2023 Indiana Code › Title 16. Health › Article 41. Public Health Measures for the Prevention and Control of Disease › Chapter 12. Communicable Disease: Precautionary Measures for Use of Human Tissues and Blood Products; Regulation of Blood Centers › 16-41-12-13. Screening Tests; Blood Labeling; Confirmatory Tests; Disposal of Blood; Notification and Referral of Donors; Records; Violations; Medical Emergencies

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