Clinical governance and complications policy (termination of pregnancy)

1. Purpose

This policy sets out how the Service identifies, records, manages, learns from, and reports clinical complications arising from termination of pregnancy.

The complications covered are not unusual; they are documented in the published evidence base. What this policy commits the Service to is consistent recognition, prompt management, transparent reporting, and structured learning.

2. Sources to verify before adoption

• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Reg 12 (Safe care and treatment): https://www.legislation.gov.uk/uksi/2014/2936/regulation/12
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Reg 17 (Good governance): https://www.legislation.gov.uk/uksi/2014/2936/regulation/17
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Reg 20 (Duty of candour): https://www.legislation.gov.uk/uksi/2014/2936/regulation/20
• Royal College of Obstetricians and Gynaecologists, Best practice in abortion care (current edition): https://www.rcog.org.uk/guidance/browse-all-guidance/other-guidelines-and-reports/best-practice-in-abortion-care/
• MHRA Yellow Card scheme: https://yellowcard.mhra.gov.uk
• BNF mifepristone monograph: https://bnf.nice.org.uk/drugs/mifepristone/
• BNF misoprostol monograph: https://bnf.nice.org.uk/drugs/misoprostol/
• Resuscitation Council UK, Quality Standards: Primary care: https://www.resus.org.uk/library/quality-standards-cpr/primary-care

3. Scope

This policy applies to:

• All terminations performed by the Service (medical and surgical).
• All complications identified during the procedure, in immediate recovery, or in the post-procedure follow-up window.
• Patient-reported symptoms post-discharge that may indicate a complication.
• All clinicians, support staff, and administrative staff involved in the clinical pathway.

4. Complications covered

The clinical complications below are recognised in the published evidence base; the Service tracks each by category in the incidents register.

4.1 Surgical termination complications

• Uterine perforation.
• Significant haemorrhage requiring transfusion or further intervention.
• Cervical injury.
• Anaesthetic complication (local or general).
• Retained products of conception requiring further intervention.
• Post-procedure infection requiring antibiotics or hospitalisation.

4.2 Medical termination complications

• Incomplete termination requiring surgical management.
• Continuing pregnancy after medical termination (rare but documented; specific patient communication required).
• Significant haemorrhage post-misoprostol.
• Sepsis (rare; high mortality if missed).
• Allergic or systemic reaction to mifepristone or misoprostol.

4.3 Aftercare complications

• Delayed-presentation infection.
• Persistent bleeding beyond expected duration.
• Pelvic pain beyond expected duration.
• Mental health crisis post-treatment.

5. Recognition and immediate management

For each complication category the Service maintains a clinical protocol covering:

• Recognition signs and triage criteria.
• Immediate-management algorithm at the Service.
• Transfer-out criteria for cases beyond Service capability.
• Post-event follow-up requirements.

Protocols are written by the Service's clinical lead, reviewed annually, and reviewed immediately after any complication occurrence that revealed a gap in the protocol.

The Service maintains transfer-out arrangements with the local NHS acute trust(s). Transfer arrangements are documented + reviewed annually.

6. Medication safety (mifepristone and misoprostol)

6.1 Storage and prescribing

Mifepristone and misoprostol are stored, prescribed, and dispensed in accordance with the Human Medicines Regulations 2012, the Service's controlled-drugs policy (where applicable), and the manufacturer's storage instructions.

6.2 Yellow Card reporting

All suspected adverse drug reactions to mifepristone or misoprostol are reported via the MHRA Yellow Card scheme. The Service's clinical lead is responsible for ensuring submissions are made promptly.

Yellow Card submissions are also logged in the Service's incidents register under [medication_error_mifepristone_misoprostol] so the report is visible in the clinical-governance cycle.

6.3 Medication error response

Where a medication error occurs (wrong dose, wrong route, wrong patient, wrong time, or contamination), the Service:

1. Stops the medication immediately.
2. Treats the patient as clinically indicated, including transfer-out where required.
3. Discloses the error to the patient in accordance with the Duty of Candour policy.
4. Logs the error in the incidents register.
5. Reviews the error at the next clinical-governance meeting + immediately if the error caused or could have caused serious harm.

7. Duty of Candour

The statutory Duty of Candour under Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 applies to every notifiable safety incident.

Where moderate harm or above has occurred (using the threshold definitions in Regulation 20), the Service:

• Notifies the patient in person as soon as reasonably practicable.
• Provides a written account within the statutory timescale.
• Records the conversation, the written notification, and any subsequent communication in the patient record.
• Reviews the case in the clinical-governance cycle.

The Service does NOT paraphrase the statutory threshold in patient-facing communication; the Regulation 20 wording is the source of truth.

8. Recording and reporting

Every clinical complication is recorded in the Service's incidents register on the day of identification, with:

• The patient (anonymised by clinical identifier in any sharing context).
• The procedure type + gestational age.
• The complication category.
• The clinical management response.
• The outcome.
• The Duty of Candour application (yes / no / pending).
• The Yellow Card submission status (where applicable).
• The CQC notification status under Regulation 17 (where applicable).

Complications meeting CQC notifiable-incident thresholds are notified via the standard CQC notification pathway, in parallel with internal investigation.

9. Investigation and learning

Every complication is reviewed at the next clinical-governance meeting (held at least quarterly; more frequent in active investigation periods).

Cases of serious harm or near-miss serious harm are subject to a structured root-cause review using:

• A documented investigation template (factual chronology, contributing factors, conclusions, actions).
• Multi-disciplinary review where appropriate (lead clinician, anaesthetist if relevant, nursing lead, patient experience lead).
• Identified actions logged in the Service's improvement-actions register with named owners and target dates.

Findings are shared back to the clinical team, with patient identifiers redacted, so the learning reaches the people who can act on it.

10. Cumulative outcome auditing

The Service runs at least annually:

• A complications-rate audit per procedure type, benchmarked against published RCOG data.
• A continuing-pregnancy audit (a serious-incident category that requires immediate patient communication where it occurs).
• A returned-for-further-treatment rate audit.
• A patient-reported aftercare audit (collected via post-procedure follow-up).

Trends are reviewed in the annual clinical-governance report and shared with the registered manager.

11. Training

All clinicians involved in termination procedures complete:

• Induction training on the Service's complication-management protocols.
• Annual update on each complication category's clinical-management algorithm.
• Annual update on Duty of Candour application.
• Annual update on MHRA Yellow Card submission process.
• Resuscitation training at the level commensurate with their role (BLS, ILS, or ALS).

Training records are kept in the Verivius training matrix.

12. Review

This policy is reviewed at least annually and whenever RCOG best-practice guidance, MHRA medication-safety guidance, or CQC regulatory requirements materially change.