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TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH SUBCHAPTER d: LABORATORIES AND BLOOD BANKS PART 460 BLOOD LABELING CODE SECTION 460.130 DONOR REQUIREMENT GUIDE
Section 460.130 Donor Requirement Guide
A guide for donor requirements follows:
a) General Appearance The donor shall appear to be in good health and free from acute respiratory diseases.
b) Age Blood donor shall be between the ages of 17 through 75 (up to 76th birthday) provided:
1) that the donor is 17 years of age or older
2) after the 76th birthday, donors may be accepted at the discretion of the blood bank director if they have specific written consent from a physician within two (2) weeks before the date of donation, and provided that they meet all other criteria for acceptability.
c) Temperature The oral temperature shall not exceed 99.6ºF. (37.5ºC.).
d) Hemoglobin or hematocrit
The measurement of either value is acceptable.
1) The hemoglobin shall be no less than 12.5 grams per 100 ml. for female donors, and no less than 13.5 grams per 100 ml. for male donors.
2) The hematocrit value shall be no less than 38 percent for females, and no less than 41 percent for males.
e) Pulse The pulse shall reveal no pathological cardiac irregularity and should be between 50 and 100 beats per minute.
f) Blood pressure The systolic blood pressure should be between 90 and 180 mm of mercury, and the diastolic should not exceed 100 mm of mercury. Prospective donors with diastolic blood pressure readings between 100 and 110 mm of mercury and donors with abnormal differences between their systolic and diastolic pressures may be accepted only after evaluation by a qualified physician.
g) Pregnancy Known existing pregnancy shall exclude a donor. Except for exceptional qualifying circumstances a donor shall be excluded for 6 weeks postpartum.
h) Dental surgery Tooth extraction or other minor oral surgery during the preceding 72 hours shall exclude a donor.
i) Receipt of blood, blood components Donors who during the preceding six months have received blood or those human blood components known to be a possible source of hepatitis shall be excluded.
j) Infectious diseases A donor shall be free from infectious diseases known to be transmissible by blood insofar as can be determined by usual examinations.
1) Viral Hepatitis
A) Donors with a history of viral hepatitis as well as those who within six months have had close contact with an individual having the disease shall be excluded.
B) A donor shall be excluded permanently:
i) If his were the only unit of blood, blood component, or derivative administered to a patient who within six months developed post/transfusion hepatitis and who received no other icterogenic blood fractions, or
ii) If his blood has ever been known to contain Hepatitis B antigen.
C) When hepatitis has developed after transfusion of blood, blood components, or derivatives from multiple donors, those donors who have not been previously suspected of hepatitis need not be rejected as future donors of whole blood. Each situation should be evaluated individually by the facility physician. The possible presence of the agent of 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 the presence of Hepatitis B antigen).
2) Malaria Travelers who have been in areas considered endemic for malaria by Malaria Program, Center for Disease Control, U.S. Department of Health, Education and Welfare, may be accepted as regular blood donors six months after return to the non/endemic area, providing they have been free of symptoms and have not taken antimalarial drugs. Prospective donors who have had malaria shall be deferred for three years after becoming asymptomatic and after cessation of therapy. Prospective donors who have taken anti/malarial prophylaxis or who have been military personnel in an endemic area shall be deferred for three 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 these restrictions.
3) Syphilis A positive serologic test for syphilis is cause for donor rejection. Donors may be acceptable when they become seronegative provided the previous positive result was not due to a condition which would result in continued exclusion.
4) Tuberculosis Prospective donors with clinically active tuberculosis are unacceptable. Donors with a positive tuberculin skin test, but without other abnormality, may be accepted if they have not taken prophylactic medication during the preceding 48 hours.
5) HIV Infection
A) Blood and blood components which have been found reactive when tested for evidence of infection with the human immunodeficiency virus (HIV) or any other identified causative agent of AIDS shall be rejected for blood donation in accordance with Section 460.140(e).
B) Prospective donors who request that their blood be tested for evidence of infection with HIV shall be referred to a HIV Counseling and Testing Center designated by the Illinois Department of Public Health.
k) Immunizations or vaccinations:
1) Symptom/free donors who have been immunized with toxoids, or killed viral, bacterial or rickettsial vaccines are acceptable after 24 hours. This includes tetanus, typhoid, paratyphoid, cholera, diptheria, typhus, Rocky Mountain spotted fever, influenza, polio (Salk), plague and prophylactic rabies duck embryo vaccines.
