1. What the regulation says
Except where paragraph (2) applies, the registered person must notify the Commission without delay of the death of a service user (a) whilst services were being provided in the carrying on of a regulated activity, or (b) which has, or may have, resulted from the carrying on of a regulated activity. (Reg 16(1), the headline duty)
Notification of the death of a service user must include a description of the circumstances of the death. (Reg 16(3), what the notification must contain)
This regulation does not apply where regulation 17 applies. (Reg 16(5), overlap with Reg 17)
The full text of the regulation is at https://www.legislation.gov.uk/uksi/2009/3112/regulation/16. Where this policy and the regulation diverge, the regulation wins.
2. Plain-English summary
When a service user dies while services are being provided, or where the death may have resulted from the regulated activity, you have to notify CQC without delay. For NHS bodies, local authorities exercising public health functions, and primary medical service providers, the duty is narrower and excludes deaths attributable to the natural course of illness; it also disapplies where the death has been reported to NHS England. The notification has to describe the circumstances of the death.
3. Scope
This policy applies to all clinical, care, and administrative staff at , every regulated activity, every service-user death (whether expected or unexpected) that occurs whilst services are being provided or that may have resulted from the regulated activity. The scope includes deaths at the provider's premises, deaths during home-based delivery of the regulated activity, deaths during patient transport by the provider, and deaths in the period shortly after the regulated activity where the death may be linked to the activity.
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4. Roles and responsibilities
- Registered Manager: accountable for Reg 16 (Registration Regulations 2009) compliance. Reviews every notification of death record. The Registered Manager's name appears on the audit trail at filing for every death notification.
- Nominated Individual: holds provider-side accountability.
- Notification Lead: the day-to-day notifications authority. Reads the death record at the moment it surfaces, runs the in-scope-or-not assessment, files the CQC notification of death within the operational window.
- Clinical Lead: confirms the clinical circumstances of the death for the notification narrative (cause of death where known, immediate antecedent events, any relevant clinical factors).
- All clinical and care staff: notify the Registered Manager and the Notification Lead of any service-user death the same shift, without exception. Do not delay to investigate cause; the in-scope assessment is a manager-level call.
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5. Procedure
The notification-of-death procedure operationalises Reg 16 of the Registration Regulations 2009.
- Death recognised. When a service user dies, the clinical or care team responsible at the time follows the relevant clinical-death procedure (verifying death; preserving evidence where appropriate; notifying next of kin per the service's bereavement protocol). The death is then surfaced to the Notification Lead and the Registered Manager the same shift.
- In-scope check. The Notification Lead applies the Reg 16(1) test: did the death occur whilst services were being provided in the carrying on of a regulated activity, or may the death have resulted from the carrying on of a regulated activity. Where either limb is met, the death is in scope for notification.
- Exclusion check. For NHS bodies, local authorities exercising public health functions, and primary medical services providers, the narrower scope under Reg 16(2) applies (excludes deaths attributable to the natural course of an illness in respect of which the person was being treated; disapplies where the death has been reported to NHS England). The Notification Lead confirms which scope applies.
- Open the notification record. A notification record is opened on the platform with the source incident (where the death is also recordable as an incident) cross-linked. The record captures the date and time of death, the service-user identifier, the regulated activity in question, the circumstances at the time, and the initial clinical statement.
- Draft the notification. The Notification Lead drafts the regulator-facing wording. Reg 16(3) requires a description of the circumstances of the death; the description must be factual, proportionate, and sufficient for the regulator to understand what happened.
- Registered Manager sign-off. The Registered Manager reads the draft before filing. Notifications of death carry significant weight; the registered-manager-level read is mandatory.
- File with CQC. The notification is filed through CQC's online system as soon as practicable after the death is identified as in scope. "Without delay" in Reg 16(1) is the standard; same-working-day where reasonably possible.
- Record evidence of filing. The CQC reference number, the submitter, the timestamp, and the confirmation receipt are captured against the platform record.
- Cross-link to incident, complaint, and safeguarding lifecycles where relevant. A death meeting Reg 16 may also be in scope for the wider statutory notifications (abuse, police involvement), the safeguarding lifecycle (where there are safeguarding concerns), the complaints lifecycle (where the family complains), or the duty of candour where the service must apply the correct Regulation 20 definition of a notifiable safety incident for its provider type. The cross-links preserve the chain of records.
- Closure and learning. Once the notification has been filed, the record is closed with the closing user and timestamp. Any clinical investigation, coroner's involvement, or learning that flows from the death is captured in the source incident record; improvement actions are opened where they apply.
6. Training requirement
- All clinical and care staff complete Reg 16 awareness training at induction and every three years.
- The Notification Lead completes role-specific training at appointment and refresher annually.
- The Registered Manager completes additional training in regulator-facing notification standards and circumstances-narrative writing.
Training records held in the tenant's training matrix register.
7. Audit
Compliance with this policy is monitored by the Registered Manager:
- Per-death check: every service-user death recorded in the trailing month is reviewed for whether the in-scope assessment was made, whether a notification was filed where one was required, and whether the timing met the "without delay" standard.
- Quarterly notification-pattern review: trailing-12-month view of death notifications by category, by clinical service line, by time-to-file. Patterns producing recurring themes are escalated.
- Annual policy review: the policy is read against the live Reg 16 (Registration Regulations 2009) text and any current CQC guidance.
Audit findings recorded in the tenant's audit register; actions logged in the improvement-actions register.
8. Record-keeping
Notification-of-death records (the platform record, the regulator-facing wording filed, the CQC reference number returned, any confirmation correspondence, links to the source incident or clinical record, any coroner's correspondence) are held for a minimum of 8 years from the date of the last entry per the NHS Code of Practice on Records Management. For deaths involving children, retention follows until what would have been the child's 25th birthday. Notifications related to safeguarding investigations follow the safeguarding retention layered on top.
Verivius preserves the per-record audit trail indefinitely while the workspace is active.
9. Related policies in this pack
10. 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.
- Care Quality Commission (Registration) Regulations 2009, Regulation 16 (https://www.legislation.gov.uk/uksi/2009/3112/regulation/16)
- CQC notification forms
- Coroner guidance
- Local safeguarding procedures (where the death may involve abuse or neglect)
- CQC Regulation 17: Good governance
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936)
11. 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.
12. Document control
| Version | Date | Author | Changes |
|---|---|---|---|
| v1 | 2026-05-19 | Verivius (sample) | Initial sample template. |
| v1.1 | 2026-06-01 | Verivius (sample) | Filled out Sections 3 to 8 with concrete content. Section 4 names the Notification Lead, Clinical Lead, and Registered Manager sign-off roles. Section 5 expanded to a 10-step procedure covering death recognition, Reg 16(1) in-scope check, Reg 16(2) exclusion check, record open, draft, Registered Manager sign-off, file with CQC, evidence of filing, cross-link to other lifecycles, closure and learning. Section 6 names training tiers. Section 7 names the per-death check, quarterly pattern review, and annual policy review cadences. Section 8 references the NHS Code of Practice on Records Management. |
| v1, 2026-06-10 | 2026-06-10 | Verivius (sample) | Re-conformed to the current Verivius policy standard, preserving the original content. Restored the verbatim Reg 16(1)/(3)/(5) blockquotes with cite labels from the guidance manifest, named the Registration Regulations 2009 as the anchor, added the standard Sources and further reading and When to seek further advice blocks, and refreshed the disclaimer and footer to the current wording. |
This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the tenant's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.