§ 16-41-12-17 — Rules

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.]

Legislative History

As added by P.L.2-1993, SEC.24. Amended by P.L.213-2013, SEC.15.