iso15189認可和cap認證的流程和體會-文庫吧資料
2025-01-20 17:51本頁面
【正文】 ， 應再次培訓并重新評審 。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。 ISO 15189 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 ） 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 education and experience necessary to meet personnel requirements as determined by the CAP ………. **REVISED** 07/31/2023 Section Director/Technical Supervisor Qualifications/Requirements Phase II Section Directors/Technical Supervisors meet defined qualifications and fulfill the expected responsibilities. NOTE: The section director/technical supervisor in each high plexity 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 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 sectio
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