The state department may adopt rules under IC 4-22-2 , after considering the guidelines of the federal Food and Drug Administration, for the minimum standards and specific requirements for operation of a blood center, including the following:
- (1) Physical facilities, including refrigeration, lighting, construction, and equipment of the blood center to ensure the operation of the blood center in a manner that protects the public health.
- (2) Testing procedures for communicable diseases transmitted by blood.
- (3) Standards for collection, processing, storage, distribution, and proper conduct of the blood transfusion service of blood.
- (4) Identification and screening of donors.
- (5) Qualifications for medical and laboratory personnel employed in a blood center.
- (6) Restrictions on the use of blood and plasma donations.
- (7) System of identifying the donor of the blood at all times, including after the blood has been administered to the recipient.
- (8) Establishment of a system for determining the inventory level of blood in all blood centers and the coordination of the distribution of blood.
- (9) Proficiency testing.
- (10) All sanitary conditions within the blood center and the blood center's surroundings needed to protect the public and the employees.
(11) A quality assurance program.
[Pre-1993 Recodification Citation: 16-8-7-8.]
As added by P.L.2-1993, SEC.24. Amended by P.L.213-2013, SEC.15.