Missing Audit Evidence for NICE Alignment Claims: A Governance Team's Guide

The Prevalence and Risk of Unsubstantiated NICE Alignment Claims

It is common for clinical services to state in board reports, quality accounts, and CQC pre-inspection documentation that practice is "aligned with," "compliant with," or "in accordance with" NICE guidance. However, when challenged, the supporting evidence is often anecdotal, fragmented, or non-existent. This creates significant regulatory risk, as the CQC's Single Assessment Framework explicitly evaluates how providers use evidence-based guidance to achieve good outcomes for people.

The gap between claim and evidence typically arises from:

• Assumption of Compliance: A belief that because guidance is disseminated, it is automatically followed.
• Lack of Systematic Audit: Absence of a scheduled audit programme specifically designed to measure adherence to NICE recommendations.
• Focus on Process over Outcome: Auditing that a policy exists, but not whether its application leads to the intended outcomes specified by NICE.
• Inadequate Data Collection: Clinical systems not configured to capture the discrete data points required to demonstrate compliance.

What Evidence Does the CQC Expect to See?

The CQC inspector will move beyond asking "Do you follow NICE guidance?" to "Show me the evidence that you follow it, and that following it leads to better outcomes." The evidence base must be multi-faceted.

The Evidence Hierarchy for NICE Compliance

A robust evidence portfolio should include, in descending order of strength:

Differentiating NICE Guidance Types in Your Evidence

It is crucial to correctly identify the type of NICE guidance being referenced, as the expected evidence varies.

• NICE Guidelines (NG): Broad recommendations for care. Evidence should show systematic implementation across a pathway (e.g., NG80 for Fractured Neck of Femur).
• Quality Standards (QS): Concise, measurable statements. Evidence should directly track the specific metrics within the QS (e.g., QS86 for Patient Experience in Adult NHS Services).
• Technology Appraisals (TA): Recommendations on specific technologies. Evidence must show adherence to funding mandates and patient eligibility criteria (e.g., TA775 for a new cancer drug).
• Medtech Innovation Briefings (MIB): Descriptive, not mandatory. Evidence would focus on governance around adoption decisions.

Building the Evidence Base: A Rapid Audit Methodology

When a gap is identified, a rapid, focused audit cycle is the most effective way to generate evidence. This approach prioritises actionable data over exhaustive research.

Step 1: Scoping the Audit – From NICE Recommendation to Auditable Question

Select a high-risk or high-volume recommendation from the NICE guidance. Transform it into a precise, auditable question.

• NICE NG19 (Suspected Cancer): Recommendation 1.3.1 - "Refer people using a suspected cancer pathway referral for suspected pancreatic cancer..."
• Auditable Question: "What percentage of patients presenting with obstructive jaundice and a palpable mass were referred via the 2-week wait (2WW) pathway in the last quarter?"

Step 2: Data Collection – Leveraging Existing Systems

Identify the quickest source of truth. Avoid manual case note reviews where possible.

• For Process Measures: Interrogate the EPR or specific databases (e.g., 2WW referral database, radiotherapy planning system).
• For Outcome Measures: Link to national audits (e.g., NORI, NCLCAP), local outcome databases, or patient-reported outcome measures (PROMs).

**NICE Guidance:** [e.g., NG149 - Hypertension in Adults]
**Auditable Recommendation:** [e.g., Recommendation 1.4.1 - Offer ABPM to confirm diagnosis.]
**Primary Audit Question:** What percentage of patients with a new GP-diagnosis of hypertension were offered ABPM within 4 weeks of diagnosis in Q1 2024?
**Data Source:** [e.g., Community Cardiology EPR module, ABPM waiting list report]
**Sample Size:** [e.g., All patients coded with 'new hypertension' in specified period (n=~120)]
**Target Standard:** [e.g., >90%, as per local policy derived from NG149]
**Lead Auditor:** [Name]
**Report Date:** [Date]

Step 3: Analysis and Action Planning – Closing the Loop

The audit report must be actionable. Use a clear format:

1. Findings: Present data clearly (e.g., "45% of eligible patients were offered ABPM against a target of 90%").
2. Root Cause Analysis: Briefly explain why (e.g., "Limited ABPM capacity, lack of clear referral pathway in EPR").
3. Actions: Assign specific, measurable, achievable, relevant, and time-bound (SMART) actions.
   • Action: Cardiology and IT to develop a streamlined EPR referral pathway by [date].
   • Owner: [Service Manager]
4. Re-audit Date: Specify when compliance will be re-measured (e.g., 6 months).

Preparing Honestly for Inspections When Gaps Remain

It is unrealistic to have 100% compliance with all NICE guidance. The CQC assesses how an organisation manages its compliance, including how it identifies and addresses gaps. Transparency and a clear, owned action plan are critical.

The "Gap Analysis and Action Plan" Approach

When an inspection is imminent and a gap exists, do not ignore it. Document it proactively.

Communicating During an Inspection

If a CQC inspector questions an area with known gaps, the response should be honest and structured.

• Acknowledge: "You've identified an area we are actively working on. Our current compliance for [specific recommendation] is [X%], which is below our target."
• Explain: "We have identified the primary barrier as [reason]. This is documented in our NICE compliance gap register."
• Demonstrate Control: "We have an agreed action plan in place, owned by [role], with a deadline of [date]. We have scheduled a re-audit for [date] to measure improvement."

This demonstrates mature governance: the ability to self-diagnose problems, plan effective solutions, and monitor progress. This is often viewed more favourably than an attempt to claim full compliance without evidence.