House File 2389 - Introduced HOUSE FILE BY PETERSEN Passed House, Date Passed Senate, Date Vote: Ayes Nays Vote: Ayes Nays Approved A BILL FOR 1 An Act relating to the creation of a postnatal tissue and fluid 2 banking network, and including the creation of an oversight 3 commission. 4 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 5 TLSB 5897YH 82 6 pf/nh/5 PAG LIN 1 1 Section 1. NEW SECTION. 135O.1 DEFINITIONS. 1 2 As used in this chapter, unless the context otherwise 1 3 requires: 1 4 1. "Amniotic fluid" means the fluid inside the amnion. 1 5 2. "Birthing hospital" means a private or public hospital 1 6 licensed pursuant to chapter 135B that has a licensed 1 7 obstetric unit or is licensed to provide obstetric services. 1 8 3. "Commission" means the postnatal tissue and fluid 1 9 banking oversight commission established pursuant to section 1 10 135O.3. 1 11 4. "Cord blood" means human blood from the placenta and 1 12 umbilical cord collected after the umbilical cord has been 1 13 detached from the newborn child. 1 14 5. "Department" means the department of public health. 1 15 6. "Iowa hematopoietic stem cell bank" or "Iowa bank" 1 16 means the Iowa hematopoietic stem cell bank of the university 1 17 of Iowa hospitals and clinics. 1 18 7. "Placenta" means the organ that forms on the inner wall 1 19 of the human uterus during pregnancy. 1 20 8. "Postnatal tissue and fluid" means the placenta, 1 21 umbilical cord, and amniotic fluid expelled or extracted in 1 22 connection with the birth of a child. 1 23 9. "Regional perinatal center" means a regional perinatal 1 24 center established by the statewide perinatal care program. 1 25 10. "Statewide perinatal care program" means the statewide 1 26 perinatal care program under the department of public health, 1 27 that provides professional training, development of standards 1 28 and guidelines of care, consultation to regional and primary 1 29 providers, and evaluation of the quality of care delivered to 1 30 reduce the mortality and morbidity of infants through a 1 31 contract with the university of Iowa hospitals and clinics. 1 32 11. "Umbilical cord" means the gelatinous tissue and blood 1 33 vessels connecting an unborn human being to the placenta. 1 34 Sec. 2. NEW SECTION. 135O.2 POSTNATAL TISSUE AND FLUID 1 35 BANKING NETWORK. 2 1 1. The department shall establish a postnatal tissue and 2 2 fluid banking network to collect, process, store, and provide 2 3 for the disposition of stored specimens for therapeutic stem 2 4 cell medical treatments and stem cell research. The network 2 5 shall include all of the following: 2 6 a. Birthing hospitals in the state as voluntary collection 2 7 sites. 2 8 b. The Iowa hematopoietic stem cell bank, which shall be 2 9 expanded, statewide, to provide for the testing of specimens 2 10 collected to determine if the specimen is eligible for 2 11 transplant or research. Specimens eligible for research shall 2 12 also be stored by the Iowa bank. 2 13 c. A partnership with a regional cord blood bank for 2 14 storage of specimens determined to be eligible for 2 15 transplantation and for entry of information regarding the 2 16 specimens into appropriate national and international 2 17 registries. 2 18 2. The Iowa hematopoietic stem cell bank shall provide 2 19 birthing hospitals with training regarding the collection of 2 20 postnatal tissue and fluids. The Iowa bank shall offer 2 21 participating birthing hospitals the option of collecting 2 22 specimens for transportation to the Iowa bank via courier 2 23 service. Quality assurance shall be monitored by the 2 24 statewide perinatal care program as part of regularly 2 25 scheduled birthing hospital site visits. Initially, specimen 2 26 collection shall focus on the collection of cord blood. At 2 27 such time as other postnatal tissue or fluids are collected, 2 28 procedures for collection shall be developed and organized 2 29 through the regional perinatal centers as primary collection 2 30 sites. Training regarding the collection of these other 2 31 postnatal tissue or fluids shall be provided to the regional 2 32 perinatal centers by the Iowa bank and the regional perinatal 2 33 centers shall in turn provide training to the birthing 2 34 hospitals in their regions. 2 35 3. Birthing hospitals and health care providers shall 3 1 promote and encourage the donation of postnatal tissue and 3 2 fluid through education, public awareness, and the removal of 3 3 barriers to donation. 3 4 a. Birthing hospitals and health care providers shall 3 5 inform potential donors no later than the beginning of the 3 6 third trimester of a pregnancy, of the options to donate to 3 7 either private banking programs or to the Iowa bank. 3 8 b. Potential donors, at a minimum, shall be informed of 3 9 all of the following: 3 10 (1) The current and potential future medical uses of 3 11 postnatal tissue and fluids. 3 12 (2) The benefits and risks associated with postnatal 3 13 tissue and fluid banking. 3 14 (3) Medical or family history criteria that may impact a 3 15 family's consideration of postnatal tissue and fluid banking. 