When choosing a semen bank, California Cryobank suggests selecting a semen bank that:
- Has been inspected and is currently accredited by the American Association of Tissue Banks.
Founded in 1976, The American Association of Tissue Banks (AATB) is a professional, non-profit, scientific, and educational organization dedicated to maintaining high standards of excellence in the tissue banking industry. To be accredited by the AATB, the tissue bank must submit to comprehensive on-site inspections. These inspections are designed to assure that the bank is professionally managed, appropriately staffed, and maintains policies and procedures to provide consistent quality. Only a few gamete banks in the world have been accredited by AATB.
- Is registered and has been inspected by the FDA for compliance with regulatory requirements.
As of May 25, 2005, establishments engaged in the recovery, screening, testing, packaging, processing, storage, labeling and distribution of human gametes or embryos are required to comply with FDA regulations specified in 21 CFR (Code of Federal Regulations) Part 1271.
- Los Angeles - La Grange FDA ID # 3005342355
- Palo Alto FDA ID # 3003351041
- Cambridge FDA ID # 3003367577
- New York FDA ID # 3005202248
California Cryobank uses reference laboratories to perform donor testing, which are registered with the FDA, and other applicable state regulatory agencies, and have a current Certificate of Compliance of Accreditation for CLIA requirements.
As required by 21 CFR 1271.55 (a)(3) of the regulations, California Cryobank includes a Summary of Records that documents the tests performed on the donor and an interpretation of the results with each shipment of donor semen.
- Has been inspected and is currently licensed by states regulating tissue banks.
Most states do not regulate semen banks. New York and California are among the states that do regulate tissue banks. In fact, New York's standards are the most stringent in the industry.
Licensure by the California State Department of Health:
- Los Angeles Tissue Bank - La Grange ID # CTB 00080474
- Palo Alto Tissue Bank ID # CTB 00080009
- Cambridge Tissue Bank ID # CTB 00080305
- New York Tissue Bank ID # CTB 00080927
Licensure by the New York State Department of Health
- La Grange Tissue Bank ID # GA007
- Palo Alto Tissue Bank ID # GA040
- Cambridge Tissue Bank ID # GA045
- New York Tissue Bank ID # GA053
- New York Clinical Lab Permit PFI# 5410
Licensure by the Maryland State Department of Health
Registration by the Oregon Department of Human Services
- Our laboratory that performs Andrology Services has been inspected and is currently certified by CLIA.
The Clinical Laboratory Improvement Amendment of 1988 (CLIA) regulations enacted by the U.S. Department of Health and Human Services establish standards that apply to laboratory testing of human semen specimens, laboratory personnel, quality control, and quality assurance. California Cryobank has a CLIA inspected and certified laboratory.
California Cryobank ensures all licensing and accreditations are current and that all applicable regulations and standards to those licenses and accreditations are followed through our Quality Management Systems.