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Quality Assurance

Read more about the Fairfax Cryobank Specimen Quality Standard.

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:

Licensed and inspected by the FDA

Accredited and inspected by the American Association of Tissue Banks (AATB)

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 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 Policy on Verifying the Accuracy of our Shipments

 

We recognize that trust and credibility are the basis for our success.  We feel that it is our obligation to make you aware of the policies and procedures we have in place to verify the accuracy of our shipments.

  • Shipping Specimens from Fairfax Cryobank 

When Client Services receives a call to place an order, the donor number will be verified at least two times with the caller.  The order is then approved by a manager who forwards the information to the lab staff.  The lab is required to have a minimum of two people verify all details of the order.  The lab staff verifies the information on the top and side of each vial along with the paperwork included in each shipment, required by FDA regulation.  All details must match the original details that were verified with the caller to ship the order.  Once the order arrives at your clinic, your physicians’ office should verify the details on the paperwork match the vial(s) in the tank.

  

  • Transferring Specimens to Fairfax Cryobank for Long-Term Storage 

Fairfax Cryobank provides a liquid nitrogen tank for the shipment of your cryopreserved specimens to our facility for storage. Once the specimens are received at Fairfax Cryobank, two trained personnel verify and check-in the specimens prior to placing into a long-term storage tank. The clinic and patient’s name are verified and the tank is checked to assure it was sealed and the specimens arrived frozen. The specimens are inventoried by patient name or donor number, freeze dates, number of vials, and identification on the vials. The information is compared to the accompanying paperwork to account for an accurate inventory. Any additional paperwork included in the shipment (freeze procedure, thaw instructions, blood test results) is checked and placed in the account holders file. You will then receive an inventory confirmation letter listing your account number with Fairfax Cryobank and stating the number of specimens in storage.

 

Fairfax Cryobank is registered with the Food and Drug Administration (FDA)- download copies here

  • #3004731690 (Fairfax),  #3005033855 (Austin), #3005287828 (Philadelphia)

Fairfax Cryobank is accredited by the American Association of Tissue Banks (AATB)- download a copy here.

  • #00191

Fairfax Cryobank Licenses- download copies here.

  • State of New York #GA010
  • State of Maryland #TB699
  • State of California #CNC80394

 

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

 
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