Clinical governance and complications policy (termination of pregnancy)

1. What the regulation says

Care and treatment must be provided in a safe way for service users. (Regulation 12(1))

assessing the risks to the health and safety of service users of receiving the care or treatment, (Regulation 12(2)(a))

doing all that is reasonably practicable to mitigate any such risks, (Regulation 12(2)(b))

the proper and safe management of medicines, (Regulation 12(2)(g))

Regulation 17 (good governance) adds the systems duty this policy operationalises:

Systems or processes must be established and operated effectively to ensure compliance with the requirements in this Part. (Regulation 17(1))

assess, monitor and improve the quality and safety of the services provided in the carrying on of the regulated activity (including the quality of the experience of service users in receiving those services) ... assess, monitor and mitigate the risks relating to the health, safety and welfare of service users and others who may be at risk which arise from the carrying on of the regulated activity. (Regulation 17(2)(a) and (b))

Regulation 20 (duty of candour) governs the openness duty when a complication causes harm:

Registered persons must act in an open and transparent way with relevant persons in relation to care and treatment provided to service users in carrying on a regulated activity. (Regulation 20(1))

As soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred a registered person must (a) notify the relevant person that the incident has occurred in accordance with paragraph (3), and (b) provide reasonable support to the relevant person in relation to the incident, including when giving such notification. (Regulation 20(2))

harm that requires a moderate increase in treatment, and significant, but not permanent, harm. (Regulation 20(7), definition of "moderate harm")

Regulation 20 of the Care Quality Commission (Registration) Regulations 2009 sets the termination-specific notification duties for non-NHS providers:

The registered person must ensure that no termination of a pregnancy is undertaken after the 24th week of gestation. (Registration Regulation 20(5))

the registered person must give notice in writing to the Commission of that information, within the period of 14 days beginning on the day on which the information is received. (Registration Regulation 20(10), death within 12 months that may be associated with a termination)

The full text is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/12 (Reg 12), https://www.legislation.gov.uk/uksi/2014/2936/regulation/17 (Reg 17), https://www.legislation.gov.uk/uksi/2014/2936/regulation/20 (Reg 20 duty of candour) and https://www.legislation.gov.uk/uksi/2009/3112/regulation/20 (Registration Reg 20). Where this policy and the regulation diverge, the regulation wins.

2. Plain-English summary

Care and treatment must be provided in a safe way. Regulation 12 lists the areas a provider must address, including risk assessment, risk mitigation, staff competence, safe premises, safe equipment, sufficient equipment and medicines, medicines safety, infection prevention and shared-care planning. Regulation 17 requires effective systems to assess, monitor and improve quality and safety and to keep accurate records. Regulation 20 (duty of candour) requires you to be open when a notifiable safety incident causes, or could cause, moderate harm or worse. Separately, non-NHS termination providers must meet the notification and record duties in Regulation 20 of the Registration Regulations 2009, including the absolute 24-week ceiling and the 14-day written notification to CQC of a death within 12 months that may be associated with a termination.

Recent legislative changes may affect the criminal-law position for women in England and Wales who end their own pregnancies. Providers must verify the current primary legislation before publishing any patient-facing wording. This does not alter the provider's obligations under the Abortion Act 1967, the Abortion Regulations 1991, the HSA1/HSA4 process or the CQC Registration Regulations unless primary legislation says so.

3. 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.

4. 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.

Before adoption, the Service must record its local clinical protocols, emergency transfer contacts, out-of-hours triage route, senior decision-maker rota, notification responsibilities and governance meeting cadence. A generic list of complications is not a substitute for those local arrangements.

5. Roles and responsibilities

• Registered Manager: owns the governance system, makes sure notification and duty-of-candour decisions are tracked, and reviews open investigations, risks and overdue actions.
• Clinical lead: approves complication protocols and transfer thresholds, provides or arranges senior clinical advice, reviews outcomes and decides when a protocol needs immediate revision.
• Treating clinician: recognises and manages the complication within competence, obtains senior help, arranges transfer where needed, records the clinical chronology and gives safe follow-up instructions.
• Recovery, triage or aftercare clinician: completes the structured assessment, acts on red flags, gives clear safety-netting and confirms who owns the next contact or review.
• Governance lead or investigator: preserves evidence, coordinates a proportionate review, tracks external reporting decisions and turns findings into owned improvement actions.
• Administrative and support staff: use the approved escalation script, transfer a concern promptly and never provide clinical reassurance or delay escalation while trying to gather a complete history.

