Accreditation of Medical Laboratories - Past, Present and Future

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Accreditation of Medical Laboratories -Past,
Present and Future

• KF Wong, MD
• Chairman, AAB Working Party on Medical Testing

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What is accreditation?

• Realize ability
• Reach for the better
• Recognise limitations

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Why we have to do it?

• Professional standards
• Quality management
• Recognition (by peers and public)

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The old adage.

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An accredited laboratory is a safe,
self-regulated and saleable laboratory.
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In the beginning.

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

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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.

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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 Chairmans resignation
• July 03 First draft of HOKLAS 015 (on ISO15189)

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MOU
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We met with the stakeholders.
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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.

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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)

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Bridging Scheme
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Whos who?
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The unnamed heroes

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

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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

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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)

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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.

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Building Confidence inMedical Testing through
Accreditation
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A serious business.
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A joyous moment!
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Whats next

• Further publicity of laboratory accreditation
• Accreditation of proficiency testing providers
• Joint assessment with overseas accreditation
  bodies

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What do we need now?

• Government support
• College collaboration
• Profession partnership
• Public recognition/acceptance

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Accreditation is hard work lets do it
professionallyand enjoy the process.