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Currently no mandatory standards or guidelines exist for Point-of-Care Testing (PoCT) in Australia. In 2001, a report on the role and value of ‘near patient testing’ in general practice outlined work that was required to assist the Australian Government to decide how to manage PoCT. Phillips Fox reported that adoption of mandatory accreditation requirements was not justified by the level of risk associated with PoCT.
If implemented appropriately, PoCT could be useful with frontline management of chronic disease, relieving stress on general practice and expanding the reach of pathology.
Interim PoCT standards in general practice were developed by a Quality Use of Pathology committee, and formed an accreditation framework for the PoCT in General Practice Trial. This trial concluded that PoCT has a role in supporting the primary healthcare team to manage chronic disease patients.
While results of the trial are still being considered, the potential impact of funding PoCT in general practice is being treated as part of the wider review of pathology funding currently taking place in Australia.
Although Australia has local models from which to draw experience, it has yet to decide the quality framework it would adopt if it was to roll out PoCT in general practice. The quality framework that Australia adopts for PoCT must achieve high quality pathology results that enhance clinical care.
Pathology in Australia is administered under the Health Insurance Act (1973). The Act states that if a laboratory is to be eligible to receive Medicare Benefits, it must be accredited under set standards and guidelines developed and maintained by the National Pathology Accreditation Advisory Council (NPAAC).1
PoCT is diagnostic testing performed at or near the site of patient care.2 As this definition implies, it is generally performed outside the routine laboratory and as such would not fall under a laboratory’s accreditation.
A key objective of PoCT is to generate a result quickly so that appropriate treatment can be implemented leading to an improved clinical or economic outcome. For PoCT to be able to improve health outcomes it needs to be performed within a quality framework.
Although PoCT has been used for several decades in Australia the debate about its use continues. The advantages and disadvantages of PoCT (Table) feature heavily in this debate. PoCT has the potential to impact on many facets of the healthcare system including the workforce. Consequently the debate on PoCT standards, accreditation and rebates involves many stakeholders and is an important one. This paper will discuss different aspects of the debate which is hopefully close to reaching resolution.
Currently there are 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 because they are performed at sites which are not accredited.
A limited number of tests (Group P9) can be rebated under the Medicare Benefits Schedule (MBS) without accreditation. These tests 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.
P9 tests include:
Sites wishing to perform other PoCT tests and receive a Medicare rebate must essentially follow accreditation procedures designed for laboratories. Steps include:
Currently if PoCT is to be performed in a hospital, general practice or a healthcare clinic wishing to be accredited, the PoCT standard, International Organization for Standardization (ISO) 22870, can be used in conjunction with ISO 15189 to accredit the site. While this standard provides an excellent quality framework for PoCT, it is ‘laboratory centric’ and more suited to PoCT run by laboratories rather than by services operating outside the laboratory.
The Australian government has been under increasing pressure to simplify regulatory requirements for PoCT so that rebates for these tests can be more easily claimed by general practitioners or other healthcare workers outside the laboratory.
In 2001, a report on ‘Review of the Role and Value of Near Patient Testing (NPT) In General Practice’ was published.4 The aim of this review was to provide a series of recommendations to the Commonwealth Department of Health and Aged Care’s expert pathology committee on ways it might progress the NPT (now referred to as PoCT) agenda. The review included a number of recommendations to government and the medical profession on how to introduce efficient cost-effective PoCT in general practice.
It also recommended that:
In 2005–06, the Department of Health and Ageing (DoHA) on behalf of the Australian Health Ministers’ Advisory Council (AHMAC) commissioned a review by Phillips Fox (a large legal practice) to assess the extent of public health risk associated with non-Medicare pathology services including PoCT.5
The Review Team acknowledged that there are risks associated with all types of healthcare but noted that the available evidence did not support perceived unacceptable levels of risk associated with non-Medicare pathology services. They concluded that adoption of mandatory accreditation requirements for PoCT would impose a substantial cost and administrative burden on specialised or small-scale providers of pathology not justified by the level of risk. This in turn could prevent the use of PoCT in rural and remote communities where it had the greatest potential to benefit clinical care.
A key recommendation of the review team was that AHMAC should convene a working party led by DoHA and comprising nominees of NATA, Royal College of Pathologists of Australasia (RCPA), consumers, Royal Australian College of General Practitioners (RACGP), Pharmacy Guild, Pathology Associations Committee and other relevant stakeholders to develop non-statutory guidelines for the conduct of pathology services in non-accredited settings including PoCT.
The Second National Workshop on Safety and Quality in Pathology was held in Canberra in 2008 to discuss issues raised in the Phillips Fox Report.6
General practice continues to be the cornerstone of Australia’s health services with 85% of Australia’s population visiting a GP at least once a year costing Medicare in 2006/7 about $4 billion.7
Chronic disease management is a major challenge confronting the Australian health system, with 77% of Australians reporting one or more long-term health problems, and more than half of those aged 65 years and older having five or more chronic conditions.8 Seven out of ten visits to general practice are due to chronic disease.9 General practitioners are usually the first point of contact in the health system thereby having a key role to play in the primary intervention, prevention, diagnosis and management of chronic disease within the community. Australia is currently experiencing a shortage of general practitioners which increases the challenge of managing chronic disease patients.10
Pathology tests are used widely in the diagnostic work-up and monitoring of patients. Identification of disease in its infant stages potentially decreases the patient’s likelihood of developing a more severe form of the disease requiring more intensive and costly care. RCPA has stated that shortages of pathologists and senior scientists are a threat to service quality, timeliness and effective treatment leading to delayed discharges, increased hospital lengths of stay and increased health costs.11
The Australian Pathology Workforce Crisis report identified that PoCT should be considered as part of the strategy to improve pathology productivity by expanding its use by clinicians and by promoting further development and adoption.12 Advantages of PoCT include faster pathology results, potentially resulting in faster patient treatment without the need for an additional patient appointment. PoCT could assist with the frontline management of chronic disease, potentially relieving stress on general practice while at the same time expanding the reach of pathology services.
