CAP实验室认可计划-临床病理中质量控制(中英文对照)课件.ppt

1、精品资料4 你怎么称呼老师？如果老师最后没有总结一节课的重点的难点，你是否会认为老师的教学方法需要改进？你所经历的课堂，是讲座式还是讨论式？教师的教鞭“不怕太阳晒，也不怕那风雨狂，只怕先生骂我笨，没有学问无颜见爹娘”“太阳当空照，花儿对我笑，小鸟说早早早”After this session,you will be able to:List key quality activities common to all lab sectionsDiscuss what constitutes compliance for these key quality activitiesTopic Ob通过这

2、次讲座,您将能够:了解在所有实验区通用的重要质量行为讨论什么为这些关键质量认证的行动制定标准讨论如何能够达到质量活动的要求演演讲讲Key QualitQuality ManagementProficiency TestingQuality ControlProcedure ManualsReagentsInstrument/Equipment MaintenanceCalibration/Calibration VerificationMethod Performance Specifications关关键键的的质量管理能力验证质量控制程序手册试剂仪器/设备的维护校准/校准验证方法学性能说明Q

3、uality MThe complex of activities that ensure that all pathology services have been accomplished in a manner appropriate to maintain excellence in patient care.质质量量质量行动的错综复杂，目的是确保完成所有的病理学方面的服务，并以一种适合的方式来表达对患者的关爱.Quality ManagemramDocumented operational plan,implemented as designedInvolves all aspect

4、s of the lab serviceQuality indicators monitored and evaluatedIncludes pre-analytic,analytic and post-analyticSystematic program to ID&correct problemsPhysician responsible for coordination with institutional QM programAnnually appraised for effectiveness质质量量管管理理文件化且可操作性的计划，并按计划实施包含实验室服务的所有的方面质量控制指标

5、的监控与评估包括分析前，分析中和分析后针对唯一标识和问题纠正的系统性计划医师负责医疗机构内QM计划的协调年度有效性评价Examples of Quaors Amount of blood used for testingCritical/panic value reporting processPreservation of specimen integrityFrozen vs.permanent section diagnosis质质量量控控制制检测所需用血量危急值的报告流程完整样本的防腐冷冻的 vs.永久的部分诊断Inspecting QuaentEach section has its

6、 own QM activitiesPeriodically changing monitors that cover entire spectrum of section activityFocused on potential problem areasCorrective action if benchmarks not metPhysician/patient satisfaction measuredPeriodic meetings for reporting,evaluation and planning检检查查质质每个部分都有自己的 QM 活动定期变更覆盖整个实验活动的监测指标

7、检查应集中在存在潜在问题的区域如果没有达到标准，要采取纠错措施医生/病人满意度调查定期应召开会议对结果报告，评估和计划的制定进行讨论QM:Common Is the QM program appraised at least annually for effectiveness?QM:是否至少每年对QM 计划的有效性进行评价?ProficiencExternal peer-comparison programCAP-approved PT required if availableAlternate PT if external not availableSplit sample testin

8、gTesting of known specimensClinical validation by chart reviewIntegrated with routine workloadEvaluation and corrective action能能力力验验证证外部同组值比对计划如果可以，需要参加CAP批准的PT如果没有CAP批准的PT，可采用替代性能力验证分割样本测试测试已知样本以图表回顾方式验证与临床的符合性能力验证的测试样本应整合到常规样本检测中评估与纠错措施Samples tested with patient samplesRotated among technologists

9、Frequency of failuresInvestigation of failuresCorrective actionAlternate PT at least twice yearlyDocumented review by DirectorPT样本和患者样本同样检测技术人员要轮岗PT失控的频率失控调查纠错措施替代评估至少每半年一次由主任进行文件审阅PT:Common For tests for which CAP does not require enrollment in PT,does the laboratory at least semiannually:1)partici

