ISO15189認(rèn)可和CAP認(rèn)證的流程和體會(huì)

1、ISO15189認(rèn)可和認(rèn)可和CAP認(rèn)證的認(rèn)證的流程和體會(huì)流程和體會(huì)浙江大學(xué)醫(yī)學(xué)院附屬第二醫(yī)院浙江大學(xué)醫(yī)學(xué)院附屬第二醫(yī)院譚運(yùn)年譚運(yùn)年2013.11.081一、為什么要做？一、為什么要做？二、認(rèn)證認(rèn)可差別二、認(rèn)證認(rèn)可差別三、體系建立和檢查手段三、體系建立和檢查手段四、申請(qǐng)流程和體會(huì)四、申請(qǐng)流程和體會(huì)HELP ! FREE3一、為什么要做？一、為什么要做？為什么不想做？據(jù)說為什么不想做？據(jù)說 聽說聽說 傳說傳說u文件工作多文件工作多u學(xué)習(xí)任務(wù)重學(xué)習(xí)任務(wù)重u硬件達(dá)不到要求硬件達(dá)不到要求u軟件達(dá)不到要求軟件達(dá)不到要求u只按部分要求做，不評(píng)只按部分要求做，不評(píng)4推動(dòng)的因素推動(dòng)的因素u外部：外部：國內(nèi)：優(yōu)質(zhì)

2、醫(yī)院、等級(jí)醫(yī)院、衛(wèi)生部重點(diǎn)專科評(píng)國內(nèi)：優(yōu)質(zhì)醫(yī)院、等級(jí)醫(yī)院、衛(wèi)生部重點(diǎn)?？圃u(píng)審。審。國外：國外：JCI (Joint Commission on Accreditation of Healthcare Organizations ,JCAHO) ，CAP（ College of American Pathologist）u內(nèi)部：內(nèi)部：自身發(fā)展的需要、自重、自尊。自身發(fā)展的需要、自重、自尊。5歸根到底：高品質(zhì)醫(yī)療服務(wù)的需要?dú)w根到底：高品質(zhì)醫(yī)療服務(wù)的需要u質(zhì)的需要：深度質(zhì)的需要：深度提供項(xiàng)目的質(zhì)量提供項(xiàng)目的質(zhì)量u量的需要：廣度量的需要：廣度覆蓋面（提供多少項(xiàng)目、覆蓋面（提供多少項(xiàng)目、服務(wù)人群、對(duì)口支

3、援單位）服務(wù)人群、對(duì)口支援單位）6回歸到正確的服務(wù)軌道上回歸到正確的服務(wù)軌道上u過去：體系不完善、服務(wù)質(zhì)量有待提高過去：體系不完善、服務(wù)質(zhì)量有待提高u現(xiàn)在：提倡服務(wù)對(duì)象至上、服務(wù)契合對(duì)象現(xiàn)在：提倡服務(wù)對(duì)象至上、服務(wù)契合對(duì)象需要需要7實(shí)驗(yàn)室如何證明自己的能力實(shí)驗(yàn)室如何證明自己的能力 u第一方證明第一方證明-自我聲明自我聲明 u第二方證明第二方證明-客戶的證明客戶的證明 u第三方證明第三方證明-公正權(quán)威的證明公正權(quán)威的證明 8浙二醫(yī)院檢驗(yàn)科浙二醫(yī)院檢驗(yàn)科uISO15189 初次評(píng)審初次評(píng)審2012.4.23-25 現(xiàn)場(chǎng)評(píng)審現(xiàn)場(chǎng)評(píng)審2012.9.29 獲得認(rèn)可（編號(hào)獲得認(rèn)可（編號(hào)121） uCAP

