Blog written by CLI Director of Operations Michelle Ottey, PhD
Which of the following statements are true?
1. Sperm Banks test their donors for a panel of infectious diseases every few months.
2. Sperm Banks have to do testing on the specimen cups to ensure no negative effect on the sperm.
3. Sperm Banks thoroughly interview and screen men so rigorously that typically less that 1% of applicants make it into donor programs.
4. Donor applicants are excluded from donating if they do not know their family medical history.
All of those statements are true and are just the tip of the regulatory iceberg. This is why I am always surprised when I see comments in the media about Sperm Banking being unregulated and having no accountability. I thought I would take this opportunity to provide some information on sperm banking regulations.
On 5/25/2005 the Food and Drug Administration’s regulations on Reproductive Tissue Banking took effect. The specific document is 21 CFR Part 1271. This focuses on the standards for screening and testing donors, proper documentation, and donor eligibility. All sperm banks undergo routine audits for compliance by the FDA via on-site inspections. These in depth and rigorous inspections are conducted by highly trained FDA auditors. Having been through several of these inspections, I can tell you that they leave no stone unturned and are often a great opportunity for banks to further develop their best practices.
Additionally, most major sperm banks are also licensed and inspected by several states, depending on their distribution; most notably New York, California, and Maryland. State licensing began as far back as 1992.
Sperm Banks also adhere to the guideline and standards of the American Society for Reproductive Medicine (ASRM) and/or the American Association of Tissue Banking (AATB.)
Also of note, is the fact that most major sperm banks are highly self-regulated with extensive controlled documentation, internal audits, and intense training programs for all staff.
It is often cited that there are around 30,000 donor Inseminated (DI) births per year, but a more accurate number would be 4,000 to 5,000 DI births per year as determined by an unpublished AATB survey. It is important to consider the fact that one vial of donor sperm dose not equate to one pregnancy. After taking into account the average number of vials per insemination, the total number of insemination attempts to become pregnant and the birth rate, the total number of offspring born through DI would be less than 130,000 over the last 30 years.
Internally, sperm banks have limitations on donor distribution by region, by total vial number, by pregnancies reported, by adherence to the ASRM standard of 25 births/donor per population of 800,000, etc. This will vary by bank.
So, as you can see we are highly regulated, highly controlled, and take what we do very seriously.
