Sperm banks are regulated at the National level by the American Association of Tissue Banks (AATB). At the state level, sperm banks are regulated as semen banks and or tissue banks/laboratories by the state department in each state. These regulatory agencies asses the quality of the lab work done at each sperm bank. They also evaluate the ethical policies that are used (i.e. informed consent). These regulatory agencies evaluate whether the sperm bank protects the rights of its clients and donors. Sperm banks should thorougly screen its applicants and test sperm samples for genetic diseases and/or other diseases such as HIV and hepatitis. Although these policies are not officially regulated by law, the regulatory agencies can remove their accredation and/or license if these standards are not met.
Sperm banks that have operated for several decades have developed their own policies to improve the overall efficacy of the sperm donation system. For example, Cryogenic Laboratories, Inc. (CLI) has been operating as a sperm bank for over 27 years, and has pioneered many techniques that are now employed by other sperm banks. CLI has been committed to track, monitor and evaluate each semen donor and their specimens in order to acquire knowledge of donor fecundity, geographical distribution of donor progeny and the clinical evaluation of donor participation in its Semen Donor Program. By collecting an analyzing this clinical data, CLI provides a greater margin of safety and higher level of success for its clients. In the future, data collection systems like the one employed CLI might be mandated.
Unofficial policy dictates the way in which sperm banks operate. Regulatory agencies asses the quality of the work and enforce infomed consent, but many of the policies employed by sperm banks have been developed unofficially over the years.
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