QUALITY MANAGEMENT


by maintaining unachievable TAT targets. By embedding structured, risk-based


breach management into their quality systems, laboratories can ensure that TAT failures drive meaningful service improvements and protect patient safety, rather than contributing to staff frustration and operational demoralisation.


Special considerations


n Managing risks and limitations of TAT-focused approaches


Although adopting a risk-based approach to TAT management offers clear patient safety benefits, laboratories must be mindful of associated challenges to prevent unintended consequences and ensure sustainable practice.


n Unintended consequences of TAT emphasis


A strict focus on meeting TAT targets can lead to distorted priorities. Laboratories may inadvertently prioritise high-volume tests that are easier to process within set timeframes, rather than those associated with the greatest clinical risk. Conversely, if prioritisation systems are poorly managed, routine or non-urgent samples can experience delays as attention shifts entirely to urgent workflows. Additionally, SLAs based on operational targets may skew laboratory priorities, diverting resources to contractual requirements at the expense of clinically urgent testing. Maintaining a patient-centred perspective is essential to ensure that TAT priorities reflect actual clinical risk and urgency, rather than convenience or contractual pressures.


n Role of point-of-care testing and hot labs


In scenarios where central laboratory processes cannot achieve clinically required TATs, alternative models such as point-of-care testing (POCT) and hot labs situated in emergency or critical care areas may provide a solution. These decentralised approaches can help mitigate TAT-related risks for specific tests, particularly where national targets, such as ED processing goals, are reliant on rapid result availability. Laboratories should consider these alternatives during TAT planning to address known performance limitations, but not use it as a way of not reviewing the central laboratory processes and risk-based TAT implementation.


n Medico-legal and contractual risks Turnaround time breaches that result in patient harm may carry medico-legal implications, especially if agreed national standards or contractual obligations are unmet. Laboratories must balance the


Component Real-Time Monitoring Periodic Monitoring TAT as KPI Reporting Levels Full Coverage vs.


Representative Tests Data Integrity


and Quality Periodic TAT Review Description


Continuous tracking via LIS/middleware; operational staff monitor live dashboards and intervene proactively to prevent TAT breaches.


Shift-level, daily, and weekly reviews of aggregate data to identify trends, bottlenecks, and emerging risks.


TAT compliance is formally reported as a Key Performance Indicator within the QMS, fulfilling ISO 15189:2022 requirements.


Departmental reporting for internal management; pan-pathology or service-level reporting for external clinical and governance stakeholders.


Decision to monitor all assays or selected representative tests (based on clinical risk and volume) must be formally documented.


Consistent timestamp definitions; known data limitations must be documented and addressed prior to implementation of formal monitoring.


Governance Reporting TAT KPIs reviewed at internal management, quality, and clinical governance and Escalation


forums; persistent failures trigger RCA and structured risk review.


Annual (or risk-based scheduled) review of TAT targets assessing clinical relevance, operational feasibility, technology impact, and service changes.


Table 3. Ongoing monitoring of risk based turnaround times.


demands of operational SLAs with clinical priorities when setting and managing TAT targets. While the legal aspects of TAT management are outside the scope of this discussion, engaging legal and governance teams during TAT framework development is recommended to ensure medico-legal risks are appropriately managed.


n Resource constraints and operational limits


Even after optimising workflows and processes, laboratories must recognise that resource and capacity limitations may prevent consistent achievement of all risk-based TAT targets. Persistent failure to meet targets despite sustained improvement efforts can indicate fundamental shortfalls in staffing, equipment, or infrastructure. In such cases, TAT targets should be formally revisited through structured governance and risk review processes, rather than adjusted informally or reactively.


Conclusions 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. Laboratories must therefore treat TAT as a critical clinical process requiring structured management under ISO 15189:2022 and ISO 22367:2020 frameworks. By shifting focus from averages to


percentage compliance against defined, clinically risk-assessed targets, laboratories can monitor the true reliability of their service. However, compliance thresholds themselves introduce residual risk, which must be consciously evaluated and accepted or addressed. Whether aiming for 95%, 99%, or 100%(!) compliance, laboratories must balance the clinical risk


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of delay against the operational risk of setting unachievable targets. Implementation of risk-based TAT management requires collaboration across laboratory and clinical teams, supported by robust IT infrastructure and real-time monitoring tools. But perhaps most importantly, it requires cultural change. From sample collection through to results reporting, every staff member has a role in ensuring timely, clinically appropriate service delivery. Persistent TAT failures should trigger


structured risk reviews and capacity assessments – not punitive responses or unrealistic expectations. Laboratories must remember that, ultimately, turnaround time management is not about compliance for its own sake, but about protecting patients and supporting clinical care.


Previous articles in this series n MacDonald S. Introduction to risk


management frameworks in clinical laboratories. Pathology in Practice. 2025 Feb; 26 (1): 29–31.


n MacDonald S. Process Mapping, FMEA and FTA: Practical Approaches to Risk Assessment. Pathology in Practice. 2025 Apr; 26 (2): 27–30.


n MacDonald S. Risk-based validation and verification in medical laboratories: an overview. Pathology in Practice. 2025 May; 26 (3): 27–31.


n MacDonald S. Risk-based quality control: planning, defining, linking and evaluating. Pathology in Practice. 2025 Jun; 26 (4): 15–18.


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. 33


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