Sample policy · Termination of pregnancy

Clinical governance and complications policy (termination of pregnancy)

Statutory anchor: Regulation 12 (safe care and treatment), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936). This policy also engages Regulation 17 (good governance) and Regulation 20 (duty of candour) of the same Regulations, and Regulation 20 (requirements relating to termination of pregnancies) of the Care Quality Commission (Registration) Regulations 2009 (SI 2009/3112). The clinical framework rests on the Abortion Act 1967, the Abortion Regulations 1991, and RCOG best practice in abortion care; these primary sources are named in the sources section and are not in the Verivius regulation manifest. · primary source

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.

The Crime and Policing Act 2026 (section 241) removed the criminal liability of a woman in England and Wales acting in relation to her own pregnancy. It does not remove or alter the provider's obligations under the Abortion Act 1967, the Abortion Regulations 1991, the HSA1 and HSA4 process or the Care Quality Commission (Registration) Regulations 2009, which continue to apply in full.

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:

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

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

7.2 Medical termination complications

7.3 Aftercare complications

8. Recognition and immediate management

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

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:

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:

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:

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:

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

14. Training

All clinicians involved in termination procedures complete:

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

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.

Note on legal change: The Crime and Policing Act 2026 (section 241) removed the criminal liability of a woman in England and Wales acting in relation to her own pregnancy. It does not remove or alter the provider's obligations under the Abortion Act 1967, the Abortion Regulations 1991, the HSA1 and HSA4 process or the Care Quality Commission (Registration) Regulations 2009, which continue to apply in full.

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

Version Date Author Changes
v1.1 2026-07-18 Verivius (sample) Added named role ownership, the complication-response workflow, local adoption controls, audit cadence and related policies.
v1 2026-06-10 Verivius (sample) Conformed to the Verivius policy standard: added statutory anchor block, verbatim Reg 12/17/20 and Registration Reg 20 quotes, plain-English summary, sources and further reading, when-to-seek-advice and document-control sections. All original sections and source URLs preserved.

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.

What good looks like here

Written from an ex-CQC inspector's chair, but the point is safe, well-led care your team can stand behind. Each row shows what strong evidence looks like, what thin evidence looks like, and where the expectation comes from.

A termination service carries a particular shape of risk: the complications it must plan for, major haemorrhage, uterine perforation, retained products, and the rare but high-mortality sepsis, are time-critical, yet the woman is often discharged the same day and any deterioration shows up at home rather than on a ward. Many services are standalone independent units that cannot themselves manage a major bleed or a perforation, so a recognised complication is only survivable if a live, tested transfer arrangement with an NHS acute trust actually works on the night. Two outcomes are distinctive to this care and easy to miss: a continuing pregnancy after a medical termination, where a woman is left believing a termination succeeded when it did not, and a delayed-presentation sepsis that reads as ordinary post-procedure discomfort until it is advanced. This is why the evidence trail is not administrative here. The complication protocol, the transfer arrangement, the safety-netting the woman was given at discharge, the candour conversation when something goes wrong, and the audit that surfaces a continuing-pregnancy or infection pattern are the mechanisms that turn a foreseeable, named complication into one caught in time rather than discovered too late. Layered on top are duties unique to this sector: the absolute 24-week ceiling and the written notification to CQC of a death within 12 months that may be associated with a termination, each a separate obligation that a general notification does not discharge.

  1. A woman who bleeds heavily, is perforated during a surgical termination, or is developing sepsis after a medical one is recognised, managed within the team's competence, and moved to definitive care under a live transfer arrangement, not held at the service while someone works out who to call. Care and treatment must be provided in a safe way (Reg 12(1)), and a service that offers termination owns the plan for the complication it can already name.

    Strong evidence: A current, dated set of complication protocols written by the clinical lead, each carrying recognition and triage criteria, the immediate-management step at the service, and the threshold and route to transfer out; the documented transfer-out arrangement with the named local NHS acute trust, reviewed and tested rather than assumed; and, on a real case, the clinical chronology showing recognition, senior advice, transfer and handover acceptance recorded at the time.

    Weak evidence: A single generic list of complications with no local recognition criteria, no immediate-management step and no transfer threshold, so what happens when someone bleeds depends on who is on that day. A transfer-out arrangement named in the policy but never confirmed with the receiving trust, with no contact route to hand and no evidence it has ever been tested. Or a chronology written up after the person had already been moved, so the sequence of a deterioration cannot be reconstructed.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, reg 12(1), reg 12(2)(a)-(b) and reg 12(2)(i)

  2. Every complication, from a retained-products return to a near-miss sepsis, reaches the incidents register on the day it is identified and travels through the governance cycle into a tracked, owned action, not a category counted once and filed. A complications-rate audit per procedure type, a continuing-pregnancy audit and an aftercare audit run on cadence, so the service sees its own pattern before an outside body does.

    Strong evidence: The incidents register showing each complication logged on the day of identification with its category, management and outcome; minuted clinical-governance meetings that reviewed the cases and turned serious-harm or near-miss events into root-cause reviews with owned actions; and the completed annual audits, benchmarked against published RCOG data, whose findings became actions that closed with evidence.

