BILL ANALYSIS ------------------------------------------------------------ |SENATE RULES COMMITTEE | SB 962| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ THIRD READING Bill No: SB 962 Author: Migden (D) Amended: 5/1/07 Vote: 21 SENATE HEALTH COMMITTEE : 6-3, 4/18/07 AYES: Kuehl, Alquist, Cedillo, Ridley-Thomas, Steinberg, Yee NOES: Aanestad, Cox, Wyland NO VOTE RECORDED: Maldonado, Negrete McLeod SENATE JUDICIARY COMMITTEE : 3-2, 4/24/07 AYES: Corbett, Kuehl, Steinberg NOES: Harman, Ackerman SENATE APPROPRIATIONS COMMITTEE : 10-6, 5/31/07 AYES: Torlakson, Cedillo, Corbett, Florez, Kuehl, Oropeza, Ridley-Thomas, Simitian, Steinberg, Yee NOES: Cox, Aanestad, Ashburn, Dutton, Runner, Wyland NO VOTE RECORDED: Battin SUBJECT : Umbilical cord blood biomedical resources program SOURCE : American Association of University Women Planned Parenthood Affiliates of California DIGEST : This bill: CONTINUED SB 962 Page 2 1.Requires the Department of Public Health to establish the Umbilical Cord Blood Biomedical Resources Program for the purpose of collecting, processing, and storing umbilical cord blood stem cells to be used for transplantation and research. 2.Requires DPH to establish fees to be collected from researchers and health are providers approved by the department to use umbilical cord blood for research or transplantation and creates the Umbilical Cord Blood Biomedical Research Program Fund into which the fees collected will be deposited. ANALYSIS : Existing law imposes various responsibilities on the Department of Health Services (DHS) and prenatal care providers with respect to prenatal care, screening and counseling. Existing law, administered by DHS, contains provisions governing the licensure of blood banks, including licensure or accreditation for purposes of umbilical cord blood banking. This bill requires the Department of Public Health (DPH) to establish the Umbilical Cord Blood Biomedical Resources Program for the purpose of collecting, processing, and storing umbilical cord blood stem cells to be used for transplantation and research. DPH will be required to establish a public repository for umbilical cord blood cells, a system to retrieve and transport donations, and a system for matching donors with recipients. This bill requires DPH to establish fees to be collected from researchers and health care providers approved by DHS to use umbilical cord blood for research or transplantation and creates the Umbilical Cord Blood Biomedical Resources Program Fund in the State Treasury into which the fees collected will be deposited. Existing law requires DHS to conduct the Umbilical Cord Blood Community Awareness Campaign (UCBCAC), which, among other things, provides that a primary prenatal care provider, as defined, may provide to a pregnant woman SB 962 Page 3 during the first prenatal visit, certain information developed by DHS regarding her options with respect to umbilical cord blood banking. Existing law, the Hereditary Disorders Act, requires DHS to establish regulations and standards for a hereditary disorders program, including prenatal testing programs for newborns. Pursuant to this act, existing regulations require clinicians to provide all pregnant women, at the first prenatal visit, with information about the use and availability of prenatal screening for birth defects of the fetus. If a pregnant woman voluntarily requests prenatal screening, these regulations, among other things, require a clinician to make available to the pregnant woman the opportunity to read and sign a consent document, as specified. Responsibility for the above provisions will be transferred to DPH on July 1, 2007. This bill restates existing law which authorizes a primary prenatal care provider, during the first prenatal visit of a woman who is known to be pregnant, to provide the cord blood banking information required by the bill's provisions to the woman. Existing law establishes the Umbilical Cord Blood Education Account, in which private donations are collected and deposited for the purpose of funding the information developed by DHS pursuant to the UCBCAC, and requires these funds to be available upon a determination of the Director of the Department of Finance that sufficient private donations have been collected and deposited into the account, and provides that no public funds may be used. This bill allows both private and public funds to be used for purposes of the UCBCAC. Existing law, the Information Practices Act, provides certain specified privacy and security provisions for personal information held, used, or disseminated by a state agency. Under existing law, the Committee for the Protection of Human Subjects (CPHS) serves as the institutional review board for the Health and Human Services Agency for the SB 962 Page 4 purpose of assuring that research involving human subjects is conducted ethically and with minimum risk to participants. This bill requires DPH, health care providers, and local health departments to maintain the confidentiality of patient information in accordance with existing law and in the same manner as other medical record information with patient identification that they possess, and that the information shall only be used (1) to identify risk factors for children's and women's diseases, (2) to develop and evaluate screening tests, (3) to evaluate and develop prevention strategies, and (4) to develop and evaluate treatments. This bill provides that, for purposes of ensuring the security of a donor's personal information, before any umbilical cord blood released for research purposes, the CPHS must determine if specified criteria and conditions are met. This bill provides that all information collected pursuant to the Birth Defects Monitoring Program shall be confidential and shall be used solely for the purposes of the program. Access to confidential information shall be limited to authorized persons who agree, in writing, to maintain confidentiality. DHS shall maintain an accurate record of all persons who are given confidential information. This bill provides that any disclosure of confidential information shall be made only upon written agreement that the information will be kept confidential, used for the approved purpose, and not be further