Assurance

Selecting Audit Standards That Stand Up to CQC Scrutiny

For NHS audit leads, governance teams, and senior trainees, the selection of audit standards is a critical governance function. This resource provides a practical framework for choosing robust, defensible standards that demonstrate quality improvement and meet regulatory expectations, directly mapping to CQC's 'Well-Led' and 'Effective' key lines of enquiry.

The Strategic Importance of Standard Selection

The clinical audit standard is the benchmark against which practice is measured. Its selection is not merely a technical step but a strategic decision that determines the audit's validity, impact, and regulatory defensibility. A poorly chosen standard can render an entire audit project meaningless, wasting clinical time and failing to provide assurance to the Board. Conversely, a well-justified standard forms the foundation of a meaningful quality improvement cycle.

CQC Alignment: 'Effective' and 'Well-Led' Domains

The CQC's Quality Statement E3 ("People’s care and treatment is based on current national guidance and evidence-based practice") and WL1.3 ("The governance system enables the organisation to evaluate and improve the quality and safety of its services") are directly addressed through robust audit standard selection. Your choice of standard is primary evidence of how the organisation ensures care is evidence-based and uses audit for improvement.

What Makes an Audit Standard 'CQC-Ready'?

A CQC-ready standard is unambiguous, authoritative, and directly relevant to patient outcomes or experience. It must withstand scrutiny during a CQC inspection interview or document review.

Core Characteristics of a Robust Standard

  • Authoritative Source: The standard is derived from a recognised, national source. This is the single most important factor.
  • Unambiguous and Measurable: The wording allows for clear, objective measurement. Avoid standards requiring subjective judgement.
  • Current and In-force: The guidance from which it is taken is the latest published version and has been fully implemented.
  • Directly Impacts Care Quality: Adherence to the standard should logically lead to improved patient safety, clinical effectiveness, or patient experience.
  • Realistic and Achievable: The standard reflects aspirational but attainable practice within the local context.

Hierarchy of Evidence for Standard Sources

When selecting a source, prioritise in the following order. This hierarchy provides the justification for your choice.

Source Type Examples Strength
NICE Guidelines (NG) NG28 (Atrial Fibrillation), NG136 (Haemorrhoids) Gold standard. Based on systematic review of evidence. CQC expects adherence.
NICE Quality Standards (QS) QS204 (Asthma in adults), QS198 (Diabetes in adults) Excellent. Concise, measurable statements derived from NICE guidelines.
Royal College / National Professional Body Guidelines BTS/SIGN Asthma Guideline, RCOG Green-top Guidelines Strong. Authoritative and specialty-specific.
National Service Specifications NHS England specialised service specifications Strong. Contractual obligations for commissioned services.
NICE Technology Appraisals (TA) & Medtech Innovation Briefings (MIB) TA775 (Sotagliflozin for type 1 diabetes), MIB232 (a device) Specific to drug/technology use. TA mandates funding; strong standard.
Trust/ICB Policy Local VTE assessment policy, sepsis pathway Good, but must be aligned with national guidance. Weaker if used alone.
Literature/Journal Article Single randomised controlled trial or meta-analysis Weaker. Requires synthesis and may not represent national consensus.

How to Justify Your Standard Selection

The justification must be documented in your audit proposal or project plan. This is the evidence you will present to your Clinical Audit Committee and, if asked, to the CQC.

The Justification Framework: A Three-Step Process

  1. Link to National Priority or Local Risk: Explain *why* this topic was chosen. Connect it to a national priority (e.g., CORE20PLUS5, Getting It Right First Time (GIRFT)) or a local incident, complaint, or risk identified from Datix.
  2. Cite the Source Verbatim and Contextualise: Quote the standard exactly as written in the source document. Then, briefly explain the clinical context and the evidence behind it.
  3. Define the Metric and Exception Criteria: State precisely how you will measure compliance and define any valid exceptions to the standard (e.g., patient refusal, clinical contraindication).

