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Wang-wah WONG
Executive Administrator
Hong Kong Accreditation Service
1
2
Health and Welfare Bureau
“Ensure the development and maintenance of a
framework of quality assurance to support the
consistent delivery of quality health services based
on knowledge and centred on patients”
(2001 Policy Address)
3
Expansion of the Hong Kong Laboratory Accreditation Scheme
(under Hong Kong Accreditation Service) to enhance the quality of
clinical pathology service.
4
SIGNING OF A MEMORANDUM OFSIGNING OF A MEMORANDUM OF
UNDERSTANDING WITH HONG KONG COLLEGEUNDERSTANDING WITH HONG KONG COLLEGE
OF PATHOLOGISTS (HKCPATH)OF PATHOLOGISTS (HKCPATH)
• to provide professional input to the accreditation
process;
• to provide advice on the technical criteria for
accreditation; and
• to provide up-dates on relevant technical advances
in medical laboratory practice.
5
STRONG SUPPORT FROMSTRONG SUPPORT FROM
HKCPATHHKCPATH
• to nominate a representative to HKAS to sit on the
Accreditation Advisory Board and this person will
chair the Working Party on Medical Testing
• to serve as the co-organiser or supporting
organisation for various seminars HKAS organised
6
7
8
Publishing of ISO
15189:2012
2012
10
20
30
MILESTONESMILESTONES
9
NUMBER OF LABORATORIES ACCREDITEDNUMBER OF LABORATORIES ACCREDITED
10
Nature of
organisations
Number of
organisations
Number accredited
Hospitals under
Hospital Authority
19 Hospitals HKAS 16
NATA 3
CAP 1 *
Laboratories under
Department of Health
6 Divisions/Services HKAS 6
Private hospitals 11 Hospitals HKAS 3
(include 4 laboratories)
NATA 1
Commercial
laboratories (include
independent laboratories
operating in hospitals)
> 200 medical
laboratories (include collection
centres, medical testing and X-ray
laboratories)
HKAS 16
(include 23 medical testing
laboratories and 31 collection
centres)
* One hospital got both CAP and HKAS accreditation
11
12
2004-2006
40 laboratory assessments
2004-2006
40 laboratory assessments
2009
61 laboratory assessments
2009
61 laboratory assessments
Initial Assessment Second Reassessment
Grading Number NC per lab Grading Number NC per lab
S 76 3.2 S 18 0.7
M 295 10.4 M 151 5.9
R 371 13.5 R 169 6.6
S: significant non-conformity
M: minor non-conformity
R: recommendation
Bella Ho, Eric Ho. The most common nonconformities encountered during the assessments of medical
laboratories in Hong Kong using ISO 15189 as accreditation criteria. Biochemia Medica 2012;22(2):247-57.
13
PERFORMANCE COMPARISON OF 27PERFORMANCE COMPARISON OF 27
LABORATORIES IN THEIR INITIALLABORATORIES IN THEIR INITIAL
ASSESSMENTS AND IN THEIR SECONDASSESSMENTS AND IN THEIR SECOND
REASSESSMENTSREASSESSMENTS
14
PERFORMANCE OF ACCREDITED MEDICALPERFORMANCE OF ACCREDITED MEDICAL
TESTING LABORATORIES IN PROFICIENCYTESTING LABORATORIES IN PROFICIENCY
TESTING / EQAPTESTING / EQAP
15
 Before 2004 – No local full time Bachelor and only one
Master course in Medical Science offered by HKU – others are
top-up overseas Master courses or distant learning courses
 In 2004 – First full time Bachelor course offered by HK
Polytechnic University
 Thereafter– Apart from the HKU MMedSc course, relevant
Master courses are also available from HKPoly U, and CUHK
 Number of medical technologists eligible to be Laboratory
Directors has increased
MORE EDUCATIONAL OPPORTUNITIESMORE EDUCATIONAL OPPORTUNITIES
16
Potential assessors taking the post-course assessment after
the medical assessor training course
17
Total: 156 technical assessors
18
As of January 2015
19
 Participate in ISO TC212 which is responsible for drafting ISO 15189
 Provide training on the implementation of ISO 15189 to Chinese
Center for Disease Control and Prevention and medical testing
professionals in Macau
 Regular exchange of experience with CNAS and TAF through annual
tripartite meetings
 Participate in APLAC Mutual Recognition Arrangement (MRA) Council
for discussion of peer evaluation reports of accreditation bodies
which are MRA partners
 Hold APLAC training courses for medical testing
20
HKAS PARTICIPATES IN INTERNATIONALHKAS PARTICIPATES IN INTERNATIONAL
ACTIVITIESACTIVITIES
21
22
For testing laboratories,
•QA/QC workshops
•Interpretation of EQAP results
•Evaluation of autoanalysers
•Measurement uncertainty for medical testing
For technical assessors,
•Annual assessor seminar
•Workshop on calibration of general equipment (e.g. thermometers, balances)
•Workshops on harmonisation of accreditation standards
For all of us,
CONTINUAL IMPROVEMENTCONTINUAL IMPROVEMENT
Seminars/workshops to enhance testing capability and raise quality standard:
WHAT DO WE DO IN THE NEXT 10WHAT DO WE DO IN THE NEXT 10
YEARS?YEARS?
