§ 16-41-12-13 — Screening tests; blood labeling; confirmatory tests; disposal of blood; notification and referral of donors; records; violations; medical emergencies

(a) Except as provided in subsection (j), a
blood center shall perform a screening test on a donor's blood and
obtain the results of the test before blood or plasma is distributed for
use.
(b) The blood center shall label blood or plasma before distribution
for use by the blood center to indicate the results of the screening tests
required by this chapter. The blood center shall also label each blood
sample according to the regulations of the federal Food and Drug
Administration.
(c) The blood center shall perform a confirmatory test on a blood
donation from a donor when the screening test performed under
subsection (a) yields repeatedly reactive results.
(d) Except for:
(1) a sample retained to perform a confirmatory test;
(2) blood or plasma units used for research purposes or in the
production of pharmaceutical products if the blood center or the
manufacturer of the pharmaceutical products has obtained
approval from the federal Food and Drug Administration;
(3) an autologous donation for stem cell transplantation; or
(4) other autologous donations of blood or HCT/Ps, if:
(A) the blood center agrees to distribute the blood or HCT/Ps
for use; and
(B) the attending physician has been informed of the screening
test results;
the blood center shall dispose of a blood donation after an inconclusive
or repeatedly reactive screening test has been performed. The disposal
must be made under rules adopted by the state department under this
chapter and IC 16-41-16.
(e) A blood center shall report to the state department the results of
each positive confirmatory test conducted under subsection (c).
(f) A blood center shall attempt to notify a donor and refer the donor
to counseling when the confirmatory test on the donor's blood is
inconclusive or indicates the presence of antibodies to the human
immunodeficiency virus (HIV).
(g) Each health care provider that administers blood transfusions
shall keep a record of the following:
(1) Blood center that furnished the blood.
(2) Unit number assigned to the blood.
(h) An employee who is responsible for conducting the screening
test required under this section who knowingly or intentionally fails to
conduct the screening test commits a Class A misdemeanor.
(i) A blood center may not ship any blood or plasma before the
completion of the screening test except in a documented medical
emergency, as described in subsection (j).
(j) This subsection applies when:
(1) a health care provider has determined that a patient is in
imminent danger of death;
(2) the results of the screening test performed on the blood
described in subsection (a) are not available at the time that the
blood is to be used;
(3) the patient or the patient's representative has been provided
notice that the results of the screening test performed on the blood
are not available and has consented in writing to the use of the
blood; and
(4) no other appropriate blood is available.
Subject to 21 CFR 610.40(g), a blood center may distribute for use
blood or plasma before the completion of the screening test in a
documented medical emergency. However, upon completion of the
screening test, the blood center shall immediately provide the test
results to the physician or hospital that received the blood or plasma
and the physician who is responsible for the patient.
[Pre-1993 Recodification Citation: 16-8-7-4.]

Legislative History

As added by P.L.2-1993, SEC.24. Amended by P.L.59-2012, SEC.1; P.L.213-2013, SEC.13.