3 16 (4) An explanation of the differences between private and 3 17 public banking. Potential donors shall be informed that 3 18 donated specimens may be purchased by companies for commercial 3 19 use. 3 20 (5) Medically=accepted uses and benefits of postnatal 3 21 tissue and fluid collection and transplantation. 3 22 (6) The costs associated with donation and storage, and an 3 23 explanation of the storage, maintenance, and viability of 3 24 transplantation of postnatal tissue and fluid. 3 25 c. Donation shall be promoted on a voluntary basis and 3 26 birthing hospitals and providers shall work with the network 3 27 to ensure that there is no cost to the donor for collection of 3 28 donated specimens, unless the donation is a directed donation 3 29 of cord blood to be stored for personal use. 3 30 4. The postnatal tissue and fluid banking network shall 3 31 develop a state postnatal tissue and fluid bank database to 3 32 maintain information regarding specimens collected and stored 3 33 for the purposes of research. The database shall utilize a 3 34 web=based format, have the capacity to search multiple 3 35 databases, deliver search results by encrypted electronic 4 1 mail, maintain patient records, and generate reports for 4 2 quality assurance and quality improvement purposes. 4 3 5. The postnatal tissue and fluid banking network shall 4 4 partner with a regional cord blood bank for the purposes of 4 5 providing specimens for transplantation and maintaining 4 6 information regarding clinically useful cord blood specimens 4 7 to link with national and international registries. Following 4 8 testing, specimens collected from birthing hospitals and 4 9 health care providers in the state that are determined to be 4 10 eligible for transplantation shall be sent to the regional 4 11 cord blood bank for storage. The partnership agreement shall 4 12 require that the specimens sent to the regional blood bank 4 13 shall be stored by the regional blood bank and that 4 14 information regarding clinically useful cord blood specimens 4 15 shall be maintained by the regional bank and also linked with 4 16 and entered into appropriate national and international 4 17 registries. Specimens determined not eligible for 4 18 transplantation shall be stored at the Iowa bank and made 4 19 available for research. 4 20 6. Specimens collected shall not be used for creation of 4 21 stem cells for reproductive cloning. 4 22 7. The postnatal tissue and fluid banking network shall 4 23 comply and coordinate with all requirements for certification 4 24 by all national and federal entities as specified by rule of 4 25 the postnatal tissue and fluid banking oversight commission. 4 26 8. All research conducted by any member of the network 4 27 shall be subject to approval of an institutional review board 4 28 that is established in accordance with federal and state 4 29 regulations. Distribution of specimens for research shall 4 30 also meet all rules adopted by the commission for such 4 31 distribution. 4 32 9. The postnatal tissue and fluid banking network shall 4 33 comply with all rules adopted by the commission including 4 34 those related to consent, privacy, and the fee structure. 4 35 Sec. 3. NEW SECTION. 135O.3 POSTNATAL TISSUE AND FLUID 5 1 BANKING OVERSIGHT COMMISSION. 5 2 1. The department shall convene and provide administrative 5 3 support to a postnatal tissue and fluid banking oversight 5 4 commission. 5 5 2. The commission shall consist of the following members, 5 6 selected by the institution or association specified or, if 5 7 not specified, selected by the director of public health: 5 8 a. The director of public health, or the director's 5 9 designee. 5 10 b. A representative of each of the public and private 5 11 colleges or universities in the state that have interest in 5 12 postnatal tissue and fluid for the purposes of research or 5 13 medical treatment. 5 14 c. A representative of the Iowa hospital association. 5 15 d. A representative of the Iowa osteopathic medical 5 16 association. 5 17 e. A representative of the Iowa medical society. 5 18 f. A physician representing a birthing hospital. 5 19 g. A prenatal health care provider. 5 20 h. A representative of the Iowa midwives association. 5 21 i. A representative of the postnatal tissue and fluid 5 22 research community. 5 23 j. A representative of recipients of postnatal tissue and 5 24 fluid transplants. 5 25 k. A representative of a postnatal tissue and fluid 5 26 transplant center. 5 27 l. A representative of a postnatal tissue and fluid bank. 5 28 m. An attorney with expertise in public health or 5 29 biotechnology law, selected by the Iowa state bar association. 5 30 n. A recognized medical ethicist who has an accredited 5 31 degree in medicine, medical ethics, or theology. 5 32 3. Members of the commission shall serve terms of three 5 33 years, beginning and ending as provided in section 69.19. 