BILL ANALYSIS                                                                                                                                                                                                    






                           SENATE JUDICIARY COMMITTEE
                        Senator Ellen M. Corbett, Chair
                           2007-2008 Regular Session


          SB 962                                                 S
          Senator Migden                                         B
          As Amended April 19, 2007
          Hearing Date: April 24, 2007                           9
          Health and Safety Code                                 6
          ADM:rm                                                 2
                                                                 

                                     SUBJECT
                                         
               Umbilical Cord Blood Biomedical Resources Program

                                   DESCRIPTION  

          This bill would require the State 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.  

          This bill would require DPH to establish fees to be  
          collected from researchers and health care providers  
          approved by the department to use umbilical cord blood for  
          research or transplantation, and would create the Umbilical  
          Cord Blood Biomedical Resources Program Fund into which the  
          fees collected would be deposited. 

          This bill would require DPH to develop standardized,  
          objective information about umbilical cord blood donation  
          that would enable a pregnant woman to be informed of her  
          options to: (1) discard umbilical cord blood; (2) donate  
          umbilical cord blood to a public bank; or (3) store the  
          umbilical cord blood in a private bank.

          This bill would require a primary prenatal care provider,  
          during a pregnant woman's first prenatal visit, to provide  
          the cord blood banking information required by the bill's  
          provisions to the woman.

          This bill would require DPH and health care providers to  
                                                                 
          (more)



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          maintain the confidentiality of patient information, and  
          would allow the use of patient information only for  
          specified research purposes.

          This bill would provide that, for purposes of ensuring the  
          security of a cord donor's personal information, before any  
          umbilical cord blood could be released for research  
          purposes, the California Health and Human Services Agency  
          must determine if specified criteria and conditions have  
          been met.

                                    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.  
                                                                       




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          Senate Bill 1555 (Speier, Chapter 484, Statutes of 2006),  
          the Maternal and Child Health Advancement Act, provides,  
          among other things, that, in order to provide 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, provides that a primary prenatal care  
          provider of a pregnant woman may, during the first prenatal  
          visit, provide a pregnant woman with information developed  
          by the State Department of Health Services 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.  




                             CHANGES TO EXISTING LAW
           
          1.    Existing law  imposes various responsibilities on the  
          State Department of 
            Health Services (the department) and prenatal care  
            providers with respect to prenatal care, screening, and  
            counseling.  [Health and Safety (H&S) Code Sections  
            120685-125107; 17 C.C.R. Sections 6404, 6500 et seq., and  
            6521 et seq.]
            
            Existing law  , administered by the department, contains  
            provisions governing the licensure of blood banks,  
            including licensure or accreditation for purposes of  
            umbilical cord blood banking.  [H&S Sections  
            1602.5-1607.]

             This bill  would require the State 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 would be required to establish: (1) a public  
            repository for umbilical cord blood cells; (2) a system  
            to retrieve and transport donations; and (3) a system for  
            matching donors with recipients.

             This bill  would require DPH to establish fees to be  
                                                                       




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            collected from researchers and health care providers  
            approved by the department to use umbilical cord blood  
            for research or transplantation.   The bill  would create  
            the Umbilical Cord Blood Biomedical Resources Program  
            Fund in the State Treasury into which the fees collected  
            would be deposited. 

          2.    Existing law  requires the department 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 during the  
            first prenatal visit, certain information developed by  
            the department regarding her options with respect to  
            umbilical cord blood banking.  [H&S Code Section 123370  
            et seq.]

             Existing law  , the Hereditary Disorders Act, requires the  
            department to establish regulations and standards for a  
            hereditary disorders program, including with respect to  
            prenatal testing programs for newborns.  [H&S Section  
            124977.]  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.  [17 C.C.R. Section 6527 (2007).]  
             Effective July 1, 2007, responsibility for the above  
            provisions will be transferred to the State Department of  
            Public Health.
             
            This bill  would, in addition, require 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. 
             
            This bill  would require the department, in addition to  
            already required cord blood banking information  
            development, to develop standardized, objective  
            information about umbilical cord blood donation that  
            would enable a pregnant woman to be informed of her  
                                                                       




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            option to do any of the following: 
            (1) discard umbilical cord blood; (2) donate umbilical  
            cord blood to a public bank; or (3) store the umbilical  
            cord blood in a private bank.

             This bill  would, upon the development of the required  
            cord blood banking information, require the department to  
            include that information in the prenatal screening  
            information materials currently established in  
            regulation.  

          3.    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 the department pursuant to the  
            UCBCAC, and requires these funds to be available upon a  
            determination of the Director of Finance that sufficient  
            private donations have been collected and deposited into  
            the account, and provides that no public funds may be  
            used.  [H&S Code Section 123371.]

             This bill  would allow both private and public funds to be  
            used for purposes of the UCBCAC.

