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Clinical engagement changing needs and ISO 15189:2022

Lead Biomedical Scientist and Laboratory and Quality Manager Hannah Keyser answers questions on clinical engagement.

The ISO 15189 revision (2022) is described as a more risk-based and patient-focused clinical laboratory standard, with an emphasis on risk and continuous improvement for the benefit of the patient. This gives laboratories some fresh and interesting challenges in interpreting and implementing these changes.

  • Why do we need clinical engagement?

An example in the standard is 7.2.2 Laboratory information for patients and users. Laboratories will need to consider the information given to users and patients, so that samples are collected safely. Clinical engagement is critical here to define factors that significantly impact the performance of the examination or the interpretation of the results. An engaged relationship will ensure the information provided remains in tune with the changing or future needs of the clinician.

  • How does a risk-based approach improve how we work?

In the standard, clauses 7.3.2 and 7.3.3 Verification/Validation of examination methods, the new version states that the results of verification/validation tests must be “sufficient to ensure the validity of results pertinent to clinical decision making” and that those who review the verification results must have “appropriate authorisation and competence”. Laboratories can determine whether these requirements are best carried out by those with clinical expertise (e.g. pathologists, clinical scientists, etc.) or to demonstrate through consideration of relevant risks, that other staff groups can demonstrate the necessary competences, streamlining the clinical process. In both circumstances, clinical engagement is key.

  • Does the risk-based approach apply to reporting?

Clause states that results of examinations shall be evaluated “against …IQC and, as appropriate, available clinical information and previous examination results”. Clause, Critical result report, instructs laboratories that the decision of when to contact users with critical results will depend on the clinical information available. Clinical teams within the laboratory will need to consider the associated risks for critical results and their clinical outcomes to determine what is appropriate for their tests and users and will also need to clarify the process for escalating when key personnel cannot be reached.

  • Are there new requirements regarding patients?

ISO 15189:22 has a new clause specifically detailing the laboratory’s requirements regarding their patients (4.3 Requirements regarding patients), so that wellbeing, safety and rights are primary considerations for the management team. Clinical engagement, both internally and across the wider patient pathway, will be required, with the local laboratory clinical team directing and being directed by the users to ensure patients are protected.

  • What about the role of the laboratory director?

As with the previous version of 15189, laboratories will need to demonstrate that they are being steered by an appropriately qualified laboratory director. The new version of the standard places a greater emphasis on this person having the clinical expertise to be able to identify patient safety risks that may occur outside the laboratory setting but which will impact on the quality of the results the laboratory produces (clauses 5.2 and 7.1). Equally, the laboratory director must have the clinical skills to support teams outside the laboratory setting, from the clinician considering the test, to the patient reviewing their results. This fits importantly into the central theme of the GIRFT Pathology report (2021), where laboratories are integral to ensuring the right test, at the right time, with the right result.

  • Can the RCPath and ACB help?

The Royal College of Pathologists (RCPath) and The Association for Clinical Biochemistry and Laboratory Medicine (ACB) can provide support for their members by further developing continuous professional development (CPD) programmes that focus on interpreting the new standard in clinical practice. Raising the profile of the new standard will be important at future RCPath and ACB meetings and conferences where ISO/UKAS/laboratory quality should become a regular component to increase awareness of the clinical input required.

It may be necessary for job planning to more fairly reflect the time required for clinical staff to engage with quality improvement programmes, of which conformance to ISO 15189:2022 must be considered. The RCPath and ACB will be able to support their members with guidance for hospital trusts. Providing sufficient job planning for laboratory staff is also vital here, to allow them time for mutual support and development of quality improvement (QI) projects to facilitate transition to ISO 15189:2022.

  • What about laboratory services’ impact on external pathways?

When laboratories were assessed against the Clinical Pathology Accreditation (CPA) standards, it was typical during assessments for laboratory users, e.g., emergency department and GPs, to be interviewed as part of the assessment process. More than simply a user survey, CPA assessors would directly seek information about the challenges and risks around their interactions with the laboratory under assessment.

ISO 15189:2012 moved away from this model into more of a user survey process, however, laboratories have often cited poor response rates to these surveys, highlighting concerns that this process provides insufficient insight into the possible problems users face and their clinical impact.

ISO 15189:2022 sets out a greater responsibility for the laboratory to support clinical teams in the safe collection and transport of samples from the patient, as well as the safe delivery of clinically useful results. Laboratories should consider alternative or adjunct methods for more routine feedback loops from users, so that clinical users can discuss challenges with laboratory clinicians and find pathways for improvements that will most benefit the patient.

  • What does improving clinical engagement mean for laboratory services?

As laboratories seek to transition from the 2012 to the 2022 version of the standard, by engaging early, clinical teams will be better able to shape and interpret the new standard. This, in turn, should increase engagement by moving away from a passive experience (where clinical teams may feel the standard is imposed on them) to a more active and dynamic process, where they can direct change and QI to ensure the patient is kept at the centre of every laboratory process.  

Hannah Keyser is a Lead Biomedical Scientist and Laboratory and Quality Manager in Neuropathology at John Radcliffe Hospital, Oxford. She would like to thank Katharine Hayden for her support with the article.

Image credit | Istock

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