03 June 2013
Dear Colleague,
Addressing the regulatory overlap between Care Quality Commission (CQC) and the Human Fertilisation and Embryology Authority (HFEA)
We are writing to you as our records show that your organisation is currently both registered with the CQC and licensed by the HFEA. This will be because your organisation is:
- an HFEA licensed clinic which is independently registered with the CQC; or
- an NHS Trust, or larger independent healthcare provider, registered with CQC which includes one or more HFEA licensed fertility clinics.
As part of a joint work programme between the CQC and the HFEA, we have recognised that for fertility clinics the current overlap creates a complex and disproportionate inspection programme, particularly for independent fertility clinics. We have therefore agreed an approach to address this overlap for licensed clinics in England which should remove the duplication and make better use of our regulatory resources. We are working together to apply this change in a proportionate way.
From 1 October 2013, the HFEA will extend its remit to include the inspection of surgical procedures (such as egg collection) that are carried out in connection with HFEA licensed activities. Any activities carried out by fertility clinics in connection with HFEA licensed activities are exempt from the need to register with CQC for the regulated activities of Treatment of Disease Disorder or Injury and Diagnostic and Scanning activities. The extension of the HFEA remit to include surgical procedures will also be covered by this exemption; this means that many fertility clinics will fall out of the scope of CQC registration.
The effect of this change will be:
- Where a fertility clinic falls out of the scope of CQC registration, it will not be inspected by CQC. This will apply where all of the services or procedures provided by a fertility clinic are done so in connection with HFEA licensed activities.
- Where a fertility clinic provides services which are not in connection with an HFEA licence you will still need to be registered with CQC if these are regulated activities. In these circumstances CQC and HFEA will work together to share information effectively and to ensure inspection of these services is proportionate.
- Some providers will also be able to apply to cancel or vary their CQC registration. This will depend on whether the clinic is within a larger registered provider or is independently registered with CQC.
HFEA inspection of surgical procedures will be looking for the same assurances as those currently sought by CQC. There will be no change in the standards that services must meet.
Next steps
The HFEA is liaising with key stakeholders to ensure that this process is rolled out as clearly and smoothly as possible. This includes liaising with the relevant professional bodies, and working on a one-to-one basis with those HFEA licensed centres due an inspection under the new regime before April 2014.
More detailed guidance about these changes will be sent to you at the beginning of September 2013. This guidance will help you to determine the implications for your service from 1 October and give information about how to apply to cancel or vary your CQC registration where applicable. It will also set out what evidence of compliance the HFEA will be looking for on inspection.
In preparation for this transition, the HFEA will be asking all HFEA licensed clinics in England to complete a brief questionnaire asking about the range of services they provide. This will help us understand the extent to which individual centres and providers are likely to be affected by these changes and will inform the detailed guidance.
Yours sincerely,
Peter Thompson
Chief Executive
Human Fertilisation and Embryology Authority
David Behan
Chief Executive
Care Quality Commission
Page last updated: 02 September 2013