SlideShare a Scribd company logo
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

More Related Content

PPTX
Clinical biochemistry changes
PPTX
Nabl 112 gap analysis general
PPTX
Importance of laboratory compliance
PDF
Iso 15189 white paper lakshy rev02_17022015 low
PDF
Pharmacovigilance role through investigating Out of Specification (OOS) for F...
PPT
Out of specifications
PDF
New requirements for sponsors and laboratories for analyzing clinical trial s...
PPT
Clinical laboratory quality audit aligning ISO15189 2012
Clinical biochemistry changes
Nabl 112 gap analysis general
Importance of laboratory compliance
Iso 15189 white paper lakshy rev02_17022015 low
Pharmacovigilance role through investigating Out of Specification (OOS) for F...
Out of specifications
New requirements for sponsors and laboratories for analyzing clinical trial s...
Clinical laboratory quality audit aligning ISO15189 2012

What's hot (19)

DOC
RAJENDRA_CV
PDF
Laboratory accreditation
PPTX
Guidelines for utilizing proficiency testing reports to improve quality of a ...
PDF
Iso 15189 medical lab_ accred
PPTX
Tga presentation National Medicines Symposium 19 may 2016
PPSX
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...
PDF
Laboratory accreditation by iso 15189
PDF
Cleaning to Control Contamination in Drug Products
PPTX
ISO 15189:2007
PPTX
POINT-of-IMPACT testing. A European perspective - Bert Niesters
DOCX
MD-Manager Nichols_Becky 2016
PPTX
Good Laboratory Practices ppt
PDF
Quality Control for Point of Care Testing - White Paper
PPTX
Overview And Principles Of Standardization 27 May 2008
PDF
ISO 15189 Accreditation Guide - Improving Laboratory Performance Through Qual...
PPTX
Guidelines regarding point of care testing
PPTX
Conducting Clinical Trials in Asia: Global Engage.May.2013
PPT
Good Laboratory Practices (http://www.ubio.in)
PPTX
Accreditation of Inspection Activities of health and social care providers - ...
RAJENDRA_CV
Laboratory accreditation
Guidelines for utilizing proficiency testing reports to improve quality of a ...
Iso 15189 medical lab_ accred
Tga presentation National Medicines Symposium 19 may 2016
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...
Laboratory accreditation by iso 15189
Cleaning to Control Contamination in Drug Products
ISO 15189:2007
POINT-of-IMPACT testing. A European perspective - Bert Niesters
MD-Manager Nichols_Becky 2016
Good Laboratory Practices ppt
Quality Control for Point of Care Testing - White Paper
Overview And Principles Of Standardization 27 May 2008
ISO 15189 Accreditation Guide - Improving Laboratory Performance Through Qual...
Guidelines regarding point of care testing
Conducting Clinical Trials in Asia: Global Engage.May.2013
Good Laboratory Practices (http://www.ubio.in)
Accreditation of Inspection Activities of health and social care providers - ...
Ad

Similar to HKAS Experience in Accreditation of Medical Testing Laboratories - W. W. Wong (20)

PPTX
1. Day 1, Overview on Quality Management System.pptx
PPTX
Strategies of assuring quality of laboratory results
PPT
Medical Laboratory Accreditation and its utilization in Japan - Katsuo Kubono
PDF
CLT-quality standards in health laboratories
PPTX
NABL.pptx
PPTX
NABL.pptx
PDF
Crucial Quality Standards for Medical Laboratories.pdf
PDF
Iso 15189 medical lab_ accred
PPTX
Significance of CAP accreditation
PPTX
National Accreditation Board for Testing and Calibration Laboratories (NABL)....
PPTX
Understanding ISO 15189 Accreditation
PDF
Harmonization of Laboratory Indicators, 09 03-2017
PPTX
8 august quality and performance indicators.pptx
PPT
Pkqa iso 17025 requirements
PPT
Pkqa iso 17025 requirements
PPTX
National Accreditation Board for Testing and Calibration Laboratories (NABL)
PDF
2. Delia Geary IDPS lab workshop march 2019
PPT
Industerial Process Validation_Bangkok story.ppt
1. Day 1, Overview on Quality Management System.pptx
Strategies of assuring quality of laboratory results
Medical Laboratory Accreditation and its utilization in Japan - Katsuo Kubono
CLT-quality standards in health laboratories
NABL.pptx
NABL.pptx
Crucial Quality Standards for Medical Laboratories.pdf
Iso 15189 medical lab_ accred
Significance of CAP accreditation
National Accreditation Board for Testing and Calibration Laboratories (NABL)....
Understanding ISO 15189 Accreditation
Harmonization of Laboratory Indicators, 09 03-2017
8 august quality and performance indicators.pptx
Pkqa iso 17025 requirements
Pkqa iso 17025 requirements
National Accreditation Board for Testing and Calibration Laboratories (NABL)
2. Delia Geary IDPS lab workshop march 2019
Industerial Process Validation_Bangkok story.ppt
Ad

