The HFEA Code of Practice sets out detailed record-keeping requirements for cryogenic storage in UK fertility clinics. These requirements exist to protect patients, enable regulatory oversight, and ensure every stored sample can be accounted for at any point during storage.
The core records that must be maintained for every cryogenically stored embryo include:
Patient identity records linking the embryo to named patients and their clinical records.
Consent records. Every embryo must be linked to a current, valid consent record specifying what the embryo can be used for, what should happen to it if either party withdraws consent, and the agreed storage period.
Creation and storage records. The date of fertilisation, developmental stage at vitrification, vitrification protocol used, and the storage location, meaning the specific dewar, canister, cane, and goblet, must all be documented.
Access and movement records. Every time a sample is moved, the movement must be documented with a date, reason, and responsible person recorded.
Alarm and temperature records. The monitoring system logs must be retained as evidence that temperature conditions were maintained throughout the storage period.
The practical standard expected is that an HFEA inspector should be able to select any patient record, follow the chain of documentation, and physically locate the stored samples or account for their disposal.
Cryolab supplies laboratory information management system support alongside cryogenic equipment for UK IVF clinics. Visit cryolab.co.uk“>Cryolab
