RISK MANAGEMENT


of analytical performance indicators, including measurement uncertainty, internal quality control (IQC), and external quality assessment (EQA) – and we spoke about some others in article 6 of this series. Together, these provide objective evidence that assays continue to deliver reliable and traceable results that can support confident clinical interpretation. Governance also plays a role. Supplier audits, field safety notices, and the coverage of methods and platforms within risk-based audit schedules must all be accounted for. Looking forward, laboratories must also anticipate changes that may affect service delivery, such as new technologies, commissioning arrangements, or shifts in clinical pathways. Finally, reviews must not overlook the


Audit and review activities deliver their greatest value when they are embedded in the laboratory’s wider quality management system.


Importantly, the audit programme should be viewed as dynamic rather than static. Where audits demonstrate sustained strong performance and residual risk is reduced to acceptable levels, the interval between audits may be extended. Conversely, where deterioration is observed, or where audits identify gaps in process adherence, audit frequency must be increased. In this way, the audit schedule not only provides assurance but also becomes part of the laboratory’s continuous improvement mechanism. Finally, the outputs of audits should


feed directly into the laboratory’s risk register. This ensures that findings are systematically captured, residual risks are visible, and subsequent audit schedules are informed by the evolving risk profile of the laboratory. In doing so, the risk register becomes a living tool, linking audit outcomes with wider governance and continual improvement processes.


Periodic review of examinations Periodic review of examinations is a core requirement of ISO 15189:2022, which states that laboratories must regularly confirm the continued suitability, clinical relevance, and performance of their testing repertoire. Unlike a one-off validation or a reactive investigation, these reviews provide assurance that examinations remain fit for purpose in a changing clinical and operational environment. To be meaningful, reviews should take a risk-based approach, of course. Clinical relevance is the first consideration. Laboratories must ask


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whether each examination continues to serve a clear diagnostic or monitoring role, whether it aligns with up-to-date guidelines and pathways, and whether requesting patterns indicate overuse or inappropriate use. Demand optimisation, demographic shifts in patient populations, and the availability of new or alternative examinations all influence this decision.


Operational suitability is equally important. Reviews should confirm that sample volumes are appropriate, that throughput can meet routine demand, and that urgent requests can be accommodated without undermining service for other patients. These operational factors link directly to patient safety, particularly when tests inform urgent treatment decisions. The technical performance of examinations is supported by a suite


Domain Clinical relevance Operational suitability Analytical performance


workforce. Competency records, ongoing training, and senior scientific oversight are fundamental to sustaining a safe and reliable service, particularly as staff turnover and new technologies alter the demands on laboratory teams. These domains can be brought together in a practical summary checklist (Table 2), which laboratories can adapt to their own scope of practice. The frequency of periodic reviews should be determined locally, reflecting the risk associated with each examination and the complexity of the repertoire. High-risk tests or processes may need closer review, while lower-risk areas may be considered less frequently. As a minimum, all examinations must be reviewed within the accreditation cycle, but the guiding principle is that frequency should always be proportionate to risk. Findings from periodic reviews should be documented and fed into the laboratory’s risk register. This ensures that emerging risks are tracked, residual risks are visible, and management review can act on the most current information to drive improvement.


Example review elements


Alignment with guidelines and pathways; demand optimisation; requesting patterns; alternatives available


Sample volume appropriateness; ability to meet urgent requests; turnaround times aligned to patient care


Measurement uncertainty within limits; IQC review; EQA participation and outcomes


Governance and compliance Supplier audits; field safety notices; inclusion in risk-based internal audits


Future developments Workforce capacity


New technologies; commissioning changes; anticipated shifts in clinical pathways


Competency records; senior staff availability; training and assessment Table 2. Areas for review as part of periodic review of examinations. OCTOBER 2025 WWW.PATHOLOGYINPRACTICE.COM


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