Evidence Under the EFFECTIVE Domain: Quality Statements 10 & 11

Understanding the CQC's Expectations for the EFFECTIVE Domain

The Care Quality Commission (CQC) assesses whether services are EFFECTIVE by evaluating if people’s care, treatment, and support achieve good outcomes, promote a good quality of life, and are based on the best available evidence. For Quality Statements 10 and 11, this translates directly into how your service systematically integrates and evidences the use of National Institute for Health and Care Excellence (NICE) guidance.

Inspectors will not simply take your word for it; they will seek tangible, auditable evidence that NICE guidance is the foundation of your clinical practice. This article outlines the key evidence streams you need to develop and maintain.

1. Clear Alignment Between Clinical Practice and NICE Guidelines

The most fundamental expectation is that day-to-day clinical decisions reflect the recommendations within relevant NICE guidance. This must be demonstrable at the point of care.

Evidencing Alignment in Clinical Records

Clinical records are the primary source of evidence. They should clearly indicate that the care provided aligns with NICE standards. This goes beyond simply following the guidance; it's about making it visible.

Integration into Patient Pathways and Decision-Support Tools

Local clinical pathways, electronic health record (EHR) templates, and order sets should be explicitly built around NICE guidance.

• EHR Integration: Build prompts, mandatory fields, or order sets into your EHR that reflect NICE recommendations. For example, an asthma review template could include forced fields for assessing inhaler technique and adherence, as per NICE NG80.
• Local Pathways: Ensure your trust's internal clinical pathways for conditions like sepsis (NICE NG51), suspected cancer (NICE NG12), or atrial fibrillation (NICE NG196) are verbatim copies or careful adaptations of the NICE pathway maps.

Training and Competency at Different Career Stages

Understanding and applying NICE guidance must be embedded at all levels.

Training Stage	Actionable Evidence	NICE Example
Medical Students / Foundation Doctors	Teaching sessions on using the NICE website; inclusion in clinical reasoning assessments; sign-off of competencies related to evidence-based practice.	Using NICE CG189 (Acute Kidney Injury) to guide fluid management in a post-op patient.
Registrars / SAS Doctors	Leading audit projects on NICE compliance; developing local protocols based on new guidance; teaching junior staff.	Leading an audit on adherence to NICE NG143 (COVID-19 management) therapeutics criteria.
Consultants & Governance Leads	Formal review of new/updated guidance and implementation plan creation; reporting to Clinical Governance Committee on compliance metrics.	Overseeing the trust-wide implementation of a new NICE Technology Appraisal (TA) for a novel drug.

2. Audits Measuring Compliance with NICE Standards

Clinical audit is the definitive tool for measuring the gap between NICE guidance and local practice. A robust, closed-loop audit cycle is critical evidence for CQC inspectors.

Designing a High-Impact NICE Audit

Audits should be focused, measurable, and lead to tangible improvements.

• Select a High-Risk or High-Volume Area: Prioritise audits on guidance where non-compliance carries significant patient risk or affects a large patient population (e.g., VTE prophylaxis, sepsis recognition, antimicrobial stewardship).
• Define Clear, Measurable Criteria: Extract specific, auditable recommendations from the guidance. Avoid vague criteria.
• Use a Standardised Audit Proforma: Ensure data collection is consistent.

3. Documentation of How NICE Guidance Informs Local Protocols

Your trust's library of policies, procedures, and protocols (PPMs) must explicitly reference the NICE guidance that underpins them. A protocol that appears to align with NICE but lacks a reference is weak evidence.

Best Practice for Protocol Documentation

• Explicit Referencing: The "Reference Documents" section of every clinical PPM should list the full title and code of the relevant NICE guidance (e.g., "NICE Guideline NG149: Hip fracture: management").
• Version Control: Protocols must have a clear review date. The review trigger should include "when significant NICE guidance is updated or published."
• Deviation Log: If a local protocol deviates from NICE guidance, there must be a documented, ratified reason (e.g., resource constraints, local expert consensus for a specific patient group). This log must be reviewed and approved by the relevant clinical governance committee.

Managing Different Types of NICE Guidance

It is crucial to correctly reference the type of NICE guidance, as they have different implications.

NICE Guidance Type	Code Prefix	Key Consideration for Protocols	Example
NICE Guideline	NG, CG	Forms the basis of clinical pathways. Often requires adaptation into local workflows.	NG17: Diabetes in pregnancy
NICE Quality Standard	QS	Provides measurable statements for audit. Should be used to set local quality priorities.	QS60: Asthma
NICE Technology Appraisal	TA	Mandatory for NHS commissioning. Local Drug Formularies and treatment pathways must comply.	TA775: Tepotinib for advanced MET-positive NSCLC
NICE Medical Technologies Guidance	MTG	Adoption is supported but not mandatory. Protocols should reference MTGs where relevant to ensure innovative technologies are considered.	MTG64: Placenta-specific Alpha Macroglobulin test

4. Evidence of Outcomes Monitoring Against Quality Standards

CQC inspectors expect to see that you are not just implementing NICE guidance but are also monitoring its impact on patient outcomes. This links directly to the "monitor and improve" aspect of Quality Statement 11.

Linking Process to Outcome

Use NICE Quality Standards (QS) as your benchmark. Each QS contains prioritised, measurable statements of quality care.

• Identify Relevant QS: For any major condition your service manages, identify the corresponding NICE Quality Standard.
• Select Key Metrics: Choose 1-2 key outcome measures from the QS to monitor regularly.
• Report to Governance Committees: Outcomes data should be presented to departmental and trust-wide governance meetings (e.g., Audit & Effectiveness, Clinical Governance Committee) with a clear narrative on performance and any required actions.

Creating a NICE Outcomes Dashboard

A dynamic dashboard is powerful evidence of proactive quality management.

Dashboard Element	Description	Data Source
NICE Guideline	e.g., NG191: Antenatal Care	N/A (Reference)
Key Recommendation	e.g., Recommendation 1.2.22: Offer nulliparous women with low-risk pregnancies a planned membrane sweep at 40 and 41 weeks.	N/A (Reference)
Compliance Metric	% of eligible women offered a membrane sweep.	Maternity EHR / Audit
Outcome Metric	Rate of induction of labour in this patient group.	Hospital Episode Statistics (HES) / Local Database
Trend	Graph showing compliance and outcome metrics over the last 12 months.	Business Intelligence Tool

Conclusion: Building a Cohesive Evidence Portfolio

Demonstrating effectiveness to the CQC is not about creating a separate portfolio of evidence for inspection. It is about embedding the principles of evidence-based practice into the fabric of your service's daily operations. The evidence streams outlined—clinical records, audit cycles, protocol documentation, and outcomes dashboards—should be interlinked and part of a continuous cycle of quality improvement.

By systematically addressing these areas, clinical teams and governance leads can confidently demonstrate to inspectors that their service is not only aware of NICE guidance but is actively using it to drive effective, high-quality care.