KMID : 0981820090290020163
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Korean Journal of Laboratory Medicine 2009 Volume.29 No. 2 p.163 ~ p.170
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The Implementation and Effects of a Clinical Laboratory Accreditation Program in Korea from 1999 to 2006
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Shin Bo-Moon
Suh Soon-Pal Lee You-Kyoung Lee Wee-Gyo Cha Young-Joo Lee Kap-No Lim Hwan-Sub Lim Young-Ae Chae Seok-Lae Kwak Yun-Sik Lee Do-Hoon Min Won-Ki
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Abstract
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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.
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KEYWORD
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Laboratory inspection, Laboratory accreditation, Quality assurance
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