QUALITY MANAGEMENT


percentage compliance with defined TAT targets. There are other, very mathematically complex approaches out there, but moving away from averages is a good first step.


This metric answers the clinically


relevant question: How often are results delivered within a clinically acceptable timeframe? For example, reporting that 92% of D-dimer results from the ED were reported within the 60-minute target directly reflects the reliability of timely diagnostic information. However, setting compliance


thresholds introduces a fundamental risk- based decision: n If 95% compliance is targeted, it must be accepted that 5% of results may breach.


n Laboratories must decide whether this residual risk of delay is clinically acceptable.


n For higher-risk tests or critical pathways, 99% or even 100% compliance targets may be appropriate.


n Conversely, unrealistic targets (eg, universal 100% compliance) can drive system stress, staff demotivation, and unintended service failures elsewhere.


The consequences of non-compliance – both clinical and operational – must be formally assessed during the initial risk evaluation when defining acceptable compliance thresholds. By monitoring percentage compliance rather than averages, and understanding the residual risk inherent in target-setting, laboratories ensure their reporting methods remain clinically meaningful and focused on patient safety outcomes.


Monitoring, reporting, and continuous improvement Effective TAT management depends on continuous and structured monitoring (Table 3). Laboratories should implement real-time tracking of sample progress through LIS systems and middleware, allowing operational staff to intervene proactively when potential breaches are identified. Alongside real-time monitoring, periodic reviews of aggregate TAT performance at shift, daily, and weekly intervals help identify systemic bottlenecks and process inefficiencies. Turnaround time compliance must


be reported as a formal KPI within the laboratory’s quality management system, meeting ISO 15189:2022 requirements for monitoring and measurement. Reporting should be structured both at departmental level, to assess internal performance, and at a pan-pathology or service level, to inform wider clinical governance and oversight committees. Laboratories should decide to what extent all assays are monitored. Selected tests can be used to represent urgent workflows or location TATs, such as those critical to patient safety or characterised by high volume, but I don’t really like that (my opinion only!). This decision should be based on workflow mapping and clinical consultation, and formally documented as part of the TAT assessment process. Turnaround time KPIs should be


regularly reported into laboratory management reviews, quality governance forums, and, where relevant, clinical governance committees. Persistent failure to meet TAT targets must be escalated through these structures, triggering structured root cause analysis (RCA) and risk reassessment. Finally, all defined TAT targets should


undergo periodic review, typically on an annual basis, but should be risk-based, of course. These reviews should evaluate the continued clinical relevance of TAT targets, operational feasibility, technological changes affecting workflows, and any reconfiguration of clinical services. This ensures that TAT targets remain clinically meaningful, operationally realistic, and aligned to both patient safety priorities and laboratory capacity.


Responding to breaches and persistent failures Even with robust systems in place, TAT breaches will occur. What differentiates a risk-based approach is how laboratories respond – not just recording failures, but treating them as potential patient safety risks requiring structured investigation and action.


n Immediate operational response When TAT breaches are imminent or occurring, operational staff are responsible for escalating the issue to senior staff or management in real time. Wherever possible, immediate workflow


Turnaround time is not merely an operational target – it is a measurable patient safety risk. Delayed laboratory results can cause missed diagnoses, treatment delays, and direct patient harm


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interventions should be implemented, such as prioritising analyser capacity or reassigning staff to manage the bottleneck. If intervention is not possible, the breach should still be formally logged for retrospective investigation.


n Structured investigation of TAT breaches


Every TAT breach should be investigated systematically to determine whether it was an isolated incident or part of a recurring trend. Investigations should identify root causes, which might include equipment failure, insufficient staffing, or workflow inefficiencies, and assess whether any clinical harm occurred or was avoided. This process must be embedded within the laboratory’s formal non-conformance management system, in line with ISO 15189:2022, ensuring that incident or non-conformance reports are raised and properly documented.


n Assessing clinical harm While potential clinical harm should be identified in advance through FMEA, laboratories must assess actual harm following serious breaches. Investigations should determine whether treatment was delayed, whether diagnostic uncertainty was prolonged, and whether harm to the patient occurred. Where clinical harm is confirmed, the incident must be escalated through appropriate clinical governance channels in accordance with local reporting frameworks.


n Persistent non-compliance and risk review


Persistent TAT breaches require formal root cause analysis to uncover systemic issues and prompt a reassessment of existing risk controls. Laboratories should review and, where necessary, update their FMEA and risk registers to reflect the current operational context. It is critical for laboratories to recognise that repeated non-compliance may indicate that existing TAT targets are no longer realistic. Rather than rigidly enforcing unattainable targets, laboratories must engage governance and risk review processes to formally revise TAT expectations where appropriate.


n Reassessing service capacity When persistent TAT failures continue despite workflow and process improvements, laboratories must re- evaluate their fundamental service capacity. This includes assessing staffing levels, shift patterns, workload distribution, analyser capacity, equipment suitability, and pre-analytical transport systems. Capacity limitations should be openly acknowledged and addressed as part of strategic planning, rather than concealed


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