Bill Text: IN HB1038 | 2013 | Regular Session | Engrossed
Bill Title: Blood donation testing.
Spectrum: Slight Partisan Bill (Republican 2-1)
Status: (Passed) 2013-05-13 - Public Law 213 [HB1038 Detail]
Download: Indiana-2013-HB1038-Engrossed.html
Citations Affected: IC 16-18; IC 16-41; IC 35-42.
Synopsis: Blood donation testing. Defines "blood" for purposes of
regulating blood centers. Includes: (1) blood and plasma used for
research purposes; and (2) human cells, tissues, or cellular or
tissue-based products; as exceptions to the requirement of the disposal
of tested materials with an inconclusive result. Requires a blood center
to obtain an individual's Social Security number if the blood donor
receives monetary compensation for the donation. Allows a blood
center to distribute blood or plasma before the completion of a
screening test in a documented medical emergency and sets forth
requirements. Amends the exception to the crime of transferring
contaminated body fluids for a person who is an autologous blood
donor. Makes conforming changes.
Effective: July 1, 2013.
(SENATE SPONSORS _ MILLER PATRICIA, BREAUX)
January 7, 2013, read first time and referred to Committee on Public Health.
January 24, 2013, amended, reported _ Do Pass.
January 29, 2013, read second time, amended, ordered engrossed.
January 30, 2013, engrossed.
January 31, 2013, read third time, passed. Yeas 95, nays 0.
February 25, 2013, read first time and referred to Committee on Health and Provider Services.
March 21, 2013, amended, reported favorably _ Do Pass.
April 1, 2013, read second time, amended, ordered engrossed.
PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana Constitution) is being amended, the text of the existing provision will appear in this style type, additions will appear in this style type, and deletions will appear in
Additions: Whenever a new statutory provision is being enacted (or a new constitutional provision adopted), the text of the new provision will appear in this style type. Also, the word NEW will appear in that style type in the introductory clause of each SECTION that adds a new provision to the Indiana Code or the Indiana Constitution.
Conflict reconciliation: Text in a statute in this style type or
A BILL FOR AN ACT to amend the Indiana Code concerning
health.
or blood components from a donor or patient for an intended
transfusion to the same donor or patient.
(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).
(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.
products 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.
(1) procurement, processing, distribution, or use of:
(A)
(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
(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
(2) is provided by a blood center under section 13(j) of this chapter and the blood or plasma 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.
(1) present medical and scientific practices in the field;
(2) rules and regulations of the federal Food and Drug Administration; and
(3) any other
(b) The blood center shall label blood or plasma
(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 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) The blood center may not ship any blood or plasma before the completion of the screening test except for 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 provide the test results immediately to the patient, the patient's representative, and the patient's health care provider.
SECTION 2, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2013]: 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 request a blood donor to provide the blood
donor's Social Security number.
(c) (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).
(d) (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:
(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
(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. and
blood products.
(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. and blood products.
(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.
(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
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 products for a
purpose other than manufacturing or research under this subsection is
subject to the penalties described in section 21 of this chapter.
(b) A person who recklessly, knowingly, or intentionally donates, sells, or transfers blood (as defined in IC 16-41-12-2.5)
(c) However, the offense is a Class A felony if it results in the transmission of the human immunodeficiency virus (HIV) to any person other than the defendant.
(d) This section does not apply to:
(1) a person who, for reasons of privacy, donates, sells, or transfers blood
(2) a person who transfers blood,
(3) a person who is an autologous blood donor.
