Evidence Under the WELL-LED Domain: Quality Statements 22 & 23

Introduction: The Strategic Imperative of NICE Alignment

For NHS Trusts, the systematic adoption of National Institute for Health and Care Excellence (NICE) guidance is not merely a clinical aspiration but a core component of corporate governance and regulatory compliance. Under the CQC's WELL-LED framework, specifically Quality Statements 22 (Systems and processes for learning, continuous improvement and innovation) and 23 (Engagement with the public, patients and partners), inspectors scrutinise the mechanisms by which an organisation ensures its services are evidence-based. This involves demonstrable board-level oversight, structured audit programmes, and clear, justifiable governance when deviating from national standards. This article provides a practical, actionable roadmap for meeting these expectations.

Establishing a Systematic Review Process for NICE Guidance Updates

A reactive approach to NICE guidance updates is a significant governance risk. Trusts must have a proactive, systematic process managed through a dedicated function, typically the Clinical Effectiveness or Clinical Guidelines Committee.

The NICE Guidance Pipeline: Roles and Responsibilities

A clear flowchart of responsibility from notification to implementation is critical. The following table outlines a recommended model.

Practical Template: NICE Guidance Clinical Review Proforma

This standardised form ensures a consistent and thorough review process. It should be completed by the Clinical Lead for the relevant specialty.

Board-Level Oversight of NICE Alignment

The Trust Board must have clear sight of the organisation's compliance with national standards. This is a fundamental aspect of their fiduciary and quality duties.

Board Reporting Mechanisms

Oversight should be structured, not ad-hoc. The following reporting mechanisms are considered best practice:

• Quarterly NICE Compliance Report to the Quality Committee: This report, generated by the Medical Director's office or Clinical Effectiveness team, should provide a dashboard view. It must include:
  • Summary of new guidance published in the quarter.
  • Status of each item (Under Review, Approved for Implementation, Implemented, Audit Complete).
  • Highlight reports on any guidance with significant resource implications or where deviation is proposed.
  • Summary of recent audit findings showing compliance levels with key NICE Quality Standards (QS).
• Annual Board Assurance Framework (BAF): NICE compliance should be explicitly referenced in the BAF. For example, a key objective might be "To ensure 95% of applicable NICE guidance is implemented within 12 months of publication," with associated risks and controls documented.
• Director of Finance & Medical Director Joint Reporting: For NICE Technology Appraisals (TAs), which often have direct and significant financial impacts, a joint report ensuring clinical adoption is aligned with budgetary planning is essential.

Example for Different Training Stages

Board-level understanding must be cultivated at all levels of seniority.

• New Executive Director: Induction should include a briefing from the Clinical Effectiveness lead on the Trust's NICE governance process, key historical deviations, and current high-priority implementations (e.g., a major NG update or costly TA).
• Experienced Non-Executive Director (NED): NEDs should be equipped to challenge the executive on the robustness of the deviation process. For example, asking: "What patient engagement was undertaken when we decided not to fully implement QS [Number] on [Topic]?"

Structuring Audit Programmes Around NICE Quality Standards

Clinical audit is the primary tool for verifying compliance. Audit programmes should be strategically aligned with NICE Quality Standards (QS), which provide measurable statements designed to drive quality improvement.

Developing the Annual Audit Plan

The Trust-wide annual audit plan should be derived from a risk-based assessment of NICE QS relevance. The process should involve:

1. Mapping: Identify all NICE QS relevant to the Trust's services.
2. Prioritisation: Prioritise audits based on:
   • High-volume or high-risk clinical areas (e.g., sepsis, maternity).
   • Areas of known practice variation.
   • New or significantly updated QS.
   • CQC or other regulatory focus areas.
3. Commissioning: Assign audit topics to clinical divisions or specific audit teams.

Conducting a High-Quality NICE Audit

Simply measuring compliance is insufficient. Audits must lead to improvement.

• Sample NICE QS Audit Structure (e.g., for QS5: Asthma):
  • Standard: "People with asthma receive a written personalised action plan."
  • Audit Criteria: Percentage of patients aged 5+ with a diagnosis of asthma who have a written personalised action plan documented in their records within the last 12 months.
  • Data Source: Retrospective case note review (electronic and paper) of 50 patients from asthma clinic.
  • Action Plan: If compliance is <90%, actions may include: updating the EPR template, delivering staff training on action plan creation, and establishing a patient leaflet.
  • Re-audit: Schedule re-audit for 6 months post-implementation of actions.

Clear Governance When Deviating from NICE Recommendations

There are legitimate reasons for not adopting NICE guidance in full, but deviation must never be arbitrary. It requires a rigorous, transparent, and documented governance process.

The Principle of Justified Deviation

Deviation is acceptable only where there is a clear, evidence-based rationale. Common justifications include:

• Local Population Factors: The guidance is not applicable to the specific demographic or health profile of the local population.
• Resource Constraints (with caveats): While not a first-resort justification, significant, insurmountable resource implications can be a reason, but this must be accompanied by a clear plan to achieve compliance in the future and a documented risk assessment of the impact of non-compliance on patient safety and outcomes.
• Superior Local Evidence: The Trust is participating in a recognised research study or has robust local audit data demonstrating a superior outcome from an alternative pathway.
• Awaiting Infrastructure: Implementation is planned but delayed due to necessary building works or IT system upgrades, with a fixed timeline.

The Formal Deviation Process

A proposed deviation must follow a formal approval pathway to ensure scrutiny.

1. Proposal: The Clinical Lead completes the NICE Review Proforma, selecting "Cannot currently adopt" and providing a detailed rationale.
2. Divisional Scrutiny: The proposal is reviewed and supported by the Divisional Governance Group, which must assess the clinical risk.
3. Committee Approval: The proposal, with the divisional endorsement, is presented to the Clinical Effectiveness Committee (CEC). The CEC must critically appraise the rationale.
4. Escalation: Any deviation with significant patient safety, legal, or financial risk must be escalated to the Trust Board's Quality Committee for final approval.
5. Documentation: The approved deviation, with its full rationale, is recorded in the NICE compliance register and the CEC minutes. A review date is set (typically 12 months).

Example Scenario: Deviating from a NICE Technology Appraisal (TA)

Scenario: NICE TA999 recommends a new, very high-cost drug for a rare condition. The Trust's specialised commissioning budget is already overspent.

Governance Action:

1. The Clinical Lead for the service submits a deviation proposal, acknowledging the clinical benefit but highlighting the unsustainable financial impact.
2. The proposal includes a risk assessment detailing the potential impact on the small cohort of affected patients and a plan to work with NHS England specialised commissioning to seek a solution.
3. The CEC reviews the proposal. The Director of Finance provides input on the budgetary context.
4. The CEC approves a time-limited deviation (e.g., 6 months) on the condition that the Clinical Lead and Finance Director escalate the issue to the regional NHS England team to find a system-wide solution. This plan and timeline are minuted.
5. The status is reported to the Board Quality Committee as a standing item until resolved.

Conclusion: Integrating Systems for Continuous Compliance

Meeting the CQC's expectations under the WELL-LED domain for NICE guidance requires an integrated system, not a series of disconnected actions. This system hinges on a proactive review process, unambiguous board-level accountability, a strategic audit programme focused on measurable standards, and a robust, ethical framework for managing deviation. By embedding these processes into the fabric of corporate and clinical governance, Trusts can confidently demonstrate to regulators, patients, and staff their commitment to providing evidence-based, high-quality care.