Explaining Deviations from NICE Guidance During CQC Inspections

Understanding the Regulatory Context

The Care Quality Commission (CQC) assesses providers against its single assessment framework, which includes the key line of enquiry (KLOE) and quality statement: "We learn and improve when things go wrong, and we make sure that our clinical decisions are based on the best information, evidence and guidance." NICE guidance (including Guidelines [NG], Quality Standards [QS], Technology Appraisals [TA], and Diagnostic Guidance [DG]) represents a cornerstone of this "best evidence." However, the CQC does not expect blind adherence. Instead, inspectors seek evidence of a robust, thoughtful, and governed process for any deviation.

When is a Deviation Justifiable?

A deviation is not a simple non-compliance; it is a defensible decision made in the best interest of an individual patient. Justifiable reasons include:

• Patient Co-morbidities or Contraindications: The patient has a condition or is on medication that makes the NICE-recommended treatment unsafe (e.g., a patient with chronic kidney disease where a first-line drug in NICE NG28 for Type 2 Diabetes is contraindicated).
• Patient Choice and Shared Decision-Making: After a full explanation of the NICE-recommended option and suitable alternatives, the patient, possessing capacity, declines the standard treatment.
• Lack of Applicability: The patient's specific clinical presentation falls outside the population studied in the NICE guidance.
• Resource Constraints (with caveats): While not ideal, a temporary deviation due to lack of a specific resource (e.g., a piece of equipment) may be justifiable if it is documented, risk-assessed, and there is an active plan to resolve the constraint. This must not compromise patient safety.
• Emerging Evidence: Where new, high-quality evidence has emerged since the NICE guidance was published that supports an alternative approach for a specific subgroup.

Core Principle 1: Document the Rationale Clearly

The clinical record is the primary source of evidence for inspectors. A deviation must be transparently documented at the point of decision-making. Vague notes such as "not following guideline" are inadequate and suggest a casual approach to governance.

Essential Elements for Clinical Documentation

The patient's notes should explicitly record:

• Reference to the Specific NICE Guidance: Clearly state the guidance being deviated from (e.g., "NICE NG149 [Suspected Cancer: Recognition and Referral] recommends...").
• The Specific Recommendation: Quote or accurately summarise the relevant recommendation (e.g., "...referral for suspected colorectal cancer using a 2WW pathway for adults aged 40+ with rectal bleeding...").
• The Reason for Deviation: Provide a clear, patient-specific clinical justification (e.g., "Patient is 39 years old, and after discussion and examination, clinical findings are more consistent with haemorrhoids. Decision made for routine referral to colorectal surgery with safety netting advice provided.").
• Evidence of Shared Decision-Making: Note that the options, including the NICE-recommended pathway, were discussed with the patient, along with the risks and benefits of the chosen path.
• Safety Netting: Document any advice given to the patient about what to do if their condition changes, including clear follow-up plans.

Examples Across Training Stages

Foundation Year Doctor: A FY2 in A&E sees a patient with a minor head injury. NICE CG176 suggests a CT head for certain criteria. The patient meets one minor criterion but has a clear GCS of 15 and no other risk factors. The FY2 discusses with the registrar, and a joint decision is made for observation. The note must document the discussion with the senior, the specific criteria not met, and the safety netting advice given to the patient.

Consultant Physician: A consultant oncologist decides not to offer a NICE TA-approved drug to a patient with end-stage cancer due to poor performance status (ECOG 3) which was an exclusion criterion in the trial underpinning the TA. The note should reference the TA, state the performance status, and explain that the potential for harm outweighs the uncertain benefit in this context.

Core Principle 2: Show Governance Approval Process

Individual clinical decisions are one aspect; systemic or recurring deviations require formal governance oversight. This demonstrates to the CQC that the organisation takes its responsibility to follow evidence-based guidance seriously.

Individual Patient Variance Forms

For significant or high-risk deviations, particularly those involving costly treatments (e.g., deviations from a TA) or major pathway changes, a formal "Individual Patient Treatment" or "Variance" form should be completed. This form is typically reviewed and approved by a clinical panel, such as a Drugs and Therapeutics Committee or a Clinical Ethics Committee.

Service-Wide Protocols and Pathways

If a service consistently deviates from NICE guidance for a valid reason (e.g., adapting a national pathway to local resource configurations without compromising safety), this must be formalised in a locally agreed protocol. This protocol should:

• Be developed by a multidisciplinary team.
• Be ratified through the trust's clinical governance structure (e.g., Clinical Policy Group).
• Explicitly reference the NICE guidance it adapts.
• Clearly state the rationale for the adaptation.
• Include a date for review (typically aligned with the review date of the NICE guidance).

Core Principle 3: Demonstrate Patient Safety Consideration

The overarching principle for any deviation must be that it does not compromise patient safety. Inspectors will scrutinise how safety risks are identified, assessed, and mitigated.

Conducting a Formal Risk Assessment

For significant deviations, a proactive risk assessment using a tool like a Risk Matrix should be considered. This assesses the likelihood and severity of potential harm from the deviation.

• Identify Hazards: What could go wrong as a result of not following the standard guidance? (e.g., delayed diagnosis, adverse drug reaction).
• Assess Risk: Rate the likelihood and severity to determine the risk level (e.g., low, medium, high).
• Define Mitigations: What actions will be taken to reduce the risk? (e.g., more frequent monitoring, specific safety netting advice, expedited review).

Informed Consent and Shared Decision-Making

Safety is intrinsically linked to patient understanding. The process of obtaining informed consent for a non-standard treatment is critical. Documentation must show that the patient was made aware of the NICE-recommended "gold standard," the reasons it may not be suitable for them, the proposed alternative, and the associated risks, benefits, and uncertainties of both paths.

Core Principle 4: Evidence Regular Review of the Deviation

Clinical practice and evidence evolve. A deviation that was justified one year may not be the next. The CQC will look for evidence of ongoing monitoring and review.

Audit and Monitoring

Service-wide deviations must be subject to clinical audit. The audit should measure the outcomes of patients on the deviated pathway against the intended outcomes of the original NICE guidance or against agreed local standards.

• Example: A trust using a modified version of the NICE CG189 (Lower UTI) pathway for catheterised patients should audit the rates of appropriate treatment, sepsis, and re-admission to ensure the deviation is not causing harm.

Scheduled Protocol Review

All locally agreed protocols that deviate from national guidance must have a fixed expiry or review date. This review should be triggered automatically by the publication of new NICE guidance on the topic. The review process should involve the same multidisciplinary and governance groups that approved the original protocol.

Individual Case Review

For individual patient deviations, the review is often built into the care plan itself (e.g., "to review response to alternative antidepressant in 4 weeks"). This demonstrates that the decision is not static but is being actively evaluated against patient outcomes.

Conclusion

A well-managed approach to deviations from NICE guidance is not a sign of weakness but a hallmark of a mature, safe, and effective healthcare organisation. It demonstrates critical thinking, patient-centred care, and robust clinical governance. By meticulously documenting the rationale, securing appropriate governance approval, prioritising patient safety through risk assessment, and committing to regular review, NHS trusts can confidently and correctly explain their clinical decision-making processes to CQC inspectors, turning a potential area of scrutiny into a demonstration of excellence.