©2012 RCPA Quality Assurance Programs Pty Ltd. All rights reserved.

Update on Point of Care Testing in Australia

Roslyn Bonar

Senior Scientist – Haematology QAP

Definitions and Guidelines – NATA, NPAAC etc

Where is PoCT used Advantages/Disadvantages Types of Devices The General Practitioners trial PoCT networks-

– Integrated Cardiovascular Clinical Network (iCCnet), – Pathology Queensland Statewide PoCT – Quality Assurance for Aboriginal and Torres Strait Islander

Medical Services (QAAMS), – NSW Health Emergency Department network (in progress)

Conclusions

Agenda

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Point of care testing is a popular means of providing laboratory testing at or near the site of patient care.

For the purpose of the GP trial, Point of Care Testing (PoCT) was defined as pathology testing performed by or on behalf of a medical practitioner at the time of consultation, allowing the results to be used to make immediate, informed decisions about patient care.

What is Point of care testing

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Department of Health guidelines

The Australian Government stipulates that a pathology service will attract Medicare benefits when performed by or on behalf of an Approved Pathology Practitioner (APP) within an approved laboratory, such as a Category M laboratory.

In accordance with the Department of Health guidelines, a Category M laboratory is laboratory in which pathology tests are provided by or under the (medical ) supervision of a medical practitioner for patients only of the medical practice in which that practitioner works.

Current Status no mandatory standards or guidelines written specifically for

PoCT in Australia.

Responsibility lies with individual organisations running PoCT to develop their own quality framework.

Most PoCT tests are not eligible for Medicare rebates – not accredited

A limited number of tests (Group P9) can be rebated under the Medicare Benefits Schedule (MBS) without accreditation.

Group P9 are classified as simple basic pathology tests which may be performed by medical practitioners in their own surgery on their own patients without need for formal quality assurance.

Guidelines Standards and guidelines developed for PoCT are designed to assist

in implementation and operation using a quality management system.

NATA is the national Association Testing Authoritory Provides accreditation for laboratories Guidelines are available from the website http://www.nata.asn.au/publications/section/4-technical-publications

NPACC is the National Pathology Accreditation Advisory Council is responsible for the development and maintenance of standards and guidelines for the practice of pathology

Royal Australian College of General practitioners together with the Dept of Health developed standards which were used for POCT during the GP Trial.

AACB Australasian Association of Clinical Biochemists provide Australian Government sanctioned guidelines.

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PoCT

Advantages

enhanced clinical management

greater patient compliance with pathology requests

greater convenience and satisfaction for patients - speed of diagnosis and treatment decision with fewer visits to the doctor

better health outcomes to the patient

greater satisfaction for the GP

savings in cost and time for patients because PoCT is done at the time of consultation

improvement in doctor/patient relationship.

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PoCT

Disadvantages

inaccurate results (due to inexperience) which leads to less than optimal health outcomes for the patient with additional testing and treatment

possible increased consultation and waiting time

Increased workload

Possible incompatibility with local laboratory results

Download and storage of results. Need for traceability.

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POCT Device Stratification

1. Non-instrumental disposable systems

e.g. drug screens, urine dip sticks, pregnancy tests

2. Hand held devices

e.g. blood glucose meters

3. Bench top analysers

e.g. blood gas analysers

• “Medium complexity devices utilising cartridge based technology (e.g. i-STAT, DCA)”

• “Low complexity devices utilising strip technology (e.g. glucose or coagulation meters”

AACB document “Guidelines for Conducting QC and QA for PoCT”

http://www.axis-shield.com/Afinion

The Afinion ACR provides a simple, fast and convenient point of care test for determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine.

Tests up to 22 tests relating to liver, lipid, kidney and diabetes including

AST, ALT, GGT, DBIL, TBIL, GLU, ALB, TP, BUN, CREA, ALP, Na, K, Cl, CHOL, HDL (LDL), TG, UA, AMY, Ca, tCo2, HbA1c

http://www.samsung.com/global/business/healthcare/healthcare/in-vitro-diagnostics/BCA-PT10/DE-features

Samsung LABGEO

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Results available in 7 mins

PoCT instruments for Chemistry

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Hemocue-Glucose

Cholestech LDX

Bay DCA 2000

INR PoCT instruments in Australia

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Coag-Sense

i-STAT

CoaguChek XS

The HemoCue® WBC DIFF

HemoControl

PoCT in General Practice Trial

GP Trial Funded by the Australian Government Department of Health

1 September 2005 - 28 February 2007 (18 month ‘live’ period)

Multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost-effectiveness and satisfaction of PoCT in General Practice

Total of 58 practices over a large geographic area (urban, rural and remote areas of SA, NSW and Vic)

26 practices randomised to the control group and 32 practices randomised to the intervention group

Participation of 247 General Practitioners

5,234 patients recruited from the practices of which 944 patients were on anticoagulant therapy, 1,967 had established diabetes and 3,819 had established hyperlipidaemia

Tests included HbA1c, urine albumin and albumin creatinine ratio, total cholesterol, HDL-C, triglyceride and International Normalised Ratio (INR)

Aims and Objectives

AIM: Should PoCT in general practice be implemented by

the Australian Governement ( for patients with established

diabetes, hyperlipidaemia or on anticoagulant therapy).

