Dr Michael Harrison, Chairman Medical Testing
Accreditation Committee

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 $)

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)

 The right result?
 Lack of errors?
 Improved health outcome?
 Increased efficiencies

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

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

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

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

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

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

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

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

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

NPAAC

NPAAC Philosophy

Requirements for Pathology
Laboratories (2007 Edition)

NPAAC Document heirarchy

NPAAC Document heirarchy
– Tier 4

NPAAC Document heirarchy
– Tier 5&6

NPAAC Strategic Plan 2010

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)

Accreditation requirements review
 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

NATA accreditation

NATA accreditation process

Outcome of NATA accreditation

Typical Accreditation report

NATA/RCPA Typical Accreditation report

Accreditation report - initial

Accreditation report response

NATA website

NATA website

NATA website

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

Monitoring Quality of testing

RCPA Quality Assurance Programs

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

Pathology Accreditation

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

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

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

I am easily satisfied with the very best.