6. Step-by-step complication response procedure

1. Receive and recognise the concern. Use the current triage protocol to identify red flags, confirm the person's location and contact details, and establish whether emergency help is needed.
2. Make the person safe. Provide care within competence, obtain senior clinical advice and arrange emergency transfer or urgent review where the local threshold is met.
3. Keep ownership visible. Name the clinician responsible for the next action, tell the person what will happen and by when, and confirm handover acceptance when another service takes over.
4. Open the clinical and incident records. Record the factual chronology, assessment, advice, treatment, transfer, communication and outcome. Preserve relevant medicine, equipment, staffing and audit-trail evidence.
5. Assess openness and reporting duties. A named senior person records the duty-of-candour assessment and each statutory, contractual, professional or medicine-safety reporting decision against the live source.
6. Provide follow-up. Confirm the person's recovery plan, warning signs, contact route, planned review and any investigation communication.
7. Investigate proportionately. Establish what happened, why controls failed or succeeded, whether other people may be at risk and what immediate risk reduction is required.
8. Complete and verify actions. Assign each action to an owner and due date, retain evidence of completion, test whether the change worked and report closure through governance.

7. Complications covered

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

7.1 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.

7.2 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.

7.3 Aftercare complications

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

8. 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 and reviewed annually.

9. Medication safety (mifepristone and misoprostol)

9.1 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.

9.2 Yellow Card reporting

Suspected adverse drug reactions, serious or unexpected reactions and medication incidents involving mifepristone or misoprostol are reported through the MHRA Yellow Card scheme in line with current MHRA guidance. 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.

9.3 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 and immediately if the error caused or could have caused serious harm.

10. 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 an incident meets the Regulation 20 notifiable safety incident threshold for the Service's provider type, 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.

11. 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 and 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).
• CQC statutory notification status, where applicable, including termination-specific notification duties under Care Quality Commission (Registration) Regulations 2009, Regulation 20.

Complications meeting CQC notifiable-incident thresholds are notified via the standard CQC notification pathway, in parallel with internal investigation. Where a death within 12 months may be associated with a termination, the Service notifies CQC in writing within 14 days under Regulation 20(10) of the Registration Regulations 2009.

12. 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.

13. Cumulative outcome audit and monitoring cadence

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.

14. 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.

15. Review

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

16. Related policies in this pack

• Medication safety policy for termination care
• Statutory notification policy for HSA1 and HSA4
• Consent and reflection policy
• Incident reporting, investigation and learning policy
• Duty of candour policy
• Risk management and risk register policy

17. Sources and further reading

This template is based on CQC's guidance for providers and managers, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and other topic-specific legislation and guidance listed below. It is a starting point for adaptation, not a substitute for legal, clinical, HR, safeguarding or specialist professional advice.

• 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
• Care Quality Commission (Registration) Regulations 2009, Reg 20 (Requirements relating to termination of pregnancies): https://www.legislation.gov.uk/uksi/2009/3112/regulation/20
• Abortion Act 1967: https://www.legislation.gov.uk/ukpga/1967/87
• Abortion Regulations 1991 (HSA1/HSA4 certification and notification): https://www.legislation.gov.uk/uksi/1991/499
• DHSC abortion notification (HSA forms) guidance: https://www.gov.uk/government/publications/abortion-notification-forms-for-england-and-wales
• 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/
• NICE abortion care guidance (NG140): https://www.nice.org.uk/guidance/ng140
• 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/
• Human Medicines Regulations 2012: https://www.legislation.gov.uk/uksi/2012/1916
• Resuscitation Council UK, Quality Standards: Primary care: https://www.resus.org.uk/library/quality-standards-cpr/primary-care
• CQC Fundamental Standards
• CQC statutory notifications guidance and CQC provider portal guidance

Note on legal change: Recent legislative changes may affect the criminal-law position for women in England and Wales who end their own pregnancies. Providers must verify the current primary legislation before publishing any patient-facing wording. This does not alter the provider's obligations under the Abortion Act 1967, the Abortion Regulations 1991, the HSA1/HSA4 process or the CQC Registration Regulations unless primary legislation says so.

18. When to seek further advice

Seek specialist advice where the issue involves serious harm, safeguarding, deprivation of liberty, restraint, children, professional misconduct, controlled drugs, radiation, termination of pregnancy, infection outbreak, water safety, employment dismissal, DBS barring referral, or regulatory enforcement.

19. Document control

This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the provider's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.