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16.—(1) 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
[F1(b)which has, or may have, resulted from the carrying on of a regulated activity.]
[F2(2) Subject to paragraph (4), where the service provider is a [F3health service body, a local authority exercising public health functions (within the meaning of the National Health Service Act 2006)] or a provider of primary medical services, the registered person must notify the Commission without delay of the death of a service user where the death—
(a)either—
(i)occurred whilst services were being provided in the carrying on of a regulated activity,
(ii)has, or may have, resulted from the provision of services by a health service body [F4, or local authority exercising public health functions (within the meaning of the National Health Service Act 2006),] in the course of carrying on a regulated activity, or
(iii)has, or may have, resulted from the provision of primary medical services in the course of carrying on a regulated activity and those services were provided within the period of two weeks prior to the death of the service user; and
(b)cannot, in the reasonable opinion of the registered person, be attributed to the course which that service user’s illness or medical condition would naturally have taken if that service user was receiving appropriate care and treatment.]
(3) Notification of the death of a service user must include a description of the circumstances of the death.
(4) Paragraph (2) does not apply if, and to the extent that, the registered person has reported the death to [F5NHS England].
[F6(4A) For the purposes of paragraph (4), where a person has reported a death to the NHS Commissioning Board Authority, established under Article 2 of the NHS Commissioning Board Authority (Establishment and Constitution) Order 2011, before the establishment of [F5NHS England], that report is to be treated as having been made to [F5NHS England].]
(5) This regulation does not apply where regulation 17 applies.
[F7(6) In paragraph (2), “provider of primary medical services” means a person who provides primary medical services pursuant to one of the following sections of the National Health Service Act 2006—
[F8(a)section 3A (power of [F9integrated care boards] as to commissioning certain health services),]
(b)section 83(2)(b) (primary medical services),
(c)section 84 (general medical services contracts),
(d)section 92 (arrangements for the provision of primary medical services),
and provision of primary medical services shall be construed accordingly.]
Textual Amendments
F1Reg. 16(1)(b) substituted (1.10.2012) by The Care Quality Commission (Registration) and (Additional Functions) and Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/921), regs. 1(2)(b), 3(a)
F2Reg. 16(2) substituted (1.10.2012) by The Care Quality Commission (Registration) and (Additional Functions) and Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/921), regs. 1(2)(b), 3(b)
F3Words in reg. 16(2) substituted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 134(4)(a)(i)
F4Words in reg. 16(2)(a)(ii) inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 134(4)(a)(ii)
F5Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1
F6Reg. 16(4A) inserted (1.10.2012) by The NHS Commissioning Board Authority (Abolition and Transfer of Staff, Property and Liabilities) and the Health and Social Care Act 2012 (Consequential Amendments) Order 2012 (S.I. 2012/1641), art. 1(2)(b), Sch. 3 para. 11(3)
F7Reg. 16(6) inserted (1.10.2012) by The Care Quality Commission (Registration) and (Additional Functions) and Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2012 (S.I. 2012/921), regs. 1(2)(b), 3(c)
F8Reg. 16(6)(a) substituted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 134(4)(b)
F9Words in Regulations substituted (1.7.2022) by The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), reg. 1(2), Sch. para. 1(1)(3) (with Sch. para. 1(2))
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