Point of care testing standard

PoCT5 – Performance of tests

Standards for general practices (6th edition)
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      7. PoCT5 – Performance of tests

PoCT5 | Performance of tests

Consumer expectation statement: I expect that this practice performs point of care testing in line with manufacturer’s guidelines and results are communicated in an understandable and timely manner.

PoCT5.A The practice follows the manufacturers’ instructions for PoCT.

The practice: 

  • demonstrates that it follows the manufacturer’s instructions for each test method  
  • demonstrates that it checks the accuracy of transfers of data and transcription of results.  

PoCT5.B The practice records and communicates results appropriately. 

The practice: 

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

PoCT5.C The practice identifies and reviews errors and deviations.

The practice: 

  • demonstrates that it records and investigates deviations appropriately.

PoCT5.D The practice ensures that specimens remain positively identified with patients throughout the testing process. 

The practice: 

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

PoCT5.E The practice has documented its requirements for PoCT technical support services.

The practice: 

  • demonstrates that it has ongoing arrangements with providers of technical support services. 

PoCT5.F The practice commissions and maintains PoCT equipment in accordance with each manufacturer’s instructions.

The practice: 

  • retains records of installation, major repairs and commissioning 
  • ensures that maintenance is undertaken by appropriately trained operators 
  • retains records of maintenance in accordance with the manufacturers’ instructions
  • retains a log of failures and investigations performed. 


The quality and safety of patient care depend on PoCT results being valid and reliable. To ensure that this is the case, equipment and consumables need 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 the practice documents and follows 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, the 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 the practice completes) 
  • education to members of the practice team who use their devices. 


The practice must follow the instructions published by the PoCT manufacturer, as they are approved by the Therapeutic Goods Administration (TGA). However, the practice could also create and maintain standard operating procedures or work instructions for the practice, as the manufacturer’s instructions may not include some critical components that the manufacturer is not responsible for, such as patient interactions and result management.  

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

The practice could: 

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


The practice needs to ensure that all PoCT results are communicated to the patient in a timely and appropriate manner in such a way that the patient understands the results.

Results also need to be recorded on and acted upon in a timely and appropriate manner.


The practice needs to regularly review deviations and issues encountered during testing. Errors and deviations may be identified or confirmed by repeat testing. 


Transcription errors are data entry errors that are usually the result of typographical mistakes made when transferring data and results. To avoid transcription errors, it is strongly recommended that results are transferred electronically(49), and that, where possible, manual transcriptions are checked by another person. The practice could demonstrate how it recognises and avoids potential transcription errors.


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

  • specimens need to remain positively identified with the patient throughout the testing process, including prior to specimen collection 
  • if specimens are kept after testing, they need to be clearly labelled and stored in accordance with relevant guidelines. 


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

  • required response time for maintenance
  • required frequency of servicing
  • ownership or leasing arrangements of instruments 
  • required training of PoCT practitioners  
  • support for technical updates and troubleshooting
  • written agreements with third parties who provide technical support services, if it is appropriate. 

Further information about business continuity and planning can be found in F1 – Defining and planning for the practice and F2 – Response planning.


When making arrangements with suppliers of consumables, consider:

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


The practice needs to make records of preventive maintenance, service and calibration as per the manufacturers’ instructions and keep these records as required by relevant state or territory and federal legislation.

Suppliers of routine maintenance should ideally provide the practice with a record of work and performance checks they undertake. If this is not possible, the practice needs to maintain its own records. This includes a log of failures and investigations undertaken.

 
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