Fertility services – Update September 2024

Homerton Healthcare has written to 32 patients who were directly affected by the serious incidents that occurred within our fertility centre to inform them of the outcome of independent investigations carried out into three incidents.

 

The full reports of the investigations, their findings and recommendations have been shared with the patients. The reports are clear that no evidence of misconduct, malice or intentional neglect was found. However, all three investigations identified several areas where there was significant room for improvement, including areas around the working environment and laboratory processes.  

 

Based on the recommendations from the investigators, the Trust has already started to implement an improvement action plan, which has been shared with the HFEA, focusing on internal governance, staff, working environment and security. Work on this action plan is monitored regularly and significant progress has already been made, particularly in relation to security of the centre, the Standard Operating Procedures and audit and competency documentation. Updates on progress will be given to our Trust Board on a monthly basis.

The licence for fertility services at Homerton was originally suspended by the Human Fertilisation and Embryology Authority (HFEA) on Friday 8 March 2024, following the incidents in the centre between May and December 2023. Each incident was reported to the HFEA at the time, and each was declared a serious incident. 

The Trust is planning a gradual return of services in its fertility centre after being informed by the HFEA that it could resume treating patients from Thursday 8 August 2024 and is working alongside the HFEA to address its concerns. 

Trust Chief Executive Bas Sadiq said: “We would like to apologise again to all the patients affected by the suspension of fertility services. We recognise the significant distress this has caused and have prioritised sharing details of these investigations with patients directly affected.

“We are committed to learning from these events and are now focused on the actions recommended from the reports. We want to make sure the services resume in the safest way possible. For this reason, despite the HFEA reinstating our licence, we will not be accepting new referrals immediately. GPs will continue to refer patients to other providers as they are currently doing.

“We will be contacting patients who wish to return to the care of Homerton fertility centre over the coming months as we scale up services in a safe, planned way.”

 

Areas for improvement identified in all three investigations include:  

 

Internal Governance     

  • Review and updates have been made to  Standard Operating Procedures for key laboratory procedures.
  • Implementation of a  robust competency assessment process for all staff to ensure they are all working to a standardised best practice.
  • An audit of practice for competency in vitrification and warming for all staff must be undertaken prior to restarting of clinical practice using training embryos where possible.  
  • Risk assessments for all vitrification and warming procedures need to be carried out or revised.  
  • The patient treatment pathway between medical, nursing and scientific leads to be reviewed, to ensure areas of responsibility and patient pathways are clear.  
  • Informed and documented consent from patients to be completed where appropriate.  

 

Staff     

  • Protected time for staff training to be introduced.    
  • Required bank of embryos donated for training needs to be created to provide future training resilience for staff.  

 

Working Environment     

  • A number of concerns were noted about the laboratory facilities, which require upgrading and investment in equipment and workstation space.  A new lay out is being worked up with models of flow and new eye baths, floor coverings and wash sinks being introduced.
  • A review is being carried out of air quality, air pressure differentials and temperature controls.
  • Infection control procedures to be enhanced, a need for regular cleaning audits.  
  • Improved Infection Prevention and Control compliance relating to staff movement around the lab, including compliance with personal protective equipment.  
  • Support needs to be provided to the team prior to the restart of clinical work.  

 

 

Security    

  • The centre had identified some gaps in the security of the clinical areas.  
  • Stringent practices and measures to address security at the centre is now in place.  

 

Click here to read a summary of the investigations.

 

The Trust will continue to work with the HFEA in the coming months as it gradually reintroduces services as part of a process that will prioritise patient safety and care.

 

Support available   

We have written to patients who were impacted by the suspension of the licence in March informing them that if they had their treatment transferred elsewhere, the treatment will continue to take place there. If the transfer process to a new provider is still underway, that process will be continuing as planned. 

For any further patient queries, please see a list of contact options shown on the righthand side of this webpage under the ‘Contact Details’ heading. 

The Trust has set up a specific email address for patients with any queries about the transfer of their care. Details are shown opposite. 

Further information

Minutes of the HFEA July meeting can be found  here  .  The statement from the Chair of the HFEA can be found  here  .