2) Smallpox: Donors are acceptable either after the scab has fallen off or two weeks after an immune reaction.
3) Measles (rubeola), mumps, yellow fever, oral polio vaccine and animal serum products: Donors are acceptable two weeks after their last immunization or last antigenic dose. German measles (rubella): Donors are acceptable three months after their last injection.
4) Rabies: Donors will be deferred until one year after their last injection.
l) Donor skin The skin at the venipuncture site shall appear free of lesions. History of a tattoo performed any place on the body within six months of donation shall be cause for rejection.
m) Alcohol, narcotics Obvious stigmata of narcotic or alcoholic habituation or intoxication shall exclude a donor.
n) Allergy Prospective donors with symptoms of bronchial asthma should be deferred.
o) Oral medication History of recent drug therapy should be evaluated by a physician since the indication for such treatment may be cause for donor rejection. Exceptions to this requirement include ingestion of vitamins or oral contraceptives.
p) Therapeutic bleedings Any blood withdrawn from a person for a therapeutic purpose and intended for future homologous transfusion shall be labeled to indicate the donor's disease. Therapeutic bleedings shall be performed only at the written request of a person's physician. The facility physician must decide whether he will accept the responsibility of bleeding the person in the facility. The use of this blood for transfusion purposes shall be submitted for the consideration of the physician in charge of the facility and of the physician attending the prospective recipient.
q) Weight and amount of blood Donors weighing 110 lbs (50 kg) or more may ordinarily give 450 plus or minus 45 ml of blood, in addition to pilot samples which shall not exceed 30 ml. Donors weighing less than 110 lbs may be bled proportionately less in a reduced volume of anticoagulant, provided the regulations oulined in Section 450.835 are met. Prospective donations of blood exceeding the recommended amounts shall be subject to evaluation by a qualified physician.
r) Medical discretion Any of the above criteria may be waived or modified by the facility physician in charge and the donor's physician, for certain medical indications related to the therapy of the donor. This waiver privilege extends to pregnancy and/or the products of the donor's conception.
s) Fasting Fasting prior to blood donation is unnecessary.
t) Before any blood is collected, all donors shall be informed that:
1) Each unit of donated blood will be tested for the presence of antibodies to HIV or any other identified causative agent of AIDS.
A) All donors shall be informed about the following:
i) the meaning of the HIV test results, such as the purpose, potential use, limitations of the test and test results; the use of additional confirmatory testing and the related notification procedures; and the availability of referrals for further information and counseling.
ii) The opportunity to refuse HIV testing. If testing is refused, then the person will not be accepted as a donor.
B) Collection of a donor's blood is not permitted without signed written consent of the donor allowing disclosure of the test results to the donor. However, the written informed consent required by P.A. 85-677 and 85-679, effective September 21, 1987 and 77 Ill. Adm. Code 697.120 is not necessary because blood donors are specifically required by law to be tested.
2) Persons infected with the HIV virus are potentially infectious to persons with whom they have contact through sexual relations or the sharing of blood or blood components. Persons with increased risk (high risk) of being infected with HIV must not donate blood, except for purposes of autologous transfusion. High risk persons include the following:
A) persons who have signs and symptoms suggestive of Acquired Immunodeficiency Syndrome (AIDS) (e.g. a combination of two or more of the following: unexpected weight loss of greater than 10% of body weight, chronic fever, chronic lymphadenopathy, night sweats or chronic diarrhea);
B) persons who have had sexual contact with HIV infected persons;
C) males who have had sexual contact with a male anytime since 1977;
D) persons who have immigrated from countries where heterosexual activity is though to play a major role in transmission of HIV infection, such as Central Africa and Haiti anytime since 1977 as recognized by the Centers for Disease Control;
E) persons who are (were) present (past) intravenous drug users by self injection;
F) hemophiliacs; or
G) current of former sexual partners of any of the above.
3) Confirmed, available, test results showing evidence of HIV infection (e.g. Western blot assay or Indirect Fluorescent Antibody tests) will be disclosed in a confidential manner to the donor's physician or the donor no later than 55 days after the date of donation as described in Section 460.840(e).
(Source: Amended at 12 Ill. Reg. 9998, effective May 27, 1988) |