iso15189認(rèn)可和cap認(rèn)證的流程和體會(huì)-免費(fèi)閱讀
【正文】 and specimen collection, handling, processing and testing 2. Monitoring the recording and reporting of test results, including, as applicable, reporting critical results 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records 4. Direct observation of performance of instrument maintenance and function checks 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples。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 2次能力評(píng)審（間隔為 30天），并記錄。 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)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)指定一位代理人不切實(shí)際 。 國(guó)外： JCI (Joint Commission on Accreditation of Healthcare Organizations ,JCAHO) ， CAP（ College of American Pathologist） ?內(nèi)部： 自身發(fā)展的需要、自重、自尊。 ISO/IEC 導(dǎo)則 2 一個(gè) 第三方 （認(rèn)證機(jī)構(gòu)）對(duì)（一個(gè)組織的）產(chǎn)品、過(guò)程或服務(wù)符合規(guī)定的要求給出書(shū)面保證的過(guò)程 是 權(quán)威機(jī)構(gòu) 對(duì)某一組織或個(gè)人有能力完成特定任務(wù)做出正式承認(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) ?誰(shuí)組織檢查：第三方還是權(quán)威機(jī)構(gòu)？ ?檢查是體系要求符合性認(rèn)定還是能力的認(rèn)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(chēng) Accreditation 14 ISO I5189 實(shí)驗(yàn)室文件體系 質(zhì)量手冊(cè) 程序文件 項(xiàng)目操作指南（ SOP) 各種記錄 ISO15189:2023《 醫(yī)學(xué)實(shí)驗(yàn)室質(zhì)量和能力的要求 》 CNASCL02： 2023《 醫(yī)學(xué)實(shí)驗(yàn)室質(zhì)量和能力認(rèn)可準(zhǔn)則 》 ISO15189:2023《 醫(yī)學(xué)實(shí)驗(yàn)室質(zhì)量和能力的要求 》 于 2023年 11月 1日發(fā)布。s 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 qualifications including degree or transcript, certification/registration, current license (if required) and work history in related field Personnel Bench Testing Phase II The person in charge of bench testing in chemistry has education equivalent to an associate39。沒(méi)有通過(guò)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。 25 CAP 人員能力評(píng)價(jià) (誰(shuí)來(lái)評(píng)估？怎樣評(píng)估？明確間隔時(shí)間？） 比 ISO15189 要求更細(xì) ISO 15189 ?未對(duì) PT 做出規(guī)定 ?整合在準(zhǔn)則核查表?xiàng)l款 糾正措施 預(yù)防措施 CAP ?對(duì) 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(bào)、分析、強(qiáng)制要求 28 PT Evaluation Phase II There is ongoing evaluation 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, puter pri ntouts, evaluation reports, evidence of review, and documentation of followup/corrective action. Evidence of Compliance: ? Records of ongoing, timely review of all PT reports and alternative assessment results by the laboratory director or designee AND ? Records of investigation of unacceptable PT and alternative assessment results including records of corrective action that is appropriate to the natu
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