The SCoR often receives enquiries from members and the public about registration requirements with the Care Quality Commission (CQC) when undertaking 3D/4D ‘souvenir’ or ‘entertainment’ ultrasound scans in pregnancy.
We have recently re-confirmed with the CQC that all providers of such scans in obstetrics must register with them if delivering these services in England, unless otherwise exempted.
‘The SCoR are aware that there are many providers offering these services using staff who have no formal qualifications or training in ultrasound, and with no recognisable clinical governance procedures.
Some services have been set up as a purchased business package which includes only minimal ultrasound training.
The legal requirement to register with the Care Quality Commission applies to providers in England, or providers based in another UK country but providing services in England.
It is the legal entity (whether this is an individual, partnership or organisation) that provides the service that must register with the CQC, individual employees of that provider are not required to do so.
Some providers state in their advertising that the 3D/4D scan is purely for entertainment purposes, therefore is not diagnostic and no written report will be issued should a maternal or fetal problem be apparent.
Although we have no evidence that SCoR members are involved in this type of provision, were this to be the case they would be operating outside of the SCoR’s Code of Conduct and Ethics and of its Professional Indemnity Insurance’.
The CQC have re-confirmed their registration requirements (17 October 2016) as follows:
‘The use of ultrasound to image the body for any purpose is aregulated activityrequiring registration with the CQC. For categorisation, it falls within the regulated activity 'Diagnostic and screening procedures'.
The purpose of the ultrasound does not actually matter. It is the fact of examining the body with ultrasound that brings it within scope of regulation.
As such, any service carrying out ultrasounds of pregnant women (or any other person) in England, even if the scan is advertised as for entertainment only, would be expected to register with the CQC unless they benefit from one of the exemptions from registration.
A given exemption may apply to a specific provider, but there is no exemption from registration generally applicable to this work.
Further information regarding this can be found within the CQC’s The scope of registration document under ‘Diagnostic and screening procedures’ which states:
‘All diagnostic procedures involving the use of any form of radiation (including x-ray), ultrasound or magnetic resonance imaging to examine the body are included.
‘This will include all main forms of diagnostic radiology, radiography and sonography (including antenatal ultrasound scans), but it will not include use of the same technology for therapeutic purposes such as radiotherapy or some forms of interventional radiology (those will require registration for the activity of 'treatment of disease, disorder or injury').
‘The activity also includes the analysis and reporting of the examinations that are carried out.
‘If you or anyone else suspects that regulated activities are being carried out by any service without registration, you can click here to be taken to the page our website where you can report an unregistered service using our online form.’