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Statutory Instruments

2010 No. 659

Public Health, England

The Health Protection (Notification) Regulations 2010

Made

9th March 2010

Laid before Parliament

11th March 2010

Coming into force

for the purpose of all regulations except regulation 4

6th April 2010

for the purpose of regulation 4

1st October 2010

The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 13, 45C(1), (2) and (3)(a), 45F(2)(a) and (b), 45P(2) and 60A of the Public Health (Control of Disease) Act 1984 M1.

In accordance with section 45Q(3) of the Public Health (Control of Disease) Act 1984, the Secretary of State declares that he is of the opinion that these Regulations do not contain any provision made by virtue of section 45C(3)(c) of that Act which imposes or enables the imposition of a special restriction or requirement or any other restriction or requirement which has or would have a significant effect on a person's rights.

Marginal Citations

M11984 c.22. See section 45T(6) of that Act for the definition of “the appropriate Minister”. Sections 45C, 45F, 45P and 45T were inserted into that Act by section 129 of the Health and Social Care Act 2008 (c.14) (“the 2008 Act”) and section 60A was inserted into that Act by section 130 and Schedule 11, paragraph 16 of the 2008 Act.

Citation, commencement and applicationE+W

1.—(1) These Regulations may be cited as the Health Protection (Notification) Regulations 2010 and shall come into force—

(a)for the purposes of all regulations except regulation 4 on 6th April 2010; and

(b)for the purposes of regulation 4 on 1st October 2010.

(2) These Regulations apply in relation to England only.

[F1(3) In these Regulations, “[F2the United Kingdom Health Security Agency]” means the executive agency of the Department of Health [F3and Social Care] known as [F2the United Kingdom Health Security Agency].]

Textual Amendments

Duty to notify suspected disease, infection or contamination in patientsE+W

2.—(1) A registered medical practitioner (R) must notify the proper officer M2 of the relevant local authority where R has reasonable grounds for suspecting that a patient (P) whom R is attending—

(a)has a notifiable disease;

(b)has an infection M3 which, in the view of R, presents or could present significant harm to human health; or

(c)is contaminated M4 in a manner which, in the view of R, presents or could present significant harm to human health.

(2) The notification must include the following information insofar as it is known to R—

(a)P's name, date of birth and sex;

(b)P's home address including postcode;

(c)P's current residence (if not home address);

(d)P's telephone number;

(e)P's NHS number;

(f)P's occupation (if R considers it relevant);

(g)the name, address and postcode of P's place of work or education (if R considers it relevant);

(h)P's relevant overseas travel history;

(i)P's ethnicity;

(j)contact details for a parent of P (where P is a child);

(k)the disease or infection which P has or is suspected of having or the nature of P's contamination or suspected contamination;

(l)the date of onset of P's symptoms;

(m)the date of R's diagnosis; and

(n)R's name, address and telephone number.

(3) The notification must be provided in writing within 3 days beginning with the day on which R forms a suspicion under paragraph (1).

(4) Without prejudice to paragraph (3), if R considers that the case is urgent, notification must be provided orally as soon as reasonably practicable.

(5) In determining whether the case is urgent, R must have regard to —

(a)the nature of the suspected disease, infection or contamination;

(b)the ease of spread of that disease, infection or contamination;

(c)the ways in which the spread of the disease, infection or contamination can be prevented or controlled; and

(d)P's circumstances (including age, sex and occupation).

(6) This regulation does not apply where R reasonably believes that the proper officer of the relevant local authority has already been notified with regard to P and the suspected disease, infection or contamination by another registered medical practitioner in accordance with this regulation.

(7) In this regulation—

“child” means a person under the age of 18 years;

“notifiable disease” means a disease listed in Schedule 1;

“parent” has the meaning given to it by section 576 of the Education Act 1996 M5; and

“relevant local authority” means the local authority within whose area R attended P on the occasion of forming a suspicion under paragraph (1).

Marginal Citations

M2See section 74 of the Public Health (Control of Disease) Act 1984 (c.22) (“the 1984 Act”) for the definition of “proper officer”.