          4.    Existing law  , the Information Practices Act, provides  
            certain specified privacy and security protections for  
            personal information held, used, or disseminated by a  
            state agency.  [Civil Code (CC) Sections 1798-1798.78.] 

             Under existing law  , the Committee for the Protection of  
            Human Subjects (CPHS) serves as the institutional review  
            board for the California Health and Human Services Agency  
            for the purpose of assuring that research involving human  
            subjects is conducted ethically and with minimum risk to  
            participants.  [See, e.g., CC Section 1798.24.]

             This bill  would require 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 for  
            the following research purposes: (1) to identify risk  
            factors for children's and women's diseases; (2) to  
            develop and evaluate screening tests; (3) to evaluate and  
                                                                       




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            develop prevention strategies; and (4) to develop and  
            evaluate treatments.
             This bill  would provide that, for purposes of ensuring  
            the security of a donor's personal information, before  
            any umbilical cord blood could be released for research  
            purposes, the CPHS must determine if specified criteria  
            and conditions are met.  [See Comment 6 for details.]

                                     COMMENT
           
          1.    Stated need for the bill  

            The author 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  
               resource.  

               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  
                                                                       




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               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 include  
               a discussion of cord blood options.  This prenatal  
               informed consent booklet has been given to pregnant  
               women for the last 20 years.  






          2.    Related pending legislation  

            Assembly Bill 34 (Portantino) would require DPH to  
            establish, by July 1, 2009, the Umbilical Cord Blood  
            Collection Program (the program) for the purpose of  
            collecting and storing umbilical cord blood for public  
            use.  The bill would require DHP to contract with up to 5  
            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.  

            The bill would establish a 15-member implementing  
            committee, as specified, to provide guidance and policy  
            suggestions to DPH on implementation of the program.  The  
            bill would allow DPH to accept both public and private  
            funds to implement its provisions.  

            The bill would require DPH, on or before January 1, 2012,  
            to submit an interim report to the Assembly and Senate  
            Health Committees on the effectiveness of the program in  
            diversifying the umbilical cord blood supply, and would  
            sunset the program December 31, 2018.  

            This bill is currently in the Assembly Appropriations  
            Committee.

          3.    Related federal legislation  

            The Stem Cell Therapeutic and Research Act of 2005,  
            enacted in December 2005, allows the Secretary of Health  
            and Human Services to enter into one-time contracts with  
            qualified cord blood banks to assist in the collection  
                                                                       




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            and maintenance of 150,000 new units of high-quality cord  
            blood to be made available for transplantation (through  
            the C.W. Bill Young Cell Transplantation Program) and  
            other specified purposes, including peer-reviewed  
            research.  [H.R. 2520, Public Law No. 109-129.]  

            A contract recipient is required to, among other things,  
            acquire, tissue-type, test, cryopreserve, and store  
            donated units of cord blood acquired with donor informed  
            consent, in compliance with federal and state  
            regulations; encourage donation from a genetically  
            diverse population; and ensure that collected cord blood  
            units meet all applicable federal transplantation  
            standards.  

            The act requires the secretary to, through a public  
            process, examine the following with respect to donor  
            informed consent: (1) the appropriate timing of such  
            consent; and (2) the information provided to the maternal  
            donor regarding her medically appropriate cord blood  
            options.  

            To the best of committee staff's knowledge, the above  
            public process and examination has not been completed.
          4.    SB 1555 (Speier, Chapter 484, Statutes of 2006); SB  
            962 would substantively alter SB 1555  

            Senate Bill 1555, the Maternal and Child Health  
            Advancement Act, provides, among other things, that the  
            State Department of Health Services is required to  
            develop standardized, objective information about  
            umbilical cord blood donation that is sufficient to allow  
            a pregnant woman to make an informed decision on whether  
            or not to participate in a private or public umbilical  
            cord blood banking program.  [H&S Section 123371.]   
            Section 123371 outlines seven pieces of information to be  
            included in the department's information: (1) current and  
            potential future medical uses of stored umbilical cord  
            blood; (2) benefits and risks involved in umbilical cord  
            blood banking; (3) the medical process involved in  
            umbilical cord blood banking; (4) medical or family  
            history criteria that may impact a family's consideration  
            of umbilical cord blood banking; (5) an explanation of  
            the differences between public and private umbilical cord  
            blood banking; (6) availability and costs of public or  
                                                                       




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            private umbilical cord blood banks; and (7) an  
            explanation that the practices and policies of blood  
            banks may vary with respect to accreditation, cord blood  
            processing and storage methods, costs, and donor privacy.  
             

            Section 123371 also provides that the primary prenatal  
            care provider of a pregnant woman may, during the first  
            prenatal visit, provide the woman with information  
            developed by the department 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.  

            Senate Bill 962 would require the primary prenatal care  
            provider of a pregnant woman, during the first prenatal  
            visit, to provide information developed by the department  
            regarding her options with respect to cord blood banking.  
             Senate Bill 962 would thus substantively alter the  
            provisions of SB 1555.  