10、pate in external PT,or2)exercise an alternative performance assessment systemfor determining the reliability of analytic testing?PT:对那些CAP没有要求参加PT的测试,实验室须要求每半年一次:1)参与外部的 PT,或者2)执行替代性能评估系统来确定分析测试的可靠性?Quality CoQuantitative-2 levels Qualitative-positive/negativeExternalInternal-built-in(on-board),elec

11、tronic Documented system for every analyteInstruments,temperatures,etc.质质量量控控制制定量的-2 水平定性的 阳性/阴性外部的内部的 内置的(机上的),电子的 针对每个检测项目的文件系统仪器,温度等等InspecWritten QC policy/planDocumentation of reviews:Before reporting patient resultsSecondary review at least monthlyCorrective action documentedValidation of targ

12、et rangeDefined tolerance limitsStatistics,graphs,etc.,organized to detect problems检检查查成文的QC 政策/计划回顾的文件:在报告病人结果之前至少每个月必须进行一次再回顾纠错措施记录靶值范围的验证定义可接受限使用统计学,图表等来发现问题InspecDaily temperature charts(with acceptance ranges)for water baths,refrigerators,freezersMean,SD,and CV for control data calculated month

13、lyReviews documentedLevy-Jennings charts reviewedfor shifts/trends.Check“out of range”/troubleshooting logs检检查查水浴箱，冰箱和冷冻设备的日温度监控表(附可接受范围)月统计均值,SD和CV数据审核要记录对Levy-Jennings 图要审核其变化/趋势，检查 失控记录和故障记录QC:Common Secondary review of QC records:Is there evidence of of records of controls,instrument maintenance

14、 and function,temperature,etc.,for all procedures as required?QC:对QC记录的再次回顾:是否能提供质控记录,仪器维护保养记录,功能监测记录,温度监控记录等所有所须程序的证据?QC:Common For QUALITATIVE tests,is a positive and negative control included with each run of patient/client specimens?Issues:Internal controlsPermitted duration of a“run”QC:对定性测试,是否

15、每批病人/客户的样本中包括了一个阳性和阴性的质控?问题:内部控制批次的界定ProcedurPolicies and technical protocolsPre-analytic,analytic and post-analytic coveredThorough annual review by a knowledgeable personTechnical staff must be familiarAdequate document control system程程序序政策与技术方面的草案包含分析前，分析中与分析后由一位资深的人员进行全面的年度审核员工必须熟悉适当的文件控制系统Inspe

16、cting ProlsDocumentation of annual reviewScientific validityClinical relevanceDocumentation of staff reviewPractice matches policy/procedureReviewed by new Director检检查查程程文件年度审核记录科学有效性临床适应性员工文件学习记录操作和政策/程序吻合文件由新主任审核Manuals:CommyIs there documentation of at least annual review of all policies and proc

17、edures by the current laboratory director or designee?Issue:Documentation that procedure is reviewed手手册册:所有政策或程序由现任科主任或其授权人至少每年审核一次，是否有记录？问题:程序审核后都要有记录ReaLabelingContent&quantity/concentration/titerStorage requirementsDate prepared/reconstitutedExpiration datePrecautionary labeling of hazardsAll use

18、d within master lot numberValidation testing/acceptability criteriaParallel testing试试标签内容和数量/浓度/滴度储藏条件制备日期/复溶日期失效期危害警示标识所有使用的试剂有内部控制批号验证测试/可接受标准平行测试All reagents used within expiration dateParallel testing of new reagent lotsLabeling of secondary containersAppropriate storageLabeling of hazardous che

19、micals所有试剂必须在其效期内使用新试剂批号的平行测试次级容器的标签适当的储存危险化学品的标签Perform parallel testing of old and new lots by:Cross testing with kit controlsUsing suitable reference materialTest retained patient serums,positive and negative新旧批号试剂平行测试可通过:用质控品进行交叉测试使用适当的参考物质测试保留病人血清,阴性和阳性的Glassware certified or checkedAutomatic p

