CRYOGENICS RISK MANAGEMENT
Reduce the risk associated with cryo-storage and improve the quality of the end product
The Cryo-facility is the area of highest associated risk in terms of potential for litigation. High profile incidents in the UK and USA in particular have demonstrated that the loss of patient material (sperm and embryos) can lead to expensive and protracted legal argument, damage to reputations and in a worse-case scenario could lead to the loss of business.
From sperm processing to long-term storage, careful risk management underpins everything you do. Careful planning of all risk areas, whether a geographical location, a facility, process or procedure, every potential hazard must be identified and where possible controlled for. Learning from previous high profile incidents is essential and will start with the potential for causing serious injury or even death. In terms of serious loss of reputation and potential for litigation, the risk of loss of, or damage to patient material must be carefully considered and all potential control measures applied. This may require a review of future storage strategy, introduction of new procedures and training; capacity requirements and resourcing.
Improve the End-Product?
Laboratories that offer long-term sperm storage can to a degree be forgiven for believing that they are merely acting as a long term biorepository for sperm since the material is rarely utilized. Utilisation rates for cryo-preserved sperm (non-donor) are widely reported at significantly less than 10%. However, ultimately the quality of the cryo-preserved 'end-product' will be tested and used in ART. Rarely do patients who use their frozen material have the opportunity to attempt any other form of treatment other than ICSI. This may be a reflection on the amount of material in storage, in which case the sensible approach is of course to utilise the form of treatment which carries the highest chance of success. However, in some cases, it is clear that cryopreservation procedures (cooling, addition/removal of cryoprotectant) are neither optimised nor adequately validated. Sperm processing and cooling procedures rates should be validated not only using published literature but also from historic data from the sperm bank which is the ultimate demonstration of the effectiveness of procedure. Sperm banks that produce 'therapeutic' donor sperm units will of course find this kind of data much easier to provide with the added benefit of the demonstration of acceptable pregnancy rates from simple insemination.
Strategic Planning and Storage Review
Whether the storage facility is modest with a few small nitrogen dewars or has expanded into large capacity vapour refrigerators, careful thought and planning is required with regard to health and safety and future capacity needs. Health and safety with regards to transport and delivery of nitrogen is paramount as is the provision of clear contingency planning if things go wrong. Risk and risk management is on a different scale when capacity needs dictate that large-scale storage is required. We can help you to design and plan your facility, develop process and procedure, assess capacity needs as well as comprehensive risk management and contingency planning