More from Mara International (6)

PPTX
Challenges to develop PT programs in the field of Forensic science - Jia Rujing
PPTX
Safety is a Must not a Choice - Andrew Swift
PPTX
Proficiency Testing (PT) – a tool to improve laboratory performance - Brian B...
PPT
GCC Proficiency Testing Program in the Field of Medical Laboratories - Adel ...
PPTX
Understanding The Process and Benefits of Proficiency Testing - Steve Hepburn
PPTX
Abu Dhabi PT program for cranes inspection - Dr. Rehab Al Ameri
Challenges to develop PT programs in the field of Forensic science - Jia Rujing
Safety is a Must not a Choice - Andrew Swift
Proficiency Testing (PT) – a tool to improve laboratory performance - Brian B...
GCC Proficiency Testing Program in the Field of Medical Laboratories - Adel ...
Understanding The Process and Benefits of Proficiency Testing - Steve Hepburn
Abu Dhabi PT program for cranes inspection - Dr. Rehab Al Ameri

Recently uploaded (20)

PPTX
Uterus anatomy embryology, and clinical aspects
PPTX
Important Obstetric Emergency that must be recognised
PPTX
CEREBROVASCULAR DISORDER.POWERPOINT PRESENTATIONx
PPT
Copy-Histopathology Practical by CMDA ESUTH CHAPTER(0) - Copy.ppt
PDF
Medical Evidence in the Criminal Justice Delivery System in.pdf
PPTX
Electromyography (EMG) in Physiotherapy: Principles, Procedure & Clinical App...
PPTX
DENTAL CARIES FOR DENTISTRY STUDENT.pptx
PPTX
NEET PG 2025 Pharmacology Recall | Real Exam Questions from 3rd August with D...
PPTX
JUVENILE NASOPHARYNGEAL ANGIOFIBROMA.pptx
PPT
OPIOID ANALGESICS AND THEIR IMPLICATIONS
PPTX
SKIN Anatomy and physiology and associated diseases
PPTX
ACID BASE management, base deficit correction
PPTX
Respiratory drugs, drugs acting on the respi system
PPTX
15.MENINGITIS AND ENCEPHALITIS-elias.pptx
PPT
genitourinary-cancers_1.ppt Nursing care of clients with GU cancer
PPT
Breast Cancer management for medicsl student.ppt
PDF
Khadir.pdf Acacia catechu drug Ayurvedic medicine
PPTX
Pathophysiology And Clinical Features Of Peripheral Nervous System .pptx
PDF
NEET PG 2025 | 200 High-Yield Recall Topics Across All Subjects
PPTX
1 General Principles of Radiotherapy.pptx
Uterus anatomy embryology, and clinical aspects
Important Obstetric Emergency that must be recognised
CEREBROVASCULAR DISORDER.POWERPOINT PRESENTATIONx
Copy-Histopathology Practical by CMDA ESUTH CHAPTER(0) - Copy.ppt
Medical Evidence in the Criminal Justice Delivery System in.pdf
Electromyography (EMG) in Physiotherapy: Principles, Procedure & Clinical App...
DENTAL CARIES FOR DENTISTRY STUDENT.pptx
NEET PG 2025 Pharmacology Recall | Real Exam Questions from 3rd August with D...
JUVENILE NASOPHARYNGEAL ANGIOFIBROMA.pptx
OPIOID ANALGESICS AND THEIR IMPLICATIONS
SKIN Anatomy and physiology and associated diseases
ACID BASE management, base deficit correction
Respiratory drugs, drugs acting on the respi system
15.MENINGITIS AND ENCEPHALITIS-elias.pptx
genitourinary-cancers_1.ppt Nursing care of clients with GU cancer
Breast Cancer management for medicsl student.ppt
Khadir.pdf Acacia catechu drug Ayurvedic medicine
Pathophysiology And Clinical Features Of Peripheral Nervous System .pptx
NEET PG 2025 | 200 High-Yield Recall Topics Across All Subjects
1 General Principles of Radiotherapy.pptx

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
  • 21. 21
  • 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
  • 24. 24