ISO15189認可和CAP認證的流程和體會(44張)課件

1、ISO15189認可和CAP認證的流程和體會2013.11.08*1第1頁，共45頁。一、為什么要做？二、認證認可差別三、體系建立和檢查手段四、申請流程和體會第2頁，共45頁。HELP ! FREE3一、為什么要做？第3頁，共45頁。為什么不想做？據(jù)說 聽說 傳說文件工作多學習任務(wù)重硬件達不到要求軟件達不到要求只按部分要求做，不評4第4頁，共45頁。推動的因素外部：國內(nèi)：優(yōu)質(zhì)醫(yī)院、等級醫(yī)院、衛(wèi)生部重點?？圃u審。國外：JCI (Joint Commission on Accreditation of Healthcare Organizations ,JCAHO) ，CAP（ College o

2、f American Pathologist）內(nèi)部：自身發(fā)展的需要、自重、自尊。5第5頁，共45頁。歸根到底：高品質(zhì)醫(yī)療服務(wù)的需要質(zhì)的需要：深度提供項目的質(zhì)量量的需要：廣度覆蓋面（提供多少項目、服務(wù)人群、對口支援單位）6第6頁，共45頁?；貧w到正確的服務(wù)軌道上過去：體系不完善、服務(wù)質(zhì)量有待提高現(xiàn)在：提倡服務(wù)對象至上、服務(wù)契合對象需要7第7頁，共45頁。實驗室如何證明自己的能力 第一方證明-自我聲明 第二方證明-客戶的證明 第三方證明-公正權(quán)威的證明 8第8頁，共45頁。浙二醫(yī)院檢驗科ISO15189 初次評審2012.4.23-25 現(xiàn)場評審2012.9.29 獲得認可（編號121） CAP

3、（Laboratory Accreditation Program, LAP)2013.7.10-12 現(xiàn)場評審2013.9.10 獲得認證（中國大陸第6家公立醫(yī)院）ISO15189 監(jiān)督擴項評審2013.10.11-13 現(xiàn)場評審9第9頁，共45頁。醫(yī)學實驗室ISO 15189CAP（LAP)評審機關(guān)各國認可機構(gòu) （官方）中國CNAS美國病理學協(xié)會（第三方）應(yīng)用法律本地法律弱化但地區(qū)法律法規(guī)適用強調(diào)美國法律所要求的技術(shù)水準國際性技術(shù)水平美國技術(shù)水準評審原則自愿，專家評審自愿，專家評審費用相對便宜略貴認可周期3年2年國內(nèi)已經(jīng)獲得認可或認證的醫(yī)學實驗室132家23（其中公立醫(yī)院6家，其它為跨國醫(yī)

4、藥公司或第三方實驗室）10背景簡介第10頁，共45頁。認可認證依據(jù)ISO15189CAP(LAP)ISO17025:檢測和校準實驗室能力的通用要求。ISO15189:醫(yī)學實驗室質(zhì)量和能力的專用要求CLIA 88（美國臨床實驗室改進修正法規(guī)88 ） CLSI（美國臨床和實驗室標準協(xié)會）11第11頁，共45頁。二、認證認可差別Certification Accreditation認證認可中華人民共和國國務(wù)院令(第390號) 中華人民共和國認證認可條例年月日起施行。 總理 溫家寶 第一章 總 則 第二條 本條例所稱認證，是指由認證機構(gòu)證明產(chǎn)品、服務(wù)、管理體系符合相關(guān)技術(shù)規(guī)范、相關(guān)技術(shù)規(guī)范的強制性要求

5、或者標準的合格評定活動。 本條例所稱認可，是指由認可機構(gòu)對認證機構(gòu)、檢查機構(gòu)、實驗室以及從事評審、審核等認證活動人員的能力和執(zhí)業(yè)資格，予以承認的合格評定活動。ISO/IEC 導(dǎo)則2 一個第三方（認證機構(gòu)）對（一個組織的）產(chǎn)品、過程或服務(wù)符合規(guī)定的要求給出書面保證的過程是權(quán)威機構(gòu)對某一組織或個人有能力完成特定任務(wù)做出正式承認的程序 12第12頁，共45頁。發(fā)個證先，你們符合結(jié)婚的條件13第13頁，共45頁。區(qū)分重點誰組織檢查：第三方還是權(quán)威機構(gòu)？檢查是體系要求符合性認定還是能力的認定？區(qū)別是建立在有一定內(nèi)涵聯(lián)系基礎(chǔ)上CAP 英文中稱Accreditation14第14頁，共45頁。ISO I51

