The Health Protection (Notification) (Wales) Regulations 2010

[F1 Duty on the operators of diagnostic laboratories to notify Public Health Wales of SARS-CoV-2 or influenza virus tests processed E+W

4A.— (1) The operator of a diagnostic laboratory must notify Public Health Wales in accordance with this regulation where the diagnostic laboratory processes a test for the detection of SARS-CoV-2 [F2 , other than a test in relation to which regulation 4AB applies,] and the test result is positive or indeterminate.

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

(3) The operator of a diagnostic laboratory must also notify Public Health Wales in accordance with this regulation where the diagnostic laboratory—

(a) processes a test for the detection of SARS-CoV-2 [F3 , other than a test in relation to which regulation 4AB applies,] and the test result is negative or void; or

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

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

(a) the name and address of the diagnostic laboratory;

(b) the date and time the sample was received by the diagnostic laboratory;

(c) where a causative agent is identified, the details of that agent;

(d) the date of the sample;

(e) the nature of the sample;

(f) the results of any antimicrobial susceptibility test and any resistance mechanism identified in respect of the sample;

(g) name of person (“P”) from whom the sample was taken;

(h) P’s date of birth and sex;

(i) P’s current home address including postcode;

(j) P’s current residence (if not home address);

(k) P’s ethnicity;

(l) P’s NHS number;

(m) the name, address and organisation of the person who solicited the test;

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

(o) where the result of a test for the detection of SARS-CoV-2 is positive or 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.

(5) Subject to paragraph (7), a notification under paragraph (3) must be provided in writing within 7 days beginning with the day on which the diagnostic laboratory becomes aware of the test result.

(6) Subject to paragraph (7), a notification under paragraph (1) must be provided in writing within 24 hours of the diagnostic laboratory becoming aware of the test result.

(7) A notification which—

(a) is under paragraph (1) or (3); and

(b) relates to a day 2 or a day 8 test within the meaning of regulation 6AB of, the International Travel Regulations,

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

(8) Without prejudice to paragraph (5), if the operator of the diagnostic laboratory considers that a particular case to which that paragraph applies is urgent, the notification must be provided orally as soon as reasonably practicable.

(9) For the purpose of this regulation, 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.

(10) Where paragraph (9)(b) applies—

(a) the day on which the diagnostic laboratory becomes aware of the test result for the purposes of paragraph (3) 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 (1) is the time at which the diagnostic laboratory became aware of the result of the test processed by that other laboratory.

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

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

(13) In this regulation—

“carer” (“gofalwr”) has the meaning given in section 3 of the Social Services and Well-being (Wales) Act 2014;

“child” (“plentyn”) has the meaning given in regulation 2(7);

“diagnostic laboratory” (“labordy diagnostig”) has the meaning given in regulation 4(11);

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

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

“International Travel Regulations” (“Rheoliadau Teithio Rhyngwladol”) means the Health Protection (Coronavirus, International Travel) (Wales) Regulations 2020;

“operator of a diagnostic laboratory” (“gweithredwr labordy diagnostig”) has the meaning given in regulation 4(11);

“parent” (“rhiant”) has the meaning given in regulation 2(7);

“Public Health Wales” (“Iechyd Cyhoeddus Cymru”) has the meaning given in regulation 4(11).]

Textual Amendments

F1 Regs. 4A-4D inserted (21.9.2021) by The Health Protection (Coronavirus, International Travel and Notification) (Wales) (Miscellaneous Amendments) Regulations 2021 (S.I. 2021/1063), regs. 1(3), 11

F2 Words in reg. 4A(1) inserted (31.10.2021 at 4.00 a.m.) by The Health Protection (Coronavirus, Restrictions, International Travel, Notification and Public Health Information to Travellers) (Wales) (Miscellaneous Amendments) Regulations 2021 (S.I. 2021/1212), regs. 1(2), 14(2)

F3 Words in reg. 4A(3)(a) inserted (31.10.2021 at 4.00 a.m.) by The Health Protection (Coronavirus, Restrictions, International Travel, Notification and Public Health Information to Travellers) (Wales) (Miscellaneous Amendments) Regulations 2021 (S.I. 2021/1212), regs. 1(2), 14(3)