6. Would the regulatory environment used for the Trial meet the needs of all the stakeholders if PoCT were to be made more generally available?

Table of contents

1. Is it safe to perform PoCT in general pratice?
2. Is the effectiveness the same or better than for the same tests using pathology laboratory testing?
3. Is it the same or more cost-effective to perform PoCT compared with pathology laboratory testing?
4. Are patients and other stakeholders more satisfied with PoCT than with pathology laboratory testing?
5. Are there differences between urban, rural and remote geographic regions in any of the parameters measured?
6. Would the regulatory environment used for the Trial meet the needs of all the stakeholders if PoCT were to be made more generally available?
7. What would be the appropriate Medical Benefits Schedule (MBS) fee for the tests selected in the Trial?

To determine whether the intervention model used in the Trial would meet the needs of all stakeholders (General Practice, Patients, Pathology Providers and the Government) if PoCT were to be made more generally available, a number of key findings from the Trial need to be considered.

Key Findings

the quality management system, which included Device Operator training and certification, IQC and EQA overseen by an accreditation program based on the (interim) Standards for PoCT in general practice, was acceptable to all stakeholders. If PoCT were to be implemented in general practice more widely, it would be necessary for a similar system to be adopted to ensure that the success seen in the Trial could be translated into practice
the (Interim) Standards for PoCT in GP were considered appropriate by all stakeholders. It was considered important that practices participate in a quality management system to provide GPs with the confidence that their clinical decisions were based on reliable and accurate results and to ensure patient safety was not compromised
that intervention practices were required to nominate a GP who was given overseeing authority and responsibility for PoCT. An essential step in introducing PoCT more broadly would be to identify a GP with the primary responsibility for the implementation and management of PoCT within a practice
that PoCT procedures were required to be conducted in association with an attendance of a GP. However, the manner in which testing was adopted in the practice was not mandated. Intervention practices were provided with protocols to follow for testing. These were seen as beneficial and it would be necessary for PoCT guidelines to be developed to assist GPs with device selection and the development of testing protocols, including interpreting and recording results
that patients and practice staff found PoCT acceptable in the framework in which it was implemented in the Trial and revealed high levels of satisfaction. The model used in the Trial may have provided reassurance that patient care was not being compromised and operated within a quality framework equivalent to traditional pathology testing
Pathology Providers indicated that they would like some involvement if PoCT were to be implemented in general practice. Pathology Providers are in a position to provide advice on test results, provide validation of PoCT results and support IQC and EQA and this role needs to be enhanced
a number of organisations already exist that can take on various aspects of the Trial model. These organisations include Divisions of General Practice, the RACGP, NATA and the RCPA QAP Pty Ltd (QAP)
the Australian Government provided funding for all aspects of PoCT examined in the Trial, many of which are likely to form a part of PoCT in general practice if the model is made more generally available. The Government was involved in the development of the Standards. An important role for the Government would be determining whether a quality management system should be mandatory, whether PoCT should be limited to the chronic disease areas investigated in the Trial and what the MBS fees for testing would be.