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Statutory Instruments

2020 No. 1549

Public Health, England

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

Made

16th December 2020

Coming into force

17th December 2020

M1The 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.

Modifications etc. (not altering text)

Marginal Citations

M11984 c. 22; Part 2A was inserted by section 129 of the Health and Social Care Act 2008 (c.14).

Citation, commencement and applicationE+W

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.

Commencement Information

I1Reg. 1 in force at 17.12.2020, see reg. 1(1)

InterpretationE+W

2.  In these Regulations—

F1...

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

[F2“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;]

[F2“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;]

[F2“point of care test” means a diagnostic test which is not carried out in a diagnostic laboratory;]

[F2“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;]

[F2“testing service provider” means a person who carries out a sample collection or a point of care test, or a diagnostic laboratory.]

F1...

F1...

Textual Amendments

Commencement Information

I2Reg. 2 in force at 17.12.2020, see reg. 1(1)

Applicable testsE+W

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

F3(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)provided [F4, 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 M2;

(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

[F5(da)not carried out using a device for self-testing.]

F6(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) In this regulation—

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

[F7(aa)“device for self-testing” has the same meaning as in regulation 32(1) of the Medical Devices Regulations 2002.]

F8(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Commencement Information

I3Reg. 3 in force at 17.12.2020, see reg. 1(1)

Marginal Citations

Test requirementsE+W

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 M3, other than solely by virtue of regulation 39(2) of those Regulations;

F9(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F10(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;

F11(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F12(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Commencement Information

I4Reg. 4 in force at 17.12.2020, see reg. 1(1)

Marginal Citations

M3S.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.

Provider requirementsE+W

5.—(1) A [F13testing service provider] must [F14be accredited to the relevant ISO Standard by a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement] in respect of any applicable test F15....

[F16(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.]

F17(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F17(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F17(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F17(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F17(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F17(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Commencement Information

I5Reg. 5 in force at 17.12.2020, see reg. 1(1)

UKAS accreditationE+W

F186.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Offence and penaltiesE+W

7.—(1) A [F19testing service provider or an operator of a diagnostic laboratory] commits an offence if, without reasonable excuse, they contravene a requirement imposed under regulation [F204 or] 5 F21....

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

Textual Amendments

Commencement Information

I6Reg. 7 in force at 17.12.2020, see reg. 1(1)

ReviewE+W

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.

Commencement Information

I7Reg. 8 in force at 17.12.2020, see reg. 1(1)

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

Bethell

Parliamentary Under-Secretary of State,

Department of Health and Social Care

Explanatory Note

(This note is not part of the Regulations)

These Regulations provide for certain tests for coronavirus to meet specified standards. Regulation 3 specifies the tests to which these Regulations apply. Regulations 4 and 5 set out standards to be met by tests and test providers, respectively. Regulation 6 requires test providers to apply for accreditation with the United Kingdom Accreditation Service. Regulation 7 provides that failure to comply with any requirement of these Regulations is an offence. Regulation 8 requires these Regulations to be reviewed within six months of their coming into force.

An impact assessment has not been produced for this instrument. An explanatory memorandum has been published alongside this instrument at www.legislation.gov.uk.