iso15189認可和cap認證的流程和體會(文件)
【正文】 athology, or qualifications equivalent to those required for board 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 must be an MD or DO certified in clinical pathology or possess qualifications equivalent to those required for certification。 如需要 ， 應再次培訓并重新評審 。 血液： 應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)應至少進行 2次能力評審（間隔為 30天），評審內(nèi)容包括： 培訓內(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。s duties, petency must be assessed at least semiannually. After an individual has performed his/her duties for one year, petency must be assessed annually. Retraining and reassessment of employee petency must occur when problems are identified with employee performance. Elements of petency assessment include but are not limited to: 1. Direct observations of routine patient test performance, including, as applicable, patient identification and preparation。 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 ISO 15189 ?未對 PT 做出規(guī)定 ?整合在準則核查表條款 糾正措施 預防措施 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 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 nature and magnitude of the problem Type of Analytes/Procedures ? CMS Regulated: BOLD TYPE Centers for Medicare Medicaid Services (醫(yī)療保險和醫(yī)療補助服務中心 ) ? CMS Nonregualated: 30 What happens when a lab has a PT failure for : a regulated analyte? ? Suspension of testing, ? Cessation of testing ? Revocation of a lab’s accreditation by CMS Nonregulated analytes? ? Each accrediting agency has different PT oversight standards. Unsatisfictory unsuccessful PT Failure Scenarios A B C Performance interpretation requirement 1 √ √ Χ At risk Needs to pass the next two events 2 Χ √ √ successful Lab is no longer at risk 3 Χ √ Χ unsuccessful 4 √ Χ √ Still at risk Has not yet passed two PT events in a row 5 √ Χ Χ Unsuccessful , at r
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