GovWire

Guidance: How to become a private provider of COVID-19 testing??

Department Of Health

October 23
14:59 2021

Self-declaration

For?general?population and Test?to?Release testing, 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 and Test to Release for international arrivals.??

For day 2 lateral flow tests, 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. This will be made available the week beginning 25 October 2021. As well as declaring that they meet the minimum standards at the start of the service, they must maintain these standards from 12 November 2021, and implement and maintain any revisions to the standards within a reasonable time period.

For day 2 and day 8 PCR testing the laboratory that conducts diagnostic test evaluation (that is, producing a test result) is responsible for completing the?self-declaration form for?mandatory COVID-19 testing for international arrivals?on behalf of the end-to-end provider.

The Department of Health and Social Care (DHSC) must also be provided with a list of all organisations that are involved (whether subcontracted or otherwise) in carrying out the testing service or genomic sequencing, 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 DHSC 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 governments 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 and Test to Release, 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. The following requirements must be met as soon as testing services are provided:??

For day 2 lateral flow tests, the end-to-end testing provider (the customer-facing organisation) must submit a self-declaration form, as detailed above. The following requirements must be met as soon as testing services are provided:??

For day 2 and day 8 PCR testing, the laboratory that conducts diagnostic test evaluation (that is, producing a test result) must submit a self-declaration form, as detailed above, against the minimum standards for day 2 and day 8 testing for international arrivals on behalf of themselves and the customer-facing organisations. The customer-facing organisation is also required to provide DHSC with a separate list of all the organisations that they work with. The following requirements must be met as soon as testing services are provided:??

Private providers can offer testing services and appear on the appropriate GOV.UK list once they have successfully completed stage 1.??

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.?

There is detailed guidance on the stage 2 UKAS?appraisal process.

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:??

  • 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) and

  • achieve full accreditation within 6 months after completing stage 2 UKAS appraisal

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, youll be contacted by DHSC to provide up to date information for the?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 DHSC conducts due diligence checks on the information supplied.???

The department reserves the right to 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. We suggest you 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.??

See a list of and information on private providers compliant with the governments minimum standards.

Further requirements

Private providers should provide clear, easy to understand information for their customers about:

  • the benefits and drawbacks of testing??

  • how reliable the results will be, and what the limitations are??

  • what a test result means, in non-medical language??

  • how they are following the measures set out in this guidance??

Private providers should understand what legislation and regulations they will need to follow, including around data protection, pati

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