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

Wang-wah WONG

Executive Administrator

Hong Kong Accreditation Service

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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)

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Expansion of the Hong Kong Laboratory Accreditation Scheme (under Hong Kong Accreditation Service) to enhance the quality of

clinical pathology service.

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SIGNING OF A MEMORANDUM OF SIGNING OF A MEMORANDUM OF UNDERSTANDING WITH HONG KONG COLLEGE UNDERSTANDING 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.

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STRONG SUPPORT FROM STRONG 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

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Publishing of ISO 15189:20122012

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MILESTONESMILESTONES

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NUMBER OF LABORATORIES ACCREDITEDNUMBER OF LABORATORIES ACCREDITED

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Nature of organisations

Number of organisations

Number accredited

Hospitals under Hospital Authority

19 Hospitals HKAS 16NATA 3CAP 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

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2004-200640 laboratory assessments

2004-200640 laboratory assessments

200961 laboratory assessments

200961 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-conformityM: minor non-conformityR: 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.

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PERFORMANCE COMPARISON OF 27 PERFORMANCE COMPARISON OF 27 LABORATORIES IN THEIR INITIAL LABORATORIES IN THEIR INITIAL

ASSESSMENTS AND IN THEIR SECOND ASSESSMENTS AND IN THEIR SECOND REASSESSMENTSREASSESSMENTS

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PERFORMANCE OF ACCREDITED MEDICAL PERFORMANCE OF ACCREDITED MEDICAL TESTING LABORATORIES IN PROFICIENCY TESTING LABORATORIES IN PROFICIENCY

TESTING / EQAPTESTING / EQAP

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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 OPPORTUNITIES MORE EDUCATIONAL OPPORTUNITIES

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Potential assessors taking the post-course assessment after the medical assessor training course

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Total: 156 technical assessors

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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 testing20

HKAS PARTICIPATES IN INTERNATIONAL HKAS PARTICIPATES IN INTERNATIONAL ACTIVITIESACTIVITIES

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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 IMPROVEMENTSeminars/workshops to enhance testing capability and raise quality standard:

WHAT DO WE DO IN THE NEXT 10 WHAT 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

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