2014 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
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IC 16-41-12
Chapter 12. Communicable Disease: Precautionary Measures
for Use of Human Tissues and Blood Products; Regulation of
Blood Centers
IC 16-41-12-1
Autologous donation
Sec. 1. As used in this chapter, "autologous donation" means the
removal and storage of blood from a donor or patient for an intended
transfusion to the same donor or patient.
As added by P.L.2-1993, SEC.24. Amended by P.L.213-2013, SEC.4.
IC 16-41-12-2
Bank
Sec. 2. As used in this chapter, "bank" has the meaning set forth
in IC 29-2-16.1-1.
As added by P.L.2-1993, SEC.24. Amended by P.L.147-2007, SEC.5.
IC 16-41-12-2.5
Blood
Sec. 2.5. (a) As used in this chapter, "blood" means any of the
following:
(1) Human blood.
(2) Human blood components.
(3) Human blood derivatives.
(b) The term does not include human cells, tissues, or cellular or
tissue-based products (HCT/Ps).
As added by P.L.213-2013, SEC.5.
IC 16-41-12-3
Blood center
Sec. 3. As used in this chapter, "blood center" includes a blood
bank, a blood storage facility, a plasma center, a hospital, or other
facility where blood is collected.
As added by P.L.2-1993, SEC.24. Amended by P.L.213-2013, SEC.6.
IC 16-41-12-4
Confirmatory test
Sec. 4. As used in this chapter, "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).
As added by P.L.2-1993, SEC.24.
IC 16-41-12-5
Directed donation
Sec. 5. As used in this chapter, "directed donation" means a
donation of blood collected from an individual on behalf of an
intended recipient of the transfusion.
As added by P.L.2-1993, SEC.24. Amended by P.L.213-2013, SEC.7.
IC 16-41-12-5.5
Distributed for use
Sec. 5.5. (a) As used in this chapter, "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.
(b) The term does not include the release or shipment of blood:
(1) to a researcher; or
(2) for further manufacturing;
as approved in writing by the federal Food and Drug Administration.
As added by P.L.213-2013, SEC.8.
IC 16-41-12-6
Hospital
Sec. 6. As used in this chapter, "hospital" has the meaning set
forth in IC 29-2-16.1-1.
As added by P.L.2-1993, SEC.24. Amended by P.L.147-2007, SEC.6.
IC 16-41-12-6.5
Human cells, tissues, or cellular or tissue-based products
Sec. 6.5. As used in this chapter, "human cells, tissues, or cellular
or tissue-based products" or "HCT/Ps" has the meaning set forth in
21 CFR 1271.3(d).
As added by P.L.213-2013, SEC.9.
IC 16-41-12-7
Physician
Sec. 7. As used in this chapter, "physician" has the meaning set
forth in IC 29-2-16.1-1.
As added by P.L.2-1993, SEC.24. Amended by P.L.147-2007, SEC.7.
IC 16-41-12-8
Screening test
Sec. 8. As used in this chapter, "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:
(1) Tests for antibodies to the human immunodeficiency virus
(HIV).
(2) Other tests determined by the state department.
As added by P.L.2-1993, SEC.24. Amended by P.L.213-2013,
SEC.10.
IC 16-41-12-9
Storage facility
Sec. 9. As used in this chapter, "storage facility" has the meaning
set forth in IC 29-2-16.1-1.
As added by P.L.2-1993, SEC.24. Amended by P.L.147-2007, SEC.8.
IC 16-41-12-10
Surgeon
Sec. 10. As used in this chapter, "surgeon" has the meaning set
forth in IC 29-2-16.1-1.
As added by P.L.2-1993, SEC.24. Amended by P.L.147-2007, SEC.9.
IC 16-41-12-11
Implied warranties; strict liability; screening tests; specification of
blood use; distributions by foreign blood centers
Sec. 11. (a) The:
(1) procurement, processing, distribution, or use of:
(A) blood;
(B) plasma;
(C) human cells, tissues, or cellular or tissue-based products;
or
(D) other human tissue, such as corneas, bones, or organs;
by a bank, storage facility, or hospital; and
(2) injection, transfusion, or transplantation of any of the human
tissue listed in subdivision (1) into the human body by a
hospital, physician, or surgeon, whether or not any remuneration
is paid;
is the rendition of a service and not the sale of a product. Such
services do not give rise to an implied warranty of merchantability or
fitness for a particular purpose, nor do the services give rise to strict
liability in tort.
(b) A hospital, physician, or other person is not required to
perform another screening test on blood or plasma that:
(1) is provided by a blood center if the blood or plasma is
labeled indicating that the blood or plasma has been tested as
required under section 13(b) of this chapter; or
(2) is provided by a blood center under section 13(j) of this
chapter and is labeled as required by 21 CFR 606.121(h).