4、（Laboratory Accreditation Program, LAP)2013.7.10-12 現(xiàn)場(chǎng)評(píng)審現(xiàn)場(chǎng)評(píng)審2013.9.10 獲得認(rèn)證（中國大陸第獲得認(rèn)證（中國大陸第6家公立醫(yī)院）家公立醫(yī)院）uISO15189 監(jiān)督擴(kuò)項(xiàng)評(píng)審監(jiān)督擴(kuò)項(xiàng)評(píng)審2013.10.11-13 現(xiàn)場(chǎng)評(píng)審現(xiàn)場(chǎng)評(píng)審9醫(yī)學(xué)實(shí)驗(yàn)室醫(yī)學(xué)實(shí)驗(yàn)室ISO 15189 CAP （LAP)評(píng)審機(jī)關(guān)評(píng)審機(jī)關(guān)各國認(rèn)可機(jī)構(gòu)各國認(rèn)可機(jī)構(gòu) （官方（官方 ）中國中國CNAS美國病理學(xué)協(xié)會(huì)美國病理學(xué)協(xié)會(huì) （第三（第三方）方）應(yīng)用法律應(yīng)用法律本地法律弱化但地區(qū)法本地法律弱化但地區(qū)法律法規(guī)適用律法規(guī)適用 強(qiáng)調(diào)美國法律強(qiáng)調(diào)美國法律 所要求的技術(shù)所要求

5、的技術(shù)水準(zhǔn)水準(zhǔn) 國際性技術(shù)水平國際性技術(shù)水平 美國技術(shù)水準(zhǔn)美國技術(shù)水準(zhǔn) 評(píng)審原則評(píng)審原則自愿，專家評(píng)審自愿，專家評(píng)審自愿，專家評(píng)審自愿，專家評(píng)審費(fèi)用費(fèi)用 相對(duì)便宜相對(duì)便宜 略貴略貴認(rèn)可周期認(rèn)可周期3年年2年年國內(nèi)已經(jīng)獲得國內(nèi)已經(jīng)獲得認(rèn)可或認(rèn)證的認(rèn)可或認(rèn)證的醫(yī)學(xué)實(shí)驗(yàn)室醫(yī)學(xué)實(shí)驗(yàn)室132家家23（其中公立醫(yī)院（其中公立醫(yī)院6家，家，其它為跨國醫(yī)藥公司或其它為跨國醫(yī)藥公司或第三方實(shí)驗(yàn)室）第三方實(shí)驗(yàn)室）10背景簡(jiǎn)介背景簡(jiǎn)介認(rèn)可認(rèn)證依據(jù)認(rèn)可認(rèn)證依據(jù)ISO15189CAP(LAP)ISO17025:檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力的通用要求力的通用要求。ISO15189:醫(yī)學(xué)實(shí)驗(yàn)室醫(yī)學(xué)實(shí)驗(yàn)室質(zhì)量和質(zhì)量

6、和能力的專用要求能力的專用要求CLIA 88（美國臨床實(shí)驗(yàn)（美國臨床實(shí)驗(yàn)室改進(jìn)修正法規(guī)室改進(jìn)修正法規(guī)88 ） CLSI（美國臨床和實(shí)驗(yàn)（美國臨床和實(shí)驗(yàn)室標(biāo)準(zhǔn)協(xié)會(huì)）室標(biāo)準(zhǔn)協(xié)會(huì)）11二、認(rèn)證認(rèn)可差別二、認(rèn)證認(rèn)可差別Certification Accreditation認(rèn)證認(rèn)證認(rèn)可認(rèn)可中華人民共和國國務(wù)院令中華人民共和國國務(wù)院令(第第390號(hào)號(hào)) 中華人民共和中華人民共和國認(rèn)證認(rèn)可條例國認(rèn)證認(rèn)可條例年月日起施行。年月日起施行。 總總理理 溫家寶溫家寶 第一章第一章 總總 則則 第二條第二條 本條例所稱本條例所稱認(rèn)證認(rèn)證，是指由認(rèn)，是指由認(rèn)證機(jī)構(gòu)證明產(chǎn)品、服務(wù)、管證機(jī)構(gòu)證明產(chǎn)品、服務(wù)、管理體系符合相關(guān)

