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January 25, 2008





HOUSE BILL No. 1020

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DIGEST OF HB 1020 (Updated January 24, 2008 9:21 am - DI 77)



Citations Affected: IC 12-7; IC 12-31; IC 16-18; IC 16-21; noncode.

Synopsis: Umbilical cord blood bank. Requires the office of the secretary of family and social services to form a nonprofit corporation to establish and operate an umbilical cord blood bank. Requires suitable postnatal donations to be available for medical treatments and scientific research. Requires the nonprofit corporation to develop a process for physicians, nurse midwives, and participating hospitals to inform pregnant patients of the option to make postnatal donations following delivery of a newborn infant. Requires the nonprofit corporation to establish an umbilical cord blood donation initiative to promote public awareness concerning the medical benefits of umbilical cord blood. (The introduced version of this bill was prepared by the health finance commission.)

Effective: July 1, 2008.





Welch, Koch, Battles, Turner




    January 14, 2008, read first time and referred to Committee on Public Health.
    January 24, 2008, amended, reported _ Do Pass.





Printer's Error
January 25, 2008

Second Regular Session 115th General Assembly (2008)


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 this style type.
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 this style type reconciles conflicts between statutes enacted by the 2007 Regular Session of the General Assembly.

HOUSE BILL No. 1020



    A BILL FOR AN ACT to amend the Indiana Code concerning health.

Be it enacted by the General Assembly of the State of Indiana:

SOURCE: IC 12-7-2-118.3; (08)HB1020.2.1. -->     SECTION 1. IC 12-7-2-118.3 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 118.3. "Initiative", for purposes of IC 12-31-2, has the meaning set forth in IC 12-31-2-1.
SOURCE: IC 12-7-2-132.5; (08)HB1020.2.2. -->     SECTION 2. IC 12-7-2-132.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 132.5. "Nonprofit corporation", for purposes of IC 12-31, has the meaning set forth in IC 12-31-1-1.
SOURCE: IC 12-7-2-142.7; (08)HB1020.2.3. -->     SECTION 3. IC 12-7-2-142.7 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 142.7. "Postnatal donation", for purposes of IC 12-31, has the meaning set forth in IC 12-31-1-2.
SOURCE: IC 12-31; (08)HB1020.2.4. -->     SECTION 4. IC 12-31 IS ADDED TO THE INDIANA CODE AS A NEW ARTICLE TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]:
     ARTICLE 31. UMBILICAL CORD BLOOD
    Chapter 1. Public Umbilical Cord Blood Bank
    Sec. 1. As used in this article, "nonprofit corporation" refers to the Indiana nonprofit corporation that is formed by the office of the secretary under section 2 of this chapter to establish and operate a public umbilical cord blood bank.
    Sec. 2. As used in this article, "postnatal donation" means any of the following donations by a patient to the public umbilical cord blood bank:
        (1) Postnatal fluid, including umbilical cord blood.
        (2) Postnatal tissue, including the placenta and tissue extracted from an umbilical cord.
    Sec. 3. (a) The office of the secretary shall form a nonprofit corporation to establish and provide for the operation of a public umbilical cord blood bank to promote public health and to exercise other essential governmental functions.
    (b) The office of the secretary shall adopt rules under IC 4-22-2 concerning the protection of individual identifiable health information regarding the operation of the public umbilical cord blood bank.
    Sec. 4. (a) The board of directors of the nonprofit corporation consists of the following:
        (1) The state health commissioner or the commissioner's designee.
        (2) The secretary or the secretary's designee.
        (3) The secretary of commerce appointed under IC 5-28-3-4 or the secretary's designee.
        (4) The director of the state department of health's office of minority health.
        (5) The following individuals appointed by the governor:
            (A) One (1) president or chief executive officer of an Indiana based hospital.
            (B) One (1) research scientist with expertise in umbilical cord blood research.
            (C) One (1) ethicist with expertise in bioethics.
            (D) One (1) physician licensed under IC 25-22.5 who specializes in birthing and delivery.
            (E) One (1) representative of a donor cord blood bank facility.
            (F) One (1) member of the interagency state council on black and minority health established under IC 16-46-6.
    (b) The board of directors shall appoint an advisory board. At least fifty-one percent (51%) of the advisory board members must be research scientists with expertise in stem cell research.
    (c) The advisory board, using criteria established by the board of directors, is responsible for reviewing applications from research scientists, research institutions, and other persons interested in receiving a postnatal donation that is ineligible for transplant use from the public umbilical cord blood bank.
    (d) The board of directors may contract with a person to perform the management and administrative operations of the public umbilical cord blood bank. The person shall follow the federal Food and Drug Administration's current good tissue practices.
    (e) Subject to approval by the budget agency, the board of directors may, without the approval of the attorney general, employ legal counsel, technical experts, and other officers, agents, and employees that the board of directors considers necessary to carry out the efficient operation of a public umbilical cord blood bank.
    (f) The board of directors shall determine the terms and conditions of the participating agreement that is executed with each participating hospital.
    Sec. 5. The nonprofit corporation shall do the following:
        (1) Establish procedures and guidelines for collecting, maintaining, and receiving postnatal donations.
        (2) Educate health care professionals about the procedures and requirements for collecting and maintaining postnatal donations following the birth of a newborn infant.
        (3) Establish procedures concerning patient informed consent and privacy that are approved by an independent institutional review board selected by the board of directors.
    Sec. 6. (a) The nonprofit corporation shall accept and maintain postnatal donations at no charge or cost to the donor.
    (b) The nonprofit corporation may allow the following to use the postnatal donations:
        (1) Transplant centers.
        (2) Research centers approved by the nonprofit corporation that will use the postnatal donation to promote medical advances, life science research, or biotechnology research.
        (3) Any other entity approved by the nonprofit corporation if the entity will use the postnatal donation to promote medical advances, life science research, or biotechnology research.
    (c) All postnatal donations donated that are of transplantable quality as set forth by the National Marrow Donor Program or other federal Food and Drug Administration approved protocol

