Korean J Lab Med.  2009 Apr;29(2):163-170. 10.3343/kjlm.2009.29.2.163.

The Implementation and Effects of a Clinical Laboratory Accreditation Program in Korea from 1999 to 2006

• Shin BM
• Chae SL
• Min WK
• Lee WG
• Lim YA
• Lee DH
• Lim HS
• Lee YK
• Cha YJ
• Suh SP
• Lee KN
• Kwak YS

• KMID: 854978
• DOI: http://doi.org/10.3343/kjlm.2009.29.2.163

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.

Keyword

Laboratory inspection; Laboratory accreditation; Quality assurance

MeSH Terms

Accreditation
Education, Medical, Continuing
Korea
Laboratories/*standards
Pathology, Clinical/*standards
*Program Evaluation

Reference

1.Lee WG., Kwak YS., Lee DH., Hwang YS., Lee KN. Clinical pathology laboratory inspection and accreditation in Korea I: development of the system and its trial. Korean J Clin Pathol. 2001. 21:86–92. (이위교, 곽연식, 이도훈, 황유성, 이갑노. 임상검사실표준화심사및신임인증제도에 관한 연구 I: 개발 및 시행에 관한 연구. 대한임상병리학회지 2001;21: 86-92.).

2.Lee WG., Kwak YS., Lee DH., Hwang YS., Lee KN. Laboratory inspection and accreditation in Korea II: analysis of the first round inspection. Korean J Lab Med. 2003. 23:363–9. (이위교, 곽연식, 이도훈, 황유성, 이갑노. 임상검사실표준화심사및신임인증제도에관한연구 II: 1차년도인증심사분석. 대한진단검사의학회지 2003;23: 363-9.).

3.Ministry for Health and Welfare Notification No. 1999-32, Part II Standards of Medical Cost and Guidelines for Medical Fee Estimation, Paragraph 1 Note: 2.4. , November 15, 1998, Standards for the Estimation of Medical Insurance Service Fees and Dispensary Costs, 092.2-413, May 27, 1999 Request for Cooperation for Service Guidance on the Execution of the Referral Sample Test Accreditation Program. (보건복지부 고시 제1999-32호 중 제2부 진료수가 기준액표및 산정지침 중 제1절 주:2.4., 1998.11.15 의료보험진료수가 및 약제비산정기준 092.2-413, 1999.5.27 검체 검사 수탁인증제도시행에 따른 업무안내등협조요청.

4.Ministry for Health and Welfare Notification No. 1999-32, Part II Standards of Medical Cost and Guidelines for Medical Cost Estimation, Paragraph 1 Code. (보건복지부 고시 제1999-32호중제2부진료수가기준액표및산정지침중제1절코드.).

5.Kwak YS. Current status of laboratory medicine and global standardization of laboratory inspection and accreditation. Korean J Lab Med. 2006. 26(S):S47–53. (곽연식. 외국 진단검사의학의 현황과 진단검사의학의국제적표준화. 대한진단검사의학회지 2006;26 (S): S47-53.).

6.Song KE. Experience of CAP accreditation. Korean J Lab Med. 2006. 26(S):S76–7. (송경은. CAP Accreditation 경험. 대한진단검사의학회지 2006;26 (S): S76-7.).

7.Shin BM. Public relations and usage of laboratory inspection and accreditation in Korea. Korean J Lab Med. 2006. 26(S):S16–7. (신보문. 인증심사의홍보및활용. 대한진단검사의학회지 2006;26 (S): S16-7.).

8.Chae SL. Development of the system of laboratory inspection and accreditation in Korea. Korean J Lab Med. 2006. 26(S):S78–81. (채석래. 대한진단검사의학회 인증심사 발전방향. 대한진단검사의학회지 2006;26 (S): S78-81.).

9.Shin BM. Quality assurance of genetic testing. J Korean Med Assoc. 2006. 49:583–8. (신보문. 유전자 검사의 질관리. 대한의사협회지 2006;49: 583-8.).

10.Chae SL. Importance of quality assurance of laboratory medicine in health care check. Korean J Lab Med. 2007. 27(S):S47–52. (채석래. 건강검진에서 진단의학검사 질관리의 중요성. 대한진단검사의학회지 2007;27 (S): S47-52.).