1. (a) Except as provided in subsection (c), a responsible head (as defined in 21 CFR 600.10(a)) shall supervise the operations of a blood center.

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

   1. (1) is certified or eligible for certification in:

      1. (A) clinical pathology; or

      2. (B) the operation of a blood bank;

         by the American Board of Pathology; or

   2. (2) has:

      1. (A) received a minimum of one (1) year of specialized training in blood banking; or
      2. (B) equivalent experience and training.

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

   1. (1) The proper performance of all medical procedures in the blood center.
   2. (2) The continuous application of quality assurance procedures in the blood center.

4. (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.