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

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Point in time view as at 24/02/2022.

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Regulation 6(10)

SCHEDULE 8E+WMandatory testing after arrival in England

This schedule has no associated Explanatory Memorandum

Interpretation of this ScheduleE+W

1.—(1) In this Schedule—

(a)default self-isolation period” means—

(i)in the case of a non-Schedule 11 passenger, the period specified in paragraph (7)(a) of regulation 9 (requirement to self-isolate),

(ii)in the case of a Schedule 11 passenger, the period specified in paragraph 10(a) of Schedule 11;

(b)“mandatory test” means a day 2 test or a day 8 test within the meaning of regulation 6(12);

(c)non-Schedule 11 passenger” means a person to whom regulation 9 applies;

[F1(d)“P”—

(i)means a person required to undertake a mandatory test under regulation 6 (requirement to book and undertake tests), and

F2(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

(e)private provider” means a test provider other than a public provider;

(f)public provider” means a test provider who provides or administers a test under the National Health Service Act 2006, the National Health Services (Wales) Act 2006, the National Health Service (Scotland) Act 1978, or the Health and Personal Social Services (Northern Ireland) Order 1972;

(g)relevant self-isolation provisions” means—

(i)in relation to a Schedule 11 passenger, regulation [F310] and Schedule 11,

(ii)in relation to a non-Schedule 11 passenger, regulation 9.

(2) Where this Schedule requires P to continue to self-isolate in accordance with the relevant self-isolation provisions—

(a)regulation 19 (offences and penalties) applies in relation to that requirement as it applies in relation to the relevant self-isolation provisions;

F4(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Requirement to self-isolate on failure to undertake a mandatory testE+W

2.—(1) Sub-paragraph (2) applies where P is [F5a person described in regulation 5(1)(b) or (c)] and—

(a)either—

(i)P fails to undertake a day 2 test, or

(ii)P's day 2 test generates a negative or inconclusive result, and

(b)P fails to undertake a day 8 test.

(2) Where this sub-paragraph applies, P must continue to self-isolate in accordance with the relevant self-isolation provisions until the end of the 14th day after the day on which they arrived in England.

F6(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F7(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F8(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F9(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F10(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8) Where P undertakes a test to which paragraph 3(7)(b) applies and which generates—

(a)a positive result, paragraph 3(1) applies as if the test were a mandatory test;

(b)a negative result, paragraph 3(4) applies as if—

(i)P had taken both a day 2 test and a day 8 test, and

(ii)both tests had generated a negative result.

[F11(9) Where P is required to self-isolate in accordance with regulation 9 under this paragraph, regulation 9(11)(a) (departing from England) does not apply to P.]

Textual Amendments

Commencement Information

I2Sch. 8 para. 2 in force at 17.5.2021 at 4.00 a.m., see reg. 1(2)

Consequences of test resultsE+W

3.—(1) [F12Where P is a person described in regulation 5(1)(b) or (c) and] a mandatory test undertaken by P in accordance with regulation 6 generates a positive result—

(a)the following do not apply in relation to P—

(i)regulation 9(11)(a) or, as the case may be, paragraph 13(1)(a) of Schedule 11 (leaving self-isolation to travel in order to leave England), [F13and]

F14(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)P and, subject to sub-paragraph (3), any person who is self-isolating with P must continue to self-isolate in accordance with the relevant self-isolation provisions until the end of the 10th day after the day P undertook the test.

F15(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F16(2A) Where P is required to self-isolate under this paragraph, P must, on request by a relevant person, notify the relevant person of the name of each person living in the same household as P.

(2B) In sub-paragraph (2A), “relevant person” means—

(a)the Secretary of State;

(b)a person who is employed or engaged for the purposes of the health service (within the meaning of section 275 of the National Health Service Act 2006) in communicable disease control; or

(c)a person employed or engaged by a local authority, including a county council, in communicable disease control,]

(3) Where a person (“B”) is self-isolating with P pursuant to the relevant self-isolation provisions, the requirement to self-isolate under sub-paragraph (1)(b) does not apply to B where—

(a)the test referred to in sub-paragraph (1) is P's day 8 test; and

(b)B undertook a day 2 test that generated a positive result.

(4) [F17Where P is a person described in regulation 5(1)(b) or (c) and] P's day 2 test and day 8 test both generate a negative result, P must continue to self-isolate in accordance with the relevant self-isolation provisions until the later of—

(a)the end of the default self-isolation period;

(b)the day on which P receives the result of their day 8 test.

