Laboratory Inspection and Accreditation in Korea II: Analysis of the First Round Inspection

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.