Criterion PoCT3.2 – Performance of tests

The quality and safety of patient care depends on the result from PoCT being valid and reliable. To ensure that this is the case, the technology needs to be used in a standard way in accordance with the manufacturers’ instructions, and errors need to be identified and acted upon.

Consistency is best achieved if your practice documents standard operating procedures and work instructions for all stages of testing and ensures that they are in accordance with the manufacturers’ instructions.

To ensure continuity of PoCT, your practice could have an established arrangement with third-party suppliers of goods and services.  

Suppliers of essential PoCT support services are also responsible for providing: 

• consumables (directly or via authorised supplier channels)  
• technical support 
• maintenance (in addition to the routine maintenance your practice completes) 
• education to team members who use their devices. 

Standard operating procedures 

Your practice must follow the instructions published by the PoCT manufacturer as they are approved by the Therapeutic Goods Administration (TGA). However, it is best practice to also create and maintain your own standard operating procedures or work instructions as the manufacturer’s instructions may not include some critical steps such as patient interactions and result management.  

It is important to formally evaluate and approve any proposed changes to the standard operating procedures and work instructions before your practice uses them. 

Communicating results 

Your practice must ensure that all PoC test results are recorded, understood, and acted upon in a timely and appropriate manner.

Deviations and errors 

Your practice must regularly review deviations and issues encountered during testing. 

Avoiding transcription errors 

Transcription errors are data entry errors that usually occur because of typographical mistakes when transferring data and results.  

To avoid transcription errors, it is strongly preferred that results are transferred electronically.¹⁰

Specimens 

Although there is no requirement to label specimens that are to be used completely in the testing process: 

• it is important that specimens remain positively identified with the patient throughout the testing process 
• if specimens are retained following testing, they must be clearly labelled and stored in accordance with relevant guidelines.   

Technical services 

When making arrangements with technical support services, consider the following: 

• required response time for maintenance
• ownership or leasing arrangements of instruments 
• required training of PoCT practitioners  
• support for technical updates and troubleshooting.  

If it is appropriate, you could have written agreements with third parties who provide technical support services.   

Consumables 

When making arrangements with suppliers of consumables, consider:

• required frequency and volume of consumables 
• required response time for urgent consumables.  

Manufacturers’ instructions 

Your practice must make records of preventative maintenance, service and calibration as per the manufacturers’ instructions and keep these records as required by legislation. These requirements may vary from state to state, so consult with your medical defence organisation or check legislative requirements to identify specific requirements you must fulfil.  

Suppliers of routine maintenance must provide your practice with a record of work and performance checks they undertake. If this is not possible, you must maintain your own records. This includes keeping a log of failures and investigations performed.   

Related Criterion 

GP5.2 – Practice equipment 

PoCT3.2 A Our practice follows the manufacturers’ instructions for PoCT.

You must: 

• demonstrate that your practice follows the manufacturer’s instructions for each test method  
• demonstrate that your practice checks the accuracy of transfers of data and transcription of results 
•  demonstrate that your practice records and investigates deviations appropriately. 

You could: 

• maintain standard operating procedures for each test method, ensuring only the latest versions are used 
• keep a copy of the relevant procedures/work instructions with each test instrument. 

PoCT3.2 B Our practice records and communicates results appropriately.  

You must: 

• demonstrate that your practice records and communicates results to the responsible clinician and the patient in a timely manner  
• demonstrate that the results are acted upon appropriately 

PoCT3.2 C Our practice identifies and reviews errors and deviations.  

You must: 

• demonstrate that your practice records and investigates deviations appropriately.

PoCT3.2 D Our practice ensures that specimens remain positively identified with patients throughout the testing process. 

You must: 

• demonstrate that specimens remain positively identified with patients throughout the testing process  
• clearly identify patient specimens retained for any purpose. 

PoCT3.2 E Our practice documents its requirements for PoCT technical support services.  

You must: 

• demonstrate that your practice has ongoing arrangements with providers of technical support services. 

PoCT3.2 F Our practice commissions and maintains our PoCT equipment in accordance with each manufacturer’s instructions.   

You must: 

• retain records of installation and commissioning 
• ensure that maintenance is undertaken by appropriately trained operators 
• retain records of maintenance in accordance with the manufacturers’ instructions
• retain a log of failures and investigation performed