(5) Where [F18P is a person described in regulation 5(1)(b) or (c) and] a mandatory test undertaken by P generates an inconclusive result P must continue to self-isolate in accordance with the relevant self-isolation provisions—

(a)until the end of the 10th day after the day P undertook the test;

(b)where P undertakes a test to which sub-paragraph (7) applies and the test generates a negative result, until the later of—

(i)the end of the default self-isolation period,

(ii)the day on which P receives the negative result; or

(c)where P undertakes a test to which sub-paragraph (7) applies and the test generates a positive result, until the end of the 10th day after the day P undertook the test.

(6) Where sub-paragraph (5)(c) applies, P is not required to undertake a day 8 test in accordance with regulation 6.

F19(6A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F20(6B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) This sub-paragraph applies to—

(a)a day 8 test;

(b)a test—

(i)complying with the requirements for a day 8 test specified in [F21paragraph 8],

(ii)undertaken in the circumstances specified in paragraph 10 (other than the circumstances in paragraph 10(2) about when a test must be undertaken), and

(iii)undertaken during the period specified in sub-paragraph (5)(a).

[F22(8) Where P is required to self-isolate in accordance with regulation 9 under this paragraph, regulation 9(11)(a) (departing from England) does not apply to P.]

Textual Amendments

Commencement Information

I3Sch. 8 para. 3 in force at 17.5.2021 at 4.00 a.m., see reg. 1(2)

Optional testsE+W

F234.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Tests other than in accordance with these RegulationsE+W

F245.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Day 2 tests: general test requirementsE+W

6.—(1) For the purposes of [F25regulation 6(12)(a)], a day 2 test complies with this paragraph where—

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

(b)it is a test provided by a private provider—

(i)in respect of—

(aa)a non-Schedule 11 passenger, on or after 1st March 2021;

(bb)a Schedule 11 passenger, on 1st or 2nd March 2021,

[F26(cc)a person who is required under regulation 6 to take a day 2 test;]

(ii)where the test complies with sub-paragraph (2), and

(iii)where the private provider complies with paragraph 7.

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

(a)it is a semi-quantitative test for the detection of coronavirus which—

(i)targets a minimum of two distinguishable SARS-CoV-2 genes other than the S gene and performance reference controls,

(ii)includes routine in silico assurance against every variant of concern, and

(iii)produces a test solution that provides extracted nucleic acid that is suitable for whole genome sequencing using a specified method;

(b)it is, in relation to a Schedule 11 passenger, a test that can be self-administered;

(c)the manufacturer of any device used for the purposes of the test states that the device—

(i)uses an established molecular detection method,

(ii)has a specificity and a sensitivity [F27greater than or equal to 99% (or a 95% two-sided confidence interval entirely above 97%),]

(iii)has a limit of detection of less than or equal to 1000 SARS-CoV-2 copies per millilitre, and

(iv)is suitable for identifying every variant of concern; and

(d)any device used for the purposes of the test—

(i)can be put into service in accordance with Part 4 of the Medical Devices Regulations 2002, other than solely by virtue of regulation 39(2) of those Regulations, and

(ii)has been validated no more than 18 months before the test is administered or provided to P.

(3) For the purposes of sub-paragraph (2)—

(a)specified method” means a targeted sequence method specific to SARS-CoV-2 or an equivalent—

(i)amplicon method, or

(ii)sequence bait capture method;

[F28(b)validated”, in relation to a device, means confirmed as having the required sensitivity and specificity using at least 150 positive clinical samples and 250 negative clinical samples against a laboratory-based RT-PCR test that is itself within the performance specification of the target product profile published by the Medicines and Healthcare Products Regulatory Agency for laboratory based SARS-CoV-2 PCR tests, by—

(i)the Secretary of State;

(ii)a laboratory which is accredited to ISO standard 15189 or ISO/IEC standard 17025i by—

(aa)the United Kingdom Accreditation Service (“UKAS”), or

(bb)an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (“ILAC”) Mutual Recognition Arrangement or the European co-operation for Accreditation (“EA”) Multilateral Agreement,

other than a laboratory which processes tests provided by the test provider for the purposes of this Schedule or is owned by the test provider or the device manufacturer; or

(iii)a laboratory which is accredited by UKAS to ISO standard 15189 or ISO/IEC standard 17025, other than a laboratory which processes tests provided by the test provider for the purposes of this Schedule or is owned by the test provider or the device manufacturer;]

(c)variant of concern” means a variant of SARS-CoV-2 identified in a designation made by the Secretary of State for the purposes of this paragraph and published in a manner as appears to the Secretary of State to be appropriate.

