Section 490.710  General

a)         The definition of a "blood bank" is interpreted to include facilities operating or located in Illinois, fixed or mobile, used for the collection, processing, storage, distribution, and/or administration of human blood or any of its derivatives prior to transfusion including plasma, packed red blood cells, platelets, or leukocytes.  (See Section 490.30 of this Part)

b)         Any changes in the program or services of a blood bank shall be reported to the Department in writing within 30 days.  This includes the discontinuance or addition of a service as well as a change in the use of any reference or research facility by the blood bank.

c)         All phases of the selection of blood donors and of the collection, storage, processing, and administration of blood or blood components shall be the responsibility of the medical director.

d)         Provisions for medical care and hospital services for donors who sustain adverse reactions shall be established by written policy.

e)         A written standard operating procedure manual shall be maintained and followed and shall include all steps in the collection, processing, compatibility testing, storage and distribution of blood and blood components for homologous and autologous transfusion purposes in accordance with FDA standards (21 CFR 60.100)(1987).