Part 3: ISO 15189:2022 - Key Updates and Implications for Point-of-Care Testing (POCT)

December 2022 saw the release of version 4 of ISO 15189, which introduced notable updates, particularly concerning point-of-care testing (POCT). Below are the key highlights from the ISO 15189:2022 document:

Specific References

While POCT is referenced throughout the document, the entire standard applies to POCT just as it does to laboratory-based tests. Specific references to POCT, such as those related to result reporting and management review, do not differ significantly from the requirements of ISO 22870. Notable clauses include:

• Clause 5.3.1: Requires medical laboratory services to document and describe their activities, including POCT locations.
• Clause 6.6: Outlines requirements for reagents and consumables, including POCT supplies. Acceptance testing must ensure that no patient result is released before verification. Although non-laboratory staff often perform POCT, the laboratory must own and control the acceptance testing process.

Service Agreements

A significant change for POCT involves the use of service agreements between the laboratory and all POCT locations (Clause 6.7). These agreements define the service level, clinical requirements, governance arrangements, and commercial considerations. They help clarify the responsibilities of all stakeholders involved in POCT service delivery.

Risk Management

In addition to formalising service relationships, the standard also emphasises robust risk management practices. Risk management actions should match the potential impact on results, personnel, and patient safety. Validation and verification must ensure clinical relevance for each test. Quality control (QC) rules should address the risk of incorrect results and assay stability, with internal quality control (IQC) tests reflecting clinically relevant decision points. It is crucial to train staff thoroughly to understand the POCT process and its importance for patient care.

Extending Accreditation

Currently, the uptake of accreditation for POCT services in the UK is low, with around 10 services accredited to ISO 22870:2016. The inclusion of POCT in ISO 15189:2022 aims to encourage laboratories to extend their accreditation to POCT services. POCT should be seen as another pathology discipline with unique clinical requirements and challenges, manageable under the same system as laboratory-based testing.

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