Case study one – a centre has stored embryos beyond the stated patient consent period
Example of how the HFEA would manage centres causing concern
During the renewal inspection of a centre, licensed to carry out treatment and storage, the inspection team found that the centre was storing embryos, for a number of patients, beyond the period for which the patients had consented their embryos to remain in storage.
The inspection team categorised this as a critical area of non compliance and recommended that the centre take the following actions:
- Inform the patients concerned;
- Undertake a complete audit of all stored gametes and embryos to determine whether the centre is storing any other sperm, eggs or embryos beyond the statutory storage period;
- Review its ‘bring forward system’ to ensure that this does not happen in the future.
The Person Responsible (PR) stated, in his response to the inspection report, that he would comply with all of the recommendations.
Given the reassurances of the PR and taking into account previous licensing history and that no other areas of critical non-compliance were found during the inspection visit, the Executive Licensing Panel granted a four year licence and endorsed that recommendations made by the inspection team must be put in place within three months.
Three months after the licence being granted and as part of the on-going monitoring of this centre, the inspector found that the centre had contacted the patients concerned but had not carried out a complete audit nor had it reviewed the it’s bring forward system.
A management review meeting was held, following this meeting, the inspector wrote to the PR requiring him to submit a plan, detailing when and how the audit and review would be completed, within two weeks.
Scenario 1:
Within two weeks, the PR submits the plan stating how the audit and review will be undertaken and that these will take place within six weeks.
After six weeks the PR submits the results of the audit and the centre’s review of it’s bring forward system.
No further action is taken: the inspector continues to monitor the centre through the normal mechanisms.
Scenario 2:
Within two weeks, the PR submits the plan stating how the audit and review will be undertaken and that these will take place within six weeks.
After six weeks the PR fails to submit the results of the audit and / or the centre’s bring forward system.
The inspector invites the PR to a formal review: at this meeting the inspector and PR agrees a timescale (a further two weeks) in which the audit / review will take place.
1) After the agreed timescale (two weeks) the PR submits, the results of the audit / review of the centre’s bring forward system – no further action is taken: the inspector continues to monitor the centre through the normal mechanisms.
2) After the agreed timescales (two weeks) the PR submits the results of the audit but fails to submit the review of centre’s bring forward system – an inspection team visit the centre to review it’s bring forward system.
3) After the agreed timescales (two weeks) the PR submits the review of the centre’s review system but fails to submit the results of the audit – the inspector refers the area of non- compliance to the Executive Licensing Panel / Licence: the Executive Licensing Panel / Licence Committee varies the centre's licence to add an additional condition requiring an external embryologist to carry out an audit of the centre’s stored gametes and embryos.
Scenario 3:
Within two weeks the PR submits the plan stating how the audit will take place but fails to submit the plan on the review will be undertaken - an inspection team visit the centre to review it’s bring forward system.
Scenario 4:
Within two weeks the PR submits the plan stating how the review of the centre’s bring forward system will take place but fails to submit the plan on the audit of the centre’s stored gametes and embryos - the inspector refers the area of non- compliance to the Executive Licensing Panel / Licence: the Executive Licensing Panel / Licence Committee varies the centre's licence to add an additional condition requiring an external embryologist to carry out an audit of the centre’s stored gametes and embryos.
Scenario 5:
Within two weeks the PR fails to submit the plan stating how the audit and review will be undertaken – the inspector refers the areas of non-compliance to the Executive Licensing Panel / Licence Committee: the Executive Licensing Panel / Licence Committee asks that an additional inspection takes place with an external embryologist in order to review the centre’s bring forward system and carry out an audit of the centre’s stored gametes and embryos.
Page last updated: 28 September 2011
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