Sec. 20. (a) Except as provided in subsection (c), a responsible head (as defined in 21 C.F.R. § 600.10(a)) shall supervise the operations of a blood center.

     (b) Except as provided in subsection (d), each blood center must employ a medical director who is a licensed physician and who:

Terms Used In Indiana Code 16-41-12-20

  • bank: has the meaning set forth in Indiana Code 16-41-12-2
  • blood: means any of the following:

    Indiana Code 16-41-12-2.5

  • blood center: includes a blood bank, a blood storage facility, a plasma center, a hospital, or other facility where blood is collected. See Indiana Code 16-41-12-3
  • Donor: The person who makes a gift.
  • physician: has the meaning set forth in Indiana Code 16-41-12-7
  • Year: means a calendar year, unless otherwise expressed. See Indiana Code 1-1-4-5
(1) is certified or eligible for certification in:

(A) clinical pathology; or

(B) the operation of a blood bank;

by the American Board of Pathology; or

(2) has:

(A) received a minimum of one (1) year of specialized training in blood banking; or

(B) equivalent experience and training.

     (c) The medical director shall supervise and is responsible for the following:

(1) The proper performance of all medical procedures in the blood center.

(2) The continuous application of quality assurance procedures in the blood center.

     (d) A blood center collecting blood exclusively for further manufacturing or research purposes under programs subject to and licensed by the federal Food and Drug Administration must employ a medical director who is a licensed physician to supervise the donor screening process. A blood center that utilizes blood for a purpose other than manufacturing or research under this subsection is subject to the penalties described in section 21 of this chapter.

[Pre-1993 Recodification Citation: 16-8-7-11.]

As added by P.L.2-1993, SEC.24. Amended by P.L.213-2013, SEC.16.