ISO 15189:2012 has undergone a review by the international community over the last few years. With its publication nearly here, we look at the standard.
There were two key reasons for the review. Firstly, because the parent standard – ISO/IEC 17025:2017 – had been updated to comply with the structure of the normative ISO 9001:2015, and secondly, as ISO/IEC 17025:2017 is a normative reference of ISO 15189, there was a requirement for the documents to be aligned. Also ISO 15189:2012 had reached its periodic review date. A vote was taken by the international community, and it was agreed that the standard required review and update to reflect the changing demands of the medical laboratory community. The standard has undergone several draft revisions, some of which have been publicly available on the British Standards Institution website (bsigoup.com), and is due to go for a vote on the final draft international standard (FDIS) within the next few weeks. This is the final voting process required to turn the draft standard into a full ISO standard. There is no longer an option to make technical changes to the document and only editorial issues will be actioned.
Robust process
There has been a robust process to revise the standard, with many thousands of comments received and reviewed from across the globe. The wording agreed must be translatable and applicable across many different and diverse health systems and medical disciplines. Legal and regulatory requirements in each country always take precedent over international standards. Standards are written as guidance documents that may be used by accreditation services to assess laboratories. The standard is written as a minimum requirement and not a maximum; there is often a misconception that if the standard does not specifically require or reference a process/activity, then it cannot be offered by an accredited organisation. This is not the case; if there is an opportunity to improve the quality of the service offered to patients and other users, then this inherently meets the requirements of the standard (old and new), so long as adequate justification and documentation is available. A decision was made very early in the revision that the updated version needed to be patient-focused and risk-based as this is a clinical standard for a service that is key to the patient pathway. There was an understanding that, as effective as the current version is, there is a high degree of prescription and over-reliance on interpretation of the standard in terms of perceived accreditation requirements. There are several useful reference standards quoted in the updated ISO 15189, none of which are compulsory, but all of which add value to any quality system. These include:
ISO 15190:2020: Medical laboratories — Requirements for safety
ISO/IEC 17043:2010: Conformity assessment — General requirements for proficiency testing
ISO 22367:2020: Medical laboratories – Application of risk management to medical laboratories.
There has been a robust process to revise the standard
Risk management
The concept of risk, and the requirement of the laboratory to be able to articulate this, will be one of the key requirements that accredited organisations will need to consider when demonstrating compliance with the updated ISO 15189. ISO 22367:2020 “Medical laboratories – Application of risk management to medical laboratories” is a useful document to support this, as it covers concepts including risk analysis, risk control, risk acceptability and risk monitoring. The intention of including a strong emphasis on risk management in the updated ISO 15189 is to understand and think about areas of risk that can impact patient care, put the patient at the heart of any decision, and weigh up any impact to the patient of decisions made in the laboratory.
During an accreditation assessment, we anticipate that there will be significant discussion between the laboratory representatives and the UKAS assessment team regarding how the accredited organisation has considered their management of risk. It is important to acknowledge that every accredited service will have service-specific risks, and that there is no “one-size-fits-all” approach to risk management.
Service agreement
The concept of service agreements is another area that needs careful review and understanding. Service agreements are the cornerstone of any service. For example, should a laboratory wish to bring its point-of-care testing (POCT) service into its accredited scope, this will need to be managed by specific agreements with the service being supported. Examples could be an agreement with the accident and emergency department for blood gas, or blood gas and urinalysis.
Requirements for a POCT service are now incorporated into the body of the new ISO 15189 standard, to replace the current ISO 22870:2016, although there is a POCT-specific annex in the updated ISO 15189, to provide additional clarity and guidance. There is no longer a specific requirement for a multidisciplinary POCT team, however, this does not mean that an accredited organisation can’t have one. If an organisation continues with a multidisciplinary POCT team, this group could be used, for example, to agree and monitor the service agreements.
Once the updated version of ISO 15189 is released, ISO 22870:2016 will be retired and any new POCT assessments will be added to ISO 15189. There will be a transition period, allowing customers currently accredited to ISO 22870:2016 time to move to being accredited against the new ISO 15189.
Technology has moved on since the 2012 standard. The standard no longer uses the term “request form” but “examination request”. This can be in any format agreed by the service user and the laboratory, for example electronic requesting systems or paper-based systems. Of course, there will need to be evidence of how the format was agreed, which takes us back to the importance of service agreements. There is still clear guidance in the new standard on what information is required when examinations are requested, regardless of the format of the examination request.
There has been some consideration for more local decision making. There are some “shall” statements followed by terms such as “as appropriate”. “Shall” statements indicate mandatory requirements, as opposed to “should” statements, which are recommendations.
Where a “shall” statement is followed by “as appropriate”, each organisation will need to consider, and provide evidence of what is and is not appropriate to their service. An example of this can be found in the requirements relating to information for patients and users; each laboratory is different and will need to make different information available to users. Consider an andrology lab, where samples may be produced by patients on site, with very specific timing and sample handling/transport requirements, compared to a histology department, which may only process formalin-fixed samples, where delivery
is less time critical, and the lab has no patient contact.
Decision making
There is a greater emphasis on risk to the patient and clinical decision making in the updated standard. For example, there is no longer a prescriptive requirement on how samples are labelled, however, these still need to be traceable to the patient. Also, the decision to process or not to process a potentially compromised sample should be linked to the risk to the patient before deciding on how to action the request. Consider the risk of not processing an inadequately labelled, potentially cancerous, skin biopsy vs. not processing an inadequately labelled urine sample.
There has been an update to the quality control (QC) section of the standard; there is no longer a requirement for the laboratory to follow the manufacturer’s minimum testing intervals, but to look at the stability of the assay and the risk to the patient of a QC fail. There is also updated advice on QC covering the range of the assay.
The definitions of verification and validation remain unchanged, and the requirement for verification data to show how the laboratory can demonstrate that a validated method is acceptable in their hands is still in place. However, the requirements for method validation and verification have been updated, to ensure a focus on the clinical question being asked and assurance that the methods are fit for that purpose.
More information will become available over the next few months, both about the content of the updated standard and about the UKAS process of transitioning from accreditation to ISO 15189:2012 to the new standard.
“Each lab is different and will need to make different information available”
What now?
The International Laboratory Accreditation Cooperation (ILAC), will set a timescale in which all organisations accredited to ISO 15189:2012 worldwide must transition to accreditation to the new standard. This is likely to be a three-year transition period but will not be confirmed until publication.
The British Standards Institution (BSI) and UKAS are working closely together, and taking advice from professional bodies, including the IBMS and RCPath, to ensure that everyone impacted by the new standard, including accredited organisations, UKAS assessment managers and technical assessors, and equipment/assay manufacturers, are aware of the updated requirements and understand how the changes affect them. UKAS will be delivering training sessions and writing a number of articles for the Biomedical Scientist throughout the rest of 2022 and beyond, to support this work.
Dr David Ricketts is the Head of Laboratory Process at Health Service Laboratory, Alyson Bryant is Healthcare Accreditation Specialist at UKAS and John Ringrow is Senior Assessment Manager at UKAS.
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