Accreditations, Licenses and Guidelines: What do They Mean?

FDA
FDA registration is required for all sperm banks and they are required to comply with FDA regulations. This became effective May 25, 2005. Sperm specimens, collected before that date, are not subject to the current FDA requirements. SpermCenter.com verifies the FDA registration of every sperm bank listed.

The FDA performs inspections to determine regulatory compliance. If serious deficiencies are found the facilities will be issued a warning letter ordering correction within a defined time period, or if more serious may order the sperm bank to cease operations immediately. The FDA does not issue licenses to sperm banks.

Accreditation
The only organization that inspects and accredits sperm banks is the American Association of Tissue Banks (AATB).  Sperm banks are not required to have AATB accreditation.

It is strictly voluntary and the sperm bank has to pay substantial fees to maintain their accreditation. The AATB has developed a comprehensive set of standards that are more extensive than the FDA and nearly all state departments of health.

Accreditation by the AATB is granted only after an onsite inspection has determined that the bank is in compliance with its standards. This is a measure of quality.

New York Department of Health
The New York Department of Health has developed a comprehensive set of regulations and requires that all sperm banks that provide donor sperm to NY residents are inspected and have a current license by the Department of Health.

Their requirements are in many ways comparable the AATB standards.  In the absence of AATB accreditation this is perhaps the best alternate measure of quality.

State Licenses Other Than New York
There are a number of other states that have licensing requirements. Some may require inspections while others only require payment of a licensing fee. In general it is difficult to determine what most of these licenses mean. In our opinion, unless there are published regulations and accompanied by an onsite inspection to determine compliance they have little value in assessing quality.

CLIA
This refers to the Clinical Laboratory Improvement Act passed by Congress. CLIA regulations do not apply to sperm or other tissue banks. These regulations are aimed at diagnostic clinical laboratories. 

Some states may require sperm banks to be CLIA licensed, but where they are required, the inspections are limited to clinical laboratory procedures and have very little value as a means to determine the quality of sperm banking procedures and practices. 

ASRM
The American Society for Reproductive Medicine (ASRM) publishes guidelines for sperm and egg donor programs.

It is important to point out that the ASRM does not perform inspections and it has no means of enforcing compliance with its guidelines.  A statement that the sperm bank follows ASRM guidelines has very little value to the public because there is no way to verify compliance.