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Joint statement on the move to UKAS accreditation and removal of the CQC registration requirement for providers of commercial coronavirus testing

Categories:
  • Organisations we regulate

The government has passed new legislation which will deliver significant changes to how private providers of commercial coronavirus testing are regulated.

Previous legislation allowed for only some providers of coronavirus testing to be in the scope of registration with the Care Quality Commission (CQC). From 15 December 2020, registration for coronavirus testing with CQC will no longer be required and there will now be a complete end-to-end accreditation scheme run by the United Kingdom Accreditation Service (UKAS) that will cover all providers of coronavirus testing. We expect that this will simplify the landscape for coronavirus testing providers entering the market and make it easier for consumers to understand the quality of the coronavirus testing services available to them.

Under the new legislation, it is be mandatory for providers of coronavirus testing to be working towards full accreditation with UKAS – fulfilling the staged requirements set out below – in order to deliver testing for coronavirus. These requirements will apply to providers of commercial coronavirus testing; they do not apply to employers who provide testing for their own staff.

The UKAS accreditation process for this activity has three stages, which providers will be required to meet by the specified deadlines. The three stages are:

  • Stage 1 UKAS application
    • apply to UKAS against the relevant ISO standard* and self-declare against the relevant minimum standards
    • existing providers must complete this stage by 31 December 2020
    • from 31 December 2020, new providers must complete Stage 1 before starting to deliver testing.
  • Stage 2 UKAS appraisal
    • there's a checklist for this stage on the UKAS website
    • existing providers must have completed this stage by 31 January 2021, to ensure that they are on track to achieve full accreditation
    • new providers must complete Stage 2 within four weeks of completing Stage 1 UKAS registration.
  • Stage 3 Full UKAS accreditation
    • full accreditation to the relevant ISO standard*
    • existing providers will be required to have reached full accreditation by 30 June 2021
    • new providers must complete Stage 3 within four months of completing Stage 2 (or by 30 June 2021, whichever date is later).

*The accreditation scheme is a specific application of the existing UKAS accreditation process for laboratories against ISO 15189 or ISO/IEC 17025 for laboratories and ISO 15189 and ISO 22870 for point of care testing.

These requirements will come into force on 31 December 2020. Providers who do not meet these requirements by the specified deadlines will be committing a criminal offence if they continue to provide a testing service and be liable for a financial penalty.

It should be noted that only registration for activities undertaken for the purposes of testing for coronavirus are being removed from CQC’s registration. Providers will need to remain registered with the CQC if they undertake other regulated activities that do not change.

Providers that would like to find out more about how they can apply for UKAS accreditation or that have questions about the process should contact UKAS at covid@ukas.com for further information.

Last updated:
15 December 2020