Laboratory Inspection and Accreditation in Korea Ⅱ

Abstract

Background :The Korean Society of Laboratory Medicine (KSLM) Laboratory Inspection and Accreditation Program (IAP) has been developed after one year of study supported by a research grant from the Ministry of Health and Welfare (MOHW) of the Republic of Korea from June 1998 to May 1999 to assess objectively the quality of laboratory work and assist the laboratories in improving the quality of their work. The IAP is bassd on peer review and voluntary participation. The IAP has been continuously improved since the first laboratory inspection began in May 1999 and it was soon expanded nationwide. The improvement was made by updating the inspection checklists to reflect feedback from inspection activities anci holding frequent inspectors training workshops. This paper describes the progress and outcome of the IAP. Methods :The IAP has been implemented nationwide through the following steps: 1) preliminary review of application papers including laboratory quality control policies and external proficiency survey results, as well as on-site inspection by inspectors; 2) addition of newly approved "Inpatient Interpretive Summary Report" checklist (IISR); 3) inspectors training workshop for the "IISR" checklist; 4) continuation of the IAP for all checklist areas including "IISR"; and 5) the first revision of checklists. Results :One hundred nineteen laboratories were accredited during the first year of the IAP. Due to the implementation of the MOHW approved health insurance reimbursement item for laboratory physicians, the "IISR" checklist was created. The mean score of the laboratory inspection results was 92.8 and hospital laboratories showed a higher score on routine testing areas, however, commercial reference laboratories showed a better score on special testing areas, The checklists were revised according to the feedback from the first round of inspections. Conclusions :The nationwide implementation of the KSLM laboratory IAP was accomplished through this study. The IAP appears to have provided a firm basis for the improvement of quality and efficiency of clinical laboratories in the country.

배경 : 임상검사실 신임 인증제도는 객관적인 국내 검사실 질관리 판단 기법의 개발을 통하여 자발적이며 전문성을 갖춘 검사실 표준화 심사 및 인증 제도의 틀을 마련하고자 대한진단검사의학회를 중심으로 보건복지부 지원하에 1998년 6월부터 연구를 시작하여 1999년 5월 개발 과정을 거쳐 완료되었다. 이에 저자 등은 검사실 신임제도가 1999년 5월 처음 심사를 시작한 이후 전국적으로 확대 시행됨에 따라 1차년도 신임 인증 제도 결과를 분석연구함으로써 향상된 시스템을 구축하고자 하였다.방법 : 검사실 신임제도의 시행은 다음과 같은 과정에 따라 진행되었다. 1) 예비심사 및 인증심사, 2) 종합검증 분야 신설, 3)종합검증 분야 워크샵 및 심사원 교육, 4) 종합검증 분야를 포함한 추가 인증심사, 5) 심사점검표 1차 개정 작업이었다.결과 : 총 119 기관이 인증심사를 받았으며, 의료보험 요양 급여기준의 개정으로 종합검증 분야가 신설되었다. 심사 결과 평균점수는 92.8점이었고, 분야별 평균 점수는 특수 분야는 전문 수탁기관이, 일반 검사 분야는 병원 검사실이 높았다. 1차년도 심사결과 분석 자료를 기초로 하여 심사점검표를 개정, 공지하였다.