一，按照《考核评价标准》也接受了相应的检查和督导。     

临床基因扩增检验实验室技术审核中存在的问题分析

聚合酶链反应（PCR）应用初期因规范性问题,曾被全面暂停在临床应用。经过PCR技术工作规范的制订和技术人员培训,卫生部于2002年出台《临床基因扩增检验实验室管理暂行办法》和《临床基因扩增检验实验室工作规范》,重新向临床开放PCR检测项目。2010年卫生部出台《医疗机构临床基因扩增检验实验室管理办法》,加强对临床基因扩增检验实验室的管理。     

A survey of quality indicator use in the clinical laboratory.

OBJECTIVE: A survey of clinical laboratories was conducted to capture information about quality indicators in use within the state of Arizona. This information was then used to determine which quality indicators are applicable across the spectrum of clinical laboratories making them suitable for benchmarking laboratory performance. The objectives of this study were also to heighten awareness of benchmarking practices for clinical laboratory managers and laboratory quality assurance personnel, to develop objective methods of quality monitoring for performance improvement, and to encourage collaboration between laboratories and accreditation agencies. METHODS: A review of the current literature was conducted to assess the status of benchmarking within the clinical laboratory. Data were also obtained from the Centers for Medicare & Medicaid Services (CMS) about all licensed clinical laboratories in Arizona. A mail survey was then created and conducted to investigate the use of clinical laboratory quality indicators in Arizona. SETTING AND PARTICIPANTS: A paper survey was mailed to a representative sample of clinical laboratory managers included in the CMS licensed laboratories listing for the state of Arizona. MAIN OUTCOME MEASURES: The selected sample was surveyed by mail and validation testing of the survey was conducted using the t-test. The compiled survey data is also presented in the form of histograms. RESULTS: Applying the t-test to the sample vs. population data proved that the sample was not a very good representation of the population and a better selection method should be used in future studies. Of the 319 of 3198 clinical laboratories randomly selected to receive the survey, 21 (6.58% of the sample or 0.66% of the population) responded with completed surveys. The information received from the respondents revealed a relationship between test volume and the number of indicators being monitored by clinical laboratories, the preference of indicators being monitored by those laboratories, the size of the laboratories where the majority of benchmarking is occurring, and a link between accrediting agencies and benchmarking activities. CONCLUSION: The survey proved that quality indicators are used for quality improvement purposes within the clinical laboratory; although it also showed that the industry still does not have a standardized approach to the use of quality indicators for benchmarking performance against other laboratories.     

广东省凝血酶原时间测定的室间质量评价

目的 探讨广东省临床实验室监测凝血酶原时间（PT）的检测状况及影响PT测定室间可比性的因素.方法 通过每年两次定期向全省参评实验室寄发质控样品（每次5个样品）,然后对其回报的数据进行统计分析,作出实验室检验水平的评价.结果 近年来全省实验室间PT（INR）测定结果的CV值尽管有逐渐下降的趋势,但室间变异仍然相当高.同一凝血活酶试剂的测定结果,PT（INR）的CV明显大于PT（sec）的CV,特别是对异常水平质评物的测定.结论 凝血活酶试剂敏感度指数（ISI）值标定的不准确性和INR计算不正确的是引起广东省临床实验室间凝血酶原时间测定变异大的主要原因.     

A national survey on pediatric critical values used in clinical laboratories across Canada