5 34 Vacancies shall be filled by the original appointing authority 5 35 and in the manner of the original appointment. Members shall 6 1 receive reimbursement for actual expenses incurred while 6 2 serving in their official capacity and may also be eligible to 6 3 receive compensation as provided in section 7E.6. A person 6 4 appointed to fill a vacancy for a member shall serve only for 6 5 the unexpired portion of the term. A member is eligible for 6 6 reappointment for two successive terms. 6 7 4. The commission shall meet at least quarterly and at the 6 8 call of the chairperson. A majority of the members 6 9 constitutes a quorum. Any action taken by the commission must 6 10 be adopted by the affirmative vote of a majority of the 6 11 members. 6 12 5. The commission shall do all of the following: 6 13 a. Develop regulations, protocols and policies, public 6 14 reporting requirements, research requirements, and fiscal 6 15 auditing and accountability measures relative to postnatal 6 16 tissue and fluid banking in the state and in partnership with 6 17 entities outside of the state with interest in postnatal 6 18 tissue and fluid banking. 6 19 b. Establish an advisory council to address ongoing 6 20 ethical, legal, and intellectual property issues. 6 21 c. Oversee the statewide expansion of the Iowa 6 22 hematopoietic stem cell bank and the development of a 6 23 partnership with an existing regional cord blood bank to 6 24 maintain specimens eligible for transplantation. 6 25 d. Promote the development of a network of birthing 6 26 hospitals in the state for the voluntary collection of cord 6 27 blood and other postnatal tissue and fluids. 6 28 e. Develop criteria for the distribution of specimens for 6 29 research and medical treatment. Specimens shall be available 6 30 to both private and public researchers. Fees for research 6 31 specimens shall be incurred by the research organization and 6 32 shall be standard and comparable to the charges levied by 6 33 similar tissue and fluid banks. 6 34 f. Provide for the collection of information regarding 6 35 postnatal tissue and fluid banking specimens. Information on 7 1 clinically useful cord blood specimens shall be maintained by 7 2 the regional cord blood bank with which the state partners to 7 3 maintain specimens eligible for transplantation and to enter 7 4 such specimens on national and international registries. The 7 5 state postnatal tissue and fluid bank database developed 7 6 pursuant to section 135O.2, subsection 4, shall maintain 7 7 information on specimens collected for the purpose of 7 8 research. 7 9 g. Promote and encourage voluntary donation of postnatal 7 10 tissue and fluid through education, public awareness, and the 7 11 removal of barriers to donation. To the extent possible, the 7 12 commission shall seek approval to utilize existing educational 7 13 and awareness materials as a basis for development of 7 14 state=specific materials. 7 15 h. Provide for consent and privacy protections for persons 7 16 who donate postnatal tissue and fluid. The protections shall 7 17 be consistent with applicable federal guidelines and shall 7 18 address the collection, retention, use, and disposition of 7 19 specimens, as well as ownership rights to the specimens. The 7 20 protections shall require that all specimens released for 7 21 transplant or research shall not contain any identifying 7 22 information upon release so as to protect from disclosure the 7 23 identity of persons making donations to the state or regional 7 24 bank. 7 25 i. Provide a fee structure for participation in the state 7 26 postnatal tissue and fluid banking network. The fee structure 7 27 shall be based on the use of the specimen stored. If the 7 28 specimen is to be used for medical treatment, fees shall be 7 29 imposed consistent with requirements of the regional bank. If 7 30 the specimen is used for research, fees shall be charged to 7 31 the entity managing the research project. Any costs incurred 7 32 by the research entity to obtain institutional review board 7 33 approval or to meet other requirements for project approval 7 34 shall be the responsibility of the research entity. 7 35 j. Report to the governor and the general assembly in 8 1 December, annually, concerning the activities of the network 8 2 and the commission with recommendations for any legislative 8 3 changes or funding necessary to fulfill the goals of this 8 4 chapter. 8 5 k. Request additional funding from any additional source 8 6 including but not limited to federal and private grants. 8 7 l. Review research request policies for consistency with 8 8 other programs including but not limited to those policies 8 9 established by the center for congenital and inherited 8 10 disorders established pursuant to section 136A.3. 8 11 EXPLANATION 8 12 This bill relates to postnatal tissue and fluid banking. 