must be allocated for medical transplants.
    (d) Postnatal donations that are donated to the public umbilical cord blood bank that do not meet the transplant requirements may be allocated by the bank for research purposes.
    (e) The nonprofit corporation shall acquire and maintain adequate liability insurance coverage.
    Sec. 7. (a) The nonprofit corporation may collect and maintain the postnatal donations
at no charge or cost to the donor.
     (b) Any postnatal donations maintained by the public umbilical cord blood bank that are of transplantable quality or suitable for research must be made available for scientific research or medical treatments that comply with relevant national practice and quality standards.
    Sec. 8. The nonprofit corporation may award a grant to a person for work with postnatal donations.
    Sec. 9. The nonprofit organization shall report annually to the health finance commission established by IC 2-5-23-3 concerning the following:
        (1) The implementation of the umbilical cord blood bank.
        (2) The number of postnatal donations used for transplants and the number of postnatal donations used for research.
    Chapter 2. Umbilical Cord Blood Donation Initiative
    Sec. 1. As used in this chapter, "initiative" refers to the umbilical cord blood donation initiative established under section 2 of this chapter.
    Sec. 2. The nonprofit corporation shall establish an umbilical cord blood donation initiative to promote public awareness concerning the following:
        (1) A pregnant woman's option to make a postnatal donation upon the birth of a newborn infant.
        (2) The medical benefits of postnatal tissue and postnatal fluids.
        (3) The importance of donating umbilical cord blood to the public umbilical cord blood bank.
    Sec. 3. The nonprofit corporation may accept a grant from the federal government or money from the state government or private contributions to establish and implement the initiative.
    Sec. 4. (a) The initiative must include the dissemination of written material that includes the following:
        (1) Information concerning the option that is available to pregnant women to make a postnatal donation upon the birth of a newborn infant.


