§ 30.30. Identification and screening of donors.
Selection for donor criteria shall at least be equivalent to all current Federal regulations and shall include the following:
(1) Donors must be identified by name, age, sex and address. There shall be a numerical system to positively identify and relate the donor, donor record, blood container and pilot tubes in each step from donor to recipient and including preparation of components.
(2) Donors shall be between the ages of 17 through 65. Donors between ages of 17 and 18 must have a written consent signed by a parent or guardian. Donors, after their 66th birthday, who meet all other criteria for acceptability may be accepted at the discretion of the medical director if they have obtained written consent from a physician within 2 weeks before the date of donation or if the medical director contacts the attending physician and secures concurrence.
(3) Intervals between donations of a full unit of blood shall be eight weeks except for autologous transfusion, and the interval between donations by plasmapheresis shall be at least 48 hours.
(4) Donors must be examined at the time of donation, and at least the following physical criteria must be within medically accepted limits for blood donors: temperature, blood pressure, and pulse. There must be no sign of acute disease or history of disease that will affect the normal use of blood. Any history of chronic disease shall disqualify the donor, unless specific approval is obtained from the donor and the medical director of the blood bank. Final acceptance of a donor is the responsibility of the medical director.
(5) Donors must weigh at least 110 pounds if they are to give a full donation of 480 milliliters. Donors weighing less than 110 pounds may be bled less than full amounts, when required, under the direct supervision of the medical director.
(6) All donors must be within normal limits of hemoglobin or hematocrit. Blood group and Rh type shall be determined and recorded for each donation. Blood group and Rh type determinations are not required for plasmapheresis donors.
(7) Donors shall be free from infectious diseases known to be transmissible by blood insofar as can be determined by usual examinations.
(i) Viral hepatitis. Donors with a history of viral hepatitis as well as those who, within 6 months, have had close contact with an individual having the disease, shall be excluded. A donor shall be excluded permanently if his was the only unit of blood, blood component, or derivative administered to a patient who, within 6 months, developed post-transfusion hepatitis and who received no other icterogenic blood fractions or his blood has ever been known to contain Hepatitis B Antigen (HBsAg). When hepatitis has developed after transfusion of blood, blood components, or derivatives from more than one donor, those donors who have not previously been suspected of hepatitis need not be rejected as future donors of whole blood; exclusion of other donors should be evaluated individually by the blood bank physician. The possible presence of the agent or viral hepatitis in donors cannot at present be detected with certainty by any available means, including history, physical examination, and laboratory tests, including a test for presence of HBsAg.
(ii) Malaria. Travelers who have been in areas considered endemic for malaria by the Malaria Program, Center for Disease Control, United States Department of Health, Education and Welfare, may be accepted as regular blood donors 6 months after return to the nonendemic area, provided they have been free of symptoms and have not taken antimalarial drugs in the interim. Prospective donors who have had malaria shall be deferred for 3 years either after becoming asymptomatic or after cessation of therapy, whichever is later. Prospective donors who have taken antimalaria prophylaxis or who have been military personnel in an endemic area shall be deferred for 3 years after cessation of therapy or after departure from the area if they have been asymptomatic in the interim. Immigrants or visitors from endemic areas may be accepted as blood donors three years after departure from the area if they have been asymptomatic in the interim. Donations to be used for the preparation of plasma, plasma components or fractions devoid of intact red blood cells are exempted from the restrictions set forth in this clause.
(iii) Syphilis and hepatitis. Donors must be nonreactive to standard serologic tests for syphilis and negative to (HBsAg) hepatitis antigen by acceptable systems of detection. If such tests are determined to be reactive or positive after blood has been obtained, the blood shall not be administered to humans. Source plasma obtained by plasmapheresis, intended for further manufacturing, may be utilized even if reactive to a standard serologic test for syphilis.
(8) Donors, other than plasmapheresis donors, shall be excluded if dental surgery has been performed within the past 72 hours.
(9) Known pregnancy shall exclude a donor. A donor shall be excluded for 6 weeks postpartum.
(10) Donors shall not give blood within 24 hours after immunization with inactivated vaccines or immunizing agents including prophylactic rabies and within 2 weeks after receiving live immunizing agents. Persons immunized for Rubella shall be acceptable as donors 2 months after receiving the last injection.
(11) Donors with a history of recent drug therapy shall be evaluated by a physician. Exceptions to this paragraph include ingestion of vitamins or oral contraceptives.
(12) Evidence of narcotic or alcoholic habituation or intoxication shall exclude a donor.
(13) Donors shall be excluded for a period of 6 months after receiving blood or blood components.
(14) The skin of the donor must be free of lesion at the site of phlebotomy.
(15) Donors with active tuberculosis shall be excluded.
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