6、89 實驗室文件體系 質(zhì)量手冊 程序文件項目操作指南（SOP) 各種記錄ISO15189:2007醫(yī)學實驗室-質(zhì)量和能力的要求CNAS-CL02：2008醫(yī)學實驗室質(zhì)量和能力認可準則ISO15189:2012醫(yī)學實驗室-質(zhì)量和能力的要求于2012年11月1日發(fā)布。國際實驗室認可合作組織（ILAC）要求各國認可組織于2016年3月1日前完成標準轉(zhuǎn)換工作。準則核查表2013.4.1實施的專業(yè)組核查表15三、體系建立和檢查手段第15頁，共45頁。CAP 實驗室文件體系 QMP PolicyStandard Operation Procedure,SOP RecordsCLIA 88美國臨床實驗室改進

7、修正法規(guī)88 Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. 2003 CDC and CMS modifiedCLSI美國臨床和實驗室標準協(xié)會Clinical and Lab

8、oratory Standards Institute is a volunteer driven, membership supported, nonprofit, standards organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.CAP3000 Checklist 16第16頁，共45頁。評審依據(jù)的內(nèi)容ISO 15189CAP (LAP)依據(jù)CNAS-

9、CL02準則醫(yī)學實驗室質(zhì)量和能力認可準則自查/核查表2013.4.1實施的專業(yè)組核查表（LIS)3000 條Checklist內(nèi)容4 管理要求4.1 組織和管理4.2 質(zhì)量管理體系4.3 文件控制4.4 合同的評審4.5 委托實驗室的檢驗4.6 外部服務(wù)和供給 4.7 咨詢服務(wù)4.8 投訴的處理4.9 不符合項的識別和控制4.10 糾正措施4.11 預(yù)防措施4.12 持續(xù)改進4.13 質(zhì)量和技術(shù)記錄4.14 內(nèi)部審核4.15 管理評審5 技術(shù)要求 5.1 人員5.2 設(shè)施和環(huán)境條件5.3 實驗室設(shè)備5.4 檢驗前程序5.5 檢驗程序5.6 檢驗程序的質(zhì)量保證5.7 檢驗后程序5.8 結(jié)果報告1

10、7第17頁，共45頁。4.1.5實驗室管理層應(yīng)負責質(zhì)量管理體系的設(shè)計、實施、維持及改進，包括：a) 管理層為實驗室所有人員提供履行其職責所需的適當權(quán)力和資源；e) 明確實驗室的組織和管理結(jié)構(gòu)，以及實驗室與其他相關(guān)機構(gòu)的關(guān)系；f) 規(guī)定所有人員的職責、權(quán)力和相互關(guān)系；h) 技術(shù)管理層全面負責技術(shù)運作，并提供資源以確保滿足實驗室程序規(guī)定的質(zhì)量要求；i) 指定一名質(zhì)量主管（或其他稱謂），賦予其職責和權(quán)力以監(jiān)督所有活動遵守質(zhì)量管理體系的要求。質(zhì)量主管應(yīng)直接向?qū)嶒炇艺吆唾Y源決策的實驗室管理層報告；j) 指定所有關(guān)鍵職能的代理人，但需認識到，在小型實驗室一人可能會同時承擔多項職責，對每項職責指定一位代

