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

PART 4STesting following arrival in Scotland

Part 4: application and interpretationS

11.—[F1(1) Subject to regulation 18 (persons not required to comply), this Part applies to a person (“P”) who is—

(a)a red list arrival, or

(b)an arrival who is not an eligible vaccinated arrival.]

[F2(1A) Regulations 15 and 16 apply to a person (“P”) who is—

(a)a red list arrival, F3...

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

F5(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) For the purposes of this Part—

“day 2 test” means a test which complies with regulation 14(9) and is undertaken in accordance with regulation 14(2),

“day 8 test” means a test provided in a testing package with a day 2 test which complies with regulation 14(9) and is undertaken in accordance with regulation 14(4),

“testing package” means—

“test provider” means a provider who provides a test in accordance with regulation 14(9).

(4) In regulations 15 and 16, references to sharing designated accommodation means sharing the place where such persons are staying (as defined by regulation 21(3) and (4)).

Requirement to possess testing packageS

12.—(1) Where P is an adult, P must, on arrival in Scotland, possess a testing package—

(a)for P, and

(b)for any child aged 11 or over [F8who is a red list arrival] with whom P is travelling and for whom P has responsibility.

(2) Where P is an adult who arrives in Scotland without possessing a testing package in accordance with paragraph (1), P must obtain a testing package as soon as practicable on arrival.

(3) Where P is a child aged 11 or over and who is unaccompanied by an adult who has responsibility for P, a person with responsibility for P must obtain a testing package for P as soon as is practicable after P arrives in Scotland.

(4) A person who possesses a testing package must provide evidence of it if requested to do so by an immigration officer.

(5) Where P is required to comply with Part 5 (managed isolation), P is deemed to have complied with this regulation where P purchases a testing package as part of a managed isolation package in accordance with that Part.

Requirement to provide informationS

13.—(1) Subject to paragraph (2), at the time the testing package is booked, P must notify the test provider that P is required to undertake the test or tests to which the testing package relates under these Regulations, and provide the test provider with—

(a)P's full name,

(b)P's sex,

(c)P's date of birth,

(d)P's NHS number (if known and applicable),

(e)P's ethnicity,

(f)the date of P's arrival in the United Kingdom,

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

(h)the date on which P last departed from or transited through—

(i)a red list country, [F9or]

[F10(ii)failing which another country, territory or part of a country or territory which is not in the common travel area,]

(i)the country or territory P was travelling from when P arrived in the United Kingdom, and any country or territory P transited through as part of that journey,

(j)P's email address,

(k)P's telephone number,

(l)P's passport number or travel document reference number (as appropriate), and

(m)P's home address, and, where relevant, the address or addresses of the specified premises where P intends to stay in accordance with Part 6 (self-isolation).

(2) 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 paragraph (1) to the test provider—

(a)the notification and information set out or referred to in paragraph (1), other than the information set out in paragraph (1)(j) and (k), must be provided to the test provider on P's behalf by another person (“X”), and

(b)either the information set out in paragraph (1)(j) and (k) must be provided by X to the test provider or, where appropriate, X must provide their own telephone number and email address to the test provider.

(3) At the time the testing package is booked, the test provider must give a test reference number to P and, where appropriate, also give that test reference number to X.

(4) For the purposes of paragraphs (2) and (3), where P is a child, “X” means a person who has responsibility for P.

Requirement to undertake testsS

14.—(1) P must undertake the test or tests in their testing package in accordance with this regulation.

[F11(1A) If a test is to be self-administered, P must undertake a test in accordance with the manufacturer’s instructions for use.]

(2) P must undertake the day 2 test no later than the end of the 2nd day after the day on which P arrived in Scotland.

(3) Where P's day 2 test generates a positive result and P would otherwise be required to take the day 8 test, P is not required to undertake the day 8 test.

(4) Where P is required to undertake the day 8 test, P must undertake that test no earlier than the end of the 7th day after the day on which P arrived in Scotland.

(5) Where P is a child aged 11 or over, any person who has responsibility for P must, so far as reasonably practicable ensure that P undertakes a day 2 test and, where relevant, a day 8 test.

(6) Where P does not undertake either a day 2 test or a day 8 test by reason of a reasonable excuse (see regulation 30), P must, as soon as practicable after the matters giving rise to the reasonable excuse no longer apply, undertake a replacement test complying with the requirements of paragraph (9).

