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Title: Section 58-2.2 - Qualifications of donors

Effective Date

09/27/2015

58-2.2 Qualifications of donors.

(a) The medical director shall be responsible for the determination that blood may be collected safely from a donor and that the donor's blood is acceptable for collection. This determination shall be made by the medical director or trained staff members under the medical director's supervision on the day of collection of the blood. In addition, autogeneic collections prior to anticipated surgery or other medical procedure shall require the written authorization of the donor's health care provider and written consent of the donor. If autogeneic blood is to be subsequently used for allogeneic transfusion, all requirements in subdivision (f) of this section must be met.

(b) Only those persons may be accepted as donors of blood for allogeneic use who are in good health as indicated by:

(1) freedom from infectious skin lesions at the phlebotomy site and from any infectious skin disease generalized to an extent that creates a risk of contamination of the blood;

(2) freedom from any disease transmissible by blood transfusion, insofar as can be determined by history and examinations required in this Subpart;

(3) freedom from active tuberculosis. A person with a history of tuberculosis may be accepted as a blood donor following completion of drug therapy;

(4) freedom from syphilis. However, blood for plasma fractionation into heat-treated or pathogen-inactivated derivatives may be accepted;

(5) freedom from a history of viral hepatitis for a duration specified by the United States Public Health Service;

(6) freedom from a history of malaria or travel to or residence in malarially endemic areas for periods of time considered to increase risks for malaria exposure, as determined by the United States Public Health Service. However, plasma for transfusion fractionation may be accepted from donors with a history of malaria or travel to a malarially endemic area;

(7) freedom from signs and symptoms of human immunodeficiency virus (HIV) infection; and

(8) freedom from other medical contraindications.

(c) For allogeneic collection, a person may not be accepted as a blood donor:

(1) whose health may be affected adversely by the bleeding;

(2) who has received a transfusion of blood or blood components within the past year, with the exception of autogeneic transfusion;

(3) who is under 17 years of age, except that donors who are 16 years of age may be accepted, if they have presented written permission specific to the occasion from a parent or guardian;

(4) who is 76 years or older, except that donors who are 76 years or older may be accepted after satisfactory case-by-case review of the donor by the medical director or his/her designee;

(5) who is known to use or presents indications of having used illegal injectable drugs;

(6) whose oral temperature exceeds 37.5 degrees Celsius (99.5 degrees Fahrenheit);

(7) whose pulse after resting is faster than 110 or slower than 45 beats per minute, except if the donir is an athlete with high exercise tolerance; or whose pulse exhibits pathologic irregularities;

(8) whose systolic blood pressure exceeds 180 millimeters of mercury, or whose diastolic pressure exceeds 100 millimeters;

(9) whose weight is less than 50 kilograms (110 pounds), except that a donor whose weight is between 40 kilograms (88 pounds) and 50 kilograms (110 pounds) may donate a volume proportionate to the donor's weight, provided that the anticoagulant is proportionately reduced and the container is appropriately labeled;

(10) whose hemoglobin content is less than 12.5 grams per deciliter or whose hematocrit is less than 38%, as determined by techniques found by the department to meet medical standards generally accepted in New York State;

(11) who is known ever to have received pituitary-derived human growth hormone; or

(12) who falls into a category of individuals determined by the United States Public Health Service to be unsuitable for blood donation.

(d) For allogeneic collection:

(1) All donors shall be given educational materials on risk activities for HIV infection and shall be advised that persons at risk for HIV infection should refrain from donating blood.

(2) Each donor shall be provided the opportunity to indicate confidentially, at the time of donation or after donation, that blood collected may be unsuitable for transfusion.

(e) For autogeneic collection only:

(1) There are no age limits.

(2) The hemoglobin concentration of the donor-patient should be no less than 11 grams per deciliter, or the hematocrit, if substituted, should be no less than 33 percent, unless otherwise approved in writing by the medical director of the blood bank or other physician designated by such medical director.

(3) The frequency of phlebotomy for autogeneic transfusion shall be determined by the medical director of the blood bank and the donor-patient's physician. Phlebotomy of the donor-patient within 72 hours of the time of the anticipated surgery or transfusion must be authorized in writing by the medical director or other physician designated by the medical director.

(4) Donation for autogeneic transfusion should not be undertaken if medically contraindicated.

(f) Blood withdrawn for autogeneic transfusion may not be used for allogeneic transfusion unless the donor meets all the criteria set forth in subdivision (b), and paragraphs (c)(2), (5) and (6) of this section, and the unit meets the requirements set forth in section 58-2.3(a) of this Subpart. The minimum hemoglobin concentration for such a unit shall be 12.5 grams per 100 milliliters or a hematocrit of 38 percent, and the minimum volume for such a unit shall be 405 milliliters.

(g) Blood withdrawn in order to promote the health of a donor otherwise qualified under the provisions of this section shall not be used for transfusion unless the container label indicates the donor's disease that necessitated withdrawal of blood, except that, in the case of a donor with hemochromatosis, blood without such labeling may be used for transfusion, provided that the blood bank has demonstrated that therapeutic phlebotomy is available free of charge to hemochromatosis patients and that all other requirements of this Subpart have been met.

Volume

VOLUME A-1 (Title 10)

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