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Accreditation of Medical Laboratories - Past, Present and Future

Accreditation of Medical Laboratories - Past, Present and Future. KF Wong, MD Chairman, A AB Working Party on Medical Testing. What is accreditation?. Realize ability Reach for the better Recognise limitations. Why we have to do it?. Professional standards Quality management

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Accreditation of Medical Laboratories - Past, Present and Future

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  1. Accreditation of Medical Laboratories -Past, Present and Future KF Wong, MD Chairman, AAB Working Party on Medical Testing

  2. What is accreditation? • Realize ability • Reach for the better • Recognise limitations

  3. Why we have to do it? • Professional standards • Quality management • Recognition (by peers and public)

  4. The old adage…. 「上醫醫未病之病、 中醫醫欲病之病、 下醫醫已病之病。」 《黃帝內經》

  5. 「上檢檢未犯之錯、 中檢檢欲犯之錯、 下檢檢已犯之錯。」 《ISO外經》 An accredited laboratory is a safe, self-regulated and saleable laboratory.

  6. In the beginning…. • Some laboratories have already sought accreditation by overseas bodies (NATA and CAP) in the late-90’s. • NATA - National Association of Testing Authorities, Australia (ISO 17025) • CAP - College of American Pathologists

  7. Let there be light…. 2001 Policy Address, Health Services Policy Objective:“Expansion of the HOKLAS to enhance the quality of clinical pathology service. Our target is to expand the HOKLAS to cover clinical pathology laboratories in 2003.”

  8. And there was light. • Apr 02 AABWP on medical testing (13 members) • Jun 02 6 Task Forces (Pathology disciplines) • Dec 02 MOU signed between HKAS & HKCPath • Mar 03 SARS • May 03 AABWP Chairman’s resignation • July 03 First draft of HOKLAS 015 (on ISO15189)

  9. MOU

  10. We met with the stakeholders.

  11. We talk and we argue…. • Difficulties faced • Differences recognised • Discrepancies narrowed We have the same vision – a safe and quality laboratory service for Hong Kong.

  12. And the rest is history. • Nov 03 Categorization of laboratories (P & S) • Feb 04 HOKLAS 015 published & launched • July 04 First application • Jan 05 Bridging Scheme • Mar 05 First accreditation • Jan 06 7 laboratories accredited (HOKLAS 8) • Feb 06 4 more applications (with 11 laboratories)

  13. Bridging Scheme

  14. Who’s who?

  15. The unnamed heroes • 16 pathologists (from 4 disciplines) • 16 medical laboratory scientists • 63 potential assessors • But, there are over 160 laboratories.

  16. What have we done…. • ISO 15189 and HOKLAS 015 • 8 supplementary criteria (SC 23-30) • 2 preparatory workshops & 3 seminars • 4 assessor training courses (2003-2005) • 21 pre-application laboratory visits • 7 laboratories accredited, more will come

  17. ISO 15189 vs ISO 17025 • Continual improvement • Laboratory and staff safety • TAT and critical/alert levels • Pre/post-examination procedures • Uncertainty of measurement It is a requirement of ISO 15189 that laboratories “shall determine the uncertainty of measurement of results, where relevant and possible”…. (5.6.2)

  18. MU…. • Questionable practicality and usefulness in clinical laboratory (semi-quantitative results). • Clinical medicine is very complex, and is both a science and an art (subjective element). • Clinicians examine the patient, look at the trend, and make judgement on the test results.

  19. Building Confidence inMedical Testing through Accreditation

  20. A serious business….

  21. A joyous moment!

  22. What’s next • Further publicity of laboratory accreditation • Accreditation of proficiency testing providers • Joint assessment with overseas accreditation bodies

  23. What do we need now? • Government support • College collaboration • Profession partnership • Public recognition/acceptance

  24. Accreditation is hard work –let’s do it professionallyand enjoy the process.

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