M3See section 45A of the 1984 Act for the interpretation of “infection”.

M4See section 45A of the 1984 Act for the interpretation of “contamination” and related expressions.

Duty to notify suspected disease, infection or contamination in dead personsE+W

3.—(1) A registered medical practitioner (R) must notify the proper officer of the relevant local authority where R has reasonable grounds for suspecting that a person (P) whom R is attending has died whilst—

(a)infected with a notifiable disease;

(b)infected with a disease which, in the view of R, presents or could present, or presented or could have presented (whilst P was alive), significant harm to human health; or

(c)contaminated in a manner which, in the view of R, presents or could present, or presented or could have presented (whilst P was alive), significant harm to human health.

(2) The notification must include the following information insofar as it is known to R—

(a)P's name, date of birth and sex;

(b)P's date of death;

(c)P's home address including postcode;

(d)P's place of residence at time of death (if different from home address);

(e)P's NHS number;

(f)P's occupation at time of death (if R considers it relevant);

(g)the name, address and postcode of P's place of work or education at the time of death (if R considers it relevant);

(h)P's relevant overseas travel history;

(i)P's ethnicity;

(j)the disease or infection which P had or is suspected of having had or the nature of P's contamination or suspected contamination;

(k)the date of onset of P's symptoms;

(l)the date of R's diagnosis; and

(m)R's name, address and telephone number.

(3) The notification must be provided in writing within 3 days beginning with the day on which R forms a suspicion under paragraph (1).

(4) Without prejudice to paragraph (3), if R considers that the case is urgent, notification must be provided orally as soon as reasonably practicable.

(5) In determining whether the case is urgent, R must have regard to—

(a)the nature of the suspected disease, infection or contamination;

(b)the ease of spread of that disease, infection or contamination;

(c)the ways in which the spread of the disease, infection or contamination can be prevented or controlled; and

(d)P's circumstances (including age, sex and occupation).

(6) This regulation does not apply where R reasonably believes that the proper officer of the relevant local authority has already been notified with regard to P and the suspected disease, infection or contamination by another registered medical practitioner in accordance with this regulation or regulation 2(1).

(7) In this regulation—

[F4Duty on the operators of diagnostic laboratories to notify [F5the United Kingdom Health Security Agency] of causative agents found in human samples and of SARS-Cov-2 or influenza virus tests processed]E+W

4.—(1) The operator of a diagnostic laboratory must notify [F6the United Kingdom Health Security Agency] in accordance with this regulation where the diagnostic laboratory [F7—]

[F8(a)]identifies a causative agent in a human sample [F9; or

(b)processes a test for the detection of SARS-CoV-2 F10... and the test result is indeterminate.]

F11(1ZA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F12(1A) The operator of a diagnostic laboratory must also notify [F13the United Kingdom Health Security Agency] in accordance with this regulation where the diagnostic laboratory—

(a)processes a test for the detection of SARS-CoV-2 and the test result is negative or void; or

(b)processes a test for the detection of influenza virus and the test result is indeterminate, negative or void.]

(2) The notification must include the following information insofar as it is known to the operator of the diagnostic laboratory—

(a)name and address of the diagnostic laboratory;

[F14(aa)the date and time the sample was received by the diagnostic laboratory;]

[F15(b)where a causative agent is identified, the details of that agent;

(ba)where the test is for the detection of SARS-CoV-2 or influenza virus, the result of the test;]

(c)date of the sample;

(d)nature of the sample;

[F16(da)the results of any antimicrobial susceptibility test and any resistance mechanism identified in respect of the sample;]

(e)name of person (P) from whom the sample was taken;

(f)P's date of birth and sex;

(g)P's current home address including postcode;

(h)P's current residence (if not home address);

(i)P's ethnicity;

(j)P's NHS number; F17...

(k)the name, address and organisation of the person who solicited the test [F18; and

(l)where the result of a test for the detection of SARS-CoV-2 is positive [F19or indeterminate], a telephone number and an email address—

(i)where P is a child or a person with a disability who is unable for that reason to provide the information set out in sub-paragraphs (e) to (j), for an appropriate parent, guardian or carer of that person ;

(ii)otherwise, for P.]

