When choosing a semen bank, California Cryobank suggests selecting a semen bank that has been inspected and is currently accredited by the following institutions.
American Association of Tissue Banks (AATB)
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.
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
- Arizona FDA ID # 3020118206
- Orange County FDA ID # 3021919854
- Spokane FDA ID # 3024831832
- Upland FDA ID # 3023887163
- Pullman FDA ID # 3024832321
- Missoula FDA ID # 3024831870
- Portland FDA ID # 3021854670
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.
State Departments of Health
Most states do not regulate semen banks, but 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.
California State Department of Health
- Los Angeles Biologics BBID # 9776
- 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
- Orange County Tissue Bank ID # CTP 00082300
- Spokane Tissue Bank ID # CTP 00080402
- Upland Tissue Bank ID # CTP 00082334
New York State Department of Health
- La Grange Tissue Bank ID # 7
- Palo Alto Tissue Bank ID # 818
- Cambridge Tissue Bank ID # 506
- New York Tissue Bank ID # 569
- New York Clinical Lab Permit PFI# 5410
Maryland State Department of Health
Oregon Department of Human Services
Illinois State Department of Public Health
- La Grange Tissue Bank ID # 1220
- Palo Alto Tissue Bank ID # 1520
- Cambridge Tissue Bank ID # 1720
- New York Tissue Bank ID # 1320
Department of Health and Human Services (CLIA)
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.