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Regulating coronavirus (COVID-19) testing

Categories:
  • Organisations we regulate

Types of test

This statement is about the following types of test:

  • swab tests used to detect the presence of coronavirus - tests that show if someone currently has coronavirus (COVID-19)
  • antibody tests - blood tests designed to show whether people have previously had coronavirus.

Diagnostic and screening procedures

You must be registered with CQC for the regulated activity of diagnostic and screening procedures if you carry out either of the following:

  • removing tissues, cells or fluids (including blood samples) from a person
  • analysing the samples (whether undertaken separately or in conjunction with one another).

This includes any of the following:

  • removing a sample from the patient and sending that sample on to a laboratory for analysis
  • both removing a sample and using equipment to examine the sample to detect the presence of coronavirus
  • using equipment to examine a sample to detect the presence of coronavirus or antibodies.

If you are already registered for this activity for other areas of your service, you do not need to register again.

Exceptions

If your organisation is selling or supplying coronavirus testing kits and is not in any way involved in either the removal of samples or the analysis (or examination) of those samples, you will not fall into scope of the diagnostic and screening procedures regulated activity. You will not need to register with CQC for this activity.

There are two other exceptions to the regulated activity. These are likely to affect many providers who carry out antibody testing. They determine whether you need to register with CQC for diagnostic and screening procedures:

  1. if you are taking a blood sample by means of a pin prick or from a vein and that sample does not need to go to a laboratory for analysis, you will not need to register with CQC in relation to this part of your service
  2. if you are already registered with CQC to carry on any of the other regulated activities, you will not need to additionally register for diagnostic and screening procedures if you are solely involved in:
  • taking blood samples
  • taking tissue samples by means of a swab specimen from any external part of the body or from the mouth, ear, nose or throat
  • analysing and reporting the results of those samples.

In both situations, antibody testing for coronavirus would not fall within scope of the diagnostic and screening procedures regulated activity.

Finally, the Safeguarding Vulnerable Groups Act 2006 (Regulated Activities) (Coronavirus) Order 2020 states that the removal of saliva or mucus from the mouth or nose of an individual for the purpose of testing for the presence of coronavirus, is not to be treated as a regulated activity when it is carried out by any of the following:

  • members of Her Majesty’s Forces
  • employees of The Boots Company plc
  • individuals employed by, contracted by or party to an agreement with Sodexo Limited or Sodexo Holdings Limited

Treatment of disease, disorder or injury

Coronavirus testing may fall into scope of CQC regulation under the regulated activity of treatment of disease, disorder or injury (TDDI) if you are involved in communicating the results of the tests and offer treatment advice.

For example, a listed healthcare professional who contacts a service user to deliver results returned from a laboratory, and also offers advice about actions to take or treatment when that result is positive, may fall under the scope of this regulated activity, unless a specific exemption applies.

Tests for coronavirus may also fall into scope of this regulated activity if they are ancillary to, or carried on wholly or mainly in relation to the regulated activity. For example, if you offer a service user a test as part of their wider treatment plan.

Please contact us to discuss whether you will need to register. If you are already registered for treatment of disease, disorder or injury for other areas of your service, you will not need to register again.

Find out more about who needs to register with CQC and the process for registration.

Our expectations

We remain acutely aware of the pressures facing health and social care providers at this incredibly challenging time. We have been clear about our main objectives throughout the coronavirus outbreak: to support providers and keep people safe during this period of unprecedented pressure on the health and social care system.

However, we still expect all providers delivering services that are subject to regulation by CQC to meet the fundamental standards of quality and safety set out in the Health and Social Care Act (Regulated Activities) Regulations 2014. In these difficult times, we must continue to uphold these core principles.

Therefore, we will continue to monitor the quality, safety and effectiveness of care during the coronavirus outbreak. We will take action where we identify providers who are not registered to deliver regulated activity or if people who use services are at risk of harm.

If you are involved with the supply of coronavirus testing, you must do so under The Health Protection (Coronavirus, Restrictions) (England) Regulations 2020 and the latest Public Health England (PHE) guidelines on social distancing and infection control. CQC will not hesitate to inform law enforcement bodies when we receive information that indicates services are not being delivered in line with the regulations.

As with the delivery of any regulated activity, we encourage all providers involved in the supply of coronavirus testing to always act responsibly and in the best interests of people using services.

Unapproved tests

CQC encourages all providers to only use tests for coronavirus that have been approved in a laboratory setting. Unapproved tests can potentially be misleading by providing inaccurate or inconsistent results. This could put those tested and those around them at risk of contracting coronavirus and transmitting it to others. If registered providers offer unapproved tests in spite of the associated risks, they must do so in accordance with Regulation 12 (safe care and treatment) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

This requires providers to properly assess the risks to people’s health and safety when offering any form of treatment. Regulation 12 also obliges providers to take all reasonable steps to prevent the spread of infection. Registered providers should be aware that the supply of unapproved tests may lead to a breach of Regulation 12. Where we have evidence that a breach has occurred, we are likely to consider taking enforcement action.

Registered providers must also comply with Regulation 9 (person-centred care) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. This requires them to support service users to understand and make informed decisions about their care and treatment options. As such, we expect providers offering unapproved tests to make it clear to service users that their test has not yet been verified in a laboratory setting and as such, the efficacy of the test is not yet proven. This will help service users to understand the risks involved and allow them to make an informed decision as to whether or not to go ahead with the test.

Charging a fee

If you charge a fee for providing coronavirus testing, you must be transparent about this under Regulation 19 (fees) of the Care Quality Commission (Registration) Regulations 2009.

You must give clear and accurate information upfront on all fees to help people make an informed decision. Where we have evidence that registered providers are not providing transparent or accurate information about fees, we are likely to consider taking enforcement action.

Last updated:
04 June 2020