RISK MANAGEMENT
Identifying the presence of risks is the first and most critical step in the risk management process, and involves recognising potential hazards and points of failure throughout the laboratory workflow
care must be taken when considering the entire testing process to ensure that potentially significant risks, that may not be as clear as those ones above, are not missed, as if they are not identified they cannot be controlled. To minimise risks associated with clinical decision-making, laboratories must implement targeted strategies across the testing workflow. The stages that can be applied are far reaching but may include development of the aforementioned Quality Control Plans including using guidance such as CLSI documents C24 and EP23 that importantly advocate for QC plans customised to the clinical significance of specific tests. This links routine laboratory processes such as frequency of QC, and rules applied to the clinical utility of tests. Even familiar metrics like audit schedules and turnaround times (TATs) ultimately should be prioritised based on clinical utility. For TATs, laboratories must establish realistic and clinically relevant benchmarks for routine and critical tests, not only to optimise delivery of clinically urgent results but also not to delay other results through incorrect prioritisation and setting unrealistic targets.
ISO 22367 highlights critical strategies for fostering continuous improvement in patient safety. Laboratories must periodically reassess their risk controls to ensure they remain effective and relevant as workflows evolve. This is part of the annual review of examinations we perform. The decisions taken from these reviews should be data-driven, where incident reports, audit non- conformances, root cause analysis and quality indicator performance suggest priority areas for improvement. These tools ensure laboratories adopt a proactive approach to risk management, focusing on prevention rather than reaction.
A simplified example illustrates the significance of continuous improvement in mitigating risks and enhancing patient safety. In a scenario where review of the examination procedure has highlighted delayed reporting of critical results as a high-risk failure in a laboratory, one of the causes was found to be intermittent communication failure between analyser and the laboratory information management system (LIMS). Mitigations, as part of the risk control procedure, may be a documented process for identification
and immediate manual verification of results flagged as critical. Further options may include routine maintenance and validation of LIMS communication protocols to prevent future disruptions, or even upgrade or replacement of software handling the communications. These controls have other implications including comprehensive staff training on manual result escalation procedures in case of software failure, evidenced by competence assessment. Of course, once implemented, these controls must be assessed prospectively to ensure the desired outcomes have been achieved, and if they haven’t, further, or alternative, control measures may be required.
Conclusions At its core, risk management frameworks like ISO 15189 and ISO 22367 aim to safeguard patient safety by proactively addressing risks across laboratory processes. These standards ensure that laboratories operate with competence, quality and a continuous focus on minimising harm. Future articles will explore tools such as Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA), which to use and when, in an attempt to demonstrate their practical use in improving patient safety outcomes.
Dr Stephen MacDonald is Principal Clinical Scientist, The Specialist Haemostasis Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Hills Road, Cambridge CB2 0QQ.
+44 (0)1223 216746.
WWW.PATHOLOGYINPRACTICE.COM FEBRUARY 2025
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