11、理人不切實際。4.1.5生化h) 應(yīng)至少有1名具有副高以上專業(yè)技術(shù)職務(wù)任職資格，從事臨床化學檢驗工作至少5年以上的人員負責技術(shù)管理工作。4.1.5血液h) 應(yīng)至少有1名具有副高以上專業(yè)技術(shù)職務(wù)任職資格，從事醫(yī)學檢驗工作至少5年以上的人員負責技術(shù)管理工作。ISO 15189 4.1 組織和管理18對比舉例一、組織和管理注：包括實驗室負責人和普通員工要求（ISO中未見一般員工要求）第18頁，共45頁。CAP PERSONNEL REQUIREMENT BY TESTNG COMPLEXITYDIRECTORS（MD or DO）SECTION DIRECTORS/TECHNICAL SUPERVI

12、SORS （ MD or DO）SUPERVISORS/GENERAL SUPERVISORSALL PERSONNEL19CAP 組織和管理第19頁，共45頁。*REVISED* 07/31/2012TLC.10100 Laboratory Director Qualifications Phase IIThe laboratory director satisfies the personnel requirements of the College of American Pathologists.The director must:a. Be an MD or DO licensed

13、to practice (if required) in the jurisdiction where the laboratory is located, andb. Be certified in anatomic or clinical pathology, or both, by the American Board ofPathology or American Osteopathic Board of Pathology, or possess qualificationsequivalent to those required for certificationORa. Be a

14、n MD, DO or DPM licensed to practice (if required) in the jurisdiction where thelaboratory is located, and b. Have at least one year of laboratory training during residency, or at least two years of experience supervising high complexity testingOR a. Hold an earned doctoral degree in a chemical, phy

15、sical, biological, or clinical laboratoryscience from an accredited institution, andb. Be certified and continue to be certified by a board approved by HHS* (or, for non-USlaboratories, by an equivalent board)OR, for non-US laboratories (not subject to US regulations) onlya. Laboratory Director shal

16、l be an MD, DO, PhD or shall have commensurate educationand experience necessary to meet personnel requirements as determined by the CAP.第20頁，共45頁。*REVISED* 07/31/2012GEN.53400 Section Director/Technical Supervisor Qualifications/Requirements Phase IISection Directors/Technical Supervisors meet defi

17、ned qualifications and fulfill the expected responsibilities.NOTE: The section director/technical supervisor in each high complexity laboratory section can be a licensed MD or DO with certification in anatomic and/or clinical pathology, or qualifications equivalent to those required for board certif

18、ication. The section director/technical supervisor responsible for anatomic pathology must be an MD or DO certified in anatomic pathology or possess qualifications equivalent to those required for certification. The section director/technical supervisor responsible for clinical pathology must be an

19、MD or DO certified in clinical pathology or possess qualifications equivalent to those required for certification; or may be an individual who meets thealternate qualifications for the specialties supervised. For laboratories subject to US regulations, alternate qualifications for the following spec

20、ialty areas can be found in Fed Register. 1992(Feb 28): 7177-7180 42CFR493.1449: bacteriology, mycobacteriology, mycology, parasitology, virology, diagnostic immunology, chemistry, hematology, cytology, ophthalmic pathology, dermatopathology, oral pathology, radiobioassay, immunohematology. Addition

21、al requirements for the section directors of the clinical cytogenetics, histocompatibility and transfusion medicine services are found in the Cytogenetics, Histocompatibility and Transfusion Medicine Checklists, respectively.第21頁，共45頁。HEM.40000 Personnel - Bench Testing Phase IIThe person in charge

22、of bench testing in hematology has education equivalent to an associates degree (or beyond) in a chemical, physical or biological science or medical technology and at least 4 years experience (one of which is in clinical hematology) under a qualified director.Evidence of Compliance: Records of quali

23、fications including degree or transcript, certification/registration, current license(if required) and work history in related fieldCHM.25800 Personnel - Bench Testing Phase IIThe person in charge of bench testing in chemistry has education equivalent to an associates degree (or beyond) in chemical,

24、 physical or biological science or medical technology and at least 4 years experience (one of which must be in clinical chemistry) under a qualified director.Evidence of Compliance: Records of qualifications including degree or transcript, certification/registration, current license(if required) and