Day 2 tests: private provider requirementsE+W

7.—(1) For the purposes of paragraph 6(1)(b)(iii), a private provider complies with this paragraph where—

[F29(za)they provide day 2 tests in a single end-to-end testing service (whether or not they arrange with another person (“X”) for X to provide one or more elements of the service on their behalf);

(zb)a registered medical practitioner has oversight and approval of medical practices undertaken by the test provider, and responsibility for reporting medical issues;

(zc)they have an effective system of clinical governance in place which includes appropriate standard operating procedures in relation to the carrying out of day 2 tests;

(zd)a registered clinical scientist has oversight of clinical practices undertaken by the test provider, and responsibility for reporting clinical issues;

(ze)they have systems in place to identify any adverse incidents or quality control issues in relation to day 2 tests and be able to report them as soon as reasonably practicable to the Secretary of State;]

F30(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)if the provider is a laboratory that conducts diagnostic test evaluation for testing in accordance with this Schedule, 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 [F31and the Department has confirmed in writing that it considers the provider meets those standards];

[F32(ba)they continue to meet the minimum standards to which the declaration mentioned in paragraph (b) relates;]

(c)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 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 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 genomic sequencing of samples;

(f)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;

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

(i)the number of tests they sold on that day, F33...

(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, [F34and]

F35(bb). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F36(cc). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F37(dd)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)] [F38, 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 (dd)];

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

[F39(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 Secretary of State 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 [F40the United Kingdom Health Security Agency] pursuant to the Health Protection (Notification) Regulations 2010; and

(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 test provider ensures that X complies with the following so far as relevant to the carrying out of that element—

F41(i). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii)paragraph [F42(zb) to (ze) and] (c) to (l) of this sub-paragraph,

(iii)paragraph 11(2), (3) and (4).

(2) For the purposes of sub-paragraph (1)(m), “single end-to-end testing service[F43means a service which comprises accepting the booking from the person to be tested, providing the test, collecting and processing the sample to be tested, carrying out genomic sequencing and providing the test result to P].

(3) 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 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 [F44;]

[F45(c)in paragraph (1), the words from “and make a declaration” to “25th November 2020” were omitted.]

Textual Amendments

Commencement Information

I5Sch. 8 para. 7 in force at 17.5.2021 at 4.00 a.m., see reg. 1(2)

Day 2 tests: general requirements for lateral flow device testsE+W

F467A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Day 2 tests: private provider requirements for lateral flow device testsE+W

F477B.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Day 8 tests: general test requirementsE+W

8.—(1) For the purposes of regulation 6(12)(b), a day 8 test complies with this paragraph where—

(a)it is a test provided by a public provider F48...

F49(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F50(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F51(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Day 8 tests: private provider requirementsE+W

F529.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Required circumstances for undertaking a day 2 test or a day 8 testE+W

10.—(1) The circumstances mentioned in [F53[F54regulation 6(12)(a)] and (b)] are as follows.

(2) In relation to—

(a)a day 2 test, P undertakes the test [F55in accordance with the manufacturer’s instructions for use] no later than the end of the second day after the day on which P arrived in England;

(b)a day 8 test, P undertakes the test [F56in accordance with the manufacturer’s instructions for use] no earlier than the end of the seventh day after the day on which P arrived in England.

[F57(3) Subject to sub-paragraph (4)—

(a)at the time the test is booked P provides the test provider with the information set out or referred to in sub-paragraph (3B) [F58.]

F59(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

F60(3A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F57(3B) The information to be provided at the time the test is booked is—

(a)notification that P is to undertake the test under these Regulations,

[F61(b)the following information about P—

(i)their full name;

(ii)their sex;

(iii)their date of birth;

(iv)their NHS number (if known and applicable);

(v)their ethnicity;

(vi)the date of their arrival in the United Kingdom;

(vii)their coach number, flight number of vessel name (as appropriate);

(viii)the date on which they last departed from or transited through a category 2 country or territory;

(ix)the country or territory they were travelling from when they arrived in the United Kingdom, and any country or territory they transited through as part of that journey;

(x)their email address,

(xi)their telephone number,

(xii)their passport number, or travel document reference number (as appropriate);

(xiii)information as to whether or not P has received a vaccine against SARS-CoV-2, and]

(c)P’s home address, and—

F62(i). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii)where P is a person to whom regulation 9(1)(a) or (b) applies, the address or addresses at which they intend to self-isolate, or are self-isolating, in accordance with regulation 9 (if different from their home address);

(iii)where P is a person to whom regulation 10 applies, the address of the accommodation designated for the purposes of Schedule 11.