(7) Where a replacement test is undertaken instead of—

(a)a day 2 test, P is to be treated as if P had undertaken a day 2 test in accordance with this regulation,

(b)a day 8 test, P is to be treated as if P had undertaken a day 8 test in accordance with this regulation.

(8) Where a test is undertaken by P after this regulation applies, and that test meets the requirements of paragraph (9) and generates a positive result, P is not required to undertake a subsequent day 2 test or day 8 test, as the case may be.

(9) The requirements of this regulation are that—

(a)the test is provided by a public provider, or where P is [F12not a red] list arrival, a public provider or a private provider, and

[F13(b)the test complies with paragraph (9A).]

[F14(9A) For the purposes of [F15paragraph (9)(b)], a test complies with this paragraph if—

(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 red list arrival, 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)in relation to a day 2 test, has a specificity and a sensitivity greater than or equal to 99% (or a 95% two-sided confidence interval entirely above 97%),

(iii)in relation to a day 8 test, has a specificity greater than or equal to 97% (or a 95% two-sided confidence interval entirely above 95%),

(iv)in relation to a day 8 test, has a sensitivity greater than or equal to 95% (or a 95% two-sided confidence interval entirely above 90%),

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

(vi)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.]

F16(9B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(10) In this regulation, “public provider” means a test provider who provides or administers a test under—

(a)the National Health Service (Scotland) Act 1978,

(b)the National Health Service Act 2006,

(c)the National Health Service (Wales) Act 2006, or

(d)the Health and Personal Social Services (Northern Ireland) Order 1972.

(11) In this regulation “private provider” means a day 2 test F17... provider, other than a public provider, who—

(a)has made a self-declaration to the Department of Health and Social Care that the provider meets the minimum standards that private sector providers must meet for coronavirus tests for persons arriving in England in terms of schedule 8 to the Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021 M1 and DHSC guidance, and

(b)is currently on the UK Government published list of private day 2 test F18... providers for persons arriving in England M2.

[F19(12) For the purposes of paragraph (9A)—

(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,

(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, or

(ii)a laboratory which is accredited to ISO standard 15189 or ISO/IEC standard 17025F20 by—

(aa)the United Kingdom Accreditation ServiceF21, or

(bb)an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (“ILAC”) Mutual Recognition ArrangementF22 or the European co-operation for Accreditation (“EA”) Multilateral AgreementF23,

other than a laboratory which processes tests provided by the test provider for the purposes of this Part or which is owned by the test provider or the device manufacturerF24,

(c)“variant of concern” means a variant of SARS-CoV-2 identified in a designation published by the UK Health Security Agency for the purposes of this paragraphF25.]

Requirement to self-isolate on failure to undertake a testS

15.—(1) Paragraphs (2) to (4) apply where—

(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 [F26required] day 8 test.

(2) Where P is required to comply with Part 5 (managed isolation), P must remain in the accommodation designated as part of P's managed isolation package in accordance with regulation 21 until the end of the 14th day after the day on which P arrived in Scotland.

(3) Where P is required to comply with Part 6 (self-isolation), P must remain in the specified premises in accordance with regulation 26 until the end of the 14th day after the day on which P arrived in Scotland.

(4) Where P is a child, any person who is sharing designated accommodation or specified premises with P must remain in such accommodation or premises until the expiry of the period mentioned in paragraph (2) or (3) (as the case may be).

Consequences of test resultsS

16.—(1) Where a test undertaken by a person (“P”) in accordance with regulation 14(2) or (4) generates a positive result—

(a)P no longer has a defence under—

(i)regulation 31(3)(a), where P is required to comply with Part 5, or

(ii)regulation 32(2)(a), where P is required to comply with Part 6, and

(b)P and, subject to paragraph (2), any person who is sharing designated accommodation or specified premises with P (“B”), must remain in that accommodation or premises in accordance with regulation 21 or 26 (as the case may be) until the end of the 10th day after the day P undertook the test.

(2) Paragraph (1)(b) does not apply to B where—

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

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

(3) Where an earlier test undertaken by P after this regulation applies meets the requirements of regulation 14(9) and generates a positive result, the requirement for P to remain in such premises or accommodation under paragraph (1)(b) only applies until the end of the 10th day after the day P undertook that earlier test.