25、 work history in related fieldin toxicology、blood gas testing (or certified or registered respiratory therapist ）GEN.54750 Testing Personnel Qualifications Phase IIAll testing personnel meet the following requirements.1. Personnel performing high complexity testing must have at a minimum an earned a

26、ssociate degree in a laboratory science or medical laboratory technology from an accredited institution, or equivalent laboratory training2. Personnel performing moderate complexity testing must have at a minimum an earned high school diploma or equivalent and documented trainingEvidence of Complian

27、ce: Records of qualifications including degree or transcript, certification/registration, current license (if required) and work history in related field22CAP 普通員工資質(zhì)要求很具體第22頁，共45頁。所有員工的資質(zhì)證明23第23頁，共45頁。對比舉例二、人員能力評價5.1.11應(yīng)在培訓(xùn)后評審每個員工執(zhí)行指定工作的能力，之后定期評審。如需要，應(yīng)再次培訓(xùn)并重新評審。生化：應(yīng)制定員工能力評審的內(nèi)容和方法，每年評審員工的工作能力；對新進員工在最

28、初2個月內(nèi)應(yīng)至少進行2次能力評審（間隔為30天），并記錄。當職責變更時，或離崗6個月以上再上崗時，或政策、程序、技術(shù)有變更時，應(yīng)對員工進行再培訓(xùn)和再評審。沒有通過評審的人員需經(jīng)再培訓(xùn)和再評審，合格后才可繼續(xù)上崗，并記錄。血液：應(yīng)制定員工能力評審的內(nèi)容和方法，每年評審員工的工作能力；對新進員工，尤其是從事血液學形態(tài)識別的人員，在最初2個月內(nèi)應(yīng)至少進行2次能力評審（間隔為30天），評審內(nèi)容包括：培訓(xùn)內(nèi)容和過程；現(xiàn)場考核；檢驗結(jié)果的分析與判斷；檢查工作單與各種記錄。當職責變更時，或離崗6個月以上再上崗時，或政策、程序、技術(shù)有變更時，應(yīng)對員工進行再培訓(xùn)和再評審。沒有通過評審的人員應(yīng)經(jīng)再培訓(xùn)和再評審，合

29、格后才可繼續(xù)上崗，并記錄。24ISO 15189 人員能力評價第24頁，共45頁。GEN.55500 Competency Assessment Phase IIThe competency of each person to perform his/her assigned duties is assessed.NOTE: during the first year of an individuals duties, competency must be assessed at least semiannually. After an individual has performed his

30、/her duties for one year, competency must be assessed annually. Retraining and reassessment of employee competency must occur when problems are identified with employee performance.Elements of competency assessment include but are not limited to:1. Direct observations of routine patient test perform

31、ance, including, as applicable, patientidentification and preparation; and specimen collection, handling, processing and testing2. Monitoring the recording and reporting of test results, including, as applicable, reportingcritical results3. Review of intermediate test results or worksheets, quality

32、control records, proficiencytesting results, and preventive maintenance records4. Direct observation of performance of instrument maintenance and function checks5. Assessment of test performance through testing previously analyzed specimens, internalblind testing samples or external proficiency test

33、ing samples; and6. Evaluation of problem-solving skills。25 CAP 人員能力評價(誰來評估？怎樣評估？明確間隔時間？） 比ISO15189 要求更細第25頁，共45頁。ISO 15189未對 PT 做出規(guī)定整合在準則核查表條款4.9不符合項的識別和控制4.10 糾正措施4.11 預(yù)防措施CAP 對PT 有非常具體規(guī)定有非常多的Checkllist舉例三、PT數(shù)據(jù)的上報、分析、強制要求第26頁，共45頁。第27頁，共45頁。28CHM.10300 PT Evaluation Phase IIThere is ongoing evaluat

34、ion of PT and alternative assessment results, with prompt corrective action taken for unacceptable results.Primary records are retained for two years These include all instrument tapes, work cards, computer pri ntouts, evaluation reports, evidence of review, and documentation of follow-up/corrective

35、 action.Evidence of Compliance:Records of ongoing, timely review of all PT reports and alternative assessment results by the laboratory director or designee ANDRecords of investigation of unacceptable PT and alternative assessment results including records of corrective action that is appropriate to