7、技術(shù)規(guī)范、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(qiáng)制性要求相關(guān)技術(shù)規(guī)范的強(qiáng)制性要求或者標(biāo)準(zhǔn)的合格評(píng)定活動(dòng)?；蛘邩?biāo)準(zhǔn)的合格評(píng)定活動(dòng)。 本條例所稱本條例所稱認(rèn)可認(rèn)可，是指由認(rèn)，是指由認(rèn)可機(jī)構(gòu)對(duì)認(rèn)證機(jī)構(gòu)、檢查機(jī)可機(jī)構(gòu)對(duì)認(rèn)證機(jī)構(gòu)、檢查機(jī)構(gòu)、實(shí)驗(yàn)室以及從事評(píng)審、構(gòu)、實(shí)驗(yàn)室以及從事評(píng)審、審核等認(rèn)證活動(dòng)人員的能力審核等認(rèn)證活動(dòng)人員的能力和執(zhí)業(yè)資格，予以承認(rèn)的合和執(zhí)業(yè)資格，予以承認(rèn)的合格評(píng)定活動(dòng)。格評(píng)定活動(dòng)。ISO/IEC 導(dǎo)則導(dǎo)則2 一個(gè)一個(gè)第三方第三方（認(rèn)證機(jī)構(gòu)）對(duì)（認(rèn)證機(jī)構(gòu)）對(duì)（一個(gè)組織的）產(chǎn)品、過程（一個(gè)組織的）產(chǎn)品、過程或服務(wù)符合規(guī)定的要求給出或服務(wù)符合規(guī)定的要求給出書面保證的過程書面保證的過程是是

8、權(quán)威機(jī)構(gòu)權(quán)威機(jī)構(gòu)對(duì)某一組織或個(gè)對(duì)某一組織或個(gè)人有能力完成特定任務(wù)做出人有能力完成特定任務(wù)做出正式承認(rèn)的程序正式承認(rèn)的程序 12發(fā)個(gè)證先，你們符合結(jié)婚的條件13區(qū)分重點(diǎn)區(qū)分重點(diǎn)u誰組織檢查：第三方還是權(quán)威機(jī)構(gòu)？誰組織檢查：第三方還是權(quán)威機(jī)構(gòu)？u檢查是體系要求符合性認(rèn)定還是能力的認(rèn)定？檢查是體系要求符合性認(rèn)定還是能力的認(rèn)定？u區(qū)別是建立在有一定內(nèi)涵聯(lián)系基礎(chǔ)上區(qū)別是建立在有一定內(nèi)涵聯(lián)系基礎(chǔ)上uCAP 英文中稱英文中稱Accreditation14ISO I5189 實(shí)驗(yàn)室文件體系實(shí)驗(yàn)室文件體系 質(zhì)量手冊(cè)質(zhì)量手冊(cè) 程序文件程序文件項(xiàng)目操作指南項(xiàng)目操作指南（SOP) 各種記錄各種記錄ISO15189:2

9、007醫(yī)學(xué)實(shí)驗(yàn)室醫(yī)學(xué)實(shí)驗(yàn)室-質(zhì)量和能力的要求質(zhì)量和能力的要求CNAS-CL02：2008醫(yī)學(xué)實(shí)醫(yī)學(xué)實(shí)驗(yàn)室質(zhì)量和能力認(rèn)可準(zhǔn)則驗(yàn)室質(zhì)量和能力認(rèn)可準(zhǔn)則ISO15189:2012醫(yī)學(xué)實(shí)驗(yàn)室醫(yī)學(xué)實(shí)驗(yàn)室-質(zhì)量和能力的要求質(zhì)量和能力的要求于于2012年年11月月1日發(fā)布。國際實(shí)驗(yàn)室日發(fā)布。國際實(shí)驗(yàn)室認(rèn)可合作組織（認(rèn)可合作組織（ILAC）要求）要求各國認(rèn)可組織于各國認(rèn)可組織于2016年年3月月1日前完成標(biāo)準(zhǔn)轉(zhuǎn)換工作。日前完成標(biāo)準(zhǔn)轉(zhuǎn)換工作。u準(zhǔn)則核查表準(zhǔn)則核查表u2013.4.1實(shí)施實(shí)施的專業(yè)組核查的專業(yè)組核查表表15三、體系建立和檢查手段三、體系建立和檢查手段CAP 實(shí)驗(yàn)室文件體系 QMP PolicySta