(3) [F20A notification under paragraph (1)(a) where the causative agent identified is not SARS-CoV-2] must be provided in writing within 7 days beginning with the day on which the causative agent is identified.

[F21(3A) [F22A notification] under paragraph (1A) must be provided in writing within 7 days beginning with the day on which the diagnostic laboratory becomes aware of the test result.

(3B) A notification under paragraph (1)(a) where the causative agent identified is SARS-CoV-2, must F23... be provided in writing within 24 hours of the causative agent being identified.

(3C) [F24A notification] under paragraph (1)(b) must be provided in writing within 24 hours of the diagnostic laboratory becoming aware of the test result.]

F25(3D) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) Without prejudice to [F26paragraphs (3) and (3A)], if the operator of the diagnostic laboratory considers that [F27a particular case to which one of those paragraphs applies] is urgent, the notification must be provided orally as soon as reasonably practicable.

(5) In determining whether the case is urgent, the operator of the diagnostic laboratory must have regard to —

(a)the nature of the causative agent;

(b)the nature of the disease which the causative agent causes;

(c)the ease of spread of the causative agent;

(d)the ways in which the spread of the causative agent can be prevented or controlled; and

(e)where known, P's circumstances (including age, sex and occupation).

(6) This regulation does not apply where the operator of the diagnostic laboratory reasonably believes that [F28the United Kingdom Health Security Agency] has already been notified in accordance with this regulation by the operator of another diagnostic laboratory in relation to the same causative agent being found in a sample from the same person.

(7) For the purposes of [F29paragraph (1)(a)], a diagnostic laboratory identifies a causative agent where—

(a)the diagnostic laboratory identifies the causative agent; or

(b)the causative agent is identified by another laboratory under an arrangement made with that diagnostic laboratory.

[F30(7A) For the purposes of paragraphs (1)(b) and (1A), a diagnostic laboratory processes a test where—

(a)the diagnostic laboratory processes the test; or

(b)the test is processed by another laboratory under an arrangement made with that diagnostic laboratory.]

(8) Where paragraph (7)(b) applies [F31—]

[F32(a)]the day on which the causative agent is identified for the purposes of paragraph (3), is the day on which the diagnostic laboratory became aware of the identification by the other laboratory;

[F33(b)the time at which the causative agent is identified for the purposes of paragraph (3B), is the time at which the diagnostic laboratory became aware of the identification by the other laboratory.]

[F34(8A) Where paragraph (7A)(b) applies—

(a)the day on which the diagnostic laboratory becomes aware of the test result for the purposes of paragraph (3A), is the day on which the diagnostic laboratory became aware of the result of the test processed by that other laboratory;

(b)the time at which the diagnostic laboratory becomes aware of the test result for the purposes of paragraph (3C), is the time at which the diagnostic laboratory became aware of the result of the test processed by that other laboratory.]

(9) It is an offence for the operator of a diagnostic laboratory to fail without reasonable excuse to comply with this regulation.

(10) Any person who commits an offence under this regulation is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

(11) In this regulation—

[F35“carer” has the meaning given in section 10 of the Care Act 2014;]

“causative agent” means—

(a)

a causative agent listed in Schedule 2, or

(b)

evidence of an infection caused by such an agent;

[F36“child” has the meaning given in regulation 2(7);]

“diagnostic laboratory” means an institution (or facility within an institution) which is equipped with apparatus and reagents for the performance of diagnostic tests for human infections;

“director of a diagnostic laboratory” means—

(a)

the clinical microbiologist, consultant pathologist or other registered medical practitioner or other person in charge of a diagnostic laboratory, or

(b)

any other person working in the diagnostic laboratory to whom the function of making a notification under this regulation has been delegated by the person mentioned in paragraph (a); F37...