(c) An autologous blood donor may specify that the donor's blood
must be used for the donor. Blood that is donated under this section
must be tested for the human immunodeficiency virus (HIV). The
blood center shall reserve the donor's blood for the purposes specified
by the donor and shall label the blood accordingly.
(d) A directed blood donor may specify that the donor's blood is
to be used for another person. The blood center shall consider the
medical suitability and the wishes of the donor and recipient in
making final distribution of the blood.
(e) The blood center is subject to penalties under this chapter if the
blood center knowingly fails to reserve the blood for the purposes
specified by the recipient under this section or if the blood center fails
to comply with subsections (c) through (d).
(f) A blood center located outside Indiana may not distribute:
(1) blood; or
(2) plasma;
in Indiana unless the blood center has certified to the state department
that the blood has undergone a screening test as required under this
chapter.
As added by P.L.2-1993, SEC.24. Amended by P.L.213-2013,
SEC.11.
IC 16-41-12-12
Rules
Sec. 12. The state department shall adopt rules under IC 4-22-2 to
carry out the purposes of this chapter. In formulating the rules, the
state department shall consider:
(1) present medical and scientific practices in the field;
(2) rules and regulations of the federal Food and Drug
Administration; and
(3) any other procedure that should be followed to reasonably
ensure the safety of the donor and recipient of blood.
As added by P.L.2-1993, SEC.24. Amended by P.L.213-2013,
SEC.12.
IC 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.
As added by P.L.2-1993, SEC.24. Amended by P.L.59-2012, SEC.1;
P.L.213-2013, SEC.13.
IC 16-41-12-14
Confidentiality of information; violations
Sec. 14. (a) A person may not disclose or be compelled to disclose
information collected under this chapter or under rules adopted under
this chapter. This information may not be released or made public
upon subpoena or otherwise, except under the following
circumstances:
(1) For statistical purposes if done in a manner that does not
identify any individual.
(2) With the written consent of all individuals identified in the
information released.
(3) To the extent necessary to enforce public health laws or to
protect the health or life of a named person.
(b) Except as provided in subsection (a), a person responsible for
recording, reporting, or maintaining information required to be
reported under this chapter who recklessly, knowingly, or
intentionally discloses or fails to protect information classified as
confidential under this section commits a Class A misdemeanor.
(c) In addition to subsection (b), a public employee who violates
this section is subject to discharge or other disciplinary action under
the personnel rules of the agency that employs the employee.
As added by P.L.2-1993, SEC.24.
IC 16-41-12-15
Donor information; informed consent
Sec. 15. (a) A blood center shall require a blood donor to provide
to the blood center the following information:
(1) Name.
(2) Address.
(3) Date of birth.
(4) The blood donor's Social Security number, if the blood
donor is receiving monetary compensation for the donation.
(b) A blood center shall report the name and address of a blood
donor to the state department when a confirmatory test of the blood
donor's blood confirms the presence of antibodies to the human
immunodeficiency virus (HIV).
(c) A blood center shall provide to a blood donor information to
enable the blood donor to give informed consent to the procedures
required by this chapter or IC 16-36. The information required by this
subsection must be in the following form:
NOTICE
(1) This blood center performs a screening test for the human
immunodeficiency virus (HIV) on every donor's blood.
(2) This blood center reports to the state department of health
the name and address of a blood donor when a confirmatory test
of the blood donor's blood confirms the presence of antibodies
to the human immunodeficiency virus (HIV).
(3) A person who recklessly, knowingly, or intentionally
donates (excluding self-donations for stem cell transplantation,
other autologous donations, or donations not intended by the
blood center for distribution or use), sells, or transfers blood that
contains antibodies for the human immunodeficiency virus
(HIV) commits transferring contaminated blood, a Level 5
felony. The offense is a Level 4 felony if the offense results in
the transmission of the virus to another person.
As added by P.L.2-1993, SEC.24. Amended by P.L.59-2012, SEC.2;
P.L.213-2013, SEC.14; P.L.158-2013, SEC.243; P.L.168-2014,
SEC.31.
IC 16-41-12-16
Blood center licensing; inspections
Sec. 16. (a) It is unlawful to operate a blood center in Indiana
without a license issued by the state department under this chapter.
A blood center that applies for a license in Indiana must also be
licensed or appropriately registered by the federal Food and Drug
Administration and remain in compliance with all applicable federal
regulations.
(b) An application for a license must be made on a form prescribed
by the state department and must be accompanied by a license fee
established by the state department.
(c) After inspection of an applicant's facility, if the state
department finds that the applicant has complied with this chapter
and the rules adopted under this chapter, the state department shall
issue a license to the applicant.
