Section 16-41-12-20 - Blood center supervision; medical directors(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.(b) Except as provided in subsection (d), each blood center must employ a medical director who is a licensed physician and who:(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.
Amended by P.L. 213-2013, SEC. 16, eff. 7/1/2013.As added by P.L. 2-1993, SEC.24.