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21 September 2011

Summary of request

The Authority was asked for information about incidents reported to the HFEA between 01/01/2000 and 31/12/2010 that involved a gamete mix up or loss of gametes due to incorrect storage:

• the name of the clinic(s) involved,
• details of what happened,
• actions taken by the HEFA in response to the incident, and
• whether any live birth resulted.

HFEA response

The Authority estimates that the cost of complying with this request would exceed the ‘appropriate limit’ set out in the Freedom of Information and Data Protection (Appropriate Limit and Fees) Regulations 2004 ('the Regulations').  This limit is £450 and for the purposes of estimating cost, staff time is calculated at notional rate of £25 per hour. Section 12 of the FOIA allows public authorities to decline to provide information requested under the FOIA where the cost of doing so would exceed this appropriate limit. 

The following advice was also given:

The framework
Section 27 of the HFEA’s Code of Practice and General Directions 0011 for clinics are available on the HFEA website. These set out the legal framework, guidance and responsibilities for clinics regarding adverse incidents ( http://www.hfea.gov.uk/3476.html and http://www.hfea.gov.uk/188.html respectively).

A copy of the HFEA’s Compliance and Enforcement Policy is also available on the HFEA website at: http://www.hfea.gov.uk/docs/Compliance_and_Enforcement_Policy.pdf . This sets out how the Authority handles non-compliance in the sector and how the Authority processes and grades reported incidents.

Grade A incidents are considered by the Authority’s Licence Committee and the Authority’s policy on the publication of Committee minutes, which came into force in October 2009, can be found at: http://www.hfea.gov.uk/1128.html .

Published information
Minutes of the Licence Committee consideration of Grade A incidents that have been published to date can be found at: http://guide.hfea.gov.uk/guide/InspectionReport.aspx?code=109&s=l&&nav=2 , http://guide.hfea.gov.uk/guide/InspectionReport.aspx?code=190&s=l&&nav=2 and http://www.hfea.gov.uk/5680.html . Please note that some Grade A incident reports are deemed by the Licence Committee to contain information that might lead to the identification of the patients who were involved, and are thus not deemed appropriate to publish.

The HFEA’s annual report details the number of incidents reported each year by clinics. These Annual Reports are published at: http://www.hfea.gov.uk/146.html . We have also released a breakdown of incidents by category for the last two financial years in response to a previous request under the FOI Act (http://www.hfea.gov.uk/6583.html ).

The HFEA’s approach
The HFEA openly encourages the reporting of incidents and continues to work closely with centres to improve quality. As a result, centres are continuing to respond positively to the opportunity to share lessons learned from incidents which have been reviewed and vigorously investigated. There has actually been a fall in the number of the most serious incidents.   In the last year there were more than 50,000 cycles of IVF which entails hundreds of thousands of laboratory procedures. The HFEA takes all incidents seriously but the total number of incidents represents a tiny percentage of all the procedures taking place.

Page last updated: 16 August 2012

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