disclosed. Any person who, in violation of a written agreement to maintain confidentiality, discloses any information provided pursuant to this section, or who uses information pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to any confidential information maintained by DHS. That person shall also be subject to a civil penalty of $1,000. The penalty provided in t his section shall not be SB 962 Page 5 construed as restricting any remedy, provisional or otherwise, provided by law for the benefit of DHS or any person. Background In December 2005, the federal government enacted H.R. 2520, the Stem Cell Therapeutic and Research Act of 2005, which establishes a national umbilical cord blood program and provides federal funding to expand and administer cord blood transplants and research. Among the many provisions in that measure is a requirement that the Secretary of Health and Human Services, through a public process, examine the issues of informed consent, including the appropriate timing of such consent, and the information provided a donor regarding medically appropriate cord blood donation options. The National Institute of Medicine (IOM) recommends that women be provided with balanced and clear information in order to actively and knowledgeably participate in the choice of whether or how to donate cord blood, with informed consent procedures. The IOM also recommends that appropriate measures should be taken to ensure the security, safety, and confidentiality of medical records, transplantable products, and patients. According to the Cord Blood Donor Foundation, "cord blood" (also known as "placental blood") is the blood that remains in the umbilical cord and placenta following birth and after the cord is cut. Newborn cord blood is recognized as a rich and powerful source of stem cells, which can be stored to retain their unique biological properties and before exposure to bacterial, viral, or other environmental factors. Stem cells recovered from umbilical cords can be used to treat as many as 70 blood diseases, including leukemia, myeloma and lymphoma; immunodeficiencies; and genetic diseases, including sickle cell anemia, thalassemia, inherited marrow failure disorders; and inherited disorders or errors of metabolisms. Prior Legislation SB 1555 (Speier), Chapter 484, Statutes of 2006 . Created the Maternal and Child Health Advancement Act, which provided, among other things, that in order to provide SB 962 Page 6 umbilical cord blood banking storage services, a blood bank shall be licensed to do so under current blood bank licensing law. In addition, SB 1555, provided that a primary prenatal care provider of a pregnant woman may, during the first prenatal visit, provide a pregnant woman with information developed by DHS regarding her options with respect to cord blood banking at the same time the provider provides required information regarding the use and availability of prenatal screening for birth defects of the fetus. Related Legislation AB 34 (Portantino) - 2007-08 Session . Requires DPH to establish, by July 1, 2009, the Umbilical Cord Blood Collection Program for the purpose of collecting and storing umbilical cord blood for public use. The bill also required DPH to contract with up to five blood banks that are licensed or accredited to provide umbilical cord blood banking storage services to collect, and make available to doctors and their patients, umbilical cord blood. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: Yes Fiscal Impact (in thousands) Major Provisions 2007-08 2008-09 2009-10 Fund Collection/storage $200 $1,000 $1,000 General DHS administration $200 $ 600 $ 600 General/ Special Fee revenue Undetermined Special* *Umbilical Cord Blood Biomedical Resources Program Fund SUPPORT : (Verified 6/4/07) SB 962 Page 7 American Association of University Women (co-source) Planned Parenthood Affiliates of California (co-source) Asian American Donor Program California Catholic Conference Cord Blood Donor Foundation National Marrow Donor Program OPPOSITION : (Verified 6/5/07) American College of Obstetricians and Gynecologists, District IX/CA ARGUMENTS IN SUPPORT : The author's office writes, "SB 962 [would] address two primary reasons why more cord blood transplants are not done today: (1) the lack of inventory and infrastructure in the state and nation; and (2) the lack of awareness and consequent opportunity on the part of pregnant women to exercise their personal choice regarding the distribution of their cord blood, now considered a valuable medical resources. "Currently, 95& of cord blood is routinely discarded by California physicians, without a woman's knowledge or consent, so most physicians are already choosing one of the three cord blood options available to women, i.e., public donation, private donation, or discarding. "Given increasing reports this year that cord blood may be being taken without a woman's consent, and that doctors are receiving financial compensation only to discuss private banking with patients, this bill is needed to ensure that women receive full information about their options and are able to exercise their personal wishes regarding the final destination of their cord blood. Patient documentation will provide future liability protection for doctors. "DHS [Department of Health Services] has requested that the author update the current AFP [alpha-protein] screening [for some genetic abnormalities] regulation, which requires informed consent for prenatal screening, to also include a requirement for information and consent for cord blood. DHS indicated to the author's office that they are already beginning to make revisions to the pamphlet to at least SB 962 Page 8 include a discussion of cord blood options. This prenatal informed consent booklet has been given to pregnant women for the last 20 years. The author's office, in response to the opposition, notes that "While ACOG is still opposed, we have addressed their main issue in Senate Judiciary Committee, which resulted in the elimination of the required informed consent provisions and are committed to addressing their remaining concern regarding the cord blood program's infrastructure in the Assembly." AGB:cm 6/5/07 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END ****