Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › LICENSING, FEES AND INSPECTIONS › Section 30.30 - Identification and screening of donors

Current through Register Vol. 54, No. 28, July 13, 2024
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.