Al Bryant, Healthcare Accreditation Specialist at UKAS, and Alison Benson, Senior Assessment Manager at UKAS, with the latest.
At a glance
- Labs accredited to ISO 15189:2012 are required to read the new standard, perform a gap analysis and provide evidence of implementation of the new requirements.
- One of the key changes to requirements is the greater emphasis on the impact pathology services can have on patients.
- For those services that have not yet completed the gap analysis or had a transition assessment, UKAS recommends that you continue working towards implementation of ISO 15189:2022.
ISO 15189 Medical laboratories – Requirements for quality and competence has been revised by the ISO Technical Committee ISO/TC 212 and was published in December 2022. The International Laboratory Accreditation Cooperation (ILAC), subsequently confirmed that there would be a three-year transition period for laboratories accredited to ISO 15189:2012 to move to ISO 15189:2022 accreditation.
In the UK, this transition process is being managed by UKAS, with engagement and support from relevant professional bodies, including the IBMS and the RCPath. Throughout 2023 UKAS, the IBMS and the RCPath worked together to publicise the transition and explain the requirements of the updated standard. As detailed in previous articles in the Biomedical Scientist, the key changes of the new standard include a greater focus on clinical impact and patient risk, as well as the incorporation of point-of-care testing service requirements.
Since the start of 2024, UKAS has mandated that all annual assessments to services accredited to ISO 15189:2012 must include the transition assessment to ISO 15189:2022. At the time of writing this article, nearly 100 transition assessments have taken place.
The requirements
The transition process requires labs to read the new standard, perform a gap analysis between the processes they currently have in place and the requirements of ISO 15189:2022, and provide evidence of implementation of the new requirements. Accredited services must focus on the key gaps first, and can provide action plans for closure of the less significant, lower-risk gaps. Any action plans provided must include reasonable timescales for completion.
Accreditation demonstrates technical competence and conformity with the relevant standard. If accredited laboratory services only perform a gap analysis but take no action to close the identified gaps, or provide UKAS with a gap analysis with no documentary evidence of actions taken to close the identified gaps, they are effectively providing UKAS with a list of ISO 15189:2022 requirements with which they do not comply. UKAS cannot accredit services with significant gaps in compliance.
The majority of UKAS transition assessments have gone well, with most laboratories being recommended to transition their accreditation to ISO 15189:2022 when they have provided evidence to close the non-conformities identified by the assessment team.
Although there are differences in the focus of ISO 15189:2012 vs ISO 15189:2022, a lot of the fundamental requirements are unchanged or just slightly amended. Accredited laboratories should continue to build on their existing management and technical processes in order to comply with ISO 15189:2022.
One of the key changes to requirements is the greater emphasis on the impact pathology services can have on patients. This can include defining and achieving clinically appropriate turnaround times, ensuring user information is kept up to date to ensure the correct sample type and volume are taken, and consideration of patient impact when non-conformities are identified. It is therefore important to engage clinical laboratory staff in reviewing and implementing the requirements of ISO 15189:2022, not just the biomedical scientists and quality team.
Non-conformities
A number of trends have been identified in the non-conformities raised during UKAS ISO 15189:2022 transition assessments so far:
Clause 6.2.3 requires accredited services to authorise personnel to perform specific laboratory activities, including selection, validation and verification of methods, and review and reporting of results. A number of services that have undergone transition assessments have not yet implemented this.
Clauses 7.3.1e and 7.3.2d require appropriately authorised personnel to periodically review examination methods, and review verification results, to ensure methods are clinically appropriate. This has not been evidenced in some transition assessments performed so far, and links back to the trend found relating to clause 6.2.3 above.
Clause 7.5 requires laboratory services to evaluate the clinical significance of any non-conforming work; this is not always evident in the non-conformity records. Although not a new requirement, the greater emphasis on clinical impact and patient risk means this area is under greater scrutiny than previously. Non-conformities might have many different types of clinical impact. For example, if an incorrect result has been released, is there a risk that other results from the same analyser or user might have been incorrect too? Have the clinicians acted on those results? Have patients received incorrect treatment as a result? If a key piece of equipment is out of action for a period of time, what impact has that had on patient care? Have turnaround times been affected? If they have, are some test results more critical than others, and therefore the delay would have a greater impact on a particular cohort of patients?
Clause 8.8.3 requires accredited services to plan their audit schedule, taking into account identified risks, non-conformities, and service changes and give priority to activities that may be higher risk to patients. This risk-based approach to auditing has not been in evidence in some of the transition assessments performed so far.
Major changes
All the clauses of ISO 15189:2022 listed above have been classified in the UKAS gap analysis template as “major” changes from ISO 15189:2012, so it is to be expected that a higher number of findings may be raised in these areas than against the “minor” changes.
Clause 5.6 is another “major” change from ISO 15189:2012, and relates to risk management processes. It is pleasing to see relatively few non-conformities are being raised against this clause, indicating that laboratory services have prioritised updating their risk management processes in line with ISO 15189:2022.
The UKAS ISO 15189:2022 transition process is off to a good start. Services that have undergone a transition assessment are to be congratulated for engaging with the transition process and, in the main, implementing the revised requirements of the standard.
For those services that have not yet completed the gap analysis or had a transition assessment, UKAS recommends that you continue working towards implementation of ISO 15189:2022. The more you can implement the new standard, the easier the transition assessment will be.
Embracing these changes early on will ultimately lead to better patient outcome and improved quality in healthcare service delivery.
Explore Further
- The ISO 15189:2022 transition hub: bit.ly/4aEDnZJ
- The new standard and point-of-care testing: bit.ly/3U78tE2
- Transition information and resources from the IBMS: bit.ly/3vMZe2c
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