Weak Deviation Documentation and Approval: A Governance Guide

Understanding Deviation Documentation Weaknesses

A deviation is a planned, justifiable, and documented departure from an established standard, such as a local policy, clinical protocol, or NICE guideline. Weak documentation occurs when this process is informal, inconsistent, or fails to capture the essential elements of clinical reasoning and risk management.

Common Indicators of Weak Documentation

• Informal or Verbal Approvals: Decisions to deviate are made in corridor conversations or team huddles without written record.
• Incomplete Rationale: Documentation states *that* a deviation occurred but fails to explain *why*, citing only "clinical judgement" without supporting evidence.
• Lack of Multi-Disciplinary Team (MDT) Involvement: Decisions affecting patient pathways are made unilaterally without appropriate MDT discussion.
• Absence of Patient Consent Discussion: Failure to record that the implications of the deviation were discussed with the patient or their family.
• No Clear Review Date or Escalation Plan: The documentation does not specify when the decision will be reviewed or what triggers a return to standard protocol.
• Fragmented Records: Information about the deviation is scattered across different parts of the clinical record (e.g., a note in the progress notes but no corresponding entry in the care plan).

Required Elements and the Formal Approval Process

A robust deviation process ensures patient safety, demonstrates sound clinical governance, and provides an audit trail. The following elements are non-negotiable for a well-documented deviation.

Essential Documentation Elements

• Patient Identifiers: NHS Number, full name, date of birth.
• Reference to Standard: Clear citation of the policy, protocol, or NICE guidance being deviated from (e.g., "Trust VTE Policy v3.0" or "NICE Guideline NG215").
• Clinical Rationale: A detailed, evidence-based explanation. This should reference patient-specific factors (comorbidities, clinical status, preferences).
• Risk-Benefit Analysis: A brief summary of the risks of deviating versus the risks of adhering to the standard in this specific case.
• MDT Involvement: Names and roles of clinicians involved in the decision-making process.
• Patient Involvement: Documentation of the discussion with the patient/advocate about the deviation, including their consent or agreement.
• Alternative Plan: A clear description of the alternative management plan.
• Review Criteria and Date: Specific triggers or a date for when the decision will be re-assessed.
• Approval Signature: Signature of the senior clinician responsible for approving the deviation (e.g., Consultant, Matron).

The Formal Approval Process

The process must be clearly outlined in your trust's governance policy. A typical workflow is:

1. Identification: A clinician identifies a valid reason to deviate from a standard.
2. MDT Discussion: The case is discussed at an appropriate forum (ward round, MDT meeting, safety huddle).
3. Documentation: The deviation is recorded using a standardised form (electronic or paper) and within the clinical notes.
4. Senior Approval: The form is reviewed and signed by a designated senior clinician (as defined by trust policy).
5. Registration: The approved deviation is logged in a central Deviation Register for monitoring and audit.
6. Implementation and Review: The alternative plan is actioned and reviewed as per the agreed schedule.

CQC Inspection Focus and Common Questions

The Care Quality Commission (CQC) assesses how services ensure safety and leadership through the lens of their Quality Statements. Weak deviation documentation directly impacts several statements.

Typical CQC Lines of Enquiry

Inspectors will likely ask questions such as:

• "Show me your policy for approving deviations from NICE guidance or trust protocols."
• "Can you provide examples of recently approved deviations and the associated documentation?"
• "How do you ensure all relevant staff, including junior doctors and nurses at different stages of training, understand and follow the deviation process?"
• "How do you track and analyse deviations to identify systemic issues? Can you show me your deviation register?"
• "Walk me through how a deviation would be raised, documented, and approved during a night shift or weekend when senior support may be different."

Examples for Different Training Stages

The process must be accessible to all staff.

• Foundation Year 1 Doctor: Should be encouraged to identify potential deviations but must escalate to the Registrar or Consultant for formal discussion and approval. The rationale should be co-written.
• Specialist Registrar (ST3+): May lead the MDT discussion and draft the documentation, but final approval should typically remain with the Consultant responsible for the patient.
• Band 5 Nurse: Should feel empowered to flag a potential deviation to the senior nurse (Band 6/7) or medical team to initiate the process.

Strengthening Documentation and Creating a Deviation Register

Moving from an ad-hoc to a systematic approach is key to satisfying CQC requirements and improving patient safety.

Actionable Steps to Strengthen Documentation

1. Develop a Clear Trust-Wide Policy: Create a single, accessible policy that defines a deviation, outlines the approval process, and mandates the use of a standard form.
2. Implement Standardised Templates: Embed the deviation form within your Electronic Patient Record (EPR) system if possible, or provide easily accessible paper forms.
3. Deliver Targeted Training: Incorporate deviation training into:
   • Induction programmes for all new clinical staff.
   • Junior doctor teaching sessions, with scenario-based examples.
   • Clinical governance meetings to discuss real, anonymised cases.
4. Establish a Centralised Deviation Register: This is a critical governance tool for monitoring and learning.

Creating and Maintaining a Deviation Register

The register is a live database (e.g., a secure SharePoint list or simple Excel spreadsheet on a secure network drive) used to log all approved deviations. It enables trend analysis and proactive risk management.

Governance Oversight: The deviation register should be reviewed regularly (e.g., monthly) by the clinical governance team or divisional leads. The review should ask:

• Are there clusters of deviations from a particular guideline? This may indicate the guideline is outdated or that staff need further training.
• Are deviations concentrated in a specific clinical area or time? This could signal a resource or systemic issue.
• Is the approval process being followed consistently?

This data should feed directly into clinical audit and quality improvement projects, closing the governance loop and demonstrating a true learning culture to the CQC.