Quality Assurance

Fairfax Cryobank, a fully inspected and licensed facility, believes it is important to provide patients with donor specimens that have the most state-of-the-art genetic and infectious disease testing in addition to the basic testing required by accreditation and licensing organizations. For this reason, Fairfax Cryobank continues to be the leader in establishing standards for genetic and infectious disease testing of sperm donors.

Credentials you can trust:

All donors are screened and specimens processed in accordance with:
Health Canada/Food and Drugs Act/ Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations) 1996, 2000.
Health Canada Directive - Technical Requirements for Therapeutic Donor Insemination, July 2000
Assisted Human Reproduction (AHR) Act 2004

Licensed and inspected by the FDA
State inspected and licensed (New York, Maryland, and California)
Accredited by the Better Business Bureau (BBB)

Additionally, Fairfax Cryobank:

  • exceeds donor eligibility, genetic and infectious disease testing standards now prescribed by the FDA and AATB, and remains dedicated to maintaining our leadership position in sperm quality, donor testing, and patient services.
  • was the first human donor sperm bank in the United States to screen for genetic carriers of cystic fibrosis  in all donors. All available donors have been CF tested to a minimum of 86 mutations. We are the ONLY sperm bank that has all available donors tested to this standard.
  • has karyotypes (chromosome analysis) on ALL available donors, unlike other sperm banks who do not have all donors tested or do not do the testing at all.
  • was the first human donor sperm bank in the United States to screen for genetic carriers of Gaucher and Canavan carriers in Jewish donors.
  • is the sperm bank making most extensive use of the molecular genetic technique PCR (polymerase chain reaction) to provide screening to detect ALL of the following organisms: Human Immunodeficiency Virus (HIV) types 1 & 2, Human T-cell Leukemia Virus (HTLV) types I & II, Herpes Simplex Virus 1 & 2, Human Papillomavirus (HPV strains 16 and 18), Cytomegalovirus (CMV), Gonorrhea, and Chlamydia.
  • offers Check Donor Medical Status as a means for anyone to check if medical issues have come up with that donor or his offspring that put others at risk. Clients are encouraged to check before using specimens or embryos stored off-site.

To review detailed descriptions of these and other tests performed on donors by Fairfax Cryobank, see Infectious Disease Testing  and Genetic Disease Testing information at this website.

  • Fairfax Cryobank is registered with the Food and Drug Administration (FDA)- download copies here
    • #3004731690 (Fairfax),  #3005033855 (Austin), #3005287828 (Philadelphia), #3011417016 (Houston), #3000243835 (Roseville), #3005108367 (Pasadena) and #1000477683 (VRL Laboratories)
  • Additionally, the Laboratories of the Genetics & IVF Institute hold the following Licensure
    • State of Virginia/CLIA
    • Molecular Infectious Disease Laboratory CLIA #49D0952503 (Certified in Bacteriology, Parasitology, Virology)
    • Semen Analysis #49D0886517
    • State of New York #847912A1
    • State of Maryland #465
    • State of Florida #L80000186