Sec. 20. (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.]
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