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Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.
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10 provisions
Title and introductory text
2023 No. 1340
Public Health, England
The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023
Made
6th December 2023
Coming into force
1st January 2024
The Secretary of State makes these Regulations in exercise of the powers conferred by sections 45C(1) and (3)(c), 45F(2) and 45P(2) of the Public Health (Control of Disease) Act 1984.
A draft of this instrument was laid before Parliament in accordance with section 45Q(4) of that Act and approved by a resolution of each House of Parliament.
In accordance with section 45D(1), the Secretary of State considers that the requirements imposed by these Regulations are proportionate to what they seek to achieve, which is a public health response to the incidence and spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in England.
Propose a change1 Citation, commencement, extent, application and interpretation
(1) These Regulations may be cited as the Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 and come into force on 1st January 2024.
(2) These Regulations extend to England and Wales and apply to England only.
(3) In these Regulations, “the Principal Regulations” means the Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020.
Propose a change2 Amendment to the Principal Regulations
The Principal Regulations are amended in accordance with regulations 3 to 8.
Propose a change3 Amendment to regulation 2
(1) Regulation 2 (interpretation) is amended as follows.
(2) Omit the definitions of “administer”, “test provider” and “UKAS”.
(3) After the definition of “applicable test” insert—
“diagnostic laboratory” means an institution (or facility within an institution) which is equipped with apparatus and reagents for the performance of diagnostic tests for human infections;
“operator of a diagnostic laboratory” means the corporate body that operates the diagnostic laboratory, or if there is no such body, the director of the diagnostic laboratory;
“point of care test” means a diagnostic test which is not carried out in a diagnostic laboratory;
“sample collection” means the taking of, or assisting with or the supervision of the taking of, a physical sample from a person who is the subject of a test;
“testing service provider” means a person who carries out a sample collection or a point of care test, or a diagnostic laboratory.
.
Propose a change4 Amendment to regulation 3
(1) Regulation 3 (applicable tests) is amended as follows.
(2) In paragraph (1)—
(a) omit sub-paragraph (a);
(b) in sub-paragraph (b) after “provided” insert “, by or on behalf of a testing service provider,”;
(c) after sub-paragraph (d) insert—
(da) not carried out using a device for self-testing.
;
(d) omit sub-paragraph (e).
(3) In paragraph (2)—
(a) after sub-paragraph (a) insert—
(aa) “device for self-testing” has the same meaning as in regulation 32(1) of the Medical Devices Regulations 2002.
;
(b) omit sub-paragraph (b).
Propose a change5 Amendment to regulation 4
(1) Regulation 4 (test requirements) is amended as follows.
(2) In paragraph (1), omit sub-paragraph (b).
(3) Omit paragraph (2).
(4) In paragraph (3), omit sub-paragraphs (b) and (c).
Propose a change6 Amendment to regulation 5
(1) Regulation 5 (provider requirements) is amended as follows.
(2) In paragraph (1)—
(a) for “test provider” substitute “testing service provider”;
(b) for “meet the following requirements” substitute “be accredited to the relevant ISO Standard by a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement”;
(c) omit “that they provide”.
(3) After paragraph (1) insert—
(1A) The relevant ISO Standard for the purposes of paragraph (1) is—
(a) in relation to sample collection or a point of care test, ISO Standard 15189:2022;
(b) in relation to a diagnostic laboratory, either ISO Standard 15189:2022 or ISO/IEC Standard 17025:2017.
.
(4) Omit paragraphs (2) to (7).
Propose a change7 Omission of regulation 6
Omit regulation 6 (UKAS accreditation).
Propose a change8 Amendment to regulation 7
(1) Regulation 7 (offences and penalties) is amended as follows.
(2) In paragraph (1)—
(a) for “test provider” substitute “testing service provider or an operator of a diagnostic laboratory”;
(b) for “4,” insert “4 or”;
(c) omit “or 6”.
Propose a change9 Transitional provisions
(1) A relevant person is not required to comply with regulation 5 of the Principal Regulations as amended by these Regulations until 6 December 2025.
(2) For the purposes of paragraph (1), a relevant person is a testing service provider who is accredited to either ISO 15189:2012 or both ISO Standards 15189:2012 and 22870:2016.
(3) A relevant applicant is not required to comply with regulation 5 of the Principal Regulations as amended by these Regulations until the date calculated in accordance with regulation 6(6B)(b) of the Principal Regulations.
(4) For the purposes of paragraph (3), a relevant applicant is a person who, prior to 1 January 2024, has made an application in accordance with regulation 6 of the Principal Regulations and is not yet accredited.
Propose a change