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02 September 2013

Dear Colleague

Inspecting surgical procedures in connection with licensed activities

Following agreement with the Care Quality Commission on how we might reduce regulatory overlap, the Authority will extend its remit to include the inspection of surgical procedures that are carried out in connection with HFEA licensed activities. As Peter Thompson and David Behan recently outlined in their Chief Executives’ letter (CE(13)01) this change takes effect on 1 October 2013. Initially, this will only affect clinics in England. However, we plan to work with the devolved nations to see whether this change can be applied in Wales, Scotland and Northern Ireland from next year. This letter provides you with details of the guidance for clinics and how this change will be applied.

The guidance

You must ensure that your clinic’s premises and practices are suitable for the activities that are carried out. In preparation for assuming responsibility for inspecting surgical procedures, we have worked with the CQC to review what practices and procedures clinics should have in place and have produced best practice guidance on the following:

• Guidance on management of medicines (pdf 171kB)
• Guidance on safeguarding (pdf 243kB)
• Guidance on infection control (pdf 165kB)
• Guidance on pre-operative assessment and the surgical pathway (pdf 256kB)
• Guidance on suitable premises(pdf 18kB)

This guidance can be found attached to this letter. We will inspect against this guidance in the course of relevant treatment and storage renewal inspections; where we see non compliance with this guidance that may pose a risk to patient safety, then we may conclude that clinics do not have suitable practices or premises as required by standard licence conditions T2 and T17.

How will this affect your clinic?

We will inspect against the guidance at renewal inspections only from October 2013. To ensure consistency, the guidance has been drafted in close consultation with the CQC and the first renewal inspections will be supported by CQC inspectors.  Following each inspection, we will consider what lessons we can learn, and will refine our guidance and inspection methodology on the basis of this learning in spring 2014 before updating the Code of Practice to incorporate the guidance in October 2014.

Our inspections of surgical procedures will look for the same assurances as those currently sought by the CQC. It is therefore likely that clinics will already be fully compliant with the guidance. By addressing this area of regulatory overlap, many fertility clinics in England should fall out of the scope of CQC registration.

What should you do?

You should review the guidance and consider how you can best demonstrate evidence of compliance. To help you prepare read more information on inspecting surgical procedures and view our Surgical Procedures FAQs.

We also suggest that you consider your CQC registration requirements. As a result of this change, some fertility clinics will be able to apply to cancel or vary their registration. The CQC will be writing to registered providers with further details, and make information available on their website. 

What will we do?

We will continue to work closely with the clinics due to have a renewal inspection between October 2013 and April 2014 so that they are prepared and understand the guidance. Before we update the Code of Practice in October 2014, we will review our guidance and inspection methodology based on the feedback we receive from clinics and our professional organisations stakeholder group. We will do this in spring 2014.

We will keep you updated on progress. In the meantime, if you have any questions, please contact your HFEA inspector.

Professor Lisa Jardine CBE
Chair, Human Fertilisation and Embryology Authority

Page last updated: 02 September 2013

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