1.4 Duty of Candour, Confidentiality & Clinical Documentation

Duty of Candour, Confidentiality & Clinical Documentation

High-quality maternity care relies upon an organizational culture of transparency, trust, and meticulous record-keeping. Midwives must navigate complex ethical and legal obligations when unexpected complications occur, safeguarding patient confidentiality while maintaining accurate clinical records that withstand legal and regulatory scrutiny.

---

The Dual Dimensions of the Duty of Candour

Following the public inquiry into the Mid Staffordshire NHS Foundation Trust (chaired by Sir Robert Francis QC), UK healthcare embedded open, honest communication into both professional codes and statutory law. Midwives operate under two distinct forms of candour: the professional duty and the statutory duty.

                    ┌──────────────────────────────────────────────┐
                    │          THE DUAL DUTY OF CANDOUR            │
                    └──────────────────────┬───────────────────────┘
                                           │
                 ┌─────────────────────────┴─────────────────────────┐
                 ▼                                                   ▼
┌─────────────────────────────────┐                 ┌─────────────────────────────────┐
│    PROFESSIONAL DUTY (NMC)      │                 │    STATUTORY DUTY (REGULATION 20)│
│                                 │                 │                                 │
│ • Applies to: Individual RMs    │                 │ • Applies to: Healthcare bodies │
│ • The Code (Standard 14)        │                 │ • Health & Social Care Act 2008 │
│ • Threshold: ANY harm, distress │                 │ • Threshold: "Notifiable Safety │
│   or near miss                  │                 │   Incident" (Moderate/Severe    │
│ • Verbal apology & explanation  │                 │   harm, death, psychological)   │
│ • Personal professional mandate │                 │ • Formal face-to-face, written  │
│                                 │                 │   follow-up, shared report      │
└─────────────────────────────────┘                 └─────────────────────────────────┘

1. The Professional Duty of Candour

Under Standard 14 of the NMC Code, every registered nurse, midwife, and nursing associate has an individual professional duty to be open and honest with service users and families:

"Be open and candid with all service users about all aspects of care and treatment, including when any mistakes or harm have taken place."

Key features of the professional duty:

• Individual Obligation: Applies directly to the registered midwife as an individual practitioner;
• Broad Threshold: Triggered whenever anything goes wrong that causes, or has the potential to cause, harm or distress—including minor errors and near misses;
• Immediate Action: The midwife must inform the woman (or her family, where appropriate) promptly, provide a compassionate, factual explanation of what happened, offer a sincere apology, and explain the steps being taken to remedy the situation and prevent recurrence.

2. The Statutory Duty of Candour

The statutory duty of candour is a legal obligation imposed on healthcare organizations. In England, it is codified under Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and enforced by the Care Quality Commission (CQC). (Comparable statutory duties operate under the Duty of Candour Procedure (Scotland) Regulations 2018, the Health and Social Care (Quality and Engagement) Act (Wales) 2020, while Northern Ireland has consulted on, but not yet enacted, a statutory duty of candour alongside its 'Being Open' guidance).

Key features of the statutory duty:

• Organizational Obligation: Binds NHS Trusts, Health Boards, and independent healthcare providers;
• Specific Legal Threshold: Applies to "Notifiable Safety Incidents"—unintended or unexpected incidents arising during regulated activity that result in, or could result in:
  1. Death of the service user (unrelated to the natural course of the illness);
  2. Severe harm (permanent lessening of bodily, sensory, motor, or intellectual functions);
  3. Moderate harm (requiring moderate clinical intervention, an unplanned return to theatre, extended hospital stay, or prolonged psychological harm);
  4. Prolonged psychological harm (continuous psychological distress experienced for at least 28 days).

Required Statutory Steps

When a notifiable safety incident occurs, Regulation 20 mandates a formal, five-step procedural response:

1. Prompt In-Person Notification: The organization must notify the relevant person (the woman or her nominated representative) face-to-face as soon as reasonably practicable;
2. Factual Account & Explanation: Provide a clear, honest account of all known facts at the time;
3. Sincere Apology: Offer a formal apology on behalf of the healthcare organization;
4. Written Follow-Up: Provide a written apology and a detailed written summary of the initial meeting within prescribed institutional timeframes;
5. Investigation Findings: Provide reasonable ongoing support, conduct an investigation, and share the full written investigation findings with the family.

---

Confidentiality, UK GDPR & The Caldicott Principles

Midwives hold a common law duty of confidentiality regarding all personal and clinical information disclosed during care. This is reinforced by the Data Protection Act 2018 and the UK General Data Protection Regulation (UK GDPR), which classify medical records as "Special Category Data" requiring the highest level of security and lawful processing.

The Eight Caldicott Principles

Originally developed by Dame Fiona Caldicott in 1997 and updated by the National Data Guardian, the Caldicott Principles govern the handling of patient-identifiable data across UK health and social care:

1. Justify the purpose(s): Every proposed use or transfer of confidential data must be clearly defined and justified;
2. Do not use personal confidential data unless absolutely necessary: Anonymize or redact data whenever possible;
3. Use the minimum necessary personal confidential data: Only share the specific data elements required for the specific purpose;
4. Access should be on a strict need-to-know basis: Only individuals who actively need access should have access;
5. Everyone with access must be aware of their responsibilities: Registrants must understand the legal and ethical duty of confidentiality;
6. Comply with the law: Every use of information must be lawful under data protection legislation;
7. The duty to share information for individual care is as important as the duty to protect patient confidentiality: Healthcare professionals must not let unjustified confidentiality concerns prevent sharing vital clinical data with colleagues caring for the woman;
8. Inform patients about how their confidential data will be used: Ensure transparency regarding who sees data and why.

Lawful Exceptions to Confidentiality

A midwife may disclose confidential patient information without consent in only three legally recognized circumstances:

1. Statutory Requirement or Court Order: Mandatory reporting under specific statutes (e.g., mandatory reporting of Female Genital Mutilation [FGM] under the FGM Act 2003 for females under 18; notification of infectious diseases under the Public Health Act; formal witness summons from a court);
2. Overriding Public Interest: When disclosure is essential to protect the public, the woman, or another individual from serious, imminent physical harm or death (e.g. serious criminal acts, violent offenses);
3. Safeguarding Children and Vulnerable Adults: Under the Children Act 1989/2004, the welfare of a child is paramount; sharing information to prevent serious abuse, neglect, or sexual exploitation is legally permissible and mandatory.

---

Contemporary Clinical Record-Keeping Principles

Under Section 10 of the NMC Code, midwives must "keep clear and accurate records relevant to your practice." In maternity litigation, medical records constitute the primary contemporaneous evidence. Because obstetric negligence claims can be brought until the child's 21st birthday (three years after reaching adulthood at 18) or indefinitely if the child lacks capacity, clear records are vital.

A widely used professional adage (not a rule of law) is: "If it is not recorded, it was not done." In practice, courts and fitness-to-practise panels find it very hard to accept that unrecorded care took place.

Core Rules for High-Quality Clinical Documentation