ObjectiveNotification of critical values to clinical staff is an important post-analytical process in all acute care clinical laboratories. No data are available however on how laboratories obtain or establish critical values, particularly in pediatric settings. This study was designed to examine and compare critical values used for pediatric patients in biochemistry laboratories in Canada and assess potential interlaboratory variability.Design and methodsFourteen clinical laboratories, including two in pediatric hospitals and twelve in hospitals caring for both children and adults, participated in a survey that included 14 pre-selected STAT chemistry tests and 19 pre-selected therapeutic drug monitoring (TDM) tests.ResultsAmong fourteen chemistry tests, good agreement was observed for critical values used for sodium and pH at both low and high levels within 14 participant laboratories. Significant interlaboratory variability existed for glucose critical values at the high end, magnesium at high end, and PO2 at the low end. For 19 TDM tests, the majority of laboratories did not have alert values to report values over the therapeutic level but not toxic. For critical values greater than the toxic range, significant variability existed at both trough and peak levels among laboratories surveyed. When asked to provide the source for critical values established at each site, only a limited number of laboratories identified their sources as either internal decision or published references.ConclusionAlthough all laboratories have established and routinely use critical values to alert clinical staff, considerable variability exists in both the critical limits reported as well as the source of such values. There is a clear need for new national efforts to standardize pediatric critical value reporting and establish evidence-based critical limits for all medical laboratories across Canada.     

HCV RNA RT—PCR测定室间质量评价的研究

目的 建立国内ＨＣＶ ＲＮＡ ＲＴ－ＰＣＲ测定的室间质量评价系统。方法：室间质量评价研究工作采用的质控血清盘由１０支冻干质控血清组成，其中包括２份强阳性、２份弱阳性，２份阴性和一个５倍位比稀释系列（４份），将血清盘寄发给各类评实验室并要求各个实验室按照规定时间检测，回报结果，然后对结果进行统计分析。结果 多数参评实验室存在不同程度的假阳性和假阴性的问题。２份强阳性标本检出率均为８７．５％，弱阳性标     

上海市及其他地区临床实验室B 族链球菌核酸检测室间质量评价分析

目的 通过开展B 族链球菌（group B Streptococcus,GBS）核酸检测室间质量评价计划（简称室间质评）,评价参评实验室检测能力,分析存在的问题,提高检测质量。方法 2021 年GBS 核酸检测室间质评计划为一年两次,每次质评计划样本盘包含4 支由灭活的GBS 培养液稀释而成的不同浓度阳性样本和1 支阴性样本。样本冷链寄送至各参评实验室,并要求其在规定时间内按要求检测并回报结果,依据回报结果计算各实验室成绩,汇总不同样本的总体符合率。结果 2021 年两次室间质评分别有33 家实验室报名参加,收到有效报告31 份和32 份。所有实验室室间质评成绩均合格,两次结果完全正确的实验室分别有87.10%（27/31）和96.88%（31/32）,样本的总体符合率为97.42%（151/155）和99.38%(159/160)。结果汇总中共出现检测错误5 例,错误类型集中表现为假阴性。结论 各参评实验室GBS 核酸检测能力总体较高,个别实验室检测能力尤其是弱阳性样本检测能力有待提高。通过参加室间质评计划能帮助实验室及时发现问题并持续改进以提高检测质量。     

Testing for maternal cell contamination in prenatal samples: a comprehensive survey of current diagnostic practices in 35 molecular diagnostic laboratories

The potential presence of maternal cell contamination (MCC) in chorionic villus or amniotic fluid samples poses a serious preanalytical risk for prenatal misdiagnosis. The aim of this study was to identify current diagnostic practices in the absence of comprehensive practice guidelines. Thirty-five clinical molecular laboratories that conduct prenatal testing agreed to participate in a clinical practice survey. The survey included questions about sample requirements, test indications, assay type, test performance and limitations, criteria and management of uninformative test results, reporting, and billing. Sixty percent of participating laboratories performed testing on direct and cultured amniotic fluid, whereas forty percent tested cultured cells only. Most also accepted chorionic villus samples. Although MCC testing of fetal samples is recommended in guidelines by the American College of Medical Genetics, only 60% of surveyed laboratories performed it without exception. Commercially available assays were used by 75% of participating laboratories, and at least five identity markers were evaluated at 87% of the laboratories. The reported lower limit of MCC detection ranged from 1 to 20% but was not determined in all laboratories. MCC testing was performed in the majority of molecular diagnostic laboratories, but guidelines for standardization are needed to ensure optimal and accurate prenatal patient care.     

