SB 157-1_ Filed 02/12/2008, 13:53
Adopted 2/21/2008


Text Box

Adopted Rejected


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COMMITTEE REPORT

            
                                                        YES:

11

                                                        NO:
0

MR. SPEAKER:

    Your Committee on       Public Health     , to which was referred       Senate Bill 157     , has had the same under consideration and begs leave to report the same back to the House with the recommendation that said bill be amended as follows:

SOURCE: Page 1, line 1; (08)CR015701.1. -->     Page 1, between the enacting clause and line 1, begin a new paragraph and insert:
SOURCE: IC 12-7-2-118.3; (08)CR015701.1. -->     "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)CR015701.2. -->     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: Page 1, line 7; (08)CR015701.1. -->     Page 1, between lines 7 and 8, begin a new paragraph and insert:
SOURCE: IC 12-7-2-142.7; (08)CR015701.4. -->     "SECTION 4. 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: Page 2, line 31; (08)CR015701.2. -->     Page 2, line 31, after "that" insert " : (1)".
    Page 2, line 32, delete "." and insert "; and".
    Page 2, between lines 32 and 33, begin a new line block indented and insert:
        " (2) includes in the opioid treatment program's diversion control plan the program's drug testing procedure for testing a patient during the patient's treatment by the program as required by section 2.5 of this chapter.".
    Page 2, between lines 37 and 38, begin a new paragraph and insert:
SOURCE: IC 12-23-18-2.5; (08)CR015701.9. -->     "SECTION 9. IC 12-23-18-2.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 2.5. (a) An opioid treatment program must periodically and randomly test a patient for the following during the patient's treatment by the program:
        (1) Methadone.
        (2) Cocaine.
        (3) Opiates.
        (4) Amphetamines.
        (5) Barbiturates.
        (6) Tetrahydrocannabinol.
        (7) Benzodiazepines.
        (8) Any other drug that has been determined to be abused in the program's locality or any other drug that may have been abused by the patient.
    (b) If a patient tests positive under a test described in subsection (a) for:
        (1) a controlled substance other than a drug for which the patient has a prescription or that is part of the patient's treatment plan at the opioid treatment program; or
        (2) an illegal drug other than the drug that is part of the patient's treatment plan at the opioid treatment program;
the opioid treatment program must administer an administrative medical detoxification program not to exceed fourteen (14) days.
".
SOURCE: Page 3, line 5; (08)CR015701.3. -->     Page 3, line 5, after "patient" delete ".".
    Page 3, after line 42, begin a new line double block indented and insert:
        " (E) A statement to be used by opioid treatment facilities that:
            (i) acknowledges that the patient will be driven from the facility by another responsible person after receiving opioid treatment medications; and
            (ii) is signed by the patient and person who will drive the patient at the time the patient arrives to receive opioid treatment medications.
".
    Page 6, between lines 10 and 11, begin a new paragraph and insert:
SOURCE: IC 12-31; (08)CR015701.16. -->     "SECTION 16. 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 formed by the office of the secretary under section 3 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 umbilical 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 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) Any postnatal donations maintained by the public umbilical cord blood bank must be allocated as follows:
        (1) Postnatal donations that are of transplantable quality according to the National Marrow Donor Program, the federal Food and Drug Administration's approved protocol, or other relevant national practice and quality standards must be allocated for medical transplants.
        (2) Postnatal donations that do not meet the transplant quality standards referred to in subdivision (1) and that are
suitable for research must be made available for scientific research or medical treatments that comply with relevant national practice and quality standards.
    (d) The nonprofit corporation shall acquire and maintain adequate liability insurance coverage.
    Sec. 7. The nonprofit corporation may maintain postnatal donations
at no charge or cost to the donor.
    Sec. 8. The nonprofit corporation may award a grant to a person for work with postnatal donations.
    Sec. 9. The nonprofit corporation 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, money from the state government, and 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 a pregnant woman 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 another 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 are collected and the steps that a pregnant woman must take before her 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 described 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, birthing centers, 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)CR015701.21. -->     SECTION 21. 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)CR015701.22. -->     SECTION 22. 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 established under IC 12-31-1-3(a), 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 blood donation initiative established under IC 12-31-2-2.
    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 12-31-1-3(a).
    Sec. 4. (a) A participating hospital or birthing center is not required to collect a 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 postnatal donation is contrary to the moral principles or beliefs of the religious denomination with which the participating hospital or birthing center is affiliated.
    (b) An employee of a participating hospital or birthing center is

not required to collect a postnatal donation if the postnatal donation 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: Page 6, line 12; (08)CR015701.6. -->     Page 6, after line 12, begin a new paragraph and insert:
SOURCE: ; (08)CR015701.27. -->     "SECTION 27. [EFFECTIVE JULY 1, 2008] (a) The office of the secretary of family and social services shall adopt the rules required by IC 12-31-1-3(b), as added by this act, in the manner provided in IC 4-22-2-37.1. The office shall immediately begin the adoption of the rules and shall adopt the final rules before March
1, 2009.
    (b) This SECTION expires July 1, 2009.
".
    Renumber all SECTIONS consecutively.
    (Reference is to SB 157 as printed January 25, 2008.)

and when so amended that said bill do pass.

__________________________________

Representative Brown C


CR015701/DI 77    2008