[F38“disability” has the same meaning as in the Equality Act 2010 (see section 6 of, and Schedule 1 to, that Act);

“guardian” has the meaning given in section 107 of the Children and Young Persons Act 1933;]

“operator of a diagnostic laboratory” means the corporate body that operates the diagnostic laboratory or, if there is no such body, the director of the diagnostic laboratory;

[F39“parent” has the meaning given in regulation 2(7).]

Textual Amendments

F18Reg. 4(2)(l) and word substituted for words in reg. 4(2)(k) (23.11.2020) by The Health Protection (Notification) (Amendment) (Coronavirus) Regulations 2020 (S.I. 2020/1175), regs. 1(1), 3(d)(iii)

Duty to notify the United Kingdom Health Security Agency of the results of mandatory tests under the Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021E+W

F404ZA.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Duty to notify the UK Health Security Agency of the results of genomic sequencing of mandatory test samples under the Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021E+W

F414ZB.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F42Duty on test providers to notify results of tests for the detection of SARS-CoV-2 or Influenza virus to [F43the United Kingdom Health Security Agency] E+W

4A.—(1) This regulation applies where a test provider carries out on a person (“P”) a valid point of care test for the detection of SARS-CoV-2 F44... or influenza virus.

(2) For the purposes of this regulation—

(a)a point of care test is a diagnostic test which is not carried out in a diagnostic laboratory; and

(b)a point of care test is valid if it is carried out in accordance with the instructions provided by the manufacturer of the testing equipment.

(3) The test provider must notify [F45the United Kingdom Health Security Agency] of the result of the test, in accordance with paragraphs (4) to (6).

(4) A notification must be provided in writing—

(a)within 24 hours of the time when the test result is received by the test provider, in the case of the result of a test for the detection of SARS-CoV-2 being positive or indeterminate;

(b)within 7 days beginning with the day on which the test result is received by the test provider, in the case of—

(i)the result of a test for the detection of SARS-CoV-2 being negative or void; or

(ii)the result of a test for the detection of influenza virus.

(5) A notification must include the following information, insofar as it is known to the test provider—

(a)in relation to P, their—

(i)first name;

(ii)surname;

(iii)sex;

(iv)date of birth;

(v)NHS number (if known);

(vi)ethnicity;

(vii)current address (including postcode);

(viii)telephone number, where the test is for the detection of SARS-CoV-2 and the result is positive or indeterminate,

(ix)email address, where the test is for the detection of SARS-CoV-2 and the result is positive or indeterminate;

(b)in relation to the test, the—

(i)name of the test provider;

(ii)nature of establishment;

(iii)specimen identification number (if applicable);

(iv)specimen type;

(v)specimen date;

(vi)test method;

(vii)result of test;

(viii)date on which the test was carried out;

(ix)name of the testing equipment manufacturer.

[F46(6)] Where P is a child, or a person with a disability who is unable for that reason to provide the information set out in paragraph (5)(a) to the test provider, the test provider must provide [F47the United Kingdom Health Security Agency] with, insofar as it is known to the test provider—

(a)the information set out in paragraph [F48(5)](a)(i) to (vii) in relation to P, having obtained it from an appropriate parent, guardian or carer of P (“X”); and

(b)where the test is for the detection of SARS-CoV-2 and the result is positive or indeterminate, X’s telephone number and email address.

[F49(7)] It is an offence for a test provider to fail without reasonable excuse to comply with this regulation.

[F50(8)] A test provider that commits an offence under this regulation is liable on summary conviction to a fine.

[F51(9)] In this regulation—

“carer”, “child”, “disability”, “guardian”, and “parent” have the meanings given in regulation 4;

“test provider” means a company, partnership, charity, corporation, unincorporated association, or other organisation or body, whether public or private, or sole trader, carrying out point of care tests for the detection of SARS-CoV-2 or influenza virus.]

Textual Amendments

Duty to notify the United Kingdom Health Security Agency of the results of lateral flow device tests undertaken by eligible travellersE+W

F524B.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Duty to provide information to [F53the United Kingdom Health Security Agency] E+W

5.—(1) This regulation applies where a notification has been made by the operator of a diagnostic laboratory to [F54the United Kingdom Health Security Agency] under regulation 4.

