Medical Testing Accreditation – the Oz Experience

1. Medical Testing Accreditation – the Oz Experience Dr Michael Harrison, Chairman Medical Testing Accreditation Committee

2. Australian Pathology • ~ 50 million testing episodes pa • > 50% of population has 1 or more tests each year • 70% of medical decisions • All cancer diagnoses • Providers - Private 60%, Public 40% • Funding – Government >90% • Funding ~ $3b pa ( 3-4% of Health $)

3. Risks: Laboratory High • Specimen mixup • Lost specimens • Misdirected reports • Incorrect interpretation • Specimen artefact • Incorrect response to request • Analytical problems Low (however the most serious common error is failure to act on a significant result)

4. What is Quality? • The right result? • Lack of errors? • Improved health outcome? • Increased efficiencies

5. Quality = Right The challenge is getting everyone to agree what right is....

6. Graph of life expectancy at birth in the top 20 OECD countries in 2005

7. Graph of mortality rates for all cancers for males and females in 2004

8. Graph of health expenditure of OECD countries for 2004, both per capita and as a percentage of GDP

9. Quote A pessimist sees the difficulty in every opportunity; while an optimist sees the opportunity in every difficulty.

10. NATA/RCPA laboratory accreditation program • Role of NATA & RCPA • Regulatory framework – HIA • Medicare Australia • Standards - NPAAC & ISO • Accreditation process • Quality system accreditation • Quality Assurance Programs

11. Role of NATA and RCPA Joint program established in early ’80’s – formal arrangement by way of MOU NATA provides secretariat, Lead Assessors, infrastructure RCPA provides professional advice (ACs), voluntary assessors, mechanisms for review of Fellows if necessary Strong program, unique in world terms

12. Regulatory framework • Prior to 1986 – voluntary • 1986 - mandatory scheme linked to Health Insurance Act • 2003 – Deed for inspection of premises for the purpose of sub-section 23DN(1) of the Health Insurance Act 1973 and, provision by NATA of pathology laboratory assessment reports, and related arrangements

13. Medicare Australia • Reports issued to MA following each assessment activity • Laboratory responsible for submitting to Medicare with APL application/renewal • Applicants – benefits cannot be paid until a report is provided (post Advisory Visit) • Renewal – (requires successful accreditation) approval period restated

14. Accreditation requirements NPAAC and ISO • What are the requirements (standards) for accreditation? • ISO – 15189 (AS 4633) • NPAAC – general & specific requirements • Field Application Document • Other Australian Standards • Expert organization guidelines

15. NPAAC

16. NPAAC Philosophy

17. Requirements for Pathology Laboratories (2007 Edition)

18. NPAAC Document heirarchy

19. NPAAC Document heirarchy – Tier 4

20. NPAAC Document heirarchy – Tier 5&6

21. NPAAC Strategic Plan 2010

22. Accreditation requirements NATA • Field Application Document (FAD) • Every 2 years • Resolutions of issues raised at assessment • General information about NATA accreditation process • Available from NATA website (free to accredited laboratories)

23. Accreditation requirementsreview • ISO – via Standards Australia • NPAAC – via drafting group review & draft circulation for public comment • NATA FAD – via professional society representation on the Medical Testing Accreditation Advisory Committee

24. NATA accreditation

25. NATA accreditation process

26. Outcome of NATA accreditation

27. Typical Accreditation report

28. NATA/RCPA Typical Accreditation report

29. Accreditation report - initial

30. Accreditation report - response

31. NATA website

32. NATA website

33. NATA website

34. NATA/RCPA laboratory accreditation program • Role of NATA & RCPA • Regulatory framework – HIA • Medicare Australia • Standards - NPAAC & ISO • Accreditation process • Quality system accreditation • Quality Assurance Programs

35. Monitoring Quality of testing

36. RCPA Quality Assurance Programs

37. Interim Reports including Quantitative, Qualitative, Clinical Review, End-of-Cycle, Performance Summary, Error Analysis, Supervisor Report, Subgroup Report and Patient Report Comments

38. Pathology Accreditation

39. Medical testing Accreditation 2011 snapshot • 640 accredited sites • 28 new sites pa • 379 assessments pa • 1040 assessors • 8 complaints

40. Where are we now? • • Mature quality framework – 25y of refinement • • Proven quality improvement – with reduction in costs • • Clearly other factors at work too – Competitive environment • • KPI and non-analytical QA programs in development: • – Risk-based framework • – Evidence and outcome driven • – Adverse incidents • – Patient Safety • – Underperforming laboratories

41. Conclusions • • The Australian pathology accreditation system has produced excellent outcomes at reasonable cost • • NPAAC and NATA, working with • professional groups, have been key • • Ongoing streamlining of the framework is underway • • New challenges relate to -omics, PoCT, workforce shortages

42. I am easily satisfied with the very best.