检验科键盘、鼠标、门把手、电话的微生物监测结果分析

目的通过调查检验科的键盘、鼠标、门把手、电话的微生物分布情况,及时找出存在的问题,减少医院感染的发生。方法对检验科各实验室及其办公室的键盘、鼠标、门把手、电话进行微生物监测,并对其结果进行分析。结果 101份标本中62份有细菌、真菌生长,键盘和鼠标的微生物检出率最高,其次是电话机,门把手的检出率较低。其中又以临床基础检验室和临床生化检验室的细菌、真菌检出率高,临床微生物检验室和血液检验室较低。结论检验科的键盘、鼠标等存在较严重的污染,其工作人员应重视电脑键盘、鼠标、电话机及门把手的定期清洁、消毒,并做到先洗手后操作,将医院感染的危险因素降到最低水平。     

福州市17家临床实验室新鲜血样本飞行调查结果分析

目的了解福州市17家临床实验室检验结果的一致性,分析医疗机构当前状况及临床检验结果互认中应该关注的几个问题,为我省实行检验结果互认提供依据。方法按临床生化、临床免疫、临床血液专业分别送组值不同的血样本5份至17家医院检验科,要求与临床标本同时检测,采用福建省室间质量评价PT方案对比对结果进行统计分析。结果临床生化20个项目中TBIL、DBIL、Cr的一致性较差。临床免疫项目AFP、CEA、FT3、FT4的检测结果离散度较大,CV值在11.79%~44.63%。临床血液项目的 CV值较小,6个项目PT成绩〉80%的单位数均为100%。结论以加强监督管理为前提,以建立参考系统、进行量值溯源及统一校准工作为保证的检验结果互认才具有现实意义,真正起到惠民减负的作用。     

Investigation of the quantitative detection of serum Helicobacter pylori antibody in clinical laboratories in China

BackgroundThis study aimed to investigate the implementation and quality control of the quantitative detection of serum Helicobacter pylori (H. pylori) antibody in clinical laboratories in China.MethodsOnline external quality assessment (EQA) questionnaires were distributed to the clinical laboratories by National Center for Clinical Laboratories (NCCL) of China. We collected information on the quantitative detection procedures of serum H. pylori antibody in clinical laboratories, including detection reagents, methods, instruments, calibrators, and internal quality control (IQC). We distributed quality control products to some select laboratories that conducted quantitative detection and analyzed the obtained test data. We evaluated the quantitative detection procedure based on the standard evaluation criteria set at a target value of ±30%.Results70.9% (146/206) of the laboratories conducted quantitative detection of H. pylori antibody; 29.1% (60/206) of the laboratories performed qualitative detection. Domestic reagents and matching calibrators accounted for more than 97.1% (200/206) of all reagents. Latex‐enhanced immunoturbidimetry was used in 89.7% (131/146) of the laboratories for quantitative determination, while the colloidal gold method was used in 66.7% (40/60) of the laboratories for qualitative determination. A total of 130 laboratories participated in the EQA; 123 completed the assessment, and the pass rate was 75.6% (93/123).ConclusionClinical quantitative detection of serum H. pylori antibody is performed at a high rate in China. Thus, further studies on the specificity of commercial detection reagents are needed. EQAs are useful to monitor and improve the detection quality of H. pylori antibodies.     

The problems and strategy relevant to the quality management of clinical laboratories.

AIM: This study is aimed to discuss the present situation, existing problems, and relevant measures concerning the management of clinical laboratories in China. METHODS: This study was carried out through the analysis of the problems relevant to the quality management of the laboratory medicine, based on the advanced experiences of ISO and developed countries in the management of clinical laboratories. RESULTS: Many problems still remain unsolved concerning the quality management of clinical laboratories. CONCLUSION: Only legalized and standardized management guarantees the quality of clinical inspection.