Inspecting surgical procedures

Following agreement with the Care Quality Commission (CQC), on 1 October 2013, we will be extending our remit to include the inspection of surgical procedures carried out in connection with HFEA licensed activity.

What’s the reason for the change?

A number of fertility clinics are inspected by both CQC and the HFEA. We have been working closely with colleagues at CQC to reduce this regulatory overlap.

By inspecting surgical procedures carried out in connection with HFEA licensed activities, a number of stand-alone fertility clinics would no longer need to be registered with the CQC. These centres would therefore be solely regulated by the HFEA. Read more about CQC registration.

A number of clinics will continue to have a degree of regulatory oversight by the CQC, either because they carry out a number of other non-HFEA licensable activities, or because of Trust or hospital registration. We suggest that these centres consider using HFEA inspection reports as evidence of compliance to CQC inspectors. This will reduce regulatory overlap for NHS centres.

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The guidance

In taking on this responsibility, CQC have identified to us what practices and procedures a centre should have in place when carrying out a surgical procedure. Having worked closely with them, we have provided best practice guidance on the following:

You should review each guidance note and ensure that your centre is able to demonstrate evidence of complying with each point.

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Inspection and non-compliance with the guidance

We want to be proportionate when inspecting against such guidance. Initially, we will only check for compliance with this guidance upon renewal inspection of treatment and storage centres, when inspecting a new clinic that has applied for a licence for the first time or inspecting a clinic that is moving premises. We will use observations and discussions with staff as much as possible although we may need to review some documentation on the day itself. We will not expect any additional documents to be submitted to the HFEA. In preparation for the inspection, we suggest you review the guidance and consider how you can best demonstrate evidence of compliance for HFEA inspectors.

Standard licence conditions T2 and T17 require centres to have suitable practices and facilities. The guidance relating to surgical procedures will be considered when assessing a centre’s compliance with these licence conditions. Where there is only minor deviation from the guidance then this will most likely be cited, in an HFEA inspection report, as an “other” area of practice that requires improvement. Where significant deviation from the guidance is observed then this will be cited as non-compliance with these standard licence conditions.

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How has the guidance been developed?

To ensure consistency the guidance has been drafted in close consultation with the CQC and the first renewal inspections, where the inspection of this new guidance is relevant, will be supported by CQC inspectors

We shared early iterations of this guidance with some of our professional stakeholders and our Licensed Centres Panel. We also worked with the first set of clinics due such an inspection before April 2014 to discuss the content of the guidance and to take on board their views.

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Next steps

Following each inspection, we will consider whether there are lessons and improvements we can make in either our guidance or inspection methodology. We will refine our guidance and methodology on the basis of this learning in spring 2014 before updating the Code of Practice to incorporate the guidance in October 2014.

Initially, this will only affect clinics in England. However, we plan to work with the devolved nations to see whether this change can/should be applied in Wales, Scotland and Northern Ireland from next year.

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Page last updated: 29 August 2013