The Health Protection (Coronavirus, International Travel) (Wales) Regulations 2020

[F1 [F2 Day 8 tests: private test provider requirements E+W

2ZA.— (1) For the purposes of paragraph 1(1)(b), a private test provider complies with this paragraph where—

(a) they comply with the requirements of paragraph 1ZA(1)(a) to (e) as if any reference in those provisions to a day 2 test were a reference to a day 8 test;

(b) if the private test provider is a laboratory that conducts diagnostic test evaluation for testing in accordance with this Schedule, they have made a declaration to the Secretary of State that they meet the minimum standards for private sector-provided testing at https://support-covid-19-testing.dhsc.gov.uk/InternationalTesting;

(c) 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 or to carry out genomic sequencing, indicating the nature of the service that each organisation is providing, and kept that list updated as appropriate;

(d) the person responsible for the taking of samples meets the relevant requirements for accreditation to ISO standard 15189 or ISO/IEC standard 17025 in respect of the taking of samples;

(e) the laboratory used by the private test provider for the processing of samples meets the relevant requirements for ISO standard 15189 or ISO/IEC standard 17025 in respect of the evaluation of the established molecular detection method and the genome sequencing of samples;

(f) they receive the information required by regulation 6AB(5), and they administer or provide the test to P no later than the end of the eighth day after the day on which P arrived in Wales;

(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 arrival into the United Kingdom of the person in respect of whom the test was sold;

(bb) whether the person in respect of whom the test was sold is a regulation 2A traveller or not;

(cc) the test reference number given to P in accordance with regulation 6AB(6);

(h) they sequence each sample with a cycle threshold less than 30 (equivalent to 1,000 viral genome copies per millilitre);

[F3 (ha) where—

(i) a sample is to be sequenced in accordance with paragraph (h), and

(ii) the sequencing is to take place at a laboratory (“the sequencing laboratory”) other than the laboratory at which the sample was initially processed (“the diagnostic laboratory”),

they secure that the sample is received at the sequencing laboratory no later than 24 hours after the result of the initial processing becomes known to the diagnostic laboratory;]

(i) in respect of the sequencing of samples, they must secure a reference genome coverage breadth of at least 50% and at least 30 times coverage;

(j) on a request by the Welsh Ministers or the COVID-19 Genomics UK Consortium, they make samples available for the purpose of dual sequencing;

(k) they preserve and transport samples in a manner that enables genome sequencing;

(l) they have in place a process to remove human reads from any data submitted in a notification to Public Health Wales pursuant to the Health Protection (Notification) (Wales) Regulations 2010;

(m) 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 private 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) as applied by sub-paragraph (1)(a);

(ii) sub-paragraph (1)(c) to (l);

(iii) paragraph 2C(2) to (4).

(2) For the purposes of sub-paragraph (1)(d) and (e), a person or laboratory (as the case may be) meets the relevant requirements for accreditation to a standard where the person who is the operator of the laboratory complies with the requirements of paragraph 2B, as if a reference to a test were a reference to a day 8 test.]]

Textual Amendments

F1 Sch. 1C inserted (15.2.2021 at 4.00 a.m.) by The Health Protection (Coronavirus, International Travel) (Wales) (Amendment) (No. 3) Regulations 2021 (S.I. 2021/154), regs. 1(2), 4 (with reg. 21)

F2 Sch. 1C para. 2ZA 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), 7(5)

F3 Sch. 1C para. 2ZA(1)(ha) inserted (4.10.2021 at 4.00 a.m.) by The Health Protection (Coronavirus, International Travel, Operator Liability and Public Health Information to Travellers) (Wales) (Miscellaneous Amendments) (No. 3) Regulations 2021 (S.I. 2021/1109), regs. 1(2), 7(b)