IC 16-41-12-20: Blood center supervision; medical directors

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.