10、ndard Operation Procedure,SOP RecordsCLIA 88美國臨床實(shí)驗(yàn)室改進(jìn)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

11、 CDC and CMS modifiedCLSI美國臨床和實(shí)驗(yàn)室標(biāo)準(zhǔn)協(xié)會(huì)Clinical and Laboratory 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 C

12、hecklist 16評(píng)審依據(jù)的內(nèi)容評(píng)審依據(jù)的內(nèi)容ISO 15189CAP (LAP)依據(jù)依據(jù)uCNAS-CL02準(zhǔn)則準(zhǔn)則醫(yī)學(xué)實(shí)驗(yàn)室質(zhì)量和能力醫(yī)學(xué)實(shí)驗(yàn)室質(zhì)量和能力認(rèn)可準(zhǔn)則自查認(rèn)可準(zhǔn)則自查/核查表核查表u2013.4.1實(shí)施的專業(yè)組核查表（實(shí)施的專業(yè)組核查表（LIS)3000 條條Checklist內(nèi)容內(nèi)容4 管理要求管理要求4.1 組織和管理組織和管理4.2 質(zhì)量管理體系質(zhì)量管理體系4.3 文件控制文件控制4.4 合同的評(píng)審合同的評(píng)審4.5 委托實(shí)驗(yàn)室的檢委托實(shí)驗(yàn)室的檢驗(yàn)驗(yàn)4.6 外部服務(wù)和供給外部服務(wù)和供給 4.7 咨詢服務(wù)咨詢服務(wù)4.8 投訴的處理投訴的處理4.9 不符合項(xiàng)的識(shí)別不符合項(xiàng)的

13、識(shí)別和控制和控制4.10 糾正措施糾正措施4.11 預(yù)防措施預(yù)防措施4.12 持續(xù)改進(jìn)持續(xù)改進(jìn)4.13 質(zhì)量和技術(shù)記錄質(zhì)量和技術(shù)記錄4.14 內(nèi)部審核內(nèi)部審核4.15 管理評(píng)審管理評(píng)審5 技術(shù)要求技術(shù)要求 5.1 人員人員5.2 設(shè)施和環(huán)境條件設(shè)施和環(huán)境條件5.3 實(shí)驗(yàn)室設(shè)備實(shí)驗(yàn)室設(shè)備5.4 檢驗(yàn)前程序檢驗(yàn)前程序5.5 檢驗(yàn)程序檢驗(yàn)程序5.6 檢驗(yàn)程序的質(zhì)量保檢驗(yàn)程序的質(zhì)量保證證5.7 檢驗(yàn)后程序檢驗(yàn)后程序5.8 結(jié)果報(bào)告結(jié)果報(bào)告174.1.4.1.5 5實(shí)驗(yàn)室管理層應(yīng)負(fù)責(zé)質(zhì)量管理體系的實(shí)驗(yàn)室管理層應(yīng)負(fù)責(zé)質(zhì)量管理體系的設(shè)計(jì)、實(shí)施、維持及改進(jìn)，包括：設(shè)計(jì)、實(shí)施、維持及改進(jìn)，包括：a) 管理層為實(shí)

14、驗(yàn)室所有人員提供履行管理層為實(shí)驗(yàn)室所有人員提供履行其職責(zé)所需的適當(dāng)權(quán)力和資源；其職責(zé)所需的適當(dāng)權(quán)力和資源；e) 明確實(shí)驗(yàn)室的組織和管理結(jié)構(gòu)，以明確實(shí)驗(yàn)室的組織和管理結(jié)構(gòu)，以及實(shí)驗(yàn)室與其他相關(guān)機(jī)構(gòu)的關(guān)系；及實(shí)驗(yàn)室與其他相關(guān)機(jī)構(gòu)的關(guān)系；f) 規(guī)定所有人員的職責(zé)、權(quán)力和相互規(guī)定所有人員的職責(zé)、權(quán)力和相互關(guān)系；關(guān)系；h) 技術(shù)管理層技術(shù)管理層全面負(fù)責(zé)技術(shù)運(yùn)作，全面負(fù)責(zé)技術(shù)運(yùn)作，并提供資源以確保滿足實(shí)驗(yàn)室程序規(guī)并提供資源以確保滿足實(shí)驗(yàn)室程序規(guī)定的質(zhì)量要求；定的質(zhì)量要求；i) 指定一名質(zhì)量主管（或其他稱謂），指定一名質(zhì)量主管（或其他稱謂），賦予其職責(zé)和權(quán)力以監(jiān)督所有活動(dòng)遵賦予其職責(zé)和權(quán)力以監(jiān)督所有活動(dòng)遵守

