Criterion PoCT1.1 – Clinical purpose

The purpose of PoCT is to help healthcare practitioners make immediate and informed decisions about a patient’s care and management.⁵ 

How you intend to use PoCT 

PoCT can improve the timeliness, efficiency and quality of care in some areas of clinical practice.⁶ When deciding on the clinical and diagnostic purposes where PoCT may benefit your patients, consider current best practice evidence. 

Because PoCT can be used to diagnose, monitor, manage or screen, your 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 than to diagnose infections with public health implications.⁷ 

Evaluation of PoCT systems 

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.⁸

Your practice needs to perform due diligence to ensure the PoCT device meets your needs. This may be through consulting literature or professional bodies. Evaluation of a PoCT system includes three aspects - Selection, Verification and quality procedures:  

1. Selection - PoCT devices should be evaluated and selected based on intended clinical use. These PoCT devices need to be assessed against the manufacturer’s claimed specifications.  
2. Verification - the purpose of the verification process is to confirm (verify) that a particular PoCT system performs to and meets the manufacturer’s stated specifications, and to validate the results against a known standard.   
3. Calibration, quality control and quality assurance – it is important that the use of calibration, quality control and quality assurance is assessed prior to implementation of a PoCT, to independently confirm appropriate and accurate performance of a POCT system.

Interpreting test results 

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

It is important that your practice: 

• agrees on which reference intervals and clinical decision limits you will use to interpret PoCT results 
• only uses reference intervals and clinical decision limits that are based on current best practice evidence. 

Quality use of PoCT 

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: 

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

Sources of information and evidence 

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. Therefore, your practice does not have to generate its own evidence. 

It is recommended that you: 

• seek information from a validated source, relevant to the PoCT being carried out
• select information that is appropriate for your practice’s clinical and diagnostic purposes and patient population. 

Evaluating PoCT systems’ analytical performance 

It is important that your practice demonstrates how the analytical performance of a PoCT device has been verified to confirm that it performs to and meets the manufacturer’s stated specifications: 

• on commissioning 
• following major repairs
• at other times as needed. 

The Australian Point of Care Practitioner’s Network (APPN) provides resources to help practices implement a PoCT program.  

The APPN also has the resource How to choose and evaluate a point-of-care testing instrument that you can refer to when evaluating a PoCT system’s analytical performance.

Quality improvement and risk management 

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 clinical team member with nominated responsibility for PoCT of adverse and non-conformance events. Adverse and non-conformance events could be included as an agenda item in team meetings.   
• review adverse and non-conformance events, including how they are addressed
• report adverse events to the TGA.

The TGA has the following resources relating to reporting relevant adverse events related to the performance of PoCT devices: Medical device Incident Reporting and Investigation Scheme (IRIS), and information on reporting an adverse event or problem for health professionals.

Continuity of care 

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

Related Criteria 

Criterion C6.4 – Information security  

Criterion QI1.1 – Quality improvement activities 

Criterion QI3.1 – Managing clinical risks 

Criterion GP2.1 – Continuous and comprehensive care 

PoCT1.1  A Our practice can describe the clinical and diagnostic purposes of PoCT based on best practice evidence, and how it can be applied. 

You must: 

• describe the clinical and diagnostic purposes for using PoCT 
• ensure the clinical and diagnostic purposes of PoCT are evidence-based. 

PoCT1.1  B Our practice’s specifications for the analytical performance of PoCT are determined by the relevant clinical and diagnostic purposes. 

You must: 

• provide evidence that the analytical performance specifications of each test method are based on the clinical and diagnostic purposes for which they will be used  
• demonstrate that the analytical performance of each test method has been evaluated upon commissioning and following major repairs.  

PoCT1.1  C Our practice uses reference data that is based on best practice evidence to interpret test results. 

You must: 

• demonstrate that your practice uses reference intervals and/or clinical decision limits for interpreting PoCT results 
• demonstrate reference intervals and/or clinical decision limits are evidence-based.  

PoCT1.1  D Our practice applies quality improvement and risk management processes to PoCT to improve quality of care and to minimise risk to patients. 

You must: 

• record and address adverse and non-conformance events 
• document how you are reviewing adverse and non-conformance events, and document the outcome of the review
• demonstrate that your practice can maintain continuity of care if PoCT is not available.

You could:

• report adverse events to the TGA