iso15189認(rèn)可和cap認(rèn)證的流程和體會(huì)(存儲(chǔ)版)
【正文】 re and magnitude of the problem Type of Analytes/Procedures ? CMS Regulated: BOLD TYPE Centers for Medicare Medicaid Services (醫(yī)療保險(xiǎn)和醫(yī)療補(bǔ)助服務(wù)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 risk Nex two events and accre in jeopardy 33 DA0206F501 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) ?Submit application request ?Complete application ?Review customized checklists and prepare for inspection ?Inspection team assigned ?Inspection concluded ?Correct deficiencies and document improvements ?All requirements met。 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 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），評(píng)審內(nèi)容包括： 培訓(xùn)內(nèi)容和過(guò)程； 現(xiàn)場(chǎng)考核； 檢驗(yàn)結(jié)果的分析與判斷； 檢查工作單與各種記錄。 ISO 15189 組織和管理 18 對(duì)比舉例一、組織和管理 注：包括實(shí)驗(yàn)室負(fù)責(zé)人和普通員工要求（ ISO中 未見(jiàn)一般員工要求 ） CAP PERSONNEL REQUIREMENT BY TESTNG COMPLEXITY ?DIRECTORS（ MD or DO） ?SECTION DIRECTORS/TECHNICAL SUPERVISORS （ MD or DO） ?SUPERVISORS/GENERAL SUPERVISORS ?ALL PERSONNEL 19 CAP 組織和管理 **REVISED** 07/31/2023 Laboratory Director Qualifications Phase II The laboratory director satisfies the personnel requirements of the College of American Pathologists. … The director must: a. Be an MD or DO licensed to practice (if required) in the jurisdiction where the laboratory is located, and b. Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or American Osteopathic Board of Pathology, or possess qualifications equivalent to those required for certification OR a. Be an MD, DO or DPM licensed to practice (if required) in the jurisdiction where the laboratory is located, and b. Have at least one year of laboratory training during residency, or at least two years of experience supervising high plexity testing OR a. Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution, and b. Be certified and continue to be certified by a board approved by HHS** (or, for nonUS laboratories, by an equivalent board) OR, for nonUS laboratories (not subject to US regulations) only a. Laboratory Director shall be an MD, DO, PhD or shall have mensurate educa
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