The Health Protection (Coronavirus, International Travel and Notification) (Wales) (Miscellaneous Amendments) Regulations 2021

PART 2 Amendments to the Health Protection (Coronavirus, International Travel) (Wales) Regulations 2020

Amendments to the Health Protection (Coronavirus, International Travel) (Wales) Regulations 2020

2.  The Health Protection (Coronavirus, International Travel) (Wales) Regulations 2020(1) are amended in accordance with regulations 3 to 8.

Amendments to regulation 2

3.  In regulation 2(1) (general interpretation), at the appropriate place insert—

““private test provider” (“darparwr prawf preifat”) means a test provider other than a public provider;”;

““public test provider” (“darparwr prawf cyhoeddus”) means a person who provides or administers a test exercising powers under the National Health Service (Wales) Act 2006(2), the National Health Service Act 2006(3), the National Health Service (Scotland) Act 1978(4), or the Health and Personal Social Services (Northern Ireland) Order 1972(5);”;

““test provider” (“darparwr prawf”) means a public test provider or a private test provider.”

Amendments to regulation 6AB

4.—(1) Regulation 6AB (requirement to book and undertake tests) is amended as follows.

(2) Omit paragraph (2)(c).

(3) In paragraphs (3), (5) and (6), for “public test provider”, in each place it occurs, substitute “test provider”.

Amendment to regulation 6J

5.  In regulation 6J(1) (charge for tests), after “day 8 tests” insert “provided by a public test provider”.

Amendments to regulation 17

6.—(1) Regulation 17 (use and disclosure of information) is amended as follows.

(2) In paragraph (2)(a)(iii)—

(a) for “public test provider”, in both places it occurs, substitute “test provider”;

(b) in sub-paragraph (bb), omit “(within the meaning given by regulation 6AB(2)(c))”.

(3) In paragraph (3)(c), for “public test provider” substitute “test provider”.

Amendments to Schedule 1C

7.—(1) Schedule 1C (mandatory testing after arrival in Wales) is amended as follows.

(2) In paragraph 1—

(a) for the heading substitute “Day 2 tests: general requirements”;

(b) the existing provision becomes sub-paragraph (2), and before it there is inserted—

“(1) A day 2 test complies with this paragraph where the test complies with sub-paragraph (2) and—

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

(b) it is a test provided by a private test provider where the private test provider complies with paragraph 1ZA.”;

(c) in sub-paragraph (2), as renumbered by paragraph (2)(b) of this regulation, for “paragraph” substitute “sub-paragraph”.

(3) After paragraph 1 insert—

“Day 2 tests: private test provider requirements

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

(a) 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);

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

(c) 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;

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

(e) 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 reasonable practicable to the Welsh Ministers;

(f) 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;

(g) 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;

(h) 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;

(i) 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;

(j) 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 second day after the day on which P arrived in Wales;

(k) 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 who the test was sold is a arrival who has not within the period of 10 days ending with P’s arrival in Wales, been in a non-exempt country or territory, or not;

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

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

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

(m) 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;

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

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

(p) 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(6);

(q) 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) paragraphs (b) to (e) and (g) to (p) of this sub-paragraph;

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

(2) For the purposes of sub-paragraph (1)(h) and (i), 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 2 test.

(3) In this paragraph, “registered clinical scientist” means a person registered as a clinical scientist with the Health and Care Professions Council pursuant to article 5 of the Health Professions Order 2001(7).”

(4) In paragraph 2—

(a) for the heading substitute “Day 8 tests: general requirements”;

(b) the existing provision becomes sub-paragraph (2), and before it there is inserted—

“(1) A day 8 test complies with this paragraph where the test complies with sub-paragraph (2) and—

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

(b) it is a test provided by a private test provider where the private test provider complies with paragraph 2ZA.”

(5) After paragraph 2 insert—

“Day 8 tests: private test provider requirements

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);

(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.”

(6) After paragraph 2A insert—

“UKAS accreditation

2B.— (1) Before providing a test, a private test provider must have been accredited by UKAS to the relevant ISO standard.

(2) If the private test provider arranges with another person (“X”) for X to carry out any element of the testing service on their behalf, the private test provider must—

(a) ensure that X complies with any provision of this paragraph that is relevant to the carrying out of that element, and

(b) subject to sub-paragraph (3), cease to provide tests under arrangement with X if X fails to comply with any such provision.

(3) Sub-paragraph (2)(b) does not apply to a test that was administered before the date that X failed to comply with this paragraph.

