Risk management in cryopreservation associated with assisted reproduction.

The process of cryopreservation of cells and tissues either for research or for therapeutic use is loaded with risk from beginning to end. Centres must focus on key areas of potential hazard or incident, particularly those associated with injury, loss or damage to stored material, and misidentification of stored material. Incidents involving any would have more fundamental consequences for the laboratory including financial loss and a threat to continuation of a service or project. Control measures to prevent injury are as much about education in the use and handling of liquid nitrogen as they are about protective clothing and more attention should be focused on preventing explosion, asphyxiation, burns and injury from manual handling. Other major losses are focused on damage to samples due to inappropriate processing, inadvertent thaw or less likely, contamination from another sample or microorganism. Complete sample losses can result from misidentification, poor inventory control and poor record keeping with regard to the use of samples in therapeutic procedures. Control and prevention of these hazards may require significant resources, although more often than not involve simple changes in procedure, ensuring that equipment and materials are fit for purpose and that personnel are suitably trained. Identification of such risk relies on a combination of a systematic prospective approach (risk assessment) with a documented and formal recognition of previous mistakes or near misses. Risk potential can be formally scored and ranked to provide services with the means of prioritising and allocating appropriate resources. Failure to implement a comprehensive risk management strategy could be translated as 'negligence' should a similar incident subsequently occur. The risk management of any services including cryopreservation should therefore be considered fundamental and integrated into business planning, objective setting and departmental budgeting to ensure continued improvement and the delivery of a quality and safe service or indeed research project.