Standards for point-of-care testing

PoCT Standard 4 - Quality outcomes

Criterion PoCT4.1 – Quality control procedures

Criterion PoCT4.1 – Quality control procedures 


PoCT4.1 A Our practice uses quality control procedures to ensure the PoCT is functioning optimally. 


Quality control (QC) testing helps your practice to: 

  • be confident that your PoCT is functioning properly 
  • detect and manage sub-optimal performance. 

QC testing 

QC testing is usually performed on artificial samples purchased from PoCT manufacturers or other commercial sources. The samples have different known levels of analytes to cover the range that practices might encounter clinically. 

QC testing is conducted on the samples, QC results are recorded, then compared with the target range or acceptable window that the practice has been given.  

Results falling within this range are considered acceptable. Results falling outside this range are unacceptable and may indicate a problem with the testing process.   

The PoCT manufacturer can provide a simple quality control record sheet to enter, review and analyse QC results. 

An acceptable window for QC results is usually determined when you first implement a PoCT device. It is recommended that QC results fall within the manufacturer’s specified limits and that practices can demonstrate that they have a system for ensuring appropriately timed QC.  

Standard decision-making rules are used to determine whether to accept or reject the QC results. QC test results must be recorded, and action must be taken should the QC result fall outside the acceptable range.11

Reviewing quality control results 

It is important that the clinical team member responsible for PoCT: 

  • regularly reviews QC results 
  • investigates unacceptable results or performance 
  • records any remedial actions taken. 

PoCT4.1  A Our practice uses quality control procedures to ensure the PoCT is functioning optimally.  

You must:  

  • demonstrate that all quality control procedures comply with manufacturers' recommendations and applicable regulations 
  • have standard operating procedures or work instructions that include the acceptable limits for quality control testing results and record actions taken in the event of an unacceptable result 
  • regularly review quality control results.  

You could: 

  • compare PoCT results with local laboratory results on the same specimen on the same patient and document the outcome.