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Shin, Chae, Min, Lee, Lim, Lee, Lim, Lee, Cha, Suh, Lee, and Kwak: The Implementation and Effects of a Clinical Laboratory Accreditation Program in Korea from 1999 to 2006
Original Article

Korean J Leg Med 2009;29(2):163-170.

Published online: 14 February 2009

DOI: https://doi.org/10.3343/kjlm.2009.29.2.163

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

Bo-Moon Shin, M.D.1, Seok-Lae Chae, M.D.2, , Won-Ki Min, M.D.3, Wee Gyo Lee, M.D.4, Young Ae Lim, M.D.4, Do Hoon Lee, M.D.5, Hwan Sub Lim, M.D.6, You Kyoung Lee, M.D.7, Young-Joo Cha, M.D.8, Soon-Pal Suh, M.D.9, Kap No Lee, M.D.10, Yun Sik Kwak, M.D.11

1Department of Laboratory Medicine, Sanggye Paik Hospital, Inje University, Seoul, Korea

2College of Medicine, Dongguk University, Goyang, Korea

3University of Ulsan College of Medicine, Seoul, Korea

4Ajou University, Suwon, Korea

5National Cancer Institute, Goyang, Korea

6Kwandong University, Goyang, Korea

7Soonchunhyang University, Bucheon, Korea

8Chung-Ang Univerisity, Seoul, Korea

9Chonnam National University, Gwangju, Korea

10Korea University, Seoul, Korea

11Department of Medical Informatics, Kyungpook National University, Daegu, Korea

Corresponding author: Seok-Lae Chae, Ph.D. Department of Laboratory Medicine, College of Medicine, Dongguk University, 814 Siksa-dong, Ilsan-gu, Goyang 411-773, Korea Tel: +82-31-961-7890, Fax: +82-31-961-7902 E-mail: rocky@duih.org

Received 14 December 20071 February 2009       Accepted 21 February 2009

Copyright © 2009 by the Korean Society for Legal Medicine

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

Keywords: Laboratory inspection, Laboratory accreditation, Quality assurance

REFERENCES

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crossref
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Table 1.
Distribution of participating laboratories according to the results of inspection scores of each laboratory (N)
  1999 2000 2001 2002 2003 2004 2005 2006
Participating institute 96 178 187 187 188 192 204 226
2-yr accreditation∗ 0 55 52 65 53 89 49 82
1-yr accreditation† 96 116 62 57 59 41 71 93
Self-inspection 0 0 55 52 65 53 81 47
Non-renewal 0 6 16 13 8 8 3 4
Non-accreditation‡ 0 1 2 0 2 1 0 0
Retrial 0 0 1 1 5 0 11 5

∗ Two-year accreditation is given to the laboratory if the total average inspection score is 90 or higher, Institutions in group B (<400 beds) scoring 80 or higher received 2-yr accreditation only during the period of 2004-2005;

† One-year accreditation is given to the laboratory if the total average score is 60 or higher but less than 90;

‡ Non-accreditation is given to the laboratory whose inspection score is less than 60.

Table 2.
The inspection scores of participating institutes by inspection checklist areas (year 2001-2006)
Parameter 2001 2002 2003 2004 2005 2006
Lab. Management (N)∗ 118 124 117 133 127 178
 Mean 91.87 93.64 92.33 93.18 93.48 95.05
 SD 7.58 5.18 5.97 6.55 6.52 4.55
Hematology (N) 117 124 116 130 122 174
 Mean 92.45 94.98 92.48 94.10 94.36 94.47
 SD 6.29 5.06 6.79 5.36 7.03 5.66
Chemistry 117 124 120 131 124 172
 Mean 93.74 95.37 90.27 94.93 94.22 95.40
 SD 7.87 3.85 13.20 6.82 5.70 4.07
Microbiology 114 121 119 129 118 156
 Mean 92.69 94.10 88.73 93.58 92.20 95.15
 SD 5.29 5.38 16.29 6.14 7.28 3.95
Blood Bank 114 125 116 129 121 170
 Mean 93.69 95.88 92.44 95.26 95.51 96.76
 SD 6.45 4.83 11.05 4.90 4.67 3.63
Immunoserology 117 124 118 132 122 172
 Mean 93.72 95.20 92.20 94.50 94.40 94.92
 SD 5.78 4.97 11.34 6.04 7.38 5.20
Flow cytometry 6 25 9 26 14 33
 Mean 97.89 98.05 97.94 98.33 97.87 98.16
 SD 2.59 1.71 2.12 1.67 2.03 1.75
HLA 16 42 19 39 29 44
 Mean 96.54 97.20 97.92 97.27 97.46 97.79
 SD 2.95 3.57 2.43 2.93 2.35 1.75
Cytogenetics 6 25 11 22 19 32
 Mean 96.38 98.16 97.48 97.37 97.84 98.09
 SD 2.71 1.58 4.06 5.69 2.50 1.90
Molecular biology 18 45 23 48 44 63
 Mean 95.09 97.25 97.02 97.40 96.28 97.40
 SD 5.67 2.45 3.05 2.69 4.50 2.96
Comprehensive            
Verification of Laboratory test            
 Result 97 103 98 105 82 128
  Mean 96.81 97.04 97.24 97.52 96.97 97.24
  SD 5.08 3.84 3.94 3.17 4.85 3.47
Reference Lab.         42 33
 Mean         84.89 95.88
 SD         9.27 3.67

∗ Number of participating institutes.

Table 3.
The result of questionnaire survey on the effects of laboratory accreditation program and its training woworkshops (%, n=274)
Effects of accreditation programs Strongly disagree Disagree Uncertain Agree Strongly agree No response
We could improve equipments functions 6.5 15.0 32.0 39.7 4.5 2.4
We could improve instrumentations 6.9 15.0 44.5 27.9 3.2 2.4
We could implement laboratory information system 10.1 17.0 34.8 27.9 5.7 4.5
We could improve the qualities of tests 2.0 2.4 21.1 56.3 15.8 2.4
We could increase the numbers of medical technologist 32.4 28.3 27.5 8.1 1.2 2.4
We could intensify the internal quality control systems 1.2 1.2 13.4 58.7 23.9 1.6
We recognized the importance of documentations 0.8 1.6 6.9 55.5 33.6 1.6
We became more aware of importance of laboratory safety 1.6 4.5 25.5 53.4 13.4 1.6
We became more interested in qualities of tests 0.4 2.0 10.5 59.1 26.7 1.2
We have pride through laboratory accreditation 2.4 8.5 37.3 36.0 14.2 1.6
Inspectors cited deficiencies and provided corrective measures 0.8 5.3 23.9 52.2 15.8 2.0
Inspectors were courteous and not nitpicking 0.8 2.4 21.5 59.9 13.8 1.6
I expressed my opinion in case of disagreement 1.2 11.3 39.7 38.9 6.9 2.0
I am aware there is KLAP homepage 18.2 15.0 16.6 22.7 25.5 2.0
I frequently visit KLAP homepage 30.0 25.1 30.8 7.3 4.5 2.4
I will use homepage in case of unsolved problems 4.1 7.7 23.9 43.3 19.8 1.2
The workshops were useful 0.8 0.8 21.1 53.0 23.5 0.8
I recommend my colleagues to attend the workshop 1.2 3.6 19.9 50.2 24.3 0.8
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