(2) [F55The United Kingdom Health Security Agency] may request that the person (R) who solicited the laboratory test which identified the causative agent to which the notification relates, provide to it the information listed at regulation 4(2) insofar as that information was not included in the notification.

(3) R must provide the information requested under paragraph (2) insofar as it is known to R.

(4) The information must be provided in writing within 3 days beginning with the day on which the request is made.

(5) Without prejudice to paragraph (4), if [F56the United Kingdom Health Security Agency] considers the case to be urgent and informs R of this fact when making the request, the information must be provided orally as soon as reasonably practicable.

(6) In determining whether the case is urgent, [F57the United Kingdom Health Security Agency] must have regard to—

(a)the nature of the causative agent to which the notification relates;

(b)the nature of the disease which the causative agent causes;

(c)the ease of spread of the causative agent;

(d)the ways in which the spread of the causative agent can be prevented or controlled; and

(e)where known, the circumstances of the person from whom the sample was taken (including age, sex and occupation).

Textual Amendments

Duty on the relevant local authority to disclose notification to othersE+W

6.—(1) This regulation applies where the proper officer of a local authority has received a notification under regulation 2 or 3.

(2) The proper officer of the local authority must disclose the fact of the notification and its contents to—

[F58(a)[F59the United Kingdom Health Security Agency];]

(b)the proper officer of the local authority in whose area P usually resides (if different); and

(c)the proper officer of the port health authority or local authority in whose district or area a ship, hovercraft, aircraft or international train is or was situated from which P has disembarked (if known to the disclosing proper officer and if that officer considers disclosure appropriate).

(3) The disclosure must be made in writing within 3 days beginning with the day that the proper officer receives the notification.

(4) Without prejudice to paragraph (3), if the disclosing proper officer considers that the case is urgent, disclosure must be made orally as soon as reasonably practicable.

(5) In determining whether a case is urgent, the disclosing proper officer must have regard to—

(a)the nature of the disease, infection or contamination or the suspected disease, infection or contamination notified;

(b)the ease of spread of the disease, infection or contamination;

(c)the ways in which the spread of the disease, infection or contamination can be prevented or controlled; and

(d)where known, the patient's circumstances (including age, sex and occupation).

Textual Amendments

Electronic communicationsE+W

7.—(1) This regulation applies to—

(a)notifications provided under regulation 2(1), 3(1) [F60, 4(1) [F61and (1A)] F62... F62[F63... and 4A(3)]];

(b)information provided under regulation 5(3);

(c)disclosures made under regulation 6(2);

(d)lists provided under regulation 3 of the Health Protection (Local Authority Powers) Regulations 2010 M6 (requirement to provide details of children attending school); and

(e)reports provided under regulations 10(1) (duty to report Part 2A applications) and 11(1) (duty to report variations or revocations of Part 2A orders) of the Health Protection (Part 2A Orders) Regulations 2010 M7.

(2) Notifications, information, disclosures, lists and reports, which are required to be in writing, may be communicated electronically if—

(a)the recipient has consented in writing to receiving the notification, information, disclosure list or report (as the case may be) by an electronic communication; and

(b)the communication is sent to the number or address specified by the recipient when giving that consent.

Textual Amendments

Marginal Citations

RevocationsE+W

8.  The regulations listed in Schedule 3 are revoked.

Signed by authority of the Secretary of State for Health.