(d) A license expires one (1) year after the date of issuance unless
the license is renewed. A blood center may submit a renewal
application on a form prescribed by the state department. The
procedure and conditions for renewal are the same as the procedure
and conditions established for the issuance of the original license.
(e) A person who inspects an applicant's facility under this section
must have knowledge in blood banking and the nationally accepted
standards of practice.
(f) For the purposes of this chapter, a hospital licensed under
IC 16-21-2 that operates a blood center within the facility is subject
to the rules adopted under this chapter concerning the operation of
the blood center. However, the hospital may be licensed only under
IC 16-21-2 and shall be surveyed concurrently, for licensure
purposes, as a blood center and a hospital.
As added by P.L.2-1993, SEC.24.
IC 16-41-12-17
Rules
Sec. 17. The state department may adopt rules under IC 4-22-2,
after considering the guidelines of the federal Food and Drug
Administration, for the minimum standards and specific requirements
for operation of a blood center, including the following:
(1) Physical facilities, including refrigeration, lighting,
construction, and equipment of the blood center to ensure the
operation of the blood center in a manner that protects the
public health.
(2) Testing procedures for communicable diseases transmitted
by blood.
(3) Standards for collection, processing, storage, distribution,
and proper conduct of the blood transfusion service of blood.
(4) Identification and screening of donors.
(5) Qualifications for medical and laboratory personnel
employed in a blood center.
(6) Restrictions on the use of blood and plasma donations.
(7) System of identifying the donor of the blood at all times,
including after the blood has been administered to the recipient.
(8) Establishment of a system for determining the inventory
level of blood in all blood centers and the coordination of the
distribution of blood.
(9) Proficiency testing.
(10) All sanitary conditions within the blood center and the
blood center's surroundings needed to protect the public and the
employees.
(11) A quality assurance program.
As added by P.L.2-1993, SEC.24. Amended by P.L.213-2013,
SEC.15.
IC 16-41-12-18
Blood shortage emergencies
Sec. 18. (a) This section does not apply to a blood center when the
blood center declares a blood shortage emergency for a specific or
unusual blood type for a specific patient.
(b) A blood center must have written criteria for a blood shortage
emergency before the blood center may declare a blood shortage
emergency. The criteria required under this section must be based on
quantitative factors within the geographic region served by the blood
center.
(c) A blood center must file the written criteria required under this
section with the state department.
(d) Unless an emergency is declared by another regional blood
center, a blood center may not declare a blood shortage emergency
for the sole purpose of selling or transferring blood to another center.
(e) Whenever a blood center declares a blood shortage emergency,
the blood center shall notify the state department and affirm that a
blood shortage emergency exists.
As added by P.L.2-1993, SEC.24.
IC 16-41-12-19
Transfusion records; financial information; proficiency
demonstrations; operation reports
Sec. 19. (a) A 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.
The record must be made available to the state department for
inspection.
(b) The state department may require a blood center to submit
financial information on allegations of financial impropriety
involving the blood supply.
(c) The state department may require the demonstration of
proficiency in the performance of the tests offered by the blood
center.
(d) The state department may require the owner and director of a
blood center to submit reports under oath that contain information
and data concerning the technical operation of the blood center.
As added by P.L.2-1993, SEC.24.
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.
As added by P.L.2-1993, SEC.24. Amended by P.L.213-2013,
SEC.16.
IC 16-41-12-21
Inspections; violations
Sec. 21. (a) The state department may designate an agent who
may, upon presentation of proper credentials, enter a facility to
inspect for possible violations of this chapter or rules adopted under
this chapter.
(b) The state department may commence an action under
IC 4-21.5-3-6 or IC 4-21.5-4 for issuance of an order of compliance
and civil penalty not to exceed ten thousand dollars ($10,000) per
violation per day against a person who:
(1) fails to comply with this chapter or rules adopted under this
chapter; or
(2) interferes with or obstructs the state department or the state
department's designated agent in the performance of official
duties under this chapter.
(c) The state department may commence an action to suspend or
revoke a blood center's license under IC 4-21.5-3-8 or IC 4-21.5-4 if
the licensee has done any of the following:
(1) Made false statements concerning material information on
the license application or any other document required by the
state department.
(2) Permitted unauthorized persons to perform medical or
technical procedures (as defined by the state department by rule
adopted under this chapter) when a licensed physician licensed
to practice medicine in Indiana is not available for consultation.
(3) Demonstrated incompetence in the performance of any
procedure.
(4) Performed a procedure for which approval was not granted.
(5) Operated the center in a manner considered hazardous to
public health.
(6) Violated this chapter or rules adopted under this chapter.
(d) The state department may report to any other board or agency
responsible for licensure, registration, or certification of health care
providers, facilities, or other health care workers an individual or
facility that is found to be operating in violation of this chapter or
rules adopted under this chapter.
As added by P.L.2-1993, SEC.24.
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