There is no question that PoCT has the potential to do harm if not implemented appropriately. To ensure that clinical care is not compromised and that risk to the public is minimal, PoCT must be implemented within a quality framework that is tailored to recognise the resources of non-laboratory environments while at the same time producing pathology results equivalent to those produced by pathology laboratory.
The (Interim) Standards for PoCT in general practice were developed by the PoCT Implementation Subcommittee of the Quality Use of Pathology Committee of the Pathology Section of DoHA.13 Development involved consultation with key representatives from relevant scientific and general practice groups and incorporated the RACGP Standards for General Practice and NPAAC Standards.
Interim PoCT standards were grouped into 5 areas:
PoCT Standards were developed to take into account resources in non-laboratory environments and to ensure that the quality of test outputs would be the same as for tests performed by pathology laboratories.
One of the key recommendations of the 2001 report was that it was essential to establish the diagnostic accuracy, and clinical and cost effectiveness of PoCT.
However, a systematic literature review concerning treatment in general practice of patients on anticoagulation therapy, with diabetes or with hyperlipidaemia failed to find robust evidence that PoCT in this setting improves clinical outcomes. The review also failed to find evidence of comparable analytical quality between PoCT and the routine laboratory.14
To investigate the questions raised in the report on NPT, the Australian Government funded the PoCT in General Practice Trial. This was a multi-centre, clustered, randomised controlled trial to determine the safety, clinical effectiveness, cost-effectiveness and satisfaction of PoCT in general practice. In addition the trial sought to determine the following:
Fifty-eight practices over a large geographical area (urban, rural and remote areas in South Australia, New South Wales and Victoria) were involved in the trial. Twenty practices were randomised in the control group and 32 practices in the intervention group. These practices involving 247 GPs recruited 5234 patients, 2034 in the control group and 3200 in the intervention group. The trial commenced in 2005 continued over an 18-month period and evaluated PoCT intervention on the management of patients with diabetes, with hyperlipidaemia and on long-term anticoagulant therapy.15
The PoCT standards discussed earlier provided the framework for developing a comprehensive accreditation program for practices in the intervention group.
The aim of the accreditation program was to ensure that the minimum standard for PoCT in the practice was met, and that all quality and safety aspects were adhered to. Practices were reviewed on site twice in the period of the trial. The surveyors included a scientist, a GP/practice manager and a member of the trial management team.
An overall conclusion of the trial was that PoCT has a role in enabling GPs to make more timely clinical decisions while facilitating discussion of self-management with patients. It was also concluded that the trial model worked within the current regulatory environment and appeared to be broadly acceptable to all stakeholders.16 While the trial showed that PoCT could be performed safely in general practice, the negative issues of cost and administrative burden highlighted by Phillips Fox5 were not addressed.
For PoCT to be rolled out nationally, the trial model provides regulatory authorities with a framework for implementation although some modifications would need to be made. Accordingly, the DoHA has convened a PoCT Trial Review group which has representatives from all stakeholders including pathology, general practice, professional organisations and consumer representatives to review the trial outcomes.
In particular, the costs of PoCT in the trial were calculated to be much higher than the same tests performed in the laboratory, a cause for concern among stakeholders. Factors that contributed to the high costs associated with PoCT tests run in the trial included:
Each of these factors needs to be considered when determining potential MBS fees.
The Australian Government is currently reviewing pathology funding as part of a broader agenda to ensure that spending on health is sustainable and provides maximum benefit to the greatest number of people. This review will look at MBS and align it with other reforms including the Review of Health Technology Assessment, the Primary Care Strategy and the National Health and Hospital Reform Commission.17
Although the results of the PoCT in General Practice Trial are still being considered by the government, the potential impact of public funding on patient access to PoCT will be treated as part of the review. The review will look at:
While Australia has yet to decide on a regulatory PoCT framework to roll out nationally, it does have some excellent local experience to draw from.
Currently at least three extensive PoCT networks are operational across Australia:
All three programs contribute to the healthcare of local communities by using PoCT operated within a quality framework managed by experienced scientists.
All stakeholders agree that PoCT has clinical benefits in the management of chronic diseases and that it should only be implemented within a quality framework.
Taking into consideration the size of Australia and how dispersed the population is, it would be hard to argue against PoCT having a place in clinical care. But whether PoCT should be funded and implemented nationally remains undecided.
Should it be the same quality framework as used in the laboratory? Probably not, but whatever the framework adopted, it has to achieve the same outcome as the laboratory framework in producing high quality results that enhance clinical care.
Ms Tirimacco is Chair of the AACB PoCT Working Party Committee.
Competing Interests: Ms Tirimacco receives research support from Roche, Hemocue and REM Systems.