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The Health Protection (Notification) Regulations 2010

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Point in time view as at 18/12/2021.

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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 M1 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 M2 which, in the view of R, presents or could present significant harm to human health; or

(c)is contaminated M3 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 M4; 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

M1See section 74 of the Public Health (Control of Disease) Act 1984 (c.22) (“the 1984 Act”) for the definition of “proper officer”.

M2See section 45A of the 1984 Act for the interpretation of “infection”.

M3See 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—

  • “notifiable disease” has the same meaning it has in regulation 2; and

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

[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) Where paragraph (1) of regulation 4ZA applies to the operator of a diagnostic laboratory, the notification required by paragraph (1) must be in accordance with this regulation and regulation 4ZA.]

[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) [F22Subject to paragraph (3D), a 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, subject to paragraph (3D),] be provided in writing within 24 hours of the causative agent being identified.

(3C) [F24Subject to paragraph (3D), a 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) A notification which—

(a)is under paragraph (1)(a) or (b) or (1A)(a), and

(b)relates to—

(i)a day 2 or a day 8 test within the meaning of regulation 6 of the Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021, or

(i)a test undertaken in accordance with regulation 9(16) of those Regulations,

must be provided within 48 hours of the time the diagnostic laboratory received the test sample.]

(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)

[F40Duty to notify [F41the United Kingdom Health Security Agency] of the results of mandatory tests under [F42the Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021]E+W

4ZA.—(1) This regulation applies to the operator of a diagnostic laboratory where—

(a)the laboratory processes a day 2 test [F43or a day 8 test (] within the meaning of [F44regulation 6 of the Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021 (“the International Travel and Operator Liability Regulations”)] [F45)],

(b)the operator is required to send a notification in relation to the test in accordance with regulation 4(1)(a) of these Regulations, and

(c)the test provider is required to sequence the test sample under [F46[F47paragraph 7(1)(h) or 9(1)(h) of Schedule 8] to the International Travel and Operator Liability Regulations].

(2) The notification required by regulation 4(1)(a) must, in addition to the information listed in regulation 4(2), include the following information so far as it is known to the operator of the diagnostic laboratory—

(a)name and address of the source laboratory (if different from the diagnostic laboratory);

(b)the date of the laboratory report;

(c)the following information about the person (“P”) from whom the sample was taken—

(i)P’s age in months and years;

(ii)P’s address and postcode;

(iii)P’s occupation;

(iv)whether or not P is immunocompromised;

(v)whether or not P has received a vaccine against SARS-CoV-2;

(d)the following information about the sample—

(i)any laboratory comments;

(ii)the organism code;

(iii)the specimen number [F48, including the laboratory’s five-letter unique identifier code];

(iv)the specimen type;

(v)the specimen date;

(vi)the test method applied;

(vii)cycle threshold values;

F49(viii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F49(ix). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F50(x)where the laboratory is able to identify it, whether there is an S-gene dropout.]

[F51(3) Where the specimen is to be sent to another laboratory for the purposes of sequencing pursuant to paragraph 7(1)(h) or 9(1)(h) of Schedule 8 to the International Travel and Operator Liability Regulations, the operator of the diagnostic laboratory must provide that other laboratory with the specimen number used to fulfil the obligation in paragraph (2)(d)(iii).]]

Textual Amendments

[F52Duty 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

4ZB.—(1) The operator of a sequencing laboratory must notify the UK Health Security Agency in accordance with this regulation.

(2) The notification must include the following information so far as it is known to the operator of the sequencing laboratory—

(a)where the sequencing laboratory is not the source laboratory—

(i)the name and address of the source laboratory;

(ii)the date and time that the specimen was received by the sequencing laboratory;

(b)a report of the results of the sequencing;

(c)the date of that report;

(d)where the specimen has been sequenced on or after 15th March 2021, a sorted BAM file containing all reads aligning to the SARS-Cov-2 reference genome with unaligned human reads removed;

(e)any metadata required to reproduce the analysis which produced the results of the sequencing;

(f)the following information about the specimen—

(i)any laboratory comments;

(ii)the organism code;

(iii)the specimen number;

(iv)the specimen type;

(v)the specimen date;

(vi)the test method applied;

(vii)cycle threshold values;

(viii)whether the specimen is a variant of concern or a variant under investigation.

(3) Where the sequencing laboratory is not the source laboratory—

(a)the notification must be provided in writing within 96 hours of receiving the specimen, and

(b)the sequencing laboratory must—

(i)ascertain the specimen number that the source laboratory used to fulfil its obligation in regulation 4ZA(2)(d)(iii) in respect of the specimen, and

(ii)use the same specimen number to fulfil the obligation in paragraph (2)(f)(iii).

(4) Where the sequencing laboratory is the source laboratory—

(a)the notification must be provided in writing within 120 hours of the time SARS-Cov-2 is identified in the specimen, and

(b)the sequencing laboratory must use the same specimen number to fulfil the obligation in paragraph (2)(f)(iii) as it used to fulfil the obligation in regulation 4ZA(2)(d)(iii).

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

(6) Any person who commits an offence under this regulation is liable on summary conviction to a fine.

(7) In this regulation—

“director of a sequencing laboratory” means—

(a)

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

(b)

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

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

“sequencing laboratory” means a laboratory which sequences a sample pursuant to paragraph 7(1)(h) or 9(1)(h) of Schedule 8 to the Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021;

“source laboratory” means the diagnostic laboratory which provided the notification required by article 4(1) and 4ZA(1) in respect of the specimen.]

Textual Amendments

[F53Duty on test providers to notify results of tests for the detection of SARS-CoV-2 or Influenza virus to [F54the 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 F55... 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 [F56the 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.

[F57(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 [F58the United Kingdom Health Security Agency] with, insofar as it is known to the test provider—

(a)the information set out in paragraph [F59(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.

[F60(7)] It is an offence for a test provider to fail without reasonable excuse to comply with this regulation.

[F61(8)] A test provider that commits an offence under this regulation is liable on summary conviction to a fine.

[F62(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

F634B.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Duty to provide information to [F64the 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 [F65the United Kingdom Health Security Agency] under regulation 4.

(2) [F66The 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 [F67the 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, [F68the 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—

[F69(a)[F70the 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) [F71, 4(1) [F72and (1A)] [F73, 4ZA] [F74, [F754ZB, [F76and 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 M5 (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 M6.

(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

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