The Health Protection (Coronavirus, Restrictions, International Travel, Notification and Public Health Information to Travellers) (Wales) (Miscellaneous Amendments) Regulations 2021

Amendments to Schedule 1C E+W

11.—(1) Schedule 1C (mandatory testing after arrival in Wales) is amended as follows.

(2) After paragraph 1ZA insert—

“Day 2 tests: general requirements for lateral flow device tests

1ZB.— (1) A day 2 test complies with this paragraph where the test complies with sub-paragraph (2) and—

(a) it is a test provided by a public test provider; or

(b) it is a test provided by a private test provider where the private test provider complies with paragraph 1ZC.

(2) A test complies with this sub-paragraph where—

(a) it is a test for the detection of coronavirus which uses one or more of—

(i) mid-turbinate or anterior nares nasal swabbing;

(ii) tonsillar swabbing;

(iii) saliva;

(b) it is uniquely identifiable;

(c) it is provided in accordance with the test manufacturer’s instructions for use including, in particular, instructions as to the target use, target user and target use settings; and

(d) any device used for the purposes of the test can be put into service in accordance with Part 4 of the Medical Devices Regulations 2002(1), other than solely by virtue of regulation 39(2) of those Regulations.

Day 2 tests: private test provider requirements for lateral flow device tests

1ZC.— (1) A private test provider complies with this paragraph where—

(a) they comply with the requirements of paragraph 1ZA(1)(a) to (e) and (h);

(b) they have made a declaration to the Secretary of State 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 21 October 2021 and the Secretary of State 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 Secretary of State 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 regulation 6AB(5), 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 Wales;

(f) they have in place a system in place to reject results from devices which have been previously used;

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

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

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

(aa) the date of the arrival in the United Kingdom 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 regulation 6AB(6);

(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 1ZA(1)(b) to (e) and (h) as applied by paragraph (a) of this sub-paragraph;

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

(iii) paragraph 2D(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 result of the test;

(f) providing notification of the test result.”

(3) For paragraph (1A) substitute—

“1A.   The circumstances mentioned in regulation 6AB(2)(a) are—

(a) that P undertake the day 2 test no later than the end of the second day after the day on which P arrived in Wales, and

(b) in relation to a test described in regulation 6AB(2)(a)(ii)(bb) not administered by a test provider, that P provides the test provider with the following information within 15 minutes of the test’s read time as determined by the manufacturer’s instructions for use—

(i) photographic evidence clearly showing—

(aa) the test device in such a way that it is identifiable as having been provided by the test provider,

(bb) the test reference number given in accordance with regulation 6AB(6), and

(cc) the test result, and

(ii) the address at which P is able to receive a confirmatory test pursuant to regulation 6E(4).”

(4) After paragraph 2C insert—

“Notification of test results: lateral flow device tests

2D.— (1) This paragraph applies to a private test provider who administers or provides a test within the meaning of regulation 6AB(2)(a)(ii)(bb) to P in the circumstances described in paragraph 1A.

(2) The private test provider must, within 24 hours of the relevant event—

(a) notify P and, where applicable, any person who arranges the test on P’s behalf, by email, letter or text message, the result of P’s test, or

(b) make P’s test result available to P and, where applicable, any person who arranges the test on P’s behalf, via a secure web portal,

in accordance with sub-paragraph (4).

(3) In paragraph (2), “relevant event” means—

(a) where the test provider administered the test, the time at which the test provider determined the results of the test;

(b) where the test provider did not administer the test, the time at which the test provider received the information required to be provided by paragraph 1A(b).

(4) The notification of P’s test result must include P’s name, date of birth, passport number, or travel document reference number (as appropriate), the name and contact details of the test provider and P’s test reference number, and must be conveyed so as to inform P whether the test was negative, positive, or inconclusive.”

(5) In paragraph 3(d), after ““single end-to-end testing””, insert “, except in paragraph 1ZC(1)(h),”.

Commencement Information

I1 Reg. 11 in force at 31.10.2021 at 4.00 a.m., see reg. 1(2)

(1)

S.I. 2002/618.