• Cultivate close partnership with different stakeholders
• Maintain high quality standard of accredited
laboratories
• Encourage more medical laboratories to get
accreditation
• Promote the benefits of accreditation
23
24

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HKAS Experience in Accreditation of Medical Testing Laboratories - W. W. Wong

  • 1. Wang-wah WONG Executive Administrator Hong Kong Accreditation Service 1
  • 2. 2 Health and Welfare Bureau “Ensure the development and maintenance of a framework of quality assurance to support the consistent delivery of quality health services based on knowledge and centred on patients” (2001 Policy Address)
  • 3. 3 Expansion of the Hong Kong Laboratory Accreditation Scheme (under Hong Kong Accreditation Service) to enhance the quality of clinical pathology service.
  • 4. 4 SIGNING OF A MEMORANDUM OFSIGNING OF A MEMORANDUM OF UNDERSTANDING WITH HONG KONG COLLEGEUNDERSTANDING WITH HONG KONG COLLEGE OF PATHOLOGISTS (HKCPATH)OF PATHOLOGISTS (HKCPATH)
  • 5. • to provide professional input to the accreditation process; • to provide advice on the technical criteria for accreditation; and • to provide up-dates on relevant technical advances in medical laboratory practice. 5 STRONG SUPPORT FROMSTRONG SUPPORT FROM HKCPATHHKCPATH
  • 6. • to nominate a representative to HKAS to sit on the Accreditation Advisory Board and this person will chair the Working Party on Medical Testing • to serve as the co-organiser or supporting organisation for various seminars HKAS organised 6
  • 7. 7
  • 9. 9 NUMBER OF LABORATORIES ACCREDITEDNUMBER OF LABORATORIES ACCREDITED
  • 10. 10 Nature of organisations Number of organisations Number accredited Hospitals under Hospital Authority 19 Hospitals HKAS 16 NATA 3 CAP 1 * Laboratories under Department of Health 6 Divisions/Services HKAS 6 Private hospitals 11 Hospitals HKAS 3 (include 4 laboratories) NATA 1 Commercial laboratories (include independent laboratories operating in hospitals) > 200 medical laboratories (include collection centres, medical testing and X-ray laboratories) HKAS 16 (include 23 medical testing laboratories and 31 collection centres) * One hospital got both CAP and HKAS accreditation
  • 11. 11
  • 12. 12 2004-2006 40 laboratory assessments 2004-2006 40 laboratory assessments 2009 61 laboratory assessments 2009 61 laboratory assessments
  • 13. Initial Assessment Second Reassessment Grading Number NC per lab Grading Number NC per lab S 76 3.2 S 18 0.7 M 295 10.4 M 151 5.9 R 371 13.5 R 169 6.6 S: significant non-conformity M: minor non-conformity R: recommendation Bella Ho, Eric Ho. The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria. Biochemia Medica 2012;22(2):247-57. 13 PERFORMANCE COMPARISON OF 27PERFORMANCE COMPARISON OF 27 LABORATORIES IN THEIR INITIALLABORATORIES IN THEIR INITIAL ASSESSMENTS AND IN THEIR SECONDASSESSMENTS AND IN THEIR SECOND REASSESSMENTSREASSESSMENTS
  • 14. 14 PERFORMANCE OF ACCREDITED MEDICALPERFORMANCE OF ACCREDITED MEDICAL TESTING LABORATORIES IN PROFICIENCYTESTING LABORATORIES IN PROFICIENCY TESTING / EQAPTESTING / EQAP
  • 15. 15  Before 2004 – No local full time Bachelor and only one Master course in Medical Science offered by HKU – others are top-up overseas Master courses or distant learning courses  In 2004 – First full time Bachelor course offered by HK Polytechnic University  Thereafter– Apart from the HKU MMedSc course, relevant Master courses are also available from HKPoly U, and CUHK  Number of medical technologists eligible to be Laboratory Directors has increased MORE EDUCATIONAL OPPORTUNITIESMORE EDUCATIONAL OPPORTUNITIES
  • 16. 16
  • 17. Potential assessors taking the post-course assessment after the medical assessor training course 17
  • 18. Total: 156 technical assessors 18 As of January 2015
  • 19. 19
  • 20.  Participate in ISO TC212 which is responsible for drafting ISO 15189  Provide training on the implementation of ISO 15189 to Chinese Center for Disease Control and Prevention and medical testing professionals in Macau  Regular exchange of experience with CNAS and TAF through annual tripartite meetings  Participate in APLAC Mutual Recognition Arrangement (MRA) Council for discussion of peer evaluation reports of accreditation bodies which are MRA partners  Hold APLAC training courses for medical testing 20 HKAS PARTICIPATES IN INTERNATIONALHKAS PARTICIPATES IN INTERNATIONAL ACTIVITIESACTIVITIES
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  • 22. 22 For testing laboratories, •QA/QC workshops •Interpretation of EQAP results •Evaluation of autoanalysers •Measurement uncertainty for medical testing For technical assessors, •Annual assessor seminar •Workshop on calibration of general equipment (e.g. thermometers, balances) •Workshops on harmonisation of accreditation standards For all of us, CONTINUAL IMPROVEMENTCONTINUAL IMPROVEMENT Seminars/workshops to enhance testing capability and raise quality standard:
  • 23. WHAT DO WE DO IN THE NEXT 10WHAT DO WE DO IN THE NEXT 10 YEARS?YEARS? • Cultivate close partnership with different stakeholders • Maintain high quality standard of accredited laboratories • Encourage more medical laboratories to get accreditation • Promote the benefits of accreditation 23
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