Benefits Overview

When we visit our GP and have samples (eg: blood, urine) taken for testing in the local hospital laboratory, we expect the results to be correct and that stringent quality control procedures are in place to ensure this.

As technology has developed more of this pathology diagnostic testing can be performed at the point of patient care, often with small portable devices and we now have the potential to provide one stop clinics with immediate management of patients. As well as being clinically effective this improves the overall patient experience, particularly if patients can self-monitor at home.

Point of care testing devices such as blood glucose meters, INR monitors, pregnancy tests and HbA1c analysers have become increasingly simple to use and it is easy to convince ourselves that the results must always be correct. Unfortunately this is not always the case.

In the same way that strict quality assurance procedures must be adhered to in the hospital laboratory, these must also be applied to any point of care testing devices in order to ensure patient safety.

As well as running the Quality Control (QC) solutions provided by manufacturers, performing satisfactorily within an External Quality Assessment Scheme (such as Qpoint) is an essential requirement.

Quality Control – What does it do? Why do I need it?

Quality Control of a diagnostic point of care testing device is carried out by testing control material supplied by the manufacturer. This material is designed to produce a result on their particular meter or device which is compared to their acceptable range. This range can be very wide. Successful QC requires 'in date' control material which has been stored according to the manufacturer's instructions.


What it does:

  • Checks analytical technique
  • Checks all consumables are performing to specification
  • Reassures the user that the device is performing satisfactorily on a daily basis
  • May alert user to incorrect device calibration
  • Compares result to a wide range of acceptable values set by the manufacturer


What it does NOT do:

  • Does not highlight results reading consistently higher or lower than the expected average.
  • Does not check user pre-analytical technique (hand washing, finger pricking)
  • Does not always highlight variation in reproducibility of results
  • Does not check the integrity of the meter display
External Quality Assessment – What does it do? Why do I need it?

External Quality Assessment (EQA) describes testing which is carried out using a sample supplied by a third party who is totally independent from the glucose meter manufacturer. The EQA material is tested in the same way as a patient sample but unlike QC, the user does not know what the expected result should be. All participants in an EQA scheme return their results to the third party scheme organisers who collate the data and report their findings back to the users.


What it does:

  • Checks analytical technique
  • Checks all consumables are performing to specification
  • Reassures the user that the device is performing satisfactorily, with comparable results to other users of the same products
  • May alert user to incorrect calibration
  • Highlights any meters reading consistently high or low
  • Highlights variation in reproducibility of results
  • Facilitates an objective view on performance from a third party which can be fed back to manufacturers
  • Provides a regular sample for testing


What it does NOT do:

  • EQA is not a substitute for QC
  • Does not provide daily reassurance that the meter is performing satisfactorily
  • Does not check user pre-analytical technique (hand washing, finger pricking)
  • Does not check the integrity of the meter display


EQA and QC are complimentary procedures which are both required for good clinical governance and compliance with national point of care testing guidelines1, they protect the meter user and the patient.

Make sure you are covered!

1 MHRA Management and use of IVD Point of Care Test Devices v1.1 (2013)

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