§ 630.3 Definitions. As used in this part and in part 610, subpart E, and part 640 of this chapter: ( a ) *Blood* means a product that is a fluid containing dissolved and suspended elements which was collected from the vascular system of a human.
( b ) *Blood component* means a product containing a part of blood separated by physical or mechanical means.
( c ) *Donor* means a person who: ( 1 ) Donates blood or blood components for transfusion or for further manufacturing use; or
( 2 ) Presents as a potential candidate for such donation.
( d ) *Eligibility of a donor* means the determination that the donor is qualified to donate blood and blood components.
( e ) *Infrequent plasma donor* means a donor who has: ( 1 ) Not donated plasma by plasmapheresis or a co-collection of plasma with another blood component in the preceding 4 weeks; and
( 2 ) 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.
( f ) *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.
( g ) *Physician substitute* means a trained and qualified person(s) who is: ( 1 ) A graduate of an education program for health care workers that includes clinical training;
( 2 ) Currently licensed or certified as a health care worker in the jurisdiction where the collection establishment is located;
( 3 ) Currently certified in cardiopulmonary resuscitation; and
( 4 ) Trained and authorized under State law, and/or local law when applicable, to perform the specified functions under the direction of the responsible physician.
( h ) *Relevant transfusion-transmitted infection* means: ( 1 ) Any of the following transfusion-transmitted infections: ( i ) Human immunodeficiency virus, types 1 and 2 (referred to, collectively, as HIV);
( ii ) Hepatitis B virus (referred to as HBV);
( iii ) Hepatitis C virus (referred to as HCV);
( iv ) Human T-lymphotropic virus, types I and II (referred to, collectively, as HTLV);
( v ) *Treponema pallidum* (referred to as syphilis);
( vi ) West Nile virus;
( vii ) *Trypanosoma cruzi* (referred to as Chagas disease);
( viii ) Creutzfeldt-Jakob disease (referred to as CJD);
( ix ) Variant Creutzfeldt-Jakob disease (referred to as vCJD); and
( x ) *Plasmodium* species (referred to as malaria).
( 2 ) A transfusion-transmitted infection not listed in paragraph (h)(1) of this section when the following conditions are met: ( i ) 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
( ii ) The disease or disease agent: ( A ) May have sufficient incidence and/or prevalence to affect the potential donor population; or
( B ) May have been released accidentally or intentionally in a manner that could place potential donors at risk of infection.
( i ) *Responsible physician* means an individual who is: ( 1 ) Licensed to practice medicine in the jurisdiction where the collection establishment is located;
( 2 ) 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
( 3 ) Designated by the collection establishment to perform the activities described in paragraph (i)(2) of this section.
( j ) *Suitability of the donation* means a determination of whether the donation is acceptable for transfusion or for further manufacturing use.
( k ) *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.
( l ) *Transfusion-transmitted infection* means a disease or disease agent: ( 1 ) 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
( 2 ) 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.