15、質(zhì)量管理體系的要求。質(zhì)量主管應(yīng)守質(zhì)量管理體系的要求。質(zhì)量主管應(yīng)直接向?qū)?shí)驗(yàn)室政策和資源決策的實(shí)直接向?qū)?shí)驗(yàn)室政策和資源決策的實(shí)驗(yàn)室管理層報(bào)告；驗(yàn)室管理層報(bào)告；j) 指定所有關(guān)鍵職能的代理人，但需指定所有關(guān)鍵職能的代理人，但需認(rèn)識(shí)到，在小型實(shí)驗(yàn)室一人可能會(huì)同認(rèn)識(shí)到，在小型實(shí)驗(yàn)室一人可能會(huì)同時(shí)承擔(dān)多項(xiàng)職責(zé)，對(duì)每項(xiàng)職責(zé)指定一時(shí)承擔(dān)多項(xiàng)職責(zé)，對(duì)每項(xiàng)職責(zé)指定一位代理人不切實(shí)際。位代理人不切實(shí)際。4.1.5生生化化h) 應(yīng)至少有應(yīng)至少有1名具有副高名具有副高以上專業(yè)技術(shù)職務(wù)任職資格，以上專業(yè)技術(shù)職務(wù)任職資格，從事臨床化學(xué)檢驗(yàn)工作至少從事臨床化學(xué)檢驗(yàn)工作至少5年以上的人員負(fù)責(zé)技術(shù)管年以上的人員負(fù)責(zé)技術(shù)管理工

16、作。理工作。4.1.5血血液液h) 應(yīng)至少有應(yīng)至少有1名具有副高名具有副高以上專業(yè)技術(shù)職務(wù)任職資格，以上專業(yè)技術(shù)職務(wù)任職資格，從事醫(yī)學(xué)檢驗(yàn)工作至少從事醫(yī)學(xué)檢驗(yàn)工作至少5年年以上的人員負(fù)責(zé)技術(shù)管理工以上的人員負(fù)責(zé)技術(shù)管理工作。作。ISO 15189 4.1 組織和管理組織和管理18對(duì)比舉例一、組織和管理對(duì)比舉例一、組織和管理注：包括實(shí)驗(yàn)室負(fù)責(zé)人和普通員注：包括實(shí)驗(yàn)室負(fù)責(zé)人和普通員工要求（工要求（ISO中中未見一般員工要求未見一般員工要求）CAP PERSONNEL REQUIREMENT BY TESTNG COMPLEXITYuDIRECTORS（MD or DO）uSECTION DIREC

17、TORS/TECHNICAL SUPERVISORS （ MD or DO）uSUPERVISORS/GENERAL SUPERVISORSuALL PERSONNEL19CAP 組織和管理組織和管理*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

18、 MD or DO licensed 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 cer

19、tificationORa. Be an 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

20、 in a chemical, physical, 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. Labor

21、atory Director shall be an MD, DO, PhD or shall have commensurate educationand experience necessary to meet personnel requirements as determined by the CAP.*REVISED* 07/31/2012GEN.53400 Section Director/Technical Supervisor Qualifications/Requirements Phase IISection Directors/Technical Supervisors

22、meet defined 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 boa

23、rd certification. 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 mu

24、st be an 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 follo

25、wing specialty 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.