(4) In this paragraph—

“the relevant ISO standard” (“y safon ISO berthnasol”) means—

(a)

in the case of a test which requires laboratory processing, ISO standard 15189 or ISO/IEC standard 17025, and

(b)

in the case of a point of care test, ISO standard 15189 and ISO standard 22870(8), and for this purpose “point of care test” means a test processed outside a laboratory environment;

“UKAS” (“UKAS”) means the United Kingdom Accreditation Service, a company limited by guarantee and incorporated in England and Wales under number 3076190(9).

Notification of test results

2C.— (1) This paragraph applies to a private test provider who administers or provides a test to P in the circumstances described in regulation 6AB and paragraphs 1 to 2A of this Schedule.

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

(a) notify P and, where applicable, any person who arranges the test on P’s behalf, by email, letter or text message, the result of P’s test, or

(b) make P’s test result available to P and, where applicable, any person who arranges the test on P’s behalf, 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 private test provider and P’s test reference number, and must be conveyed so as to inform P whether the test was negative, positive, or inconclusive.”

(7) In paragraph 3, after sub-paragraph (c) insert—

“(d) “single end-to-end testing service” means a service which comprises accepting the booking from the person to be tested, collecting and processing the sample to be tested, carrying out genomic sequencing and providing the test result to P.”

Amendments to Schedule 3A

8.  In Schedule 3A (countries and territories subject to additional measures), omit the following entries—

“Bangladesh”

“Egypt”

“Kenya”

“Maldives”

“Oman”

“Pakistan”

“Sri Lanka”

“Turkey”.

(1)

S.I. 2020/574 (W. 132), amended by S.I. 2020/595 (W. 136), S.I. 2020/714 (W. 160), S.I. 2020/726 (W. 163), S.I. 2020/804 (W. 177), S.I. 2020/817 (W. 179), S.I. 2020/840 (W. 185), S.I. 2020/868 (W. 190), S.I. 2020/886 (W. 196), S.I. 2020/917 (W. 205), S.I. 2020/942, S.I. 2020/944 (W. 210), S.I. 2020/962 (W. 216), S.I. 2020/981 (W. 220), S.I. 2020/1015 (W. 226), S.I. 2020/1042 (W. 231), S.I. 2020/1080 (W. 243), S.I. 2020/1098 (W. 249), S.I. 2020/1133 (W. 258), S.I. 2020/1165 (W. 263), S.I. 2020/1191 (W. 269), S.I. 2020/1223 (W. 277), S.I. 2020/1232 (W. 278), S.I. 2020/1237 (W. 279), S.I. 2020/1288 (W. 286), S.I. 2020/1329 (W. 295), S.I. 2020/1362 (W. 301), S.I. 2020/1477 (W. 316), S.I. 2020/1521 (W. 325), S.I. 2020/1602 (W. 332), S.I. 2020/1645 (W. 345), S.I. 2021/20 (W. 7), S.I. 2021/24 (W. 8), S.I. 2021/46 (W. 10), S.I. 2021/48 (W. 11), S.I. 2021/50 (W. 12), S.I. 2021/66 (W. 15), S.I. 2021/72 (W. 18), S.I. 2021/95 (W. 26), S.I. 2021/154 (W. 38), S.I. 2021/305 (W. 78), S.I. 2021/361 (W. 110), S.I. 2021/454 (W. 144), S.I. 2021/500 (W. 149), S.I. 2021/568 (W. 156), S.I. 2021/584 (W. 161), S.I. 2021/646 (W. 166), S.I. 2021/669 (W. 170), S.I. 2021/765 (W. 187), S.I. 2021/826 (W. 193), S.I. 2021/863 (W. 202), S.I. 2021/867 (W. 203), S.I. 2021/915 (W. 208), S.I. 2021/926 (W. 211) and S.I. 2021/967 (W. 227).

(2)

2006 c. 42.

(3)

2006 c. 41.

(4)

1978 c. 29.

(5)

S.I. 1972/1265 (N.I. 14).

(6)

S.I. 2010/1546 (W. 144), amended by S.I. 2020/232 (W. 54).

(7)

S.I. 2002/254. There are amendments not relevant to these Regulations.

(8)

ISO 22870 Point-of-care testing (POCT) requirements for quality and competence was published in November 2016.

(9)

See S.I. 2009/3155, amended by S.I. 2019/696, for the functions of UKAS. S.I. 2009/3155 and S.I. 2019/696 were made under section 2(2) of the European Communities Act 1972 (c. 68) and are accordingly saved by virtue of section 2(2)(a) of the European Union (Withdrawal) Act 2018 (c. 16).