Maintenance of cryopreserved Sperm in fertility clinics is a risky task: A precautionary note for clinics

Fertility clinics are involved with the cryopreservation of human spermatozoa. This commentary discusses issues related to the maintenance of the preserved sperm and potential liabilities associated with it in fertility clinics. The authors' view is that there is opportunity for improving the management of securing frozen sperm that are stored in fertility clinics. The present maintenance strategies for preserving sperm in clinics are far from perfect, and the existing guidelines from the regulatory agencies are not sufficient to streamline the preservation of frozen samples in the clinics. The authors' concern came from the experiences gathered when dealing with cryopreserved samples in a number of fertility clinics and inspecting the clinics as inspectors, as well as ethical and legal experiences. The unique drawback of preserved sperm is that once it is stored, it remains out of sight and thus can become a forgotten entity for both patient and clinic personnel. Another unique feature is that preserved sperm require continuous servicing, and thus the responsibility of filling tanks with liquid nitrogen never ends. Any negligence in filling a cryo tank can influence the quality or cause total loss of the pooled samples, leading to liability consequences. There is no practical solution to prevent the impact of age and handling related collapse of the specimen vials and storage tanks. Performing inventory of preserved sperm is essential but not an easy task to accomplish. Negligence in record keeping and changes in personnel can complicate the inventory task. The decision for disposal of sperm is not an easy one, either. Establishing contact with the patient can sometimes be difficult; further, legal and ethical issues can also complicate the disposal decision. Examples of legal consequences of mistakes or mishandling of preserved sperm are cited, and lessons can be learned from those legal citations. Regulatory surveillance of fertility clinics can be made more stringent by reviewing the clinics' performances for the optimum maintenance of preserved sperm. In summary, the systemic limitations, deficiencies, and obstacles associated with the management of cryopreserved sperm in fertility clinics, as well as legal consequences, have been discussed. Incompetent performance by the laboratory personnel in labeling, book keeping, and maintaining cryopreserved sperm specimens can result in catastrophic consequences, both for fertility clinics and the patients. Clinic personnel responsible for the management of the preserved sperm must have appropriate knowledge, skill, experience, accountability, and a high degree of diligence in order to prevent any unexpected occurrence. Implementing legally acceptable contracts, signed and obeyed by all involved parties, is essential. Furthermore, a concerted effort among fertility clinics, patients, and regulatory agencies can play a role in effective sperm preservation and management.