TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER d: LABORATORIES AND BLOOD BANKS
PART 490 ILLINOIS BLOOD BANK CODE
SECTION 490.720 DONORS AND DONOR BLOOD – CRITERIA FOR DONOR SELECTION


 

Section 490.720 Donors and Donor Blood Criteria for Donor Selection

 

The following rules shall be applied on the day of donation by trained persons and results shall be recorded (See Section 490.440 of this Part).

 

a) The following requirements shall apply to determine donor suitability.

 

1) Prospective donors with a history of chronic disease of the heart, kidneys, lungs, liver, etc.; or with a history of cancer, except minor skin cancer; or abnormal bleeding tendencies; shall be excluded subject to evaluation by a physician on the day of donation.

 

2) The interval between individual donations shall be at least 8 weeks.

 

3) The amount of whole blood (not including anticoagulant) removed from a donor during a plasmapheresis procedure or in any 48-hour period, shall not exceed 1,000 ml unless the donor's weight is 80 kg (176 pounds) or greater. If the donor's weight is 80 kg or greater, the amount of whole blood removed during a plasmapheresis procedure or in any 48-hour period shall not exceed 1,500 ml. Within a 7-day period, the amount of whole blood removed shall not exceed 2,000 ml. unless the donor's weight is 80 kg (176 pounds) or greater, in which case it shall not exceed 2,400 ml.

 

4) Whole blood donations shall be deferred for at least 48 hours after plasmapheresis.

 

b) The donor shall be free of disease transmissible by blood transfusion as ascertained at the time of collection in accordance with the guide for donor requirements. (See subsection (c) of this Section).

 

c) If the following requirements are not met, the donor shall be rejected.

 

1) General Appearance

The donor shall appear to be in good health and free from acute respiratory diseases.

 

2) Age

Blood donor shall be between the ages of 17 through 75 (up to 76th birthday) provided:

 

A) that the donor is 17 years of age or older

 

B) 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 they meet all other criteria for acceptability (See Section 490.40(c)(5) of this Part).

 

3) Temperature

The oral temperature shall not exceed 99.6 degrees Fahrenheit (37.5 degrees Centigrade)

 

4) Hemoglobin or hematocrit

 

The measurement of either value is acceptable.

 

A) The hemoglobin shall be no less than 12.5 grams per dl.

 

B) The hematocrit value shall be no less than 36 percent for females, and no less than 38 percent for males.

 

5) Pulse

The pulse shall reveal no pathological cardiac irregularity and shall be between 50 and 100 beats per minute.

 

6) Blood Pressure

The systolic blood pressure shall be between 90 and 180 mm of mercury, and the diastolic shall not exceed 100 mm of mercury.

 

7) Pregnancy

Known existing pregnancy shall preclude donation. A prospective donor shall be excluded for 6 weeks postpartum.

 

8) Receipt of blood or blood components

Prospective donors who during the preceding six months have received blood or human blood components known to be a possible source of hepatitis, shall be excluded.

 

9) Infectious Diseases

A donor shall be free from infectious diseases known to be transmissible by blood insofar as can be determined by usual examinations and history as indicated below.

 

A) Viral Hepatitis

 

i) Prospective donors with a history of viral hepatitis shall be excluded.

 

ii) A prospective donor shall be excluded permanently if the donor's blood was the only unit of blood or blood component administered to a patient who within six months developed posttransfusion hepatitis and who received no other blood derivative known to transmit vital hepatitis and there was no other probable source of infection.

 

iii) A prospective donor shall be excluded permanently if the donor has a history of a reactive test for hepatitis B surface antigen.

 

iv) 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 blood bank physician.

 

B) Travelers who have been in areas considered endemic for malaria by the Malaria Branch, Centers for Disease Control, U.S. Department of Health and Human Services, may be accepted as regular blood donors six months after return to the nonendemic area, providing they have been free of unexplained febrile illnesses 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 antimalarial prophylaxis or who have been 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 derivatives devoid of intact red blood cells are exempted from these restrictions.

 

C) Syphilis

A donor whose blood tests positive for syphilis shall be rejected. Prospective donors may be acceptable when they become seronegative upon approval by the blood bank medical director.

 

D) Tuberculosis

Prospective donors with clinically active tuberculosis are unacceptable. Prospective donors with a positive tuberculin skin test, but without underlying medical conditions, may be accepted if they have not taken prophylactic medication during the preceding 48 hours.

 

E) HIV Infection

 

i) 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 490.750(b).

 

ii) 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.

 

10) Immunizations or vaccinations:

 

A) Persons recently immunized with toxoids and killed virus, bacterial and rickettesial vaccines are acceptable, if they are symptom-free and afebrile. These include vaccines against hepatitis B, tetanus, diphtheria, pertussis, typhoid, paratyphoid, cholera, typhus, Rocky Mountain spotted fever, influenza, polio (injection) and plague. The same rules apply for rabies vaccine (duck embryo or human diploid) unless the vaccination has been given following a bite by a rabid animal in which case the donor is deferred until 1 year after the bite.

 

B) After vaccination for smallpox, donors are acceptable when the scab has fallen off or 2 weeks after an immune reaction. Following inoculation with attenuated virus vaccines such as polio (oral), measles (rubeola), mumps or yellow fever, donors are deferred for 2 weeks; following inoculation for German measles (rubella), deferral is for 4 weeks.

 

C) Prospective donors shall be deferred for 12 months after receiving Hepatitis B Immune Globulin (HBIG).

 

11) Donor skin

The skin at the venipuncture site shall be free of lesions and no tattoo was performed any place on the body within six months prior to donation.

 

12) Alcohol, narcotics

Obvious stigmata of narcotic or alcoholic habituation or intoxication shall exclude a donor.

 

13) Oral medication

History of recent drug therapy shall 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.

 

14) 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 blood bank medical director shall decide whether the person will be bleed in the blood bank. The use of this blood for transfusion purposes shall be determined by the physician in charge of the blood bank and of the physician attending the prospective recipient.

 

15) 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, except that it is not necessary to reduce the amount of anticoagulant calculated for 450 ml of blood when the amount of blood drawn is 300 ml to 405 ml. Prospective donations of blood exceeding the recommended amounts shall be subject to evaluation by a physician.

 

16) Medical discretion

Any of the above criteria may be waived or modified by the medical director and the donor's physician, for certain medical indications related to the therapy of the donor.

 

d) 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 AIDS Confidentiality Act Ill. Rev. Stat 1987, ch. 111, par. 7301 et seq.) 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 HIV 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 virus must not donate blood, except for the purpose 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 than 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 the HIV infected-persons;

 

C) males who have sexual contact with a male anytime since 1977;

 

D) persons who have immigrated from countries where heterosexual activity is thought 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 or 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 490.750(b) of this Part.