RISK MANAGEMENT
Integration with governance Audit and review activities deliver their greatest value when they are embedded in the laboratory’s wider quality management system. At the local level, findings should be recorded in the risk register and discussed at management review meetings, where they can be linked with non-conformance reports, corrective and preventive actions, and quality indicators. This ensures that risks identified during audits and reviews are not treated in isolation, but are considered alongside the full picture of laboratory performance.
The outputs of audits and periodic
reviews also extend beyond the laboratory. Results may highlight recurring risks, emerging trends, or examples of best practice that are of relevance to the wider organisation. When escalated appropriately, this information feeds into organisational governance processes such as clinical governance meetings, patient safety forums, or wider quality committees. In this way, the laboratory contributes to the broader assurance that patient care across the service is safe, effective, and continuously improving.
Good integration also prevents
audits from becoming a paperwork exercise. When findings are actively communicated, both within and between laboratories, they become a source of shared learning. Improvements made in one area can be applied in another, and the organisation benefits from efficiencies created by risk-based auditing.
The laboratory’s role in clinical audit
Alongside internal quality audits, laboratories also have an important role in supporting clinical audit, which remains one of the key mechanisms for improving patient care across healthcare systems. While clinical audits are often initiated and led by clinicians, they rely heavily on laboratory input to be meaningful. Data such as turnaround time compliance, critical result reporting, demand optimisation, and test utilisation provide objective measures that link laboratory performance with patient outcomes. Laboratory staff may also contribute
directly to multidisciplinary audits of specific clinical pathways – for example, anticoagulation monitoring, stroke management, or sepsis bundles – where the timeliness and reliability of laboratory results are integral to patient safety. In these settings, the laboratory does not just act as a passive data provider but as a partner in interpreting
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results, understanding the risks of laboratory variation, and identifying where changes to processes could reduce harm. By engaging with clinical audit, laboratories help to ensure that their internal risk-based audits are not siloed but contribute to a wider programme of patient-centred assurance. This collaboration strengthens the link between laboratory processes and clinical outcomes, and reinforces the laboratory’s place within the broader governance framework of the organisation.
Residual risk and benefit–risk analysis in audit cycles Risk management begins with identifying inherent risk – the potential for harm that exists before any controls are applied. Once mitigation measures are in place, the level of risk that remains is referred to as residual risk. This distinction, defined
clearly in ISO 22367:2020, is central to understanding the outcomes of risk- based audits and reviews. Residual risks are unavoidable. No
process, however well controlled, is completely without potential for error. The task of the laboratory is therefore to determine whether the residual risks are acceptable in light of patient safety. This requires a conscious decision, not an assumption, and must be informed by both technical performance and clinical impact.
Audits and periodic reviews play a key
role in exposing residual risks. In some cases, these relate to assays. For example, a rare specialist assay may participate in EQA, but the small number of peer laboratories limits the statistical power of comparison. Even with robust IQC, there remains a residual risk that errors may go undetected. Similarly, measurement
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