Donor Application/Intake Form

1Personal Information
2FDA Eligibility Determination
3Additional Information

Legal First Name:

Legal Last Name:

Date of Birth

Sun Mon Tue Wed Thu Fri Sat

Height

Weight

lbs

Address Line 1:

Address Line 2:

City:

Country

State/Province:

Zip/Postal Code:

Cell Phone:

Home Phone:

Work Phone:

Email Address:

Preferred Primary Contact:

Preferred Secondary Contact:

Are you a citizen or permanent resident of the United States and/or Canada?

Yes

Have you ever been an egg donor?

Have you ever been a surrogate?

Have you ever been rejected from another program?

Do you have regular menstrual cycles?

Have you ever been diagnosed with infertility?

What form of birth control do you use?

Have you received a bite from an animal suspect for rabies within the past 6 months?

Are you willing to have HIV and other infectious disease testing?

Have you or anyone in your family been diagnosed with Autism Spectrum Disorder (ASD/AS)?

Yes

The following Questions listed below are the FDA Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).

If you have one or more of the conditions and/or behaviors listed below, you are ineligible to be a donor.

Following is a list of conditions and behaviors that increase the donor’s relevant communicable disease risk. Except as noted in this section, and in accordance with § 1271.75(d), you should determine to be ineligible any potential donor who exhibits one or more of the following conditions or behaviors.

I have injected drugs for a non-medical reason in the preceding 5 years, including intravenous, intramuscular, or subcutaneous injections

I have hemophilia or other related clotting disorders who have received human-derived clotting factor concentrates in the preceding 5 years. A donor who received clotting factors once to treat an acute bleeding event more than 12 months ago may be eligible to donate

I have engaged in sex in exchange for money or drugs in the preceding 5 years.

I have had sex in the preceding 12 months with any person described in criteria 1 through 3 and/or a Man who has had sex with another man in the proceeding 5 years and/or any person who has HIV infection, including a positive or reactive test for HIV virus

I have been exposed in the preceding 12 months to known or suspected HIV, HBV, and/or HCV-infected blood through percutaneous inoculation (e.g., needle stick) or through contact with an open wound, non-intact skin, or mucous membrane.

I have been in juvenile detention, lock up, jail or prison for more than 72 consecutive hours in the preceding 12 months.

I have lived with (resided in the same dwelling) another person who has hepatitis B or clinically active (symptomatic) hepatitis C infection in the preceding 12 months.

I have undergone tattooing, ear piercing or body piercing in the preceding 12 months, in which sterile procedures were not used, e.g., contaminated instruments and/or ink were used, or shared instruments that had not been sterilized between uses were used.

I have had a past diagnosis of clinical, symptomatic viral hepatitis after their 11th birthday, unless evidence from the time of illness documents that the hepatitis was identified as being caused by hepatitis A virus, Epstein-Barr Virus (EBV), or cytomegalovirus (CMV).

I have had smallpox vaccination (vaccinia virus) in the preceding 4 months.

I have acquired a clinically recognizable vaccinia virus infection by contact with someone who received the smallpox vaccine within the last 4 months.

I have had a medical diagnosis or suspicion of West Nile Virus (WNV) infection (based on symptoms and/or laboratory results or confirmed WNV viremia) within the last 4 months.

I have tested positive or reactive for WNV infection using an FDA-licensed or investigational WNV NAT donor screening test in the preceding 120 days.

I have been treated for or had syphilis within the preceding 12 months and treatment was unsuccessful.

I have been treated for or had Chlamydia trachomatis or Neisseria gonorrhea infection in the preceding 12 months and treatment was unsuccessful.

I have been diagnosed with vCJD or any other form of CJD “Creutzfeldt-Jakob Disease” (mad cow disease) or “variant Creutzfeldt-Jakob Disease,”.

I have been diagnosed with dementia or any degenerative or demyelinating disease of the central nervous system or other neurological disease of unknown etiology.

I am at increased risk for CJD. Donors are considered to have an increased risk for CJD if they have received a non-synthetic dura mater transplant, human pituitary-derived growth hormone, or have one or more blood relatives diagnosed with CJD.

I have a history of CJD in a blood relative unless the CJD was relating to illness caused by medical examination or treatment or gene sequencing shows that the donor does not have a mutation associated with familial CJD.

I have spent three months or more cumulatively in the United Kingdom (U.K.) from the beginning of 1980 through the end of 1996.

I am a current or former U.S. military members, civilian military employees, or dependents of a military member or civilian employee who resided at U.S. military bases in Northern Europe (Germany, Belgium, and the Netherlands) for 6 months or more cumulatively from 1980 through 1990, or elsewhere in Europe (Greece, Turkey, Spain, Portugal, and Italy) for 6 months or more cumulatively from 1980 through 1996.

I have spent 5 years or more cumulatively in Europe) from 1980 until the present (note this criterion includes time spent in the U.K. from 1980 through 1996)

I have received any transfusion of blood or blood components in the U.K. or France between 1980 and the present.

I or my sexual partners who were born or lived in certain countries in Africa (Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, or Nigeria) after 1977.

I have received a blood transfusion or any medical treatment that involved blood in the countries listed in criterion 24, after 1977.

I am a xenotransplantation product recipients or intimate contacts of a xenotransplantation product recipient. For the purpose of this document, we define the following terms:

i. Xenotransplantation is any procedure that involves the transplantation, implantation, or infusion into a human recipient of either: (1) live cells, tissues, or organs from a nonhuman animal source; or (2) human body fluids, cells, tissues, or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.

ii. Xenotransplantation products include live cells, tissues, or organs used in xenotransplantation. Biological products, drugs, or medical devices sourced from nonliving cells, tissues or organs from nonhuman animals, including but not limited to porcine insulin and porcine heart valves, are not considered xenotransplantation products.

iii. Xenotransplantation product recipient means a person who undergoes xenotransplantation

iv. Intimate contact of a xenotransplantation product recipient means a person who has engaged in activities that could result in intimate exchange of body fluids, including blood or saliva, with a xenotransplantation product recipient. Examples of intimate contacts include sexual partners, household members who share razors or toothbrushes, and health care workers or laboratory personnel with repeated percutaneous, mucosal, or other direct exposures. We do not consider sharing of housing or casual contact, such as hugging or kissing without the exchange of saliva, to be intimate contact.

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