How to Become a Private COVID-19 Test Provider
All commercial COVID-19 testing service providers must meet the appropriate legal requirements, as outlined below.
For tests intended for the general population, including tests used for the purpose of entering another country, the end-to-end testing provider (the organization that clients approach to access testing services and whose name appears on these lists) is responsible for completing the self-declaration form for general population screening services.
For day 2 PCR tests, also known as arrival tests, the laboratory that performs the diagnostic test evaluation (i.e. produces a test result) is responsible for completing the self-declaration form for day 2 PCR testing of international arrivals on behalf of the end-to-end supplier.
The UK Health Security Agency (UKHSA) must also receive a list of all organizations that are involved (subcontracted or not) in the performance of the testing or genomic sequencing service, indicating the nature of the service provided by each organization. This list should be updated as needed.
The provider must use the appropriate self-declaration form for their service. If an organization completes the wrong 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 via [email protected]
Reporting is a mandatory requirement for vendors beginning January 1, 2021, or before vendors begin testing (whichever is later).
Any organization that intends to operate a commercial COVID-19 testing service or perform any element of that service on behalf of an end-to-end provider must meet the legal minimum standards relevant to its role in the process. of testing. The test provider must document in the self-declaration form if they outsource any elements of the testing process.
It is the overall responsibility of the testing provider to ensure that the services meet the government’s minimum standards.
The organization providing sample collection and/or sample analysis services will need to undergo UKAS accreditation to the relevant ISO standards.
The accreditation process is chargeable. See information on fees charged by UKAS for accreditation.
The UKAS accreditation process has 3 stages:
Organizations providing sample collection and/or sample testing (including laboratory testing and point-of-care testing services) must apply for UKAS accreditation.
For tests intended for the general population, the test provider (customer-facing organization) must submit a self-declaration form, as detailed above, to show that they meet the minimum standards for their provision of testing. The following requirements must be met as soon as testing services are provided:
For day 2 PCR tests, the laboratory performing the diagnostic test evaluation (i.e. producing a test result) must submit a self-declaration form, as outlined above, against the minimum standards for day 2 testing for international arrivals on their behalf and on behalf of the client agencies. The organization in contact with the client is also required to provide UKHSA with a separate list of all the organizations they work with. The following requirements must be met as soon as testing services are provided:
The self-declaration is then reviewed to ensure that the standards are met. UKHSA will confirm in writing whether it considers that the standards have been met for the provision of the tests. At this stage, private providers can offer testing services and appear on the appropriate GOV.UK list once they have passed Step 1. Listing on GOV.UK may require additional checks.
The organization undergoing UKAS accreditation must complete the UKAS assessment within 4 weeks of the end of Stage 1, i.e. the date the organization applied for accreditation valid.
There is detailed guidance on the UKAS Stage 2 assessment process.
Contact [email protected] for more information.
The organization undergoing UKAS accreditation must undertake a comprehensive business assessment in accordance with the relevant ISO standards.
For Step 3, organizations should:
obtain a positive recommendation from UKAS within 4 months of completion of Stage 2 (i.e. the date the organization has submitted evidence to UKAS demonstrating compliance with the requirements of UKAS assessment) and
achieve full accreditation within 6 months of completing UKAS Stage 2 assessment
The Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 set out the steps and timelines for obtaining accreditation and state that test providers must stop selling tests if they don’t meet those deadlines.
Full guidance on the accreditation process can be found on the UKAS website. For any other questions, contact [email protected]
Read the UKAS FAQ for private providers
For more information contact [email protected]
Get listed on GOV.UK
Once the submitted self-declaration form has been reviewed and all outstanding issues have been resolved, you will be contacted by UKHSA who will confirm in writing whether they consider that the standards have been met for their testing provision. At this point they will ask your organization to provide updated information for the GOV.UK list.
Please note that it will take a minimum of 2 working days for your details to be published on the relevant GOV.UK list, as UKHSA carries out due diligence on the information provided.
UKHSA may remove your ad from GOV.UK.
Reasons why this may occur include:
- no longer meets the minimum standards for your testing provision
- non-compliance with your legal reporting obligations
- be subject to specific compliance and enforcement actions due to poor or unsafe service delivery
- failing to meet the stipulated deadlines required by the UKAS accreditation process (if applicable)
You can also request to be removed from the GOV.UK list, or not be listed, at any time. Your organization must request to be removed from the list if you are out of stock or stop providing the relevant testing services. Removal requests will be processed within 2 business days.
UKHSA remove your organization if we identify that your organization is out of inventory or has ceased to provide the relevant testing services.
See a list and information about private providers that meet minimum government standards.
Private providers must provide their clients with clear and easy-to-understand information about:
the pros and cons of testing
how reliable the results will be and what are the limitations
what a test result means, in non-medical language
how they follow the measures set out in this guide
It is important to know that self-declaration against government minimum standards and/or UKAS accreditation itself does not discharge the general legal obligations of a private provider in relation to the provision of test.
It is the provider’s responsibility to understand the laws and regulations they will need to follow, including consumer and data protection laws, patient privacy, mandatory reporting to UKHSA in accordance with public health legislation and how they will comply with it when required.
Private providers offering COVID-19 testing services should keep themselves informed:
- relevant minimum standards and applicable regulations
- the accreditation deadlines, if applicable, and the communication of data
- the latest government guidance on restrictions, testing, isolation and specific advice on travel obligations
The main self-isolation guidance pages are as follows:
For specific advice on travel obligations, visit:
Compliance and Enforcement
The aim of the legislation governing private testing is to ensure that the UK has a continuous supply of high quality testing service providers for COVID-19. This includes ensuring that suppliers must continue to meet the minimum standards set out in the legislation, which includes continuing to meet accreditation deadlines and ensuring that their actions do not degrade the trust of the audience in test programs.
UKHSAThe goal of is to focus on supporting suppliers, encouraging best practices and improving compliance. However, where we do not receive appropriate and timely responses to requested changes and improvements, we may engage with major regulatory bodies to pursue legal action for breach of standards and obligations.
UKHSA carefully monitors issues raised by the public and will contact organizations directly, taking action where appropriate.
National regulators can also intervene in cases where providers fail to meet their general obligations under consumer law or other legal requirements such as data protection. For example, on August 25, 2021, the Competition and Markets Authority (CMA) sent an open letter to PCR test providers warning that a range of harmful practices in the industry could breach consumer protection law. the CMA also sent letters to 25 PCR suppliers, warning them to review their terms and conditions – and other practices – or risk facing enforcement action.
Private providers should consult a lawyer if they are unsure which regulations apply to their business. The Laboratories and Testing Industry Organization (LTIO) offers support to its members who provide PCR testing services and 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 behavior.
UKHSA may remove a private supplier from GOV.UK during this process and forward the information collected to the main regulatory bodies. UKHSA will do everything possible to ensure that the process is followed and that the reasoning for any decision is communicated to you in a timely manner. However, in some situations UKHSA may be unable to communicate all details.
Note that the tests remain valid if the providers are removed from the list. Private providers will be notified directly when they can no longer provide testing services.
Once compliance or enforcement action has been completed, which may include removal of the private provider from the private provider lists on GOV.UK, UKHSA will review all submissions based on evidence that shows the supplier complains about the process or evidence of corrective action the supplier has taken.
This proof should be sent to [email protected]
UKHSAwill review and review all evidence and decide whether a supplier should be delisted or reinstated on the GOV.UK list, where appropriate.