§ 16-41-12-16 — Blood center licensing; inspections

(a) It is unlawful to operate a blood center
in Indiana without a license issued by the state department under this
chapter. A blood center that applies for a license in Indiana must also
be licensed or appropriately registered by the federal Food and Drug
Administration and remain in compliance with all applicable federal
regulations.
(b) An application for a license must be made on a form prescribed
by the state department and must be accompanied by a license fee
established by the state department.
(c) After inspection of an applicant's facility, if the state department
finds that the applicant has complied with this chapter and the rules
adopted under this chapter, the state department shall issue a license to
the applicant.
(d) A license expires one (1) year after the date of issuance unless
the license is renewed. A blood center may submit a renewal
application on a form prescribed by the state department. The
procedure and conditions for renewal are the same as the procedure and
conditions established for the issuance of the original license.
(e) A person who inspects an applicant's facility under this section
must have knowledge in blood banking and the nationally accepted
standards of practice.
(f) For the purposes of this chapter, a hospital licensed under IC 16-21-2 that operates a blood center within the facility is subject to the
rules adopted under this chapter concerning the operation of the blood
center. However, the hospital may be licensed only under IC 16-21-2
and shall be surveyed concurrently, for licensure purposes, as a blood
center and a hospital.
[Pre-1993 Recodification Citation: 16-8-7-7.]

Legislative History

As added by P.L.2-1993, SEC.24.