roslyn bonar - royal college of pathologists of australasia - update on poct in australia
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Royal College of Pathologists of Australasia (RCPA) Quality Assurance Program (QAP), presented "Update on Point of Care Testing in Australia" at the National Pathology Forum 2013. This annual conference provides a platform for the public and private sectors to come together and discuss all the latest issues affecting the pathology sector in Australia. For more information, please visit the conference website: http://www.informa.com.au/pathologyforumTRANSCRIPT
©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