26、 Additional 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.HEM.40000 Personnel - Bench Testing Phase IIThe person in charge o

27、f 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 qualif

28、ications 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,

29、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

30、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 as

31、sociate 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 Complianc

32、e: 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)要求很具體普通員工資質(zhì)要求很具體所有員工的資質(zhì)證明所有員工的資質(zhì)證明23對(duì)比舉例二、人員能力評(píng)價(jià)對(duì)比舉例二、人員能力評(píng)價(jià)5 .5 .1 .1 .1111應(yīng)在培訓(xùn)后評(píng)應(yīng)在培訓(xùn)后評(píng)審每個(gè)員工執(zhí)審每個(gè)員工執(zhí)行指定工作的行指定工作的能力，之后定能力，之后定期評(píng)審。如需期評(píng)審。如需

33、要，應(yīng)再次培要，應(yīng)再次培訓(xùn)并重新評(píng)審。訓(xùn)并重新評(píng)審。生化生化：應(yīng)制定員工能力評(píng)審的內(nèi)容和方法，每年評(píng)審員工的工應(yīng)制定員工能力評(píng)審的內(nèi)容和方法，每年評(píng)審員工的工作能力；對(duì)新進(jìn)員工在最初作能力；對(duì)新進(jìn)員工在最初2個(gè)月內(nèi)應(yīng)至少進(jìn)行個(gè)月內(nèi)應(yīng)至少進(jìn)行2次能力次能力評(píng)審（間隔為評(píng)審（間隔為30天），并記錄。當(dāng)職責(zé)變更時(shí)，或離崗天），并記錄。當(dāng)職責(zé)變更時(shí)，或離崗6個(gè)月以上再上崗時(shí)，或政策、程序、技術(shù)有變更時(shí)，應(yīng)個(gè)月以上再上崗時(shí)，或政策、程序、技術(shù)有變更時(shí)，應(yīng)對(duì)員工進(jìn)行再培訓(xùn)和再評(píng)審。沒有通過評(píng)審的人員需經(jīng)對(duì)員工進(jìn)行再培訓(xùn)和再評(píng)審。沒有通過評(píng)審的人員需經(jīng)再培訓(xùn)和再評(píng)審，合格后才可繼續(xù)上崗，并記錄。再培訓(xùn)和再評(píng)

34、審，合格后才可繼續(xù)上崗，并記錄。血液：血液：應(yīng)制定員工能力評(píng)審的內(nèi)容和方法，每年評(píng)審員工的工應(yīng)制定員工能力評(píng)審的內(nèi)容和方法，每年評(píng)審員工的工作能力；對(duì)新進(jìn)員工，尤其是從事血液學(xué)形態(tài)識(shí)別的人作能力；對(duì)新進(jìn)員工，尤其是從事血液學(xué)形態(tài)識(shí)別的人員，在最初員，在最初2個(gè)月內(nèi)應(yīng)至少進(jìn)行個(gè)月內(nèi)應(yīng)至少進(jìn)行2次能力評(píng)審（間隔為次能力評(píng)審（間隔為30天），評(píng)審內(nèi)容包括：天），評(píng)審內(nèi)容包括：培訓(xùn)內(nèi)容和過程；培訓(xùn)內(nèi)容和過程；現(xiàn)場(chǎng)考核；現(xiàn)場(chǎng)考核；檢驗(yàn)結(jié)果的分析與判斷；檢驗(yàn)結(jié)果的分析與判斷；檢查工作單與各種記錄。檢查工作單與各種記錄。當(dāng)職責(zé)變更時(shí)，或離崗當(dāng)職責(zé)變更時(shí)，或離崗6個(gè)月以上再上崗時(shí)，或政策、程個(gè)月以上再上崗時(shí)，

35、或政策、程序、技術(shù)有變更時(shí)，應(yīng)對(duì)員工進(jìn)行再培訓(xùn)和再評(píng)審。沒序、技術(shù)有變更時(shí)，應(yīng)對(duì)員工進(jìn)行再培訓(xùn)和再評(píng)審。沒有通過評(píng)審的人員應(yīng)經(jīng)再培訓(xùn)和再評(píng)審，合格后才可繼有通過評(píng)審的人員應(yīng)經(jīng)再培訓(xùn)和再評(píng)審，合格后才可繼續(xù)上崗，并記錄。續(xù)上崗，并記錄。24ISO 15189 人員能力評(píng)價(jià)人員能力評(píng)價(jià)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 individu