Template: Standard Justification for Audit Proposal

Audit Topic: Management of Newly Diagnosed Atrial Fibrillation (AF)
Selected Standard: "People with AF who are assessed as having a high risk of stroke are offered anticoagulation with a DOAC."
Source: NICE Quality Standard QS93 (Atrial Fibrillation), Statement 4. Derived from NICE Guideline NG196.
Justification:

  • Rationale: Stroke prevention is a primary goal in AF management. This topic aligns with the national NHS Long Term Plan focus on cardiovascular disease and was triggered by a recent SIRI where a patient with high-risk AF was not anticoagulated.
  • Metric: Percentage of patients with a new diagnosis of AF and a CHA₂DS₂-VASc score ≥2 (males) or ≥3 (females) who are prescribed a DOAC at discharge. Exceptions: Patient refusal documented in notes, confirmed contraindication (e.g., active major bleeding).
  • Expected Compliance: 95%, based on national GIRFT cardiology data.

Examples for Different Training Stages

Senior Trainee (e.g., ST6+): Expected to lead audits with complex standards, potentially involving multiple guidelines. For example, auditing the management of acute upper GI bleed against the BSG guideline, requiring measurement of timing of endoscopy, use of Glasgow-Blatchford score, and appropriate use of proton pump inhibitors.

New Audit Lead: Should start with a straightforward, single standard from a NICE Quality Standard (QS). For example, auditing "Patients presenting with a suspected UTI have a urine sample sent for culture before antibiotics are started" from QS90 (Urinary Tract Infection).

Red Flags That Weaken Audit Credibility

These are common pitfalls that CQC inspectors or your Clinical Audit Committee will immediately identify as weaknesses.

1. The 'Invented' Standard

Red Flag: Creating a standard that seems logical but has no authoritative source. (e.g., "All patients with chest pain should have a troponin result within 2 hours").
Why it's weak: It is not benchmarked against national evidence. An inspector will ask, "Where is that standard from?" If it's not from NICE or a Royal College, it is merely a local opinion.
Solution: Always trace back to a source. If a precise standard doesn't exist, use the closest related recommendation and justify its application.

2. The 'Outdated' Standard

Red Flag: Using a standard from superseded guidance. (e.g., Auditing AF stroke risk assessment against the old CHADS₂ score instead of CHA₂DS₂-VASc, as per current NG196).
Why it's weak: Demonstrates that the service is not using contemporary evidence-based practice, a direct breach of CQC Quality Statement E3.
Solution: Before starting an audit, check the publication date of your source and confirm it is the current version on the NICE or Royal College website.

3. The 'Unmeasurable' Standard

Red Flag: Selecting a standard that is vague or requires subjective interpretation. (e.g., "Patients should receive good communication," or "Discharge summaries should be timely").
Why it's weak: It is impossible to measure compliance reliably. What is "good" or "timely"? This leads to inconsistent data collection.
Solution: Make it measurable. Change "timely" to "Discharge summaries must be sent to the GP within 24 hours of discharge," referencing the Trust's policy or a national target.

4. The 'Mismatched' Standard

Red Flag: Auditing a specific patient group against a standard intended for a different population. (e.g., Applying an adult diabetes standard to a paediatric audit).
Why it's weak: The standard is not applicable, making the audit irrelevant.
Solution: Ensure the source guidance explicitly covers the patient population you are auditing.

Turning Red Flags into Strengths: The CQC Perspective

When the CQC assesses governance, they look for a systematic approach. A robust standard selection process, overseen by the Clinical Audit Committee, is evidence of this. Having a Trust-wide proforma that mandates source citation and justification turns a potential weakness into a demonstrable strength for the 'Well-Led' domain.

Actionable Summary: A Checklist for Selection

Use this checklist when proposing any new clinical audit.

  • Is the standard sourced from the top tiers of the evidence hierarchy (NICE NG/QS, Royal College)?
  • Is the guidance the most current published version?
  • Is the standard quoted verbatim from the source?
  • Is the metric for measurement clearly defined (numerator/denominator)?
  • Are the exception criteria (e.g., contraindications) explicitly stated?
  • Is the rationale for the audit topic linked to a priority or risk?
  • Has the standard been reviewed and approved by the relevant clinical lead or audit committee?

By rigorously applying this framework, clinicians and governance teams can ensure that their clinical audits are built on a foundation of robust, defensible standards. This not only maximises the impact of audit on patient care but also provides clear and compelling evidence of effective clinical governance to regulators.

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