8 13 The bill establishes a postnatal tissue and fluid banking 8 14 network to collect, process, store, and provide for the 8 15 disposition of stored specimens for therapeutic stem cell 8 16 medical treatments and stem cell research. The network 8 17 includes birthing hospitals in the state as voluntary 8 18 collection sites; the Iowa hematopoietic stem cell bank at the 8 19 university of Iowa hospitals and clinics, which is to be 8 20 expanded, statewide, to provide for the testing of specimens 8 21 collected to determine if the specimen is eligible for 8 22 transplant or research, with specimens eligible for research 8 23 to also be stored by the Iowa bank; and a partnership with a 8 24 regional blood bank for storage of specimens determined to be 8 25 eligible for transplantation and for entry of information 8 26 regarding these specimens into appropriate national and 8 27 international registries. 8 28 The bill directs the Iowa hematopoietic stem cell bank to 8 29 provide birthing hospitals with training regarding collection 8 30 of postnatal tissue and fluids. Participating birthing 8 31 hospitals may transport specimens collected to the Iowa bank 8 32 via courier service. Quality assurance is to be provided by 8 33 the statewide perinatal care program. Initially, specimen 8 34 collection shall focus on collection of umbilical cord blood. 8 35 At such time as other postnatal tissue or fluids are 9 1 collected, procedures for collection shall be developed and 9 2 organized through the regional perinatal centers as primary 9 3 collection sites. 9 4 The bill directs birthing hospitals and providers to 9 5 promote and encourage the donation of postnatal tissue and 9 6 fluid through education, public awareness, and the removal of 9 7 barriers to donation. The bill specifies information that, at 9 8 a minimum, is to be provided to potential donors no later than 9 9 the beginning of the third trimester of a pregnancy, regarding 9 10 options to donate to either private banking programs or to the 9 11 Iowa bank. Donation is on a voluntary basis and birthing 9 12 hospitals and providers are to work with the network to ensure 9 13 that there is no cost to the donor for collection of donated 9 14 specimens, unless the donation is a directed donation of cord 9 15 blood to be stored for personal use. 9 16 The bill directs the postnatal tissue and fluid banking 9 17 network to develop a state postnatal tissue and fluid bank 9 18 database to maintain information regarding specimens collected 9 19 and stored for the purposes of research and to partner with a 9 20 regional cord blood bank for the purposes of providing 9 21 specimens for transplantation and maintaining information 9 22 regarding clinically useful cord blood specimens to link with 9 23 national and international registries. The bill prohibits 9 24 specimens collected from being used for creation of stem cells 9 25 for reproductive cloning. 9 26 All research conducted by any member of the network is 9 27 subject to approval of an institutional review board, and 9 28 distribution of specimens for research shall also meet all 9 29 rules adopted by the postnatal tissue and fluids banking 9 30 oversight commission for such distribution. 9 31 The bill also directs the department of public health to 9 32 convene and provide administrative support to a postnatal 9 33 tissue and fluid banking oversight commission. The bill 9 34 specifies the membership of the commission, the terms of 9 35 appointments, meetings of the commission, and other procedural 10 1 requirements. The duties of the commission include: 10 2 developing regulations, protocols and policies, public 10 3 reporting requirements, research requirements, and fiscal 10 4 auditing and accountability measures relative to postnatal 10 5 tissue and fluid banking in the state and in partnership with 10 6 entities outside of the state with interest in postnatal 10 7 tissue and fluid banking; establishing an advisory council to 10 8 address ongoing ethical, legal, and intellectual property 10 9 issues; overseeing the statewide expansion of the Iowa 10 10 hematopoietic stem cell bank and the development of a 10 11 partnership with an existing regional cord blood bank to 10 12 maintain specimens eligible for transplantation; promoting the 10 13 development of a network of birthing hospitals in the state 10 14 for the voluntary collection of umbilical cord blood and other 10 15 postnatal tissue and fluids; developing criteria for the 10 16 distribution of specimens for research and medical treatment; 10 17 providing for the collection of information regarding 10 18 postnatal tissue and fluid banking specimens; promoting and 10 19 encouraging voluntary donation of postnatal tissue and fluid 10 20 through education, public awareness, and the removal of 10 21 barriers to donation; providing for consent and privacy 10 22 protections for persons who donate postnatal tissue and fluid; 10 23 providing a fee structure for participation in the state 10 24 postnatal tissue and fluid banking network; reporting to the 10 25 governor and the general assembly annually; requesting 10 26 additional funding from any additional source including but 10 27 not limited to federal and private grants; and reviewing 10 28 research request policies for consistency with other programs. 10 29 LSB 5897YH 82 10 30 pf/nh/5