The Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020

UKAS accreditation

6.—(1) Before providing an applicable test, a test provider must—

(a) make a valid application to UKAS for accreditation to the relevant ISO standard; and

(b) make a declaration to the Secretary of State that they meet the minimum standards for private sector-provided testing published by the Department of Health and Social Care for that purpose on 25th November 2020(1), (“stage one”).

(2) The declaration referred to in paragraph (1)(b) must be made on the on-line portal provided by the Department of Health and Social Care at the following web page—

• https://support-covid-19-testing.dhsc.gov.uk/PrivateSectorSelfDeclaration.

(3) A test provider who completes stage one on or before 31st December 2020 must, before 31st January 2021, comply with the requirements published by UKAS on 24th November 2020 in relation to accreditation to the relevant ISO standard(2) (“stage two”).

(4) A test provider who completes stage one on or after 1st January 2021 must complete stage two on or before whichever is the later of—

(a) 31st January 2021; or

(b) the date four weeks after the date on which they completed stage one.

(5) A test provider who completes stage two on or before 31st January 2021 must be accredited by UKAS to the relevant ISO standard on or before 30th June 2021.

(6) A test provider who completes stage two after 31st January 2021 must be accredited by UKAS to the relevant ISO standard on or before whichever is the later of—

(a) 30th June 2021; or

(b) the date four months after the date on which they completed stage two.

(7) Subject to paragraph (9), a test provider must cease to provide applicable tests if they have not—

(a) completed stage two by the date specified in paragraph (3) or (4), as applicable; or

(b) been accredited by UKAS to the relevant ISO standard by the date specified in paragraph (5) or (6), as applicable.

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

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

(b) subject to paragraph (10), cease to provide applicable tests under arrangement with X if X fails to comply with any such provision.

(9) Paragraph (7) does not apply to an applicable test that was administered before the dates referred to in that paragraph.

(10) Paragraph (8)(b) does not apply to an applicable test that was administered before the date that X failed to comply with this regulation.

(11) In this regulation “the relevant ISO standard” 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(3), and for this purpose “point of care test” means a test processed outside a laboratory environment.

(1)

See https://www.gov.uk/guidance/self-declare-as-a-private-sector-covid-19-testing-provider. Hard copies of the standards are not available but a print-out may be obtained from Ministerial Correspondence and Public Enquiries Unit, Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU.

(2)

http://www.ukas.com/C19-Stage2-UKAS-Appraisal. Hard copies are not available but a print-out may be obtained from the Department of Health and Social Care at the above address.

(3)

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