How to become a private provider of COVID-19 testing
Guidance for prospective providers on how to be listed as a testing provider for general population testing.
Thank you for your continued support throughout the UK’s response to COVID-19. In line with the Living with COVID-19 strategy, we have reviewed the contents of the legislation. Subject to parliamentary approval, from 1 January 2024, clinical COVID-19 testing services (diagnostic laboratories, point of care testing and sample collection) will be required to be accredited as per these draft regulations to trade: The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023.
Private providers must comply with the timetable set out within the current regulations The Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 – the final date for new applications to the current system (self-declaration against minimum standards followed by achieving accreditation from the United Kingdom Accreditation Service (UKAS)) is 31 December 2023. Anyone wishing to progress with their current accreditation must contact UKAS before 31 December.
All commercial providers of COVID-19 testing services must meet the appropriate legal requirements as set out below.
Self-declaration
For general population testing, including tests used for the purpose of entering another country, the end-to-end testing provider (the organisation that customers approach to access testing services and whose name appears on these lists) is responsible for completing the self-declaration form for general population testing services.
The UK Health Security Agency (UKHSA) must also be provided with a list of all organisations that are involved (whether subcontracted or otherwise) in carrying out the testing service, indicating the nature of the service that each organisation provides. This list should be updated as appropriate.
The provider must use the appropriate self-declaration form for their service. If an organisation completes the incorrect self-declaration form their evidence will not be reviewed and they will have to submit the correct self-declaration form.
Any changes to the original self-declaration must be communicated to UKHSA through privateproviderselfdecqueries@dhsc.gov.uk
The declaration is a mandatory requirement for providers with effect from 1 January 2021, or before providers begin testing (whichever is later).
Any organisation which intends to run a commercial COVID-19 testing service or carry out an element of that service on behalf of an end-to-end provider, must meet the relevant legal minimum standards for their role in the testing process. The test provider must document in the self-declaration form if they subcontract elements of the testing process.
It is the overall responsibility of the test provider to ensure that the services comply with the government’s minimum standards.
UKAS accreditation
The organisation providing sample collection and/or sample testing services will need to undergo UKAS accreditation to the relevant ISO standards.
There is a charge for the accreditation process. See information on the fees UKAS charges for accreditation.
There are 3 stages to the UKAS accreditation process:
Stage 1
Organisations that provide sample collection and/or sample testing (including laboratory testing and point of care testing services) must apply for UKAS accreditation.
For general population testing, the test provider (the customer-facing organisation) must submit a self-declaration form, as detailed above, to show they meet the minimum standards for their provision of testing.
General population testing: minimum standards must be met as soon as testing services are provided.
The self-declaration is subsequently reviewed to ensure standards are being met. At this point, private providers can offer testing services and appear on the appropriate GOV.UK list once they have successfully completed stage 1.
Getting listed on GOV.UK may require further checks.
Stage 2
The organisation undergoing UKAS accreditation must undertake UKAS appraisal within 4 weeks of completing stage 1 – that is, the date on which the organisation made a valid application for accreditation.
Detailed guidance on the stage 2 UKAS appraisal process is available on the UKAS website.
Contact medlabscustomerservice@ukas.com for more information.
Stage 3
The organisation undergoing UKAS accreditation must undertake a full assessment of activities in line with the relevant ISO standards.
For stage 3, organisations must:
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Achieve a positive recommendation from UKAS within 4 months after completing stage 2 (that is, the date on which the organisation submitted evidence to UKAS demonstrating compliance with the UKAS appraisal requirements).
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Achieve full accreditation within 6 months after completing stage 2 UKAS appraisal.
The Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 set out the stages of and deadlines for obtaining accreditation and state that test providers must stop selling tests if they do not meet those deadlines.
Full guidance on the accreditation process can be found on the UKAS website. For further queries contact covid@ukas.com
Read the UKAS FAQs for private providers
For further information, contact privateproviderselfdecqueries@dhsc.gov.uk
Get listed on GOV.UK
Once the submitted self-declaration form has been reviewed and any outstanding queries are resolved, you’ll be contacted by UKHSA, who will confirm in writing when they consider that standards have been met for their provision of testing. At this point, they will request that your organisation provides up to date information for GOV.UK listing.
