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Point-of-care testing and the new ISO 15189:2022

David Ricketts, Alyson Bryant and Sarah Glover look at accreditation and point-of-care testing.

In December 2022, version 4 of ISO 15189 was released. One major change was the inclusion of requirements relating to point-of-care testing (POCT). This is set out in the introduction, as one of the three main changes. The other two are the realignment of the document to the format of ISO 17025 (Requirements for Calibration and Test Laboratories) and an increased emphasis on risk management. The standard highlights the importance of risk identification and management, encourages continuous improvement and puts the patient at its centre.

POCT was previously covered by two other ISO standards, ISO 22870, for POCT supported by medical laboratories, and ISO/TS 22583, a guidance document for services provided without access to medical laboratory support. The advent of ISO 15189:2022 replaces ISO 22870 as an international standard, as of December 2025.

ISO 22870 was first written in 2003 and reviewed in 2016, to align with the 2012 version of ISO 15189. ISO 22870 provided specific requirements applicable to POCT and was required to be used in conjunction with ISO 15189. ISO 15189:2022 combines the two, creating one document for medical labs. The integration of POCT into ISO 15189:2022 helps to bring the accreditation of POCT to the fore, alongside accreditation of lab-based tests. Lab-supported POCT should be included in the scope of the management system and follow the requirements of the standard.

Specific references

Whilst there are references to POCT throughout the document, the whole standard applies to POCT, as for any lab-based test. Where specific references to POCT are made in the standard (for example, with regard to reporting of results and management review), these don’t represent significant changes from the requirements of ISO 22870.

Specific references to POCT include clause 5.3.1, which requires medical laboratory services to describe and document their laboratory activities, including any POCT locations. This links to clause 6.3.1, which requires the facilities for POCT to be suitable premises to safely conduct POCT activities.

Clause 6.6 sets out the requirements for reagents and consumables, including POCT supplies. The acceptance testing requirements in this section give scope for various ways of acceptance testing, as long as no patient result is released before the test is verified. Whilst it is commonplace that non-lab staff perform POCT testing, it is important that the lab owns and controls the acceptance testing process.

Service agreements

A significant change for POCT is in the use of service agreements, between the laboratory and all locations using laboratory-supported POCT (clause 6.7).

A service agreement is the tool medical laboratories will use to agree the level of service with clinical teams, including defining the clinical requirements, the governance arrangements and any commercial considerations. It is an opportunity to define and communicate the responsibilities for all stakeholders who are involved in the clinical and financial approval or delivery of a POCT service.

Many organisations will recognise the challenges of establishing and running a multi-disciplinary POCT committee and will welcome the removal of this mandatory requirement from the standard. However, this certainly does not prohibit such committees. Services with a well-functioning committee may well continue to use this forum to agree and monitor POCT services and service agreements.

The revised ISO 15189 standard sets out requirements regarding patients, including the need to:

  • establish and implement opportunities for patient and laboratory users to provide helpful information, to aid the laboratory in selection of methods and interpretations of results.
  • provide patients and users with publicly available information about examination processes and when to expect results.
  • establish processes for identifying risks of harm to patients in pre-examination, examination and post-examination processes and mitigate these risks.
  • identify opportunities for improved patient care and fulfilment of user needs, e.g. expanding the scope of activities, to develop actions to address these and to assess the effectiveness of those implemented.

These requirements are equally applicable to POCT services as lab-based testing, if not more so due to the direct patient contact involved in POCT testing.

Risk management

Risk management and the impact on the patient are paramount in this version of the standard. Actions taken to address risks should be appropriate to the potential impact on results, personnel and patient safety. Validation and verification requirements include the service being clinically relevant to the question being asked for each test. The rules of quality control (QC) should be set and applied with regard to risk of a wrong result and assay stability. Other QC requirements point to the need of the IQC being as close to the human matrix as possible and that IQC tests clinically relevant decision points.

It is important that the personnel delivering POCT testing have a good understanding of these requirements and ensure that any identified risks, deviations to process, or opportunities for improvement are recorded and discussed with the supporting laboratory.

One common pitfall when attempting to deliver POCT services is that there is often variation in location and staff/skill mix performing the tests. Care needs to be taken when training staff, to ensure that everyone understands the process, importance of POCT, and its impact on patient care.

Annex A of ISO 15189:2022 summarises specific requirements relating to POCT services, including governance, quality assurance and training (note that all of these are covered in detail throughout the main body of the standard). This Annex provides a good overall guide for the governance of POCT, including roles and responsibilities within a POCT service. The Annex also outlines the requirement for individual(s), with appropriate training and experience, to be appointed to be responsible for POCT quality, training and competency assessment. Each organisation will need to decide where these responsibilities will lie and be able to demonstrate how these are defined.

Extend accreditation

Uptake of accreditation of POCT services in the UK is relatively low, with approximately 10 services holding accreditation to ISO 22870:2016. It is hoped that the inclusion of POCT in ISO 15189:2022 will encourage laboratories to extend their accreditation to include POCT services. POCT testing can be viewed as “just another pathology discipline” with its own clinical requirements and challenges, but able to be managed under the same management system as laboratory-based testing.

Even if POCT services don’t feel ready to apply for accreditation, working towards the requirements of ISO 15189:2022 will support service development and improvement.

ISO 15189:2022 aims to promote the welfare of patients, reducing potential harm to patients, personnel, the public and the environment. The standard facilitates cooperation between medical laboratories and other healthcare services and sets out the requirements to identify risks and opportunities for improvement throughout the patient pathway, from patient preparation to result reporting and advice to users.

The National Strategic Guidance for Point of Care Testing, published in May 2023, outlines how to deliver safe and high-quality POCT within an accreditable framework. High-quality, safe and effective POCT has a vital role in supporting rapid growth in the delivery of healthcare and diagnostics closer to patients, at the point of need.

David Ricketts is Head of Laboratory Process Improvement at Health Services Laboratories, Alyson Bryant is the Healthcare Accreditation Specialist at UKAS and Sarah Glover is a Consultant Clinical Biochemist and POCT Clinical Lead at Harrogate and District NHS Foundation Trust. UKAS will be delivering talks on accreditation of POCT services at IBMS Congress on 25, 26 and 28 September.

Image credit | Shutterstock

 

 

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