Statutory anchor: Regulation 16 (notification of death of service user), Care Quality Commission (Registration) Regulations 2009 (SI 2009/3112). This policy also engages Regulation 17 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936) (good governance) and the wider statutory notification duties under the Registration Regulations 2009. · primary source
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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)
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. Purpose and scope
This policy sets out how the provider identifies a death that may require notification, makes and records the Regulation 16 scope decision, submits the notification without delay where required and links the notification to any related investigation, safeguarding, complaint or duty-of-candour record.
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.
(Tenant updates the angle-bracket placeholder.)
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.
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.
(Tenant updates the named role-holders.)
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.
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.
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.
v1.2
2026-07-21
Verivius (sample)
Made the policy purpose explicit alongside its Regulation 16 scope.
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.
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.
The risk peculiar to this policy is the word 'expected'. In a care home, or in a domiciliary service supporting people at the end of life, almost every death is expected, and 'expected' quietly becomes shorthand for 'nothing to notify'. Regulation 16(1) contains no expectedness test at all. It asks only whether services were being provided in the carrying on of a regulated activity when the person died, or whether the regulated activity may have contributed. A narrower natural-course route does exist, but it belongs to health service bodies, local authorities exercising public health functions and providers of primary medical services, and even there it turns on whether the illness would have taken that course had the person been receiving appropriate care and treatment. That is why an unexamined 'expected death' label is dangerous for the next person in the same bed: a pressure ulcer, a missed deterioration, a dosing error or an unwitnessed fall can all sit underneath a death that looked entirely ordinary. The people best placed to notice are the care team who were present, and they are also the ones grieving, sitting with the family and managing the practical aftermath, so the question slips while everyone assumes someone senior has it. For the family, a factual and prompt account of the circumstances is what lets the regulator, and where relevant the coroner, ask the right questions while the trail is still fresh, and it is what stops a bereaved relative learning something significant months later that the service already knew. A service that gets this right records a decision for every death, including the deaths it concludes fall outside the duty.
Every service-user death carries a recorded in-scope decision against the Regulation 16(1) test (death whilst services were being provided in the carrying on of a regulated activity, or which has, or may have, resulted from the carrying on of a regulated activity), including a reasoned not-applicable decision, so the deaths judged out of scope can be read back as clearly as the ones notified rather than leaving no trace.
Strong evidence: The notification record opened on the platform capturing the date and time of death, service-user identifier, regulated activity and circumstances (procedure steps 2 and 4), the per-death audit check that the in-scope assessment was made (Audit per-death check), and the checklist rows 'Deaths are considered against current CQC death-notification guidance' and 'Not-applicable decisions explain why the threshold was not met'.
Weak evidence: The only death records that exist are the ones you chose to notify, so there is no way to see that every service-user death was tested against the two Regulation 16(1) limbs (a death whilst services were being provided in the carrying on of a regulated activity, or a death that has or may have resulted from that activity). The deaths judged out of scope leave no trace and the reasoning cannot be read back. Two patterns fail here. A blanket assumption that an expected death is never notifiable, applied without a per-death decision, ignores that Regulation 16(1) contains no expectedness test. And the death of a service user liable to be detained under the Mental Health Act 1983 logged as 'not notifiable under Regulation 16' is wrong on its face, because Regulation 16(5) routes that death to Regulation 17 of the same Registration Regulations 2009 rather than out of scope altogether.
Our recommended baseline. Not a legal or regulatory requirement, but a sensible standard we suggest where the rules leave the detail to you. Adapt it to your service.
The notification was filed 'without delay' after the death was identified as in scope, and the record shows the time from identification to filing, so the interval itself is visible to whoever picks the record up next rather than only the fact that a notification eventually went in. Same-working-day is the service's own operational standard, not the statutory test.
Strong evidence: Filing as soon as practicable with 'without delay' as the standard (procedure step 7), the per-death check on whether timing met the 'without delay' standard (Audit per-death check), and the checklist row 'Decision record shows event date, identification date and decision date'.
Weak evidence: The record carries a submission date but no identification date, so nobody can tell how long the death sat before it was filed. Regulation 16(1) sets 'without delay' as the statutory standard and the service's own same-working-day target sits on top of it as an operational one, so a notification that eventually went in, with no note of when the death was recognised as in scope and no reason recorded for the gap, cannot be tested against either. A batch of notifications all filed on the same date some time after a run of deaths is the pattern to look for.
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 (SI 2009/3112), reg 16(1)
The filed notification actually describes the circumstances of the death (Regulation 16(3)) in factual, proportionate terms that match the source record, not a bare statement that a death occurred.