        (2) An explanation of the benefits of public umbilical cord blood banking.
        (3) The benefits of umbilical cord blood in accordance with the National Marrow Donor Program or other federal Food and Drug Administration approved protocol and the use of umbilical cord blood for medical treatment, including the following:
            (A) A list of the diseases or conditions that have been treated through the use of umbilical cord blood.
            (B) A list of the diseases or conditions for which scientific research indicates that treatment through the use of umbilical cord blood is promising.
        (4) Information on the public umbilical cord blood bank.
        (5) Information concerning the process by which postnatal tissue and postnatal fluid is collected and the steps that a pregnant woman must take before the child is born to arrange to have the postnatal tissue and postnatal fluid collected and donated.
    (b) The nonprofit corporation shall:
        (1) update the material required in subsection (a); and
        (2) distribute the material to the following persons that treat pregnant women:
            (A) Physicians licensed under IC 25-22.5.
            (B) Participating hospitals.
            (C) Ambulatory surgical centers.
            (D) Health clinics.
            (E) Maternity homes registered under IC 16-26-1.
            (F) Nurse midwives licensed under IC 25-23-1-13.1.
    Sec. 5. The nonprofit corporation shall develop a process for physicians, nurse midwives, and participating hospitals to inform eligible candidates of the opportunity to make postnatal donations to the public umbilical cord blood bank following delivery of a newborn infant.
    Sec. 6. The nonprofit corporation that establishes the initiative described in this chapter must meet all the requirements and responsibilities set forth in IC 23-17.
    Sec. 7. (a) Any intellectual property developed by the nonprofit corporation establishing the initiative under this chapter is the property of the nonprofit corporation. A donor must consent to release to the public umbilical cord blood bank any property right related to the postnatal donation, including any claim of intellectual property rights derived from the postnatal donation.
    (b) The entire right, title, and interest in and to any intellectual property derived from a postnatal donation transfers with the postnatal tissue and postnatal fluid after the postnatal donation is allocated by the public umbilical cord blood bank for research purposes.

SOURCE: IC 16-18-2-36.5; (08)HB1020.2.5. -->     SECTION 5. IC 16-18-2-36.5, AS ADDED BY P.L.96-2005, SECTION 3, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 36.5. (a) "Birthing center", for purposes of IC 16-21-2 and IC 16-21-7.5, means a freestanding entity that has the sole purpose of delivering a normal or uncomplicated pregnancy.
    (b) The term does not include a hospital that is licensed as a hospital under IC 16-21-2.
SOURCE: IC 16-21-7.5; (08)HB1020.2.6. -->     SECTION 6. IC 16-21-7.5 IS ADDED TO THE INDIANA CODE AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]:
     Chapter 7.5. Hospital and Birthing Center Requirement Regarding Umbilical Cord Blood Donation
    Sec. 1. As used in this chapter, "postnatal donation" has the meaning set forth in IC 12-31-1-2.

     Sec. 2. Before a hospital or birthing center participates in collecting donations for the public umbilical cord blood bank, the hospital or birthing center shall enter into a written agreement with the public umbilical cord blood bank establishing the:
        (1) conditions of the hospital's or birthing center's participation; and
        (2) obligations of the hospital or birthing center;
in the umbilical cord donation initiative.
    Sec. 3. (a) Except as provided in section 4 of this chapter, a participating hospital or birthing center licensed under this article must offer a patient who delivers a newborn infant at the participating hospital or birthing center the option of making a postnatal donation following delivery of the newborn infant.
    (b) A patient may not be charged for the collection, storage, or donation to the public umbilical cord blood bank established under IC 12-31-1.
    Sec. 4. (a) A participating hospital or birthing center is not required to collect the postnatal donation if either of the following applies:
        (1) In the professional judgment of a physician licensed under IC 25-22.5 or a nurse midwife licensed under IC 25-23-1-13.1, the collection would threaten the health of the mother or the infant.
        (2) The participating hospital or birthing center is affiliated with a religious denomination that believes that the blood transfer is contrary to the moral principles or beliefs of the religious denomination.
    (b) An employee of a participating hospital or birthing center is not required to collect a postnatal donation if the blood transfer is contrary to the religious principles or beliefs of the employee.
    Sec. 5. A participating hospital or birthing center shall cooperate with the nonprofit corporation (as defined in IC 12-31-1-1) in accomplishing the public health goal of maximizing postnatal donations.

     Sec. 6. A hospital or birthing center is not required to enter into an agreement with the public umbilical cord blood bank and may enter into contracts concerning postnatal tissue and postnatal fluids with any person.
SOURCE: ; (08)HB1020.2.7. -->     SECTION 7. [EFFECTIVE JULY 1, 2008] (a) The office of the secretary of family and social services shall immediately begin the adoption of the rules required under IC 12-31-1-3, as added by this act, and adopt the final rules before March 1, 2009.
    (b) This SECTION expires July 1, 2009.