COVID-19 minimum testing standards
The Department of Health and Social Care DHSC) has updated guidance for private providers who wish to provide COVID-19 testing services. It contains COVID-19 minimum testing standards that businesses who purchase testing services should consider.
The number of providers providing testing services has exploded in recent months. Other than ‘CE’ marking, there are very few quality standards applicable to COVID-19 testing services. It is sometimes difficult to tell if a test has been certified or validated in any meaningful way.
The wild west of COVID-19 testing
As an example, we have been approached on an almost daily basis by suppliers offering tests. Some of the suppliers make fantastic claims about the accuracy of the tests, although frequently cannot substantiate the claims.
We have been approached by businesses from all parts of the world, many of whom do not seem to have had prior experience working healthcare. One business offering to supply tests was, until June this year, a wholesale provider of pet store supplies.
Regulation is coming soon
That makes the forthcoming regulations being implemented by the DHSC so helpful. As of January 1st 2021, any business wishing to provide COVID-19 tests or testing services must be registered to do so with the DHSC.
The application process, although relying on a self-declaration, does at least require responsible medical oversight from a clinician registered with the GMC. You can easily check the GMC Register in a couple of clicks, if you ever need to.
From January, all private providers must show that they are meeting minimum acceptable standards of care provision.
Minimum testing standards
The standards are:
- A clinical or medical director must be appointed – they must be a registered medical professional
- Tests must have a CE or UKCA marking – emergency CE approval is not enough
- The tests must use MHRA/DHSC approved test profiles – this defines the quality standards the tests must meet
- Providers must have approved reporting procedures linking with Public Health England
- Adverse event reporting procedures must be in place – commonly the MHRA ‘yellow card’ system
- Samples should be taken by providers meeting relevant ISO standards – this is likely to become law by June 2021
- Private providers must have clinical governance procedures in place – including ensuring any positive results are provided to employers – there is more guidance at https://www.gov.uk/government/publications/coronavirus-covid-19-testing-guidance-for-employers
- Only UKAS and ISO accredited labs can be used for PCR ‘swab’ testing – this is also likely to become law by June 2021
- ‘Point of care’ testing providers must meet ISO and UKAS quality standards – this is also likely to become law by June 2021
- Providers must legal and regulatory standards for sample collection and processing standards
The DHSC are planning to publish a list of all approved private COVID testing providers in the coming weeks. We’d encourage any business considering purchasing COVID tests or testing services to check that register closely before selecting a partner. ‘Caveat emptor’ is probably the best advice applicable to all other providers.
The government have also launched a ‘test to release’ programme to enable international travellers to reduce their quarantine period by arranging for a COVID test from a list of approved providers. The standards required to qualify for approved ‘test to release’ provision are also more stringent than the core self-declaration associated with independent testing.
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