            The author and sponsor report that the implementing  
            regulations called for in SB 1555, with the required  
            standardized, objective umbilical cord blood banking  
            information, have not been adopted or promulgated. 

            In addition, neither the specificity of what cord blood  
            banking information nor the appropriate timing of when  
            such information should be provided to a pregnant woman  
            have been determined at the state or federal level.




          5.    Privacy and confidentiality concerns raised by the  
            bill; suggested amendments  

            Because this bill would allow for the collection,  
            processing, and storage of umbilical cord blood stem  
            cells for transplantation and research, a donor's  
            personal and confidential information and privacy  
            interests should be protected to the greatest extent  
            possible.  And, while the Information Practices Act  
            provides some privacy and confidentially protections,  
                                                                       




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            committee staff suggests that further protections be  
            added to the bill.  

             Suggested amendments:  

            On page 6, after line 15, add the following:

               All information collected pursuant to the Umbilical  
               Cord Blood Biomedical Resources 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.

               The department shall maintain an accurate record of  
               all persons who are given confidential information.

               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 the department.  That person shall also  
               be subject to a civil penalty of $1,000.  The penalty  
               provided in this section shall not be construed as  
               restricting any remedy, provisional or otherwise,  
               provided by law for the benefit of the department or  
               any person.  

               Notwithstanding the restrictions of this section, an  
               individual to whom the information pertains shall have  
               access to his or her own information.  

          6.    Research security provisions provided in the bill  

            This bill would require the following for purposes of  
            security of a donor's personal information for research:  
            (1) a plan sufficient to protect personal information  
            from improper use and disclosures, including sufficient  
                                                                       




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            administrative, physical, and technical safeguards; (2) a  
            sufficient plan to destroy or return all personal  
            information as soon as it is no longer needed for the  
            research activity; and (3) sufficient written assurances  
            that the personal information will not be reused or  
            disclosed to other persons or entities, except as  
            specified.  

          7.    Opponents California Medical Assoc. (CMA) and American  
            College of Obstetricians and Gynecologists (ACOG)  
            arguments  

            CMA and ACOG oppose the bill for a number of reasons.   
            Both opponents argue that SB 962 reverses work done on SB  
            1555.  "SB 962 puts physicians in an untenable 'Catch-22'  
            situation requiring them to hand out informational  
            brochures that the state is only required to provide and  
            keep current if there is funding to do so.  This could  
            require doctors to give out outdated, medically  
            inaccurate brochures or risk violating the law.  SB 1555  
            solved this problem by making this provision voluntary on  
            the part of the doctor."  

            Opponent ACOG argues that the bill would interfere with  
            and diminish "the physician-patient relationship by  
                                      requiring mandated, possibly out-of-date and medically  
            inappropriate material for the physician-patient  
            discussion.  ACOG Perinatal Guidelines state a discussion  
            should occur, but that discussion will vary depending on  
            that particular woman's genetic background and  
            situation."  

            ACOG also argues that even when a statute, such as this  
            one, requires the state-mandated materials to be kept  
            up-to-date, in practice that does not occur.  For  
            example, the breast cancer brochure is required to be  
            updated every three years, but it has yet to be updated  
            since its initial 1995 version.  This "puts physicians in  
            a legally tenuous position when they are mandated to  
            distribute medically inaccurate information to their  
            patients, potentially opening them up to allegations of  
            negligence.  At a minimum, it creates confusion and a  
            potential situation for suspicion of the physician when  
            the physician's statements and the materials conflict.   
            This scenario is why SB 1555 was changed to having the  
                                                                       




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            distribution of materials be voluntary."  

            Opponent CMA also states it is "troubled by the link this  
            bill makes between umbilical cord blood banking and  
            prenatal genetic screening.  Requiring these  
            conversations to occur concurrently may send the wrong  
            message to expectant parents and could pressure them to  
            privately bank their baby's cord blood, which is usually  
            unnecessary and can be very costly.  The universal  
            solicitation this bill [would mandate] is inappropriate  
            and unnecessary since it is already the ACOG standard of  
            care for a discussion to occur between physician and  
            patient about umbilical cord blood banking options."  

          Support:   Asian American Donor Program; CA Catholic  
                 Conference; Cord Blood Donor Foundation 

          Opposition:   CA Medical Assoc.; American College of  
          Obstetricians and 
                    Gynecologists, District IX/CA

                                     HISTORY
           
          Source:   Author; American Association of University Women;  
          Planned 
                 Parenthood Affiliates of CA

          Related Pending Legislation:   AB 34 (Portantino of 2007)  
                                (See Comment 2.)

           Prior Legislation:   SB 1555 (Speier, Chapter 484,  
                        Statutes of 2006).  (See Comment 4.) 
          
          Prior Vote:  Senate Health Committee (Ayes 6, Noes 3)
          

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