RISK MANAGEMENT The steps involved in the management of risk in the clinical laboratory.
standard ensures a systematic approach to identifying, assessing, and mitigating risks across all stages of medical laboratory processes.
Risk identification Identifying the presence of risks is the first and most critical step in the risk management process. It involves recognising potential hazards and points of failure throughout the laboratory workflow, including the pre-analytical, analytical and post-analytical phases. Laboratories are encouraged to adopt tools such as hazard identification checklists and process mapping to systematically identify risks and their potential impact. Of course, this is the first step, but it doesn’t end there – the potential for harm needs to be assigned to each of the risks identified. This includes terms such as severity of harm and then how likely it is to occur – the likelihood. Tools at our disposal in laboratories include historical data identifying when it has occurred previously or trend analysis of processes moving towards a critical failure point. The likelihood is combined with the severity, simply understood as the potential impact of a risk on patient safety. As ever, frameworks have been developed to help us make these assessments. Structured tools such as Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA) are instrumental in this process, and we will cover both of these, and some others, in future articles. FMEA assigns numerical values to severity, likelihood and detectability to calculate a Risk Priority Number (RPN), which helps prioritise risks for mitigation. FTA provides a visual representation of the root causes and interdependencies of failures, enabling laboratories to address underlying systematic issues.
30 Risk control
Once identified, and prioritised, proactive and targeted risk control measures are needed to mitigate identified risks. These measures may include automating manual processes to minimise human error, such as introducing automated pipetting systems or result verification software. Designing of focused, risk based QC protocols to detect deviations early may include implementation of rules or increasing the frequency of QC checks for high-risk assays. This will be the focus of an entire article. As we now expect, each risk control measure must be documented, implemented and regularly reviewed to ensure its effectiveness in reducing risk to acceptable levels.
Residual risk assessment An important distinction to make early on is the difference between inherent risk and residual risk. The initial assessment of the process identifies the inherent risk, in the absence of any control measures. Residual risks refer to those that remain even after mitigation measures have been applied. We must determine whether or not these residual risks fall within acceptable thresholds as defined by risk management policies, and those acceptable limits of course must be directly related to risk of harm. These risks, according to ISO 22367 should also be regularly reviewed, but also should be checked as workflows, technologies or clinical requirements change. So, acceptable risks may change, as well as our ability to control them.
Not just the laboratories Risk management in medical laboratories is a shared responsibility that extends beyond laboratory personnel to include manufacturers of in vitro diagnostic (IVD) devices. ISO 22367 aligns closely with
ISO 14971, the standard for medical device risk management so highlights the shared responsibility between laboratories and manufacturers to manage risks effectively. Both standards emphasise the need for collaboration between laboratories and manufacturers to ensure that risks are effectively identified and controlled throughout the lifecycle of diagnostic devices. When manufacturers clearly define the operational limits and accuracy of their devices under standard conditions, this gives the minimum benchmark that laboratories should be striving to achieve. Additionally, disclosing residual risks associated with their devices allows the laboratory to pre- emptively put controls in place. Detailed guidance on mitigating these risks may be provided through recommended maintenance protocols. All of these must be associated with the analytical performance specifications of the clinical utility of the test. This was also the subject of a previous article and will be extended in the risk setting in this series. For example, a manufacturer might specify that a particular analyser requires daily calibration to maintain accuracy – or metrological traceability. By providing instructions for addressing calibration failures, or if a device exhibits increased variability at low concentrations, the laboratory might establish additional QC checks or implement confirmatory testing for results within this range. For laboratories, the onus starts
with proper verification, including on an ongoing basis, under real-world operating conditions. Laboratories are responsible for validating manufacturer- provided performance characteristics and integrating these into their risk management systems.
Common risk areas impacting patient safety Examples where risk management directly influences patient safety include implementing haemolysis/icterus/ lipaemia (HIL) checks to identify a haemolysed sample due to improper handling. This reduces the risk of incorrect results in tests where HIL may be a significant interference. Calibration drift, reagent instability, or instrumentation failures can also result in inaccurate test results. Delayed communication of critical values, such as troponin levels in patients with suspected myocardial infarction, can impede timely treatment. Miscommunication of results between laboratories and clinicians or errors in transcription can have severe consequences, particularly in urgent care settings. These examples are clear, but
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