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Medical Testing
Accreditation – the
Oz Experience
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 $)
Risks: Laboratory
High
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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)
What is Quality?
 The right result?
 Lack of errors?
 Improved health outcome?
 Increased efficiencies
Quality = Right
The challenge is getting
everyone to agree what
right is....
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
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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
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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
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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
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• 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.