Gillian Merron

Minister of State,

Department of Health

Regulation 2(7)

SCHEDULE 1E+WNotifiable Diseases

Acute encephalitis
Acute meningitis
Acute poliomyelitis
Acute infectious hepatitis
Anthrax
Botulism
Brucellosis
Cholera
[F64COVID-19]
Diphtheria
Enteric fever (typhoid or paratyphoid fever)
Food poisoning
Haemolytic uraemic syndrome (HUS)
Infectious bloody diarrhoea
Invasive group A streptococcal disease and scarlet fever
Legionnaires' Disease
Leprosy
Malaria
Measles
Meningococcal septicaemia
[F65Monkeypox]
Mumps
Plague
Rabies
Rubella
SARS
Smallpox
Tetanus
Tuberculosis
Typhus
Viral haemorrhagic fever (VHF)
Whooping cough
Yellow fever

Textual Amendments

Regulation 4(11)

SCHEDULE 2E+WCausative Agents

[F66Acquired carbapenemase-producing Gram-negative bacteria]
Bacillus anthracis
Bacillus cereus (only if associated with food poisoning)
Bordetella pertussis
Borrelia spp
Brucella spp
Burkholderia mallei
Burkholderia pseudomallei
Campylobacter spp
Chikungunya virus
Chlamydophila psittaci
Clostridium botulinum
Clostridium perfringens (only if associated with food poisoning)
Clostridium tetani
Corynebacterium diphtheriae
Corynebacterium ulcerans
Coxiella burnetii
Crimean-Congo haemorrhagic fever virus
Cryptosporidium spp
Dengue virus
Ebola virus
Entamoeba histolytica
Francisella tularensis
Giardia lamblia
Guanarito virus
Haemophilus influenzae (invasive)
Hanta virus
Hepatitis A, B, C, delta, and E viruses
Influenza virus
Junin virus
Kyasanur Forest disease virus
Lassa virus
Legionella spp
Leptospira interrogans
Listeria monocytogenes
Machupo virus
Marburg virus
Measles virus
[F67Monkeypox virus]
Mumps virus
Mycobacterium tuberculosis complex
Neisseria meningitidis
Omsk haemorrhagic fever virus
Plasmodium falciparum, vivax, ovale, malariae, knowlesi
Polio virus (wild or vaccine types)
Rabies virus (classical rabies and rabies-related lyssaviruses)
Rickettsia spp
Rift Valley fever virus
Rubella virus
Sabia virus
Salmonella spp
SARS coronavirus
[F68SARS-CoV 2]
Shigella spp
Streptococcus pneumoniae (invasive)
Streptococcus pyogenes (invasive)
Varicella zoster virus
Variola virus
Verocytotoxigenic Escherichia coli (including E.coli O157)
Vibrio cholerae
West Nile Virus
Yellow fever virus
Yersinia pestis

Textual Amendments

Regulation 8

SCHEDULE 3E+WRevocations

1.  The Public Health (Prevention of Tuberculosis) Regulations 1925 M8.E+W

Marginal Citations

2.  The Public Health (Infectious Diseases) Regulations 1988 M9.E+W

Marginal Citations

Explanatory Note

(This note is not part of the Regulations)

These Regulations place obligations on various persons to disclose information to specified third parties for the purpose of preventing, protecting against, controlling or providing a public health response to the incidence or spread of infection or contamination.

Regulation 2 obliges registered medical practitioners to notify the local authority if a patient they are attending is believed to have a disease listed in Schedule 1 or is otherwise infected or contaminated in a way that may cause significant harm to others. Regulation 3 extends this obligation to cover notification of suspected disease, infection or contamination in a dead body. Regulation 6 obliges the local authority to disclose notifications under regulations 2 or 3 to other specified bodies with a health protection role.

Regulation 4 obliges the operators of diagnostic laboratories to notify the Health Protection Agency (HPA) if they identify a causative agent listed in Schedule 2, or evidence of such an agent, in a human sample. Regulation 5 enables the HPA to approach the person who solicited the laboratory tests for certain information not provided by the operator of the diagnostic laboratory and obliges that person to provide the information where known.

Regulation 7 enables specified documents to be sent electronically where certain conditions are met.

Regulation 8 revokes 2 sets of regulations.

A full impact assessment of the effect that this instrument will have on the costs of business, the voluntary sector and the public sector is available from the Department of Health, Room 514, Wellington House, 133-155 Waterloo Road, London, SE1 8UG and is annexed to the Explanatory Memorandum which is available alongside the instrument on the OPSI website (www.opsi.gov.uk).