Please note it will take a minimum of 2 working days for your information to be published on the relevant GOV.UK list as UKHSA conducts due diligence checks on the information supplied.
UKHSA may remove your listing from GOV.UK.
Reasons why this may occur include:
- no longer meeting the minimum standards for your provision of testing
- failing to meet your statutory reporting duties
- being subject to specific compliance and enforcement actions due to low quality or dangerous service provision
- failing to meet the stipulated timelines required by the UKAS accreditation process (if applicable)
You may also ask to be removed from the GOV.UK list, or to not be listed, at any time. Your organisation must ask to be delisted if you run out of stock or stop providing the relevant testing services. Removal requests will be acted on within 2 working days.
UKHSA will remove your organisation where we identify your organisation no longer has stock or has stopped providing the relevant testing services.
See a list of and information on private providers compliant with the government’s minimum standards.
Further requirements
Private providers should provide clear, easy to understand information for their customers about:
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the benefits and drawbacks of testing
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how reliable the results will be, and what the limitations are
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what a test result means, in non-medical language
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how they are following the measures set out in this guidance
It is important to be aware that self-declaring against the government’s minimum standards and/or UKAS accreditation itself does not discharge a private provider’s general legal obligations in relation to the provision of testing services.
It is a provider’s responsibility to understand what legislation and regulations they will need to follow, including around consumer and data protection law, patient confidentiality, mandatory reporting to UKHSA in accordance with public health legislation and how they will meet these as required.
Private providers offering COVID-19 testing services should keep up to date with:
- relevant minimum standards and applicable regulations
- deadlines for accreditation where appropriate and reporting of data
- the latest government guidance on restrictions, testing, isolation and specific advice on travel obligations
Compliance and enforcement
The purpose of the legislation governing private testing is to ensure that the UK has a continued supply of high-quality providers of testing services for COVID-19. This is specifically by ensuring that providers must continue to meet the minimum standards set out in legislation, which includes continuing to meet accreditation deadlines and ensuring their actions do not degrade public trust in the testing schemes.
UKHSA’s goal is to focus on supporting providers, encouraging best practice and improving compliance. However, when we do not receive appropriate and timely responses to requested changes and improvements, we may engage with key regulatory bodies to pursue legal action for a breach of standards and obligations.
UKHSA carefully monitors issues raised by the public and will reach out to organisations directly, taking action where appropriate.
National regulatory enforcement bodies may also intervene in instances where providers fail to comply with their general obligations under consumer law or other legal requirements such as data protection. For example, on 25 August 2021, the Competition and Markets Authority (CMA) sent an open letter to PCR test providers warning that a range of harmful practices in the sector could breach consumer protection law. The CMA also sent letters to 25 PCR providers, warning them to review their terms and conditions – and other practices – or risk facing enforcement action.
Private providers should seek legal advice if they are unclear on which regulations apply to their business. The Laboratory and Testing Industry Organisation (LTIO), which provides support for its members who provide PCR testing services, has published a code of conduct designed to address potential consumer protection issues in the sector.
UKHSA may also act if we believe there is a public health concern or risk of fraudulent or illegal behaviour.
UKHSA may remove a private provider from GOV.UK during this process and pass collected information through to key regulatory bodies. UKHSA will make every effort to ensure that the process is being followed and reasoning for any decision is communicated to you in a timely manner. However, in some situations UKHSA may be unable to communicate all of the details.
Note: tests remain valid if providers are removed from the list. Private providers will be instructed directly when they can no longer provide testing services.
Once compliance or enforcement action has concluded, which may include the private provider being removed from the private provider lists on GOV.UK, UKHSA will consider any evidence-based submissions which shows that the provider is complaint with the process or evidence of corrective action the provider has taken.
This evidence should be sent to privateproviderselfdecqueries@dhsc.gov.uk
UKHSA will review and consider all evidence and decide on whether a provider should be kept off or reinstated to the GOV.UK list as appropriate.
Last updated 25 October 2023 + show all updates
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Updated notice about upcoming requirements.
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Added note on legislation and guidance being under review.
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Updated to reflect end of international travel testing.
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Updated guidance around self-isolation.
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Updated to reflect new rules for international arrivals in England from 11 February 2022.
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Updated to add a link for the self-declaration form for providers of day 2 lateral flow tests for international arrivals.
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First published.