(4) Where an earlier test undertaken by B after this regulation applies meets the requirements of regulation 14(9) and generates a positive result, the requirement for B to remain in such premises or accommodation under paragraph (1)(b) only applies until the end of the 10th day after the day B undertook that earlier test.

(5) Where P's day 2 test and P's day 8 test both generate a negative result, P must remain in the designated accommodation or specified premises until—

(a)the later of—

(i)the date specified in regulation 21(1), where P is required to comply with Part 5, or

(ii)the date specified in regulation 26(2), where P is required to comply with Part 6, or

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

(6) Subject to regulation 15, where a test undertaken by P generates an inconclusive result, P must remain in the designated accommodation or specified premises until—

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

(b)where P undertakes a test to which paragraph (8) applies and the test generates a negative result, the later of—

(i)the end of the period of 10 days beginning with the day after the day of P's arrival in Scotland, or

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

(c)where P undertakes a test to which paragraph (8) applies and the test generates a positive result, until the end of the 10th day after the day P undertook the test.

(7) Where paragraph (6)(c) applies, P is not required to undertake a day 8 test.

(8) This paragraph applies to—

(a)a day 8 test, and

(b)a replacement test—

(i)complying with the requirements for a day 8 test other than the requirement that the test be administered or provided to P no earlier than the beginning of the 7th day after the day on which P arrived in Scotland,

(ii)undertaken in the circumstances specified in regulation 14, and

(iii)undertaken during the period referred to in paragraph (6)(a).

Eligible vaccinated arrivals: notification of result of self-administered testS

F2716A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Eligible vaccinated arrivals: confirmatory testS

F2816B.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Charge for testing packageS

17.—(1) The Scottish Ministers, or a person designated by the Scottish Ministers, may impose a charge in respect of a testing package provided by a test provider in accordance with regulation 14(9).

(2) The Scottish Ministers—

(a)must publish details of the charges in such manner as they consider appropriate, and

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

Part 4: persons not required to complyS

18.—(1) [F29A] person (“P”) is not required to comply with this Part where P is—

(a)a child (without prejudice to regulations 12(1)(b) and (3), 13(2), 15 and 16),

(b)a person who—

(i)has arrived from England, and

(ii)is in Scotland, temporarily, for a reason mentioned in regulation 32(2)(a) to (j),

(c)a person who has arrived in Scotland from elsewhere within the common travel area in order to travel immediately onwards to—

(i)another part of the United Kingdom, or

(ii)elsewhere outside of the United Kingdom,

[F30(d)a person who, on arrival in the United Kingdom—

(i)passes through to another country or territory outside the common travel area without entering the United Kingdom, or

(ii)enters the United Kingdom for the sole purpose of continuing a journey to a country or territory outside the common travel area and—

(aa)remains within their port of entry until their departure from Scotland, or

(bb)travels directly from their port of entry to another port of departure in Scotland,]

[F31(da)a person who—

(i)arrives in Scotland on a cruise ship, and

(ii)is due to depart from Scotland on the same cruise ship within 48 hours of their arrival,]

[F32(e)a person described in any of the following paragraphs of Part 1 of schedule 4 (exemptions: diplomats, Crown servants, visiting forces etc.)—

(i)paragraph 1(1) (diplomats, consuls, heads of State etc.),

(ii)paragraph 1(2), (3) and (4) (international organisations, foreign representatives, etc.), where prior to P’s arrival in the United Kingdom, the Foreign, Commonwealth and Development Office has confirmed in writing—

(aa)if P is not a specified person, to the stipulated person or person acting on their authority that P is not required to comply with this Part,

(bb)if P is a specified person, to P that P is not required to comply with this Part,

(iii)paragraphs 2, 3 and 4 (border and defence activities),

(iv)paragraphs 5 and 6 (essential government work, etc.) where, prior to P’s arrival in the United Kingdom, the relevant Department or the Scottish Ministers have certified that P—

(aa)meets the description in paragraph 5 or, as the case may be, 6, and

(bb)is not required to comply with this Part,

(f)a person described in Part 2 of schedule 4 (exemptions: transport), other than in paragraph 11 (in-flight security officers),

(g)a person described in Part 5 of schedule 4 (exemptions: healthcare).]

F33(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F35(4) In paragraph 1(e)(ii), “specified person” and “stipulated person” have the meanings given in paragraph 1(10) of schedule 4.]