ISO 22870:2006 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of ISO 22870:2006 apply when POCT is carried out in hospital, clinic and by a healthcare organization providing ambulatory care. It can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters.
Patient self-testing in a home or community setting is excluded, but elements of ISO 22870:2006 can be applicable.
The quality manager is responsible for the design, implementation, and operation of quality control that ensures POCT conforms to the quality standards of the central laboratory.
Parameters based on which the quality audit of POCT is done
- Complexity of the devices
- Inbuilt checks
- Frequency of testing
- Non-laboratory operators
- Cost
Quality Control Management of POCT instruments is challenging. The principles of IQC and EQA must apply but there is no universal strategy. A pragmatic approach taking into account the manufacturer’s recommendations, the device technology and the capability of the users should aim to increase the benefit/risk ratio for the patient.