20、ipettes:Checked for accuracy&reproducibilityChecked at periodic intervalsThermometers certified or checkedTolerance limits for all temperature-dependent equipmentPeriodic speed checks for centrifuges有证的或检校合格的玻璃器皿自动加样器:检定精确度和重复性定期检校有证的或检校合格的温度计所有温度依赖的仪器的容许限定期检查离心机转速Inspecting InstrmentGlassware chipp

21、ed,cracked?Certified thermometerCertified weights for scalesSecondary review of temperature and maintenance recordsCorrective action documentedMaintenance/repair records kept:At instrumentFor life of instrument检检查查仪仪玻璃器皿有缺口,破碎了?已检定的温度计天平砝码检定温度和维护记录的二次审核记录纠错措施维护/维修记录保存:按仪器按仪器寿命Instrument/Equipment Ma

22、ion DeficiencyAre records maintained AT OR NEAR each instrument to document all repairs and service procedures?Issues:Immediate availabilityPresent for life of instrument仪仪器器/设设备备的的维维 记录是否放在每台仪器旁以便记录所有维修和服务的程序?问题:便于取阅显示仪器状态Calibration/nCalibration:Relationship between reagent system/instrument respo

23、nse and the corresponding concentration/activity values of an analyteCalibration verification:Confirmation that current calibration settings remain valid校校准准校准:试剂系统/仪器的反应与一种分析物相应的浓度/活性数值之间的关系校准验证:确认当前的校准设置的有效性Calibration/nCalibrate according to manufacturers instructionsCriteria for calibration veri

24、fication:At complete change of reagentsWhen indicated by QC dataAfter major maintenanceWhen recommended by manufacturerVerify Analytical Measurement Range校校准准根据生产商的说明校准校准确认的标准:当试剂完全改变的时候当 QC 数据指示需要时在大的仪器维护之后当生产商建议的时候验证分析测量范围Calibration/nCalibration verification materials:Materials provided by the ve

25、ndorPT or PT-validated materialPreviously tested patient materialPrimary standard or reference materialsCalibratorsFor Analytical Measurement Range,add:Linearity materials(matrix appropriate)Control materials(must span AMR)校校准准/校准验证物质:供应商提供的物质PT 或PT-有效的物质先前测试过的病人样本一级校准品或参考物质校准品对分析测量范围,附加:线性物质(适当的基质效

26、应)质控物质(必须含盖分析测量范围)Inspecting CalibracationThree levels-low,medium,highPatient results outside of AMR verified by dilution or alternate methodCriteria for Calibration Verification followedLab has acceptance criteriaManufacturers guidelines followedCorrective action documented检检查查校校准准三个水平 低,中,高病人结果超AM

27、R，通过稀释或改变方法确认遵循校准验证的标准实验室有可接受标准遵循厂家说明记录纠错措施Calibration/VerificaeficiencyIf the laboratory uses more than one instrument to test for a given analyte,are the instruments checked against each other at least twice a year for correlation of patient/client results?校校准准/校校准准如果实验室使用不止一台仪器对同一给定的分析物进行检测,是否至少每

28、半年进行病人/客户的结果比对?Method PerformantionsLab should have data for every tests:SensitivityPrecisionSpecificityInterferencesSource of data may be:ManufacturerPublished studiesLaboratorys own studies方方法法学学实验室需要有每种测试的数据:敏感性精密度特异性实验干扰数据来源可能是:厂商已发表的研究成果实验室自己的研究Method PerformantionsEstablished/verified referenc

29、e intervals(normal ranges)Comparisons:Between instrumentsBetween methods方方法法学学已建立的/验证的参考区间(正常值 范围)比较:各仪器间各方法间Method Performance Specifon DeficiencyHas the laboratory verified or established and documented analytic interferences for each test?方方法法学学性性能能实验室已经为每种测试项目建立或验证并以文件化形式规定了分析干扰了吗?ConclUnderstanding how to inspect for key quality activities that are common to all checklists will result in more consistent and efficient inspections结结理解怎样检查所有检查条款共性的关键质量活动将会使检查变得更加一致和有效。