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
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
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 80s

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.