ISO 15189:2022 for POCT: what changed

What happened, and when

ISO 15189:2022, "Medical laboratories: requirements for quality and competence", was published in December 2022 as the fourth edition of the standard. It replaced the 2012 edition and, importantly for point-of-care services, withdrew ISO 22870:2016, which had been the separate standard for POCT accreditation. The requirements specific to point-of-care testing now sit in Annex A of ISO 15189:2022, and the annex is normative: it is part of the requirements, not guidance. Accreditation bodies set a three-year transition, so laboratories accredited to the 2012 edition were expected to have moved to the 2022 edition by December 2025.

The new structure

The 2012 edition was organised around management requirements (clause 4) and technical requirements (clause 5). The 2022 edition adopts the layout of ISO/IEC 17025:2017 so that the two standards read alike:

Annex A: point-of-care testing inside the standard

ISO 22870 had described POCT as an activity a laboratory could be accredited for alongside ISO 15189. Annex A makes it simpler and stricter: where a laboratory is responsible for POCT, the laboratory's management system applies to it, and the annex adds what is specific. In outline, the annex requires:

• Governance: the laboratory is responsible for the POCT it supports. There must be a defined structure, typically a multidisciplinary group or committee, with authority over device selection, procedures, training and quality assurance across the sites where testing happens.
• A quality assurance programme for POCT that covers internal quality control, external quality assessment and the review of results, applied to each device and location.
• Training and competence of the people performing POCT, who are usually not laboratory staff, with authorisation to test tied to demonstrated competence and its maintenance.
• Documented procedures, controlled by the laboratory, for each device and test, including result reporting, record keeping and what to do with abnormal or critical results.
• Equipment and consumables managed under the same clauses as laboratory equipment: acceptance, records, maintenance, calibration, reagent lot control and storage conditions.

The consequence is that a POCT service can no longer sit slightly outside the laboratory's system with its own arrangements. Its devices are laboratory equipment, its operators are people whose competence the laboratory controls, and its records are laboratory records.

Themes that changed the day-to-day

• Risk-based thinking replaces some prescription. The 2022 edition asks the laboratory to identify risks to patients and to its own operation and to act on them proportionately, rather than listing every document it must hold. A risk register with a defined scoring method and periodic review is the usual evidence.
• Ensuring the validity of results (7.3.7) brings IQC, EQA and comparability into one place. IQC has to be reviewed at a defined frequency with action on rejections; EQA participation is expected where schemes exist, with investigation of unsatisfactory performance; and where the same analyte is measured on more than one device or site, comparability between them has to be demonstrated periodically.
• Measurement uncertainty (7.3.4) is expected for quantitative examinations, with a defined procedure, and made available to users on request.
• Competence (6.2) is about demonstrated ability, authorisation and maintenance over time, with records. For POCT, this is the training matrix and the evidence behind it.
• Adverse incidents and field safety notices (6.4.6) require a process for reporting device incidents to the manufacturer and the regulator, and for acting on notices, which means knowing which lots and devices are affected.
• Management review (8.9) lists inputs that now include POCT data: QC, EQA, nonconformities, complaints, audits, risks and the effectiveness of actions.

The records POCT services are now asked to show

A gap check for a POCT service

• A named group with authority over POCT, with terms of reference and minutes
• A device inventory that includes every POCT device, with a verification file and equipment record for each
• A QC procedure per device with rules, review frequency and evidence of review and action
• EQA enrolment where schemes exist, and a record of investigations
• A comparability plan for analytes measured on more than one device or site
• A competence framework for POCT operators with current authorisations
• A procedure for critical and abnormal results at the point of care, and evidence it is followed
• Reagent lot control and storage monitoring at every POCT location
• A route for device incidents and field safety notices that can identify affected lots and results
• POCT inputs in the risk register, the internal audit programme and the management review

Where software helps

Most of the rows above are hard because the evidence is created on wards and in clinics by people whose job is not record keeping. Software that sits where the testing happens can generate the records as a by-product: QC captured from the analyser with rules and a signed monthly review, EQA deadlines and investigations, competence per operator per device, equipment records, lot traceability, and a quality system with an ISO 15189:2022 checklist that includes Annex A and a management-review pack drawn from the live data. Whether a service is accredited is decided by the accreditation body on the evidence; the software's job is to make sure the evidence exists.

Questions people ask

This article is general guidance for laboratory and point-of-care professionals. It is not a substitute for the standards themselves, your accreditation body's requirements or the analyser manufacturer's instructions for use. Catenix does not interpret clinical results and provides no clinical decision support.