N.Y. Comp. Codes R. & Regs. Tit. 10 § 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 or 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 of age, or older, except
that donors who are 76 or older may be accepted at the 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 donor 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 percent, 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.
Notes
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