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.

Day 2 tests: general private provider requirements

2. (1)

For the purposes of paragraph 1(2)(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 is reasonably 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 8(5)(b) and (c), 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)

the test reference number given to P in accordance with regulation 8(6);

(l)

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

(m)

where—

(i)

a sample is to be sequenced in accordance with paragraph (l), 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;

(n)

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;

(o)

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

(p)

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

(q)

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 201026;

(r)

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 (q) of this sub-paragraph;

(ii)

paragraph 4(2) and (3).

(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 3.

(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 200127.

UKAS accreditation

3. (1)

Before providing a day 2 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, 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.

Notification of test results by private providers

4. (1)

This paragraph applies to a private test provider who administers or provides a day 2 test to P.

(2)

The private test provider must, within the relevant timeframe—

(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.

(4)

In this paragraph, “relevant timeframe” means no later than 48 hours after the sample taken for the purposes of the test is received by the diagnostic laboratory.

Interpretation

5.

In this Schedule—

“single end-to-end testing service” (“un gwasanaeth profi o’r dechrau i’r diwedd”) 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;

“specified method” (“dull penodedig”) means a targeted sequence method specific to coronavirus or an equivalent—

(a)

amplicon method, or

(b)

sequence bait capture method;

“validated” (“wedi ei dilysu”), in relation to a device, means confirmed as having a sensitivity of at least 97% and a specificity of at least 99% for at least 150 positive samples and 250 negative samples, by—

(a)

the Welsh Ministers,

(b)

the National Institute for Health and Care Excellence, or

(c)

a laboratory which is accredited by the United Kingdom Accreditation Service (“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;

“variant of concern” (“amrywiolyn sy’n destun pryder”) means a variant of coronavirus identified in a designation made by the relevant expert UK Group28 for the purposes of these Regulations and published in a way that the Welsh Ministers consider to be appropriate.