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

Made: 16th December 2020

Coming into force: 17th December 2020

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.

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 serious and imminent threat to public health which is posed by the incidence and spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in England.

Citation, commencement and application

1

• (1) These Regulations may be cited as the Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 and come into force on the day after the day on which they are made.

• (2) These Regulations apply to England only.

Interpretation

2

In these Regulations—

• ...

• “applicable test” means a test to which regulation 3 applies;

• “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.

• ...

• ...

Applicable tests

3

• (1) An applicable test is a test for the detection of coronavirus which is—

• (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) provided , by or on behalf of a testing service provider, in the course of a business;

• (c) not a test provided or administered under the National Health Service Act 2006 ;

• (d) not a test provided by a person (P) solely to—

• (i) P's employees;

• (ii) persons contracted to provide services to P; or

• (iii) both of the above; and

• (da) not carried out using a device for self-testing.

• (e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (2) In this regulation—

• (a) “coronavirus” means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

• (aa) “device for self-testing” has the same meaning as in regulation 32(1) of the Medical Devices Regulations 2002.

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Test requirements

4

• (1) Any device used for the purposes of an applicable test must meet the following requirements—

• (a) it 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;

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3) In this regulation—

• (a) “device” means an in vitro diagnostic medical device within the meaning given in regulation 2(1) of the Medical Devices Regulations 2002;

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Provider requirements

5

• (1) A testing service provider must be accredited to the relevant ISO Standard by a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement in respect of any applicable test ....

• (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.

• (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

UKAS accreditation

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Offence and penalties

7

• (1) A testing service provider or an operator of a diagnostic laboratory commits an offence if, without reasonable excuse, they contravene a requirement imposed under regulation 4 or 5 ....

• (2) An offence under this regulation is punishable on summary conviction by a fine.

Review

8

The Secretary of State must review the effectiveness of the provisions made by these Regulations before the expiry of the period of six months beginning with the day after the day on which they come into force.

Signed

Signed by authority of the Secretary of State for Health and Social Care.

Bethell — Parliamentary Under-Secretary of State, — 2020-12-16

Explanatory note

(This note is not part of the Regulations)

Footnotes

[^f00001]: 1984 c. 22; Part 2A was inserted by section 129 of the Health and Social Care Act 2008 (c.14).

[^f00002]: See S.I. 2009/3155 for the functions of UKAS.

[^f00003]: 2006 c. 41.

[^f00004]: S.I. 2002/618, as amended by S.I. 2003/1697. Further amendments are prospectively made by S.I. 2019/791 with effect from 1st January 2021. There are other amending instruments not relevant to these Regulations.

[^f00005]: A body corporate established under section 232 of the Health and Social Care Act 2012 (c. 7).

[^f00006]: ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 1 rue de Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. ISO 15189 Medical Laboratories requirements for quality and competence was published in November 2012.

[^f00007]: ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories was published in November 2017.

[^f00008]: S.I. 2002/254. There are amendments not relevant to these Regulations.

[^f00009]: 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.

[^f00010]: 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.

[^f00011]: ISO 22870 Point-of-care testing (POCT) requirements for quality and competence was published in November 2016.

Editorial notes

[^c24381241]: 1984 c. 22; Part 2A was inserted by section 129 of the Health and Social Care Act 2008 (c.14).

[^c24381261]: 2006 c. 41.

[^c24381271]: S.I. 2002/618, as amended by S.I. 2003/1697. Further amendments are prospectively made by S.I. 2019/791 with effect from 1st January 2021. There are other amending instruments not relevant to these Regulations.

[^key-0a071ec6f0762f5ee734bcfef731abb4]: Reg. 1 in force at 17.12.2020, see reg. 1(1)

[^key-d42711d110e0eca2cd66262268e81a6c]: Reg. 2 in force at 17.12.2020, see reg. 1(1)

[^key-492835b5e3d621742be8a6521128d6e7]: Reg. 3 in force at 17.12.2020, see reg. 1(1)

[^key-c97c02a453eeac2ba8f6315bcec8bcbd]: Reg. 4 in force at 17.12.2020, see reg. 1(1)

[^key-2e398b2f83f0be6f924904af97502d32]: Reg. 5 in force at 17.12.2020, see reg. 1(1)

[^key-6ba502b8158fc23e24b673c380d10eae]: Reg. 7 in force at 17.12.2020, see reg. 1(1)

[^key-67a1a9715c092eee18a59ce32ec1f2f3]: Reg. 8 in force at 17.12.2020, see reg. 1(1)

[^key-061ece94ea8268e1016c837d94e2ca98]: Regulations applied (with modifications) (24.10.2021 at 4.00 a.m.) by S.I. 2021/582, Sch. 8 para. 7B(3) (as inserted by The Health Protection (Coronavirus, International Travel and Operator Liability) (England) (Amendment) (No. 16) Regulations 2021 (S.I. 2021/1179), regs. 1(2), 10(5))

[^key-37ceb5f57aae1bc4cf6d202079f81b6d]: Reg. 3(1)(da) inserted (1.1.2024) by The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 4(2)(c) (with reg. 9)

[^key-3d9875c4ea48e28eba48a3574066f519]: Reg. 3(1)(a) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 4(2)(a) (with reg. 9)

[^key-30cc5407597acc2f60e4aabfc0a0b842]: Words in reg. 3(1)(b) inserted (1.1.2024) by The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 4(2)(b) (with reg. 9)

[^key-5554649b6cce2b9587290bad003c6364]: Reg. 3(1)(e) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 4(2)(d) (with reg. 9)

[^key-a4be54384f2a0c88cb323bb901cd5637]: Reg. 3(2)(b) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 4(3)(b) (with reg. 9)

[^key-182679133a62210e2805f407d00dd956]: Reg. 3(2)(aa) inserted (1.1.2024) by The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 4(3)(a) (with reg. 9)

[^key-8f0de238df3fbaefa8b6f407179df943]: Words in reg. 2 omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 3(2) (with reg. 9)

[^key-14ed7fca1faea6fa2f52fb0c2dc61807]: Words in reg. 2 inserted (1.1.2024) by The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 3(3) (with reg. 9)

[^key-4853997029b080b40023950b8814f2bb]: Reg. 4(1)(b) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 5(2) (with reg. 9)

[^key-6a7ba9ecd932abc403d003ce2bf799e5]: Reg. 4(2) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 5(3) (with reg. 9)