    Weak evidence: Complications kept as a running tally with no case ever reaching a governance meeting, or meetings that 'noted' a complication and moved on with no action, owner or re-audit. Audits downloaded, scored highly and filed, with no benchmark and nothing showing practice changed. The quarterly meeting cadence and the RCOG benchmark are the service's own recommended standard, not a fixed statutory interval; what the regulation requires is that the systems actually assess, monitor and improve the safety of the care.

    What the regulator expects to see. Not a law in itself, but CQC judges you against it, so an inspector will look for it and expect a reason where you depart from it.

  3. When a complication reaches the notifiable-safety-incident threshold for this provider type, the woman is told what happened as soon as reasonably practicable, given a genuine apology and told what the service will do next, with the conversation, who was present and the wording of the apology recorded, not a line reading 'patient informed'. Most independent termination providers are not health service bodies, so the definition that applies to them is the one at reg 20(9), where moderate harm is not the trigger.

    Strong evidence: The duty-of-candour assessment recorded against the provider-type definition and the legal source; the conversation note capturing that it happened as soon as reasonably practicable, the attendees, and an apology that is an expression of sorrow or regret in respect of the incident; and the written follow-up with proof it was sent, held in the patient record.

    Weak evidence: The incident's harm grade carried straight through as the candour decision with no separate Regulation 20 test, or a service that is not a health service body reading the health-service-body definition and treating moderate harm as its trigger, so the wrong incidents cross the line. An apology logged as 'sorry you feel that way', a notification given by phone with nothing explaining why it was not in person, or a written follow-up ticked as sent with no copy retained.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, reg 20(2), reg 20(3) and reg 20(7); notifiable safety incident defined at reg 20(8) for health service bodies and reg 20(9) for any other registered person

  4. The termination-specific external duties are each owned and evidenced on their own terms: gestational age is assessed and recorded before every termination so that none is undertaken after the statutory 24-week ceiling, and a death within 12 months that may be associated with a termination is notified to CQC in writing within 14 days. These sit alongside, and none discharges, the general CQC statutory notification, the duty of candour owed to the woman, a safeguarding referral, a Yellow Card report and the Abortion Act notification to the Chief Medical Officer.

    Strong evidence: The gestational-age assessment recorded on the clinical record with the control that prevents a termination beyond the 24-week ceiling; and a notifications tracker showing, for a relevant event, the written termination-associated-death notification to CQC within 14 days beginning on the day the information is received, cross-linked to but distinct from the candour record, the general CQC notification and the Abortion Act notification to the Chief Medical Officer.

    Weak evidence: One 'notified' box treated as if it discharged every duty at once, so a submitted CQC notification sits with the candour panel blank, or a death-within-12-months notification never opened because someone assumed the general notification covered it. Gestational age recorded loosely with no control showing how the 24-week ceiling is held. A Yellow Card report or a notification to the Chief Medical Officer logged in a way that cannot be told apart from a CQC notification, so nobody can show each duty was met.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Care Quality Commission (Registration) Regulations 2009, reg 20(5) and reg 20(10)

  5. Because a medical termination can occasionally fail with the pregnancy continuing, the service has a specific route to detect it and to tell the woman clearly, so she is not left believing a termination succeeded when it did not; this is a recognised, documented outcome the service actively looks for, not one it waits to hear about. A continuing-pregnancy audit runs so the service knows its own rate and can act on it.

    Strong evidence: The clinical protocol for confirming outcome and for recognising and communicating a continuing pregnancy, the follow-up pathway capable of detecting it, and the completed continuing-pregnancy audit reviewed in the governance cycle.

    Weak evidence: No follow-up route capable of detecting a continuing pregnancy, so the first the service knows is when the woman presents again later. A protocol that recognises the outcome clinically but says nothing about how, when and by whom she is told. Or a continuing-pregnancy audit that has never been run, so the service cannot say whether this has happened to any of its patients. The clinical detail of confirmation sits in the protocol and its RCOG and NICE sources.

    The recognised standard from a professional or clinical body, such as NICE or a royal college. Not a legal duty, but the accepted mark of safe practice, and a departure needs a documented reason.

  6. Mifepristone and misoprostol are managed safely end to end (Reg 12(2)(g)): stored and prescribed to the manufacturer's instructions and the Human Medicines Regulations, any suspected adverse reaction reported through the MHRA Yellow Card scheme, and any medication error stopped, treated, disclosed to the woman under duty of candour and logged, with each of those a separate duty rather than one action standing in for the rest.

    Strong evidence: The medicines records showing storage and administration completed at the time and a stock and expiry trail; a Yellow Card submission for a suspected adverse reaction, also logged in the incidents register; and, for a medication error, the record of the clinical response, the candour disclosure and the governance review, kept as distinct entries.

    Weak evidence: Storage logs of suspiciously identical readings with no action when one falls out of range, or administration ticks back-filled at audit time rather than at the point of care. A suspected adverse reaction treated as an internal incident only, with no Yellow Card report and no note of why one was not needed. Or a medication error closed as 'logged' with no evidence the woman was told, so the candour duty is assumed rather than done. The doses and concentrations themselves sit in the service formulary and its BNF source.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, reg 12(2)(g)

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Last verified 23 July 2026

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Last reviewed 10 June 2026