F63(3C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

(4) Where P is a child, or a person with a disability who is unable for that reason to provide the notification and information set out or referred to in sub-paragraph [F64(3B) F65...] F66... to the test provider—

(a)the notification and information set out or referred to in sub-paragraph [F67(3B) F68...] F69..., other than the information set out in paragraph [F70(b)(x) and (xi) of that sub-paragraph], is provided to the test provider on P's behalf by another person (“Y”); and

(b)either the information set out in [F71sub-paragraph (3B)(b)(x) and (xi)] is provided by Y to the test provider or, where appropriate, Y provides their own telephone number and email address to the test provider.

(5) At the time the test is booked and payment made the test provider gives P [F72a separate test reference number in respect of each test to be provided to P] in the format specified in sub-paragraph (6) and, where appropriate, also provides that test reference number to Y.

(6) A test reference number must consist of 12 characters comprising 5 letters followed by 7 digits.

Textual Amendments

Commencement Information

I7Sch. 8 para. 10 in force at 17.5.2021 at 4.00 a.m., see reg. 1(2)

Notification of test resultsE+W

11.—(1) This paragraph applies to a private provider who administers or provides a test F73... to P in the circumstances described in paragraph 10.

(2) The private provider must, [F74within 48 hours of the time when the sample taken for the purposes of the test is received by the diagnostic laboratory]

(a)notify P or, where paragraph 10(4) applies, Y by email, letter, or text message, of the result of P's test; or

(b)make P's test result available to P, or where paragraph 10(4) applies, to Y via a secure web portal,

in accordance with sub-paragraph (3).

(3) 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 using one of the following forms of words, as appropriate—

[F75Form A: negative test result

Your coronavirus (COVID-19) test result is negative. It’s likely you were not infectious when the test was done.

[F76If you develop symptoms of coronavirus, it is advised that you take a PCR test. If you have any of the main symptoms, the public health advice is to avoid contact with other people where possible.

For more information visit https://www.gov.uk/coronavirus]

Form B: positive test result

[F77Your coronavirus test result is positive. This means you probably have the virus.

You are no longer legally required to self-isolate.

However, if you have a positive test result, the public health advice is to stay at home and avoid contact with other people where possible.

It is advised that you do not travel, including to leave the UK.

For more information visit https://www.gov.uk/coronavirus.

Contact 111 if you need medical help. In an emergency dial 999.]

Form C: unclear test result

Your coronavirus test result is unclear. It is not possible to say if you had the virus when the test was done.

[F78It is advised that you take another coronavirus test.

You are no longer required to self-isolate.

However, if you have symptoms of coronavirus, the public health advice is to get a PCR test and avoid contact with other people where possible.

For more information visit https://www.gov.uk/coronavirus]].

(4) Where—

(a)regulation 4 [F79, 4ZA [F80, 4ZB] or 4A] of the Health Protection (Notification) Regulations 2010 applies in relation to the test provider; or

(b)if the test provider arranges with another person (“X”) for X to carry out any element of the single end-to-end testing service on their behalf, either of those regulations applies to X in the carrying out of that element,

the regulation applies as if it required the information described in sub-paragraph (5) to be included in the notification to [F81the United Kingdom Health Security Agency].

(5) The information mentioned in sub-paragraph (4) is—

(a)the date on which P last departed from or transited through a category 2 country or territory;

(b)P's coach number, flight number or vessel name (as appropriate);

F82(ba). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(bb)P’s passport number or travel document number (as appropriate);

(bc)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);

(c)the country or territory P was travelling from when P arrived in England, and any country or territory they transited through as part of that journey;

(d)the date on which P undertook the appropriate test;

(e)whether the test is—

F83(i). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F84(ii)F85. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iia)a day 2 test for a person who is [F86not an eligible traveller], or]

F87(iii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Commencement Information

I8Sch. 8 para. 11 in force at 17.5.2021 at 4.00 a.m., see reg. 1(2)

Notification of test results: lateral flow device testsE+W

11A.  F88. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Charge for day 2 tests and day 8 testsE+W

12.—(1) The Secretary of State or a person designated by the Secretary of State may impose a charge in respect of [F89any test provided in accordance with this Schedule by a public provider].

(2) The Secretary of State—

(a)must publish details of the charges in such manner as the Secretary of State considers appropriate; and

(b)may recover any sum owed by a person pursuant to such a charge as a debt.

Textual Amendments

Commencement Information

I9Sch. 8 para. 12 in force at 17.5.2021 at 4.00 a.m., see reg. 1(2)

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This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.

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