PoCT1 – Clinical purpose

When deciding on the clinical and diagnostic purposes where PoCT may benefit patients, consider current best practice evidence. 

Because PoCT can be used to diagnose, monitor, manage or screen, the practice needs to define its analytical performance requirements, based on its intended clinical and diagnostic purposes. For example, using PoCT to monitor a patient’s diabetes may have different analytical requirements to when it is used to diagnose infections with public health implications⁽⁴⁶⁾. 

When evaluating PoCT systems, all aspects of PoCT need to be considered, including specimen collection, analysis, reporting and actioning. The quality of PoCT may be affected by many factors, including the storage of consumables, the knowledge and skills of PoCT practitioners, specimen quality, and variability between instruments⁽⁴⁷⁾.

The practice needs to perform due diligence (for example, consulting literature and professional bodies) to ensure a PoCT device meets the practice’s needs. Evaluation of a PoCT system needs to address three aspects - Selection, Verification and Quality:  

• Selection – PoCT devices need to be assessed against the manufacturer’s claimed specifications, and can be evaluated and selected based on the practice’s intended clinical use.
• Verification – This confirms (verifies) that a particular PoCT system performs to and meets the manufacturer’s stated specifications, and that the results have been validated against a known standard.   
• Quality (calibration, quality control and quality assurance) – always assess calibration, quality control and quality assurance before implementing a PoCT system, to independently confirm that its performance is appropriate and accurate.

The practice can interpret test results by using reference data obtained from various sources, including PoCT suppliers, pathology providers, international bodies and professional societies.

The practice needs to:

• agree on which reference intervals and clinical decision limits it will use to interpret PoCT results 
• only use reference intervals and clinical decision limits that are based on current best practice evidence
• regularly review reference intervals and clinical decision limits
• document reference intervals for groups where there are well recognised differences (for example, children and pregnancy). 

Having a consistent approach to PoCT, which includes having agreed reference intervals and clinical decision limits, may help GPs to interpret test results.  

Each GP needs to exercise clinical judgement when: 

• deciding whether to use PoCT 
• deciding whether to use results of PoCT to make decisions about patient management. 

Safe and effective PoCT is possible only if: 

• GPs have the required skills and have received appropriate training 
• PoCT is undertaken often enough to maintain those skills 
• the practice records, addresses and reviews non-conformance and adverse events.   

PoCT suppliers, pathology providers, international bodies, professional societies and other sources can provide evidence about the clinical and diagnostic purposes, analytical performance and reference data for PoCT. The practice does not have to generate its own evidence. 

It is recommended that the practice: 

• seeks information from a validated source, relevant to the applicable PoCT
• selects information that is appropriate for the practice’s clinical and diagnostic purposes and patient population. 

The practice needs to demonstrate how the analytical performance of a PoCT device has been verified to confirm that it performs to and meets the manufacturer’s stated specifications at the following times: 

• on commissioning 
• after major repairs, new methods, reagent formulation changes and device maintenance
• at other times as needed (for example, if a result does not match the clinical picture). 

To improve quality of care and to minimise risks to patients: 

• apply quality improvement and risk management processes to PoCT  
• record and address adverse and non-conformance events in a timely manner  
• notify the member of the clinical team with nominated responsibility for PoCT of adverse and non-conformance events (adverse and non-conformance events could also be included as an agenda item in team meetings)   
• review adverse and non-conformance events, including how they are addressed.

The practice could report adverse events to the Therapeutic Goods Administration (TGA). The TGA has the following resources on reporting relevant adverse events related to the performance of PoCT devices:

• Medical device Incident Reporting and Investigation Scheme (IRIS)
• information on reporting an adverse event or problem for health professionals.

In the event of unplanned loss of PoCT, the practice needs to demonstrate how it will ensure continuity of care for patients.