• Directions
• Chair's letters
• Chief Executive's letters
• Multiple Births Minimisation Strategy: achievements and compliance
• Frequently used guidance
• Do I need to be registered by either the CQC or licensed by the HTA?
• Retrieval of storage of gametes where patients are unable to consent
• Surrogacy and legal parenthood – changes from 1 October 2013

Through our joint working programme we have looked at how to reduce the burden of an HFEA licensed centre being registered by either the Care Quality Commision (CQC) or Human Tissue Authority (HTA). Some of the outcomes of this are listed below. Depending on the service that you intend to offer, you may still be required to register with the CQC and/or HTA.

CQC regulated centres

There are three CQC-regulated activities for which HFEA-licensed centres have historically sought registration: Treatment of Disease, Disorder or Injury, Diagnostic and Screening Procedures and Surgical Procedures.

Treatment of Disease, Disorder or Injury (TDDI)

Unless centres are carrying out activities in addition to those specifically licensed by the HFEA, they are not required to register with the CQC for TDDI.

Diagnostic and Screening Procedures

A change to the law on 18 June 2012 explicitly exempts centres from the requirement to register with the CQC for Diagnostic and Scanning Procedures where such activities are undertaken in connection with HFEA licensed activities.

Surgical Procedures

HFEA licensed centres carrying out egg collection or other surgical procedures are currently required to register with the CQC for this activity. However, through our joint working programme we have agreed that, from 1 October 2013, the HFEA will extend its remit to include the inspection of surgical procedures (such as egg collection) carried out in connection with HFEA licensed activities. This change will only affect licensed clinics in England, following agreement with the Care Quality Commission (CQC). Further information on what evidence of compliance the HFEA will be looking for on inspection, and guidance on how to apply to cancel or vary your CQC registration, will be provided in September 2013. We will keep you updated on progress. 
 

HTA regulated centres

The HFEA and HTA have worked together to review the overlap between HTA and HFEA statutory functions and regulations, leading to:

• clarification about our shared position on the regulation of storage of ovarian and testicular tissue
• arrangements for joint inspections of all establishments licensed by both HFEA and HTA.

We are also working with the HTA to obtain external legal advice on legal barriers to further minimise the impact of regulation.

Page last updated: 10 June 2013

• Send to a friend