OBJECTIVE: to determine if the PoCT practices are able to

obtain EQA results within the acceptable analytical goals

and to implement a quality management system.

EQA Material – HbA1c

Developed with and manufactured by Australian Scientific Enterprise

EQA Material– Urine ACR & Lipids

EQA Material– INR

RCPA Haematology QAP

Outcomes of trial

All the serious adverse events (SAE) reported – were deemed not attributable to the trial. Most common was inpatient hospitalisation.

Intervention group had a lower SAE than the control group

Acceptable QC/QA results

High levels of concordance between PoCT and lab results for all the tests and the mean differences in results and the 95% limits of agreement were clinically acceptable

http://www.health.gov.au/internet/main/publishing.nsf/Content/health-pathology-poctt-index.htm 26

Australian PoCT Networks

iCCnet SA – cardiac monitoring

Pathology Queensland – i-STAT analyser network

QAAMS – Aboriginal Diabetes monitoring

NSW Health – Emergency department (new initiative)

iCCnet SA

Integrated Clinical Cardiovascular Network

South Australia

iCCnet PoCT Responsibilities Identify need for PoCT

Selection of PoCT equipment

Implementation of PoCT

Provide a 24 hour/7day a week technical support service

Quality Assurance

PoCT consumables procurement and distribution

iCCnet SA

Provides an integrated solution to ensure patients presenting to rural health facilities receive access to appropriate cardiac care

Includes clinical tools, resources & systems designed to support the practice of evidence based acute cardiac care by practitioners from a diverse range of backgrounds, experience & training

iCCnet SA

Provision of POCT to support timely risk stratification and decision making regardless of geographic location

Accessibility to Consultant Cardiology advice

24hours/ 7 days a week

Access to Tertiary Cardiac Services

Transfer of patients to city hospitals if required

Provision of comprehensive cardiac education

Pathology Queensland Statewide PoCT Testing

Pathology Queensland

Pathology Queensland provides pathology services to all Queensland Health public hospitals

networked system of 33 laboratories

district laboratories in rural hospitals, group laboratories in large regional hospitals and unit base laboratories providing tertiary referral services in metropolitan teaching hospitals

A State-Wide Basic Path System Statewide PoCT Testing

213 Abbott i-STAT analysers

140 sites

Largest i-STAT network in the world

Performs ~ 700 patient episodes / day

Performs blood gases, basic chemistry, cTnI & INR

All analysers are linked to the Statewide Pathology Computer

All results are added patients record

PoCT Benefits

PoCT is effective

PoCT has been shown to:

– reduce hospital stay time

– improve patient response to treatment

– reduce complications

QAAMS

Quality Assurance for Aboriginal & Torres Strait Islander Medical Services

provides culturally appropriate and clinically effective diabetes management to Aboriginal & Torres Islander people through the use of PoCT for HbA1c and Urine ACR that is conducted under a quality management system

150 sites Largest PoCT Network in Australia

QAAMS

Arose from recommendation of National Diabetes Strategy Report

Commenced in 1999

On-site POCT

HbA1c (diabetes control)

urine ACR (early renal disease)

Funded by the Australian Government

Department of Health

Managed by

Flinders International Centre for PoCT

RCPA Quality Assurance Programs

QAAMS

Aboriginal Health Professionals trained as PoCT operators

Siemens DCA 2000/Vantage

QAAMS Model

Safety and quality framework

1. Training

– initial operator training – competency certificates – continuing education

2. Quality Monitoring

– internal quality control – external quality assurance

3. Support Services

– telephone hotline – workshops – newsletters

There is sound, long-term evidence to show that QAAMS :

Meets defined clinical need

Analytically sound

Culturally effective

Clinically effective

Cost effective, safe & sustainable

Adaptable and transferable

Effectiveness of QAAMS

Evaluation Campbell Research & Consulting Independent Review of

QAAMS, Commissioned by Australian Government; Final Report 2008

“All sources of evidence suggest that QAAMS is meeting best practice standards in the areas of Indigenous healthcare, diabetes management and Point of Care testing.”

“QAAMS is one of the few programs to successfully navigate the cultural complexities and potential pitfalls of chronic disease management in Indigenous communities.”

PoCT EQA Urine Dipstick Chemistry PoCT Chemistry/troponin Blood Gas and Electrolytes Glycohaemogoblin On-site Urine Toxicology Screening Urine Pregnancy INR Haemoglobin Glucose meters in hospitals PoCT HIV PoCT Influenza A & B PoCT Syphilis PoCT RSV Ag

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POC-INR enrolments

Year No. of POC-INR enrolments

2009 109

2010 126

2011 168

2012 182

2013 195

7 Overseas 24 POCD MLabs 58 GPs, Medical Centres, Pharmacies and Collection centres (31%)

Conclusions

PoCT has the potential to provide improved patient care if performed within the guidelines of a quality management system.

Networks such as QAAMS, iCCnet and Queensland Health Pathology have shown that PoCT in a well controlled environment is both possible and beneficial to patient care.

The GP trial showed clinically acceptable results. There did not appear to any major difference when assessing location.

Funding is still the main issue.

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Acknowledgements

Janice Gill

Manager RCPAQAP Chemical Pathology, SA