ABSTRACT
BACKGROUND: The Korean Laboratory Accreditation Program (KLAP) by the Korean Society of Laboratory Medicine (KSLM) was started in 1999. We summarized history and achievement of KLAP for the last 8 yr. METHODS: We analyzed 8 yr data (1999-2006) of historical events, trends of participating laboratories, and scores according to the impact of the question to the outcome of the tests. Inspection check lists are for 'laboratory management', 'clinical chemistry', 'diagnostic hematology', 'clinical microbiology', 'diagnostic immunology', 'transfusion medicine', 'cytogenetics', 'molecular genetics', 'histocompatibility', 'flow cytometry', and 'comprehensive laboratory test verification report'. The laboratories with score 90 or higher got 2-yr certificate and laboratories with score between 60 and 89 got 1-yr certificate. The laboratories with score below 60 failed accreditation. RESULTS: The number of accredited laboratories was 2.4 times higher in 2006 (n=227) than in 1999 (n=96). Inspection check lists have been revised 5 times till 2006. The average accreditation rate was 99.6% during these periods and the 2-yr accreditation rate was 32.4% in 2000, 45.6% in 2001, 53.3% in 2002, 47.3% in 2003, 68.5% in 2004, 37.7% in 2005, and 47.7% in 2006. Number of participants in inspector training workshops increased from 89 in 2000 to 766 in 2006. CONCLUSIONS: The KLAP has been in place successfully and stabilized over the past 8 yr. It seemed to enhance the laboratory quality. Efforts for improvement of quality control and inspector training workshops appeared to be in the main contributing factors.
Subject(s)
Accreditation , Education, Medical, Continuing , Korea , Laboratories/standards , Pathology, Clinical/standards , Program EvaluationABSTRACT
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 based 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 and 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.
Subject(s)
Accreditation , Checklist , Education , Financing, Organized , Insurance, Health, Reimbursement , Korea , Laboratories, Hospital , Peer Review , Quality Control , Republic of KoreaABSTRACT
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 based 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 and 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.
Subject(s)
Accreditation , Checklist , Education , Financing, Organized , Insurance, Health, Reimbursement , Korea , Laboratories, Hospital , Peer Review , Quality Control , Republic of KoreaABSTRACT
BACKGROUND: A policy development research project 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 performances, hence to accomplish cost effectiveness of laboratory testing throughout the country. METHODS: The authors developed applicable inspection standards including 1) qualification 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 developed accordingly. The College of American Pathologists Inspection and Accreditation Program was used as the model. Checklists for laboratory areas contain questionnaires with corresponding scores. The score is assigned from 2 to 4 according to the 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), flow cytometry (102), cytogenetics (137), molecular biology (232), and independent laboratory (542). The philosophy involved in the program was fairness, consistency, courteousness, consultation, and providing guidelines for future developments. Experts' consensus on subject 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. RESULTS: 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. CONCLUSIONS: The laboratory I and A program was successfully tested for its feasibility and we confirmed that its nationwide implementation was ready.