The catalogue of genes, genetic tests and genetic laboratories was established as a component within the
.
Areas for Future Consideration
Further possible work by the Genetics Working Party set up under the Pathology Funding Agreement.
Policies, Procedures and Guidelines for Point-of-Care Testing (2011)
Description
This project was a comprehensive review and analysis of national and international point-of-care testing (PoCT) quality management regulation policies and protocols.
Grant Recipient
Royal College of Pathologists of Australasia Quality Assurance Programs Pty Ltd (RCPA QAP)
to review the current regulatory requirements and professional opinion with regard to the implementation and quality management of PoCT
to summarise currently available international standards, regulatory procedures, government policy, evidence-based guidelines and/or authoritative guidelines or statements from professional colleges or associations which describe procedures under which PoCT may be performed in general practice or the community.
These aims and objectives were achieved by this project.
Findings
(Only findings applicable to Australia have been identified; for international findings please refer to the original report.)
Use and Implementation of PoCT Devices
PoCT is not a single unified entity and different circumstances may require different solutions.
A principal conclusion arising from the quality management aspect of the Australian Government funded multi-centre Point-of-Care Testing in General Practice Trial found the trial model provided a framework that worked within the current regulatory environment. This framework could form the basis for the implementation of PoCT in general practice more broadly.
Point-of-Care drug testing is generally designed to screen for the presence of designated drugs or groups of drugs.
Quality Assurance
In order for equivalent clinical decisions to be made, the accuracy and reliability of laboratory testing, including PoCT, should not be site dependent.
The advantages of PoCT testing largely depend on proof of acceptable analytical performance. This concept dominates policy statements from government agencies of many jurisdictions, articles published in peer-reviewed journals and statements made by international professional commentators on PoCT.
There are many ‘official’ and professionally based standards and guidelines which define the manner in which PoCT should be implemented, managed and the performance quality checked and maintained. Most, if not all, professionally based guidelines follow a similar template and provide similar information which includes specific reference to quality control and quality assurance.
Regardless of the particular assay or method, PoCT, in common with all laboratory testing, requires regular quality control and external quality assessment (EQA) to assure acceptable performance. There is also a growing literature describing the potential and actual errors arising from poorly controlled PoCT while inspection and accreditation processes have been very successful in achieving the goal of reducing PoCT error.
The required analytical performance of a test (fitness for purpose) is determined by its intended clinical use and not by the location where testing occurs. The accuracy and reliability of laboratory testing, including PoCT, should be equivalent irrespective of the testing site for equivalent clinical decisions to be made.
The Point-of-Care Testing in General Practice Trial provided confirmation that quality management practices are required for PoCT.
For PoCT to provide value in the general practice setting, an effective quality management system is essential. Clinicians need reassurance that their decisions are based on reliable, accurate and precise results to ensure patient safety is not compromised.
Actual clinical trials or large-scale reviews to assess the effectiveness of PoCT are much less numerous than publications which describe the potential risks associated with PoCT and issues with specific devices or with specific tests.
Cost Issues
The innovation and functionality of PoCT brings many challenges for health care funding authorities, particularly the value it may bring to the patient care process.
Payment for most types of PoCT is available through Medicare provided such testing is undertaken by an accredited pathology service (laboratory).
With the exception of special funding arrangements (such as Quality Assurance for Aboriginal and Torres Strait Islander Medical Services [QAAMS]) or State Government sponsored public hospital PoCT testing, only accredited PoCT laboratories may receive Government reimbursement or (Medicare) testing fees.
When costs of implementing a quality system are raised, the real question to ask is how much is poor quality going to cost or how much is it costing now? The principal issue, particularly when discussing health economics, is the influence of “cost shifting”, in terms of poor quality of one sector of the health systems adds costs to another sector as increased resource requirements. Poor quality in laboratory and PoCT often results in increased doctor visits, additional unnecessary test procedures, inappropriately changed medication or additional unnecessary medication and/or hospitalisation. The real cost of not identifying testing problems, or unnecessary repeat testing and poor patient outcomes, is often hidden until a quality system has been implemented.
Follow on Initiatives and Projects
It is anticipated that this work will be promoted in a scientific journal.
PoCT Training, Certification, Support and Skill Maintenance Program (Australian PoCT Practitioners Network – APPN) (Current).
Areas for Future Consideration
Investigate the framework for PoCT in General Practice recommended by the Point-of-Care Testing in General Practice Trial (http://www.health.gov.au/internet/main/publishing.nsf/Content/health-pathology-poctt-index.htm.)
