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The Health Protection (Notification) Regulations 2010

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[F1Duty on the operators of diagnostic laboratories to notify [F2the United Kingdom Health Security Agency] of causative agents found in human samples and of SARS-Cov-2 or influenza virus tests processed]E+W

This section has no associated Explanatory Memorandum

4.—(1) The operator of a diagnostic laboratory must notify [F3the United Kingdom Health Security Agency] in accordance with this regulation where the diagnostic laboratory [F4—]

[F5(a)]identifies a causative agent in a human sample [F6; or

(b)processes a test for the detection of SARS-CoV-2 F7... and the test result is indeterminate.]

F8(1ZA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F9(1A) The operator of a diagnostic laboratory must also notify [F10the 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;

[F11(aa)the date and time the sample was received by the diagnostic laboratory;]

[F12(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;

[F13(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; F14...

(k)the name, address and organisation of the person who solicited the test [F15; and

(l)where the result of a test for the detection of SARS-CoV-2 is positive [F16or 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) [F17A 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.

[F18(3A) [F19A 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 F20... be provided in writing within 24 hours of the causative agent being identified.

(3C) [F21A notification] under paragraph (1)(b) must be provided in writing within 24 hours of the diagnostic laboratory becoming aware of the test result.]

F22(3D) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) Without prejudice to [F23paragraphs (3) and (3A)], if the operator of the diagnostic laboratory considers that [F24a 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 [F25the 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 [F26paragraph (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.

[F27(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 [F28—]

[F29(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;

[F30(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.]

[F31(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—

[F32“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;

[F33“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); F34...

[F35“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;

[F36“parent” has the meaning given in regulation 2(7).]

Textual Amendments

F15Reg. 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)

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