Laboratories should be aware that Standards Australia have recently published SA TS ISO 22583:2021 Guidance for supervisors and operators of point-of-care testing (POCT) devices and SA TS ISO 20914:2021 Medical laboratories – Practical guidance for the estimation of measurement uncertainty as direct adoptions of the ISO Standard.
Whilst these documents will not be used as accreditation criteria laboratories may find them useful.
AS ISO 22367:2021 Medical laboratories – Application of risk management to medical laboratories as a direct adoption of the ISO Standard. Whilst the document will not be used as accreditation criteria laboratories may find it useful when considering their risk management processes.
ISO 20914 abstract
This document provides practical guidance for the estimation and expression of the measurement uncertainty (MU) of quantitative measurand values produced by medical laboratories. Quantitative measurand values produced near the medical decision threshold by point-of-care testing systems are also included in this scope. This document also applies to the estimation of MU for results produced by qualitative (nominal) methods which include a measurement step. It is not recommended that estimates of MU be routinely reported with patient test results, but should be available on request.
ISO 22583 abstract
This document gives guidance for supervisors and operators of point-of-care testing (POCT) services where POCT is performed without medical laboratory training, supervision or support. It includes the key components that should be considered to provide safe and reliable POCT results. Self-testing is excluded from this document.