2020 No. 1549
The Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020
Made
Coming into force
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 M1.
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 applicationI11
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.
InterpretationI22
In these Regulations—
“administer”, in relation to an applicable test, means the collecting of a sample to be tested from the individual who is the subject of the test;
“applicable test” means a test to which regulation 3 applies;
“test provider” means a person who provides an applicable test;
“UKAS” means the United Kingdom Accreditation Service, a company limited by guarantee and incorporated in England and Wales under number 3076190 M2.
Applicable testsI33
1
An applicable test is a test for the detection of coronavirus which is—
a
provided in a single end-to-end testing service (whether or not the provider arranges with another person (“X”) for X to provide one or more elements of the service on their behalf);
b
provided in the course of a business;
c
not a test provided or administered under the National Health Service Act 2006 M3;
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
e
administered on or after 1st January 2021.
2
In this regulation—
a
“coronavirus” means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);
b
“single end-to-end testing service” means a service which comprises arranging to provide the test to the person to be tested, collecting and processing the sample to be tested, and providing the test result to that person.
Test requirementsI44
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 M4, other than solely by virtue of regulation 39(2) of those Regulations;
b
it has been validated no more than 18 months before the test is administered.
2
In this regulation “validated”, in relation to a device, means confirmed by—
a
the Secretary of State;
b
the National Institute for Health and Care Excellence M5; or
c
as having the levels of sensitivity and specificity stated by the manufacturer.
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
“sensitivity”, in relation to a device, means how often the device correctly generates a positive result;
c
“specificity”, in relation to a device, means how often the device correctly generates a negative result.
Provider requirementsI55
1
A test provider must meet the following requirements in respect of any applicable test that they provide.
2
The test provider must ensure that a registered medical practitioner has oversight and approval of medical practices undertaken by the test provider, and responsibility for reporting medical issues.
3
The test provider must have an effective system of clinical governance in place which includes appropriate standard operating procedures in relation to the carrying out of applicable tests.
4
The test provider must ensure that a registered clinical scientist has oversight of clinical practices undertaken by the test provider, and responsibility for reporting clinical issues.
5
The test provider must have systems in place to—
a
identify any adverse incidents or quality control issues in relation to applicable tests, and
b
report any such incidents or issues as soon as reasonably practicable to the Secretary of State.
6
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 ensure that X complies with any provision of this regulation that is relevant to the carrying out of that element.
7
In this regulation “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 2001 M8.
UKAS accreditationI6C16
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 2020M9, (“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.
F12A
For the purposes of this regulation—
a
a test provider who completes stage one on or before 31st December 2020 is a “first channel test provider”;
b
a test provider who completes stage one on or after 1st January 2021 is a “second channel test provider”.
3
4
A F4second channel test provider F5... 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.
F65A
A first channel test provider who does not achieve a positive recommendation on or before 30th June 2021 must not provide applicable tests.
5B
A second channel test provider who does not achieve a positive recommendation 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
must not provide applicable tests.
5C
A test provider who does not achieve a positive recommendation by the date in paragraph (5A) or the appropriate date in paragraph (5B) (as applicable) may provide applicable tests after they have achieved a positive recommendation.
6A
A first channel test provider who is not accredited by UKAS to the relevant ISO standard by 31st August 2021 must not provide applicable tests.
6B
A second channel test provider who is not accredited by UKAS by the later of—
a
31st August 2021, or
b
the date two months after the appropriate date in paragraph (5B)
must not provide applicable tests.
6C
A test provider who is not accredited by UKAS by the date in paragraph (6A) or the appropriate date in paragraph (6B) (as applicable) may provide applicable tests after they have been accredited by UKAS.
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 F7.
F8b
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 F9or provided before the dates referred to in that paragraph.
10
Paragraph (8)(b) does not apply to an applicable test that was administered F10or provided 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 22870M11, and for this purpose “point of care test” means a test processed outside a laboratory environment.
F1112
In this regulation a “positive recommendation” means a written notice from UKAS which—
a
reports UKAS’s assessment of the test provider’s readiness to be fully accredited, and
b
informs the test provider of any actions the provider must take in order to be fully accredited,
where “fully accredited” means accredited by UKAS to the relevant ISO standard.
Offence and penaltiesI77
1
A test provider commits an offence if, without reasonable excuse, they contravene a requirement imposed under regulation 4, 5 or 6.
2
An offence under this regulation is punishable on summary conviction by a fine.
ReviewI88
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 by authority of the Secretary of State for Health and Social Care.
1984 c. 22; Part 2A was inserted by section 129 of the Health and Social Care Act 2008 (c.14).