§ 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.]

Legislative History

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