36、als duties, competency must be assessed at least semiannually. After an individual has performed his/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 compete

37、ncy assessment include but are not limited to:1. Direct observations of routine patient test performance, including, as applicable, patientidentification and preparation; and specimen collection, handling, processing and testing2. Monitoring the recording and reporting of test results, including, as

38、 applicable, reportingcritical results3. Review of intermediate test results or worksheets, quality control records, proficiencytesting results, and preventive maintenance records4. Direct observation of performance of instrument maintenance and function checks5. Assessment of test performance throu

39、gh testing previously analyzed specimens, internalblind testing samples or external proficiency testing samples; and6. Evaluation of problem-solving skills。25 CAP 人員能力評(píng)價(jià)人員能力評(píng)價(jià)(誰來評(píng)估？怎樣評(píng)估？明確間隔時(shí)間？）誰來評(píng)估？怎樣評(píng)估？明確間隔時(shí)間？） 比比ISO15189 要求更細(xì)要求更細(xì)ISO 15189u未未對(duì)對(duì) PT 做出規(guī)定做出規(guī)定u整合在準(zhǔn)則核查表?xiàng)l款整合在準(zhǔn)則核查表?xiàng)l款4.9不符合項(xiàng)的識(shí)別和不符合項(xiàng)的識(shí)別和控制

40、控制4.10 糾正糾正措施措施4.11 預(yù)防措施預(yù)防措施CAP u對(duì)對(duì)PT 有非常具體規(guī)定有非常具體規(guī)定u有非常多的有非常多的Checkllist舉例三、舉例三、PT數(shù)據(jù)的上報(bào)、分析、強(qiáng)制要求數(shù)據(jù)的上報(bào)、分析、強(qiáng)制要求28CHM.10300 PT Evaluation Phase IIThere is ongoing evaluation of PT and alternative assessment results, with prompt corrective action taken for unacceptable results.Primary records are retain

41、ed for two years These include all instrument tapes, work cards, computer pri ntouts, evaluation reports, evidence of review, and documentation of follow-up/corrective action.Evidence of Compliance:Records of ongoing, timely review of all PT reports and alternative assessment results by the laborato

42、ry director or designee ANDRecords of investigation of unacceptable PT and alternative assessment results including records of corrective action that is appropriate to the nature and magnitude of the problemType of Analytes/Proceduresn CMS Regulated: BOLD TYPECenters for Medicare & Medicaid Serv

43、ices (醫(yī)療保險(xiǎn)和醫(yī)療補(bǔ)助服務(wù)中心醫(yī)療保險(xiǎn)和醫(yī)療補(bǔ)助服務(wù)中心)n CMS Non-regualated:30What happens when a lab has a PT failure for : a regulated analyte?uSuspension of testing,uCessation of testinguRevocation of a labs accreditation by CMSNon-regulated analytes?uEach accrediting agency has different PT oversight standards.Unsati

44、sfictory unsuccessfulPT Failure ScenariosABCPerformance interpretationrequirement1At riskNeeds to pass the next two events2 successfulLab is no longer at risk3unsuccessful4Still at riskHas not yet passed two PT events in a row5Unsuccessful , at riskNex two events and accre in jeopardy33D-A0206-F-501

45、 糾正預(yù)防措施報(bào)告記錄表CNAS 申請(qǐng)安排現(xiàn)場(chǎng)評(píng)審資料審查不符合項(xiàng)整改發(fā)證四、申請(qǐng)流程和體會(huì)四、申請(qǐng)流程和體會(huì)vSubmit application requestvComplete applicationvReview customized checklists and prepare for inspectionvInspection team assignedvInspection concludedvCorrect deficiencies and document improvementsvAll requirements met; accredited for two yearsvConduct self-inspection at one yearvPerformance monitored continually