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Adverse Occurrence type:
This is the first time an incident of this nature has been reported to the HFEA. Rare - difficult to believe it could happen again.
Alerting signals, symptoms, evidence of occurrence:
The amount of patient samples removed from storage from a member of staff was only discovered when the original patient made a complaint resulting in an audit of the storage tanks. The audit indicated that samples for a further 36 patients had been removed from storage and allowed to perish (although still within the consent period).
Demonstration of imputability or root cause:
An unreasonable timetable was given to the patient regarding contacting the clinic to arrange further storage. Insufficient efforts were made to contact the pt to establish whether further storage was required. Complete failure to follow the protocol for removal and destroying stored semen of pts that are unable to be contacted by post or phone. Inconsistent approach by the clinic in contacting the pt resulting in a partially complete pt record. Failure to take into account previous communications with the pt regarding his wishes for semen storage to continue. Fundamental lack of understanding of the use and function of the Quality Manual System within the fertility clinic.
HFEA. Adverse incidents in fertility clinics: lessons to learn, 2010-2012