70 
Test providers 
3. —(1) A test provider complies with this paragraph w here— 
(a)  they provide appropriate tests in a single end-to-e nd testing service (whether or not they 
arrange with another person (“X”) for X to provide one or more elements of the service 
on their behalf); 
(b)  they have made a declaration to the Department of H ealth and Social Care that they meet 
the minimum standards for private sector-provided t esting at https://support-covid-19-
testing.dhsc.gov.uk/PrivateSectorSelfDeclaration; 
(c)  in relation to a test which requires laboratory processing— 
(i)  the person responsible for the taking of samples me ets the relevant requirements for 
accreditation to ISO standard 15189 or ISO/IEC stan dard 17025, in respect of the 
taking of samples, and 
(ii)  the laboratory used by the test provider for the pr ocessing of samples meets the 
relevant requirements for accreditation to ISO stan dard 15189 or ISO/IEC standard 
17025, in respect of the processing of samples; 
(d)  in relation to a point of care test, they meet the relevant requirements for accreditation to 
ISO standard 15189 and ISO standard 22870( a); 
(e)  a registered medical practitioner has oversight and  approval of medical practices 
undertaken by the test provider, and responsibility for reporting medical issues; 
(f)  they have an effective system of clinical governanc e in place which includes appropriate 
standard operating procedures in relation to the carrying out of appropriate tests; 
(g)  a registered clinical scientist has oversight of cl inical practices undertaken by the test 
provider, and responsibility for reporting clinical issues; 
(h)  they have systems in place to identify any adverse incidents or quality control issues in 
relation to appropriate tests and be able to report  them as soon as reasonably practicable 
to the Secretary of State; 
(i)  they administer or provide an appropriate test to P , on or after the fifth day after the day 
on which P arrived in England having received the i nformation required by paragraph 
4(b) and (c) (as appropriate); and 
(j)  if they arrange with another person (“X”) for X to carry out any element of the single 
end-to-end testing service on their behalf, the tes t provider ensures that X complies with 
any of paragraphs (c) to (i) and 5(2), (3) and (5) as is relevant to the carrying out of that 
element. 
(2)  For the purposes of sub-paragraph (1)— 
(a)  “point of care test” means a test processed outside  a laboratory environment; 
(b)  “registered clinical scientist” means a person regi stered as a clinical scientist with the 
Health and Care Professions Council pursuant to article 5 of the Health Professions Order 
2001( b); 
(c)  “single end-to-end testing service” means a service  which comprises accepting the 
booking from the person to be tested, collecting an d processing the sample to be tested, 
carrying out genomic sequencing and providing the test result to P. 
(3)  For the purposes of sub-paragraph (1)(c) and (d), a person or laboratory (as the case may be) 
meets the relevant requirements for accreditation to a standard where that person, or in the case of 
a laboratory where the person who is the operator of the laboratory— 
(a)  has made a valid application for accreditation to UKAS (“stage one”); and 
                                                                                                                                            
(a) ISO 22870 Point-of-care testing (POCT) requiremen ts for quality and competence was published in November 2016. 
(b) S.I. 2002/254.