As used in this part and in part 610, subpart E, and part 640 of this chapter:

Blood means a product that is a fluid containing dissolved and suspended elements which was collected from the vascular system of a human.

Blood component means a product containing a part of blood separated by physical or mechanical means.

Donor means a person who: (1) Donates blood or blood components for transfusion or for further manufacturing use; or

Presents as a potential candidate for such donation.

Eligibility of a donor means the determination that the donor is qualified to donate blood and blood components.

Infrequent plasma donor means a donor who has:

Not donated plasma by plasmapheresis or a co-collection of plasma with another blood component in the preceding 4 weeks; and

Not donated more than 12.0 liters of plasma (14.4 liters of plasma for donors weighing more than 175 pounds) in the past year.

Intimate contact with risk for a relevant transfusion-transmitted infection means having engaged in an activity that could result in the transfer of potentially infectious body fluids from one person to another.

Physician substitute means a trained and qualified person(s) who is:

A graduate of an education program for health care workers that includes clinical training;

Currently licensed or certified as a health care worker in the jurisdiction where the collection establishment is located;

Currently certified in cardiopulmonary resuscitation; and

Trained and authorized under State law, and/or local law when applicable, to perform the specified functions under the direction of the responsible physician.

Relevant transfusion-transmitted infection means:

Any of the following transfusion-transmitted infections:

Human immunodeficiency virus, types 1 and 2 (referred to, collectively, as HIV);

Hepatitis B virus (referred to as HBV);

Hepatitis C virus (referred to as HCV);

Human T-lymphotropic virus, types I and II (referred to, collectively, as HTLV);

Treponema pallidum (referred to as syphilis);

West Nile virus;

Trypanosoma cruzi (referred to as Chagas disease);

Creutzfeldt-Jakob disease (referred to as CJD);

Variant Creutzfeldt-Jakob disease (referred to as vCJD); and

Plasmodium species (referred to as malaria).

A transfusion-transmitted infection not listed in paragraph (h)(1) of this section when the following conditions are met:

Appropriate screening measures for the transfusion-transmitted infection have been developed and/or an appropriate screening test has been licensed, approved, or cleared for such use by FDA and is available; and

The disease or disease agent:

May have sufficient incidence and/or prevalence to affect the potential donor population; or

May have been released accidentally or intentionally in a manner that could place potential donors at risk of infection.

Responsible physician means an individual who is:

Licensed to practice medicine in the jurisdiction where the collection establishment is located;

Adequately trained and qualified to direct and control personnel and relevant procedures concerning the determination of donor eligibility; collection of blood and blood components; the immunization of a donor; and the return of red blood cells or other blood components to the donor during collection of blood component(s) by apheresis; and

Designated by the collection establishment to perform the activities described in paragraph (i)(2) of this section.

Suitability of the donation means a determination of whether the donation is acceptable for transfusion or for further manufacturing use.

Trained person means an individual, including a physician substitute, who is authorized under State law, and/or local law when applicable, and adequately instructed and qualified to perform the specified functions under the direction of the responsible physician.

Transfusion-transmitted infection means a disease or disease agent:

That could be fatal or life-threatening, could result in permanent impairment of a body function or permanent damage to a body structure, or could necessitate medical or surgical intervention to preclude permanent impairment of body function or permanent damage to a body structure; and

For which there may be a risk of transmission by blood or blood components, or by a blood derivative product manufactured from blood or blood components, because the disease or disease agent is potentially transmissible by that blood, blood component, or blood derivative product.