36、 the nature and magnitude of the problem第28頁，共45頁。Type of Analytes/Procedures CMS Regulated: BOLD TYPECenters for Medicare & Medicaid Services (醫(yī)療保險和醫(yī)療補助服務(wù)中心) CMS Non-regualated:第29頁，共45頁。30What happens when a lab has a PT failure for : a regulated analyte?Suspension of testing,Cessation of testingR

37、evocation of a labs accreditation by CMSNon-regulated analytes?Each accrediting agency has different PT oversight standards.第30頁，共45頁。Unsatisfictory unsuccessful第31頁，共45頁。PT Failure ScenariosABCPerformance interpretationrequirement1At riskNeeds to pass the next two events2 successfulLab is no longer

38、 at risk3unsuccessful4Still at riskHas not yet passed two PT events in a row5Unsuccessful , at riskNex two events and accre in jeopardy第32頁，共45頁。33D-A0206-F-501 糾正預(yù)防措施報告記錄表第33頁，共45頁。CNAS 申請安排現(xiàn)場評審資料審查不符合項整改發(fā)證四、申請流程和體會Submit application requestComplete applicationReview customized checklists and prepa

39、re for inspectionInspection team assignedInspection concludedCorrect deficiencies and document improvementsAll requirements met; accredited for two yearsConduct self-inspection at one yearPerformance monitored continually, including PTContinue quality improvement process34ISO 15189CAP第34頁，共45頁。35附表1

40、-1：申請認可的授權(quán)簽字人一覽表附表1-2：授權(quán)簽字人申請表附表2：申請檢驗?zāi)芰Ψ秶奖?：檢測能力變更申請表/確認表附件1：醫(yī)學實驗室質(zhì)量和能力認可自查/核查表附件2：儀器設(shè)備配置表/檢驗?zāi)芰Υ_認表附件3：能力驗證計劃/實驗室間比對匯總表/確認表附件4：實驗室人員一覽表二、申請書附表附件一、醫(yī)學實驗室質(zhì)量和能力認可申請書申請?zhí)峤坏奈募Y料（ISO 15189)第35頁，共45頁。36法律地位證明：包括法人證書、組織機構(gòu)代碼證、執(zhí)業(yè)許可證及執(zhí)業(yè)范圍復(fù)印件；管理體系文件：包括實驗室現(xiàn)行有效受控的質(zhì)量手冊和程序文件；概況圖：實驗室平面圖、組織機構(gòu)圖；檢驗服務(wù)文件、表單：全部檢驗項目清單；全部檢測設(shè)

41、備清單；全部作業(yè)指導(dǎo)書（SOP）清單；客戶清單（適用于獨立醫(yī)學實驗室）；委托實驗室及委托項目清單；檢驗申請單；檢驗報告；樣本采集手冊；申請認可項目生物參考區(qū)間、危機值和報告時間一覽表；申請認可項目量值溯源性一覽表；檢測系統(tǒng)/方法：室內(nèi)質(zhì)量控制SOP、分析性能驗證報告(包括實驗室內(nèi)比對報告)；評審報告及相應(yīng)記錄：生物參考區(qū)間評審報告、危機值評審報告、合同評審報告、內(nèi)部審核報告、管理評審報告等報告及相應(yīng)記錄；評估報告：不確定度評估報告、實驗室風險評估報告、人員培訓(xùn)與能力評估報告；實驗室簡介；其他資料：無 有（如有請?zhí)顚懀?第36頁，共45頁。37申請?zhí)峤坏奈募Y料（CAP）（on-line)第37頁，共45頁。38第38頁，共45頁。39第39頁，共45頁。40總 結(jié)ISO15189CAP(LAP)申請材料遞交難易（在線完成）體系建設(shè)易難不符合項整改3個月1個月使用語言英語檢查周期3年2年核查表更新速度慢快（每年，更細）公正公平環(huán)境好（具體導(dǎo)致客觀）第40頁，共45頁。41ISO 15189 CAP目的相同提高實驗室服務(wù)水平不