Subject 111-8-9 BLOOD LABELING
Unless a different meaning is required by the context, the following terms as used in these rules and regulations shall have the meaning hereinafter respectively ascribed to them:
|(a)||"Act" means "The Blood Labeling Act" (O.C.G.A. § 31-24-1et seq.);|
|(b)||"Person" means any individual, blood bank, clinical laboratory, hospital, firm, corporation or any other entity;|
|(c)||"Department" means the Georgia Department of Community Health;|
|(d)||"Board" means the Board of Community Health;|
|(e)||"Clinical Laboratory" means a single facility for the biological, microbiological, serological, immunological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body, for the diagnosis of, recommendation of treatment of, or for the purpose of providing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, man; the term "clinical laboratory" shall include blood banks which provide through their ownership or operation a system for the collection, processing, or storage of human blood and its component parts as well as tissue banks which store human or animal tissues designed to be used for medical purposes in human beings.|
|(f)||"Director" means a person who is responsible for the administration of the technical and scientific operation of a clinical laboratory, including supervision of procedures for testing and the reporting of results;|
|(g)||"Blood" means whole human blood, packed red blood cells, blood platelets, concentrated leukocytes, and blood plasma. It does not include blood derivatives manufactured or processed for industrial use.|
|(h)||"Donation" means any transaction involving the person from whom blood is withdrawn, whether he presents himself for the withdrawal of blood on his own initiative or on the initiative of another person, in which he receives no consideration other than credit through blood assurance programs or other intangible benefits.|
|(i)||"Purchase" means any transaction involving the person from whom blood is withdrawn, whether he presents himself for the withdrawal of blood on his own initiative or on the initiative of another person, in which he receives a monetary consideration in any form. Time off from work granted by an employer for the purpose of giving blood shall not be considered a direct monetary consideration.|
|(j)||"Industrial use" means a use of blood in which the blood is modified by physical or chemical means to produce derivatives for therapeutic or pharmaceutic biologicals and laboratory reagents or controls.|
|(k)||"Transfusion" means a use of blood in which the blood is administered to a human being for treatment of sickness or injury.|
No blood may be withdrawn from any individual in this State for transfusion or industrial use unless he qualifies to be a blood donor under the laws of this State. Criteria for donor selection shall conform to those required in accordance with provisions of the act providing for the control and operation of clinical laboratories (O.C.G.A. § 31-22-1et seq.) and the Rules and Regulations as adopted and promulgated thereunder entitled "Rules and Regulations for Licensure of Clinical Laboratories".
|(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:
|(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.|
|(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.|
|(4)||All certificates from out-of-state blood banks shall be retained by the receiving Georgia bank for at least five years.|
|(5)||All costs for both certificates and labels shall be borne by the blood bank involved.|
|(1)||No person may administer blood, transfer, or offer to transfer, blood or blood components for transfusion purposes by any type of transaction unless the container of such blood is labeled as required by these regulations. The label may not be removed before or during the administration of the blood or blood components.|
|(2)||A record must be maintained in the blood bank to identify the source of each unit as by "donation" or "purchase".|
|(3)||The identification numbers of the unit(s) of blood transfused shall be recorded in the patient's medical record by the person authorized to administer the blood. Records accompanying each unit of blood or blood products leaving a Blood Bank shall indicate whether such unit was acquired by donation or purchase.|
Blood and blood components, including salvage plasma, may be used and transferred for industrial uses without regard to whether its original acquisition was by purchase or donation.
Determination of fulfillment of these requirements shall be made by the Department of Community Health as a part of, and using the procedures of the Act providing for the control and operation of clinical laboratories (O.C.G.A. § 31-22-1et seq.).
Any person violating the provisions of the Act on which these Rules are based shall be guilty of a misdemeanor and upon conviction thereof shall be punished as for a misdemeanor.
The administration and enforcement of these rules and regulations shall be in accordance with the provisions of the Act providing for the control and operation of clinical laboratories (O.C.G.A. § 31-22-1et seq.), and in compliance with the applicable minimum requirements as prescribed by the Georgia Administrative Procedure Act (O.C.G.A. § 50-13-1et seq.).