Regulation of independent providers offering Coronavirus (Covid-19) testing

Regulation of independent providers offering Coronavirus (Covid-19) testing

Please note: this statement is in reference to swab tests used to detect the presence of Coronavirus i.e. tests that show if a patient currently has Covid-19. It does not cover antibody testing. Antibody tests are blood tests designed to show whether people have had Covid-19 and are now immune. At the time of writing, antibody tests are still in development and none have been verified in a laboratory setting. On 18 April 2020, Professor John Newton, national coordinator of the UK Coronavirus testing programme, released a statement advising against the use of unapproved antibody tests in the UK.

In recent weeks we have been made aware of a small number of independent providers who are offering Coronavirus swab testing kits for sale to the general public. Here we aim to provide clarification on when such activity will fall within scope of CQC registration. We also set out our expectations of providers offering this service.

When does the provision of swab testing to detect Coronavirus fall within scope of CQC registration?

The removal of tissues, cells or fluids from a service user and/or the analysis of those samples (whether undertaken separately or in conjunction with one another) are both activities that fall within scope of the Diagnostic and Screening Procedures (D&SP) regulated activity.

If you are selling or supplying Coronavirus swab testing kits and you are involved in either a) removing the sample from the patient and/or b) using equipment to examine that sample for the purposes of detecting the presence of Covid-19 then you will need to register with CQC for the Diagnostic & Screening Procedures activity. Note: those who are already registered for this activity with regards to other areas of your service do not need to register again. In addition, you will not need to register for the D&SP activity if you are already registered with CQC to provide any of the other registered activities.

If your organisation is selling or supplying Coronavirus swab testing kits and is not in any way involved in either the removal of samples or the analysis (or examination) of those samples then 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.

However, a provider who sells or supplies Coronavirus swab testing kits and is not involved in the removal or analysis (or examination) of samples, may fall into scope of CQC regulation under the Treatment of Disorder, Disease or Injury (TDDI) regulated activity if you are involved in communicating test results. For example, if a listed healthcare professional contacts the service user to deliver results returned from a laboratory AND they offer advice re. actions to take and/or treatment when that result is positive, then this may fall under the TDDI activity, unless a specific exemption applies.

In such a scenario, it is recommended that you contact us to discuss whether or not you will need to register. Those who are already registered to undertake TDDI with regards to other areas of your service will not need to register again.

Guidance for providers on who needs to register with CQC and the process for registration is available on our website.

Our expectations of providers delivering regulated activity:

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

Having said that, 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 ensure we continue to uphold these core principles.

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

If you are involved with the supply of Coronavirus swab testing then you must do so in accordance with The Health Protection (Coronavirus, Restrictions) (England) Regulations 2020 and the latest 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.

Where providers are charging a fee for the provision of Coronavirus swab test kits, they must do so in a transparent manner in accordance with regulation 19 (fees) of the Care Quality Commission (Registration) Regulations 2009. Clear and accurate information on all fees should be given upfront to enable service users to make an informed decision. In instances where we have evidence that providers are not providing transparent and/or accurate information with regards to fees then we are likely to take enforcement action.

As with the delivery of any regulated activity, we encourage all providers involved in the supply of Coronavirus swab testing kits to act responsibly and in the best interests of people using services at all times.