How NICE guidance functions in clinical negligence
NICE guidance is not law. Its role in negligence cases is evidential, not prescriptive. The legal test remains the Bolam principle: a doctor is not negligent if they act in accordance with a practice accepted as proper by a responsible body of medical opinion. The 1997 Bolitho addendum requires that the body of opinion must also be logical and defensible. NICE guidelines are a powerful, but not conclusive, piece of evidence within this framework.
In practice, a court assesses whether a clinician's actions were reasonable. Adherence to a contemporaneous NICE guideline is strong evidence of reasonableness. Departure from it is not automatically negligent, but it requires a clear, documented, and justifiable explanation.
The critical importance of the applicable version
The single most common point of failure in using NICE guidance defensively is incorrect versioning. A guideline is only relevant if it was in force at the time of the alleged incident. Citing a 2023 guideline for a 2019 case is worse than useless; it demonstrates a failure to understand the standard of care applicable at the time.
For example, consider a claim involving the timing of surgery for a fractured neck of femur. NICE guideline CG124 was updated in June 2023 to recommend surgery on the day of, or the day after, admission. Prior to that, the 2011 version stated surgery should occur "on the day of, or the day after, admission." While the wording is similar, the clinical context and supporting evidence had evolved. A trust defending a 2022 case must rely on the 2011 version and its interpretation at that time. Using the 2023 update would be incorrect.
Maintaining an accessible, timestamped record of the guidance in effect is crucial. A canonical guidance view that clearly displays the publication and last update dates is essential for audit and legal preparedness.
How NICE guidance is used by claimants
Claimant solicitors use NICE guidelines as a benchmark. They will obtain the version current at the time of the incident and map the patient's journey against its recommendations. Deviations are flagged as potential breaches of duty.
Common areas of focus include:
- Timeliness: Failure to meet recommended timeframes for assessment, referral, or treatment. For instance, a 4-hour target for sepsis bundle completion or a 62-day cancer pathway target.
- Investigation: Omission of a recommended test. A classic example is not performing a D-dimer in a low-probability Wells score scenario for PE, as per CG144.
- Treatment Choice: Prescribing a medication not recommended as a first-line option, or failing to offer a NICE-approved therapy.
The claimant's argument is straightforward: "The national standard, as set by NICE, was X. You did Y. Therefore, you fell below the standard."
Defending a departure from NICE guidance
A documented departure is not indefensible. The Bolam principle allows for differing responsible practices. A successful defence often hinges on demonstrating that the decision was patient-specific and logically reasoned.
Valid justifications include:
- Patient Comorbidity: The guideline recommendation was contraindicated for this specific patient due to other conditions.
- Patient Choice: The patient, after informed discussion, declined the recommended pathway.
- Resource Limitation (in specific contexts): While weak, the unavailability of a NICE-recommended technology at the trust, provided a suitable alternative was used, can be argued. This is highly fact-specific and risky.
- Clinical Judgment: The patient's presentation was atypical and fell outside the scope of the guideline's recommendations.
The key is contemporaneous documentation. A note that says, "Discussed NICE guideline CG150 for UTI. Decided against antibiotic X due to patient's history of C. diff. Agreed to use antibiotic Y instead," is defensible. A note with no mention of the guideline is vulnerable.
Local policy vs. national guidance
Trusts often have local policies that adapt or supplement NICE guidance. These can create a "double-bind". A clinician can be accused of breaching both the local policy and the national standard.
In a case I was involved with, a local trust policy for chest pain mandated a specific troponin assay at 0 and 3 hours. The contemporaneous NICE guideline CG95 was less prescriptive on the assay type but emphasised rapid rule-out protocols. A clinician used a high-sensitivity troponin assay at 0 and 2 hours, adhering to the evolving national standard but breaching the local policy. The patient had an outcome. The trust's defence was complex: they had to argue that the local policy was outdated and the clinician's actions represented a responsible and logical application of newer evidence. It was messy.
The lesson is that local policies must be regularly reviewed against current NICE guidance. A clinician caught between an outdated local policy and a newer national standard is in a precarious position.
Bolitho and the weight of NICE guidance
The Bolitho judgment is where NICE guidance carries significant weight. It allows the court to reject a body of medical opinion if it is deemed illogical. If a defendant clinician defends a practice that directly contradicts a clear, evidence-based NICE recommendation, the court may find that no responsible body of practitioners *should* hold that view. It becomes indefensible.
For example, if a clinician argued that it was acceptable to withhold thrombolysis from a stroke patient within the time window, contrary to NICE CG188, and called an expert who supported that view, the court could use Bolitho to rule that such an opinion is not logical or reasonable, given the weight of national evidence. NICE guidance here sets a floor for what is considered a defensible practice.
Practical examples from case law
Cases rarely turn on a single guideline, but they provide critical context.
Example 1: Failure to Monitor. In a case involving a post-operative patient who developed serotonin syndrome, the claimant cited NICE guideline CG90 (Depression in adults). The guideline recommends caution when prescribing drugs with serotonergic effects. The allegation was a failure to recognise the drug interaction and monitor for symptoms. The trust's defence relied on the fact that the combination was not absolutely contraindicated and that the patient's post-operative sedation masked early signs. The case settled, but the NICE guideline formed the core of the breach of duty argument.
Example 2: Versioning Error. A claim involved a delay in diagnosing Cauda Equina Syndrome. The claimant's expert cited a 2019 NICE guideline (NG) on back pain that had specific red flag recommendations. The incident occurred in 2017. The trust's defence correctly identified that the applicable guideline was the 2009 Clinical Knowledge Summary (CKS) on back pain, which had different wording. The difference in recommendations was material to the case. Using the correct version was pivotal.
The role of audit and governance
For governance leads, the proactive use of NICE guidance is a risk management tool. Regular audit against key guidelines (e.g., sepsis, VTE prophylaxis, stroke) identifies systemic drift from national standards before it leads to a critical incident.
I reviewed a serious incident report where a trust had a 40% compliance rate with a specific element of the sepsis six bundle, as per NICE NG51. This audit data was used not for blame, but to secure funding for a new electronic alert system. This is the ideal use of guidance: to drive improvement and mitigate risk. In a subsequent negligence claim related to sepsis, the trust could demonstrate a proactive system-wide effort to improve compliance, which is a powerful mitigating factor.
Conclusion: Guidance as a tool, not a rule
NICE guidance is a central feature of the modern clinical landscape. In negligence law, it provides a clear, authoritative benchmark for the standard of care. Its misuse—primarily through incorrect version application—is a common pitfall. The defence of a clinical decision lies not in slavish adherence, but in reasoned, patient-centred, and documented decision-making. For clinicians, understanding the nuance between a mandatory standard and a benchmark is critical. For trusts, maintaining robust systems to ensure easy access to the correct historical versions, such as a comprehensive guideline versions index, is a fundamental part of clinical governance and risk management.