Strong evidence: The drafted regulator-facing wording describing the circumstances of the death (procedure step 5), read and signed off by the Registered Manager before filing (procedure step 6), and the checklist row 'Submitted wording matches the source record and is factual'.
Weak evidence: The filed wording says only that a named service user died on a given date, which does not meet the Regulation 16(3) requirement for a description of the circumstances of the death. Boilerplate circumstances lifted unchanged from a template across several deaths, a narrative that contradicts the clinical record or the Clinical Lead's statement, or no saved copy of the exact words submitted so the description can never be checked back against source, all fail this check.
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 (SI 2009/3112), reg 16(3)
The proof of filing is stored against the record (the CQC reference number, submitter, timestamp and confirmation receipt), not a claim it was submitted with nothing to show for it.
Strong evidence: The evidence-of-filing capture on the platform record (procedure step 8, Record-keeping section) and the checklist rows 'Reference numbers, portal confirmations, PDFs or email receipts are saved' and 'Submitted notifications show category, route, submitter and submission date'.
Weak evidence: The record asserts the notification was submitted but there is nothing to show for it: no CQC reference number, no portal confirmation, no receipt and no named submitter. Regulation 16 requires the notification itself, not the receipt, so this is the Verivius standard for making the filing provable rather than a statutory duty. Without an artefact, a verbal 'yes, it went in' is all that survives the manager who filed it leaving, and the service cannot show the death was ever notified.
Our recommended baseline. Not a legal or regulatory requirement, but a sensible standard we suggest where the rules leave the detail to you. Adapt it to your service.
The correct scope was applied for the provider type. The narrower Regulation 16(2) route (the natural-course-of-illness exclusion, and disapplication where the death has been reported to NHS England) is open only to health service bodies, local authorities exercising public health functions and primary medical services providers; any other registered person notifies under the full Regulation 16(1) test, so a natural-causes exclusion claimed by a provider type that does not hold it leaves a death unnotified.
Strong evidence: The exclusion check confirming which scope applies (procedure step 3) and the annual policy review against the live Regulation 16 text (Audit annual review).
Weak evidence: A death is waved through as 'natural causes, not notifiable' by a provider with no entitlement to the narrower Regulation 16(2) route, which is open only to health service bodies, local authorities exercising public health functions and providers of primary medical services, with a further disapplication under Regulation 16(4) where the death has been reported to NHS England. No record states which scope the provider sits under, so the exclusion is claimed by default rather than by entitlement. The second failure belongs to providers that do hold the narrower scope and read it as plain 'natural causes': the test is whether the death can be attributed to the course the illness or medical condition would naturally have taken had the person been receiving appropriate care and treatment, so a death that looks natural but followed poor care remains notifiable.
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 (SI 2009/3112), reg 16(2) and reg 16(4)
A death that also engages other duties was cross-linked rather than filed as a death notification in isolation, so the family and the colleague who picks the record up next can see each duty on its own: the separate statutory notification of an abuse allegation or police involvement, the safeguarding lifecycle, the complaints lifecycle, and the duty of candour owed to the person. Notifying the Care Quality Commission of the death does not discharge a local-authority safeguarding referral, and the Regulation 20 duty of candour is owed to the person rather than to a regulator, so neither is met by the death notification.
Strong evidence: The cross-links to the incident, complaint and safeguarding lifecycles and to the duty of candour applying the correct Regulation 20 notifiable-safety-incident definition for the provider type (procedure step 9), with the source incident record carrying any coroner involvement and learning (procedure step 10).
Weak evidence: The death notification is filed in isolation with no link to the incident, safeguarding or complaints records, and the duty owed to the family is treated as discharged by having told the regulator. Notifying CQC of the death is not the Regulation 20 duty of candour, it is not a local-authority safeguarding referral under local multi-agency procedures, and it does not cover the separate Regulation 18 notification of an allegation of abuse or of police involvement, so each of those duties is left unmet and untraceable. The specific error to look for is a death recorded as outside candour because it was 'expected', without the Regulation 20 definition for the provider type being applied, under which a death is a notifiable safety incident where it relates directly to the incident rather than to the natural course of the person's illness or underlying condition.
Our recommended baseline. Not a legal or regulatory requirement, but a sensible standard we suggest where the rules leave the detail to you. Adapt it to your service.
A policy is the intent; the evidence is what a CQC inspector actually asks to see. This matching checklist turns the policy above into the records to keep, the audit to run, and the places small services most often fall short.
A Verivius consultant can read your adapted policy against the live regulation and your service shape. The work fits inside a Mock Inspection engagement or a shorter consulting brief. A 20-minute conversation is the fastest way to find out whether the fit is right.