임상검사실 표준화 심사 및 신임 인증제도에 관한 연구 Ⅰ : 개발 및 시행에 관한 연구

초록

Background :A policy development research proiect entitled Feasibility study and development of clinical pathology laboratory inspection and accreditation system and its impact was funded by the Ministry of Health and Welfare, Republic of Korea in 1998 to standardize and improve laboratory peformances, hence to accomplish cost effectiveness of laboratory testing throughout the country. Method :The authors developed applicable inspection standards including 1) qualifcation and the role of laboratory director, 2) quality control and quality improvement, 3) facility and safety, and 4) inspection application requirements and detailed checklists for each laboratory discipline were developedaccordingly. The College of American Pathologists Inspection and Accreditation Program was used as the model. Checklists for laboratory areas contain questionnaires wish corresponding scores. The score is assigned from 2 to 4 according clothe impact of the question to the outcome of the test. Checklists are for laboratory management (203 questions), hematology (146), routine chemistry (126), special chemistry(198), urinalysis (85), microbiology (282), immunology and serology (70), blood bank (246), HLA laboratory (117), row cytometry (102), cytogenetics (137), molecular biology (232), and independent laboratory(542). The philosophy involved in the program was fairness, consistency, courteousness, consultation, and providirig guidelines for future developments. Experts` consensus on subiect matter was obtained before checklists were in use. Cut off for accreditation was based on a score of 80%. Three dry and four wet workshops were held to produce 69 trained inspectors. While conducting wet workshops, 2 CAP accredited university hospital laboratories and 1 non-accredited university hospital laboratory as well as 1 CAP accredited large commercial laboratory were inspected by using newly developed checklists. Result :All 4 laboratories were accredited with the mean score of 94%. The most common deficiencies were lack of proper documentation on quality control, outdated reagents in use, etc Conclusion :The laboratory 1 and A program was successfully tested for its feasibility and we confirmed that its nationwide implementation was ready.

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