Textual Amendments
F1Sch. 2C inserted (15.2.2021 at 4.00 a.m.) by The Health Protection (Coronavirus, International Travel) (England) (Amendment) (No. 7) Regulations 2021 (S.I. 2021/150), regs. 1(1), 19 (with reg. 23)
7.—(1) For the purposes of paragraph 6(1)(b)(iii), a private provider complies with this paragraph where—
(a)they comply with the requirements of paragraph 3(1)(a) and (e) to (h) of Schedule 2A as if any reference in those provisions to an appropriate test were a reference to a day 2 test,
(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 at https://support-covid-19-testing.dhsc.gov.uk/InternationalTesting,
(c)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,
(d)the laboratory used by the test provider for the processing of samples meets the relevant requirements for accreditation to—
(i)in respect of the evaluation of the established molecular detection method, ISO standard 15189 or ISO/IEC standard 17025;
(ii)in respect of the genome sequencing of samples, ISO standard 15189,
(e)they receive the information required by paragraph 10(3) or (4) (as appropriate), and they administer or provide the test to P no later than the end of the second day after the day on which P arrived in England,
(f)they sequence each sample with a cycle threshold less than 30 (equivalent to ~1,000 viral genome copies per millilitre),
(g)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,
(h)on a request by the Secretary of State or the COVID-19 Genomics UK Consortium, they make samples available for the purpose of dual sequencing,
(i)they preserve and transport samples in a manner that enables genome sequencing,
(j)they have in place a process to remove human reads from any data submitted in a notification to Public Health England pursuant to the Health Protection (Notification) Regulations 2010, and
(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)(e) to (h) of Schedule 2A as applied by sub-paragraph (1)(a);
(ii)sub-paragraph (1)(c) to (i);
(iii)paragraph 11(2), (3) and (4).
(2) For the purposes of sub-paragraph (1)(h), “single end-to-end testing service” has the meaning given in paragraph 3(2)(c) of Schedule 2A.
(3) For the purposes of sub-paragraph (1)(c) and (d), 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 regulation 6 of the Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 as if—
(a)a reference to an applicable test were a reference to a day 2 test;
(b)a reference to a test provider were a reference to a private provider.]