F1SCHEDULE 2CMandatory testing after arrival in England

Annotations:
Amendments (Textual)

Day 2 tests: private provider requirements7

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.