The Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021

[F1 Day 2 tests: private provider requirements for lateral flow device tests E+W

7B.— (1) For the purposes of paragraph 7A(1)(b)(ii), a private provider complies with this paragraph where—

(a) they comply with the requirements of paragraph 3(1)(a) and (d) to (h) of Schedule 10 (including, in relation to paragraph 3(1)(d), the requirements of paragraph 3(3A) of that Schedule) as if in those provisions—

(i) any reference to an appropriate test were a reference to a day 2 test;

(ii) the term “single end-to-end testing service” has the meaning given by sub-paragraph (2) of this paragraph;

(b) they have made a declaration to the Department of Health and Social Care that they meet the minimum standards for private sector-provided testing published at gov.uk/guidance/day-2-lateral-flow-tests-for-international-arrivals-minimum-standards-for-providers on 21st October 2021 and the Department has confirmed in writing that it considers the provider meets those standards;

(c) they continue to meet the minimum standards to which the declaration mentioned in paragraph (b) relates;

(d) they have provided the Department of Health and Social Care with a list of all organisations that they work with (whether by sub-contract or otherwise) to carry out the testing service, indicating the nature of the service that each organisation is providing, and kept that list updated as appropriate;

(e) they receive the information required by paragraph 10(3) or (4) (as appropriate), and, if they administer the test to P, they do so no later than the end of the second day after the day on which P arrived in England;

(f) they ensure that they only accept results from the first use of a device;

(g) each day, they notify the Secretary of State in writing of—

(i) the number of tests they sold on that day,

(ii) in relation to each test sold on that day—

(aa) the date of the arrival in England of the person in respect of whom the test was sold,

(bb) whether it is a polymerase chain reaction or lateral flow device, and

(cc) the test reference number given to P in accordance with sub-paragraph (5) of paragraph 10 (required circumstances for undertaking a day 2 test or a day 8 test), and

(iii) in relation to each test the purchase of which was cancelled on that day, the information set out in sub-paragraph (ii)(aa) to (cc);

(h) if they arrange with another person (“X”) for X to carry out any element of the single end-to-end testing service on their behalf, the test provider ensures that X complies with the following so far as relevant to the carrying out of that element—

(i) paragraph 3(1)(d) to (h) of Schedule 10 as applied by paragraph (a) of this sub-paragraph;

(ii) paragraph (c) to (g) of this sub-paragraph

(iii) paragraph 11A(2) and (4).

(2) For the purposes of sub-paragraph (1)(h), “single end-to-end testing service” means a service which comprises any of the following elements where they are part of the service offered by the test provider—

(a) accepting the booking from the person to be tested;

(b) providing the test;

(c) collecting and processing the test once it has been undertaken;

(d) analysing the test;

(e) verifying the test result;

(f) providing notification of the test result.

(3) Where a private provider provides a day 2 LFD test, the Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 apply to a private provider as if regulation 6(1)(b) were omitted.]

Textual Amendments

F1 Sch. 8 paras. 7A, 7B inserted (24.10.2021 at 4.00 a.m.) by The Health Protection (Coronavirus, International Travel and Operator Liability) (England) (Amendment) (No. 16) Regulations 2021 (S.I. 2021/1179), regs. 1(2), 10(5)