Indiana Code 16-41-12-13. Screening tests; blood labeling; confirmatory tests; disposal of blood; notification and referral of donors; records; violations; medical emergencies
(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.
Attorney's Note
Under the Indiana Code, punishments for crimes depend on the classification. In the case of this section:| Class | Prison | Fine |
|---|---|---|
| Class A misdemeanor | up to 1 year | up to $5,000 |
Terms Used In Indiana Code 16-41-12-13
- autologous donation: means the removal and storage of blood from a donor or patient for an intended transfusion to the same donor or patient. See Indiana Code 16-41-12-1
- blood: means any of the following:
Indiana Code 16-41-12-2.5
- blood center: includes a blood bank, a blood storage facility, a plasma center, a hospital, or other facility where blood is collected. See Indiana Code 16-41-12-3
- confirmatory test: means a laboratory test or a series of tests approved by the state department and used in conjunction with a screening test to confirm or refute the results of the screening test for the human immunodeficiency virus (HIV) antigen or antibodies to the human immunodeficiency virus (HIV). See Indiana Code 16-41-12-4
- distributed for use: refers to a blood center releasing or shipping blood for use in a blood inventory intended for or made available for transfusion or injection to a patient. See Indiana Code 16-41-12-5.5
- Donor: The person who makes a gift.
- hospital: has the meaning set forth in Indiana Code 16-41-12-6
- in writing: include printing, lithographing, or other mode of representing words and letters. See Indiana Code 1-1-4-5
- physician: has the meaning set forth in Indiana Code 16-41-12-7
- screening test: means a laboratory screening test or a series of tests approved by the federal Food and Drug Administration and required by the state department to be performed on blood collected under this chapter, including the following:
Indiana Code 16-41-12-8
(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 C.F.R. § 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.