Rule 111-8-9-.03. Labeling for Containers of Blood; Certificates for Out-of-State Blood

(1) It shall be the responsibility of the licensed laboratory director to assure the legal requirement that every unit of blood drawn from an individual and any components derived by physical processes (including plasmapheresis for transfusions and blood for auto transfusions), shall have affixed to each container of such blood or components, a label which indicates whether the blood was obtained by purchase or donation. The label must be affixed prior to bleeding of the donor. The label shall meet the following specifications: (a) Labels shall state that content is "Blood From Paid Donor" or "Blood From Volunteer Donor". (b) Labels must be affixed in a prominent position, in such manner as not to obscure any other necessary identifying labels, and using non-toxic permanent type adhesive which is non-leachable through plastic blood bag. (c) If incorporated into the product label, the wording must be easily read, with block lettering in size described below: (d) If a separate label is used, such label must be: 1. No less than 3/8 inch by 11/4 inch in overall size; 2. With black letters on an orange background; and 3. Using bold Helvetica or similar block letters, capital height no less than five (5) points in size. See example below. BLOOD FROM VOLUNTEER DONOR BLOOD FROM PAID DONOR (e) If blood is received from out-of-state with individual labels which meets the above specifications, it need not have an additional label applied.

1. (2) The director of any blood bank who receives blood from a federally licensed blood bank in another state shall be responsible for acquiring a certificate from the out-of-state blood bank certified by its director, indicating which blood units in each shipment were acquired by "donation" or "purchase" as defined in these regulations. If he holds a certificate which certifies that the blood was received by donation, he may label such blood as donated blood. If he cannot obtain such a certificate, he shall label each unit of blood as blood acquired by purchase. In those instances where the supplying out-of-state blood bank draws blood exclusively from volunteer donors, only one certificate per year, acquired in advance, will be required.
2. (3) The certificate accompanying each shipment of blood or the single annual certificate shall be signed by the Director in whose name the blood bank is federally licensed or an individual authorized by him and so recorded.
3. (4) All certificates from out-of-state blood banks shall be retained by the receiving Georgia bank for at least five years.
4. (5) All costs for both certificates and labels shall be borne by the blood bank involved.

Authority: O.C.G.A. §§ 31-2-5, 31-2-7 and 31-24-1et seq.

History. Original Rule entitled "Labeling of Containers of Blood; Certificates for Out-of-State Blood" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.